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HACCP MA

Senior Management Committment:The companys senior

management must provide the human and financial resources
required to implement the processes of the quality management
system and the food safety plan as per this audit checklist.

HACCP: The HACCP study must be developed by a multi-disciplinary

team. Staff appointed as HACCP team members must have specific
training on HACCP principles.

The HACCP team must have a designated team leader who has
demonstrable competence in HACCP.

A full description of the product must be in place. The products

supplied should be included within this description.

The intended use for the product must be defined within the program.
The site must have process flow diagrams which cover each product
supplied.
The process flow diagram must have been formally signed off by
members of the HACCP team.
The hazard analysis must be based on a likelihood and severity of a
risk assessment.
A documented hazard analysis must be available for all physical,
chemical, and microbiological hazards.

For each hazard identified, critical control points must be determined.

Critical limits must be defined to ensure that the product is safe. The
2.10 process must be capable of operating consistently within the
defined limits

Monitoring procedures must be established for each CCP to ensure

compliance with the critical limits.
CCP's are monitored according to the documented procedures.
Corrective actions must be documented in the event of a CCP
deviation.
The operation of the HACCP plan must be validated to confirm that it is
effective. (e.g. If a sanitising chemical is used at 200ppm, effectivity
can be demonstrated by challenge testing at differing strengths and
back up with microbiological information)
The HACCP plan must be reviewed at a pre-determined frequency
(minimum annually) or prior to changes of product/process which may
affect product safety

Raw Materials Testing - There must be a documented procedure for

raw material recieving. All raw materials must be checked by trained
staff and records maintained. On raw materials where COA's are
utilized, periodic validation testing of stated analyses is conducted.

Intake records must be detailed document and retained.

Temperature Check (where required)
Visual check on the vehicle (including load security)
Packaging Integrity
Coding information
Check for evidence of pest activity
Pallet Condition
Certificates of compliance / conformance

A suitable stock rotation system must be in place (FIFO based on

expiration date).

Record Keeping - Documented procedure for the retention of records

should be in place and as minimum should be the shelf life of the
product.
Key records - as a minimum CCP monitoring documents, ingredient batch
sheets, product delivery, temperature monitoring, production start up and
cleaning sign off records must be counter signed /verified.

Corrective and preventative action. There must be a documented

procedures which records, investigates, analyzes and corrects the
cause of non conformity against all standard requirements relating to
product and process safety, legality and quality.

Corrective actions must be logged with all appropriate details of the

issue, action taken, assigned responsibility, timescales for completion,
status and final sign off and date. (examples: Out of tolerance results
for process, microbiological testing, pest control sign off, mock recall,
serious breach of GMP, internal audit findings)

Management of incidents, withdrawals and recalls. -Procedures

must be in place to manage all incidents which could affect food
safety, legality, or quality
Key primary and secondary 24/7 contact information must be
maintained as a minimum for:
Internal contacts (Supplier recall team)
Customers
Suppliers (raw materials and services)
Government / Enforcement bodies

A mock recall (or mock incident) must be undertaken by the site to

test the effectiveness of and understanding of the Recall Plan and
Incident Management Procedures (minimum annually).

As part of the mock recall, the site must be able to demonstrate that
the traceability system allows product be traced one step forward and
one step back to all processes including rework, work in progress and
packaging within 2 hours. Documentation will include traceability
documents and completed communication documents.

Traceability Documented procedures must be in place to enable

traceability one step forward and one back through out the process.
Identification at all stages must be transparent.

Where any re-working operation is performed, traceability must be

maintained. Also the site must guarantee that where re-work is used
within a process it does not affect the safety or legality of the finished
product (e.g. ingredient declaration / declared allergen).

Internal Audits - The site must have a documented system for internal
audits. As a minimum the internal audits must cover the following
areas at least annually:HACCP
Allergen Controls (where applicable)
Process Controls (where applicable)Sanitation program
Site Security
GMP including facility condition
Customer Complaints - Complaints must be investigated in detail by
competent personnel. The complaint investigation should determine
whether the complaint is specific to a particular product/ batch or a
wider issue.
Supplier Selection: There must be an effective process in place for
approving suppliers of ingredients and food packaging materials.
The approval of suppliers must be based on a product risk
assessment. Procedures for supplier approval should include clear
methods for initial and ongoing assessment (i.e. in house checks,
certificates of analysis, supplier assessment questionnaires) and the
methods and frequency of assessment should be based on risk.
An up-to-date approved supplier list should be in-place.
The site must have systems in place for handling contingency raw
materials/suppliers.
Specifications - Specifications must be available for all ingredients,
finished products and for all food contact packaging.

Specified parameters detailed within the specification (including in

line weights and compositional controls) must be monitored in
accordance with specification and records maintained.
External Site Standards - The premises must be designed,
constructed and maintained to control the risk of product
contamination and comply with all relevant legislation.

External areas must be kept clean, organized, and free from

unnecessary items that could provide potential pest harbourage.
Site Security - All access points into the establishment should be
secured by guards, alarms, cameras or other security hardware.
Doors, windows, roof openings, vent openings, trailer bodies, railcars
and bulk storage tanks should be secured (e.g. locks, seals, sensors)
at all times.
Outside storage tanks for materials and potable water supply should
be protected from, and monitored for, unauthorized access.
Visitors, guests and other non-plant employees (contractors, sales
people, truck drivers, etc.) should be restricted to non-product areas
unless accompanied by an authorized plant representative.

Access to in-plant laboratory facilities should be strictly controlled.

Comprehensive and validated security and disposal procedures should
be in place, particularly for the control of reagents, hazardous
materials and live cultures of pathogenic bacteria.

Returned goods should be examined for evidence of possible

tampering before salvage or use in rework. Records should be kept on
the use of all returned goods in rework.

the use of all returned goods in rework.

Factory Layout - Suitable space must be provided within the factory

in order to conduct all operations and to ensure product safety and
integrity.
Suitable facilities must be provided for washing equipment, trays and
utensils and must be located to prevent product contamination.

The building will be maintained in a good state of repair such that

there is no imminent risk of contamination.
Finished products are stored to prevent cross contamination.

High Risk / High Care Operations - Suitable segregation must be in

place between raw and cooked/finished products and production
activities in order to prevent cross contamination. Segregation of high
risk / high care areas should be by physical barriers. In some
exceptional, tightly controlled circumstances segregation of raw and
cooked products by time and space may be accepted.
Protective clothing worn by staff within the high-risk / high care area
must be visually distinctive from other protective clothing.

Fabrication - Walls - Walls must be designed, constructed, finished

and maintained to prevent the accumulation of dirt, to reduce
condensation, mould growth and to facilitate cleaning. If signs are
placed onto the walls they must be fully sealed to prevent possible
mould growth.

Wall / floor junctions and corners should be coved / curbed to facilitate

cleaning. Cavities in the surface of walls should be avoided to prevent
debris from lodging and pest harbourage.
Drains must be accessible for cleaning and fitted with screens or traps
to prevent pest entry and odours.

Fabrication Ceiling - Ceilings and overheads must be designed,

constructed, finished and maintained to prevent the accumulation of
dirt, reduce condensation, mould growth and facilitate cleaning.
Fabrication Doors - All external doors must be kept closed when not
in use and effectively proofed against pests. If strip curtains are fitted,
they must be maintained, kept clean and effectively proofed against
pests.
Fabrication - Lighting - Lights and light bulbs are adequate in
number and strength to effectively illuminate the entire production
facility.
Lights within production and storage areas should be protected by
shatter proof covers and / or sleeves (on the light tubes / bulbs).
Where lights are not protected then these must be covered as part of
a glass management program.
Fabrication - Ventilation - Ventilation and extraction systems must be
effective at preventing condensation, excessive dust, pest entry, and
not pose a risk to product.
Exhaust fans to the outside are adequately screened and equipped
with self-closing shutters.
Fabrication - Windows - Where windows are designed to be opened for
ventilation purposes, they must be adequately screened to prevent
the entry of pests.

Glass windows in production areas must be protected against

breakage. Where windows are not protected then they must be
covered as part of a glass management program.

Utilities - Water used as an ingredient of products or for cleaning

must be from a potable water source. In areas were the local water
supply is not safe, systems must be in place for filtration/ sterilization
of the water supply. Systems used to filter / sterilize water must be
regularly maintained and records kept. Water / steam / air / ice which
come into contact with food must be monitored at least an annually.
Equipment - All equipment must be designed and constructed to
enable hygienic cleaning and maintenance. It must be maintained in a
good condition to prevent contamination.
Equipment and fittings (e.g folk lifts) must be easily accessible for
ease of cleaning and servicing.
Lifting equipment must be stored away from food products when not
in use where applicable
Battery charging areas must be segregated away from product
storage areas where possible
Maintenance - A system of planned maintenance must be in place
for all key pieces of equipment, specifically those critical to product
safety, legality and quality.
Measures to ensure that product safety, legality and quality is not
jeopardized during maintenance activities must be in place. A system
must be in place to verify that an area is clean after maintenance work
has taken place.
Lubricants / Greases which may come into contact with product to be
Procedures / Records of a food grade nature.
A system must be in place to segregate food grade and non food
grade Records lubricants.
Maintenance areas must be clean and well maintained. Any idle
machinery must be cleaned, stored and organized to prevent pest
harbourage.

All tools and parts must be controlled. A system must highlight and
initiate an investigation if a tool or part is missing.
String, wire, tape, etc are not used for permanent repairs.
Documentation is in place for temporary repairs showing date of
repair.

Chemical Control - All chemicals must be suitably stored and

labelled. MSDS sheets to be available for all chemicals on site.
Metal / Sieve / Filter Control / Magnet - Knife, blade, scissors, magnet
and needle control must be in place.
Sieving/Filtering/ Magnets must be inspected forintegrity at predefined documented intervals as identified in the risk assessment and
recorded. Sieve and magnet tailings must be recorded and monitored.
Glass / Brittle Plastic and Ceramic Controls - Glass items other than
packaging materials for finished product must not be brought into
production areas.

A detailed procedure must be in place for the management of glass,

brittle plastic and ceramic breakages. Documented report must be
available for glass/brittle plastic and ceramic breakage and adequate
cleaning
Wood Control - The use of wooden pallets within the site production
and storage areas are suitably controlled. Other wooden items must
be eliminated such as wooden handle broom etc.

Sanitation - Sanitation Program must be in place (Master Sanitation

Schedule) which ensure appropriate standards of hygiene are
maintained in all areas at all times and that the risk of contamination
is minimized.

Documented cleaning procedures (SSOP) must be in place and

maintained for building, utilities, plant and all equipment.
Documentation that shows sanitation has occurred (e.g.. sign off
sheets) must be maintained.
A pre-operational inspection program must be established to include
daily inspection of equipment.
Sanitation equipment must be used as intended. Equipment must be
colour coded for its area of intended use. These must be stored
separately from one another and captive to that area. Cleaning
equipment should be fit for use and if laundered must be suitably
controlled.
Microbiological testing of environmental surfaces is utilized and
documented, to monitor the effectiveness of cleaning and/or
sanitation procedures.
The effectiveness of cleaning and disinfection procedures must be
verified and recorded (e.g. environmental bioluminescence swabbing
(ATP) or visual assessment).

Cleaner/sanitizer concentration and application comply with sanitation

program. A system to routinely verify chemical dosing strength must
be in place.

Raw materials and finished products are covered or otherwise

protected during clean-up
Waste Control - Adequate system to be in place to control the
disposal of waste. (e.g. Cardboard, general trash, inedible waste)
Waste disposal must meet legal requirements, and licensed
contractors must be used where applicable.
External and internal waste containers and compactors must be
managed in a way to minimize risk of product contamination and
covered where applicable. Waste containers must be cleaned at an
appropriate frequency

Pest Control - The company must be responsible for minimizing the

risk of pest infestation on site. Regular inspections of the site by
competent personnel must be conducted to monitor the pest control
activities.

All Pest Control resources must be suitably competent, certified and

insured (according to local legislation).

The frequency and type of visits should take into account the type of
pest risk. Records of all pest inspections must be kept.
An up to date pest control device map showing both internal and
external bait points and monitoring devices must be in place and must
be reviewed annually.

No evidence of pest activity within any of the process or non process

areas.

All Pest Control resources must be suitably competent, certified and

insured (according to local legislation).

The frequency and type of visits should take into account the type of
pest risk. Records of all pest inspections must be kept.
An up to date pest control device map showing both internal and
external bait points and monitoring devices must be in place and must
be reviewed annually.

No evidence of pest activity within any of the process or non process

areas.
Effective pest proofing measures need to be in place to prevent
possible entry of pests. (E.g. fly screen, bristle strips etc)

Pest control devices must be effective, well maintained and are

applicably located. Electric Fly Killers are located away from exposed
food products and ingredients (at least 3 meters or approximately 10
feet), cleaned regularly and bulbs changed annually for Electric Fly
Killers (i.e. Electric Fly Killers not above product).
Bait stations must be of tamper resistant construction, secured in
place if required by regulation, suitable for the location and located to
prevent possible contamination.
In the event of an infestation (in either process / non process areas)
there must be a full program of follow up visits to ensure complete
eradication of the issue.

Transport - Suitable measures must be in place to control and

monitor temperature sensitive products through the distribution chain.
Records of temperatures must be maintained according to the
company's record retention policy.
Each vehicle must be checked for cleanliness and strong odours
before loading and maintained in good repair. Records of the checks
conducted prior to loading must be maintained according to the
company's record retention policy.

Internal and third party transportation procedures must include vehicle

breakdown and loss of temperature control.
Finished product must be shipped on a first in first out basis.

Handling requirements for specific materials - Procedures must be in

place to control any materials with specific implications for product
safety, legality or quality, where applicable* [e.g. known allergens,
vegetarian, GMO (in areas of the world where the use of GMO is
restricted by legislation), products where provenance is important. ]
*Not applicable is not an option for level 2 supplier.

Risk assessments must be carried out and control measures

implemented to prevent cross contamination by known allergens.
Foreign Body Detection (metal detection / X-ray)- Foreign body
detection equipment must be in place unless it can be justified that it
is not necessary.
The sensitivity of detection must be in line with best practice with
regards to the nature of the food.

The foreign body detector must incorporate a suitable rejection

mechanism.
The operation of the foreign body detector must be verified by the site
on a regular basis (as a minumum hourly basis).
In the event of a metal detection failure all product produced since the
last satisfactory metal detector check must be rechecked.

Non Conforming Product / Hold Procedures - The site must have

a documented non conforming product procedure. This will include:
Release by concession
On hold / Quarantine
Customer returns
Rework
Product Rejection Specified designated areas.
Identification of personnel responsible for initiation, evaluation and
release /disposal of held product.
Facility will maintain documentation with regard to quantities of held
product, evaluation of held product, approval/release for use to the
production area (where applicable), and final disposition of product.
Product will be properly tagged or otherwise physically identified on
the exterior surface, to prevent potential shipment.
Product Inspection and Testing - Product testing must be
conducted in accordance with recognised methods and by an
accredited laboratory where applicable* (*accredited laboratory where
applicable is compulsory for a level 2 supplier)
Where applicable the site must keep retention samples for all
production runs for the shelf life of the product.

Temperature Control - Temperatures of refrigerated and freezer

storage areas must be checked and recorded at least 3 times a day.
For automated systems there must be a process of review and sign
off. Temperature records must be maintained.

Quantity / Weight / Volume Control - An appropriate mechanism

for quantity/ weight / volume control must be in place and appropriate
records kept. Records must be maintained by the site to demonstrate
that legal requirements have been achieved where appropriate*
(*where appropriate is not an option for a level 2 supplier

Calibration - All measuring equipment critical to product safety,

legality or quality must be calibrated by an external company (to a
nationally recognized standard) at a predetermined frequency and an
appropriate certificate of calibration be available.

A system of internal verification of the accuracy of measuring

equipment at appropriate frequencies between calibration intervals
must be in place.

A master calibration log must be maintained by the site.

There will be at least annual internal/external correlation studies
conducted between individuals performing the same testing in order
to maintain consistency of testing.

GMP - Personal Hygiene - The site must have documented GMP

program and Self-audits on GMPs are conducted monthly, at a minium,
and include corrective action.
Eating and drinking must only be permitted within designated areas
and is not permitted in storage and production areas.
Smoking must only be permitted within designated areas and not
permitted in storage or production areas.
The site must have clearly defined rules in terms of the wearing of
jewellery.
The company's hygiene rules must make reference to the wearing of
perfume / make up / false nails / nail polish.
The plaster / bandage used for cuts and grazes must be waterproof
suitably coloured, company issued and metal detected where
applicable

Training - All employees have received an appropriate induction

training, including an element of food hygiene and food safety.

Personnel must be specially trained to the requirements of their job

role that has an impact on controlling the KPIs and be able to
demonstrate competence. (e.g. CCP checks, chemical concentration
checks, foreign body detection)
A system for annual employee refresher training must be in place.
(e.g. this can take the form of a competency test where applicable)
Health and Wellness - The Company must have a procedure for the
notification by employees, including temporary employees, of any
relevant infectious disease or conditions which they may have be
suffering or have been in contact. A return to work procedure must
be in place.
The Company must have in place a documented system for preemployment health and wellness screening where applicabl
A system for health and wellness check of visitors to the site must be
in place. GMP sign in sheet should be in place for visitors and
contractors.
Staff Facilities - Suitable changing facilities must be provided for
staff. A dedicated changing area must be provided for personnel
working in any high-risk area.
Suitable and sufficient hand washing facilities must be provided at the
access to and at other appropriate points within the production areas.
Suitable temperature water, bactericidal soap, and hand drying
facilities must be made available
Toilet facilities must be equipped with hand wash station and soup
AND not open directly into production, packing or storage areas.
Staff facilities (lunch room, restrooms, lockers, etc.) must be
maintained in a clean and sanitary condition.
Protective Clothing - appropriate company issued clothing for food
handlers and others working in or visiting food handling areas must be
provided and cover personal clothing above the knees.
Clothing used in high risk areas is identifiable. High risk / high care
protective clothing must be put on and removed in a designated
changing area.

Protective clothing must be maintained in clean condition and

laundered regularly either on site against specified wash parameters
or off site by an external approved laundry.
Protective clothing should not be worn outside of the production and
warehouse area where applicable.
Hair / beards must be fully covered. A tightly knit hair net must be
provided for confining hair / beards.
Suitable footwear must be worn where appropriate. (foot covers are
permitted).

REMOVE CLAUSE

HACCP MANUFACTURING AUDIT STANDARD

AUDIT GUIDELINES

1) Organisational charts to demonstrate each department are adquatley resourced including

2) The most senior manager on site must be present during the audit opening and closing
meeting as a minimum. 3)There must be an appointed dedicated person to manage audit
corrective actions. 4) 100% of corrective actions from the previous audit must be complete.

)The HACCP team must be documented within HACCP program. 2) The HACCP team must con
of members of the Technical team, production and engineering. 3)Team leader must have a
recognised external HACCP based certificate. 4) Team members training can be external or
internal by the competent HACCP team leader. 5) Training material and team members traini
assessment and record must be on file.

The HACCP team leader (the person who develops the HACCP program / the key QA
representative on site) must be able to demonstrate their competency in HACCP either throu
having attended a course, or through their level of knowledge of HACCP principles as
demonstrated by the quality of the HACCP study.

The product description should detail, 1) product description2) type, 3) packaging, 4) storage
distribution conditions 6) primary shelf life (manufacture recommended shelf life and conditio
and secondary shelf life (restaurant product shelf life) if applicable

The usage of the food by the ultimate consumer needs to be taken into account when assess
risks. All protein must be fully cooked. This must be covered as part of a background stateme
forming part of the HACCP study.
The process flow diagrams must show interactions and sequence of all process steps as well
introduction of utilities and other contact materials (e.g. packaging).
This may be via signing of the flow diagrams or within a HACCP meeting document.

The likelihood and severity risk assessment may be in the form of a numerical model.
The HACCP study will be expected to have included an assessment of physical, chemical and
microbiological risks.

A decision tree or similar may be used to demonstrate if a hazard will be a CCP

Target, upper and lower limits need to be documented for each CCP. Review of records will sh
the tolerances are consistently met.

The company needs to be able to demonstrate that established procedures are in place for e
CCP and through records of checks that monitoring is being carried out at the defined freque
and that results are within defined and acceptable limits. For example where cooking is a crit
control point, records of cooking temperature need to be available and the minimum accepta
cooking temperature clearly defined.
Corrective actions in the event of any CCP's deviation must be documented. Operatives follow
the documented procedures correctly.

Verification of the CCPs can be in the form of known published data, supplier documented
recommendation or companies own challenge testing.

Auditor will review minutes of HACCP meeting to ensure any changes have been appropriate
assessed.

Raw material procedures must give clear detail for receiving all materials and ingredients an
include 1) Vehicle condition acceptance. 2) method of verifying compliance to specification (s
as COA's, key attribute sheets) 3) sampling plan detailing testing frequency and methods. 5)
corrective action should a product be out of specified tolerances. 6) Training record for staff
recieving raw material must be provided. 7) When COA is used as acceptance, evidence that
COA has been compared to specification for compliance.

Records must encompass all of the documented requirements for all raw material deliveries a
forms must include the following:
Temperature Check (where required)
2) Visual check on the vehicle (including load security)
3) Packaging Integrity
4) Coding information
5) Check for evidence of pest activity
6) Pallet Condition
7) Certificates of compliance / conformance

IFO (First In First Out). Documented procedure outlining the method of stock rotation, stock m
be rotated using a manufacture date (not receiving date), if no manufacture date is available
expiry or lot code can be used. Auditor must look for evidence of product being used / deliver
out of rotation.

Documented procedure in place. The retention time for records shall be established with due
consideration to legislative and customer requirements as a minimum this would be expecte
be for the shelf life plus a period reflecting the time period in which a customer or legal comp
could be instigated.

Counter signatories role is to ensure that all relevant sections are correctly completed and an
any deviations, corrective actions are implemented.

This Sectin should be summarised at the end of the audit. Corrective and preventative actio
procedures must be in place for each programs outlined in the audit e.g. pest control, HACCP
sanitiation and GMP etc. The corrective and preventative action procedures must include as a
minimum the following: 1) Issue raised 2) investigation 3) analyse 4) corrective action 5)
responsibility at each step.

Records may be in the form of non conformance / Corrective action reports or logs and detail
the requirements. Any corrective action deviations for all audit sections will be recorded unde
this clause. Records must include the following elements: 1) Issue 2) action taken 3) assigned
responsibility 4) Reasonable timescales for completion 5) status 6) final sign off of completion
within timescales and date (final sign off must be different to assigned responsibility)

The product recall procedure would be expected to include the following elements:1)
identification and location of suspect product. 2) the reconciliation and disposition of recover
product. 3) Notification of contact. 4) decision protocol defining when and if a regulatory age
will be notified 5) outline of responsibilities for individuals on supplier recall team.

The 24/7 Key contact information must be current, easily accessible to all authorised staff
members in the event of an incident and kept as hard copies in the recall program. 'Contact
refers to the following lists:
Internal contacts (Supplier recall team) Customers
Suppliers (raw materials and services)
Government / Enforcement bodies NOTE: must be provided with a copy of the supplier reca
team contact list.

The site is expected to conduct their own mock within the following guidelines: 1) minimum
annual basis. 2) the mock recovery must trace either and ingredients or a food contact packa
to ingredient supplier(s), finished product and first external customer within 2 hours. 3) date
time test intitiated and completed. 4) overview of records and evidence that were reviewed t
obtain the amounts of product involved. 5) Summary of calculations. 6) the effectiveness of t
test including amount of product recovered. 7) A documented review by the recall team. 8) A
review of issues uncovered or opportunities to improve the system. 9) a provision for re- test
any part of the mock recovery system that fails within 60 days.

The auditor will validate the suppliers's ability to trace product to be traced one step forward
one step back to all processes including rework, work in progress and packaging to 100% wit
hours. The auditor will select a finished product by product code and ask the supplier to trace
product to first external customer (one step forward). And using the same finished product an
select a minimum of 1 ingredient and food contact packaging, traced back to the supplier (on
step back).

Procedures must include: 1) methods to ensure traceability throughout each stage of the pro
This includes each stage of the process from the receipt of raw materials through shipment t
first external customer. 2) Identification of what records are used for traceability. 3) What spe
tracebility information is on each record. 4) Who is responsible for completing each record (ca
by job title) 5) How packaging and raw materials are coded. 6) Method to link each ingredien
food contact packaging material to finished product lots. 7) Methods used to code finished
product with month/day/year/lot etc 8) Method used to track production codes shipped to eac
external customer.

Rework procedures must include the following elements: 1) how work in process is handled a
added back to production. 2) how to control the addition of rework and work in process so the
product continues to conform to specification and functional requirements. 3) Temperature lim
for temperature sensitive products. 4) time limits for product awaiting rework. 5) maximum a
back and / or rework rate allowed. 6) methods to ensure temperatures, counts and
measurements are maintained during the rework process. 7) how rework is traced through th
system and finished products. 8) documentation related to rework.

Internal audits must be undertaken on the following areas at least annually:

1) HACCP
2) Allergen Controls (where applicable)
3) Process Controls (where applicable)
4) Sanitation program
5) Site Security
6) GMP including facility condition The reports will highlight conformity as well as non conform
and follow the usual steps as laid out in the corrective action section of the standard.

Customer complaint collation should be in a standardised format which must include the follo
elements: 1) Nature of complaint 2) date and product details. 3) Investigation details includin
determination whether the complaint is specific to a particular product / batch or a wider issu
timescales for completion / response to customer. 5) Corrective actions where required.

Supplier approval procedures must be in place

The approval of new and existing suppliers of raw materials and packaging shall be based on
and could include the following components :- Historical experience of the supplier Supplie
questionnaires Supplier audits either directly or via third parties Supplier certification to t
GFSi benchmark such as BRC / IFS.
The company should maintain an updated list of approved suppliers.
Evidence of contingency sytems to be demonstrated to auditor

Specifications must be available

A selection of documented on line and archived records will be selected production runs by t
auditor. Where raw material specifications are provided in the suppliers format these shall be
assessed to ensure that they adequately specify the parameters critical to the safety and
performance of the ingredient.

Local activities which could have an adverse affect could include; derelict buildings, rubbish
dumps, wasteland etc. presenting a harbourage for rodents; adjacent water courses at risk o
flooding. This is a general assessment of the building type and it's suitability in terms of
fabrication and location.

Areas must be free from high weeds, standing water and trash. Any external storage such as
engineering parts or pallets must be properly organised. Trash containers and waste compac
must be suitably covered.
Supplier must demonstrate how the chosen method is effective. Auditor will observe access
points during the audit to ensure there are no breaches in site security

The auditor should verify compliance to the following: 1) Access to in-plant laboratory facilitie
are strictly controlled to authorized personnel; 2) The facility is designed so there is a separa
that will prevent laboratory practices from having a detrimental effect on manufacturing; 3)
Personnel adhere to good laboratory practices, e.g. no eating, drinking or smoking or eating
storage of food and drink are allowed; 4) Testing equipments are well maintained; 5) media,
prepared media, reagents and chemcials are labelled & used within their shelf life; 6) Media
prepared media, reagents and chemicals are dated when opened or prepared; 7) Validated
Security & Disposal procedures for control of reagents, hazardous materials and lives culture
pathogenic baterica; 7) Material disposal records & sign off

Facility has procedures and method to ensure returned goods are in "wholesome" condition
before salvage or use in rework:

1) determining the number of cases represented by each product sampling and testing. This
ensure all returned products between acceptable tests is captured
2) Identify, segregate and hold return goods as raw materials, packaging or finished products
Tes methods

4) Identify appropriate responsibility and provisions for sign-off on product release 5) defining
methods of rework (maximum rework level is 5% assuming specification parameters are met
6) Defining testing for rewokred product to vefify compliance to

specification /Quality Assurance Program

7) Records (including product name, quantity, batch code etc must be kept on the use of all
returned goods in rework
The auditor will verify that the process flow does not allow cross contamination for example
between raw and cooked foods and high and low risk personnel.

Washing of equipment etc will be in a segregated area or when there is no production and ris
contamination to product. Sinks must be adequately labelled.

In general the internal and external condition of the building must be well maintained and no
pose a risk to food safety. This is a more general clause and specific areas are dealt with in th
own sections such as walls, floors, ceilings.
Finished products are not at risk of contamination from operations, fabrication, cleaning,
maintenance or other ingredients/ materials on site.

Time and space segregation will be discouraged and only accepted as a temporary measure
long as it is tightly controlled. All suppliers must plan to have physical segregation

The walls in rooms where foods are prepared treated or processed, must be kept in a sound
condition and shall be easy to clean and where necessary disinfect. The walls should have a
smooth impervious finish. Tiling should be avoided but, if present, should be in good conditio
with no cracks or loose tiles. Painted surfaces should be in a good state of repair and free fro
flaking paint. Ledges should be kept to a minimum to avoid dust collection. Vulnerable wall
surfaces or corners should be protected from damage with metal plating or barriers properly
sealed to prevent debris accumulation. For any recurring issues in relation to walls/floors and
ceilings, all points may be awarded if there are frequent inspections to monitor the issues an
risk assessed corrective action approach is maintained with there being no risk to food safety

The floors in rooms where foods are prepared treated or processed, shall be kept in a sound
condition and shall be easy to clean and where necessary disinfect. Floors should be constru
of materials, which are impervious, hard wearing, repairable and resistant to chemical attack
Mezzanine floors and walkways should be completely sealed and have adequate sidewalls to
prevent contamination of product below. For any recurring issues in relation to floors, all poin
may be awarded if there are frequent inspections to monitor the issues and a risk assessed
corrective action approach is maintained with there being no risk to food safe
Drains must be clean and screens must be present and intact

In rooms with high ceilings which are difficult to clean or maintain, line covers should be fitte
over open product to reduce the risk of contamination. For any recurring issues in relation to
walls/floors and ceilings, all points may be awarded if there are frequent inspections to monit
the issues and a risk assessed corrective action approach is maintained with there being no r
to food safety

No evidence of excessive dust and condensation observed.

The systems must prevent pest entr

The protection of glass windows must be adequate to prevent splinters of glass entering
production areas should the window be broken. This may be achieved by the use of adhesive
plastic sheeting or wire reinforced glass.

Chemical and microbiological analysis of water takes place min. annually. Water samples sho
be taken at point of use. Water test must include: 1) Total Plate Count, 2) Coliform, 3) E. Coli,
Nitrates / Nitrites, 5) Heavy metals - lead and mecury, 6) Off flavour and odour. For filtration
sterilisation systems, maintenance records including 1) date of last check, 2) condition of
equipment and filter, 3) corrective action where filters have needed repair or replacement, 4)
signature of individual who performs the maintenance

Planned maintenance may be done internally or via contracted services. Maintenance undert
internally should be documented in the form of a plan and records maintained.For equipment
is maintained under external contracts evidence of contractual agreements must be availabl

A job sheet sign off to detail work done and a 'sign back' system to ensure that the equipmen
in a sanitary condition to return to production.

MSDS will be available.

A procedure for reconciling pars and tools after maintenance is performed. All parts and tools
must be accounted for by checking a list or signature on records indicating all parts and tools
reconciled.
Temporary repairs must be rectified in a reasonable timeframe - it is expected that there will
record of ordering parts along with expected delivery dates.

Storage areas used for all potentially harmful chemicals used on site e.g. Pesticides, caustic s
cleaning chemicals, should be lockable and access restricted. Bundied areas should be provid
around oil tanks. Acid and alkaline materials should be stored securely and separately. MSDS
sheets must be available for all chemicals on site during the audit.
Documented procedure detailing 1) the control of these items, 2) detailing type and 3) freque
of checks and 4) corrective actions.

Inspection records must include: 1) date and item, 2) findings, 3) corrective action, 3) status,
sign off

Procedure to include the following elements: 1) handling of all lights and glass within the faci
including production, warehouse and storage, 2) handling of glass breakage within the facility
any brittle or hard plastic that is broken in a location where it could impact the product, 4)
computer or video monitor should be covered with a plastic film to prevent shattering; 5)
handling of non-tempered / non-protected office glass; 6) Where products are packed into gla
containers, bottles and jars specific glass breakage procedures must be in place. 7) System f
staff to report glass / brittle plastic and ceramic breakage. In addition, Documented Reports m
be available.

A written wood control policy is required detailing handling of wooden pallets and other wood
items. Facility should not use damaged wooden pallets in production and storage of food item
inspection must be carried to check pallet condition before use in the facility

The level of sanitation throughout the site will be observed and assessed accordingly. The
Sanitation program must include: 1) frequency of cleaning; 2) responsibility; 3) defined meth
and procedure for each task; 4) cleaning products and concentration used; 5) individual
accountability and sign off for each task completed; 6) cleaning procedures are designed and
ordered to prevent potential contamination of products and re- contamination of clean areas;
Cleaning equipment and utensils must be colour coded and specific to the area (raw Vs cook
8) Sanitizer / Cleaner concentration used. In addition, auditor will observe the sanitation is
sufficient and not causing potential / imminent contaminati

Cleaning procedures should include: 1) equipment, 2)methods and 3) frequency of cleaning;

4)required chemicals and concentrations. Cleaning procedures should be of sufficient detail f
cleaning to be carried out to a consistent acceptable standard. This may require detail of
breakdown of equipment for cleaning purposes. In addition, sign off sheet for each individual
cleaning task completed and matches the frequency in the Master Sanitation Schedule.
Pre-operational inspection program includes documented visual inspection and confirmation
equipment / production area is clean.

Sanitation Equipment must be intact, clean and colour coded for intended use.

Written program must include the following elements: 1) a plan to test all food contact areas
frequency of testing; 3) acceptance criteria; 4) follow up action and retesting where applicab
records of findings

The effectiveness of cleaning may be assessed by inspection or by microbiological or ATP

systems as appropriate to the risk. Records shall be maintained of cleaning assessments.

1) Sanitizer and cleaning chemical concentration must match the frequency outlined in the
Sanitation Program; 2) Automatic system must be routinely calibrated as per the manufactur
suggested frequency; 3) Test strips or kits may be used for verification of sanitizer and cleani
chemical concentration; 4) Cleaning chemical and sanitizer concentration must be reported o
list that is signed and dated each time a manual mixture is made; 5) Records will be in place
demonstrate routine testing including CIP procedure.

The terms of the contract with the waste disposal company should include reference to the
contractors responsibility to meet legislative requirements. A letter from the contactor

Particular consideration should be given to pest control implications of external waste collect
containers.

Pest Control Program must include the following elements: 1) designated Pest Control Compa
or Operators; 2) Frequency of scheduled service; 3) A full list of pesticides; 4) current Master
Control Map (dated within the last 12 months); 5) liability insurance certificate; 6) Company
license (where applicable or members of an approved pest control association); 7) Certificatio
for the PCO.

Where pest control operations are carried out by the companys own personnel training recor
must be available to demonstrate the competence of all pest control operators. Certificates e
must be on file and suitably in date.

The frequency of inspection and treatment of premises to eradicate or deter infestation shall
based on the product risk, age design and location of buildings and equipment. In general it
would be expected that inspection/treatment visits should be carried out at least 8 times per
year. The contract should have provision for additional treatments where required to eradicat
any infestation which may occur.

Pest Control Map must include the following elements: 1) location of pest control devices; 2)
numbered; 3) dated; 4) identification of pest control devices. Auditor should verify the actual
location and number of the pest control devices against the map.

All areas must be free from reoccurring/existing internal pest activities. There must be no
evidence of the following: 1) No recurring/existing rodent activities; 2) and/OR nesting birds;
evidence of live animals & insects on products, ingredients or packaging; 4) no evident of
excreta/pellets; 5) no evident of rodent damaged ingredient bags; 6) no decomposed rodents
any other animals (traps must be checked often as per the freqency outlined in the pest cont
program).

Where pest control operations are carried out by the companys own personnel training recor
must be available to demonstrate the competence of all pest control operators. Certificates e
must be on file and suitably in date.

The frequency of inspection and treatment of premises to eradicate or deter infestation shall
based on the product risk, age design and location of buildings and equipment. In general it
would be expected that inspection/treatment visits should be carried out at least 8 times per
year. The contract should have provision for additional treatments where required to eradicat
any infestation which may occur.

Pest Control Map must include the following elements: 1) location of pest control devices; 2)
numbered; 3) dated; 4) identification of pest control devices. Auditor should verify the actual
location and number of the pest control devices against the map.

All areas must be free from reoccurring/existing internal pest activities. There must be no
evidence of the following: 1) No recurring/existing rodent activities; 2) and/OR nesting birds;
evidence of live animals & insects on products, ingredients or packaging; 4) no evident of
excreta/pellets; 5) no evident of rodent damaged ingredient bags; 6) no decomposed rodents
any other animals (traps must be checked often as per the freqency outlined in the pest cont
program).

Effective location of pest control devices and use of bristle strips and fly screen etc)

As a guide, 1)Internal traps should be positioned at 8 meters intervals (25 feet); External trap
shall be positioned at 15 meters (50 feet) intervals; 2) Freezers and coolers shall have traps
located within 2 meters (6 feet) on both sides of entry doors (both inside and outside of the
doorway); 3) Traps should be positioned against the wall; 4) Interior of traps, bottom of glue
boards shall have service labels dated and initial after each treatment by the PCO (electronic
scan methods are acceptable). 5) EFK UV bulbs must be changed at least annually.

This should be detailed in the contract or procedures.

Records must include the following elements: 1) Out-bound trailer pre- cooling temperature i
least 5 degC (41F) for refrigerated items and -12 degC (10F) for frozen items; 2) List of produ
delivered; 3) Product temperatures are recorded before loading; 4) Product temperature at
delivery or restaurants

Records must indicate the requirements have been checked, signed and dated by designated
personnel.

Procedure must detail: 1) the action of driver must take to report of vehicle breakdown or the
refrigeration breakdown and 2) timescale for vehicle / product recovery; 3) Product temperat
measurements upon delivery; 4) Corrective action for out-of-tolerance product temperature a
any point of delivery.
Auditor will check the despatch records to ensure FIFO is practiced.

Any allergens or other specific material relevant to the market being supplied must be identi
by the supplier and where applicable and where required, procedures must be in place to ver
and control.

Control methods are effective and include the following: 1) Facility has determined if it has an
food allegens in the facility 2) Processing order or change over procedures specifically addres
ensuring allergens are not transferred to a non-allergen containing product 3) Sanitation
procedures and practices do not allow cross contamination of allergens to non allergen produ
4) Ingredient weighing / handling practices do not allow for cross contamination of allergens
non-allergen products and ingredients Example of food allergens are : peanuts, soybeansm m
eggs, fish, crustacean, tree nuts, and wheat. Additional allergens may be identified by local
requirements / regulations and must be included.

For no foreign body detection equipment, a risk assessment must be in place to justify absen
The company must be able to demonstrate how the sensitivity level has been deduced.

The rejection mechanism can be a divert valve, line stop (with alarm), belt retraction or arm
mechanism and should be diverted to a suitably secure container.

The auditor will verify the effectiveness of metal detection testing during the audit.

Records must contain the following: 1) Product name and date 2) identification of metal dete
3) Quantity of product to be rechecked. 4) Person responsible for recheck 5) Result of recheck
Sign off by supervisor.

The procedure contain the following elements:

1) Release by concession (e.g shelf life extension of expired product)
2) On hold / Quarantine
3) Customer returns
4) Rework
5) Product Rejection
6) Specified designated areas and product identification (e.g hold tag). 7) Identification of
personnel responsible for initiation, evaluation and release / disposal of held product.

This can be in the form of computerised stock management system, a database or paper rec

An acceptable alternative would be situations where bar coding is in place to prevent shipme
product designated on hold by computer and where no physical tagging is in place

Laboratories used must be suitably accredited where applicable (compulsory for level 2) to
conduct each test and using recognized test methods.

The expectation is that retention samples are kept, any deviation will be agreed with theCert

The auditor must verify that all temperature control measures are effective: 1) Procedures de
the process by which the facility temperatures are monitored and documented in each critica
area : coolers, freezers, cool docks, blast chilling or any storage trailers where temperature
senitive ingredients and products are stored, 2) Temperature records must be maintained, wh
temperature sensitive ingredients and products are stored, manually "at least 3 times" a day
automated temperature graph recorder is used. If an automated, continuous on-line tempera
graphs recorder is used, facility temperatures shall be manually taken and recorded and sign
"once daily". 3) For temperature sensitive products / ingredients, product temperatures shal
documented before products are shipped.
4) Docks must be enclosed and cooled to less than 500F / 100C if temperature sensitive item
shipped.

For example for minimum and average weight systems an automatic check weigher system m
be used or individual weights taken and recorded at pre determined frequencies. Records mu
contain the following: 1) Date and product name 2) Target weight of product, weight control
method (average/ minimum / gross / net) including packaging tare weights where applicable.
Weight tolerances 4) Time of checks 5) Actual product weights (may be in the form of a print
automated) 6) Corrective actions taken in the event of weights being out of tolerance)

Calibration program must be in place for establishing and maintaining calibration and accura
key testing and measuring equipment used in QA labs and in manufacturing, storage and
distribution. The following elements must be included: 1) Identify all key mesauring equipme
including all equipment used to measure a product attribute products as outlined in the
specifications . This shall include autoclave whereas on-site micro. test is carried out and the
detector/s. 2) Maintaining schedules for calibration testing
3) Documented methods and frequency of calibration
4) Identifying appropriate reference standards 5) Record / certificates of calibration must be u
date and maintained.

1) Identify all key mesauring equipment including all equipment used to measure a product
attribute products as outlined in the specifications .2) Maintaining schedules for calibration
testing 3) Documented methods and frequency of calibration 4) Daily checks before producti
for thermometers and scales used in the process, including floor scales, filled load cells, and
quality testing scale
5) Establishing procedures for proper maintenance of reference standards (for example mast
calibration thermometer/ stamped weights) 6) Records must be maintained.

A master calibration log must be maintained by the site and include the following:1) Measuri
Equipment, 2) Calibration Frequency, 3) Scheduled Date for Calibration, 4) Date of Calibration
Status
Microbiological and chemical proficiency based test must be in place with an accredited
laboratory.

1) A written GMP program must encompass all the GMP requirements , for employee, visitors
contractors. (In addition to the local Regulatory Requirements shall be used as a basis for
requirements). 2) The GMP's must be displayed in prominent staff areas or as appropriate 3)
audits on GMP must be conducted min. every month. Results of the audits and the corrective
action must be recorded
NOTE: Issues relating to corrective actions not completed must be scored

The employees training program must include the following elements: 1) New employees mu
trained in GMP and food safety before commencement of work (work safety within 3 months)
2) GMPs, Food Safety, Work Safety Training materials; 3) Competency assessment, e.g. quiz;
Training records of all employees

The training program must include the following elements: 1) Job titile and job summary; job
training methods;
responsible parties for training; Training effectiveness and competency assessment, e.g. Quiz
Training records

1) Schedule for annual employee refresher training inlcuding GMPs, Food Safety, Work Safety
training that has an impact on controlling the KPIs; 2) Training assessment; 3) Training record

There will be a system for checking and sign off by a competent line manager for return to w
forms, records will be available. (Details of the policy will be in general GMP section

There will be a system for checking and sign off by a competent line manager for visitor form
Form and records must be in place.

There will be a system for checking and sign off by a competent line manager for visitor form
Forms and records must be in place.

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2

LEVEL 2