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Welcome to Neville-Clarke

Training On
ISO/TS 16949
Process Approach Internal Auditing

Neville-Clarke International Ltd, 2003


Slide No 0:1 AMS 23 Issue 1.0/03 Rev1 Mar04
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

Neville-Clarke International Ltd, 2003


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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.

Neville-Clarke International Ltd, 2003


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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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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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Types of audit
8.2.2.1 Quality management system audit
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
The organization shall audit each manufacturing process
to determine its effectiveness.
8.2.2.3 Product audit
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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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 own
1st Party
Organisation

Certification
3rd Party
Body

2nd Party Subcontractor


or 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 Effectiveness
Review the Effectiveness of the
process
Require understanding the input and
output of the process
Looking for the Objective of the
process
Compare actual achievement with the
objectives

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Audit Efficiency
Review the efficiency of the process
Looking for the objectives
Require understanding the input and output
of the process
Compare the result and the effort
(resources)
o Benchmarking with others
o Looking for the excellence models
Resources may
o Money, time, man power, natural resources ,
energy, materials
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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:
conducting opening meeting,
writing nonconformances
Conducting closing meeting
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

Neville-Clarke International Ltd, 2003


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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

Customer Customer
s(and Management s (and
other responsibility other
Interested Interested
Parties) Parties)
Resource Measurement , Customer
management analysis ,
Satisfaction
improvement

Customer Input Product Output


Product
Requirement realization
s Key
Value adding activities
Information flow
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Slide No 0:34 QMS X Issue 1.0/03
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
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

Interaction of one COP with


another
Within an organization, there are many
COPs
Each COP interfaces with the customer
Neville-Clarke International Ltd, 2003
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COP Examples

Request Formal Order


Customer for Quotation Order accepted
quotation

Customer Bid/ Order


Oriented processing
Processes
quotation

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COP Examples

Customer Prototype
Customer Spec. Test request Prototype
Result

Customer Product Product


Oriented
Processes
Validation Development

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COP Examples

Warranty Warranty Action Corrective,


Customer Claim accepted Request preventive
actions

Customer Customer
Oriented Warranty Feedback
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!

Neville-Clarke International Ltd, 2003


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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.

Neville-Clarke International Ltd, 2003


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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

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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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Slide No 0:49 QMS X Issue 1.0/03
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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Slide No 0:50 QMS X Issue 1.0/03
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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Slide No 0:51 QMS X Issue 1.0/03
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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Slide No 0:54 QMS X Issue 1.0/03
Audit by process approach
How? With Who?
(method, technique) (skill, training)

INPUT 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!
Neville-Clarke International Ltd, 2003
Slide No 0:56 QMS X Issue 1.0/03
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?

Neville-Clarke International Ltd, 2003


Slide No 0:57 QMS X Issue 1.0/03
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 COP with linkages to
MOP & SOP.

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Exercise 2

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Session 5

Audit Planning

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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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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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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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Audit Criteria
ISO/TS 16949
Customer Specific
requirements
Company
documented Quality
Management
System

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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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Terminology

Definition of Terms
Shall - mandatory requirement
Notes - for guidance in understanding or clarifying
the associated requirement
should in a Note is for recommendation only
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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Audit Scope
the extent and boundaries of audit
Include:
o Physical locations
o Organizational units
o Activities
o processes

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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
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Contact Auditee
Auditor Contacts
Department Manager
Explains the processif
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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Review document
Obtains
representative
documents, e.g.
procedures,
guidelines
Checks on
outstanding
nonconformities in
previous audit

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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 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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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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Exercise 3

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Session 6

Conducting Audit

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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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Opening meeting
Courtesy to talk to
Manager first
Shows openness
Auditor can
Explain process
Set expectations
Confirm plan
Answer questions

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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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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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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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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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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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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
& Dont forget the Please
Show Me.

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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
7.3 7.5.2 APQP
7.2 7.1 Phase 5
FMEA MSA SPC Mass
Production
7.5 8.0
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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.

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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
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PAP
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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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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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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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Evaluate Audit evidence

Audit Criteria
Audit Evidence

Audit Finding

Weigh Evidence against criteria to obtain


Audit Finding
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Exercise 4

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Session 7

Reporting Audit

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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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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

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Audit Report
A formal, factual
and agreed record
of Audit including
nonconformities,
observations,
corrective action,
timescales,
conclusions,
recommendations.

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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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Typical Audit Report Content

Opportunity
Conclusion NonConformit For
y Statement Improvemen
(NCR) t
(OFI)

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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

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Minor Nonconformity
A failure in some part of the
organizations documented
QMS relative to ISO/TS 16949,
or
A single observed lapse of
following one item of a
companys 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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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
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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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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 whats 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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Slide No 0:106 QMS X Issue 1.0/03
Audit Report Nos!
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

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Exercise 6

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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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Slide No 0:114 QMS X Issue 1.0/03
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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Slide No 0:116 QMS X Issue 1.0/03
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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Slide No 0:119 QMS X Issue 1.0/03

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