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Welcome to Neville-Clarke

Training On
ISO/TS 16949
Process Approach Internal Auditing

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Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
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Course Content

• Session 1 ISO/TS 16949 Background


• Session 2 Introduction to Auditing
• Session 3 Audit Overview
• Session 4 Automotive Process Approach
• Session 5 Audit Planning
• Session 6 Conduct Audit
• Session 7 Reporting Audit
• Session 8 Post-audit Actions

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Course Objectives
To provide delegates with a good
understanding of:
• Process-approach auditing
• Audit skills and technique
• Planning, conducting and reporting on
an internal audit performed against
the requirements of ISO/TS 16949.

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Session 1

ISO/TS 16949 BACKGROUND

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What is ISO/TS 16949?
• Harmonization of automotive industry
requirements.
• Developed by Automotive Task Force(IATF)
and Japan Automobile Manufacturer
Association (JAMA), supported by ISO/TC
176
• Established based on major industry
standard
o ISO 9001:2000
o AVSQ (Italian), EAQF (French), QS-9000 (U.S.)
and VDA6.1 (German) automotive catalogs
• Recognized by major European, American
and Japanese automotive manufacturer.
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Copyright of the Technical Specification is held by ANFIA, CCFA/FIEV, SMMT, VDA and
Daimler Chrysler, Ford Motor and General Motor.

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Goal of ISO/TS 16949
• Continual improvement
• emphasis on defect prevention
• Reduction of variation and waste in
supply chain
Intention of ISO/TS 16949
• To avoid multiple certification
• To provide a common approach to
QMS in Automotive industry
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Why Do We Need
ISO/TS 16949?
• New market opportunities
o AFTA
o Global sourcing trend
• International Recognition
o Wider recognition, including Big 3, Major
European and Japanese automotive industry
o Independent third party registration for
assessment and certification serves as good
evidence of company capability
• Customer pressure/ demand
• Discontinuance of QS-9000
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Scope of ISO/TS 16949
Flexibility:
ISO/TS 16949 becomes the common platform,
other customer imposed requirements are easily
added on.
Customer Customer specific Coupled with
imposed requirements customer-specific
Additional
requirements
requirements defines quality
ISO/TS16949 system
requirements for
ISO 9001:2000 use in the
automotive supply
chain
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ISO/TS 16949 Vs Other
Automotive Requirements
ISO/TS 16949 QS-9000/ VDA 6.1/
• International initiative AVSQ/ EAQF
• Recognized by major • Regional/country
initiative
automotive manufacturer
• Only recognized by the
• single certification specific customer
• A common platform to • require multiple
build QMS; can have certification if supply to
customer-specific more than one customer
requirements as add-on • Not flexible, as it is a
to the QMS. customer-specific
requirement.

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Session 2

Introduction to Auditing

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What is Audit?
• A ‘check and balance’ process to
ensure activities are performed
in an appropriate manner.
• Usually conducted on an
independent basis.
• Objective evidence is required.

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Formal definition of Audit

• ‘Systematic,
independent and
documented process
for obtaining audit
evidence and
evaluating it
objectively to
determine the
extent to which
audit criteria are
fulfilled’
Source: ISO 9000: 2000
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8.2.2 Internal Audit
• Planned intervals; annual plan
• Audit criteria, scope, frequency and
methods shall be defined
• Auditors shall not audit their own work
• Documented procedure
• Action are taken without undue delay
• Follow up on action taken and record results
• Cover all shifts
• Internal auditor qualifications

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8.2.2 Internal audit


The organization shall conduct internal audits at planned intervals to determine whether the
quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International
Standard and to the quality management system requirements established by the
organization, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and importance of
the processes and areas to be audited, as well as the results of previous audits. The audit
criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of
audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit
their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting
results and
maintaining records (see 4.2.4) shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow-up
activities shall include the verification of the actions taken and the reporting of verification
results (see 8.5.2).
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.

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Types of audit
• 8.2.2.1 Quality management system audit
ƒ The organization shall audit its quality management
system to verify compliance with this Technical
Specification and any additional quality management
system requirements.
• 8.2.2.2 Manufacturing process audit
ƒ The organization shall audit each manufacturing process
to determine its effectiveness.
• 8.2.2.3 Product audit
ƒ The organization shall audit products at appropriate
stages of production and delivery to verify conformity to
all specified requirements, such as product dimensions,
functionality, packaging and labeling, at a defined
frequency.
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There are many approaches to analyse quality management system, product quality and
process performance. In the context of the internal audit clause, internal audit for the
organization should be independent of those having direct responsibility for the work
performed. Personnel should not audit their own work.

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Purpose of Conducting Audit
• Looking at the overall
process
• Auditing for conformity
• Auditing for
effectiveness
• Approving Suppliers/
Subcontractors
• Assessing for
Certification
• Investigating problems
• Way of improving

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Key principles of auditing
• Ethical conduct
• Fair presentation
• Due professional
care
• independence
• Evidence-based
approach
o Source: ISO 19011

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Common Internal Audit
Failure
• Perceive audit as • Over-reliance on
waste of time. Quality department
• Lackluster auditor • Poor auditor
selection process judgment leads to
• Lack of proper lack of confidence
system to train in internal audit
auditors result.
• Inadequate process • See auditor as
to evaluate ability fault-finder or
to perform audit. trouble-maker

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Audit Types
Your
Yourown
own
1st Party Organisation
Organisation

Certification
Certification
3rd Party Body
Body

Subcontractor
Subcontractor
2nd Party
or
orSupplier
Supplier

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Adequacy Audit
• Document Vs
Standard
• Look for quality
management
system document
adequacy
• Also known as
Document Audit

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Compliance Audit
• Practice Vs
Standard
• Find things on the
ground/ in the field
• Interview staff
doing the job
• Take samples
• Look at results of
activity

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Audit Terminology
• Auditee • Audit programme
• Auditor • Audit plan
• Audit Team • audit scope
• Audit Criteria
• Audit Evidence
• Audit Findings
• Audit Conclusion

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Session 3

Audit Overview

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Typical Internal Audit Cycle

1 Planning The Audit

2 Conducting The Audit

3 Reporting The Audit

4 Corrective Action & Follow up

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Planning the audit
1

Appoint audit team

Define audit objective, scope and criteria

Contact auditee

Review document

Prepare audit plan

Prepare Checklist
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Conducting the audit
2

Conduct Opening meeting

Collecting & verify


audit evidence

Evaluate audit evidence


against audit criteria

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Reporting the audit
3

Auditor review meeting

Review audit finding with auditee

Conclusion & Report Writing

Closing Meeting

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Corrective Action & Follow-up
4

Circulate Audit Report

Update Audit Schedule

Corrective Action
(performed by auditee)

Verify completed actions

Close case
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What auditors need to know
• Auditors for ISO/TS 16949 are
required to demonstrate
competence for:
o ISO/TS 16949 Technical Specification
o Audit methodology:
ƒ conducting opening meeting,
ƒ writing nonconformances
ƒ Conducting closing meeting
ƒ how to close out nonconformances
o Automotive process approach to audit
o Core tools (APQP, FMEA, SPC, MSA,
PPAP)
o Customer-specific requirements
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Session 4

Automotive Process Approach

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Key Focus of ISO/TS 16949
Audit
• Customer-specific
requirements
• Customer
satisfaction
• Efficient handling of
customer-oriented
processes
• Operational
performance

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Less focus on paper work
• 7 areas require
documented
procedures
• Flexibility allowed for
other areas.
• Shift of focus from
documentation to
results of processes.

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Model of Process Based QMS
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM

Customers Customers
(and other Management (and other
Interested responsibility Interested
Parties) Parties)

Resource Measurement , Customer


management analysis ,
Satisfaction
improvement

Customer Input Product Output


Product
Requirements realization
Key
Value adding activities
Information flow
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What is a Process?

“Set of interrelated or interacting


activities which transforms inputs
into outputs.”
ISO 9000, 3.4.1

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Model of a process

Output of a process can


PROCESS be input to the next
process
INPUT TRANSFORMATION OUTPUT

A sequence of processes
Each process step adds value to the step before till the output
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What is Process Approach?
• For an organization, there may be
numerous inter-linked processes.
• The systematic identification and
management of the various processes
and the interactions between such
processes may be referred to as
“process approach” to management.

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Functional Vs Process
Approach
Customer Customer

Functional Thinking Process Thinking


Priority: to meet Priority: To meet
functional objective customer needs
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Customer Oriented Process
• COPs are processes
which start with the
customer input and Customer
results in outputs I O
delivered to the
customer Organization
Organization
• COPs are primary
processes which
interact with the
customer.
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Multiple COPs in an
Organization
Customer
I O I O I O I O I O
Interaction
with
Organization customer
Organization

Interaction of one COP with


another
• Within an organization, there are many
COPs
• Each COP interfaces with the customer
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COP Examples

Request Formal Order


Customer for Quotation Order accepted
quotation

Customer
Customer Bid/ Order
Oriented
Oriented processing
Processes
quotation
Processes

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COP Examples

Customer Prototype
Customer Spec. Test request Prototype
Result

Customer
Customer Product Product
Oriented
Oriented
Processes
Validation Development
Processes

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COP Examples

Warranty Warranty Action Corrective,


Customer Claim accepted Request preventive
actions

Customer
Customer Customer
Oriented
Oriented Warranty Feedback
Processes
Processes process

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Focus on process links
• How each organization perceive a
process is unique and always different.
• DO NOT ‘nit-pick’ on process category.
Emphasize on the linkage of the
processes! DO NOT spend time
arguing how the process should be
categorized!

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Auditors Perspective
• Each COP in detail is complex and involve
many sub-processes performed by various
functions of the organization.
• Some of these sub-processes do NOT have
direct interface with customers.
• Depending on the nature and organization
perspective, these processes can be
classified as support and management
process.

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How COPs Are Described
• Description of the COP can be found
through documentation which tell ‘who
does what, when and where’:
o by graphics, e.g. flow charts
o by text, e.g. procedures

It does NOT matter how it is described!

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Exercise 1

Identifying
COP

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What To Look For?
• 3 aspects
Improvement

Effectiveness

Conformance

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Conformance

What should What is


be done actually done

• Conformance is the basic principle.


• Compare the actual activity against
the audit criteria

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How To Determine
Effectiveness
• How do we know if a process is
effective?
o Ability to maintain ‘mountains’ of
documentation?
o Able to follow procedures strictly?
o Ability to produce results?
o Look at inputs or outputs?

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Effectiveness of process
• Effectiveness of a
process is shown by
the result it achieved
with the delivered
output. Hence, auditors
shall look at indicators/
measurable metrics to
tell is customer
requirements are met.
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Examples of common metrics
Process metrics

Delivery On Time Delivery -OTD

Production Yield, utilization, cycle


time, Cpk, ppm

Inspection/ test defect rate, pass ratio

Planning Delay, progress vs


plan
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Improvement
• Look for trends
• Compare current
results against past
results

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Process Analysis
• Every process has these characteristics:
o Process owner(s)
o Process is defined and if appropriate,
documented
o Process linkages/ interface of the processes
are established
o is monitored to tell the performance and is
improved if needed
o has records to show as evidence
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Audit by process approach
How? With Who?
(method, technique) (skill, training)

INPUT Process
Process OUTPUT

What key criteria? With What?


(measurement, assessment) (equipment, material)

Other than input, output, auditor should look at ‘who does


what’, ‘with what’, ‘how it is done’ and ‘key criteria measured’

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Audit by Process Approach
A process in sequence:

When auditing, look at the process from various


angle

An output of previous process becomes the


input to the next process. Processes are inter-
link!
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 54
Question Auditors
Should Ask
• Who is the process owner?
• What is the purpose of your process?
• What are the inputs to your process?
• What are your process outputs?
• What type of process are you working on?
• What are the important process parameters?
• What do you measure about your process?
• What do you do with these measurements?

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Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 55
Summary Points
• Automotive process approach audit MUST
NOT be driven by a ‘clause’ or an ’element’
driven checklist
• Purpose of checklist: an audit tool to verify
the completeness of the audit
• Audit should cover all applicable
requirements to a Customer Oriented
Process (COP) with linkages to Management
Oriented Process (MOP) & Support Oriented
Process (SOP).

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AMS 23
Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 56
Exercise 2

Understanding
Process Base
Approach
Auditing

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 57
Session 5

Audit Planning

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 58
Planning the audit
1

Appoint audit team

Define audit objective, scope and criteria

Contact auditee

Review document

Prepare audit plan

Prepare Checklist
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 59
Appoint Audit Team
• Independent of audit
area
• Auditors must be
trained
• Has good sense of
judgement
• Works effectively /
efficiently
• Reports findings clearly
• Can communicate at all
levels of Organisation
• Is objective and ethical

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The organization should define the minimum qualification requirements for personnel responsible for
performance of internal audits, taking into account
DelegateanyNotes
customer-specific requirements.
Delegate Notes

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 60
Determine Audit Objective
• To investigate quality issue
• To assess readiness for
external audit
• Routine ‘balance and check’
• To identify improvement
• To evaluate capability to
meet statutory, regulatory,
contractual requirements

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AMS 23
Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 61
Audit Criteria
• ISO/TS 16949
• Customer Specific
requirements
• Company
documented Quality
Management
System

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AMS 23
Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 62
ISO/TS 16949 Requirements
• 0 Introduction • 6 Resource management
6.1 Provisions of resources
• 1 Scope
6.2 Human Resources
• 2 Normative reference 6.3 Infrastructure
• 3 Terms and definitions 6.4 Work Environment
• 4 Quality Management
• 7 Product Realization
System
7.1 Planning of product realization
4.1 General requirements 7.2 Customer related processes
4.2 Documentation 7.3 Design & Development
Requirements 7.4 Purchasing
• 5 Management Responsibility 7.5 Production & Service provision
5.1 Management Commitment 7.6 Control of Monitoring &
Measuring devices
5.2 Customer focus
5.3 Quality Policy • 8 Measurement, Analysis and
5.4 Planning Improvement
5.5 Responsibility & Authority and 8.1 General
Communication 8.2 Monitoring & Measurement
• 5.6 Management Review 8.3 Control of Nonconforming
Product
8.4 Analysis of Data
8.5 Improvement
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Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 63
Terminology

• Definition of Terms
ƒ ‘Shall’ - mandatory requirement
ƒ ‘Notes’ - for guidance in understanding or clarifying
ƒ the associated requirement
ƒ ‘should’ in a Note is for recommendation only
ƒ ‘such as’ - suggestions given are for guidance only

Contents Page - ISO 9001 heading are normal


type face, additional requirements are in italics.
In the Technical Specification - ISO 9001
requirements are “boxed”, Sector-Specific
supplemental requirements are outside the
boxes.
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 64
Audit Scope
• “the extent and boundaries of audit”
• Include:
o Physical locations
o Organizational units
o Activities
o processes

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Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 65
ISO/TS 16949 Audit Scope
• Product: all automotive products supplied to
customer
• Activity: design & development, production,
installation and service.
• Applicable to any activity within the
automotive supply chain.
• Coverage: all sites & locations:
Site Remote location
location at which value- location that supports sites
added manufacturing and at which non-production
processes occur processes occur
© Neville-Clarke International Ltd, 2003
Slide No 0:66 QMS X Issue 1.0/03

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 66
Contact Auditee
• Auditor Contacts
Department Manager
• Explains the process—if
required
• Confirms Date / Time
Audit
• Sets up Opening Meeting
• Gets information for
Audit Plan e.g. Check
which people/processes
will be available on audit
• Checks if protective
clothing needed
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Slide No 0:67 QMS X Issue 1.0/03

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 67
Review document
• Obtains
representative
documents, e.g.
procedures,
guidelines
• Checks on
outstanding
nonconformities in
previous audit

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 68
Audit Plan
o Details who looks at what and when
o Should ‘follow the process’
o Allows auditee to know what is
planned
o Makes efficient use of time
o Should be flexible
o Should not restrict the audit
o Need not be conveyed to company
if appropriate
o Must cover all shifts
o To cover all remote location and sites

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Audit planning should include the following activities in the following sequence:
1. Identification of processes based on quality management
Delegate Notessystem documentation and any additional
information provided by the organization. Delegate Notes
2. Analysis of processes according to the criteria
• Products and/or services provided to customer
• Risks to the customer
• Interfaces (inputs/outputs)
• Possibilities to group processes for economical and effective audit
3. Prioritization of audit activities considering
• Follow up issues of prior audits (external and internal)
• Customer complaints
• Value (add) to audited organization
4. Finalization of audit plan including sequence/process steps, timing and interview partners

AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 69
Audit Plan Content
• Objectives of Audit
• Audit Scope
• Documents required Audit Plan
• Personnel you want Audit Plan
to see
e.g. Key Managers,
typical cross-section
of staff
• Timetable of events

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Issue 1.0/-03 ISO/TS 16949 Process Approach Internal Auditing
Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 70
Audit Checklist
• Aide Memoire
• Concise
• Should follow ‘process’
• Avoid tick sheets Check-list
• Should not take over
Audit What?
• Separate checklist for Where?
each area When?
• Useful for new Auditors Why?

• Can evolve over time


How?
Who?
• Aids time management
Checklist is a tool to verify ‘completeness’ of audit,
NOT to take over audit!
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Slide No 0:71 QMS X Issue 1.0/03

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 71
Exercise 3

Creating
Check List

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 72
Session 6

Conducting Audit

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 73
Conducting the audit
2

Conduct Opening meeting

Collecting & verify


audit evidence

Evaluate audit evidence


against audit criteria

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 74
Opening meeting
• Courtesy to talk to
Manager first
• Shows openness
• Auditor can
– Explain process
– Set expectations
– Confirm plan
– Answer questions

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 75
Opening meeting Agenda
1. Introduction
2. Purpose and scope
3. Plan for the day
4. Explanation of ‘Value
added process’
5. Confirm authorized
person to acknowledge
audit report
7. Reporting method
8. Any questions

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 76
Collecting & verifying
information
• Methods include:
Question o Interview
(Ask them what they do)
o Observe activities
o Review documents
• ‘Audit Triangle’

Observe Check
(See what they actually do) (What the procedure says they should do)

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 77
Where to look for
information?
• Observe activities and
the surrounding work
environment
• Examine records
o Inspection/test reports,
meeting minutes, result
of measurement
• Ask for documents
o Objectives, procedures,
plans, instructions,
specification, drawing

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 78
Sampling
• Sampling cannot be
statistically significant
• Select examples, such
as:
o a purchase order
o a part number
• Follow the Audit Trail,
using the example to
provide you with
evidence of
conformance to the
Standard

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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 79
Key points for Interview
• Who do we audit?
o The person
responsible for the
activity to be audited
• How to begin?
o Ask the auditee to
explain/ describe the
activity
• When?
o Normal working
hours

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 80
Asking Question –
Filter Funnel
• Open questions
o Encourage Auditee to talk
freely
o Use What, Where, When,
Why, How and Who?
• Probing questions
o Follow-up or focusing on
more precise detail
• Closed questions
o Used where you want a
clear ‘Yes’ or ‘No’ answer
& Don’t forget the Please
‘Show Me’.

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 81
Feasibility
Review Relations of Core tools

Contract
7.2 Review
6.0
7.3 7.3
APQP APQP APQP APQP
PAP
Phase 1 Phase 2 Phase 3 Phase 4
Product Process
Planning Validation
Development Development
7.2 7.1 7.3 7.5.2 APQP
Phase 5
FMEA MSA SPC Mass
Production
7.5 8.0
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 82
How to Audit Core tools?
• Select a few products as ‘audit
samples’
• Use the products to run though each
phase of APQP (process approach)
• Ask for the relevant documents/
records to justify if the activities in
each phase of APQP are executed to
meet customer needs.

© Neville-Clarke International Ltd, 2003


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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 83
Auditing Customer
Specific Requirement
• Customer Specific
Feasibility Requirements are identified
Review at the beginning of new
contract/ planning
Contract Product
Incorporated
Review Product Related Process
Requirements design
Special
Regulatory Characteristic
APQP Quality
Phase 1 Business
System Related Incorporated
Planning Requirements Process
Delivery
Communication
© Neville-Clarke International Ltd, 2003
PAP
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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 84
Put people at ease
• Find best place for interview
• Reason for interview & note
taking should be explained
• Smile when appropriate
• Avoid barriers, e.g. across
table
• Keep at same physical level as
Auditee
• Be assertive
• Don't infringe 'personal space'
• Be open in speech and manner
• Use humour - but only if
appropriate
• Be calm, cool and objective

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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 85
Interview process
1.Identify individual to be
audited
2. Introduce yourself
3. Explain why you are there &
‘break the ice’
4. Ask open question(s)
5. Ask the detailed questions
6. Do ‘show me please’
7. Check facts and make notes
8. Thank Auditee
9. Identify next Auditee on trail
drawing
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 86
Taking Notes
• Record
– Suspected
nonconformities
– Observations
– Info’ to be provided
later
– Items to be followed
up
– Improvement ideas
– (Positive evidence of
conformance)

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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 87
Evaluate Audit evidence

Audit Criteria
Audit Evidence

Audit Finding

• ‘Weigh’ Evidence against criteria to obtain


Audit Finding
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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 88
Exercise 4

Classifying
Document vs
Record

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 89
Session 7

Reporting Audit

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 90
Reporting the audit
3

Auditor review
meeting

Review audit finding with auditee

Conclusion & Report Writing

Closing Meeting

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 91
Auditor Review Meeting
• When?
o Before final audit conclusion
o At suitable time during audit to
review findings
• To utilize team experience in
evaluating audit findings
• To avoid making wrong audit
conclusions
• Purpose: To review audit
findings in a collective
manner

© Neville-Clarke International Ltd, 2003


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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 92
Audit Report
• A formal, factual
and agreed record
of Audit including
nonconformities,
observations,
corrective action,
timescales,
conclusions,
recommendations.

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 93
Audit Report Should include
• Identification of client • Identification of audit
and audited team
organization • Summary of audit
• Audit objectives, scope process
and plan • Statement
• Audit criteria confidentiality
• Date & place of audit • Report distribution
• Audit findings • Evidence objectives of
• Identification of audit achieved
auditees • Agreed action plans
o Source: ISO 19011 • Unresolved
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 94
Typical Audit Report Content

Opportunity
Conclusion NonConformity For
Statement Improvement
(NCR)
(OFI)

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 95
Nonconformities should
• Be factual/objective
• Be clear and concise
• Give clause number of Quality Standard/Company
document
• Be locatable by other Auditors
• Define the exact instance – Objective Evidence
• Be given a unique identifier
• Be categorised (e.g. minor/major)
• Be accepted/signed by authorized personnel
representing auditee

© Neville-Clarke International Ltd, 2003


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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 96
Minor Nonconformity
• A failure in some part of the
organization’s documented
QMS relative to ISO/TS 16949,
or
• A single observed lapse of
following one item of a
company’s QMS.
Does NOT results in:
• reduced ability to assure
control of process or products
& failure of the QMS.
o Source: Rules for achieving IATF
recognition

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Major Nonconformity
• Absence, or total breakdown, of a
system to meet a requirement of
ISO/TS 16949. A number of minor
nonconformities against one
requirement which can represent a
total system breakdown can be
considered a major nonconformity.
• Probable shipment of nonconforming
products causing failure or materially
MAJOR
reduce the usability of the products
or services for the intended purpose.
• Reduced ability to assure control of
process or products & failure of the
QMS.
o Source: Rules for achieving IATF
recognition
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Opportunity For
Improvement
• Statements outside
scope of the Audit
which may be
useful, e.g:
o Moving towards a
nonconformity
o Risks identified but
no problems yet
o If allowed,
OFI
recommendations

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 99
Writing Nonconformity
Statements
Nonconformity Statement should be concise,
informative and CLEAR!
• 3 elements of a good audit
statements:
• Explain the statement of fact/
problem
• Record the objective evidence: quote
references, including part numbers,
document numbers, equipment
numbers, location, etc
• The reason why it is a
nonconformity, quote requirements
in ISO/TS 16949 and/or relevant
procedure
© Neville-Clarke International Ltd, 2003
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AMS 23
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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 100
Example 1
• Document revision status is not clearly indicated
in visual inspection specification AQ 535 located in
dept 16, used for product inspection purpose. This
is contrary to ISO/TS 16949 clause 4.2.3 (c) and
procedure QA-P-03.

Can you identify the:


o Statement of fact & evidence?
o Location, making it easy to be found?
o Requirements violated?

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Rev 1 Mar04 © Copyright Neville-Clarke International Ltd, 2003 Page 0: 101
Example 2
• Nonconforming parts push rods, part no.
AA589 located in department 12 has no tag
or label as identification and the supervisor
of the area has no knowledge of the
problem. Nonconforming parts are not
adequately identified. This is contrary to
ISO/TS 16949 clause 8.3 and procedure
QP-125

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Example 3
• Jonathan Clarke of warehouse department
had received fork lift truck driver training in
march 2002 but this had not been indicated
in the training records held in the human
resource department. Training records are
not always maintained for operators. This is
contrary to ISO/TS 16949 clause 6.2.2 and
procedure HR-P-387

“Can you tell what’s wrong with this report?”

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Example 3
• Jonathan Clarke of warehouse department
had received fork lift truck driver training in
march 2002 but this had not been indicated
in the training records held in the human
resource department. Training records are
not always maintained for operators. This is
contrary to ISO/TS 16949 clause 6.2.2 and
procedure HR-P-387

Audit system, NOT individual!

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Audit Report ‘No’s!
• Should not contain:
o Individuals names in
nonconformities
o Confidential
information
o Subjective
statements
o Emotive statements
o Information not
raised previously

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Closing Meeting
• Balanced summary
can be presented
• Manager gets direct
feedback
• Queries can be
resolved
• Manager can ‘buy in’
to findings

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Closing Meeting Agenda
1. Thanks for co-
operation, etc.
2. Summary of good
points
3. Nonconformities /
findings
4. Observations and
advice
5. Corrective action
6. Report details
7. What happens next
8. Questions & Answer
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Exercise 5

Writing Audit
Report

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Exercise 6

Classifying
Findings

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Session 8

Post-audit Actions

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Corrective Action & Follow-up
4

Circulate Audit Report

Update Audit Schedule

Corrective Action
(performed by auditee)

Verify completed actions

Close case
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Follow-up Action
• Report circulated
• Audit programme
updated
• Checklists filed
• Corrective action
performed
• Trends fed into
management review
• Corrective action
verified

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Corrective Action
• Department
Manager defines
action and ACTION PLAN
timescales
• Action may be in
two stages: Actions
o Fix the symptoms
o Fix the underlying Timescales
cause
• Timescales must be Responsibilities
realistic
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Corrective Action Vs
Correction
• Corrective Action • Correction
o Act on nonconformity o Act on current
discovered problem only
o Eliminate root cause o DO NOT eliminate
o Prevent recurrence root cause
o No guarantee that
the same event may
NOT repeat.

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Verification of Corrective
Action
• To look at: • Containment action
o Actions taken as quick fix
have eliminated CANNOT be
root cause acceptable!
satisfactorily
o Results achieved
are satisfactory.

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How To Get The Most Out Of
Internal Audit
• Must be a ‘no-blame’ culture
• Auditor and Auditee should work in partnership
• Encourage staff to reveal problem areas
• Both Auditor and Auditee should look for
improvements
• Audits must be seen as essential part of
business
• Positive terms can be used (e.g. ‘finding’ not
‘nonconformity’)
• ‘Findings’ or ‘nonconformities’ should be seen as
‘opportunity to improve’
• Must be adequate time and resources for
Auditee/Auditor to perform audit
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THANK YOU FOR ATTENDING
THIS COURSE

NEVILLE | CLARKE

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