Welcome to Internal Auditing

Training Course
Delegates Introductions
Please introduce yourself
Your name
A brief description of Education &
Experience.
A brief Job description
Your involvement in QHSE Assurance.
Aim
To provide training for potential auditors
and prepare them for that role
Enable delegates to be aware of QHSE
system requirements
Satisfy the requirement of ISO 9001:2008,
14001:2004 & OHSAS 18001:2007
for auditor training
Enable delegates to be prepared to act as
auditees
Course Structure
Lectures and discussions on each topic.
Exercises/ case studies to enable delegates to
experience audit practices and report findings.
Ongoing assessment to evaluate delegates
ability based on participation, teamwork,
application and comprehension..
Course competence test - to ensure retention
of knowledge of auditing.
Auditor
A person who has the qualification to
perform quality audits
A auditor must be authorized for each audit
Persons selected as auditor shall be
Free from bias
Independent
of the activity
being audited
Free from
influence
Auditors Responsibilities
Comply with auditing requirements
Communicate and clarify audit requirements
Plan and carry out assigned responsibilities
Assess effectiveness of quality system
Document audit observations
Report audit results
Co-operate with team and support lead auditor
Maintain confidentiality
Retain and safeguard documents
Verify corrective action
Additional Abilities
Address searching questions
Display an authoritative presence
Think quickly
Stand their ground
Remain calm and polite
When required make suggestions for
improvement
Lead Auditor
An auditor authorised and appointed to
manage a quality audit
Duties include:
Assisting with the team selection
Controlling, planning and co-ordinating the audit
Representing the audit team with the auditees
management
Writing and submitting the report
Additional Lead Auditor
Tasks
Review quality documentation for
compliance to standard
Assess extent of comformance
Review contents of teams checklists
Decide on the validity and categories
of noncompliances
Make clear written and verbal reports
to management
Auditor Training
Specialist knowledge of applicable
specifications, standards, codes,
procedures, industrial practices in the
areas to be audited
Ability to manage an audit team
An in-depth knowledge of quality system
requirements
That they will audit objectively and
thoroughly without bias
They have appropriate experience in the
area being audited
Section 2
Introduction to Quality
What is Quality ?
What does Quality mean to you ?
What does Quality mean to your
organisation ?
Quality
The totality of characteristics of an entity
that bear on its ability to
satisfy stated and implied needs
Introduction to Quality
To be successful, an organisation must
offer a service and/or products which :-
Meet a well defined purpose or need
Satisfy its users / customers
expectations and contractual
requirements
Comply with applicable standards and
specifications
Introduction to Quality
To be successful, an organisation must offer a
service and/or product which :-
Will yield a profit on the resources invested
Is supplied within delivery timescales agreed
/ required by the user / customer.
In other words In other words -- Provide a Product and/or Provide a Product and/or
Service which is totally fit for the purpose Service which is totally fit for the purpose
Definition:
an audit by an organization of its own
systems and procedures
Objective:
to assure maintenance, development and
improvement of the Quality System
Requirement:
ISO 9001; 4.17
guidelines found in ISO 10011
FIRST PARTY
(INTERNAL AUDIT)
Definition
an audit by organization on
suppliers and sub-contractors
Objectives
to determine suitability of suppliers
/ sub-contractors
to appraise supplier / sub-
contractor performance
SECOND PARTY
(EXTERNAL AUDIT)
Definition
an audit by a body which is independent
of the organization, its suppliers and
customers
Objective
to determine whether an organisations
Quality System has been documented
and implemented in accordance with a
specified standard
THIRD PARTY
(EXTERNAL AUDIT)
Accreditation Scheme
Department of Trade and Industry
DTI
Accredit
Certification Bodies
Calibration & Test Houses
Certify
Companies / Organisations
United Kingdom Accreditation Service
UKAS
EXAMPLES SHOWN
FOR UK REGISTRATION
Section 3
Quality Management
System
Document Control
Typical Documents Requiring Control:
the quality manual
Procedures
Work Instructions including works
orders/route cards
Quality Plans
Drawing - including as built
Specifications
Quality Management
System
Documentation
Quality
Manual
Quality
System
Procedures
Work
Instructions
Forms
Quality Manual
Quality Policy
Objectives
Overview
Organisation
Responsibilities
Requirements
Policy/Responsibility/Procedure
Reference
QUALITY MANUAL CONTENTS
Title page
Scope
Amendments page
Table of contents
Introduction to organisation
Quality Policy
Policies for specific aspects of Quality System
Organisation structure
Quality system outline
Cross-reference to Standard requirements
Title page
Index of procedures
Amendments record
Procedures
Cross-reference to associated
documents
QUALITY PROCEDURES MANUAL
Quality System Procedures
A set of procedures which detail how
the requirements of the quality manual
are to be implemented
Detailed procedures which define how
the processes are to be performed and
controlled
Specifying who is responsible for doing
what
Department, or
Function, or
Group of
functions
Understandable
Useable
Written for
Written In an agreed format
QUALITY SYSTEM PROCEDURES
PROCEDURE FORMAT
PURPOSE
SCOPE
REFERENCES
DEFINTIONS
PROCEDURE/
METHODS
ASSOCIATED
DOCUMENTS
Objectives/intention
applicability, boundaries
who, what, where, when, how
other documents quoted
explain confusing terms
list those referred to / used
who is responsible ?
what is actioned / controlled ?
what methods / equipment / records ?
how is information processed ?
where - location ?
when - timing / frequency ?
PROCEDURE/ METHOD SECTION
Title
Number
Issue status
Page numbers - paginated
Approval authority
Issuing authority
Issue date
ESSENTIAL INFORMATION
ON A PROCEDURE
Work Instructions
Detailed Instructions for the performance
of specific tasks
Such Instruction may cover
Materials
Processes
Verification
These must be:
documented
implemented
controlled
WORK INSTRUCTIONS
Operating instructions
Job cards
User manuals
Inspection plans/instructions
Technical manuals
Manufacturers recommendations
Performance standards
EXAMPLES OF WORK
INSTRUCTIONS
Quality Management
System
Sales Design Purchasing Manufacture Accounts Personnel After Sales
Level 1
Level 2
Level 3
Level 4
Quality Manual
Procedures
Work Instructions
Forms
Standard
ISO 9000
Policy Statement
Commitment, Organisation,
Responsibilities
Company Practice
& Interfaces
Written Instructions
to Control
Tasks
Quality
Records
Documenting Procedures
Say what you do
Do what you say
and where necessary
Show what you did
Document Control
Inspection and test plans
records
Purchasing specifications, orders &
acknowledgements
Quotes, tenders, contracts / contract reviews
Audit plans & records
Management reviews
Design reviews
Document Control
Control requirements
Responsibility for the creation, authorization,
revision and issuing of controlled documents
Formats to be used
Identification of issue, revision for the change
Instructions for removal of superseded
documents
Document control
A controlled document is:
Properly authorized by approved signatories
Serial numbered for identification
Issue/revision referenced and dated
Issued within a registered circulation
subject to control of all changes
Updated to the same distribution
Document Control
Uncontrolled document
UNCONTROLLED COPY - Will not be
maintained
THIS COPY WILL NOT BE KEPT UP TO
DATE
CHECK FOR LATEST ISSUE BEFORE
USE
Document Control
Typical Audit Questions
Do the documents conform with statements
made in the Quality Manual?
Are the appropriate to the user?
Do they cover the scope required?
Are they properly authorized?
Are the responsibilities adequately defined?
Are they communicated to the people who
need them?
Document Control
Are they updated when necessary ?
Are there any gaps or overlaps which
could cause confusion?
Are interfaces properly defined?
Document Control
Desktop Assessment
Are the documents in evidence and being
worked to?
Are the documents in evidence applicable to
the activity in which they are being used?
Is the correct issue in use?
Are they circulated in a timely manner?
Are they superseded or obsolete issues
withdrawn?
DOCUMENTATION MUST BE
Readable
Useable
Accessible
Usually a control document
Provides a statement of the operation
Identifies procedures used
Defines hold points
Indicates monitoring process
Indicates the record system
may be a Level 2 or Level 3 document
QUALITY PLAN
Section 4
Introduction to ISO
9001:2000
01. General
To address customer satisfaction by
meeting customer and applicable
regulatory requirements.
Standard can be use for
external/internal parties to audit.
QMS requirements are complementary
to technical requirements for product.
0.2 Process Approach
Process approach to quality
management encouraged.
When used within Quality Management
System it include...
Introduces and explain the process
model as conceptual presentation of
QMS requirements specified.
Management
responsibility
Measurement,
analysis,
improvement
Resource
management
Product
(and/or service)
realization
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Q I Y SYSTEM
CONTINUAL IMPROVEMENT
Fig. 1 Quality anagement rocess odel
Input
Output
Product/
Service
ISO 9001:2000 Management
1 Scope
1.1 General
Standard specifies QMS requirements for use .
demonstrate organizations ability to consistently
provide product meeting customer and
applicable regulatory requirements.
Address customers satisfaction through
effective application of the system .
1.2 Application 1.2 Application
Requirements are generic.
Requirements may be excluded in case
of non-applicability
Exclusions must:
Not affect ability to provide conforming
product.
Be limited to clause 7.
2. Normative reference
Replica of present clause 2
Users encouraged to use most recent
revisions.
ISO 8402:1994 replaced by ISO
9000:2000,Quality management
systems-Fundamentals and vocabulary.
3. Terms and definitions
ISO 9000 :2000 applies
3. Terms and definitions
Organization replaces Supplier
Supplier replaces Sub-contractor
The term Product may also refer to
Service.
4. Quality management system
4.1 General requirements
Establish,document,implement,maintain and
continually improve QMS in accordance with
the standard.
The organization shall
identify the process
Determine sequence and interaction
Determine criteria and methods for operation
and control
Ensure availability of resources and
information.
Monitor ,measure and analyze the
process
Implement actions necessary
4.2 Documentation
requirements
4.2.1 General
Documented Policy and Objectives
A quality Manual
Documented procedures required by the
standard
Documents to ensure effective planning,
operation and control of its processes
Records
4.2 General Documentation
Requirements
Extend
Size and type of
organization
Complexity and
interaction of
processes.
Competence of
personnel.
To Include
Documented
procedures required
by standard.
Documents required
by organization to
ensure effective
operation and control
process.
4.2.2 Quality Manual
Establish and maintain a quality manual
which includes
The Scope
The documented procedures and their
reference.
Description of interaction between the
processes of QMS
4.2.3 Control of Documents
Documents shall be controlled
A documented procedure shall be
established to define the controls
needed
to approve documents for adequacy
prior to issue.
to review and update, and re approve
documents.
Changes and revisions are identified.
Availability of documents at points of use.
Documents are legible and readily
identifiable.
Documents of external origin are identified
and their distribution controlled.
Suitable identification of obsolete documents
and unintended usage.
Control of Documents
(Contd..)
4.2.4 Control of records
Records shall be established and
maintained
Documented procedures for
identification, storage, retrieval,
protection, retention time and
disposition of quality records.
5 Management responsibility
5.1 Management
Commitment
5.2 Customer Focus
5.3 Quality policy
5.4 Planning
5.4.1Quality objectives
5.4.2 Quality Planning
5.5 Responsibility,authority
and communication
5.5.1 Responsibility &
authority
5.5.3Internal communication
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6.0 Resource Management
6.1 Provision of resources
6.2 .1 general
6.2.2 Competence,awareness
and training
6.3Infrastructure
6.4 Work environment
5.1 Management Commitment
Top management shall provide evidence of
commitment to the development and
improvement of QMS by:
Communicating the importance of meeting
customer and legal/regulatory requirements.
Establishing quality policy and objectives.
Management Reviews
Provision of resources.
5.2 Customer Focus
Customer requirements are met with the
aim of enhancing customer satisfaction.
5.3 Quality Policy
Appropriate to the purpose of organization.
Commitment to meet requirements and
continual improvements.
Frame work for establishing and reviewing
quality objectives.
Communicated and understood within the
organization.
Is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality Objectives
Establish quality objectives at relevant
functions and levels.
Objectives must be measurable and
consistent with the quality policy.
5.4.2 Quality Planning
Planning of Quality Management
System to meet the requirement given
as well as quality objectives.
Integrity of Quality Management
System is maintained when changes
occur.
5.5 Responsibility, authority and
communication
5.5.1 Responsibility and authority
Define and communicate the
responsibilities and authorities.
5.5.2 Management representative
Member of the management who has
responsibility and authority for
ensuring that processes of the QMS are
established and maintained.
Reporting on performance of QMS including needs
for improvement.
Promoting awareness of customer needs and
requirements..
5.5.3 Internal Communication
Ensure communication between various
levels and functions regarding the
processes of the QMS and their
effectiveness.
5.6 Management Review
5.6.1 General
Review of QMS by top management at
planned interval.
Ensure QMS suitability ,adequacy and
effectiveness.
Evaluate the need for changes and
improvements to QMS including policy
and objectives.
5.6.2 Review Input
Review performance and improvement opportunities
related to:
Audit results
Customer feedback
Process performance
Product conformance
Status of preventive and corrective actions.
Follow up actions from earlier reviews.
Change that could affect the QMS.
Recommendations for improvements.
5.6.3 Review output
Output to include decisions and actions
related to
Improvement of QMS and its process
improvement of product
resources needs
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 Assignment of personnel
6.2.2 Training,awareness and competency
6.3 Infrastructure
6.4 Work environment
6.1 provision of resources
Determine and provide
To implement and maintain the Quality
Management System and continually
improve effectiveness.
To enhance customer satisfaction by
meeting customer requirements.
6.2 Human resources
6.2.1 General
Those who have responsibilities defined
in the QMS must be competent on the
basis of applicable
education,training,skills and experience.
6.2 Competence, awareness
and training
Identify competency needs
Provide required training
Evaluate the effectiveness of training
provided.
Ensure staff aware of relevance and
importance of their activities and
contribution to achieving objectives.
Maintain appropriate records
education,training,qualification and
experience.
6.3 Infrastructure
Identify ,provide and maintain the
facilities needed to achieve product
conformity.This shall include
Building, workspace & associated
facilities
Process equipment, hardware and
software
supporting services.
6.4 Work environment
Identify and manage human and
physical factors of the work
environment needed to achieve product
conformity.
7 Product Realization
7.1Planning of product realization
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service provision
7.6 Control of measuring & monitoring
devices.
7.1 Planning of realization
processes
Plan and develop processes for product realization
consistent with this standard
While planning product realization determine the
following
Quality objectives and requirements for the
product
the need for processes,documentation,resources
and facilities specific to the product.
Required verification, validation, monitoring,
inspection and test activities specific to the
product and acceptance criteria.
Records.
7.2 Customer related process
7.2.1 Determination of requirements
related to the product.
Product requirements specified by the customer
including delivery and post delivery activities.
Requirements not specified but necessary for
intended or specified use.
Obligations related to product, including regulatory
and legal requirements.
Any additional requirements determined by the
organization.
7.2.2 Review of Product
requirements
Review identified requirements and
ensure before commitment to
supply product that;
product requirements are defined.
Difference between tender and contract are
resolved.
Organization has ability to meet the requirements.
In case of no documented customer
requirements, they shall be confirmed by the
organization before acceptance.
In case of any changes concerned personnel and
documents are up dated.
7.2.3 Customer
communication
Identify and implement arrangements for
communication with customers relating
to:
product information
inquiries contract and order handling
including amendments.
Customer feedback including
complaints.
7.3 Design & development
7.3.1 Design & development planning
7.3.2 Design & development input
7.3.3 Design & development output
7.3.4 Design & development review
7.3.5 Design & development verification
7.3.6 Design & development validation
7.3.7 Control of changes.
7.3.1 Design & development
planning
Plan & control D&D of the product
Planning to include:
D&D stages
required review ,verification and validation
activities
responsibilities and authorities for D&D.
Interfaces between groups must be managed.
Planning to be updated as the D &D progresses.
7.3.2 Design & development
input
Define & document product requirements
including
Functional and performance requirements.
Applicable regulatory and legal requirements.
Information from previous similar designs.
Any other essential requirements.
Review input for adequacy
Review for adequacy and resolve any
ambiguous,incomplete or conflicting
requirements.
7.3.3 Design & development
output
Document D & D output allowing verification.
Provide information for production or
operations.
D & D outputs shall
meet the input requirements
Provide appropriate information for purchasing,
production and for service provision,
Contain or reference product acceptance criteria.
Specify the characteristics of the product that are
essential for its safe and proper use.
7.3.4 Design & development
review
At suitable stages review D &D to;
evaluate the ability to fulfil
requirements.
Identify problems and propose follow-
up.
Involve all functions concerned.
Record the results and follow up actions.
7.3.5 Design & development
verification
Verify D & D to ensure that out put
meets the input requirements.
Record the results of verification and
subsequent follow up actions.
7.3.6 Design & development
validation
Perform D & D validation to confirm that
product is capable of meeting the
requirements for intended use.
Whenever applicable to be done prior to
delivery.
Results of validation and follow up actions
must be recorded.
7.3.7 Control of Design and
Development changes
Design and development changes shall be
identified and records maintained
Before implementation changes would be
reviewed, verified, and validated.
Evaluation of the effect of the changes.
Record results of review of changes and
follow up actions.
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased
product.
7.4.1 Purchasing Process
Control purchasing process to ensure that
purchased product meets requirements.
Type & extent of control .
Select suppliers based on their ability to supply
conforming product.
Define criteria for selection and periodic
evaluation of suppliers.
Results of evaluation and follow up actions must
be recorded.
7.4.2 Purchasing Information
Purchasing information shall describe
Requirements for approval of product
.procedure, processes,equipment and
personnel.
Requirements for qualification of
personnel.
Quality management system requirements.
Ensure adequacy of specified purchase
requirements prior to communication to
supplier.
7.4.3 Verification of purchased
product
Identify and implement activities
needed to verify purchased product.
Where organization or its customer
purpose verification at supplier
premises,organization must specify in
purchasing information:.
7.5 Production & service
operations
7.5.1 Control of production and
service provision
7.5.2 Validation of processes
7.5.3 Identification & Traceability
7.5.4 Customer property
7.5.5 Preservation of product.
7.5.1 Control of Production
and service provision
Controlled conditions for production & services
operations through:
Availability of information specifying product
characteristics.
Work instructions available where necessary.
Use of suitable equipment.
Availability & use of measuring and monitoring
devices.
Implementation of monitoring and measurements
activities.
Implementation of release,delivery and post delivery
activities.
7.5.2 Validation of Processes for
Production and Service Provision
Shall validate process when
defined criteria for review and approval
approval of equipment and qualification
of personnel
use of defined methods & procedure
requirements for record
re-validation
7.5.3 Identification and
tracebility
Where appropriate identify product
through all stages of operations.
Identify status with respect to
measurement & monitoring
requirements.
Where traceability is required control &
record unique identification of product.
7.5.4 Customer property
Care for customers property being under
organizations control or being used by
organization.
Identification,verification,protection &
maintenance of customer property provided
for use or incorporation.
Any customer property that is lost,damaged
or found un suitable must be recorded &
reported to customer and record maintained.
7.5.5 Preservation of product
Preserve conformity of product during
internal processing and final delivery to
intended destination.
Include identification, handling,
packaging, storage and protection.
This applies to constituent parts of
product.
7.6 Control of monitoring &
measuring devices
Shall establish process
Calibrate & adjust measuring and monitoring devices at
specified intervals as prior to use.
Traceability to international or national standards.Where
no such standard exist record the basis.
Safeguard MMD from adjustments invalidating
calibration.
Protect MMD from damage or deterioration during
handling,maintenance or storage.
Record results of calibration
Assess validity of previous results when devices found to
be out of calibration.
7.6 (Significant addition or
Modifications).
The following specific requirements have been omitted
from the ISO 9001-1994 standard.
Documented Procedures omitted
measurement uncertainty is known replaced with
measurement capability is consistent with the
measuring requirements
test software replaced with validated prior to use
comparative references omitted
technical data.. Made available.. To customer
omitted
prescribed intervals replaced with periodically
or prior to use
define the process employed for the calibration.
Unsatisfactory replaced with the basis used for
calibration shall be recovered
identify with a suitable indicator or approved
identification record to show the calibration status
omitted.
Ensure environmental conditions are suitable..
now covered by devices shall be used and
controlled to ensure that measurement capability is
consistent with the measuring requirements.
8 Measurement,analysis and
improvement
8.1 General
8.2 Monitoring &
measurement
8.2.1 Customer
satisfaction
8.2.2 Internal audit
8.2.3 Monitoring &
measurement of
processes
8.2.4 Measurement
and monitoring of
product
8.3 Control of non-
conformity
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual
improvement
8.5.2 Corrective
action
8.5.3 preventive
action
8.1 General
Plan & implement measurement and
monitoring activities needed to assure
Conformance of the product
Conformance to the quality
management system.
Continual Improvement
8.2 Monitoring and
Measurement
8.2.1 Customer satisfaction
Organization shall monitor information
on customer satisfaction and /or
dissatisfaction.
The methodologies for obtaining and
utilizing such information must be
determined.
8.2.2 Internal audit
Conduct periodic internal audit to determine if
QMS:
Conforms to the requirements of the
standard.
Has been effectively implemented &
maintained .
Plan the audit program considering:
Status and importance of the activity
Results of previous audits
8.2.2 Internal audit
Auditors shall not audit their own work
The documented procedure must cover:
Responsibilities & authorities for
conducting audits
Ensuring independence
Recording results and reporting to
management
Timely corrective actions.
Follow up to verify & report
implementation of verification results.
8.2.3 Measurement and
monitoring of processes
Apply suitable methods for
measurement and monitoring of those
realization processes necessary to meet
customers requirements.
When planned results are not achieved
8.2.4 Measurement and
monitoring of product
Measure & monitor product characteristics at
appropriate stages.
Evidence of conformity with the acceptance
criteria
Records must indicate the authority
responsible for release of product.
Release or delivery must not proceed until all
the specified activities have been completed
unless otherwise approved by the customer.
8.3 Control of non conformity
product
Documented procedures for control non
conforming product to prevent unintended use or
delivery.
The organization shall deal with non conforming
product.
Taking action to eliminate the detected .
Authorize under concession
Preclude the original intended use
Records of concession shall be maintained.
Re verification
Non conformity detected after delivery
8.4 Analysis of data
Collect & analyze data determine suitability and
effectiveness of QMS and to identify
improvements that can be made.
Analyze data provide info on:
Customer satisfaction and
conformance to product requirement.
Characteristics of product & process and
their trends
suppliers
8.5 Improvement
8.5.1 Continual Improvement
Facilitate continual improvement using:
quality policy
objectives
audit results
analysis of data
corrective actions
preventive actions.
Management review
8.5.2 Corrective action
Action appropriate to the impact of problem.
Documented procedures shall define requirements for:
Reviewing non-conformities
determine the causes
evaluating the need for corrective action
determine corrective action needed and implemented.
Recording results of action
Reviewing corrective action taken
8.5.3 Preventive action
Organization must identify preventive action to
eliminate the causes of potential non conformances
to prevent occurrences.
Actions appropriate to the impact of potential problem.
Documented procedures must define the requirements
for
Determining potential nonconformaties and their
causes
Evaluating the need for action to prevent occurrence
of nonconformaties
Determining and ensuring implementation of
preventive action needed.
Recording results of action taken.
Reviewing preventive action taken.
QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 1 - CUSTOMER-FOCUSED
ORGANISATION
Organisations depend on their customers and therefore should
understand current and future customer needs, meet customer
requirements and strive to exceed customer expectations.
PRINCIPLE 2 - LEADERSHIP
Leaders establish unity of purpose and direction of the
organisation. They should create and maintain the internal
environment in which people can become fully involved in
achieving the organisations objectives.
QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 3 - INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organisation and their
full involvement enables their abilities to be used for the
organisations benefit.
PRINCIPLE 4 - PROCESS APPROACH
A desired result is achieved more efficiently when related
resources and activities are managed as a process
QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 5 - S STEM APPROACH TO
MANAGEMENT
Identify, understanding and managing a system of interrelated
processes for a given objective improves the organization's
effectiveness and efficiency
PRINCIPLE 6 - CONTINUAL IMPROVEMENT
Continual improvement should be a permanent objective of the
organisation
QUALITY MANAGEMENT
PRINCIPLES
PRINCIPLE 7 - FACTUAL APPROACH TO DECISION
MAKING
Effective decisions are based on the analysis of data and
information
PRINCIPLE 8 - MUTUAL BENEFICIAL SUPPLIER
RELATIONSHIPS
An organization and its suppliers are interdependent, and a
mutually beneficial relationship enhances the ability of both to
create value
SECTION # 5
Internal Audit Cycle
The Audit
Assign the auditors to their area
Sample the system
Collect objective evidence of system
effectiveness
Compare findings from checklist with
requirements
decide compliance or noncompliance
Audit team daily meeting
Reasons for conducting Audits
To examine a Quality Management
System for improvements.
To ensure ISO 9000 requirements are
being complied with.
To determine compliance or non-
compliance
To meet regulatory requirements
Auditing Procedure
The method for planning, initiating and
conducting audits and follow up
activities including corrective actions
The rules for deciding the criticality of
noncompliance
Auditing Procedure
The format and distribution of audit
reports, noncompliance reports,
checklists or other forms required for
reporting
Records, storage and retention
PHASES OF AN AUDIT
PLANNING
- Information Gathering
- Annual Schedule
- Estimate Resource
- Findings
- Required Actions
- Verify effectiveness
PERFORMANCE
- Opening
- Assess
- Review Finding
- Closing Meeting
PREPARATION
- Review Documents
- Checklist
- Agenda
REPORT &
FOLLOW-UP
QUALIFIED
EXPERIENCED
SECTION 5-1
Planning
Initial Planning
Decide who shall carry out the audit
Identify the relevant quality
specification or requirements
Plan the date/time
Gather information
Detailed Planning
Prepare program - send copy to auditee
Decide team composition
Arrange team briefing
Team prepare checklists
Detailed Planning
Notify auditee of arrangements /
requirements
Duration of audit
Composition of audit team
Facilities for review etc.
Planning
The audit team
The Team Leader if possible should
have the appropriate knowledge and
experience of the industry and
technology involved.
The Lead Auditor shall be adequately
trained and have the ability to organize
and lead the audit team.
Planning
The auditor team members, shall be
trained in auditing techniques and have
knowledge of the industry and
technology involved
Auditors may be selected on the basis
of their specialist discipline or
expertise.(e.g., Design, Production,
Computer Systems, etc.)
Planning
The audit Team must be supplied with
copies of :
The specification
Copies of any documents they may
have to complete (e.g non-compliance,
reports, checklists,etc)
Planning
Team Size and Audit duration will
depend upon
The size and complexity of the
departments operation
The standard/specification to be applied
Note: A small dept. may take half day
whereas a larger one may take a two
days or more
Planning
Audit Team briefing
It is good management to arrange for a
meeting of the team, prior to the audit,
to brief them on the requirements.
The briefing should cover:
the program
allocation of individual audit areas
audit policies and practices
AUDIT PLANNING AUDIT PLANNING AUDIT PLANNING AUDIT PLANNING
Team Leader Team Leader
Candidates should be selected from qualified
auditors with auditing experience.

Candidates should have a demonstrated ability to
communicate effectively both orally and in writing.


Responsibilities Responsibilities
y
Make final decisions
y
Assist with selection of auditors
y Represent audit team with management/
submit audit report

y
Direct follow-up activities
EXAMPLE OF AN AUDIT PLAN EXAMPLE OF AN AUDIT PLAN
AUDIT PLAN
Procedure/
Department
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
AUDIT KEY
P - PLANNED
P/D - PLANNED & DONE
U - UNSCHEDULED AUDIT PERFORMED
F - FOLLOW-UP AUDIT PLANNED
F/D - FOLLOW-UP COMPLETED
AUDIT ITINERARY AUDIT ITINERARY
Time Team A (PM) Team B (WL)
09:00-09:15 Opening Meeting
09:15-12:00 Sales Department Engineering Department
- Contract Review - Document & Data control
- Customer Complaint - Product Design & Development
- Sample Control - Control of Production Fixture & Tools
PMC Department - Control of Inspection, Measuring
- Production Planning & Text Equipment
- Material Planning
12:00-13:)0 Lunch
13:00-13:30 Auditors Meeting
13:30-16:45 Store Production
- Material Store - Process Control
- Finished Store - In-process Inspection
Quality Department - Control of Non-conforming Products
- Incoming Inspection & Testing Personnel Department
- Final Inspection & Testing - Training
- Corrective & Preventive General Manager
Action - Internal Audit
- Management Review
16:45-17:30 Auditors Meeting
17:30-18:00 Closing Meeting
SECTION 5-2
Preparation
AUDITEE AUDITOR AUDITOR
Non Non- -conformance Statements conformance Statements
Audit objectives Audit objectives
Audit Schedule Audit Schedule
Notification of Audit Notification of Audit



Selection of Audit Team Selection of Audit Team
Prepare Checklist Prepare Checklist
Audit Plan Audit Plan



Audit team Audit team
Auditee Auditee





Audit team Audit team






CAR (s) / Audit Report CAR (s) / Audit Report

CAR Status Log CAR Status Log



Team Leader Team Leader





Team Leader Team Leader
QMR QMR
Planning Planning
Preparation Preparation
Conduct Audit Conduct Audit
Complete Audit / Complete Audit /
Discuss Findings Discuss Findings
Audit Report Back Audit Report Back
and Recording and Recording
Follow Follow - - up up
Close Close - - out out
- -investigate cause of investigate cause of
nonconformance nonconformance
- -return completed CAR return completed CAR
- -implement necessary implement necessary
corrective / preventive corrective / preventive
action and monitor for action and monitor for
effectiveness. effectiveness.
AUDIT PREPARATION AUDIT PREPARATION
Selectio of Audit Team
y
Auditor Independence Auditor Independence


y Trained Auditor Trained Auditor


y Auditor credibility Auditor credibility

AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION
Checklists Checklists- - Preparation Preparation
y
Reflects objective and scope of the audit Reflects objective and scope of the audit
y
Sources of information for checklists Sources of information for checklists
- previous internal Audit Report / CAR (s)

- previous checklist
- auditee Quality Documents
- known quality problems
AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION
Checklist -Preparation
WHAT WHAT the auditor wants to look for

WHOM WHOM
the auditor wants
to speak to


WHAT WHAT the auditor wants to speak about

AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION AUDIT PREPARATION
Checklist Questio s
Based on Quality Documentation used by
the Dept.to be Audited.
From the documentation Identify all the
key things involved / to be done
Record the key things on the checklist
as things to be checked.
Include references to all forms and other
documentation, i.e. other procedures / W.I.
IDENTIF ING PROCEDURES TO AUDIT IDENTIF ING PROCEDURES TO AUDIT
ISO Elements ISO Elements
Area Area
Stores
x x x x o x x x x x x
Product line 1
x x x x x x x x x x x x x
Q.A.
Legend: X = Direct Relationship
O = In-direct Relationship
Doc
Ref
Requirement Y N Comments
4.1
4.2
Doc# Purchasing - AB-Q501 / Rev: 1
Stock items established via monthly
meeting - Comm. / Purch Mgr
Non stock via PR from dept. sent to
Comm. Mgr
Cap-ex items approved by M .
4.4
4.3
4.6
4.8
4.7
ASL held by commercial dept
R.M. specifications in Lab
Supplier approved via Head Office
Supplier approved Local:
- satisfactory supply
- on-site assessment (TP 453)
- product samples
- other users experience
Purchase orders approved by Comm. Mgr.
P.O. contain: - description of goods/services
- type,class,grade, quality
- drawings specifications
Revisions: New P.O. released identified as
revised
AUDIT PREPARATION
Study Documents
Agenda Checklist
Team Briefing
Compliance or Documentation
Review
An audit to determine the extent to which the
documented system meets the requirements
of a specified standard.
Normally carried out in advance of an audit
and may be referred to as a desktop audit
Conformance or Compliance Audit
An audit conducted to determine that the
quality system is being implemented
Checklists
Used by the assessor as an aide memoire
Ensure that all elements of a specification are
addressed
Are compiled from the results of a detailed
study of the procedure/specification
Ensure that all relevant requirements
contained in the specification are covered
Checklists
Assist with obtaining proof that the
requirements contained in the
specification are being implemented
Used to reference each question to the
relevant clauses of the specification
Are an invaluable aid when writing the
audit report.
Space should be left on the checklist so
that answers to the questions can be
noted for later use.
Checklists
Checklists will be expected to ensure that :-
Each requirement of the specification to
which the auditees quality system has been
documented is examined, to ensure that the
system covers every element/requirement
and that each one is effective.
Procedures and work instructions are
reviewed for completeness, adequacy and
issue levels against a master list.
Checklists
Evidence of the implementation of
procedures and instructions in the work
areas being audited. The procedures
and instructions are to the required
issue and their distribution controlled.
Corrective actions which have been
undertaken to clear any previous
noncompliances, are to be followed up.
To provide guidelines for the
auditor
To ensure every part of the audit
is completed
To reinforce objectives and scope
PURPOSE OF THE CHECKLIST PURPOSE OF THE CHECKLIST
Consider:
the processes taking place
relevant procedures
documents in use
records
requirements of ISO 9001
PREPARING A CHECKLIST PREPARING A CHECKLIST
AUDIT CHECKLIST
Job Ref : NDB
Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan
Sheet No. 1 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
Receiving Check
For small packet, By Foreman
- Visual check
- Identified & Marked off against the P.O.
- Until required (what does it means?), unpacked/
inspected / put into store
For Plant / Equipment, By Foreman
- Quantity check against Engineers order
- Damage check
- For specialised equipment, need to sign DN,
may be by Chargehand
- Equipment Acceptance Cert send to Contract Engineer
By Foreman for all items:
- Check DN about Order No.,
Quantity or Weight
Suppliers name & her Order No.
Description
4.01
4.02
4.01
AUDIT CHECKLIST
Job Ref. : NDB
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Sheet No. 2 of 4
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
- Check DN against PO
- Send test Cert to site eng.
If all Ok, sign Material Received Copy, send to Engg:
Dept with D.N.
IF Non-conformity found
Inform Contract Engineer
Indicated with Red Label with defects detail, separately
located
Disposition by Site Engineer
Fill Non-conforming item input sheet (Distribution
required?)
If found after stored, remedial work.
Record on either one
- Non-Conforming Item Report Sheet
- Non-Conforming Workmanship Report Sheet
4.01
4.06
4.11
4.09
AUDIT CHECKLIST
Item
No.
Requirement Comments/
Remarks
Activity Compliance
Yes/No
Storage / Issuance
Site/Contract Engg ensure suitable stores facilities
Goods Received Register fill by Foreman
- Date received
- Supplier
- Item description
- Quantity record
- NDB order No.
- Remark of shortage / defects
Establish item location with identification.
Location of major item to be agreed by site Engg.
Label of acceptable item used and with necessary
description.
Whos responsibility
4.03
4.04
4.05
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Job Ref. : NDB
Sheet No. 3 of 4
AUDIT CHECKLIST
Item
No.
Requirement
Activity Compliance
Yes/No
Comments/
Remarks
Item issued by Foreman or Site Engg with Material
issued Register
- Item description
- Quantity
- Stock balance
- Recipient
- Issue date
- Foreman or Engg Signed
How about Plant / Equipments? (Not mentioned in QP)
Stores Foreman conduct regular check on stock item
for
- Condition
- Quantity Vs Balance of Material Issued Register
Inform Engg to Re-order.
4.07
4.08
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Job Ref. : NDB
Sheet No. 4 of 4
SECTION 5-3
AUDIT Conduction
AUDITEE AUDITOR AUDITOR
Non Non- -conformance Statements conformance Statements
Audit objectives Audit objectives
Audit Schedule Audit Schedule
Notification of Audit Notification of Audit



Selection of Audit Team Selection of Audit Team
Prepare Checklist Prepare Checklist
Audit Plan Audit Plan



Audit team Audit team
Auditee Auditee





Audit team Audit team







CAR (s) / Audit Report CAR (s) / Audit Report

CAR Status Log CAR Status Log



Team Leader Team Leader





Team Leader Team Leader
QMR QMR
Planning Planning
Preparation Preparation
Conduct Audit Conduct Audit
Complete Audit / Complete Audit /
Discuss Findings Discuss Findings
Audit Report Back Audit Report Back
and Recording and Recording
Follow Follow - - up up
Close Close - - out out
- -investigate cause of non investigate cause of non- -
conformance conformance
- -return complete CAR return complete CAR
- -implement necessary implement necessary
corrective / preventive corrective / preventive
action and monitor for action and monitor for
effectiveness. effectiveness.
The Audit
REMEMBER : THE AUDIT TEAM IS
ATTEMPTING TO APPROVE THE
SYSTEM BASED UPON AN UNBIASED
ASSESSMENT.
IT IS NOT ATTEMPTING TO FAIL IT!
The Audit
ESTABLISHING THE FACTS AND FINDING
THE PROOF WITHOUT
NONCOMPLIANCES THE EVIDENCE
MAY BE THE EFFECT AND NOT THE
CAUSE
Sampling
Scope
Duration of Audit
Requirements of
the standard
Complexity of the
process
Considerations:
Previous Problems
Important aspects
Auditor skills /
knowledge
Sample size and its
significance
Auditor
Auditee
PERSONAL CONDUCT
positive, professional, constructive approach
co-operative, open, honest
Support from management
Trained auditors
Independence of audit function
Timely access to facilities,
documents, personnel
Access to all levels of
management
Defined audit procedures
FUNDAMENTAL REQUIREMENTS
FOR EFFECTIVE AUDITING
FUNDAMENTAL REQUIREMENTS
FOR EFFECTIVE AUDITING
The Opening Meeting
Punctuality - arrive on time
The meeting should be brief and to the point
General introductions by the audit team and
management
A review of the program
good communication
co-operation
openness
THE OPENING MEETING
NECESSARY FOR:
People
Processes
Equipment / tools / materials
Documentation
AN AUDITOR "VERIFIES" BY
OBTAINING OBJECTIVE EVIDENCE
Record
Past implementation
Examined / Observed
Current implementation
Method Stated
Staff knowledge & understanding
OBJECTIVE EVIDENCE OBJECTIVE EVIDENCE
Objective Evidence
Try to establish :-
That authorised documents are in use
That superseded drawings have been
removed
That good housekeeping is practised
That facilities are adequate
That supervision is adequate
IAC S7 . 5 . 1
Objective Evidence
That orderly records are kept
That staff are adequately trained
Assess attitude of management and
staff towards the quality system
Well prepared checklists will assist
when answering these questions
LAC S7 . 6 . 1
Objective Evidence Objective Evidence
Establish the fact and find the
proof
With nonconformities the evidence
may be the effect and not the
cause
meet the area representative first
always talk to those performing the task
explain the purpose of the visit
be calm, polite, reassuring
never talk down
speak clearly and carefully
THE AUDITOR'S APPROACH
examine objective evidence
ask open-ended questions
refer to checklists
make notes
consider impact on other activities
examine physical conditions
CONDUCTING THE AUDIT
ASK
LOOK
LISTEN
How
Where
When
What
Why
Who
QUESTIONING TECHNIQUES
6 important
words
Audit Techniques
Ask Questions
Examine Objective Evidence
Observe Activities
Listen to Reactions
Record Findings
The Auditors Six Friends The Auditors Six Friends
When asking questions..
Who ?
What ?
Where ?
When ?
Why ?
How ?
and the seventh Ok Show Me ?
Question Technique
YES / NO questions
Often elicit dead end answers - you gain nothing -
Only useful as a leader question
How - What - Why - When - Where - Who ?
Direct questions - will achieve more detailed
answers.
Explanation questions
Useful for comparing interfaces
Questioning Techniques
Keeps conversation going
Repeat last word or phrase - say
something nice
Avoid double questions (2 questions in 1)
Only one answer is likely to result
IAC S7 . 4 . 1
Audit Techniques
Forward Trace - An audit which follows
the natural flow of a product or service
process
Background Trace - An audit which
traces records back through the system
Observations
Notes made by an auditor during
assessment may lead to
noncompliances being raised or to
provide information for the audit report.
Notes provide Objective Evidence back
up
Observations
Observations may be obtained through
any of the following methods:
Seeking objective evidence that the
system is functioning as prescribed.
Samples taken of the system will allow
the auditor to obtain the required
evidence
Observations
Always establish objective evidence when an
apparent noncompliance is found remember
the occurrence discovered may be the effect
and not the cause.
Where processes are involved the audit may
examine the process controls and records to
establish conformance with the specification
Both positive and negative observations are
recorded
Observations
Throughout the entire audit the
evidence collected in the form of
OBSERVATIONS is to be recorded on
the auditors checklists.
This evidence is then to be examined to
determine if there are any
noncompliances which need to be
reported.
Observations Observations
A statement of fact made during an audit and
substantiated by objective evidence
Observations are recorded on the auditors checklist
throughout the audit
Both positive and negative observations are recorded
Negative observations may lead to noncompliances
being raised where evidence exists, indicating a
deviation from the standard
Observations may be included in the audit report to
draw managements attention to improvement
opportunities
Definition
Noncompliance Reporting
Complete audit findings
Must be factual
Must be understandable and traceable
Raise noncompliances on completion of an audit
The auditee is requested to sign signifying an
understanding and acceptance of the noncompliance.
MAJOR
total breakdown of a procedure, work instruction or
operation of the Quality System
total absence of a procedure required by Standard
number of minor lapses indicating a total breakdown
of system
immediate hazard to the quality of the product or
service
MINOR
y a single observed lapse in a procedure, work
instruction or operation of the Quality System
CLASSIFICATION OF CARs CLASSIFICATION OF CARs
Noncompliance Noncompliance
Nonfulfilment of a specified requirement
It is important to establish the ownership of
each noncompliance
Nonconpliances are owned by the auditee
not the auditor
It is important to establish who has the
authority to sanction the corrective action
resulting from noncompliances
Definition
Noncompliance Noncompliance
The opening meeting should establish the
authority and the reporting routes
The auditee should have an internal system
for dealing with corrective actions
The noncompliance report is the method
used to indicate the devations to the system
Noncomformities arise from observations
made during the audit
Noncompliance Reporting
What is the Problem ?
describe clearly, concisely and
factually
Why is it a noncompliance ?
i.e. against what requirement
Where did it occur ?
i.e. which department or activity
Who ? - avoid apportioning blame
(i.e. naming individuals)
Noncompliance Reporting
Complete audit findings
Must be factual
Must be understandable and traceable
Raise noncompliances on completion of an
audit
The auditee is requested to sign, signifying an
understanding and acceptance of the
noncompliance
Noncompliance Reporting Noncompliance Reporting
Information to be recorded
Identification /Serial number
The nature of the noncompliance Where, What,Why
Reference numbers of Documents/ Materials etc.
Auditee/ contact
Clause of the standard or specification applicable
Category of noncompliance (if applicable)
Agreed corrective action and timescale
Follow up action
See Noncompliance Report Form
the audited process or procedure
is being not conducted or
completed as it should
NONCONFORMANCE NONCONFORMANCE
comply with the Standard
implement quality manual,
procedures or other documented
requirements
implement a code of practice,
regulation or contract
_______________
no requirement = no nonconformance
A NONCONFORMANCE MAY BE A
FAILURE TO:
A NONCONFORMANCE MAY BE A
FAILURE TO:
include:
overview of finding
description of
nonconformance
example of objective evidence
summary of requirement
FINDING STATEMENT FINDING STATEMENT
EXAMPLE OF
NON-COMPLIANCE STATEMENT
EXAMPLE OF
NON-COMPLIANCE STATEMENT
Standard: ISO 9001:2000
Procedure: QP6 Issue 2
Area: Purchasing Dept.
1. The procedure is not being implemented in full in
that not all purchase orders are being fully
completed. For example; Pos 1234 and 1235
do not contain prices or delivery dates.
2. All Purchase Orders must be completed in
accordance with Procedure QP6.
Used to:
report nonconformances
classify nonconformances
record acceptance of nonconformances
record actions taken to correct
nonconformances
record auditor acceptance of corrective
action implementation
CORRECTIVE ACTION REQUESTS
(CARs)
CORRECTIVE ACTION REQUESTS
(CARs)
CORRECTIVE ACTION REQUEST (CAR) FORM CORRECTIVE ACTION REQUEST (CAR) FORM
CORRECTIVE ACTION REQUEST
AUDIT NO.:
AUDITOR: CAR NO.: OF
DEPT. REPRESENTATIVE AUDIT DATE:
PROCEDURE NO: AREA/DEPT/FUNCTION
ISSUE:
DETAILS OF NONCONFORMANCE:
SIGNED: SIGNED:
AUDITOR DEPT. REP
CORRECTIVE ACTIONS:
SIGNED:
DEPT. REP.:
RE-AUDIT RESULTS:
SIGNED:
AUDITOR: DATE:
COMPLETING THE AUDIT COMPLETING THE AUDIT
- audit team meeti g to discuss all fi di gs
Review Audit Findings: Review Audit Findings:
- team leader to make fi al decisio s
- all fi di gs to be supported by objective evide ce
Write non Write non- -compliance statements compliance statements
- o -co forma ce stateme ts to be recorded o the CAR
Report Report- -back meeting back meeting
NON NON- -CONFORMANCE CONFORMANCE NON NON- -CONFORMANCE CONFORMANCE
A failure to comply with a requirement. The fault A failure to comply with a requirement. The fault
may be caused by the failure of the system to comply or may be caused by the failure of the system to comply or
failure to implement the system itself failure to implement the system itself. .
_______________________________________
NON NON- -CONFORMANCE STATEMENTS CONFORMANCE STATEMENTS NON NON- -CONFORMANCE STATEMENTS CONFORMANCE STATEMENTS
Non Non--conformance statements are statements that conformance statements are statements that
explicitly express the identified non explicitly express the identified non--conformity conformity
along with the supporting evidence. They generally along with the supporting evidence. They generally
include the following: include the following:
The Deficiency The Deficiency
The Objective Evidence The Objective Evidence
Details of the Deficiency Details of the Deficiency
Where
What
Who
NON NON- -CONFORMANCE STATEMENTS CONFORMANCE STATEMENTS
In the machine shop, a diameter on drawing D330 issue A In the machine shop, a diameter on drawing D330 issue A

had been changed by the Forman. There was no evidence had been changed by the Forman. There was no evidence
that the change had been authorized by the design that the change had been authorized by the design
department. department.



The operator(s) in the Machine Shop were supposed to The operator(s) in the Machine Shop were supposed to
sign off each operation on the route card. On the route sign off each operation on the route card. On the route
card for batch number 134 there were no signature(s) card for batch number 134 there were no signature(s)
against completing machining operations 1 and 4. against completing machining operations 1 and 4.
NON NON- -CONFORMANCE CONFORMANCE
STATEMENTS STATEMENTS




L/C 341 L/C 341--6787 for a customer under credit grade of # 8 6787 for a customer under credit grade of # 8
for the amount of USD 400,000 FOB, there was no for the amount of USD 400,000 FOB, there was no
evidence of any insurance provided. evidence of any insurance provided.
The procedure requires that for the issue of L/Cs to The procedure requires that for the issue of L/Cs to
customers under credit grade 7 customers under credit grade 7--10 over USD 325,000 10 over USD 325,000
under FOB and C&F terms evidence of insurance is under FOB and C&F terms evidence of insurance is
required. required.
For L/C 1234567 issued by a local bank for For L/C 1234567 issued by a local bank for
USD 65,000 no verification was done by CSC. USD 65,000 no verification was done by CSC.
According to the procedure all L/C issued According to the procedure all L/C issued
by local banks for values over USD 50,000 by local banks for values over USD 50,000
from to be verified by CSC before being sent to from to be verified by CSC before being sent to
TPC for scanning and advising. TPC for scanning and advising.
NON NON- -CONFORMANCE STATEMENTS CONFORMANCE STATEMENTS
NON NON- -CONFORMANCE STATEMENTS CONFORMANCE STATEMENTS




Customer complaint from the ABC company had not Customer complaint from the ABC company had not
been followed up and no action had been carried out been followed up and no action had been carried out
whatsoever. whatsoever.
According to the procedure QP 13 paragraph 4.6 all According to the procedure QP 13 paragraph 4.6 all
customer complaints are to be followed up in the Quality customer complaints are to be followed up in the Quality
Improvement Committee. Improvement Committee.
LAC 09.08 / 05
EXAMPLE OF CORRECTIVE ACTION REQUEST EXAMPLE OF CORRECTIVE ACTION REQUEST
Company:
Job No:
Assessor:
Company Representative:
Procedure No:
Issue:
Details of Non-Conformance:
Signed:
Company
Representative:
Corrective Action taken to prevent recurrence:
Signed:
Company Representative
Acceptance of Corrective Action/Comments
Visit No:
Assessment Date:
Area/Dept/Function:
CAR No.: of
ISO 9001/2/3/REF
Clause
Major CAR
Proposed
Close out date:
Signed:
Assessor:
Date:
:
not essential
effective corrective action more
important
audits should be positive and
constructive
purpose is system improvement
CLASSIFICATION
FIRST PARTY AUDITS
CLASSIFICATION
FIRST PARTY AUDITS
Closing meeting
Thank management
Explain that sample taken has determined
conclusion reached
Present summary report
Quantify noncompliance
Conclusion
Recommendations
Closing Meeting
Each team member to present noncompliance
details
Invite questions - for clarification only
Agree distribution of final report
Make statement of confidentiality
be side-tracked
be led or misled
get "bogged down"
let the auditee dictate the pace
make assumptions or presumptions
CONTROL THE AUDIT
DO NOT
Be prepared
Be punctual
Insist on auditee answering questions
As little talking as possible
Avoid misunderstandings
Keep questions clear and concise
Polite and calm
CONTROL THE AUDIT
DO
good points which may benefit
other areas of organisation
areas of concern
deficiencies given the benefit of
the doubt
suggestions for action
OBSERVATIONS OBSERVATIONS
aggressive auditees
timid auditees
missing people
missing documents
pre-prepared samples (choose your own !)
BE AWARE OF
SECTION 5-4
Audit Follow Up & Close
Out
AUDITEE AUDITOR AUDITOR
Non Non- -conformance Statements conformance Statements
Audit objectives Audit objectives
Audit Schedule Audit Schedule
Notification of Audit Notification of Audit



Selection of Audit Team Selection of Audit Team
Prepare Checklist Prepare Checklist
Audit Plan Audit Plan



Audit team Audit team
Auditee Auditee





Audit team Audit team







CAR (s) / Audit Report CAR (s) / Audit Report

CAR Status Log CAR Status Log



Team Leader Team Leader





Team Leader Team Leader
QMR QMR
Planning Planning
Preparation Preparation
Conduct Audit Conduct Audit
Complete Audit / Complete Audit /
Discuss Findings Discuss Findings
Audit Report Back Audit Report Back
and Recording and Recording
Follow Follow - - up up
Close Close - - out out
- -investigate cause of non investigate cause of non- -
conformance conformance
- -return complete CAR return complete CAR
- -implement necessary implement necessary
corrective / preventive corrective / preventive
action and monitor for action and monitor for
effectiveness. effectiveness.
Hold an Opening Meeting
Conduct the audit
Analyse the results
Report the findings
AUDIT PROCESS AUDIT PROCESS
Action taken to eliminate the causes
of an existing noncompliance,
defect or other undesirable situation
in order to prevent recurrence
CORRECTIVE ACTION CORRECTIVE ACTION
Action by management of area audited:
y take immediate remedial action
y analyse effects on product
y identify root cause
y identify other areas where problem may
exist
y develop effective actions to prevent
recurrence
y implement and monitor actions
CORRECTIVE ACTION PLAN CORRECTIVE ACTION PLAN
RESPONSIBILITY OF MANAGERS RESPONSIBILITY OF MANAGERS
RECEIVING A CAR RECEIVING A CAR
1. Investigate the problem Investigate the problem


2. Determine the cause Determine the cause


3. Decide on appropriate corrective action Decide on appropriate corrective action
and target date for implementation and target date for implementation..


4. Send the completed form to the CAR Send the completed form to the CAR
administrator administrator

5. Implement corrective action Implement corrective action
C.A.R. FLOW C.A.R. FLOW
C.A.R. Raised
Signed & Issued Accepted
Investigate & Analyze
Implemented
Corrective Action Documented
Reviewed
Reviewed
Reject Accept
Closed Out
Record Record
The Report should:
y describe audit scope
y identify auditors
y identify departmental
representatives
y state overall findings
y describe deficiencies,
observations
y provide objective evidence
y be easy to read and understand
AUDIT REPORT AUDIT REPORT
INTERNAL AUDIT REPORT INTERNAL AUDIT REPORT
INTERNAL QUALITY SYSTM AUDIT REPORT
AUDITORS NAME AUDIT REPORT NUMBER
DEPARTMENTAL REPRESENTATIVE DATE OF AUDIT
QUALITY FUNCTION or PREVIOUS AUDIT DATE AND RESULTS
PROCEDURES(S) AUDITED
SUMMARY AUDIT:
SIGNED: _______________________(AUDITOR) DATE: _______________________
exists
is complete
operates correctly
is effective
AIMS OF THE AUDIT
To verify that the quality system:
REPORTS and RECORDS REPORTS and RECORDS
Complete and sign all CAR. Complete and sign all CAR.
Prepare Audit Report. Prepare Audit Report.
Prepare for the report Prepare for the report- -back meeting back meeting
explain, support and justify findings
obtain agreement on CARs
ensure good points are mentioned
state overall degree of compliance
reinforce objectives and scope
PRESENTING THE FINDINGS PRESENTING THE FINDINGS
R REPORT BACK MEETING EPORT BACK MEETING
y Have Your Reports Ready


Discuss Positive As Well As Negative Aspects


y Make Sure Reports Are Agreed By All Parties


R REPORT EPORT--BACK MEETING BACK MEETING
CHECKLIST CHECKLIST
To be chaired by audit team leader. To be chaired by audit team leader.
Repeat purpose and scope of audit.
Thank auditee
Comment on good points.
State overall compliance
Read non-compliance statements.
Do not argue.
Arrange follow-up (to close out corrective actions).
Take minutes of meeting for any follow up.
Close meeting.
Checklist
F F O L L O W UP O L L O W UP
Subsequent follow up should review: Subsequent follow up should review:
- - audit file audit file
c - - corrective action file corrective action file
Review should examine actions Review should examine actions
required and required and whether completed and whether completed and
whether the actions have been effective whether the actions have been effective
to prevent recurrence. to prevent recurrence.
Action by Quality Manager:
y approve proposed corrective actions
y monitor progress in completing
corrective actions
y arrange follow-up to verify
effectiveness
y escalate to higher management if
necessary
CORRECTIVE ACTION PLAN CORRECTIVE ACTION PLAN
shows status of:
y CARs
y follow-up action
y close-out
y CARs from second and third party
audits
CAR STATUS LOG CAR STATUS LOG
CAR STATUS LOG
CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATE
SERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CAR
NO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED
DATE
CORRECTIVE ACTION REQUEST (CAR) STATUS LOG
AUDIT FOLLOW-UP AUDIT FOLLOW-UP
audit objective evidence
verify corrective action(s) implemented
ensure short and long term
effectiveness
record details of follow-up
sign-off forms
audit documents retained as records
Why ??
FOLLOW FOLLOW--UP UP OF OF
THE CORRECTIVE ACTION THE CORRECTIVE ACTION
To ensure corrective action has prevented To ensure corrective action has prevented
any recurrences any recurrences
To determine whether corrective action has To determine whether corrective action has
been effective? been effective?
CLOSE CLOSE--OUT THE CAR OUT THE CAR
Each non Each non- -conformance is to be closed out conformance is to be closed out
individually individually
Ensure that the corrective action has Ensure that the corrective action has
addressed the addressed the root cause of the non root cause of the non- -
conformance conformance
Not treated the symptoms only but Not treated the symptoms only but
prevented recurrence of the non conformity. prevented recurrence of the non conformity.
When the auditor is satisfied there is no When the auditor is satisfied there is no
further further example of the non example of the non- -conformance conformance..
MANAGEMENT REVIEW MANAGEMENT REVIEW
internal audits reported
audit results analysed
status of corrective actions reported
preventive actions identified
INTERNAL AUDIT INTERNAL AUDIT -THE SYSTEM THE SYSTEM
Management Management
Management
Review
Follow-up/
Close out
Audit Schedule
Corrective/
Preventive Action
Conduct Audit
CAR Requests
SECTION 6
Auditor Desirable
Characteristics
Management Style
Tell
This approach is where the team leader plans
and makes the decisions up front and then
gives clear instructions - directing the team
the way he or she wants the task to proceed
This style may well be welcomed by the less
experienced team members, but may not
always receive approval from those more
experienced who feel they have something to
contribute.
Management Style
Consult
The consult approach is where the team
leader takes time to talk to the team
members first, listen to their ideas and
evaluate their capabilities before making a
decision.
This is probably the preferred approach, but
if time is a constraint and the team ia not
available then this approach may not be
possible.
Management Style
Team
The team approach is when the team leader
acts more as a chairperson seeking concise
opinions and allowing other team members to
take an active role in the decision making
process.
This approach is perhaps more useful when
preparing for the final report. Giving the
opportunity for the final report to be truly
representative of the whole teams findings.
good listener
open-minded
diplomatic
unbiased
honest
patient
self-disciplined
SELECTING AUDITORS
DESIRABLE TRAITS
SELECTING AUDITORS
DESIRABLE TRAITS
arrogant
opinionated
self-important
lazy
argumentative
shy
timid
SELECTING AUDITORS
UNDESIRABLE TRAITS
SELECTING AUDITORS
UNDESIRABLE TRAITS
Auditor Characteristics
These include skills of
being :
Diplomatic
Patient
Honest
Fair minded
Impartial
Articulate
Communicative
Analytical
Helpful
Co-operative
Persistent
Observant
Ethical
Professional
Code of Conduct
To act in strictly trustworthy and unbiased
manner
To disclose any relevant relationships
Not accept inducements
Not to disclose findings
Not to act in any way prejudicial to the
organization
In the event of an alleged breach co-operate
fully
stay within audit scope
communicate audit requirements
collate objective evidence
document CARs
report audit findings
verify effectiveness of corrective
actions
retain and safeguard documents
AUDITORS SHOULD AUDITORS SHOULD
prepare - know the subject material
learn about the auditee
remain objective
control the audit
assist if there is a misunderstanding
listen
obtain objective evidence
compliment the auditee
WHAT AN AUDITOR SHOULD DO WHAT AN AUDITOR SHOULD DO
swear
be sarcastic
discuss/criticize company policies
personalities
be negative
criticise
argue
compare auditee with others
WHAT AN AUDITOR
SHOULD NOT DO
WHAT AN AUDITOR
SHOULD NOT DO
introduce self and team
ensure agenda is known and
understood
keep to agenda
keep to time
keep control
avoid arguments
listen to others
maintain records
GOOD PRACTICE AT MEETINGS