BRC Global Standard For Consumer Products PCH Issue 4

BRC Global Standard for Consumer Products PCH Issue 4
1 Senior management commitment
1.1 Senior management commitment and continual improvement

Statement of intent
FUNDAMENTAL
The sites senior management shall demonstrate they are fully committed to the implementation of the
requirements of the Global Standard for Consumer Products and to processes which facilitate continual
improvement of product safety and quality management.
Interpretation
The statement of intent for this clause is a fundamental requirement. Without commitment from the
sites senior management, which has the authority to allocate budget and resources and set site policies,
it is not possible to properly implement the Standard. A department manager or quality manager may
think it is a good idea to adopt the Standard and try to address matters on their own initiative, but many
of the requirements need support from different parts of the site and demand commitment at the highest
level. The requirement encompasses a need to effect continual improvement as consumer quality and
safety expectations rise and legal requirements become more complex. Site standards from 20 years
ago would not be acceptable today.
Example
At the opening meeting, none of the sites senior management is present. The quality manager informs
the auditor that the sites senior management is dealing with an important client and has authorised the
quality manager to deputise. The auditor also notices that none of the sites senior managers were
present at the opening meeting last year. The auditor asks the quality manager to ensure that the sites
senior manager is available, but this is not possible.
Senior management does not understand the importance of its commitment. If the senior management
was unavailable due to exceptional circumstances, then the audit visit should have been postponed.
The auditor will decide whether to continue with the audit after consultation with the certification
body, if necessary, and depending on the conditions of business between the certification body and the
site.
Clause 1.1.1: foundation

The site shall have an implemented policy which demonstrates the sites intention to meet its obligation
to produce safe and legal products to the specified quality and its responsibility to its customers. This
shall be:
authorised by the person with overall responsibility for the site

communicated to all staff.
Interpretation
The sites senior management is required to establish a policy that is understood by all of the
employees. This policy needs to address the product safety, legality and quality as well as any customer
or customer-specific requirements. At the fundamental level the policy may or may not be in a readily
documented format although it needs to be something the sites senior management can endorse. This
could be achieved through a training programme.
Example
During the audit of a site making toilet-rim blocks, the auditor questions one of the line operatives to
determine their understanding of the sites policy. The employee replies that they are not aware of any
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such policy and a further review of the employees training record shows that they were not trained in
understanding the policy during their induction.
This would result in a non-conformity as the employee is unaware of the sites policy.
Clause 1.1.1: higher

The site shall have a documented policy which states the sites intention to meet its obligation to
produce safe and legal products to the specified quality and its responsibility to its customers. This
shall be:
authorised and signed by the person with overall responsibility for the site
communicated to all staff.
Interpretation
The sites senior management is required to document a policy that is understood by all of the
employees. This policy needs to address the product safety, legality and quality as well as any customer
or customer-specific requirements. At the higher level the policy must be in readily accessible,
documented format authorised by the sites senior management. In addition, this should be included in
a training programme to ensure that there is a full understanding of the requirement.
Example
During the audit of a site making wet-wipe tissues, the auditor questions one of the line operatives to
determine their understanding of the sites policy. The employee replies that they are not aware of any
such policy and the policy is not displayed anywhere on site. A further review of the employees
training record shows that they were not trained in understanding the policy during their induction.
This would result in a non-conformity as the employee is unaware of the sites policy.
Clause 1.1.2
The sites senior management shall ensure that clear objectives are defined to maintain safety and
legality and improve the quality of products manufactured, in accordance with the sites product safety
and quality policy and commitment to implementing the requirements of this Standard. These
objectives shall be clearly communicated to relevant staff and monitored, and results reported at least
annually to site senior management.
Interpretation
The sites senior management needs to set objectives concerning legality, safety and quality so that the
workforce can understand what is required from them. Setting such objectives also enables the
allocation of suitable budgets and resources. Auditors will be looking for evidence that this has been
done and communicated to the appropriate staff. Objectives may include, for example:
reducing customer complaints

fewer non-conforming products
better customer satisfaction scores
fewer lots rejected by customers
improving on time in full delivery
the introduction of Lean principles such as Six Sigma (6)
increased production efficiencies (uptime or downtime).
There are many other objectives that could be included here. In each case, the objective should be
measurable and documented. It is then possible to review success or failure. The objective is to show a
coherent relationship between the objectives and the policy which will subsequently be reviewed at the
management review. This will then help to deliver continuous improvement.
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Examples
A detergent company has set objectives for the level of customer complaints each year and can
demonstrate that it has diligently monitored the complaint levels for the past five years. There is no
evidence that actions have been taken to address the failure to meet objectives.
This would result in a non-conformity. Effort is being made to collect data but it is not being used
effectively.
The quality manager of a toy manufacturer shows the auditor a document stating that there are
documented key performance indicators (KPIs) set for the level of customer rejects. When the auditor
visits the site, none of the operators is aware of this document and there is no evidence that the rejects
are being monitored. The auditor is told this is done by George who is away on holiday.
A non-conformity would be raised, as there is no evidence that the KPIs are monitored.
A wet-tissue manufacturer has set an objective to reduce the amount of solution rework to less than 1%
of production within two years and has set KPIs for various departments in order to achieve this. The
auditor is shown monitoring charts from the various departments and the results of the KPIs to support
the objective. In addition, there are a number of projects in place to reduce errors at various stages in
the manufacturing process. The projects are assigned to designated persons who have the backing of
senior management.
The auditor would consider this acceptable.

The site shall have a programme of management meetings which enable product safety, legality or
quality issues to be brought to the attention of senior management for resolution.
Records of the minutes from these meetings shall be maintained.
Interpretation
The sites senior management needs to determine that the systems and procedures are effective in
delivering the results required in relation to product safety, legality and quality. The meetings are also
to determine progress against the set objectives, setting new ones and determining who is responsible
within certain timescales. The meetings are required to be undertaken at regular intervals, possibly
monthly or quarterly. The evidence that such meetings occur would be minutes of the meetings and
diarised future meetings.
Example
The auditor is shown handwritten minutes from a meeting with senior management present. The
minutes detail the progress being made with the KPIs from the objectives set at the beginning of the
year. The last agenda item is the date of the next meeting at the beginning of the next quarter.
The auditor would accept the evidence.

Management review meetings attended by the sites senior management shall be undertaken at
appropriate planned intervals, at least annually, to review the sites performance against the Standard
and the objectives set out in clause 1.1.2. The review process shall include the evaluation of:
previous management review action plans and timeframes

results of internal, second-party and/or third-party audits (relevant to the scope of this Standard)
customer complaints and results of any customer feedback
product safety and quality incidents, corrective actions, out-of-specification results and non-
conforming materials
management review of the systems for product risk assessment, changes in legal requirements and
process performance
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resource requirements.
Records of the meetings shall be documented and used to revise the objectives. The decisions and
actions agreed within the review process shall be effectively communicated to appropriate staff and
actions implemented within agreed timescales.
Interpretation
The management review process is an important part of the system. It usually takes place annually,
although other shorter time periods are acceptable. The review should be a specific meeting with a
defined agenda. Topics discussed during other events, such as a brief mention of safety matters in a
weekly management meeting, do not constitute a review.
Note that this clause gives a list of aspects to be covered. All the bulleted points should be addressed. It
is acceptable to consider additional points relevant to the review, but not to omit any of the points listed
in the Standard.
Second- and third-party audits are audits done by, or on behalf of, customers, or audits carried out by
independent bodies (such as a BRC audit).
Example
A company has not discussed resource requirements at a meeting because the senior manager does not
think that financial and staff information should be disclosed to the technical team.
It is a requirement to discuss resource needs. There is nothing in the Standard to say that detailed
financial information has to be revealed and the manager could have withheld sensitive information
while still addressing the topic.
A non-conformity would result.
Clause 1.1.4
The sites senior management shall provide sufficient human and financial resources required to
produce and improve products safely and in compliance with the requirements of this Standard.
Example
The auditor notes that the quality manager has not attended the last risk assessment meeting, the
internal audit programme is behind schedule, and the pH meter normally used to measure the incoming
raw material is out for repair (hence no tests are being undertaken). The quality manager explains to the
auditor that she is really busy and does not have time to do the audits. Not only this, but money is tight
and there is no budget for a new pH meter.
The auditor will raise non-conformities against this clause concerning the goods-in process and the
internal audit process as they are not in line with the requirements.
Clause 1.1.5
Where the site is certificated to the Standard, it shall ensure that announced recertification audits occur
on or before the audit due date indicated on the certificate.
Interpretation
A number of situations may arise when a late audit is acceptable. For example:
the area around the factory is closed due to government restrictions

the site is not operational as it is flooded or there has been a fire
the auditor cannot travel due to severe weather
there is a war in the region and the auditor is advised not to travel.
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It is the responsibility of the site to adhere to the audit date and it would not be acceptable if the quality
manager was ill or the management team had other appointments.
Example
The site is overdue for the audit by one week and the management has no explanation for the lateness.
The auditor will raise a non-conformity during the subsequent visit.
Clause 1.1.6
The site shall have a genuine hard copy or electronic version of the current Standard available with a
position statement and be aware of any changes to the Standard or protocol that are published on the
BRC website.
Interpretation
The site could subscribe to BRC Participate which would address the requirement to be aware of BRC
publications and make the Standard available in an electronic format. The site could also download a
copy free of charge from the BRC Bookshop.
Example
The auditor asks to see the sites copy of the Standard and is shown a printed copy. The auditor then
asks to see where the Standard came from and is directed to the BRC Participate website, to which the
quality manager has access.
The auditor would accept the evidence.
Clause 1.1.7
Where required by legislation, the site shall be registered with or approved by the appropriate
government agency and evidence of this shall be available.
Interpretation
This clause does not apply to all products. It refers to the requirement for some sites to be registered
concerning the safe production of their products. Auditors will expect to see evidence of up-to-date
registration for the correct range of products. A number of products require the licensing of the site
and/or the product itself, while other products are subject to voluntary codes.
Cosmetics
Each cosmetic product must be notified to the European Commission using the Cosmetic Product
Notification Portal (CPNP) prior to placing the product on the market.
The Food and Drug Administration (FDA) does not license cosmetics firms. However, state or local
authorities may require licensing or have other requirements you need to know about. The Voluntary
Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by
manufacturers, packers and distributors of cosmetic products that are commercially distributed in the
United States.
Medical devices
If you place certain medical devices on the EU market, you or your authorised representative (agent)
must be registered with the competent authority (national health regulator) in the EU state where you
have an office or place of business. In the UK, the Medicines and Healthcare Products Agency
(MHRA) is the competent authority for the registration of medical devices. MHRA will only register
manufacturers or authorised representatives that have a place of business in the UK.
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Owners or operators of places of business (also called establishments or facilities) that are involved in
the production and distribution of medical devices intended for use in the United States are required to
register annually with the FDA. This process is known as establishment registration.

A system shall be in place to close out non-conformities raised with consideration of the root cause.
Interpretation
Within the management team there needs to be an understanding of the techniques used to determine
root cause when a non-conformity is raised during a third-party audit. Normally there are 28 days (90
days for a first audit) to close out the issue raised (corrective action) and in addition the site must
determine the long-term corrective action in order to prevent recurrence.

The sites senior management shall ensure that the root causes of non-conformities identified at the
previous audit against the Standard have been effectively addressed to prevent recurrence.
A system shall be in place to close out non-conformities raised at internal, second-party and third-party
audits, with consideration of the root cause.
Interpretation
Within the management team there needs to be an understanding of the techniques used to determine
root cause when a non-conformity is raised during a third party audit. Nominally there are 28 days (90
days for a first audit) to close out the issue raised (corrective action) and in addition the site must
implement the long-term corrective action in order to prevent recurrence. The sites senior management
team is also required to review the effectiveness of the action taken.
Example
Applies at both foundation and higher levels
During the audit the auditor raises a non-conformity because a production record is incomplete.
Twenty days later the auditor is sent details of the closure of the non-conformities raised during the last
audit. This includes a copy of the internal audit of the production records which shows that all records
were completed following a toolbox talk (an informal group discussion that focuses on a specific
issue). In addition, the site also sends information regarding the toolbox talk and a five whys
document showing the root cause of the issue, which was that the paperwork was used by several of the
personnel, some of whom took the paperwork to the processing area in order to record the data. This
meant that on occasions the paperwork was not available to the other team members and they
sometimes forgot to add the data after the event.
The toolbox talk was not just a retraining exercise but the demonstration of a new way to capture the
data for all staff using a personal digital assistant (PDA).
The auditor would accept the evidence provided.
1.2 Organisational structure, responsibilities and management authority

Statement of intent
The site shall have a clear organisational structure and lines of communication to enable effective
management of product safety, legality and quality.
Interpretation
If an organisation is well-structured with clear roles, reporting lines and responsibilities, it is much
simpler to communicate with staff and manage the site. This requirement applies to any type of site,
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whether small or large, and whether making simple low-risk products or more complex items. In all
cases the same principle applies, even though the actual structures needed may be more complex in
some cases.
Clause 1.2.1
The site shall have an up-to-date organisation chart for key staff demonstrating the management
structure of the company. The responsibilities for the management of activities which ensure product
safety, legality and quality shall be clearly allocated and understood by the managers responsible.
There shall be clear evidence of who deputises in the absence of the responsible person.
Interpretation
There is a requirement for an organisation chart. The Standard specifies a chart, so text describing the
organisation will not be sufficient. Additionally, the site must clearly state who deputises for whom.
This also implies that the deputy should understand the requirements of the job they are deputising for.
There may be more than one person deputising for another. Production, and any associated problems,
will continue when people are off sick or on holiday. It is unacceptable to produce unsafe products
because someone was absent, and action on withdrawals or recalls will not usually wait for someone to
return to work. Even on a small site, written procedures that make arrangements to cover absence are
required to remove any doubt as to who is responsible for what for example, by appointing deputies.
It is particularly important that the site provides cover for the individual with nominated responsibility
for safety and quality. This is another indication of management commitment.
Clause 1.2.2
The sites senior management shall ensure that all employees are aware of their responsibilities. Where
documented work instructions exist for activities undertaken, the relevant employees shall have access
to these and be able to demonstrate that work is carried out in accordance with the instructions.
A senior member of staff should be identified with responsibility and authority to stop production, if
required.
Interpretation
This clause requires that there are instructions for general work duties, which are communicated in
addition to information concerning particular product productions or individual items of equipment.
Many general procedures such as those for methods of work, housekeeping and site systems can
contribute to the assurance of safe products and could, therefore, be detailed. These general
requirements may sometimes be part of a job description or contained in a general site manual.
Detailed instructions on how to carry out specific tasks may be recorded in work instructions. These
documents contain the practical details of how to carry out tasks in a form easily understood by the
employee. They can be pictorial, diagrammatic, in text format or a combination of all three.
Examples
A company cleaner is provided with detailed instructions about cleaning duties. The site has a cleaning
procedure covering general requirements but the cleaners work instructions include:
details of the area to be cleaned

schedule to be followed
how to clean what materials to use
how to dispose of waste materials
how to fill in a log book to show that work has been completed.
The instructions are provided in simple text and in a language that the cleaner understands.
The auditor would consider this to be satisfactory.
Production-line workers in a cosmetics factory have work instructions in the form of flow charts and
diagrams, provided at each station. These clearly show how to mix ingredients together, and include:
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how to check the formulation being made

the order of adding chemicals
how to transfer chemicals to the vat and control quantity
mixing time
mixing temperature and how to record it
what to do when batch mixing is complete, and how to sign off
how to record the batch production.
The instructions provided are referenced, approved and dated. The individual formulations are also
recorded and approved and have to be checked by a supervisor before production begins.
The auditor would check that all aspects of the batch-mixing production are properly included and can
be understood by the employees.
Production-line workers in a television factory have work instructions in the form of flow charts and
diagrams, provided at each station. These clearly show how to assemble the components, and include:
how to check the circuits

the order of assembly
how to ensure that there is no possibility of static
solder bath temperatures
Hi Pot1 test parameters
what to do in the event of Hi Pot failure
how to record the batch production.
The instructions provided are referenced, approved and dated. The individual specifications are also
recorded and approved and have to be checked by a supervisor before production begins.
1
Hi Pot stands for high potential. A Hi Pot test is used to test the insulation of a product far beyond the
voltages it would normally encounter.
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2 Product risk management

Statement of intent
FUNDAMENTAL
The site shall have a management process in place to ensure that a risk assessment is completed on
each product group to ensure safety, legality and quality in the regions of intended sale, where known.
Interpretation
This fundamental clause is about the management of the scheme and ensuring that information is
available to support full risk assessments. It stresses that the management must be comprehensive and
systematic, so the availability of a few isolated risk reports on a small proportion of products would not
be deemed sufficient. The concept of risk should be integral to the whole operation. This is a
fundamental clause because an understanding of risk and management of the procedures and processes
using a risk-based approach is essential to the implementation of the Standard. Auditors will look for
systematic product and process risk assessments, and decisions made on the basis of risk.
The whole clause has been deemed fundamental, rather than individual subclauses, because each part is
important to the operation of a site in conformity with the Standard.
In order to decide whether a product is likely to cause injury it is helpful to review past injury data.
Finding information and data about injuries that have occurred can be difficult. Sites may have their
own information resulting from customer complaints (or lack of complaints), and information may be
available from the authorities. Details provided with product recalls may also highlight injuries that are
known to have occurred.
The USA has a website which gives detailed injury reports: www.cpsc.gov/LIBRARY/neiss.html
The European injury database also gives some information on types of injury:
https://webgate.ec.europa.eu/idb
2.1 Legislation and safety requirements

Clause 2.1.1
The site shall have a system to demonstrate knowledge of all applicable legislation, product standards
and product safety issues in the place of production and regions of intended sale of each product. This
may be within the company or by use of external expertise.
Interpretation
The site may have access to applicable websites such as:
http://eur-lex.europa.eu/
http://www.legislation.gov.uk/
https://www.usa.gov/
http://www.lawinfochina.com/legal
An affiliation with test houses, trade associations and consultants will also support the information
requirements.
Examples
Set out below are some examples of legislation for different products from around the globe.
Legislation changes on a regular basis, and although great care has been taken to ensure this is correct
at the time of issue, the legislation will need to be reviewed to ensure it is up to date. Also, you should
refer to the general legislation and/or product-specific legislation as well as codes of practice.
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United Kingdom and Europe
In the UK the Sale of Goods Act 1979 requires that all products must be fit for purpose, of
satisfactory quality and fit their description. This means that your products must fulfil the purpose the
customer has been led to expect and the reasons that led them to buy it. Consumers are protected by the
Consumer Rights Act 2015.
In the EU, the General Product Safety Directive (GPSD) 2001/95/EC refers to products that do not
have specific regulation.
The Waste Electrical and Electronic Equipment Directive (WEEE Directive) is the European
Community directive 2012/19/EU on waste electrical and electronic equipment (WEEE). This, together
with the RoHS Directive 2002/95/EC, became European law in February 2003.
In Europe the consolidated version of the Regulation (EC) No 1907/2006 of the European Parliament
and of the Council on the registration, evaluation, authorisation and restriction of chemicals (REACH)
sets out, among other things, that AZO dyes (which may release one or more of the 22 aromatic amines
in detectable concentrations, above 30 ppm in the finished articles or in the dyed components) may not
be used in textile and leather articles that may come into direct and prolonged contact with the human
skin or oral cavity.
Since Annex XVII of REACH came into force in 2009, the AZO Directive 2002/61/EC has been
replaced by the REACH regulation. AZO dyes are now on the REACH restriction list.
Washing powders and detergents are regulated by EC Regulation EC No 648/2004 on detergents. The
regulation establishes common rules to enable detergents and surfactants to be sold and used across the
EU, while providing a high degree of protection to the environment and human health. The 2012
amendment introduced new limits to reduce the damage phosphates from detergents may have on
ecosystems and water quality, which is a phenomenon known as eutrophication.
For cosmetics in Europe, the following legislation applies:
EU Cosmetics Directive 76/768/EEC

New Cosmetic Products Regulation (EC)1223/2009.
CE marking applies to a range of products, from electrical equipment to toys and from civil explosives
to medical devices. CE marking is covered by the following legislation:
2001/95/EC: (New) General Products Safety Directive

93/68/EEC: CE Marking Directive
93/465/EEC: Conformity Assessment Procedures & CE Marking Rules.
Even if your product is manufactured outside the EEA, you must ensure that it bears CE marking if it
comes under the scope of a directive requiring CE marking. Not all products sold in the EU need to
bear CE marking.
The following categories of product require CE marking if you wish to sell them within the EU or
member states of the EEA:
toys
electrical products
construction products
pressure vessels
telecommunications equipment
medical devices
machinery, equipment and safety components
personal protective equipment
satellite station equipment
gas appliances
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pressure equipment
appliances (other than gas)
non-automatic weighing instruments and equipment
measuring instruments
recreational craft
lift machinery
equipment and protective systems for explosive atmospheres
in vitro diagnostic medical devices
marine equipment
safety components and subsystems for incorporation into cableway installations
cableway equipment (ski tows etc.).
China
In China the Restriction of Hazardous Substances (RoHS), officially known as the Administrative
Measure on the Control of Pollution Caused by Electronic Information Products, is a Chinese
government regulation to control certain materials, including lead. There are currently six substances
considered environmentally hazardous by the China RoHS directive:
lead
mercury
cadmium
hexavalent chromium
polybrominated biphenyls
polybrominated diphenyl ethers.
The China RoHS does not allow any technology exemptions, unlike the EU RoHS 2 Directive.
The product quality law of the Peoples Republic of China consists of two articles:
Article 1 This law is enacted for the purposes of strengthening the supervision and administration
of product quality, improving product quality, determining the liability of product quality,
protecting the legal rights and interest of consumers, and safeguarding the social economic order.
Article 2 Those who undertake the production and sale of products within the territory of the
Peoples Republic of China must abide by this law.
United States of America
In the US consumers are protected by the Federal Trade Commission (FTC), which maintains and
pursues law enforcement through federal and state legislatures, including US and international
government agencies. The Consumer Product Safety Commission (CPSC) imposes new testing and
documentation requirements and sets new acceptable levels for several substances. Those affected
include manufacturers of apparel, shoes, personal care products, accessories and jewellery, home
furnishings, bedding, toys, electronics and video games, books, school supplies, educational materials
and science kits.
Toys and childrens products sold in the US are covered by HR 4040, the Act known as the Consumer
Product Safety Improvement Act of 2008. The sections that apply are as follows:
101 Childrens products containing lead; lead paint rule

102 Mandatory third party testing for certain childrens products
103 Tracking labels for childrens products
104 Standards and consumer registration of durable nursery products
105 Labeling requirement for advertising toys and games
106 Mandatory toy safety standards
107 Study of preventable injuries and deaths in minority children related to consumer products
108 Prohibition on sale of certain products containing specified phthalates
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Specific import-export provisions include:
221 Export of recalled and non-conforming products

222 Import safety management and interagency cooperation
223 Substantial product hazard list and destruction of noncompliant imported products
224 Financial responsibility
225 Study and report on effectiveness of authorities relating to safety of imported consumer
products
In the US the Lacey Act Amendments of 2008 prohibit the sale of certain animal-derived products,
such as feathers, and wooden products. It requires that no Lacey Act prohibited species is sold and
that the retailer shows due care. This means that a person facing a particular set of circumstances
must undertake certain steps that a reasonable person would take to do their best to ensure that they do
not violate the law. They should also check botanical resources (such as the GRIN taxonomy) to
confirm:
the validity of any scientific names

the geographic distribution.
Additional non-Lacey regulations apply for products imported to the US.
Composite wooden products are also required to meet CARB-ATCM 91320/S.1660-formaldehyde

emission from composite wood products.
For cosmetics in the US, the following legislation applies:
Safe Cosmetics Act of 2011 (H.R. 2359)

California Safe Cosmetics Act (SB 484).
For cosmetics in Canada:
Canadian Environmental Assessment Regulations

Canadian New Substances Notification (NSN) Regulations.
Clause 2.1.2
If the site relies on information concerning product safety, quality and legality provided by their
customer or a third party, it shall have a process in place to validate the credibility of the provider of
the information and retain evidence of this validation.
Interpretation
On large sites there may be a team which has the sole responsibility of following product safety
information. Small sites, on the other hand, may have no such specialist team and may just view safety
as something that gets in the way of production.
In many cases, sites rely on information supplied by their customers or independent consultants. This
may take the form of a customer quality or safety manual, or may be more specific to an order such
as, We need a test report showing compliance with standard before we will accept this order. Such
information is helpful and forms a good basis, but the following should also be considered:
Customer information should be systematically stored and acted upon. It builds into a knowledge
system about product requirements.
Customer manuals must be the current versions and checked frequently for updates.
Customers are not always right. They may ask for the wrong tests or miss something important.
Dont assume they are right and check from another source whenever possible.
Back up any information from more than one source, such as trade association certification body
newsletters, legislative portals and websites.
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When sites wish to sell their products in diverse geographical markets, often working in languages that
they dont understand, this becomes more difficult. Whatever the system, it is vital to update it
frequently as new issues emerge, and changes in legislation and standard updates regularly occur.
The site can review the government sites (examples below) in order to ensure that the information is
correct:
Electronic Code of Federal Regulations (E-Cfr)

legislation.gov.uk
europa.eu/eu-law/index_en.htm
Example
A small giftware company has little expertise on product safety so it has signed up for safety updates
from two independent test houses and also to receive notification of all product recalls in its sector. The
administrator is tasked with routinely checking this information. The administrator has been on a short
training course to help them understand the issues and has a contact at the test house to consult for
more information. The administrator is also responsible for logging any client requests concerning
safety.
The auditor should find this satisfactory. A system appropriate to the level of the operation is in place
and as information is from various sources, cross-checking is also evident.
Clause 2.1.3
The companys senior management shall have a system in place to ensure that the site is kept informed
of and reviews:
changes in legislation
scientific and technical developments
industry codes of practice
new risks to raw materials, components, packaging and finished product.
Any changes shall be implemented in a timely and controlled manner or as defined by legal
requirements.
Interpretation
The best system of information gathering is of no use if the information is not acted upon. This clause
ensures that any changes are adopted in a timely manner. Most changes allow a reasonable time for
implementation before they are enforced, and they may require:
additional cost
redesign of product
sourcing of new materials
training of staff
new packaging or labelling.
Procedures should be in place to ensure changes are adequately considered within an appropriate
timescale.
Clause 2.1.4
Copies of applicable legislation, standards, codes of practice and similar documents shall be available
to relevant staff.
Interpretation
The legislation may be accessible through the internet as long as the relevant personnel can have access
to the documents. Codes of practice may come directly from the customer and these should be
implemented into the systems and procedures. Any changes should be reflected through the system.
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2.2 Product risk assessment

Clause 2.2.1
The company shall ensure that a product hazard and risk assessment is undertaken for each product or
product group. The assessment shall be documented and include:
a description of the product assessed (for example, approved samples or mock-ups, sample
drawings, computer graphics, photographs, specification)
the intended use of the product and foreseeable abuse conditions
the hazards, the risk level for each hazard and whether the risk is acceptable
the date performed, name of the person responsible and the evidence from which the assessment
was derived.
If the assessment indicates that a product may present an unacceptable risk to consumers, that product
shall not be produced by the site. If the product requires modification, a new risk assessment shall be
completed on the modified design.
Interpretation
This clause ensures that proposed designs and materials allow for the production of safe and legal
products. A risk assessment of the product design and materials is essential to ensure a safe and legal
product. This assessment should address matters such as:
the materials used in the make-up to ensure that they have the correct mechanical properties such
as strength and durability
the chemical composition of materials to ensure that toxic or dangerous substances are not used
the assembly of the parts to ensure that the materials work together (for example, the correct type
of adhesive)
the mechanical assembly for example, screwing or gluing
the technical features of the design such as the shape of moulds or the fit of components.
It is likely that the assessment will be carried out over different stages, starting with the concept
drawings and continuing until the first pre-production samples are produced. Assessment of the product
design should then continue based on feedback obtained from all sources.
Once a site is in routine production, it may not be necessary to carry out a complete assessment for
every variant. However, changes should not be made without an assessment of the new parts or
materials, and the likely effect on the product.
Sites may be concerned about sharing confidential information, formulations and design details with
the auditor. Auditors must be able to view sufficient information to ensure that the site has made a
complete risk assessment. All audits are confidential between the site and the auditor. No proprietary or
design/formulation information is released on the audit report and the site can decide whether to allow
its report to be viewed by third parties.
It may be that the product design is supplied to a site and that the site has no input into the risk
assessment of the product. In these situations, a site sometimes thinks that the risk assessment process
is not relevant, and that all it needs to do is produce items to the specification it has been given. This
misconception has caused a number of unsafe products to reach the marketplace.
When the product design is supplied to the site it is essential that the site:
has a formal written specification

is provided with a validated copy of the risk assessment, if this exists
is able to carry out an assessment or commission an assessment if one does not exist. If an
assessment is commissioned the site must validate the capability of the external party to conduct
the risk assessment
has formally agreed to abide by the content
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has a system in place for communicating key information to the workforce and back to the
specifier, if necessary
has a procedure for taking the design risk assessment and producing a process risk assessment,
establishing any key control points in the process.
It is not acceptable for a site to produce an unsafe or illegal product because it was supplied with a
faulty design brief.
Example
A candle maker has a design of candle which it has made and sold successfully and safely for many
years in a range of colours. It decides to add a dark red colour to the range and assumes it will be
satisfactory because of its record.
The company receives several complaints about candles flaring up, and is informed of one fire
incident. On investigation, it is found that the red pigment affects the burning characteristics of the
wax, giving rise to high, smoky flames and unstable burning. A check of the pigment characteristics or
a test burn following a risk assessment of the change to the original product may have avoided these
problems.
A hair dye manufacturer has developed a system which it has made and sold successfully and safely for
many years in a range of colours. It decides to add a dark red colour to the range and assumes it will be
satisfactory because of its record.
The company receives several complaints about skin irritation, and is informed of one serious skin
complaint. On investigation, it is found that the red pigment affects the characteristics of the product,
giving rise to higher sensitivity in some users. A skin trial of the pigment characteristics following a
risk assessment of the change to the original product may have avoided these problems.
Clause 2.2.2
The risk assessment shall be produced by suitably trained and competent internal or external resources.
Evidence of this shall be available unless the risk assessment is provided by the customer.
Staff with responsibility for decision-making shall be trained to ensure they understand risk assessment
procedures or outcomes necessary for their activity.
Interpretation
In order to conduct a satisfactory risk assessment, the manager in charge (risk assessment team leader)
must be competent and the rest of the team should understand the principles that are used. Methods of
risk assessment could include:
Design Failure Mode Effect Analysis

Fishbone or Ishikawa diagram
Hazard Analysis Critical Control Point (HACCP).
It is very unusual for one person to be able to carry out the entire assessment; it is likely that a team of
people will be required. For example, an engineer who can evaluate the strength of a moulding may not
be able to evaluate the toxicity of the materials used to make the product.
A suitable team should be assembled to cover all aspects and there should be a designated responsible
person of sufficient authority to approve the outcomes. The team must have the commitment of senior
management.
This does not mean that a whole range of staff has to be employed for the purpose. While this may be
appropriate for very large, complex operations, it is more likely that the duties will form just a part of
someones job, or external resources will be used. There are numerous third parties that provide risk
assessment services, but they must be correctly briefed about the sites products and processes. The
final responsibility for the risk assessment will rest with the site producing the items and, at the very
least, a staff member at the site should coordinate and be responsible for the assessment.
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For a product risk assessment, the team is likely to include some of (but is not limited to) the following:
designers
chemists
materials scientists
human factors specialists, such as ergonomics experts or child psychologists
engineers
quality assurance staff
line operatives
hygiene staff
legal staff.
Clause 2.2.3
The site shall determine and maintain up-to-date information about the legislation and mandatory
standards applicable to each product and to the materials from which it is made, relevant in the regions
of intended sale.
Clause 2.2.4
The risk assessment shall be reviewed at least annually, and following any significant complaints or
incidents, to ensure that the assessment remains up to date, and reflects any changes in specification,
manufacturing process and legislation.
Interpretation
A regular review is necessary because new safety information may have been published, there may
have been recalls of similar products or the legislation may have changed. In general, consumers
expectations of safety increase over time. A good example is passenger cars, which originally did not
have seat belts and, until recently, did not have air bags. Electrical equipment was purchased in the past
without a plug top whereas today all electrical items come with a plug top fitted, thus reducing the
incidence of electrocution due to poorly fitted plug tops.
Reviews can be carried out more frequently if required. Where products are made for less than a year
and the risk assessment is no longer relevant to production, there is no need to conduct a full review but
any complaints or incidents relating to products no longer in production should still be part of a review
process. The review should be carried out by those responsible for risk assessments and a summary
reported to senior management as part of the overall system review.
Examples
A company has a good system and most of the documentation is in order. The auditor finds that the risk
assessment has not been reviewed following a change of supplier for a component.
Following further investigation, although the component has had no detrimental effect on the product,
the auditor is likely to raise a minor non-conformity. The company needs to take care that the system is
operated correctly but there are no real concerns that there is a breakdown of the system or that
product safety is compromised.
A company has some risk assessments documented but they are not signed or dated. It is not
completely clear whether assessments have been reviewed in the past 12 months.
This would warrant a major non-conformity as the Standard is systematically not being adhered to. It
is not a critical non-conformity as some aspects of the Standard are in place and the auditor does not
consider that the lapse will result in an unsafe or illegal product.
A factory has a team responsible for carrying out a risk assessment of product design. There are
representatives from the design, production, quality assurance and management teams and all team
members have had training in risk assessment. Each product idea is passed to the team at each stage of
development and a full report produced and signed by the team leader. Any additional external
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resources or information are included in the documented risk assessment pack along with the team
findings.
Procedures have been followed correctly and an auditor would be satisfied by this approach.
Clause 2.2.5
Where there is a legal requirement to do so or when it is necessary to confirm its safety or legality, a
representative product should be submitted for testing to a suitably qualified and, where applicable, an
accredited laboratory (internal or external). The results of the test should form part of the risk
assessment.
Interpretation
This clause addresses the specific cases when testing of a product that is representative of overall
production must be carried out because of legislation.
It will often be the case that the allowed test organisations are also specified. This would be true, for
example, of a toy, a cosmetic product or childrens clothing, or indeed any product requiring CE
marking.
Example
The two most important laws pertaining to cosmetics marketed in the United States are the Federal
Food, Drug, and Cosmetic Act (FD & C Act) and the Fair Packaging and Labeling Act (FPLA). The
FDA regulates cosmetics under the authority of these laws. The FDA advises manufacturers to use
whatever testing is necessary to ensure the safety of their products and ingredients. The companies and
individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of
their products.
Clause 2.2.6
Where legally required, the identity, competence, qualifications and/or licence of the person producing
the safety review or risk assessment shall be documented and verified.
Interpretation
A competent person is someone who has sufficient training, experience, knowledge and other qualities
that allow them to assist the site properly. The level of competence required will depend on the
complexity of the situation and the particular help needed.
Examples
In US law, competence concerns the mental capacity of an individual to participate in legal
proceedings or transactions, and the mental condition a person must have to be responsible for his or
her decisions or acts. Competence is an attribute that is decision-specific.
In Europe the Cosmetics Products Regulation (EC) 1223/2009 requires there to be a responsible
person. This is the person or business within the EU who places a cosmetic product on the market. It
may be any one of the following persons:
the manufacturer (if based within the EU)

a representative of the manufacturer appointed under a written mandate
the importer of the product into the EU
a representative appointed under written mandate by the importer into the EU
a distributor who modifies a product already on the market or by applying its own name or trade
mark to the goods (i.e. own branding).
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2.3 Product labelling and claims

Clause 2.3.1
The site shall verify that information shown on primary (consumer) package labels and outer cartons is
correct and meets the regulatory and safety requirements of the region of intended sale.
Interpretation
Because consumers usually receive products in some type of packaging, the specification of the
packaging can be as important as the product itself. For many products there are regulatory
requirements about the amount of packaging that can be used, its composition, and labelling or marking
requirements. The site should assess and document its packaging in this respect.
Mislabelling is a common problem. Labels should be stored appropriately and separated to prevent
confusion. This is particularly important when different language versions of a similar label are being
used. Care should also be taken to use labels in order of production so as to prevent old, out-of-date
stock remaining and being inadvertently used. Likewise, products and labelling need to be carefully
monitored during changeover periods to ensure that the correct labels are applied.
Sites should ensure that the responsibility for all language versions of label copy is clearly defined. It is
expected that this information would be part of the technical file.
Examples
Cosmetics
The two most important laws pertaining to cosmetics marketed in the US are the Federal Food, Drug,
and Cosmetic Act (FD & C Act) and the Fair Packaging and Labeling Act (FPLA). The FDA regulates
cosmetics under the authority of these laws.
Household products
A site produces bleach. It sells the item in a bottle with a child-proof opening but it considers that there
is still a small risk of someone ingesting the bleach.
It has labelled the bottle with instructions on what to do if someone does swallow the bleach and
provided an emergency helpline. The bottle also has raised labelling in Braille so visually impaired
people know its contents.
This would be acceptable to the auditor.
Nappy sacks
A site producing nappy sacks will need to take into account the risk of suffocation to babies where a
sack has not been properly disposed of. Appropriate packaging must be labelled with clear warnings.
Clause 2.3.2
The site shall have a process in place to ensure that any claims made about a product shall be fully
validated to ensure that products meet the stated claim.
Interpretation
The most claims made most frequently for a product are about size, weight, volume or quantity. Sites
need documented procedures to check that any claims made are accurate.
The tolerable negative error is related to the nominal quantity. It varies between 9% on pre-packages
nominally of 50 g or 50 ml or less to 1.5% on packages nominally of 1 kg or l or more.
In the US, the Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal
Trade Commission and the FDA to issue regulations requiring that all consumer commodities be
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labelled to disclose net contents, identity of commodity, and name and place of business of the
products manufacturer, packer, or distributor. The Act authorises additional regulations where
necessary to prevent consumer deception (or to facilitate value comparisons) with respect to
descriptions of ingredients, slack fill of packages, use of cents-off or lower-price labelling, or
characterisation of package sizes. The Office of Weights and Measures of the National Institute of
Standards and Technology, US Department of Commerce, is authorised to promote to the greatest
practicable extent uniformity in State and Federal regulation of the labelling of consumer commodities.
Sometimes sites make particular claims about products for example, washable-ink pens, suitable
for children 3 to 6 years, sun protection factor 10, etc. Whenever a claim is made, there should be
evidence to substantiate that it is correct and justified. This evidence must be documented and reviewed
at intervals, and the methods determined.
Examples
A suntan lotion company has rated a product as factor 10. It has done this on the basis of copying a
competitors formulation and has no evidence to show that the factor is correct.
The auditor would find this to be a non-conformity and, depending on the technical information about
the formulation, could decide that the product was unsafe.
A company claims that its washing machine is the quietest on the market. Although this was true
several years ago, the company has not kept up to date with research. Several models are now available
that are quieter; the claim is no longer valid and should be removed.
An auditor may be aware of the situation and challenge the claim.
Clause 2.3.3
Where applicable, the site shall ensure that product-in-use evaluation (internal or external), reliability
trials and shelf-life tests are validated. It shall be verified that the production of a safe and legal product
is maintained, taking account of the category of consumers at risk.
Interpretation
For products that claim a certain level of performance there needs to be evidence that they actually
meet such claims. Products such as cosmetics usually have a best before end or use after opening
date on them and stability trails must be conducted to ensure that the product is usable within these
time periods.
For fabricated products, tests are usually necessary to establish that a product is fit for purpose and
likely to endure for a suitable (or guaranteed) use period for example, light bulbs are tested to
establish their minimum life.
It is expected that a site would provide documentary evidence to substantiate any statement regarding
shelf life or minimum durability, taking into account environmental conditions or usage that the
product would need to withstand during the stated period.
Example
A company producing shampoo labels the bottles with the net weight. The weight is described using
the European average weight system. The company is obliged to check a defined number of products
and to record that the average weights are within the defined acceptable tolerances.
The auditor is likely to ask to see an example of the records and, if they are not available, a non-
conformity would be raised.
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2.4 Packaging materials

Clause 2.4.1
Packaging shall be assessed for fitness for purpose and found suitable with regard to:
protecting the product from damage

maintaining product integrity
protecting the consumer from injury
preventing contamination.
Interpretation
Because consumers usually receive products in some type of packaging, the specification of the
packaging can be as important as the product itself. For many products there are regulatory
requirements about the amount of packaging that can be used, its composition, and labelling or marking
requirements. The site should assess and document its packaging in this respect.
Additionally, the packaging must be suitable for its purpose in protecting the product from damage or
contamination and itself being safe when handled by consumers. The packing process must not
increase the risk of producing an unsafe product. In this respect there is legislation regarding the levels
of heavy metals. This is enacted in the UK by The Packaging (Essential Requirements) Regulations
2015 and in Europe the Council Directive on Packaging and Packaging Waste (94/62/EC).
The aggregate heavy metal limits apply to cadmium, mercury, lead and hexavalent chromium in
packaging or packaging components. They require that the total by weight of such metals should not
exceed 100 ppm (subject to some exemptions).
Auditors will look for evidence of rejected packaging materials and will examine how the rejected
material is treated. Such material should be subject to the process for non-conforming products and
suitably recorded, segregated, disposed of and reworked as necessary.
Example
A company includes sachets of silica gel in its packing in order to keep products dry. The silica gel is
contaminated with an irritant chemical that causes injury to customers. The company is made aware of
this through a product safety information sheet and takes action to use a different material. It has
documented the actions and removed the contaminated packets from stock items.
The auditor is satisfied that the company took appropriate action on packaging once the information
became available.
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3 Product safety and quality management
3.1 Product safety and quality management system

Statement of intent
The sites processes and procedures to meet the requirements of this Standard shall allow consistent
application, facilitate training, and support due diligence in the production of a safe and legal product
to agreed quality.
Clause 3.1.1
The site shall have an established quality management system (QMS) in place which is appropriate to
the size of business and risk associated with the products.
The QMS shall be fully implemented, collated in a navigable and readily accessible way, and translated
into appropriate languages if necessary.
Interpretation
Documentation may be produced and stored in several different ways, including electronic copies,
databases, intranet systems, photographs and diagrams. Records must be permanent (or at least have a
defined lifetime) and therefore adequate storage or back-up systems will be necessary.
This Standard does not specifically demand a quality manual, although there are many instances where
documentation is required and many sites will find it easiest to collate this into some kind of manual. If
a manual is used it must be readily accessible to those who need it.
3.2 Documentation control

Statement of intent
The site shall operate an effective document control system to ensure that only the correct approved
versions of documents, including recording forms, are available and in use.
Interpretation
When a document is changed, a record needs to be made of the change and the reason for it. This can
be achieved by keeping a copy of the previous version with the reason for change written on it, or by
keeping a history of amendments log.
In order to be useful, documents must be available where and when they are needed, and controlled so
that there is no confusion between different versions of the same document, out-of-date requirements,
alterations made by writing unauthorised notes on the margins of specifications, and other similar
issues.
The method the site uses to control documents should be documented as a procedure or work
instruction, so that any member of staff producing documents understands the system and operates in
the same way.
Examples
An auditor notices a print worker adding thinner to an ink and consulting a piece of paper that appears
to give mixing proportions. The piece of paper has no identification or date. When consulted, the print
worker says that they had been given the instructions by the person who ran the machine previously,
and that this was always used to make sure the press ran smoothly.
A document that is important to the correct functioning of the process should be controlled and
authorised. A non-conformity would be raised.
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An auditor notices that throughout the factory all documents appear suspiciously clean and new.
Because they are in such good condition, the auditor is unconvinced that people are actually using the
documents. However, when the staff are consulted, the auditor finds that they use the documents and
are well informed, and that the quality assurance manager produced new copies of everything the day
before the audit to create a good impression.
This is acceptable and would not result in a non-conformity, although the extra work was unnecessary.
The auditor expects to see a working site and not a showcase. As long as the system is operating well, a
little wear and tear is to be expected.

The site shall be able to demonstrate that key documents which form part of the product safety and
quality system are identified with a version number and issue date.
This shall include a list of controlled documents indicating the last version number.

The site shall have a document control procedure to ensure that all key documents which form part of
the product safety and quality system are effectively managed.
This shall include:
a list of all controlled documents indicating the latest version number

the method for the identification and authorisation of controlled documents
a record of the reason for any changes or amendments to documents
the system for replacement of existing documents when these are updated.
Documents which are in electronic form shall be suitably protected to prevent loss or malicious
intervention.
Interpretation
Documents need to be identified by, for example, an identification number, issue date, version number,
author and approval authority. Documents should show page numbers and the total number of pages
(for example, page 4 of 7). A method for rescinding previous versions, in part or in whole, should also
be in place.
Note that the system for document control extends to the issuing of external documents, such as copies
of standards (including the Global Standard), customer specifications and legal information.
Examples of documents that need to be controlled include:
product specifications
procedures, such as those for supplier approval, or for selecting reference samples
work instructions
forms
records
other similar documents.
3.3 Record completion and maintenance

Statement of intent
The site shall maintain original, accurate, timely and legible records to demonstrate the effective
control of product safety, legality and quality.
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Interpretation
Senior management is responsible for the procedures relating to overall control of records. It must
ensure that the data is properly collected, used, stored, reviewed and maintained.
Example
Loss of records often occurs as a result of wider changes in a company. A textile company is about to
move to new premises and the managing director decides to have a clear-out. Many old record boxes
are sent for disposal by the site services manager, without considering their content. The company
installs a new computer system in its new premises. Unfortunately, some of the record files use old
software no longer compatible with the new system. Important records are lost by both actions.
This would result in a non-conformity. It highlights the importance of management commitment to, and
understanding of, the requirements of the Standard.
Clause 3.3.1
Records shall be maintained in good condition and retrievable. Any alterations to records shall be
authorised and justification for alteration shall be recorded. Where records are in electronic form these
shall be suitably backed up to prevent loss.
Interpretation
Records are documents that contain evidence about past effects. They provide information to act upon
and data to help with continuous improvement. There should be a clear understanding of why records
are to be kept and what purpose the information will serve. In order to be useful, they must be legible
and genuine. It is also essential that they are signed, dated and authorised so that the person making the
record can be identified and consulted as necessary.
Records relating to the safety, legality or quality of the products must be kept securely and in good
condition so that they can be consulted if necessary. There is no point recording every detail if, when
needed, the records are found to have been lost, destroyed or damaged.
Records are documented information about measurements or events. Examples include:
a signed checklist to show each time pest control stations have been checked
a control chart of tests done to check the strength of a seam
the product release form from a goods-in department showing when each product was signed for
release
documented evidence of employee training.
There will always be occasions when mistakes are made and records need to be amended. Such
amendments must be clear and identified for example, by simply crossing out a result, recording the
correct one and initialling the change. If appropriate, a brief reason for the change can also be included.
The use of pencil (which can be erased) and correction fluid (which obscures the original) is not
acceptable for records. Records that store results electronically, whether by manual or automatic
processes, should have suitable security systems to prevent unauthorised changes. Auditors will ask for
a demonstration of this.
Records must be true observations of the event at the time and should not be completed after, or even
before, the event.
Data can be backed up in many different ways such as by having a cloud server or using a daily,
weekly or monthly back-up to a disc or tape from a mainframe server; usually these are kept off site.
Examples
An operator on a line producing fabric conditioner has a record sheet on which to enter the results of
half-hourly pH checks. The auditor notes that the operator has pre-initialled the column used to
authorise results for the whole day, even though only two readings have been taken.
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This is a non-conformity and also may encourage the auditor to investigate whether similar methods
are used by others.
An auditor is shown a data logger attached to a viscosity gauge in the same factory. The auditor asks
the operator about an unusual result. The operator says that it must have been a rogue result, and
deletes it.
A non-conformity would be raised as the record was changed with no evidence or authorisation.
A factory has a record of all knives, to whom they have been distributed, and when. The records also
include evidence that all broken parts of a knife are returned before a new one is issued. The record is
signed by the distributor and receiver of the knives.
This is a satisfactory record and acceptable to the auditor.
Clause 3.3.2
Records shall be retained for a defined minimum period with consideration given to:
legal requirements
the shelf life of the product
customer requirements.
Interpretation
The length of time for which a record needs to be kept (known as the retention period) depends on a
number of criteria:
Legal requirements in the country/regions of sale Some countries have minimum periods,
especially related to product liability laws.
Customer requirements Some customers demand a minimum period. For example, baby
diapers/nappies are stamped with manufacturing date and, in some countries, an expiry date.
Product lifetime This is a reasonable approach but may be difficult to determine in practice. An
estimation of the lifespan of a product should be part of a risk assessment.
Time for any effects to have been realised For some products, this is simple. For example, once
a piece of kitchen paper has been used, there is not likely to be any further effect, but for some
products, particularly chemical products with potential or even unknown long-term effects, this
can be very difficult. For example, some of the chemicals previously used in hair dyes are no
longer acceptable. In such situations, it is recommended that industry best practice is consulted, or
records are kept for as long as possible.
3.4 Internal audit

Statement of intent
The company shall be able to demonstrate that it verifies the effectiveness of the product safety and
quality requirements implemented from the Global Standard for Consumer Products.
Interpretation
It is important to check periodically that any system is functioning and working as expected. This is
why internal audits are necessary and crucial in providing evidence that the site is committed to its
safety and quality goals.
The BRC has published a separate guideline, Internal Auditing, which may be useful for those
requiring more information.
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The internal audit shall consist of a scheduled programme of recorded inspections by trained staff to
ensure that the factory environment and processing equipment is maintained in a suitable condition for
production of safe and legal product against GMP guidelines.
Interpretation
The internal audit schedule should be prepared in advance so that different areas or activities are
scheduled throughout the year. A single internal audit of all areas on a single day is not sufficient to
cover the full requirements of an internal audit programme as it will not provide the depth of
assessment or level of confidence required.
Guidance on the internal audit process, as well as an example of an internal audit plan, is provided in
the BRCs best-practice guideline, Internal Audit (Issue 2). The plan includes areas that need auditing
along with a proposed schedule for completion. The example also highlights that the frequency of
internal audits may vary; activities in key areas such as hygiene, good manufacturing practice, foreign
body risks and critical control points (CCPs) need to be audited more frequently than those in some
other areas.
How often an area is audited may be influenced by risk, known issues within the company, best
practice or customer requirements. However, all activities should be covered at least once a year. The
clause requires that documented inspections are undertaken to investigate any contamination risk from
the equipment or building structure, and takes account of areas such as overhead beams, ceiling
fittings, void areas, equipment contact surfaces and areas where dirt might accumulate and could easily
be missed from routine cleaning cycles.
The Standard does not specify a frequency for such inspections; this would depend on the site structure
as well as the types of product being produced. The auditor is likely to ask for a justification of the
frequency chosen if they have doubts as to the effectiveness of the inspections.
A record of inspections should be kept. Actions that are said to have been completed should be verified
to prove that they have been done and that they successfully address the non-conformity. It is essential
that audits and follow-up actions are recorded clearly and completely. If matters are not recorded, it is
not possible for an auditor to verify that the work has been done, nor for the site to refer to issues at a
later date.

There shall be a scheduled programme of internal audits throughout the year with a scope which covers
the implementation of the process risk assessment, GMP and documented procedures to achieve this
standard. The scope and frequency of the audits shall be established in relation to the risks associated
with the activity and previous audit performance.
Interpretation
The Standard requires that internal audits are scheduled and the scopes defined. This ensures that
aspects of the Standard do not get missed or glossed over and that, over a 12-month period, all
departments and processes are covered.
Examples
A new quality manager is appointed in an electric toothbrush factory and enthusiastically sets up an
ambitious and frequent internal audit programme. Several months into the job, the quality manager
realises the programme is unrealistic and cuts back because some of the audits are not necessary.
Unfortunately the change is not documented, nor is a new schedule devised. When the auditor reviews
the audits they discover that some aspects have been audited many times but others have not been
covered at all.
This results in two non-conformities: one because the documented audit procedure has not been
followed, and two because aspects of the Standard have not been audited.
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Blades on a cutting machine have to be checked and cleaned or replaced weekly. An internal audit is
scheduled at six-monthly intervals to confirm that the records have been correctly completed. It shows,
through interview, that the operative has been following the procedure. At the same time, the
operatives training records are examined to demonstrate their competence. The auditor records that the
operative had the correct version of the procedure, followed it and was adequately trained. The auditor
also notes that the records of machine maintenance had been completed correctly since the last audit.
This is satisfactory.

Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be
independent (i.e. not audit their own work).
Interpretation
Auditors are expected to have received training (internal or external) on how to audit and what the
process entails. They will also need to know how to report findings.
Many skills of internal auditing do not depend on technical knowledge of the process, but sometimes
this will be required. It can be difficult to source such knowledge from someone who is independent of
the operation being audited. Internal auditors should never audit their own work, since it will not be
possible to remain objective, or the audit will not be viewed as objective. If this situation arises, then
the person responsible for internal auditing may need to seek external independent resources to assist
with the audit.
Example
A small company produces household cleaning materials and needs to carry out an internal audit of the
use of dangerous chemicals. This is carried out by the company engineer who finds that assessments
have been made and a procedure is in place, but still feels unable to evaluate whether the justifications
for using dangerous chemicals are adequate.
There are several ways to handle this situation. The internal auditor should first check whether the
evaluation has been validated by another competent person. If not, the auditor could contact the trade
association for further information, seek help from another staff member or possibly employ an
external resource for this matter. The company engineer should not just accept the findings and hope
that they are correct.
A company has a documented procedure for how to calibrate a balance before use. An internal auditor
can check that an employee is following the requirements even if they do not actually know how to use
the balance themselves.
This is satisfactory.

The inspection programme shall be fully implemented, and the results shall be reported to a suitable
person. Records of any non-conformities and corrective actions shall be available within agreed
timescales and completion verified.

The internal audit programme shall be fully implemented and tracked. Internal audit reports shall
identify conformity as well as non-conformity and the results shall be reported to the personnel
responsible for the activity audited. Corrective actions and timescales for their implementation shall be
agreed and completion of the actions verified.
Interpretation
The audit programme may be scheduled according to department, procedures or by sections of the
standard. Either way, the system needs to be divided into manageable elements, then the trained
independent auditors can be assigned to each element at appropriate intervals and the frequency
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determined according to risk. The system needs to be kept up to date according to the schedule. The
results of the internal audit must demonstrate the positive points for example, those areas that work
well although any actions required need to be agreed. The timescale for implementation should
ensure that corrections are actually done and it should be clear who is responsible. It sets an
expectation that can be reviewed against the actual result achieved.
A record of audits should be kept. Actions that are said to have been completed should be verified to
check that they have been done and that they successfully address the non-conformity. It is essential
that audits and follow-up actions are recorded clearly and completely. If matters are not recorded, it is
not possible for an auditor to verify that the work has been done, nor for the site to refer to issues at a
later date.
Examples
A company has an audit schedule which it keeps to. Audit reports are available, but they only list the
non-conformities found.
This results in a non-conformity and highlights the need for better training or procedures for audit
reporting.
It is not possible to judge from the reports whether all aspects have been considered during the audits,
since positive aspects are not included in the report.
Following an internal audit, the site supervisor of a cosmetics factory has agreed to improve cleaning in
the packing area. They revise the cleaning schedule for walls and windows and document a new
procedure within a month. The internal audit subsequently contains an update note that the action has
been delayed by a week due to illness. The action was implemented a week later but was found to be
satisfactory.
This would be acceptable. Although the deadline was missed, it was carried through in a reasonable
period and the reason for the delay was clear.
3.5 Supplier approval and performance monitoring
3.5.1 Management of suppliers of raw materials, components and packaging
Statement of intent
The site shall have an effective supplier approval and monitoring system to ensure that any potential
risks from raw materials, components or packaging to the safety, legality and quality of the final
product are understood and managed.
Interpretation
This clause sets out the requirement for sites to control their purchasing of anything that affects product
safety, legality and quality. This includes not only raw materials but also components, subcontracted
work, packaging materials, instruments, machinery and possibly processing aids if they can result in
unsafe products being produced. It is essential that potential suppliers are evaluated.
Clause 3.5.1.1: foundation

The site shall have a defined and implemented process for supplier approval, including a list of
approved suppliers of raw materials, components and packaging impacting product safety, legality or
quality.
The approval of these suppliers shall be based on at least one or a combination of the following:
supplier questionnaire
certificate of analysis
supplier audits
supplier certification with a scope covering the products supplied
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historical evidence of good supply.
Interpretation
It is essential that sites work with reliable suppliers and that they know the basis on which they have
chosen their suppliers. It is increasingly necessary in some product sectors to be assured that suppliers
not only supply to specification but also maintain adequate traceability systems.
The precise methods of supplier approval are not prescribed and may vary depending on the items to be
purchased and the level of associated risk, as well as the suppliers experience of working with the site.
Whichever method is used, a documented procedure is required. This should set out the procedures to
be followed, whether a risk assessment has been conducted, the records to be kept, the criteria for
approval and how exceptions are to be handled.
Clause 3.5.1.1: higher

The site shall have a documented procedure for supplier approval, including a list of approved
suppliers for products, materials and services impacting product safety, legality or quality.
The approval of these suppliers shall be based on at least one or a combination of the following:
supplier questionnaire
certificate of analysis
supplier audits
supplier certification with a scope covering the products supplied.
Interpretation
Every new supplier of goods (or services) that could affect the safety and quality of the final product
needs to be formally evaluated to ensure that it is able to reliably deliver the specified products. Sites
can either have a formal documented supplier-approval system and checklist, or adopt a case-by-case
approach. Either is satisfactory provided the key issues are addressed and suppliers are reviewed at
intervals to ensure that they continue to meet the criteria used for their initial approval and that their
products meet requirements.
This performance review should include an assessment of how complaints are handled, their customer
service in case of problems, and the actual supply record.

Documented procedures shall be established which include clear criteria for ongoing assessment of the
standards of performance required. Ongoing assessment may employ one or more of the following or
other acceptable methods:
in-house checks
certificate of conformity
supplier audits
traceability checks.
Records of this monitoring shall be retained with consideration given to legal requirements, product
shelf life and customer requirements.
Example
A company is purchasing paint with which to decorate baby cots. It has approved the supplier based on
the fact that the supplier has current ISO 9000 certification.
The auditor would not accept this without further research. Unless the factory is carrying out its own
testing on each batch of paint supplied, the approval process is unlikely to be sufficient. It would be
more usual to insist that batches of paint are delivered with certificates of analysis.
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Documented procedures shall define how exceptions are handled; for example, the use of products
where audit or monitoring has not been undertaken.
Based on a batch or delivery basis, the procedure may involve the assessment of certificates of
analysis.
Interpretation
Only approved suppliers should be used, but as an exception a site may find that it either requires
materials at short notice, or is not in a position to wait for materials; for example, when an approved
supplier has unexpected problems with delivery. If such a situation might occur, the site must have a
procedure in place to determine how to handle it and in what circumstances an unapproved supplier can
be used. Any instances when an unapproved supplier is used must be documented.
Example
A cosmetics company sources its perfumes from two approved suppliers but finds that both are having
trouble supplying a particular fragrance. Rather than stop production it sources from a third company,
following its procedure for unapproved suppliers. This requires the supplying company to fill in a self-
assessment evaluation, for the batch of material to be tested before use and a small trial run to be
carried out.
An auditor would find this approach satisfactory.
3.5.2 Control and acceptance of incoming raw materials, components and packaging
materials
Statement of intent
FUNDAMENTAL
The company shall have an effective process to ensure that incoming raw materials, components and
packaging materials are suitable for use and do not adversely affect the safety, legality or quality of the
finished product.
Interpretation
Sites carry out internal product inspections at various points in production; this includes an inspection
programme for incoming components, subcontracted work or home work.
The requirements of the Standard mean that inspections are carried out on a defined and rational basis
and that, in any subsequent investigation, it can be seen whether the inspection checked the parameter
in question and whether the sampling programme was sufficient to highlight the levels of defects
subsequently detected.
Further details of the requirements and technical details of inspection and sampling procedures are
available in the international standard ISO 2859 Sampling Procedures for Inspections by Attributes.
Other similar, commonly used standards include Mil Standard 105, ANSI Z1.4 and BS 6001.
Example
A company is producing skin lotion; it has carried out an assessment and established that if the water
quality is not controlled, there is a risk of product contamination. A further assessment shows that both
the incoming quality of the water and the cleanliness of interior pipes are important and that monitoring
is required.
An auditor would look for the actions that have been put in place as a result of this evaluation.
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Raw materials, components and packaging shall be checked on arrival to ensure they conform to
agreed specifications and any agreed acceptance criteria, e.g. certificates of analysis.
Interpretation
It is vital that the correct raw materials and components are used for products. If the wrong materials
are used, it is very unlikely that products can be corrected at a later stage of production. This clause is
therefore a fundamental requirement for all sites.
Incoming materials and components can be controlled in a number of ways, depending on the situation.
They may require testing, checking of certificates of analysis or conformity, visual inspection or other
checks.
It is usual that accepted product can be identified in some way to help traceability, and to prove that it
has been through an acceptance procedure. Items and materials that are stored pending acceptance
should be segregated so there is no possibility of their being confused with accepted products.
Similarly, any rejected goods must be labelled and segregated.

Raw materials, components and packaging shall have documented approval procedures to ensure they
conform to agreed specifications and requirements, and documented positive batch release.
Incoming goods, including materials returned to site from subcontractors (and home workers), shall be
subject to a documented positive batch release procedure.
Interpretation
It is vital that the correct raw materials and components are used for products. If the wrong materials
are used, it is very unlikely that products can be corrected at a later stage of production. This clause is
therefore a fundamental requirement for all sites.
Incoming materials and components can be controlled in a number of ways, depending on the situation.
They may require testing, checking of certificates of analysis or conformity, visual inspection or other
checks, which should be described in a documented procedure. The procedure should also specify the
means of release of acceptable raw materials and components and any labelling or recording
requirements.
It is usual that accepted product can be identified in some way to help traceability, and to prove that it
has been through an acceptance procedure. Items and materials which are stored pending acceptance
should be segregated so there is no possibility of their being confused with accepted products.
Similarly, any rejected goods must be labelled and segregated.
Any materials likely to affect the safety, quality and legality of a product must have written approval
procedures.
It is a requirement that a positive release system is in place i.e. someone has to check the delivery and
approve it. The rationale on which they make that decision should be clear. They might need to check
that it is accompanied by a test report or they might need to physically inspect it for size, colour or
another parameter.
Example
A company has been using a chemicals supplier for a long time with no problems. The supplier is
supposed to supply surfactants with certificates of analysis but this is no longer checked, as there have
never been any problems in the past.
This is not acceptable. If the approval procedure states this should be checked as goods come in, then
that should be done and documented. If this is inappropriate, the procedure should be reviewed, and a
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new approach documented and validated before changes are allowed. This would result in a non-
conformity.

The company shall have a process to ensure that raw materials, components and packaging used by
home workers (when used and if authorised by the customer) are approved.

The company shall have a documented procedure to ensure that raw materials, components and
packaging used by home workers (when used and if authorised by the customer) are approved.
Interpretation
Work produced by home workers and the material they use must be controlled in the same way as work
produced on site, because the same safety or quality problems may occur. Home workers should have
documented work instructions and any equipment they use must be subjected to maintenance
procedures and calibration as necessary. Home workers shall be made aware of any issues concerning
product safety that are pertinent to their work for example, avoiding foreign-body contamination or
control of knives.

The company shall have in place a process to ensure the authenticity of raw materials, components and
packaging to prevent fraud.

The company shall have in place a documented procedure to ensure the authenticity of raw materials,
components, packaging and documentation to prevent fraud.
Interpretation
Applies at both higher and foundation levels
This may necessitate some form of risk assessment, such as Vulnerability Assessment Critical Control
Point (VACCP) or Threat Assessment Critical Control Point (TACCP).
Further information on risk assessments is given in the publicly available specification PAS 96:2014
(free of charge) and ISO/IEC 27001:2013 (ISO 27001) for information security management systems
(ISMS). See also the Global Standard for Food Safety Issue 7: Understanding Vulnerability
Assessment (UK).
An assessment should be undertaken of what types of products are bought from where to determine
whether there is a likelihood of substitution or fraud. This should be followed by actions such as
enhanced supplier approvals, shortening the supply chain, mass balance exercise or extra audits of the
supply chain. These actions may be supported by horizon scanning to see if similar products or
materials have been affected.
Example
The auditor is shown a project undertaken on manuka honey used in a face cream. The data and
research showed this product to be vulnerable to substitution. Previously the site had bought this
product through an agent but since discovering the issue has now approved a source from a broker who
purchases directly from the farm in New Zealand.
This would be accepted by the auditor.
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3.6 Specifications and technical files

Statement of intent
A system shall be in place to manage specifications and technical data for raw materials, components
and packaging materials.
Interpretation
This clause covers two important but different needs:
to have information about the materials and components used to make the product
to keep all the technical information about the product itself.
It requires such information to be accurate and accessible within a reasonable period of time to those
employees who need to use it. The Standard refers to the collection of product information as the
technical file.
In some product sectors there is a formal legal requirement to maintain a technical file. For example, in
cosmetics it is referred to as the product information file (PIF); this clause would also apply to such
files. It does not mean that all the information has to be physically available on one file at all times, but
it has to be available for each product; it can be assembled from different sources if necessary.
In some countries and for some products (for example, electrical products in the EU) there is a legal
requirement to produce such a file for the authorities within a defined timescale and in a language they
can understand. It is therefore advisable to test and ensure that a technical file can be assembled from
the available information if it is stored in a variety of locations.
Some industry sectors call these collections of data product information packages or job bags. It
does not matter what the information is called, as long as the content is correct. The site must be aware
of what comprises its technical file, even if it is not in one place. This can be achieved, for example, by
keeping a list of documents considered to form the file and their location.
Clause 3.6.1
Suitably detailed and accurate specifications shall be held for all raw materials, components, packaging
materials and finished products to ensure compliance with relevant safety, legislative, quality and
customer requirements. The specifications shall be accessible to relevant staff and the company shall
seek formal agreement of specifications with relevant parties.
Interpretation
The correct materials and components are essential to the safety and quality of the product. If items are
not clearly specified or bought on well-defined specifications, it is likely that they may be unsuitable
for the purpose. The supplier cannot be responsible for supplying the wrong grade of material if it has
not been correctly specified. The use of inadequate components and raw materials has caused many
product failures and safety issues.
The specification must relate to the safety and quality and not just the performance or physical
characteristics of the product. If the site is manufacturing a customers own-label product it is essential
that there is a documented agreement regarding the specification of the finished product and the
materials used.
Clause 3.6.2
A specification shall be available for each finished product and shall have been verified to ensure it is
fit for purpose, meets customer requirements and is compliant with relevant safety and legislative
requirements in the regions of intended sale.
As a minimum, the specification may include the following, although this is not an exhaustive list:
product name and description
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composition
physical and/or chemical parameters
assembly diagrams
packaging
labelling
intended shelf life
warnings
instructions for use.
Examples
A qualified, board-registered toxicologist has assessed a cosmetic for safety and produced a favourable
report. The American company produces the material and ships it to another state. On the way, many of
the bottles explode, contaminating products and leaving sharp plastic parts in the boxes.
The toxicologists review was concerned with chemical safety. The site did not consider the physical
problems of overfilling bottles, or the build-up of pressure due to volatile components within the
specification.
Auditors will expect to see that all aspects have been addressed by the risk assessment.
Clause 3.6.3
Companies shall maintain the data in a technical file that is accessible to relevant staff containing all
relevant data (or details of where such data is located) to ensure that products meet the requirements of
the specification and legislative and customer requirements.
Relevant data may include:
bill of materials
safety data sheets on all chemicals used where relevant to the safety, legality or quality of the
product
risk assessment(s)
description of the conformity assessment procedure
test reports
inspection reports
list of the legislation and product standards with which the products are manufactured to comply
production control procedures and charts
approvals by any government body (if applicable)
declarations of conformity to legal requirements (if applicable)
self-inspection reports
corrective actions.
Interpretation
The technical file should be the source of all technical information about the product. The list provided
in the Standard is only given to suggest the type of information required and is not exhaustive or
compulsory. The actual information will depend on the type of product being produced and specific
requirements in the regions of intended sale. It should be treated as a living document, updated when
necessary by adding information as it becomes available. It is not something to set up at the beginning
of production and then forget about. The auditor will expect to see evidence that the technical file is
being used.
3.7 Corrective and preventive action

Statement of intent
FUNDAMENTAL
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The site shall be able to demonstrate that it uses the information from identified failures in the product
safety and quality management system to make necessary corrections and prevent recurrence.
Interpretation
There are many different ways in which non-conformities are discovered, both internal and external
for example:
Problems may be noticed internally by inspection, or quality assurance staff or operators working
at the packing lines.
Evidence may come via internal audits or routine reviews.
Externally, non-conformities may be found during customer or third-party audits, customer
complaints, or actions of enforcement agencies.
A site needs to have an efficient means of recording and investigating actual and potential non-
conformities and reporting the findings. Even if, on investigation, there is no actual non-conformity,
the investigation should still be recorded and it may help if the problem recurs.
The Standard requires issues to be investigated in a timely way. It does not define timely, but
auditors would expect the site to have some requirements or guidelines in place that specify the
timescales appropriate to the level of risk to the consumer.

The company shall operate an effective system for the capture, recording and timely corrective actions
of non-conformities or matters reported as possible non-conformities critical to product safety, legality
or quality.

The company shall operate an effective documented process for the capture, recording and timely
investigation of non-conformities or matters reported as possible non-conformities critical to product
safety, legality or quality.
Interpretation
It is essential that sites have good systems in place to discover, record and investigate cases where their
products or procedures fall short of requirements. Sites failing to demonstrate that they have a robust
system will not be certified because they will not be able to give the auditor confidence in their ability
to reliably place safe and legal products of agreed quality onto the market.

An appropriate staff member shall be identified and assigned the responsibility and accountability for
each corrective action. This shall be documented.
Interpretation
The Standard requires that a named individual is responsible for each identified corrective action. This
has been found to be one of the most reliable ways of ensuring that actions are completed, and avoids
any confusion. It does not mean that one person has to do all the work to correct the non-conformity; in
many cases this is likely to be a team effort. The responsible person must, however, be documented and
held accountable for the successful completion of the corrective action.
Agreement of the actions is required, along with the timescale for implementation, to ensure that
corrections actually get done and that it is clear who is responsible. It sets an expectation and can be
reviewed against the actual result achieved.
Example
The site supervisor of a cosmetics factory has agreed to improve cleaning in the packing area. They
revise the cleaning schedule for walls and windows and document a new procedure within a month.
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The internal audit subsequently contains an update note that the action has been delayed by a week due
to illness. The action was implemented a week late but found to be satisfactory.
This would be acceptable.
Although the deadline was missed, it was carried out in a reasonable period and the reason for delay
was clear.

The company shall ensure that corrective actions prevent recurrence of the problem and shall monitor
and record their completion.

The company shall ensure that effective corrective actions are taken to prevent recurrence of the
problem and shall monitor and record their completion within an appropriate timescale.
Interpretation
The Standard requires sites to investigate non-conformities in order to understand the root cause of the
problem and to put in place a sustainable solution that will prevent recurrence. This clause also requires
the completed action to be carried out within an appropriate timescale, and to be recorded.
Example
A wet-wipe manufacturer has found a non-conformity during an internal audit. The liquid solution pH
was found to be not to specification which meant that there was a risk that the product would be
vulnerable to mould growth. The problem was investigated and it was found that the mix setting had
been altered. The setting was corrected, checked and the non-conformity was signed off.
The company is surprised to receive a non-conformity for this, because everything had been properly
documented. However, it did not address the part that prevents recurrence (root cause). The company
did not try to find out why the setting had been changed and how this could be prevented, and therefore
did not try to discover the root cause of the issue.

The company shall review its processes at least annually and adopt preventive measures as they
become available.
Interpretation
This clause is self-explanatory and requires an annual review to ensure that appropriate measures are
adopted and new ideas taken up when appropriate. Sites would be expected to review the recurrence of
similar issues and take action to investigate the causes, rather than just deal with issues as they occur.
A summary of this data, any obvious trends and the effectiveness of corrective actions taken as a result
of it, should be part of the annual management review.
3.8 Control of non-conforming materials

Statement of intent
The company shall ensure that non-conforming raw materials, packaging, components and products are
clearly identified, labelled, quarantined, investigated and documented.
Interpretation
Auditors will look for evidence of rejected packaging materials and how the rejected material is
treated. Such material should be subject to the process for non-conforming products and suitably
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recorded, segregated, disposed and reworked as necessary. It is vital that non-conforming products or
materials cannot be mixed up with good items. All non- conforming raw materials, components,
products and packaging must be identified, segregated and investigated. Non-conforming materials
include any items that do not meet the stated specification and are not just those that are considered to
give rise to a safety or legal problem.
Clause 3.8.1
Clear procedures for the control of non-conforming materials and products, including customer returns,
shall be in place and understood by all relevant, authorised personnel. These shall include effective
identification and quarantining before a decision has been made on the final disposition of the non-
conforming product by rejection, acceptance by concession or regrading for an alternative use.
Interpretation
Procedures are required so that employees know what to do when a non-conforming material is
discovered. If the actions required are not clearly stated, there may be a tendency to ignore the
problem.
In some cases, a non-conforming material may be suitable for an alternative use for example, a
plasticiser unsuitable for childrens toys may be satisfactory for adult products. In other cases, a
material that falls slightly outside the agreed tolerance may still be usable without a major problem
for example, a plastic master batch for a bucket manufacturer that is the wrong colour.
If concessions are made to allow use, there must be a written procedure for this and all concessions
documented and authorised. The reason for the existence of all non-conforming materials must be
investigated, ideally to prevent recurrence. Reduction in rework should inform a sites KPIs and should
be reviewed as part of an internal audit. Procedures are also required to ensure that the subsequent use,
return or disposal of non-conforming materials is handled and documented correctly. The product to be
reworked must be subject to the methods and inspection or testing requirements that are in place for
production.
A procedure for the disposal of unsafe or non-conforming material must be available and fully
implemented.
If unsafe or non-conforming products are allowed to be removed from a site without proper disposal,
there is a risk of their reaching the consumer or being confused with good products. It is possible to use
products as seconds, provided there is no safety or legal issue and that it is not a breach of customer
requirements. Any such products must, however, be identified separately from good products.
In cases where it is warranted, auditors would expect to see that disposal had been observed and signed
off by a site representative or suitable independent third party, or carried out by an approved
professional contractor.
Example
A company has rejected some plastic mouldings because the shape is incorrect. The items are
segregated and sent to be ground up. The material is to be used as regrind and added into the mix for
another product at 8% of the total. Before the material is used, it is subjected to testing to ensure that
the content of toxic elements is within the allowed limits. Pre-production samples of the product are
prepared to ensure that the physical performance is appropriate. The material is also checked for
homogeneity. All the procedures are documented.
The auditor finds this acceptable. The auditor also reviews the records and test results for the products
made with this material to ensure that they conform to specification.
3.9 Traceability
Statement of intent
FUNDAMENTAL
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The site shall be able to trace all raw materials, components and packaging from its suppliers through
all stages of processing and dispatch to its primary customers, and from the customer back to the
supplier.
Interpretation
It is worth remembering that a good traceability system makes sound business sense and prevents or
limits the scope of recalls or withdrawals of product. The best traceability systems incorporate a tool
such as mass balance for reconciling quantities of bought in raw materials, components and packaging
with finished product. To this end the Global Standards auditor will require to see not just traceability
from the customer to the supplier and from the supplier to the customer but also elsewhere a
component or material has been used.
Additionally, Global Standards auditors are required to carry out a full vertical audit which entails
reviewing each and every step of the production process following the traceability of a product.
Clause 3.9.1
The site shall have a system in place which has the ability to trace and follow all raw materials,
components and packaging materials from the supplier through all stages of processing and distribution
of the finished product, and vice versa, in a timely manner.
Interpretation
This is a fundamental requirement because it is vital that stock can be traced in order to take
appropriate action. There are two aspects to consider:
tracing back to suppliers raw materials and components used within the site to produce the
products
tracing forward finished products to the initial customers (i.e. retailers or wholesalers who have
purchased the items). In some cases, it will be a legal or customer requirement that products (for
example, motor cars) can be further traced, perhaps even to the final consumer.
It is worth remembering that a good traceability system usually makes sound business sense and
prevents or limits the scope of unnecessary recalls or withdrawals of product.
Example
A company sources bottles for its childrens sunscreen products from three separate suppliers and
places them all in a single storage bin. It is subsequently informed by one supplier that one of the
batches of bottles did not pass a migration test. The company has to withdraw all the production as it
cannot identify which bottles have been used with which products.
The company will receive a non-conformity because it did not have a system in place. The company
will have also wasted time and money recalling good products because it cannot distinguish them from
bad ones.
Clause 3.9.2
Identification of lots/batches of raw materials, including packaging, processing aids, intermediate/semi-
processed products, part-used materials, rework, finished products and materials pending investigation,
shall be sufficient to ensure traceability.
Interpretation
Lots or batches are easier to define in some industries than others. For example, a curtain manufacturer
making curtains from one roll of fabric might easily define that as a batch. On the other hand, a
computer manufacturer assembling thousands of different parts, all from different batches or even
different suppliers, may need a more sophisticated process. If each product has a serial number that
uniquely identifies it, then it may become a batch of one. When products are made by a continuous
production technique, the site may need to adopt an empirical approach and define the batch in such a
way as to limit the damage from any issues that occur for example, by using a date or hour code. The
auditor may ask the site to explain the rationale behind the selection of a batch.
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Finished product shall be identified with a unique code such as a batch code applied to the product or
packaging where legally required or specified by the customer.
Procedures must be in place to trace a finished product back to the batch of raw materials or packaging
used.

Finished product shall be identified with a unique code such as a batch code applied to the product or
packaging.
Documented procedures must be in place to trace a finished product back to the batch of raw materials
or packaging used.
Clause 3.9.4
Subcontracted manufacture of products or components shall have prior customer approval and shall be
traceable to a level appropriate to the risk.
Interpretation
Outer packaging is defined in the glossary of the Standard as the packaging visible when the product
is released from the site. It is likely to be, for example, a cardboard box or multipack rather than an
individual consumer product unit. The Standard does not require individual products to be marked
unless this is a legal or customer requirement.
Clause 3.9.5
The system shall be tested to ensure traceability can be determined from raw-material receipt to
finished product and vice versa. This shall occur at a predetermined frequency, at least annually, and
results shall be retained. The time taken to complete the exercise shall be measured and recorded.
Clause 3.9.6
The need for extended traceability through the chain should be established on the basis of risk and any
legal or specific customer requirements. Where required, extended traceability shall be implemented.
Interpretation
The BRC publishes a best-practice guideline, Traceability, which gives more detail for those requiring
further information. It includes examples of methods to be used and case studies. Therefore, this
guideline does not address each subclause of section 3.9 in detail but offers further clarification on
subclauses 3.9.2 and 3.9.4.
3.10 Complaint handling

Statement of intent
The company shall operate an effective system for the capture, recording and investigation of product
complaints at all levels of severity.
Interpretation
This clause of the Standard covers customer complaints about safety, quality or legal issues. The
system for recording complaints may be much wider and may include issues such as delivery, value
and customer service. In this case, it must be possible to extract the complaints relevant to the scope of
the Standard.
Customer complaints, especially for larger producers, are likely to be received from a wide range of
sources. A defined system and staff training are likely to be required to ensure that an effective capture
system exists and that complaints are well managed.
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For sites needing more guidance on complaint handling, the BRC produces a best-practice guideline,
Complaint Handling.
Clause 3.10.1
All complaints shall be recorded, investigated using root analysis and the results of the investigation
recorded where sufficient information is provided. Actions appropriate to the seriousness and
frequency of the problems identified shall be carried out to reduce the likelihood of recurrence.
Interpretation
This clause simply requires that appropriate actions are carried out by suitably trained staff. It should
be noted that the frequency of problems identified is mentioned; sites would therefore be expected to
review the recurrence of similar issues and take action to investigate the causes rather than just deal
with issues as they occur.
Corrective action plans must be clearly documented, giving details of the investigation and actions
taken to prevent a recurrence.
In some ways complaint handling is very similar to dealing with non-conformities. The site needs to
ensure that complaints are captured and recorded effectively. Depending on the nature of the business,
it is likely that complaints are received from a wide range of sources and delivered to a number of
people for example, individual consumers calling customer service lines, comments made to sales
people during business development meetings, letters sent to the chief executive, and product returns
from unsatisfactory deliveries. Whatever the source, the site needs a system to capture and collate the
information.
Many sites will record product safety and quality complaints along with a much wider range of issues.
This is quite acceptable provided that quality and safety issues can be identified and are routed to an
appropriate person for investigation in a timely manner. For sites of all sizes, it is important that a
customer is made aware of information relevant to their products, whether the information is positive
or whether there is a problem or issue. For higher-risk products, where such information could relate to
safety or legal matters, the Standard requires that individuals are responsible for customer
communication. This does not mean that a person has to be employed solely for this task, or that the
same person has to be responsible for all communication, but it does mean that a system has to be in
place, people have to be aware of their responsibilities and any communication has to be found to be
effective.
In complex supply chains, customer complaints may be delegated to third parties such as agents or
importers.
In such cases, the allocation of responsibilities must be clear and documented in advance. It is
important that problems do not arise because of the unclear division of responsibility, or because
people think that someone else is handling the issue. It is also important that the third party knows the
extent of their authority when offering remedial actions or refunds. In these circumstances, clear
communication with the provider of this service is essential to ensure that information is captured
appropriately and that a management system is in place.
The effectiveness of this system should be checked and reviewed. There are a number of ways to do
this for example, follow-up calls or visits, customer surveys, reviewing complaints, logging customer
contact and feedback but the Standard is not prescriptive.
Clause 3.10.2
The company shall have a process in place to respond in a timely manner to consumers and customers
regarding complaints.
Interpretation
Complaints are an important source of information concerning business performance and customer
satisfaction. It is important that this information can be recorded accurately and that it is not hidden or
lost because people are worried about the implications of reporting negative comments. Complaints
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should be seen as opportunities for improvement. It is a requirement of the Standard that the complaint
data is analysed and used to drive continuous improvement. A summary of this data, any obvious
trends and the effectiveness of corrective actions taken as a result of it, should be part of the annual
management review.
Example
A company has a procedure for logging complaints and a simple form on the companys intranet site
where all employees can record information. The system is explained to an employee as part of their
initial training. Each section manager is responsible for reviewing the input to the system on a monthly
basis and a customer services manager has overall responsibility to review the complaints and follow
up on any necessary actions. When complaints concern safety, quality or legality, they are coded so
that the quality manager also receives the complaint immediately and can review the urgency of any
action to be taken.
An auditor reviews the complaints on the intranet system and selects one example. They follow the trail
of the complaint to ensure that all parties have carried out the required actions and that the correct
information has been logged. During this investigation, the auditor takes the opportunity to question
staff about the system and finds it to be well understood and used.
The auditor is satisfied with the process.

Complaint data shall be analysed for significant trends. This analysis shall be made available to
relevant staff.
3.11 Management of incidents, product withdrawal and product recall

Statement of intent
The company shall have a plan and system in place to manage incidents effectively and enable the
withdrawal and recall of products should this be required.
Interpretation
A product recall system is a fundamental component of a companys product safety management
system. EU legislation stipulates an obligation to all sectors of the supply chain to ensure effective
systems are in place to minimise safety risks to consumers. This risk must be controlled by the
introduction, implementation and maintenance of effective and efficient product recall processes.
The BRC has developed Product Recall, a guideline that gives an insight into what is involved in a
product recall, as well as guidance and advice on creating or improving product recall processes.
Example
A company produces a depilatory cream. It has a problem with complaints of rashes and has decided to
carry out a recall. They identify the faulty batch and recall all products from 40 customer sites. The
system details the requirements for the staff and the contact details of the responsible people in the
process. In addition, the procedure enables the rapid identification of the customers and sites involved
so that contact can be made and accurate information given. The certification body is notified within 3
days of the decision.
This would be deemed acceptable by the auditor.

The site shall have a system in place to monitor issues which could result in the need to withdraw or
recall products including consumer complaints, product rejections and feedback from customers. There
should be a process in place to notify senior management of an incident or emergency that may affect
the legality, safety and quality of a product.
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The site shall determine and provide written or other guidance to relevant staff regarding the type of
event that would constitute an incident or emergency situation that impacts product safety, legality or
quality, and a documented reporting procedure shall be in place which shall include informing their
customers in a timely manner.
Interpretation
A product recall is from the market place where the product is in the hands of or available to the
consumer, whereas in a withdrawal the product is still within the distribution network and under the
control of the site.
An incident could be as a result of an issue recognised internally or as a result of a customer or even a

consumer complaint.
For example:
Someone has had an allergic reaction to the new hair dye developed.
The bottles received at a store are leaking from the cap.
A non-production glass jar was broken in the filling area.
Equally it could be as a result of a similar product being recalled or withdrawn from sale.
Any of these issues needs to be fully investigated and resolved to ensure that there is not a potential for
a product recall.
Clause 3.11.2
The site shall have a documented procedure in place to effectively manage product withdrawals and
recalls. Procedures shall exist to ensure that customers are notified immediately on issues of
significance to the customer or consumer in terms of product safety, quality or legality.
Examples
A company recalls a mascara because of potential Bacillus cereus, Staphylococcus epidermidis and
Staphylococcus warneri contamination. It also instigates a voluntary recall of certain shampoo, body
lotion, conditioner and shower gel products due to microbial contamination from bacteria.
Having received five reports regarding consumers who were seriously burned after applying a
flammable, continuous-spray sun care product, a manufacturer voluntarily withdrew its products from
US markets because they could cause the skin to catch fire if a person came into contact with an
ignition source before the product was completely dry.
Clause 3.11.3
The documented product withdrawal and recall procedures shall include as a minimum:
identification of key staff constituting the incident management team and their key responsibilities
an up-to-date list of key contacts, with details of agencies providing advice and support
a list of persons who can initiate a recall.

The site shall have written technical and quality agreements in place with agents and distributors and
other parties in the supply chain where these are necessary to ensure effective withdrawal/recall.
Interpretation
The agreement should detail the traceability requirements and contact details in order to initiate an
effective recall or withdrawal.
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Clause 3.11.5
In the event of a product recall, the certification body issuing the current certificate and the appropriate
enforcement authorities shall be informed in a timely manner. The company shall be aware of and
adhere to any legal reporting obligations in the regions of sale.
Interpretation
This part of the Standard ensures that there are adequate procedures in place should unsafe or illegal
products be distributed beyond the site. In Europe, the term usually means the physical return of the
product either for replacement or repair. The systems a site has in place to deal with the issue should
reflect the regions in which its products are available for sale. However, they should all include the
need to contact the certification body which issued the BRC certificate.
Product withdrawal refers to actions taken for products that have not reached the consumer, such as
those in retailer stores, storage depots and distribution points.
The BRC has produced a best-practice guideline, Product Recall, which may help those requiring more
detail. Authorities such as the Consumer Product Safety Commission (CPSC) in the US and the
Directorate-General for Health and Consumer Affairs (DG Sant) in the EU also produce information
and guidance.
The reason for the requirement to inform the certification body of any recalls is so that it can
investigate whether there is any need for a re-audit and whether the recall casts doubt on the
certification. The BRC does not require any definite action to be triggered on its behalf and the
certification body may feel that actions have been carried out in accordance with defined procedures
and therefore no further work is needed.
It is also courteous to inform the certification body in case its audit is called into question following the
recall.
Example
A company discovers that one of its sun cream products contains a chemical that is not allowed in the
country of sale even though it is acceptable in the home market. It immediately informs the US and
European authorities and posts recall notices. It also informs its certification body, which seeks
information as to the cause of the problem and how it has been addressed. The company has
established that bought-in perfume contained the banned substance even though it had been supplied
with a certificate of conformity. The company has reviewed and improved its supplier-approval
policies and instigated additional test procedures.
The certification body decides that the incident has been dealt with correctly and that there is no need
to revisit or suspend the certification.
Clause 3.11.6
Products which are to be disposed of on safety grounds, as the result of a recall or withdrawal or as
substandard trademarked materials, shall be disposed of securely. This may be delegated to a specialist
in secure waste disposal. Records of such material destruction or disposal shall be maintained.
Interpretation
It is vital that, having determined that a component, product or even product packaging is illegal,
unsafe, or of a quality that requires it to be destroyed, it does not make its way back on to the market.
Guidance could come from BS EN 15713:2009, which provides a framework of key conditions to be
adhered to by companies who destroy confidential information on behalf of their customers.
Checks as to whether a licensed waste disposal company could securely dispose of product might
include:
video surveillance
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background checks on all employees

secure facility
chain-of-custody procedures
alarm-monitored facility.
Example
In the US, lead-painted toys fall under the category of products that would need to be destroyed or
properly disposed of, according to the Consumer Product Safety Commission. They cannot be exported
for resale.
Disposal is therefore determined as part of recall negotiations with the CPSC, in accordance with state
and federal environmental laws.

The product recall and withdrawal procedures shall be tested at least annually.

The product recall and withdrawal procedures shall be regularly tested, at least annually, in a way that
ensures their effective operation. Results of the test shall include timings of key activities and shall be
retained.
The company's senior management shall ensure that results of this test shall be used to implement
improvements as necessary.
Interpretation
This is not to be confused with the traceability test. Certainly the test requires that traceability is
effective, but it needs a much wider-ranging evaluation. Product recalls can cost millions or even
billions of pounds, so this activity is worth practising rather like a fire drill to ensure that everyone
(including deputies) is well versed in the activity ,which it is hoped will never happen.
A product recall system is a fundamental component of a companys product safety management

system. EU legislation stipulates an obligation to all sectors of the supply chain to ensure effective
systems are in place to minimise safety risks to consumers. This risk must be controlled by the
introduction, implementation and maintenance of effective and efficient product recall processes.
Improvements from the test may include timings or ensuring that phone numbers are updated. The test
should ensure that the system works even when the site is at its most vulnerable; for example, just
before or during a major holiday, or at a time when senior management is away from the site.

The company shall develop contingency planning for business continuity in the event of major
incidents such as:
disruption to key services (e.g. water, energy, staff availability)

events such as flood, fire and natural disaster
malicious contamination or sabotage.
Interpretation
This requirement is in place to ensure that business processes continue if unexpected events occur. The
Standard is concerned only that guidance is in place concerning product safety and legality, although a
full business continuity plan is likely to cover a much wider scope of activities.
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4 Site standards
4.1 External standards

Statement of intent
Sites used for manufacturing, storage or distribution shall be of suitable size, location, construction and
design to facilitate maintenance, prevent contamination and enable the production of safe and legal
products.
Interpretation
This part of the Standard is one of the most straightforward. It requires that sites are fit for purpose,
both externally and internally, and requires that operations are conducted in an orderly fashion so as not
to jeopardise the safety or quality of the product. For many products, the external conditions around a
site will have no effect, but there are some situations when they can have a substantial impact on the
products being manufactured. In all cases, it is important to ensure that the site is of adequate size and
construction to produce the stated products safely.
Example
A company stores cardboard boxes in an outbuilding, in an area of high rodent population. This could
have an impact on the products, but the company keeps the area around the outbuilding as clear as
possible and has good pest control. There is no evidence of rats entering the building.
The auditor considers that this is satisfactory and that practical steps have been taken. It is not
necessary or cost-effective to move the store but the site should continue to monitor the situation.

The site to be included in the audit shall be clearly defined, and shall be located and maintained so as to
allow the production of safe and legal products.
The external areas and surroundings shall be maintained in good order.
Interpretation
The site needs to be well defined with boundaries clearly marked partly so that the auditor is clear
about the premises to be audited, and partly so that proper consideration can be given to the state and
suitability of the location. As part of the audit visit, the auditor will look around the exterior site to
establish the suitability of the location, the possibility of contamination and any other potential
problems that may be caused by a lack of clarity about the responsibility for shared or communal areas.
Auditors understand that conditions are not always ideal and that sites and their surroundings often
develop over time. They will understand that some buildings may be old or that new methods have had
to be accommodated in buildings for which they were not intended. The auditor will need to be
satisfied that any shortcomings in this regard do not pose a risk to the safety and quality of the product.

The site to be included in the audit shall be clearly defined, and shall be located and maintained so as to
allow the production of safe and legal products.
The external areas and surroundings shall be maintained in good order.
A site plan shall be retained and readily available.
Example
A company produces bath and shower gel products in a purpose-built unit. The auditor observes that
part of the site is not named on the factory plan, and establishes that this area has been sublet to a
separate chemical formulation research company.
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Because the area is not clearly separate from the main operation, the auditor would want to determine
that there is no risk to the production site from the use or disposal of chemicals from the sublet unit.
The auditor would investigate how the company controlled the sublet area, any areas of overlap,
common services, etc., and ask to see copies of documented procedures, as well as observing the
activities on the factory floor.
Since it is probable that the company would not be able to control the activity of the sublet operation
sufficiently, it is likely that the auditor would issue a non-conformity.

Consideration shall be given to local activities and the site environment and measures shall be taken to
prevent contamination.
Where measures have been put into place to protect the site (from potential contaminants, flooding,
etc.), they shall be regularly reviewed in response to any changes.
Interpretation
This clause requires a site to consider its external environment. In most cases there will be no concerns,
but if measures have to be taken the site must demonstrate that it checks these measures and ensures
that they are still adequate.
Example
A cosmetics factory producing mouthwash is in a rural setting and initially the site was not surrounded
by anything more than a few houses and open fields that were used for grazing horses and sheep. In
recent years some of the land has been turned over to a pig farm and the rest to arable farming.
The auditor would raise a non-conformity as the site has not taken any action regarding the changing
environment and the potential for pesticides and odours contaminating the products.
4.2 Security
Statement of intent
Security shall be maintained to prevent access of unauthorised persons to production and storage areas.
Clause 4.2.1
Access to the site by employees, contractors and visitors shall be controlled and a visitor-reporting
system shall be in place.
Interpretation
Access to sites should be controlled in order to prevent any accidental or malicious damage to the
product or materials.
Care should be taken that the system for site security is maintained during shift work and any shutdown
periods.

Contractors involved in maintenance or repair shall be qualified or supervised and a member of staff
shall oversee their activities.

Contractors involved in maintenance or repair shall be qualified or supervised, and a nominated staff
member shall be responsible for their activities with regard to potential effects on the safety, legality or
quality of products.
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Interpretation
A large percentage of all incidents and accidents are as a direct result of contractor activity on site.
Contractors should be suitably qualified and supervised, when appropriate. Whether or not continual
supervision is appropriate, a nominated staff member should be designated as responsible for any
contractors on site and ensure that appropriate procedures are respected.
Example
The maintenance manager of a factory producing washing-up liquid has arranged for the back flushing
of the newly installed water treatment plant. This process involves the introduction of a strong saline
solution to the plant thus reactivating the resin bed. The maintenance manager has failed to inform the
quality manager or the production manager of the activity. During the operation a line QC check is
conducted and it is discovered that the washing-up liquid is the wrong density. Further investigation
reveals that during the back-flushing operation the main water feed to the line had not been isolated and
as a result a full batch of product is wasted.
The auditor would raise a non-conformity against such activity.
4.3 Layout, product flow and segregation

Statement of intent
FUNDAMENTAL
The factory layout, flow of processes and movement of personnel shall be adequate to prevent the risk
of product contamination and mix-ups and to comply with relevant legislation.
Interpretation
The layout of a plant is fundamental to an efficient production process.
Clause 4.3.1
The layout process flow of machinery and equipment shall be arranged to minimise the risk of product
contamination and damage.
Interpretation
This clause is far more important in some industries than others. It is especially relevant when the
product is likely to become contaminated or damaged by being placed in contact with other stages of
production. It is particularly likely to be relevant to continuous-flow sites where dead space in pipes or
potential mixing with the wrong components may give rise to non-compliant products.
Any site should be able to produce a plan of its process. The auditor can, to some extent, use this as a
site guide. Care should be taken to include all relevant processes. This should cover not only the main
production area but also ancillary storage or mixing facilities, and their relationship with the main
process.
Example
A company produces sachets of liquid laundry detergents. The product has to be adjusted to the right
pH at the end of the line. Any cross-contamination with earlier stages of mixing will result in a
potentially contaminated product. The factory is arranged so that the final stage of mixing is at the end
of the production line and has an automatic check immediately prior to the form fill seal process,
removing any possibility of cross-contamination.
The auditor would find this satisfactory provided the automatic check is adequately calibrated and
tested at suitable intervals.
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Clause 4.3.2
Premises shall allow sufficient working space and storage capacity to enable all operations to be carried
out and, if necessary, in hygienic conditions. The necessary level of hygiene shall be maintained for
each product.
Interpretation
It is self-evident that if a site is too cramped, the quality of the operation is likely to suffer. Auditors
will wish to evaluate the work pattern and discuss how peaks in demand are dealt with. It is essential
that equipment is located with sufficient space to allow easy access for operating, cleaning and
maintenance.

The location of facilities and services, including toilets, cleaning and catering facilities, shall be
segregated and separated from production areas and shall not jeopardise the integrity of the product.
Interpretation
This applies to products where it is important not to risk the product integrity by possible
microbiological or chemical contamination caused by workers or their food and personal effects.
Example
An auditor observes staff eating their lunch on a table situated adjacent to a production line. There is
the potential for staff members to spill food into the product being assembled.
This is unsatisfactory and would result in a non-conformity. All staff facilities should be located so that
product contamination is not possible.

When critical to product safety, legality, quality or customer requirements, controls shall be in place to
ensure that raw materials, work in progress, rework, waste materials, packaging, components and
finished products of different specifications are not inadvertently mixed and are effectively segregated.

There shall be effective segregation to minimise the risk of product cross-contamination taking into
account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and
utilities.
Documented control procedures shall be in place.
Interpretation
It may be necessary to segregate a product for many different reasons for example, to prevent
microbial contamination or to ensure that products for different geographical locations do not mix.
Example
A factory is producing perfumed talcum powder on the same equipment as it uses to produce baby
powder which is unperfumed. The production schedule starts the week with the baby powder and ends
the week with the perfumed powder. The perfume is injected through a separate system directly into
the flow of powder. There are no additional recipe materials. At the weekend the equipment is cleaned
out and an initial charge of unperfumed powder is put through the machine; this is monitored to ensure
that there is no residual perfume, and retained to be added back into the first run of the perfumed
powder. Once the quality control supervisor is certain that there is no smell, a sample is taken to the
laboratory to verify the finding. If the laboratory determines that there is residual perfume, a further
sample is taken and all prior production is added back to the first perfumed batch. If a second sample
fails then the line is stopped and another full clean is carried out.
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The auditor would deem that this was sufficient if there was also evidence that tests had been carried
out to ensure that the first containers of fragrance-free powder did not contain any traceable perfume.
Clause 4.3.5
Where materials or products require special handling procedures to be in place, these shall be
maintained to ensure product safety, quality and legality are not compromised.
Interpretation
It is essential that products are not accidentally mixed for example, when a product is legal in one
country but not another, or where a product contains materials unsuitable for some consumers (such as
when products are separated for older and younger children). It may also be necessary to separate raw
materials or components carefully so that there is no chance of their being used in the wrong products;
for example, making sure that paints containing toxic metals are separated from those that are suitable
for use on childrens products, or separating products that contain fragrances from those that do not.
The Standard is not prescriptive about how separation is done, only that it is considered and carried out
effectively if found to be necessary.
Clause 4.3.6
The company shall determine whether allergenic or sensitising materials are used and, if so,
documented policies shall exist for the handling of such materials including:
physical or time segregation from other products

use of identified, dedicated equipment if necessary
adequate labelling of final products.
Interpretation
This clause relates to the specific cases of handling allergenic or sensitising materials. In these cases,
careful handling is important for several reasons, including:
to avoid cross-contamination of products

to make sure that the correct warning labels are placed on the products with the potential allergens
to ensure ingredients are not confused
to enable good traceability of such materials.
It is also necessary to ensure that the subsequent use, return or disposal of non-conforming materials
are handled and documented correctly. The product to be reworked must be subject to the methods and
inspection or testing requirements that are in place for production.
The auditor will assess whether the segregation is adequate.
Example
A company is producing a fragranced liquid handwash that contains a number of allergenic
compounds. There is a requirement for these chemicals to be listed on the product label. The company
has a system for separating out products at the end of the packing line into a discrete area.
The auditor finds this to be acceptable but wishes to establish how cross-contamination is avoided in
the mixing area. The company needs to demonstrate a suitable cleaning and checking programme.
Clause 4.3.7
Materials and products requiring segregation (e.g. materials intended for different geographical
regions) shall have documented control procedures in place to ensure that product integrity is
maintained.
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Interpretation
Care needs to be taken to ensure that products are not inadvertently mixed. In the case of Forest
Stewardship Council (FSC) paper, for example, the chain of custody needs to be maintained.
Segregation may be physical or by time, although clear identification is the important control.
It is also necessary to ensure that the subsequent use, return or disposal of non-conforming materials is
handled and documented correctly. The product to be reworked must be subject to the methods and
inspection or testing requirements that are in place for production.
The auditor will assess whether the segregation is reliable.
4.4 Building interiors

Statement of intent
The interior of the site, buildings and facilities shall be suitable for the intended purpose.
Interpretation
Buildings should be adequate to allow products to be made safely and of the quality required. The
exact requirements will change depending on product type. A site needs to consider which factors may
affect its products and whether it has taken reasonable steps to avoid or control the risks from these
factors, particularly with regard to appropriate cleaning measures.
Clause 4.4.1
The site shall be maintained to minimise potential for product contamination The quality and finish of
site buildings and facilities, including any pipework and drainage, shall be suitable for the intended
purpose with due regard to the risk to product safety, legality and quality, and shall be maintained to an
appropriate standard. This shall include, as defined by the risk assessment:
a clean, tidy and organised factory

adequate lighting
adequate ventilation
walls, floors, windows, doors and ceilings maintained in a good condition to prevent foreign body
risks
suitable and sufficient removal of any by-products and contaminants.
Interpretation
Judging whether a site is sufficiently clean, tidy and in good repair is subjective, but auditors will be
considering the condition of the site with regard to the potential for any adverse effects on production.
Auditors will expect to see a working environment rather than showcase conditions, but will raise non-
conformities for unnecessarily dirty or untidy sites as well as for unreasonably cramped or congested
locations. A generally clean and tidy site, relative to the product group, may be seen as a reflection of
management commitment and worker safety.
Clause 4.4.2
Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of
products, and effective cleaning.
Interpretation
In a textile site, for example, the exact quality and intensity of light may be specified and important for
colour- and pattern-matching. At a site making plumbing fittings, on the other hand, as long as it is well
lit and operatives can see clearly to work, no further requirements would be necessary. As a guide, the
auditor will want to understand the importance the site places on lighting crucial to the product and, at
the very least, be reassured that eyestrain is avoided.
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Particular industries will have their own detailed requirements and the clauses in this section reflect the
more stringent needs for sites making products with potential cleanliness issues or within particular
environmental settings.
Clause 4.4.3
The site shall be assessed for any particular requirements relevant to the products being produced, such
as temperature, humidity and electrostatic discharge. Any identified requirements shall be adopted,
calibrated, documented, monitored and regularly reviewed.
Interpretation
An assessment should be made to first establish whether any control is needed. Many products are
made satisfactorily in the ambient conditions of the location and do not need further control. Some
products, however, are susceptible to variations in conditions and need to be produced in conditions
where temperature and humidity are controlled. If so, the requirements must be met and compliance
with these requirements monitored. The site should have contingency plans for any failures to meet the
required conditions.
Examples
A site manufactures a variety of household products including some aerosol products with a high
alcohol content. The alcohol-containing products are produced in a separate part of the factory. At the
entrance all personnel are required to undertake a static check and if they fail they are required to wear
a wristband and attach themselves to an earthing cable. The area is enclosed and has been assessed for
possible ignition sources including lighting and mechanical devices.
An auditor in the UK would also wish to see that the site has carried out an assessment in accordance
with The Dangerous Substances and Explosive Atmospheres Regulations 2002 (DSEAR) requirement
(employers are required to control the risks to safety from fire, explosions and substances corrosive to
metals) and may want to see the alcohol licence issued from HM Customs and Excise.
A factory produces toilet tissue. If the humidity is not controlled, it is difficult to prevent mould growth
and/or there is a dust problem. The site has installed humidifiers in the production areas and the area is
checked daily to confirm that a humidity of 5060% is achieved. The humidifiers spray a fine mist that
helps to keep the dust down.
Provided the company can show that the level of control is sufficient to prevent mould growth, this
action would be considered satisfactory.
Clause 4.4.4
Where water quality presents a risk to the final product it shall comply with the required specification
(as defined in the region of intended product sale), suitably treated to prevent contamination and
regularly monitored.
Interpretation
These requirements apply to sites producing goods that need to avoid microbiological contamination.
A site would be expected to demonstrate how it controls the quality of water used on site, and its
knowledge of the requirements for water quality specified for the product in the country of sale.
Auditors would normally expect to see evidence of water sampling and testing for chemical and/or
microbiological contamination done at appropriate frequencies.
4.5 Staff facilities

Statement of intent
Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be
designed and operated to minimise the risk of product contamination. The facilities shall be maintained
in a good and clean condition.
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Interpretation
This clause focuses on staff facilities, from the perspective of eliminating product contamination. There
may be other requirements relating to the health, safety and wellbeing of employees but these are not
part of the scope of the Standard.
Clause 4.5.1
Staff facilities such as washrooms and break areas must be provided and maintained in a clean
condition and segregated from production areas to prevent product contamination.
Where a site provides food service the food preparation areas must be clean and fit for purpose and
adequately segregated from production areas.
Interpretation
The requirement is not for any specific design or type of facility but to ensure that product
contamination is minimised. This generally means that break activities, such as eating, should be in a
place physically removed from any production or packing area.
Example
A customer complaint shows that a customer has received part of a sandwich inside a package they
have purchased containing washing powder.
An investigation reveals that an operator on the packing line had been eating lunch in the area and
mistakenly placed the food into the box.
The auditor would look to see that procedures are now in place that do not allow for the eating of food
near production areas, and that these procedures are effectively monitored otherwise a non-
conformity would result.
Clause 4.5.2
Where smoking or use of electronic cigarettes is allowed under national law, it shall only be permitted
in designated controlled smoking areas which shall be isolated from production and storage areas and
fitted with air extraction to the exterior of the building. Adequate arrangements for dealing with
smokers waste shall also be provided at smoking facilities, both inside buildings and at external
locations.
Interpretation
Smokers waste, such as cigarette ends, matches, ash, snuff and chewing tobacco, can become a source
of product contamination and so must be controlled. External waste should also be controlled to
prevent its being transferred inside the site.
Clause 4.5.3
Storage facilities of sufficient size to accommodate all reasonable personal items shall be provided for
all personnel who work in areas where they are unable to keep possessions with them.
Interpretation
If staff are not allowed to bring their possessions with them into production areas, because of possible
product contamination, they must be provided with adequate and safe storage for their items. This is so
that staff do not try to carry items with them for fear of their being lost, damaged or stolen. The
Standard is not prescriptive on this matter and any solutions suitable to the size and complexity of the
site are acceptable.

Based on risk assessment, the site shall determine and provide workwear as required and make
provisions for changing areas for all personnel: staff, visitors and contractors.
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The site shall use risk assessment to determine where a change to workwear in different areas is
required. Any required changing facilities shall be provided for all personnel: staff, visitors and
contractors. Changing areas should be sited to allow direct access to the production, packing or storage
areas without exposure to any external area. Where this is not possible, the site shall use the risk
assessment to help determine the activities required to mitigate any risk. This procedure shall be
documented.
Interpretation
Applies to both foundation and higher levels
This is intended to prevent general as well as microbiological contamination. Once staff have changed
into their workwear they should be able to enter the production site without the risk of recontaminating
it on their journey from the changing facilities. This is equally important for others (such as
maintenance staff or visitors) entering the site.
In some cases, the design of the site may not allow direct access to the production area from the
changing facilities. If so, the person responsible for the quality, safety and legality of the product must
carry out an assessment to gauge the risk of contamination. It may be necessary to define a specific
procedure (or route) to reach the production area. If the assessment reveals that it is not possible to
reach the production area without a risk of contamination, then the facilities will need to be redesigned.
Clause 4.5.5
Suitable and sufficient hand-cleaning facilities shall be provided at access to production areas, and at
other appropriate points within these areas, based on appropriate risk.
Interpretation
The risk assessment should determine whether hand cleaning is required in order to protect the product
from contamination due to contact from hands. This is more relevant after eating, drinking, smoking or
visiting the toilet.
Where hand cleaning is essential, facilities must be provided in washrooms and other appropriate
points, such as entrances. It is also a requirement that signs or notices are placed near the washing
points. These act as a reminder and should also contain information about how the cleaning shall be
done. It is often appropriate to include pictures or diagrams rather than a lot of text.
4.6 Housekeeping and hygiene

Statement of intent
FUNDAMENTAL
Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene
are maintained at all times and the risk of product contamination is minimised.
Interpretation
No matter what types of products are being made, a clean, tidy site prevents unnecessary contamination
and ensures that the work is carried out in an orderly fashion.
Example
A site has installed a new paint storage section in a previously disused area. The cleaning protocol is
modified to include more frequent cleaning, removal of any paint spillages using a proprietary
specialist cleaner, and checking drain filters to ensure there are no blockages.
The auditor observes the paint store, which appears clean and well organised, and is satisfied the
procedure is operating.
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Clause 4.6.1
Equipment, production and storage areas shall be maintained in a state of cleanliness appropriate to the
operations undertaken. Cleaning practices shall be completed so as to minimise risk of contamination
and records kept.
Interpretation
No matter what types of products are being made, a clean, tidy site prevents unnecessary contamination
and ensures that the work is carried out in an orderly fashion.
The cleaning carried out shall be effective and not cause any product contamination.
Both routine and exceptional cleaning (such as that needed for new equipment, after a close-down or
after maintenance) should be appropriate and of adequate frequency. The use of suitable tools, which
do not in themselves cause contamination, should be considered for example, not using cloths or
mops that are prone to leave threads, or employing colour-coded materials and equipment for use in
different areas. Dedicated, colour-coded equipment can be used for certain areas; for example, red for
toilets.
Example
The auditor asks questions regarding the housekeeping and hygiene equipment and is shown to a
cupboard under the stairs. The cleaner is called and they open the cupboard door to reveal the contents.
Inside there are a number of cleaning chemicals and a book in which there is a material safety data
sheet (MSDS) for each one. The chemicals are not perfumed and are suitable for the cleaning tasks.
The equipment is colour-coded as follows:
red for toilets

yellow for offices
blue for production.
The auditor notices a blue mop and a red mop together with the heads of the mops touching. The
auditor will raise a non-conformity as there is a possibility of cross-contamination from the mops.
Clause 4.6.2
Suitable cleaning chemicals shall be identified, clearly labelled and controlled to prevent the risk of
product contamination. Chemicals shall not be decanted unless into properly labelled and identified
containers. Adequate storage facilities shall be provided and sited so as not to compromise the safety,
legality and quality of the product.
Interpretation
The chemicals used should be chosen carefully so as to leave no taint or smell. Cleaning materials
often contain potentially dangerous chemicals which may become hazardous if mixed with other
materials. All chemicals used on site should be adequately labelled and securely stored. This clause is
included here because the primary use of chemicals on many sites is for cleaning, but the requirements
also apply to any other chemicals used, such as pest control chemicals, weed killers and machine
lubricants. It is not good practice to decant chemicals into other containers, especially if the shapes are
associated with other liquids (for example, decanting a colourless solvent into a soft drink bottle). If
liquids have to be decanted, they must be clearly labelled with as much of the original information as
possible, in particular any safety or warning information and any instructions for use.
Example
A small unlabelled plastic spray bottle is on top of a printing press. The bottle contains solvent to thin
the ink on the press if it becomes sticky.
The auditor will raise a minor non-conformity. The bottle should be labelled with the contents,
warnings and instructions for use.
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Clause 4.6.3
If cleaning services are outsourced, the service providers shall have signed a contract which identifies
the scope and frequency of the work, and records shall be maintained. A defined company
representative shall be responsible for ensuring that the work is carried out satisfactorily.
Interpretation
It is recognised that the cleaning of sites is often carried out by a third-party company. This clause
ensures that the responsibility for a clean, tidy site is not abdicated by the site management and that the
cleaning company used is committed to following suitable methods at a defined frequency.
The clause contains a requirement for a log book to be maintained. This can be done in any format (for
example, signed-off work sheets or computer entries) as long as the information is recorded, signed
and dated.

Documented cleaning procedures shall be in place, validated and maintained for the building, utilities,
plant and all equipment. Where more than basic cleaning is required, cleaning procedures shall include
the following information as a minimum:
responsibility for cleaning

item/area to be cleaned
frequency of cleaning
method of cleaning
cleaning materials to be used
cleaning records and responsibility for verification.
Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented
procedures, and records shall be maintained.
Interpretation
Specified cleaning procedures are needed; the Standard outlines the minimum details to be covered.
Additional information should be added as necessary in order to define the cleaning adequately.
Cleaning personnel should also be trained with regard to the cleaning practices. Training is likely to
take the form of practical demonstrations as well as checks to ensure that the protocols and procedures
are understood. This requirement also applies to any temporary or third-party staff that may be used.

The standard of cleaning shall be appropriate to the product being manufactured and shall be verified
and documented and, where relevant, agreed with the customer. Corrective actions shall be
documented.
Cleaning procedures shall be revalidated following building work, maintenance, changes to equipment
or new product introduction.
Interpretation
In areas where cleanliness is vital, the effectiveness of the cleaning must be confirmed. There are a
number of ways to achieve this and the site would need to assess the most appropriate means for its
own operation. Examples of controls might include:
swabbing to check microbiological cleanliness

confirmation of times and temperature used during steam cleaning
visual and or olfactory inspection
verification that the surface is free from residue
audit of the full cleaning procedure.
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4.7 Waste and waste disposal

Statement of intent
Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation,
mix-up, risk of contamination and the attraction of pests.
Interpretation
This clause is a general requirement for a system to be in place. It does not define the type of system
but does require it to prevent the use of unfit or defective materials. Auditors will observe the
production or packaging site to identify any possible areas where waste may be misused or is poorly
controlled.
Clause 4.7.1
Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation,
mix-up, risk of contamination and the attraction of pests.
Interpretation
Waste material allowed to accumulate in a site may be a source of product contamination, become
confused with satisfactory products or materials, and present a risk of materials being misused.
Example
A company has left a number of drums of rejected plastic stabilising solution outside the factory for
disposal. An employee has been on holiday for a week and does not know they have been rejected.
Thinking they can be used, the employee takes the drums to the production area, without first checking
with the supervisor.
The site should have procedures in place to identify this error before the material is used. Normally the
drums should be clearly labelled as rejected product. If no such procedures are in place, the company
will receive a non-conformity as there is the possibility of an out-of-specification product being
produced.
Clause 4.7.2
Where legally necessary, waste shall be removed by identified, licensed contractors, and records of
disposal shall be maintained by the site.
Interpretation
There are a number of reasons why waste may need to be categorised and segregated. Examples
include:
disposal of toxic waste

disposal of highly flammable waste
segregation for recycling purposes, such as plastic or paper
measurement of weight or volume of some waste, such as batteries.
Some countries have legal requirements covering the waste measures indicated above, as well as
others.
In some cases, particularly those concerning toxic waste, disposal may be carried out only by registered
and licensed operators. If so, the site must demonstrate that appropriate contractors were identified and
evaluated through the sites supplier-approval scheme. The site must also demonstrate that appropriate
records are maintained and include information such as:
identification of material disposed

quantity (volume, weight, number as appropriate)
type and number of containers
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date and time of disposal

signature of waste contractor (or responsible staff member if in-house).

Waste materials shall be controlled, clearly labelled and where necessary quarantined to ensure that
they are not reintroduced into non-waste production flows.
Interpretation
If waste material is not separated from good stock it is likely to become confused. A variety of
quarantine methods, appropriate to the site, can be used and may include:
separate storage areas

defined and colour-coded/fenced-floor areas
separate bins or containers.
If unsafe or illegal products have been identified, they must be disposed of securely to ensure that they
cannot re-enter the supply chain. The site may also have specific customer requirements for products
that do not meet their specifications. In such cases, disposal must be carried out securely and the
disposal/destruction validated and recorded. This work is often subcontracted to specialists. These
specialists must have been evaluated under the supplier-approval procedure.
Any evidence that destroyed product has re-entered the supply chain shall be rigorously investigated.
Example
A company has sent a lot of branded disposable rubber gloves for disposal as the finish does not meet
the customer requirements and the customer has requested that they are destroyed. A batch of rubber
gloves is for sale on the internet, which appears to match the description of the destroyed samples. An
investigation reveals that an employee took a carton from the premises, because they thought it was
wasteful to destroy them.
A site would be expected to deal with this on a number of levels, and to review.

External waste collection containers and compactors shall be managed in such a manner as to minimise
risk to the product if necessary.
Interpretation
This clause is self-explanatory and requires that the containers are managed so as not to present a risk
to the product.
4.8 Pest control

Statement of intent
The whole site shall have an effective preventive pest control programme in place to minimise the risk
of pests. Sufficient resources shall be available to respond rapidly to any issues that occur, in order to
prevent risk to products.
Interpretation
Sites need some form of pest control to ensure that products are not damaged or contaminated. Even
when the product itself is unlikely to be damaged by pests, customers may still have pest control
requirements so as to avoid the problem of infestation in the warehouses or transport.
There are many publications providing further detail on pest control, including the BRC best-practice
guideline, Pest Control.
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Example
A site manufactures facial tissues impregnated with balm. The audit has been scheduled for the two
days immediately prior to a national holiday. The factory manager has requested that all of the
factory/good manufacturing practice elements are undertaken on the first day of the audit with the
paperwork/office side being audited on the second day. During the visit the auditor asks to review the
pest control system on site and is shown a risk assessment that determines an electronic system will
suffice to deter any unwanted pests. Reading the data supplied by the manufacturer, the auditor learns
that the system emits a sine wave that resonates in the heads of small mammals, therefore discouraging
them from staying on site.
On the second day the auditor asks to revisit the production area. They are informed that all staff have
gone home and the area is empty. Still the auditor asks to see something on the shop floor and is taken
down to the production area.
Upon entry to the area the manager switches on the electricity to the production hall. The auditor
enquires if this switch includes the mains plugs, into which the pest control system is plugged, and is
informed that it is.
The auditor raises a non-conformity as the pest control device will be off for the duration of the
holidays.
Clause 4.8.1
The pest control programme shall be based on a documented risk assessment which should include the
product, the material included, the location and type of premises, the possible types of pest, and the
process.
The pest control provider shall be a specialist or a trained employee.
The pest control programme shall include a documented inspection schedule.
Interpretation
The important factor is to identify the target pest. This will vary from region to region; in some
countries lizards and snakes are prevalent, and in others, mammals. Additionally, some products attract
specific pests that will require specialist treatment. In the rare cases where a site considers that no pest
control is required, it must justify its reason for the decision and review it every year.
Note that a site is responsible for managing the risk from pests even if it subcontracts the activity.
Typically, the annual control programme for rodents in the UK would be eight technician visits and one
field biologist visit.
Clause 4.8.2
The company shall either have a clearly defined contract with external contractors which reflects the
activities of the site, or have trained staff.
During each visit activity/action reports shall be completed. These should include observations of pests
or evidence of pest activity and recommendations for action by the site.
Interpretation
Pest control is often subcontracted to external companies, which may need to be licensed or approved
by the authorities. Where contractors are used, the signed contract must clearly define the scope and
level of activity to be provided. If is handled in-house, responsible employees must have undergone
formal training and have demonstrated their competence.
The activity found and any actions undertaken must be recorded so that any trends can be reviewed.
Trends may be seasonal, or there may be a particular hot spot on the site.
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A nominated manager is required so that the sites management team is aware of any issues.
Clause 4.8.3
When necessary, materials or products shall be fumigated, and records of this process shall be kept.
Fumigated goods may not be supplied to customers without full professional safety clearance and
correct clearance documentation. All fumigation operations shall be controlled by staff with
appropriate professional qualifications and/or training.
Interpretation
The fumigation certificate, in respect of international shipping of sea freight (also referred to as a pest
control certificate), is the proof that any wooden packing materials used in international sea freight
shipping, such as pallets, crates or wood, have been fumigated or sterilised prior to the international
shipment.
In general, manufacturers of wooden packaging must meet the International Standards for
Phytosanitary Measures 15 (ISPM15), as this is the standard most commonly used around the world.
If you are despatching goods to another country within the EU there are no additional controls or
standards, other than the presumption that any packaging made from wood produced in EU member
states automatically complies with European Community internal plant health regulations.
Exporters to Portugal are encouraged to use ISPM15-compliant wood packaging to enable its
subsequent reuse outside of Portugal. This is because of emergency measures against the spread of pine
wood nematode present there.
The US Department of Agricultures Animal and Plant Health Inspection Service (APHIS) regulates
the importation of wood and wood products. APHIS requires wood and wood products to undergo
certain phytosanitary procedures prior to importation in order to eliminate the risk of introducing non-
native pests and diseases into the United States.
Clause 4.8.4
Full material safety data sheets for all chemical pest control agents used shall be controlled, available to
relevant staff at all times and kept in a designated place.
Interpretation
The report should contain details of what chemicals were used in which trap. Additionally, MSDS
should be readily available to the site; for example, in the case of accidental poisoning.
4.9 Product storage, dispatch and transport

Statement of intent
Facilities for the storage and transportation of products shall be suitable for purpose and minimise the
risk of product contamination, damage and malicious intervention.
Interpretation
Products are at risk from contamination during storage and when they are being moved around a site or
transported off site. Off-site transport is often outside the control of the production site but, where it has
responsibility for such transport, it must not introduce hazards. The individual requirements listed in
this clause are self-explanatory. Concerns to be considered include:
storage temperature
protection from rain or dust
stacking limitations
handling procedures manual and via pallet truck, etc.
cross-contamination of materials
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security.
Clause 4.9.1
All materials, work in progress and product shall be properly identified and protected during storage by
appropriate packaging to protect the product from contamination.
Clause 4.9.2
Where storage of raw materials, components, packaging, intermediate or finished product is necessary
it shall be maintained in good condition and be securely protected from contamination, deterioration
and damage.
All handling operations during storage shall be managed to prevent product damage.
Clause 4.9.3
Vehicles or containers used for transportation and dispatch of product shall be inspected prior to
loading to ensure that they are fit for purpose. Records of inspection shall be maintained.

Documented procedures to maintain product safety and quality during loading and transportation shall
be developed and implemented.
Clause 4.9.5
Where product is vulnerable to weather damage, vehicles and containers for transportation shall be
loaded and unloaded so as to protect the product.
Clause 4.9.6
Where a third-party haulage contractor is used, all the requirements shall be defined within a contract
and effectively managed.
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5 Product inspection and testing
5.1 Product inspection and laboratory testing

Statement of intent
FUNDAMENTAL
The company shall have a programme for product inspection and testing to control products during and
after production to ensure that products are safe, legal and meet the quality specification.
Interpretation
Inspection includes the measures aimed at checking, measuring, or testing of one or more product
characteristics and to relate the results to the requirements in order to confirm compliance.
Testing is generally carried out using a laboratory to verify product parameters.
This clause addresses the general quality control testing and specific cases when testing of a product
representative of overall production must be carried out because of legislation. The test laboratories are
also often specified. Although this is a fundamental requirement, if a site is making simple, low-risk
products, testing may not be necessary. The site is required to consider this matter, document why no
testing is needed and relate this to the product risk, if any. Once this has been done, the remaining
clauses of the section are not applicable. Sites should expect an auditor to challenge their decision and
be able to justify it.
Clause 5.1.1
There shall be a scheduled product-testing programme according to risk for each product or product
group as defined in the specifications. This shall be based on information such as:
the outcome of the product and process risk assessments

any legal requirements for testing in the regions(s) of intended sale
the sites requirements for demonstrating the production of safe products.
The methods, frequency and specified limits of testing shall be clearly defined.
Interpretation
The testing programme must be established, taking account of the range of factors listed in the
Standard. Usually the programme should be determined before production starts, although there may be
occasions where the need for additional testing is determined at a later date for example, as a result of
complaints, in order to improve features, or to take account of the need to substitute one or more raw
materials.
It is good practice to ensure that products meet the requirements of defined product standards in the
countries or regions of intended sale. For some products this will be a mandatory requirement but, even
when the standards are voluntary, compliance is usually the most straightforward way to show that the
product meets the requirements of the intended market.
Sites should note that some specifiers have their own product standards, which may contain additional
requirements. A site is advised to check if this is the case and, if it is, to make sure that it or its testing
organisation has copies of the most up-to-date requirements.
The test programme must relate to all parts of in-process production and product where testing is
required. It includes tests on raw materials, component parts and products during production as well as
final products. The programme may include testing carried out by third-party laboratories as well as in-
house testing, if this is necessary. When raw materials are specified to be supplied with test reports, this
should also be documented as part of the programme.
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A test programme is not complete unless it details how and when samples are selected, by what criteria
the results should be assessed, and who is responsible for checking and accepting the results.
Example
A company produces pepper mills made with plastic and metal parts. Its test programme comprises the
following:
Polycarbonate bodies are purchased with requirement for a test certificate on each batch to show
the product meets the safety of materials in contact with food requirements. The actual tests and
test methods are defined and all tests must be carried out in a laboratory accredited to ISO 17025
for the defined methods. There is a procedure in place for checking certificates before accepting
goods.
The company has decided that it is foreseeable that these items will be placed in a dishwasher so it
has conducted dishwashing tests to a defined product standard to check suitability. This test has
been carried out by a company experienced in the testing but not accredited.
The company carries out stress-cracking tests on initial samples to confirm that the design does
not have inherent weaknesses, and on a random but defined basis. Quality assurance is responsible
for testing and analysing results.
In-process testing is carried out to ensure that the screws are assembled to the correct torque. There
is an internal procedure which defines the method and equipment to be used for this check. Each
operator checks a sample hourly and records the result on a production control chart. The chart has
clearly defined action and warning limits and there is an established procedure for the operator.
The final product is subject to a performance test to grind 50 g of pepper. The conditions and
procedure for this test are defined. The test is carried out by the quality assurance department.
Every six months a sample of final production is sent to an independent third-party accredited
laboratory to check for compliance with legislation. The precise legislation is defined.
The factory has a procedure for use testing of the mills at home by volunteers, and records of the
performance are kept on a defined chart. The quality assurance manager reviews this information.
An auditor would accept this as an appropriate test programme. Auditors are experienced in the
product categories and may have specific comments to make about any tests that are missing or
inappropriate. Note that the test programme covers quality and performance issues as well as safety
and legality.
Clause 5.1.2
The testing programme shall be implemented and records kept of all test results. Results which are
outside the defined specification shall be reviewed promptly by an authorised competent person. The
need for corrective action shall be assessed and documented, and any action carried out as necessary.
Interpretation
The stages at which a product is tested depends on the product type, and any legal and customer
requirements. It is usually more cost-effective to carry out tests relating to design issues as early on in
the process as possible, so that errors may be corrected before high costs are incurred.
For many higher-risk products, a type test needs to be carried out by an approved third-party
laboratory. This is a test to ensure that the model is made in conformity with the appropriate legal
requirements. Once the product passes this test it is the sites responsibility to ensure that the ongoing
production continues to match the tested sample. Even if there is no legal requirement for a type test,
sites should ensure that the general production samples meet the same standards as tested products.
Note that a site needs to be cautious when accepting testing of raw materials packaging and
components as an alternative to final-product testing. It may be that all individual components and
materials are satisfactory, but that there is an interaction between them or the way they in which they
are used, which means that the final product is unsafe. It is industry best practice to test the final
product randomly to ensure that the product going to the consumer is satisfactory.
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Example
A company uses a solvent-based glue to assemble a product. The glue and the plastic materials being
assembled have both been tested and comply with legal requirements and the specification. When
assembled, the solvent from the glue affects another component adjacent to the glued area, causing it to
weaken and break under some conditions.
Testing of the final product would have revealed this issue.
Clause 5.1.3
Where the company undertakes or subcontracts analyses which are critical to product safety or legality,
the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in
accordance with the requirements and principles of ISO/IEC 17025.
Documented justification shall be available where accredited methods are not undertaken.
Interpretation
There are many things to consider when deciding where testing is to be performed and who will carry it
out.
It is essential to use accredited laboratories only for tests critical to safety or legality that are not also
validated by additional tests. For example, a strength test carried out on the site does not need to be
accredited if some random samples are also sent to a third-party laboratory for verification of the
results.
An accredited laboratory is one which has been audited by the appropriate national accreditation
service to check that it operates in accordance with ISO 17025. There are other accreditation schemes
in some countries but these generally follow the same principles. If a laboratory is working to an
alternative scheme, this can be accepted provided it has been audited by a competent and independent
third party and can show that it follows the requirements of ISO 17025.
Sites should note the following important points about accreditation:
Each accredited laboratory has a scope of accreditation, which is publicly available. Only those
tests listed on the scope are accredited.
A laboratory is unlikely to be accredited for all the tests it performs. This does not mean that it is
performing other test work to a lower standard but it may indicate that it performs the testing less
frequently, does not have exactly the right equipment or has not found accreditation to be cost-
effective. If in doubt, a site should ask the laboratory why it is not accredited for a particular test.
When an accredited laboratory is not available for some tests, the site wishing to test products
should confirm that its chosen laboratory is working to the principles of ISO 17025. An auditor
would ask for justification of the use of such a laboratory if the test was key to safety or legality.
The Standard is not prescriptive about this, as long as testing is carried out competently and meets
customer and legal requirements. The following should be considered when planning testing:
Customers may have preferred or required test laboratories.

Testing the final product in the country of origin may give faster response times and make it
easier to discuss results, but testing in the country of sale may be more acceptable to the
customer.
Some type tests must be carried out by laboratories approved by the authorities.
Even if capabilities exist in-house, it is sometimes useful to have independent verification of
key results both as a benchmark and to reassure clients.
Some test results are subject to interpretation and differing opinions. It can be useful to get
more than one view on tests for important projects.
Sites should always be satisfied that testing is carried out by competent and trained staff.
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Clause 5.1.4
Procedures shall be in place to ensure reliability of test results, other than those critical to safety and
legality. These shall include:
use of recognised test methods and reference standards, where available

documented testing procedures
ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
use of a system to verify the accuracy of test results (e.g. ring or proficiency testing)
use of appropriately calibrated and maintained equipment.
Interpretation
It is essential that inaccurate results are not relied on. It is also important that the test methods used are
precise, accurate and can meet the required detection limits for the substance being measured.
Likewise, the correct level of discrimination must be possible.
Part of the assessment to ISO 17025 is that the laboratory uses suitably validated test methods and has
the right quality assurance procedures in place. Even when tests are being carried out by non-accredited
entities, it is still important that test results are accurate and robust. The Standard suggests a number of
possible ways to do this but the list is not exhaustive. For straightforward tests and measurements, very
simple means may be available (for example, cross-checking a measurement with two different makes
of measuring rule), but in other cases more complex work will be required.
The advantage of using recognised test methods, published in national or international standards or
similar documents, is that the methods have already been validated and checked so sites can use them
with confidence and just have a procedure in place for ensuring the quality of their own performance. If
a site wishes to use a method that is not recognised or is an in-house method, it will need to record and
document the data justifying its validity.
Example
A company uses a spring-loaded micrometer gauge to measure the thickness of plastic sandwich bags.
The results are quoted to an accuracy of 0.001 mm but when checked the instrument is only accurate
and calibrated to 0.01 mm.
Auditors will check the validity of results. In this case a non-conformity would result as the bag
thickness has not been correctly checked.
Clause 5.1.5
Test and inspection results shall be reviewed regularly to identify trends. The significance of external
laboratory results must be understood and acted upon accordingly.
Appropriate actions shall be implemented promptly to address any unsatisfactory trends.
Interpretation
The Standard requires that all results falling outside the defined specification are reviewed and actioned
by the responsible person. It is essential that such results are not ignored until the annual review. It may
be appropriate, depending on the risk, to define a maximum length of time before reviewing the
relevant procedures.
It is also possible that a nominated deputy will need to be assigned to this task. Although this is not a
specific requirement of the Standard, it is good practice for the responsible person to also review a
selection of results that are in specification, since errors can be made with false pass results as well as
failures. This review should form a part of the internal audit for the department responsible.

Where testing is submitted to third parties, the required testing shall be clearly defined, including
reference to the number, date and version of the test standard or method to be used.
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In cases where the company relies on the expertise of third-party testing organisations to determine
appropriate test requirements, the company shall ensure that the third party receives a clear written
briefing on the purpose of the test and that the testing programme is formally agreed and documented.
Interpretation
A test programme should be defined as precisely as possible to remove ambiguities. For example, if the
tests required are referenced by a product standard, the edition and section of that standard should be
clearly stated. Sites often rely on their test houses to advise on the appropriate requirements, as test
houses have more expertise in this area. This is quite acceptable but the site must ensure that the
laboratory receives a written brief as to the requirements. Examples of this would be:
defining the countries of intended sale

clarifying any testing which is not required for example, chemical testing of components
indicating any user or usage information for example, the intended age range for childrens
products
explaining any limitations to the sample for example, the final product will be in a different
colour
the availability or unavailability of more samples so that the laboratory knows whether it has to
do all tests on the product provided.
The individual responsible for the testing programme and follow-up must be clearly identified.
5.2 Quantity control

Statement of intent
The company shall operate a quantity control system which conforms to the legal requirements in the
country where the product is sold and any additional customer requirements.
Interpretation
For many product types, and in many countries, product quantity labelling is a legal requirement and
the accuracy of information on this labelling is defined. The method and frequency of validating the
information may also be legally set. Sites should be aware of, and abide by, any such requirements.
Example
A company producing shoe polish for the European market labels the bottles with the net weight. The
weight is described using the European average weight system. The company is obliged to check a
defined number of products and to record that the average weights are within the defined acceptable
tolerances.
The auditor is likely to ask to see an example of the records and, if they are not available, a non-
conformity would be raised.
Clause 5.2.1
Where necessary the company shall operate a quantity control system which conforms to legal
requirements and/or specified customer requirements in the region where the product is available for
sale.
Documentary evidence shall be available on site to substantiate claims.
Interpretation
Documentary evidence must be available on site to substantiate any quantity claims, such as net weight
or average contents. These are governed by legislation such as the following:
UK The Weights and Measures (Packaged Goods) Regulations 2006

USA The Fair Packaging and Labeling Act (FPLA)
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Canada Weights and Measures Act (RS 1985).
Clause 5.2.2
Where quantity checking is required, the frequency and methodology used based on valid sampling
plans shall meet the minimum requirements of any legislation governing quantity verification.
Interpretation
In Europe, quantity checking is governed by Council Directive 76/211/EEC of 20 January 1976 on the
approximation of the laws of the member states relating to the making-up by weight or by volume of
certain pre-packaged products.
In the UK it is enacted by the Weights and Measures (Packaged Goods) Regulations 2006. These
regulations set out three rules with which packers and importers must comply:
The contents of the packages must not be less on average than the nominal quantity.
The proportion of packages that are short of the stated quantity by more than a defined amount (the
tolerable negative error) should be less than a specified level.
No package should be short by twice the tolerable negative error.
This statement is taken from the regulations themselves and it simply means that on average the
average of the average must not be less than the nominal stated average.
The regulations provide protection for consumers against short measures.
Packers and importers must ensure that packaged goods are labelled with the quantity. The information
must be visible, indelible, easy to read and not able to be damaged.
In Canada the Consumer Packaging and Labelling Act and Regulations (RSC, 1985, c. C-38) apply.
There are three principles that must be met to comply with the accuracy requirements of the Consumer
Packaging and Labelling Act and Regulations:
The declared quantity on a package should accurately reflect the quantity being supplied, so the
average net contents of the packages in a lot (batch) may not be less than the declared quantity.
The control over production should be such that the individual packages are within allowable
tolerances. No more than 2.5% of the lot may have a negative error larger than the tolerance.
The number of packages that may have excessive negative errors is limited. Not more than one
package may contain less than twice the permitted tolerance. For example, if tolerance 1 (T1) is set
at 5 g then a single unit with less than 10 g (T2) is illegal.
5.3 Product sample control

Statement of intent
The site shall ensure that procedures are in place for the selection, handling, storage, approval and use
of reference samples taken from pre-production, subcontracted and finished production in accordance
with customer requirements.
Interpretation
It is helpful if a site keeps a sample of the product it intends to make. It may also be useful to keep
subassemblies or components if there are a number of variations to the same model.
A site will often operate a final approved sample system with its customers. If so, a documented
procedure, in which samples are matched with first examples from the production line, should be in
place to ensure compliance with customer requirements.
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Example
A company makes a number of slight variations on a basically similar insect repellent spray. It decides
to keep one complete sample and samples of various components of packaging to cover the entire
range. For each style, a full specification and parts list (of the aerosol components) are generated.
The auditor will be satisfied with the approach provided that the company can demonstrate that all
variants of assembly and manufacture are covered.

Where legally required or specified by a customer, a reference sample of the product which has been
approved by the customer or a representative of the agreed specification shall be retained.
Interpretation
Sites must determine how samples are to be selected, taking into account whether samples are kept at
various stages before production for example, first model, looks like, works like model or final pre-
production sample. They should also consider how samples are identified and selected, and who
approves the sample. Any known differences between the sample and production should be noted.
Customers often have their own requirements concerning samples. If so, a copy of their requirements
should be available and the site procedure should detail how these requirements are implemented and
reviewed. These are often referred to as red, black or gold sealed samples.

Where legally required or specified by a customer, a sample of the product which has been approved
by the customer or a representative of the agreed specification shall be retained.
The company shall document a process to identify, select and categorise reference samples. If
customers have a defined system of sealed samples referring to different stages of sample approval, the
customers procedure shall be documented and followed.
Interpretation
Sites must have a written procedure to explain how samples are selected, which takes into account
whether samples are kept at various stages before production for example, first model, looks like,
works like model and final pre-production sample. The procedure should include how samples are
identified and selected, and who approves the sample. Any known differences between the sample and
production should be noted.
Customers often have their own requirements concerning samples. If so, a copy of their requirements
should be available and the site procedure should detail how these requirements are implemented and
reviewed. These are sometimes referred to as red or bronze for pre-production samples or green or
gold sealed samples for production.
Clause 5.3.2
Reference samples shall be stored and recorded in suitable environmental conditions to maintain their
original status for a specified period.
Interpretation
It is helpful if a site keeps a sample of the product it intends to make. It may also be useful to keep
subassemblies of materials or components if there are a number of variations to the same product. A
site will often operate a final approved sample system with its customers. If so, a documented
procedure, in which samples are matched with first examples from the production line, should be in
place to ensure compliance with customer requirements. Samples must be stored correctly; where an
investigation of a production issue is necessary, it will be unhelpful to find the reference sample rotten,
faded or otherwise deteriorated.
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Requirements usually concern keeping products at the right temperature and/or humidity, but other
aspects, such as light or freedom from magnetism, can be important in some cases. If the site does not
know what storage conditions are suitable for its products, it should examine the samples at suitable
intervals to determine whether any deterioration is noticeable.
The site would be expected to understand the impact of storage conditions on the quality of stored
product, and apply suitable controls.
Example
A company makes a number of slight variations on a basically similar washing-up liquid. It decides to
keep one filled labelled bottle and samples of labels and manufactured liquid to cover the entire range.
For each variant a recipe and bill of materials are generated.
The auditor will be satisfied with the approach provided that the company can demonstrate that all
issues of manufacture and filling are covered.

A secure and tamper-evident system shall be in place for the storage of samples. A sample-tracking
process shall be in place and temporary removal of samples shall be managed.

A secure and tamper-evident system shall be in place for the storage and tracking of samples, with
access by authorised personnel.
The removal and return of samples to storage shall be documented and authorised by a designated
responsible person.
Interpretation
Storage of sealed, pre- and post-production samples must be secure. If samples are not controlled it is
not possible to say whether they have been substituted, left in unsuitable conditions, modified or
otherwise changed. Samples may also be removed or lost without secure storage. The level of such a
system, and whether each product needs to be controlled or if it is sufficient to keep products in a
locked room or cupboard with controlled entry, will depend on the type of product, the site and any
customer requirements. The auditor will be looking for a system which gives confidence that the
samples are reliable reflections of the pre-production model.
This requirement is not intended to prevent samples being used or examined but to ensure that such
events take place in a controlled way and with an appropriate procedure in operation.
Examples
A small company is manufacturing disposable tableware products. It labels an example of each type
with a numbered paper label and stores it in a locked cupboard. The label issue is controlled on a
spread sheet detailing the product by label number.
This is appropriate for the activity and an auditor would find it an acceptable approach.
A large factory manufactures baby nappies (diapers) with a variety of designs used on the elasticated
waistbands for the high street retailers. The customer requires that each design is sealed in a bag with a
tamper-proof seal and a log signed by the responsible person. If the bag is opened or the seal broken,
the factory has to contact the customer.
The auditor would check that the process had been followed and look for evidence of missing samples
or samples with damaged seals. If any evidence is found and the customer has not been informed, then
a non-conformity would be raised.
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Clause 5.3.4 higher

Documented procedures shall be in place to determine the retention time for samples. This should
normally be the foreseeable lifetime of the product unless otherwise justified.
page 68 of 89
6 Process control
6.1 Control of operations

Statement of intent
FUNDAMENTAL
The sites programme of process and quality controls to ensure the production of safe and legal
products of consistent quality shall be based on a risk assessment of the production process and the
potential for product contamination.
Interpretation
This is a fundamental requirement because, without proper control of the sites process, safe products
that are fit for purpose cannot be consistently achieved.
There are various aspects to product safety, quality and legality:
designing a product
selecting materials that are capable of resulting in a safe, quality product
ensuring that the manufacturing process is controlled so that this is achieved on a consistent basis
packaging products appropriately
ensuring that products contain suitable warnings and adequate instructions.
The risk assessment should consider the whole programme from new product development through to
dispatch. It should take into account all components, including packaging and the legal requirements
for the country in which the product is to be sold.
6.1.1 Process risk assessment

A hazard and risk analysis shall be carried out by a multi-disciplinary team or demonstrably competent
manager.
In the event of the site not having appropriate in-house knowledge, external expertise may be sought
but the day-to-day management of the system shall remain the responsibility of the site.

A hazard and risk analysis shall be carried out by a multi-disciplinary team including representatives
who are experienced in the particular activities undertaken by the site. The team members shall have
knowledge of the hazard and risk analysis principles.
Interpretation
For a comprehensive hazard and risk analysis to be established and maintained, it needs to be managed
by a nominated team with relevant skills and experience. The number of team members needs to be
appropriate to the size and structure of the company, as the team will include representatives of each
department with responsibility for the operation of the Standard. There will always be more than one
person, since a single person does not constitute a team. The team needs knowledge of the types of
operations that are carried out at the site and the hazards these operations may present to the product.
It is good practice to document the team members within the study, with a summary of their roles
within the company. Membership of the team needs to be reviewed and, when necessary, updated (e.g.
when job responsibilities change or personnel leave or join the company).
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The team leader must be able to demonstrate competency and experience in using the HARA tools and
processes. This can be shown by:
the quality of the plan

documented evidence of the team leaders qualification (e.g. successful completion of an industry-
recognised risk assessment training course)
demonstrable, extensive experience in implementing or training e.g. FMEA, HACCP, HARPC,
nomograms, ISO 31000:2009 or AS/NZS 4360:2004.
Training records (see clause 7.1) need to demonstrate that adequate training has been given to all
HARA team members. This may be achieved through either an external course or internal training.
Senior management commitment (see clause 1.1) is required to support the HARA team. This may be
demonstrated by the presence of senior management within the team, policy statements referring to
HARA, or evidence within management review meetings that HARA issues are discussed and
reviewed. The results of the HARA plan must be integrated into the product safety and quality
management system.

The person responsible for leading the hazard analysis shall receive sufficient training to be able to
demonstrate competence in the understanding of hazard and risk management principles and their
application.
In the event of the site not having appropriate in-house knowledge, external expertise may be sought
but the day-to-day management of the system shall remain the responsibility of the site.
Interpretation
The team leader must be able to demonstrate competency and experience in using the HARA tools and
processes; this can be shown by:
the quality of the plan

documented evidence of the team leaders qualification (e.g. successful completion of an industry-
recognised risk assessment training course)
demonstrable, extensive experience in implementing or training (e.g. FMEA, HACCP, HARPC,
nomograms, ISO 31000:2009 or AS/NZS 4360:2004.
Training records (see clause 7.1) need to demonstrate that adequate training has been given to the
HARA team leader. This may be achieved through either an external course or internal training.
Clause 6.1.1.3
Where the hazard and risk analysis study has been undertaken centrally by the head office, accurate
flow diagrams shall be available on site.
It must be possible to demonstrate that a central hazard and risk analysis has been verified to meet the
specific activities of the local operation. Verification activities include internal audits and complaints
analysis.
Interpretation
The flow diagram should include all of the inputs to the manufacturing process, from new product
development to delivery.
Clause 6.1.1.4
The scope of the hazard and risk analysis shall be defined in terms of the products and processes that
are covered.
The site shall establish precise process flow diagrams identifying each step in the production of the
products.
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The site shall consider the potential product safety and quality issues which could occur at each process
stage.
Each potential issue shall be assessed to determine the level of risk and suitable controls established to
reduce or eliminate the risk.

The site shall consider the potential product safety and quality issues which could occur at each process
stage. This should include:
physical or chemical product contamination

microbiological contamination
product quality or safety issues as appropriate to the products manufactured.
The results of this assessment shall be documented.
Interpretation
See the interpretation guidance given for clause 6.1.1.6: higher.

An analysis of any identified issues shall be undertaken in order to decide which need to be controlled.
The following should be considered:
the likely occurrence of the issue

the severity of the hazard (e.g. injurious to health, potential to cause, rejection or a product recall)
existing activities that effectively prevent or reduce the issue to acceptable limits.
Interpretation
The site needs to identify the hazards that might be introduced if production is not adequately
controlled. Hazards may be contamination issues or indeed poor controls leading to poor performance.
They can be introduced in a number of ways, including:
poor control of equipment settings

use of incorrect parameters, such as time or temperature
malfunctioning equipment
use of unsuitable raw materials.
contamination from machinery, buildings, other products, etc.
poor or ineffective quality checks
A site should carry out and document the assessment even if, subsequently, no additional hazards or
control points are required.

Where any significant product safety or quality issues are controlled by process monitoring the process
parameters shall be defined and records retained of checks of the process.

For each issue which requires control, control points shall be reviewed to identify those that are critical
to prevent, eliminate or reduce a significant issue to acceptable limits.
Interpretation
Process monitoring shall be established and adequately controlled to ensure products are produced
within the required process specification.
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Which parts of the process (if any) need to be monitored is established following the assessment of
potential hazards and required process control. Monitoring may be needed on the product itself (for
example, pH or viscosity measurements) or the environmental conditions. In all cases the parameter to
be measured should be clearly defined as well as the acceptable tolerance, frequency of measurement,
measuring equipment and means of recording results.
It is likely that auditors will ask to view some of these records, such as control charts filled in by
operators, or automated electronic records.
Examples
A cosmetics company has to control the temperature settings on the mixing machines to ensure a
consistent mix with no lumps. The process is monitored by automatic temperature checks, visual
examination, filtration and viscosity testing on site. All results are plotted on control charts with
defined process limits. Photographs are available to compare acceptable results against rejects.
This is a good example of the appropriate action being taken.
A household chemical company is manufacturing a toilet bleach. It has carried out a risk assessment
and knows that if the product becomes contaminated with aluminium, aluminium hydroxide would
form causing a hazard as the bottle could expand and leak or even explode. In order to avoid this, the
site measures the levels of contamination in the finished product.
By comparing the levels of contamination with the maximum safety level, the company knows whether
the products easily satisfy requirements or are close to the limit. This may determine if the
manufactured product is suitable for bottling.
A company is producing skin lotion; it has carried out an assessment and established that if the water
quality is not controlled, there is a risk of product contamination. A further assessment shows that both
the quality of the incoming water and the cleanliness of interior pipes are important and monitoring is
required.
An auditor would look for the actions that have been put in place as a result of this evaluation.
Clause 6.1.1.8
If there are identified critical control points (CCPs) where product safety and legality require control
measures to be in place, then for each CCP the site shall:
establish and validate critical limits

establish a system to monitor control of the CCPs
establish the corrective action to be taken when monitoring indicates that a particular CCP is not
under control
establish procedures of validation and verification to confirm that the system is working
effectively, including auditing of the system
establish appropriate documentation concerning all procedures and records.
Interpretation
Critical control points (CCPs) are those points at which a parameter must be controlled and monitored
in order to prevent critical problems occurring in the process. This is usually recognised as the last
point in the process which can be detected and monitored and as a result there can be no subsequent
step that will eliminate or reduce the effect. There would not normally be many of these points, since
there are usually only a few really critical steps. Other points that need to be controlled, but are not
critical to the product integrity, are called control points and may well be controlled through
monitoring programmes.
The monitoring at a CCP should be something that can be done and recorded in order to detect
problems. The control points should have defined monitoring and set limits outside of which action
must be taken.
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A common misperception is that the complete product safety test represents a CCP; in fact this is
unlikely to be the case. This is because a CCP reflects many different aspects of manufacturing, usually
takes several days, and the result is only known when production is complete. Unless there is a positive
release system in place, then this is not a control as the product could be sold before the safety test
results are known.
Examples
A company is making childrens SPF factor 50 washable sun cream. It is important that the product
meets all safety requirements so the company has set a CCP that it has to pass in order to meet the
product standard for Regulation (EC) No 1223/2009. It has one product per batch tested to this standard
by an external laboratory from a production of 20,000 bottles.
The test is important but it is not a CCP. It is not a test that gives an indication of where a critical
production issue has to be controlled. A more realistic CCP might be an online check to ensure that the
total viable count of microorganisms is below the required specification and/or that the laboratory
analysis of the sunscreen pH is as the specification. This can be checked, recorded and action taken if
it is outside the allowed tolerance.
A company is monitoring the pH of a skin cream as a CCP. Records show that the pH was outside of
the specification on several occasions but no actions were documented and it did not appear that any
action had been taken.
This would result in a major or even critical non-conformity since control at this point has been
designated as critical to the process, but no action has been taken.
Clause 6.1.1.9
Corrective action shall be taken in the event of deviation of the process from specification. This shall
be recorded.
Clause 6.1.1.10
The hazard and risk analysis shall be reviewed whenever new product types are manufactured or
significant changes are made to production methods.
Interpretation
Once the HARA has been developed it must be reviewed if anything in the process changes. This could
include buying raw materials from a different source or developing a new product or processing
method. The HARA must be reviewed to establish that no new risks have been introduced. Failures of
the product or similar products in service might also trigger this review as they may indicate some
hitherto underlying issue that has yet to be discovered.
Other factors may include changes in legislation; some legislation, such as REACH, has been updated
on a regular basis. As a result, a chemical in use now may not be acceptable in the future. For example,
on 6 April 2016 the results of 48 substances evaluated under the Community Rolling Action Plan
(CoRAP) were released by the European Chemicals Agency (ECHA). Since 1 September 2016
companies must apply for the approval of active substances in biocidal products that used to be outside
the scope under the previous directive but now fall within the scope of the Biocidal Products
Regulation. This regulation concerns two groups of substances:
active substances in food-contact materials for surface action; for example, antimicrobial
substances used on plastic chopping boards to give them an antimicrobial surface (product type 4,
disinfection of material which may have contact with food)
in situ-generated active substances with precursors that were not in the scope of the directive
because they were not placed on the market, or because no claim was made that these precursors
could be used for a biocidal purpose. For example, ozone generated from oxygen from the air
(product type 5, disinfection of drinking water), which may be used in drinks dispensers.
page 73 of 89

The hazard and risk analysis shall also be formally reviewed at least annually and this review shall be
documented.
6.1.2 Line clearance and in-process checks

Before the start of any manufacturing operation and following changes of product, checks shall be
made to ensure that the production line has been cleared and made ready for use.
All work instructions, raw materials, components and packaging with the necessary equipment shall be
available for use.

Before the start of any manufacturing operation, documented checks shall be carried out to ensure that
the production line and the relevant areas around it have been cleared and, where necessary, cleaned, to
avoid mixing with materials from the previous operations.
All documentation, raw materials, components and packaging with the necessary equipment shall be
available for use.
It shall be possible to identify the production line with its name or identifying code as determined by
the risk assessment.
Interpretation
It is vital that all previous production materials are cleared away, including labels and packaging as
well as components and chemicals. This is to avoid inadvertent mixing. Additionally, any instructions
on manufacture or assembly should also be removed so that there is no possibility of confusing them in
any way.
6.2 Equipment and equipment maintenance

Statement of intent
Equipment shall be suitable for the intended purpose and shall be used in such a way as to minimise the
risk of contamination of product.
Interpretation
Equipment to manufacture product should be specified prior to commissioning. The equipment must be
fit for purpose and even if it has been altered so as to manufacture a product it must perform in a way
that doesnt compromise product safety quality or legality. For example, if the product is a low pH
cleaner then the plant including pipework mixing vessels and filling heads should be constructed of
non-reactive materials that wont leach chemicals into the product and or wont fail due to becoming
brittle for example.
Clause 6.2.1
All equipment shall be fit for purpose and constructed of appropriate materials.
The design and placement of equipment shall ensure it can be effectively cleaned and maintained.
Interpretation
Equipment to manufacture product should be specified prior to commissioning. The equipment must be
fit for purpose; even if it has been altered to manufacture a product it must perform in a way that does
not compromise product safety, quality or legality. For example, if the product is an injection-moulded
plastic the plant, including pipework, mixing vessels and filling heads, should be constructed of non-
reactive materials that will not leach chemicals into the product and will not fail because of erosion.
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Clause 6.2.2
In the case of equipment failure, procedures shall be in place to establish the safety and legal status of
the product prior to release.
Interpretation
Steps must be taken to ensure the product is still safe, legal and of the right quality in the event of plant
or equipment failure. This is especially important in the case of in-line testing equipment, coding
equipment or parameter monitoring/controlling equipment for a CCP.

An implemented maintenance programme covering all items of equipment and plant which are critical
to product safety, legality and quality shall be in place.

A documented planned preventive maintenance programme based on risk assessment and covering all
items of equipment and plant which are critical to product safety, legality and quality shall be in place.
Interpretation
Planned preventive maintenance (PPM) or planned maintenance (PM) is a form of scheduled
maintenance to any item of equipment. This can be carried out by on-site engineers or by a
subcontractor on a scheduled service visit, to ensure that an item of equipment is operating correctly
and therefore avoiding any unscheduled breakdowns and downtime. Such maintenance must be carried
out according to the manufacturers recommendations or legislation.
Example
In the UK, a fork lift truck is legislated for under the Lifting Operations and Lifting Equipment
Regulations 1998 (LOLER), which requires the truck to be serviced (dependent upon use
approximately twice per year) by a competent service engineer. Other mechanical equipment such as a
power press is legislated for under the Provision and Use of Work Equipment Regulations 1998
(PUWER) (SI 1998/2306) which implement the provisions of the Use of Work Equipment Directive
(89/655/EEC) and Directive 95/63/EC on the Amended Use of Work Equipment. Once again, the
frequency of servicing is determined and whilst it is not concerned with productivity, some safety
maintenance activities will also have production benefits.
The auditor will review the equipment during the site tour and may ask to see more details of the
specifications or maintenance schedules. An auditor might also examine production control records to
establish whether the equipment is capable of consistently producing products which meet
specification.
Clause 6.2.4
Materials (e.g. chemical lubricating oils and paints) used for equipment and plant maintenance shall be
assessed to establish whether they pose a risk by direct or indirect contact with raw materials,
intermediates, components, packaging and finished products. If necessary, they shall be suitably
identified for the intended use and controlled.
Interpretation
In the UK, the Control of Substances Hazardous to Health Regulations 2002 (COSHH) requires
employers to either prevent or reduce their workers exposure to substances that are hazardous to their
health. Safety data sheets (SDSs) provide information on all chemical products to help users of those
chemicals make a risk assessment. They describe the hazards the chemical presents, and give
information on handling, storage and emergency measures in case of accident.
In the US, the Occupational Safety and Health Act of 1970 (OSH Act) (29 USC 651 et seq.; 29 CFR
Parts 1900 to 2400) requires manufacturers and importers of hazardous materials to conduct hazard
evaluations of the products they manufacture or import. If a product is found to be hazardous under the
terms of the standard, the manufacturer or importer must so indicate on containers of the material, and
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the first shipment of the material to a new customer must include a material safety data sheet (MSDS).
Employers must use these MSDSs to train their employees to recognise and avoid the hazards
presented by the materials.
In Australia, the Work Health and Safety Regulations (WHS) require the manufacturer or importer of a
hazardous chemical to prepare an SDS for the chemical. Additionally, a supplier must provide the
manufacturers or suppliers current SDS for the hazardous chemical on first supply to a workplace and
upon request.
If a chemical was to pose a risk to a worker, then that chemical would possibly pose a risk to the end-
consumer.
Clause 6.2.5
Repairs or servicing of equipment shall be completed by competent maintenance personnel.
Clause 6.2.6
When possible, equipment shall be positioned so as to give access beneath, inside and around it for
ease of cleaning and servicing.
6.3 Product contamination control

Statement of intent
Appropriate facilities and procedures shall be in place to control the risk of foreign body, chemical or
biological contamination.
Interpretation
The site must identify the level of control that is required. There are various kinds of foreign-body
detection but this clause most commonly applies to metal detectors. The BRC best-practice guideline,
Foreign Body Detection, gives guidance for those seeking further information.
6.3.1 Identification and prevention of risk of product contamination
Clause 6.3.1.1
The site shall ensure that all necessary steps are taken to identify and prevent the risks of foreign body,
chemical and biological contamination as identified by risk assessment. This shall include any
contamination potentially introduced by raw materials, components or packaging.
6.3.2 Chemical and biological control
Clause 6.3.2.1
Processes shall be in place to manage the use, storage and handling of non-production chemicals and
biological materials to prevent contamination. These shall include as a minimum:
a list of approved chemicals for purchase

availability of material safety data sheets
the labelling and/or identification of containers of chemicals and biological materials at all times
a designated storage area with access restricted to authorised personnel.
6.3.3 Metal control
Clause 6.3.3.1
Tools and other sharp metal implements including knives, cutting blades, needles, perforation blades
and wires used in production shall be controlled where there is a risk of product contamination.
Methods such as, but not limited to, the following may be used:
page 76 of 89
tools permanently attached to equipment to prevent loss

items controlled by an issue listing and registration procedure
recovery of all parts of broken needles before the issue of a replacement needle.
Snap-off-blade knives shall be prohibited.
Clause 6.3.3.2
Staples, paper clips and drawing pins shall not be used in open product areas.
Where staples or other items are present as packaging materials or closures, appropriate precautions
shall be taken to minimise the risk of product contamination.
Interpretation
There should be clear controls in the case where staples are used to close boxes, or metal closures are
used for banding. This is important both with regard to the loose staples or closures and to the quality
of the form so that there are no sharp edges or other hazards.
6.3.4 Glass, brittle plastic, ceramics, wood and similar materials control
Clause 6.3.4.1
Glass or other brittle materials shall be excluded or protected against breakage in areas where there is a
risk of product contamination.
Interpretation
Breakages need to be controlled. There should be a process for ensuring all of the sharp material is
accounted for in the event of a breakage. In some cases this may involve reconstructing the broken item
to see if anything is missing. As well as cleaning up the broken items, some companies will use
dedicated or disposable equipment to prevent the spread of small particles.
Clause 6.3.4.2
Where there is a potential risk to product all glass, ceramic, wood and brittle-plastic items in
production areas (except where the item is part of the product) shall be included in the risk assessment
and listed in a register. Documented procedures for handling these materials shall include:
regular checks of the condition of these materials carried out at specified intervals and recorded
recording of all breakages in an incident report
segregation of contaminated product
recording details of cleaning or replacement to minimise potential for product contamination.
Interpretation
It is important to assess the risk to the product from any non-production glass, ceramics or indeed any
material that could become sharp when broken. The risk is obvious in the case of a glass window in a
production hall, but may be considerably less obvious for a changing-room mirror.
Examples
During the audit the auditor notices that the mirror in the ladies changing room is cracked. Upon
investigation the site quality manager tells the auditor that they had not considered the changing rooms
to be an area where the glass needs to be monitored and it is not mentioned in the register. The auditor
reviews the risk assessment and confirms that the site thought that the mirrors and windows in the
changing areas were far enough away from the production hall to be of little or no risk to the product.
The auditor would accept this argument if the consideration was reasonable. However, if there was a
possibility of glass fragments being transferred into the production areas on the staffs workwear, the
auditor would raise a non-conformity.
page 77 of 89
During the audit the auditor notices that the reed diffuser filling line and the candle line both have glass
receptacles. The process is defined and in the event of glass breakage the line operatives are required to
use a disposable broom and dustpan system. The equipment is colour-coded yellow and is thrown away
following the clear-up.
This would be acceptable.
6.3.5 Foreign body detection and removal equipment
Statement of intent
The risk assessment shall identify the potential use of equipment to detect or remove foreign body
contamination.
6.3.5.1 Filters and sieves
Clause 6.3.5.1.1
Filters and sieves used for foreign body control shall be of a specified mesh size or gauge and designed
to provide the maximum protection that is practical for the product. Material retained or removed by
the system shall be examined and recorded to identify risks.
Clause 6.3.5.1.2: foundation

Filters and sieves shall be regularly inspected and tested for damage.
Defective sieves and filters shall be segregated and appropriate action taken to replace them.
Records shall be maintained.
Clause 6.3.5.1.2: higher

Filters and sieves shall be regularly inspected and tested for damage at a documented frequency
determined by the risk assessment.
Defective sieves and filters shall be segregated and appropriate action taken to replace them.
6.3.5.2 Metal detectors and X-ray equipment
Clause 6.3.5.2.1
Where a metal or other foreign body detector is required based on risk assessment, the company shall
establish documented procedures specifying the methods and frequency of testing, critical limits for
detection, and recording of test results.
Clause 6.3.5.2.2
The metal detector or X-ray equipment shall incorporate one of the following:
an automatic rejection device

a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very
large packs)
in-line detectors which identify the location of the contaminant to allow effective segregation of
the affected product.
Clause 6.3.5.2.3
Systems shall be in place to segregate product rejected by the metal detector to prevent accidental
reintroduction and allow investigation of the source of the metal contaminant.
page 78 of 89
Clause 6.3.5.2.4: foundation

The company shall examine product rejected by the metal detector and retain any metal contaminant.
The source of the contamination shall be investigated and appropriate corrective action taken to
minimise the risk of further contamination.
Clause 6.3.5.2.4: higher

There shall be a documented procedure to examine product rejected by the metal detector and to retain
any metal contaminant.
The source of the contamination shall be investigated and appropriate corrective action taken to
minimise the risk of further contamination.
6.3.5.3 Magnets
Clause 6.3.5.3.1
The type, location and strength of magnets shall be recorded in a register.
Documented procedures shall be in place for inspection, cleaning, strength testing and integrity checks.
Records of all checks shall be maintained.
Clause 6.3.5.3.2
Optical sorting equipment shall be checked on the basis of the manufacturers instructions or
recommendations.
Records of all checks shall be maintained.
6.4 Calibration and control of measuring and monitoring devices

Statement of intent
Measuring equipment used to monitor product safety, quality and legality shall be calibrated and of
suitable accuracy for its intended purpose.
Interpretation
This section requires equipment to be properly identified, listed and calibrated at an appropriate
frequency by suitably qualified staff. It is easy to believe test results, but if the equipment being used to
take the measurements is incorrect this can lead to a false sense of security and unsafe products being
produced.
The clauses require that equipment is not adjusted by untrained operators and that each piece is suitably
labelled with its calibration status. Auditors will wish to see calibration certificates.
The calibration range and discrimination are very important. For example, if a thermometer has been
calibrated as accurate between 10C and 100C, it cannot be reliably used for measurements of 150C.
If a balance has been confirmed as accurate for weighing between 10 g and 100 g at an accuracy of
0.1 g, it cannot be used to record weights to the nearest 0.001 g.
Example
A factory has a number of balances with which it check-weighs products to ensure that they are to
specification. It also operates within temperature- and humidity-controlled environments, which are
monitored. None of the equipment has been calibrated over the past year. The auditor is told that the
page 79 of 89
calibration laboratory has increased its prices and the site cannot afford to maintain calibration. A
representative of the site says they are sure that the equipment will still be acceptable, because it was in
calibration when it was last checked.
This would not only raise a non-conformity about the calibrations but would also highlight a lack of
provision of resources for a key task.
Clause 6.4.1
The site shall have a list of equipment used to make measurements relevant to product safety, legality
and quality.
Interpretation
Although this sounds relatively simple, in some industries where the process is steamy or oily the
labels may simply not stick. A good deal of research may therefore be needed to find a system that
works. In many cases where gauge use is high the system used is colour-coded to show the calibration
status of the gauge.
Clause 6.4.2
The equipment used to accept or reject a product shall be calibrated to a specified accuracy and
precision at a defined frequency (or before use).
Examples
A laboratory uses a pH meter and calibrates it every day. The results of the calibration are reviewed by
the auditor, who notes that the readings show two points at which the meter is calibrated: pH 4.0 and
pH 7.0. The recorded calibration readings show a record of pH 4.0 and pH 7.0 for every calibration.
The auditor asks to see the calibration being performed and watches the technician follow the
procedure, press the calibration button and record the reading after calibration.
The auditor raises a non-conformity as there is no record of the as-found measurement, without
which it is not possible to determine whether once a day is the correct frequency.
The auditor asks to see the micrometer used by a sheet metal worker. On examination the auditor holds
the gauge up to the light and discovers that the spindle of the gauge is not parallel to the frame. As a
result it does not sit squarely on the anvil. The worker admits to having dropped it the previous week.
The auditor raises a non-conformity as the gauge is no longer in calibration and the incident had not
been reported.

The calibration of identified equipment shall be traceable to a recognised national standard. Where
such a standard does not exist, the basis by which calibration is declared shall be verified.
Interpretation
A calibration check may be carried out in-house, as long as it is performed to a documented method by
competent staff, using appropriate reference standards/equipment. The reference standards/equipment
will need to be calibrated by a laboratory that can demonstrate competence, measurement capability
and traceability. For example, in the UK this would be a UKAS-accredited calibration laboratory
(ISO 17025); in the US, the National Institute of Standards and Technology (NIST); in India, the
National Accreditation Board for Testing and Calibration Laboratories (NABL).
As a guide, any instrument or reference standard should have an accuracy 10 times greater than that of
the device being calibrated.
Example
A device having a 0.5% tolerance might be calibrated using a standard having an uncertainty of
0.05%. There may, however, be exceptions to this rule where a factor of 2 or 5 may be acceptable.
page 80 of 89
This science is known as metrology and is used for the determination of accurate gauges measuring
optical and ionizing radiation and properties that are:
dimensional
electromagnetic
environmental
mechanical
thermodynamic
time- and frequency-dependent.
Some gauges are not traceable to a national standard (e.g. pH or the classification of a steel type
according to ISO/TS 4949:2003) so standards have been set up by which comparisons can be made.

Records of the results of calibration and verification shall be maintained for a suitable period, taking
account of the life of the products being produced.

Adjustment of identified equipment by unauthorised staff shall be prevented and the equipment shall be
marked to show its calibration status and period of validity.
A process shall be in place for actions to be taken if equipment is found not to be operating within
specified tolerances and/or limits.

Adjustment of identified equipment by unauthorised staff shall be prevented and the equipment shall be
marked to show its calibration status and period of validity.
Procedures shall be in place for actions to be taken if equipment is found not to be operating within
specified tolerances and/or limits.
Interpretation
Gauges such as thermometers can be reset to zero at any point so this requirement needs to be
controlled by access and authority.
If a gauge is found to be out of calibration for whatever reason it is usual to refer to the last time the
equipment was in calibration, then recheck the results from that point until now.
6.5 Final product packing and control

Statement of intent
The company shall ensure that products are packed in accordance with customer-specified
requirements and any relevant safety criteria, quality and legal requirements.
Interpretation
Even if a product has been made successfully, it can be unsafe or not of the right quality if it is not
packaged correctly or put in the wrong box. The site needs to have a procedure in place to ensure that
this cannot happen. In the case of quantities, it may well be a legal requirement that suitable checks are
in place.
Examples
A company making hair dye does not have an appropriate final pack procedure. It packs the wrong
colour dye into the wrong boxes. Many consumer complaints are received.
page 81 of 89
The same company corrects the error but packs the wrong language edition of the instruction sheet into
the boxes. Customers cannot understand the instructions and are at risk of damaging their hair or even
injuring themselves through incorrect application.
Both these actions would result in a non-conformity, and highlight the importance of proper control at
the packing stages.

Before the start of the packaging operation and following changes of product, checks shall be carried
out to ensure that the packing line has been cleared and made ready for packing.
All work instructions and packaging materials shall be available for use.

Before the start of the packaging operation, documented checks shall be carried out to ensure that the
packing line and the relevant areas around it have been cleared, and where necessary cleaned, to avoid
mixing with materials from the previous operations.
All documentation and packaging materials shall be available for use.
The packing line shall be identifiable by its name or identifying code as determined by the risk
assessment.
Interpretation
Almost a third of all product recalls are as a result of the wrong item in the box. One way this can
occur is when the line changes over and the previous packaging (including insertions) is still available.
Some companies have adopted a just-in-time approach where the product and packaging are brought to
the line only when they are needed.

The company shall ensure that product packing is effectively managed to ensure that it meets customer-
specified packing requirements for the product.
This shall include methods of ensuring that the correct product(s) and components are correctly
packaged and placed in the correct outer packaging.

The company shall have a validated, documented procedure for the packing of products taking
particular account of customer requirements.
This shall include methods of ensuring that the correct product(s) and components are correctly
packaged and placed in the correct outer packaging.
Clause 6.5.3
The quantity of product should match the quantity markings, which should be accurate, verified and in
accordance with the legal requirements in the country of sale.
6.6 Stock control and product release

Statement of intent
The company shall ensure that stock and finished product are not released unless all agreed procedures
have been followed and the release is suitably controlled.
page 82 of 89
Clause 6.6.1
Controls shall be in place to ensure correct stock rotation and that materials and products are used in
the correct order and within the allocated shelf or usage life as applicable.
Interpretation
This section of the Standard addresses stock rotation. This is obviously important if products have a
limited shelf life, but it is generally good practice to ensure that stock is shipped in the order of
production. Even products that do not deteriorate with age should be considered because information
such as addresses, phone numbers or instructions, can become out of date. Companies should be able to
demonstrate how they control the organisation of the dispatch process.
Clause 6.6.2
The company shall ensure that product brought in from off-site subcontractors shall be included in the
product release procedure.
Interpretation
Sites often have problems with subcontracted work as they do not control it as rigorously as work
produced on site. This clause ensures that any subcontracted work is subject to the same level of
control as work produced on site.
There shall be a procedure for the selection and instruction of subcontractors and for the acceptance of
products received from subcontractors. This may include documentation checks, inspection, testing or a
combination of these. The products shall be subject to an authorised positive release system.
Subcontractors may be subject to the same KPIs as the site of major manufacture. This clause includes
work produced by home workers and the material they use, which must be controlled in the same way
as work produced on site, because the same safety or quality problems may occur. Home workers
should have documented work instructions and any equipment they use must be subjected to
maintenance procedures and calibration as necessary. Home workers must be made aware of any issues
concerning product safety that are pertinent to their work for example, avoiding foreign-body
contamination and control of sewing needles.

Only products conforming to specification and agreed quality requirements are to be released for
dispatch.
If no such control is conducted, the company shall have a full justification for its absence documented
in the customer agreement, which shall be reviewed at least annually.

A documented procedure shall be in place to ensure that only products conforming to specification are
released for dispatch. Procedures may include, but are not limited to:
positive final release by authorised staff

online test methods
automatic rejection process (which shall be validated and monitored).
If a risk assessment determines that no such control is required, the company shall have a full
justification for its absence, which is documented in the customer agreement and shall be reviewed at
least annually.
Interpretation
Once products have been produced, the final stage is to control the dispatch so that no substandard
products are released. The Standard requires a robust system to be in place. It does not specify the
procedure to be used but suggests some common methods.
page 83 of 89
The most usual method is by positive release, where products have to be approved for release by a
suitable person authorised to do so. This means that products do not just get sent out and only stopped
when or if there is a problem, but that every batch is checked and positively agreed to be satisfactory
before it can be shipped. For example, a mascara may be held until the microbiology results are
available.
page 84 of 89
7 Personnel
7.1 Training and competency

Statement of intent
FUNDAMENTAL
The company shall ensure that personnel performing work that affects product safety, legality and
quality are demonstrably competent to carry out their activity, through training, work experience or
qualification.
Interpretation
In order to produce anything successfully, it is important that employees are competent, well trained
and understand their duties. Auditors will expect sites to be able to show that staff meet these
requirements, and they will probably interview and observe staff to judge the extent to which this
requirement has been met.
Auditors are likely to focus mainly on production, quality and technical staff but any others who could
influence the products should also be considered, such as dispatchers, cleaners and administrators
taking orders. It is a requirement that those carrying out the risk assessment (to ensure products are safe
and legal) have some formal training. The training types and methods are not specified because
different levels and types of training will be appropriate in different industries. However, it is likely
that the auditor will challenge staffs understanding of risk methods. If the auditor is in any doubt as to
the staffs understanding of a process or is unconvinced by the results of risk assessments, they will
evaluate the training.
Note that the requirements of this section apply to general duties as well as to specific job training.
Basic understanding of a sites procedures is as important as specialist knowledge. Misunderstanding
the site procedures (relating, for example, to storing products in the wrong places, not using the correct
tools, or not understanding the site requirements for hand-washing) may have a deleterious effect on
safety.
Example
An auditor is visiting a factory producing first-aid kits and asks an operative what their duties are with
regard to packing the cartons into outer boxes. The operative does not appear to understand and is not
packing the same way as operatives on other lines. The auditor seeks clarification from the supervisor
and is told that the operative, whose first language is not used on the site, is new and has been sent by
an agency as temporary staff to help with a backlog of work.
The auditor raises a non-conformity. The site must have a way of ensuring that all staff are competent
and clearly understand their job. In this case, some hands-on training, followed by sign-off after the
operative had demonstrated competence, would be appropriate.

The company shall ensure that all employees are able to demonstrate competence with regard to their
activity.

The company shall ensure that all employees are able to demonstrate competence with regard to their
activity.
The company shall:
identify the need for training

document training procedures and records to demonstrate that training is effective and regularly
reviewed
page 85 of 89
ensure that training includes both general information on the company and specific job training
retain all training records.
Interpretation
The auditor will judge the competency of staff through records, observation and interview. They will
look for job descriptions and ensure that they correspond with staffs own views of their roles. They
will also look for evidence that any necessary training has been carried out and its success evaluated.
The need for training and records does not mean that experienced personnel without formal
qualifications are not acceptable. Their experience can be evaluated and documented and grandparent
rights may be an acceptable assessment in some cases.
Clause 7.1.2
Training records shall be stored in such a way as to ensure privacy of personnel is protected and legal
compliance with data protection laws in the country of operation are respected, while also allowing
auditors access to necessary information. Training shall be traceable to an individual employee.
Interpretation
A training record should be traceable to an individual, and should cover all their relevant
responsibilities, taking account of any privacy laws that apply. The site should give due attention to
refresher training.
The auditor will wish to review training procedures and records on part of their site tour. For example,
they will observe how staff have been trained to use a new piece of equipment, or how they are made
aware of the requirements of a new customer. The auditor does not want to see payroll information, tax
details or health details; this type of information can be divulged only with the employees express
permission.
Examples
A factory operative is asked by the auditor about methods of adjusting a computer-controlled cutting
machine. The operative does not appear to know. When asked, the supervisor produces evidence that
the operative was sent on an external course to learn about the machine. On further questioning it
appears that the operative did not understand the course, they did not go back for the second day of
instruction, and no evaluation or questionnaire about the course had been completed.
The operator could not demonstrate competence or adequate training and so a non-conformity would
be raised.
The test laboratory in a factory has just bought a new piece of equipment to test its products for toxic
metals. The laboratory supervisor used a similar machine several years ago but other staff are not
familiar with it. An in-house training session has been arranged with the supplier, and all staff will
complete the training before commissioning the new equipment. The laboratory has also signed up to a
correlation trial to ensure that its results are reliable.
This is a satisfactory way of addressing an issue when no-one on site has the required competence to
carry out training.
A qualified supervisor has carried out some basic hygiene training for shift workers. Unfortunately,
although the training has been minuted and dated, it is not possible to check which operators were
present at the time.
The auditor would raise a non-conformity, although the problem could easily have been solved if each
operative had signed an attendance sheet, which was then filed with the record of the training.
page 86 of 89
7.2 Protective clothing

Statement of intent
The company's standards shall be documented and adopted by all personnel, including contractors and
visitors to the production facility.
Interpretation
Any clothing provided as protection shall not, itself, present a contamination risk to the products. In
many industries no particular requirements are necessary, but even so, appropriate controls should be in
place, such as using only approved laundry companies. If, for example, protective clothing is required,
the laundering methods (including frequency and suitability) shall be documented and assessed. When
staff are responsible for their own laundry, the site should have clear procedures on the process that
should be used, to ensure that product safety and quality are maintained.
Clause 7.2.1
The company shall use risk assessment to determine the need for protective clothing.
Where a need for protective clothing has been identified by the risk assessment, this shall not pose a
contamination risk to the product.

Based on the assessment of risk to the product integrity, suitable footwear shall be worn within the
factory environment.

Protective clothing, where provided, shall be effectively laundered at an appropriate frequency.
Disposable protective clothing, if used, shall be subject to adequate control to avoid product
contamination.
7.3 Hygiene practices

Statement of intent
Standards of hygiene shall be applied with due regard to the risk of product contamination.
Interpretation
This clause encompasses good manufacturing practices and requirements for HARA. It is very
important in high-risk product areas such as nursery accessories, cosmetics and medical devices.
It is necessary not only to meet the requirements but also to monitor whether they are being
implemented and take action on any lapses. The auditor will observe whether this requirement is being
complied with throughout the course of the audit.

Where the risk has been identified, the company shall have a policy to control the wearing of jewellery
so that it poses no risk of product contamination.

The company shall have a policy to control the wearing of jewellery so that it poses no risk of product
contamination.
page 87 of 89
Clause 7.3.2
All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is issued and
monitored by the site, to avoid contamination of product.

Where metal foreign body detection is in place, detectable plasters shall be used and shall be regularly
tested through the detector.
Clause 7.3.4
Hand-cleaning shall be performed at a suitable frequency to maintain hygienic conditions.
Clause 7.3.5
Eating, drinking or smoking shall only be permitted within designated areas and where there is no risk
of contamination of products.

The company shall use risk assessment to determine the need for all head and facial hair to be covered
and fully contained to prevent product contamination.
Interpretation
It is estimated that 50150 head hairs per day fall out and if you run your fingers through your hair,
five or six can be dislodged. Information on beard shedding is not as readily available. Comment
groups suggest that beards may shed hair at a somewhat lesser rate but it would appear that the longer
the beard, the more similar the rate is to head hair. If it is determined that hair covering is required, then
the wearing of the hairnet/beard snood must cover all hair and not allow any hair to be exposed.

Where there is a risk to product safety and quality, fingernails shall be kept short, clean and
unvarnished.
False fingernails shall not be permitted.

Where there is a risk to product safety and legality, the site should have a procedure for the notification
by personnel, including temporary personnel, visitors and contractors, of any relevant infectious
diseases or conditions which they may have been in contact with or be suffering from.

The site shall have a documented procedure for the notification by personnel, including temporary
personnel, visitors and contractors, of any relevant infections, diseases or conditions which they may
have been in contact with or be suffering from.
Interpretation
Certain infectious diseases can be passed on; therefore high-risk products are commonly tested for the
following bacteria:
Staphylococcus aureus found in the nose

Escherichia coli found in the lower intestine
Pseudomonas aeruginosa found on the skin
Candida albicans found in the mouth and on nails
Aspergillus niger found on fruits and vegetables.
The notification can be in the form of a voluntary declaration; however, there is legal protection for the
non-disclosure of sensitive information, such as:
page 88 of 89
religious beliefs
health
ethnic background
age
sexual health
criminal records
political opinions.
In Europe this is Directive 95/46/EC on the protection of individuals with regard to the processing of
personal data and on the free movement of such data. In the US it is the Privacy Act of 1974.
page 89 of 89

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1 Senior management commitment

1.1 Senior management commitment and continual improvement

Clause 1.1.1: foundation

authorised by the person with overall responsibility for the site

Clause 1.1.1: higher

reducing customer complaints

The auditor would consider this acceptable.

Clause 1.1.3: foundation

Records of the minutes from these meetings shall be maintained.

The auditor would accept the evidence.

Clause 1.1.3: higher

previous management review action plans and timeframes

A non-conformity would result.

the area around the factory is closed due to government restrictions

The auditor will raise a non-conformity during the subsequent visit.

The auditor would accept the evidence.

Clause 1.1.8: foundation

Clause 1.1.8: higher

The auditor would accept the evidence provided.

1.2 Organisational structure, responsibilities and management authority

details of the area to be cleaned

The auditor would consider this to be satisfactory.

how to check the formulation being made

how to check the circuits

2 Product risk management

2.1 Legislation and safety requirements

United Kingdom and Europe

For cosmetics in Europe, the following legislation applies:

EU Cosmetics Directive 76/768/EEC

2001/95/EC: (New) General Products Safety Directive

United States of America

101 Childrens products containing lead; lead paint rule

Specific import-export provisions include:

221 Export of recalled and non-conforming products

the validity of any scientific names

Additional non-Lacey regulations apply for products imported to the US.

Composite wooden products are also required to meet CARB-ATCM 91320/S.1660-formaldehyde

For cosmetics in the US, the following legislation applies:

Safe Cosmetics Act of 2011 (H.R. 2359)

For cosmetics in Canada:

Canadian Environmental Assessment Regulations

Electronic Code of Federal Regulations (E-Cfr)

2.2 Product risk assessment

has a formal written specification

Design Failure Mode Effect Analysis

the manufacturer (if based within the EU)

2.3 Product labelling and claims

This would be acceptable to the auditor.

An auditor may be aware of the situation and challenge the claim.

2.4 Packaging materials

protecting the product from damage

3 Product safety and quality management

3.1 Product safety and quality management system

3.2 Documentation control

Clause 3.2.1: foundation

Clause 3.2.1: higher

This shall include:

a list of all controlled documents indicating the latest version number

Examples of documents that need to be controlled include:

3.3 Record completion and maintenance

Records are documented information about measurements or events. Examples include:

This is a satisfactory record and acceptable to the auditor.