WELCOME

TO

AUDITING
TECHNIQUES

TRAINING
 COURSE OBJECTIVE

To provide participants with fundamental knowledge of the

concepts and conducts of quality auditing.

As a result of attending this training, the participants

will be able to:

 realize the importance of quality audit as a

management tool in evaluating activities related
to quality

conduct quality audit in their respective areas

improve existing quality audit system in their

working area
 QUALITY MISCONCEPTIONS

 Quality is only concerned with tangible

 Quality is responsibility of the quality

department

 Quality requires piece-by-piece inspection

at every phase
 QUALITY MEANS.......

Fitness Customer
for use Satisfaction

Conformance
to Requirement
QUALITY IS........

Totality of characteristics of an entity that bears

its ability to satisfy stated implied needs.
QUALITY CONTROL

The operational techniques and activities that

are used to fulfill requirements for quality.

QUALITY ASSURANCE

All those planned and systematic actions

necessary to provide adequate confidence
that a product or service will satisfy given
requirements.
QUALITY SYSTEM is...

The organizational structure

 responsibilities

 procedures

 processes

 resources for implementing quality management

QUALITY
POLICY

Overall intentions and direction of an

organization with regard to quality, as
normally expressed by top management.
 OUR QUALITY
PRINCIPLES
Our Quality Principles are:

The Customer is the judge of our Quality. His or her opinion of our products and
services is paramount.

Our Quality goal is to be Defect Free and provide Industry Leading Reliability.

Not only do our Customers assess the quality of our products, but also the quality of
our services. Deliveries must be on time.

Inquiries, offers, samples and complaints must all be dealt promptly and thoroughly
through ownership. It is imperative that agreed and committed deadlines be met.

Each and every employee in the company contributes to achieve our quality goal
through continuous effort and training.

All work must be without defects from the very beginning. The standard of quality can
be attained by completing standardized process, which assures not only improvement
in the quality level, but also effects cost optimization.
OUR QUALITY
PRINCIPLES
The quality of our products is also dependent upon the quality of sourced parts. We
demand the highest quality from our supplier, and assist them in defining and meeting
to our mutual quality goals.

Prevention by eliminating the cause of a defect is more important than to diminish the
defect itself, as defect elimination is effected by preventive methods rather than
curative measures. A variety of test methods are employed and strictly applied to
detect and prevent potential defects.

Ensuring achievement of our quality goals is an important management duty. When

appraising the performance of our employees, particular emphasis is placed on the
quality of their work.

Our quality directives are compulsory. Additionally specified Customer requirements

will also be our requirements.
 Quality Manual shall be the
QUALITY basic documentation used for
MANUAL the overall planning and
administration of activities
which impact on quality

Document stating the quality policy and

describing the quality system of an

organization.
ISO 8402:1994

FACILITATORS NOTE :
SPECS TO READ : 01-0200-2638
 QUALITY SYSTEM
DOCUMENTATION PROGRESSION
APPLICABLE NATIONAL/
INTERNATIONAL CUSTOMER REQUIREMENTS
STANDARDS/REQUIREMENTS

QUALITY Level 1
Defines Approach
MANUAL and Responsibility
-Customer Reference Manuals
- Advanced Product Quality
Level 2 - Planning and Control Plan
AAWW SPECIFICATIONS General definition of - Product Part Approval Process
Who, What, When

SITE SPECIFICATIONS/ JOB Level 3

Detailed definition
DESCRIPTION of Who, What, (AS GUIDELINE)
ATP, ATK etc.+ When - SAC Standards
JOB INSTRUCTIONS - Failure Mode and Effect Analysis
Lot Traveller Cards, Special Work Instruction, Level 4 - Measurement Systems Analysis
Answers - Fundamental SPC
Bonding Diagrams, etc. How

OTHER DOCUMENTATION Level 5

Results: Shows that the
Reports, Forms, etc. system is operating

FACILITATORS NOTE :
PPAP/QS/ISO
 QUALITY SYSTEM ELEMENTS
4.1 MANAGEMENT RESPONSIBILITY
4.2 QUALITY SYSTEM
4.3 CONTRACT REVIEW
4.4 DESIGN CONTROL
4.6 PURCHASING
4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT
4.8 PRODUCT IDENTIFICATION AND TRACEABILITY
4.9 PROCESS CONTROL
4.10 INSPECTION AND TESTING
4.11 CONTROL OF INSPECTION, MEASUREMENT AND TEST EQUIPMENT
4.12 INSPECTION AND TEST STATUS
4.13 CONTROL OF NONCONFORMING PRODUCT
4.14 CORRECTIVE AND PREVENTIVE ACTION
4.15 HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY
4.16 CONTROL OF QUALITY RECORDS
4.17 INTERNAL QUALITY AUDITS
4.18 TRAINING
4.19 SERVICING
4.20 STATISTICAL TECHNIQUE
FACILITATORS NOTE :
BIG “3 “ TRUCK MANUFACTURER
Requirements of ISO 9001:2000
0 Introduction 6.2 Human Resources
1 Scope 6.3 Infrastructure
6.4 Work Environment
2 Normative reference 7 Product Realisation
3 Terms and definitions 7.1 Planning of product realization
4 Quality Management System 7.2 Customer related processes
4.1 General requirements 7.3 Design & Development
4.2 Documentation Requirements 7.4 Purchasing
7.5 Production & Service provision
5 Management Responsibility 7.6 Control of Monitoring & Measuring
5.1 Management Commitment devices
5.2 Customer focus
8 Measurement, Analysis and
5.3 Quality Policy
5.4 Planning Improvement
5.5 Responsibility & Authority 8.1 General
and Communication 8.2 Monitoring & Measurement
5.6 Management Review 8.3 Control of Nonconforming Product
8.4 Analysis of Data
6 Resource management 8.5 Improvement
6.1 Provisions of resources
QS 9000 - US AUTOMOTIVE
INDUSTRY STANDARD
 Harmonization of customer
requirements for GM, Ford and
Chrysler
 Developed from ISO 9001:1994,
an International Standard for
Quality Systems
 Requires independent third
party registration for assessment
and certification
 QUALITY SYSTEM
REQUIREMENTS
• QS 9000

• QSA MSA SPC FMEA PPAP

APQP

• Semi Conductor Supplement

• AEC-A1000
• TE Supplement
• TE QSA
• Reliability & Maintainability Guidelines
 Limitations of QS-9000
• QS-9000 was a Customer
Requirement of Ford, GM and
Chrysler...
• It was NOT an International
Specification.
• Might not recognized by some
automotive makers.
• Sometimes not flexible
• Aim to be International Automotive
Standard
• Coupled with customer-specific
requirements defines quality system
requirements for use in the
automotive supply chain
• Requires independent third party
registration for assessment and
certification
• First Edition, 1999; Second Edition, 2002
 ISO/TS 16949 : 1999
• Harmonization of customer requirements for
International Automotive Task Force(IATF)
member company
• Prepared by IATF
• Established based on ISO 9001:1994, AVSQ
(Italian), EAQF (French), QS-9000 (U.S.) and
VDA6.1 (German) automotive catalogs
• Japanese automobile manufacturers not
involved
• QS-9000 more widely accepted
 ISO/TS 16949:2002
• Harmonization of customer requirements for
International Automotive Task Force(IATF)
and Japan Automobile Manufacturer
Association (JAMA) member company
• Prepared by IATF, JAMA and ISO/TC 176
• Established based on ISO 9001:2000 and ISO
9004:2000, AVSQ (Italian), EAQF (French), QS-
9000 (U.S.) and VDA6.1 (German) automotive
catalogs
• Majority of global automobile manufacturers
involved.
INTERNATIONAL AUTOMOTIVE TASK
FORCE (IATF)
• The IATF is an "ad hoc" group of automotive
manufacturers and their respective trade
associations, formed to provide improved quality
products to automotive customers worldwide.

• IATF members include the following vehicle

manufacturers: BMW, Daimler-Chrysler, Fiat, Ford
Motor Company, General Motors (including Opel
Vauxhall), PSA Peugeot-Citroen, Renault SA,
Volkswagen and their respective trade associations -
AIAG (U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.)
AND VDA (Germany).
Some of the IATF member
companies
Japan Automobile
Manufacturers Association
(JAMA)

• Tokyo-based trade association

representing 13 Japanese car, truck, bus
and motorcycle manufacturers

Can you recognize their country of origin ….?

 Why called TS?
• An ISO Technical Specification (ISO/TS)
represents an agreement between the
members of a technical committee and is
accepted for publication if it is approved by
2/3 of the members of the committee
casting a vote
• To be reviewed at a basis of three years for
confirmation or withdrawn
FUNDAMENTAL
• The ISO/TS 16949 does not replace AVSQ,
EAQF, QS-9000 or VDA6.1. The document
represents an option for suppliers.
WHY HAVE AUTOMAKERS
ADOPTED THIS STANDARD?
 Unifies big three customer
requirements
 Aligns international standards
with industry best practices
 Utilizes resources and
experience of registrars
 Sets precedent for other
automakers to follow
 AUTOMOTIVE INDUSTRY GOAL
FOR ISO/TS 16949 IMPLEMENTATION
•To develop fundamental
Quality Systems that provide for:

 continual improvement
 emphasizing defect
prevention
 reduction of variation and
waste in the supply chain
 QUALITY AUDIT

A systematic and independent examination to

determine whether quality activities and related
results comply with planned arrangements are
implemented effectively and are suitable to achieve
objectives.

ISO 8402:1994
 AUDIT PURPOSE
 Gather factual information based on unbiased assessment
• of effective evidence rather than subjective opinion.
 Serve management as a means of determining the
• effectiveness of existing procedures and identifying areas
• requiring correction or improvement.
 Identify non-conformances and program deficiencies.
 Verify correction of previously-identified program deficiencies.
 Comply to customer quality program requirements.
 Quality system is in place and effective
 Quality activities and related results are as planned
 WHO ARE INVOLVED ?

AUDITEE
The organization to be audited

The organization that requested

CLIENT for the audit

AUDITOR
A person who has the qualification
and is authorized to perform all or
any portion of a QUALITY SYSTEM
AUDIT
NEW AUDIT PHILOSOPHY - THEMES
Auditors must be fact-finders, not fault finders
Auditors should not be conducted in a covert
manner, avoid secrecy

NEW AUDIT PHILOSOPHY - TECHNIQUES

OLD METHODS
Personal Bias/Interest
Cloak and Dagger Conduct
Laying Blame/Criticizing
Informal Audits
Surprise Audits*
NEW METHODS
Objective Evidence/Facts
Keep Auditee Informed
Impersonal Audit Report
Formal, Documented Audits
Pre-audit Notification

* Can have exceptional cases

 AUDIT CLASSIFICATION

INTERNAL (1 st Party) - performed by a company or

QAR department on itself as a conducted by the
own staff.

EXTERNAL (2nd Party) - performed by a company on its

ANALOG supplier and/or sub-contractor.

EXTRINSIC (3rd Party) - performed by an independent

QS9000 registration body with the view to establishing
the Auditee’s capability against a defined
QUALITY MANAGEMENT SYSTEM
 TYPES OF AUDIT
- System Audits based on QS9000/ISO9000
System audits shall be focused on the elements of
the applicable standard ( e.g. ISO9000,QS9000 & SAC )

- Manufacturing QOS/Process Conformance and

Effectiveness audits
Basis shall be CCAR ( Customer Corrective Action ) from
previous semester . Priotirization shall be on the Top
Areas “ having the most problems

- Product Audit
Product audit shall be utilized at appropriate stages of production
including Packing station & delivery to verify conformity to all
specified requirements such as: “actual “ product dimensions,
functionality (applicable at test), marking & labeling and
packaging.
 USES OF INTERNAL AUDITS

 Give assurance to management that its quality systems

are effectively achieving the planned quality objectives
 Identifies problems
 Opportunity to improve
 Keeps staff “on their toes”
 Enables auditors and observers to better understand the
company and learn new skills
 Meet requirements in ISO 9000
 Input to Management Review
 Helps management find out what is happening in the
organization
 1SO9001 SYSTEM ELEMENT

4.17 INTERNAL QUALITY AUDITS

The Supplier shall establish and maintain documented procedures for

planning and implementing Internal Quality Audits to verify whether quality
activities and related results comply with planned arrangement to determine
the effectiveness of the Quality System.

Internal Quality Audits shall be scheduled on the basis of the status and
importance of the activity to be audited and shall be carried out by personnel
independent of those having direct responsibility for the activity being audited.

The results of the audits shall be recorded (see 4.16) and brought to the
attention of the personnel having responsibility in the area audited. The
management personnel responsible for the area shall take timely corrective
action on deficiencies found during the audit.

Follow-up audits activities shall very and record the implementation and
effectiveness of the corrective action taken (see 4.16).

Notes: The results of internal quality audits form an integral part of the
input to management review activities (see 4.1.3).
 CHARACTERISTICS AN AUDITOR
MUST HAVE

1. GENERAL KNOWLEDGE - of Quality Systems,

Production requirements, Engineering Systems
and Customer contractual requirements.

SPECS
2. AUDITING TECHNIQUES - an Auditor to be
successful must understand the style of
questioning, auditing methods, tactics and
preparation required.

3. AUDITOR PERSONALITY TRAITS.

INTERPERSONAL BEHAVIOR

PASSIVE
The aim is to avoid conflict and to please
or placate others

ASSERTIVE
Work towards satisfying needs and wants
of all parties

AGGRESSIVE
The aim is to win, if necessary at the expense
of others
 PROJECTING THE RIGHT IMAGE

1. LOOK THE PART. As a representative of the company’s management

the auditor must dress to reflect the appropriate image of his/her
organization.

2. REMAIN CALM AND COURTEOUS. The auditor sets an example to

others by his/her own conduct during the audit.

3. BE PUNCTUAL. A punctual auditor gives the impression that he means

business.

4. BE PRECISE. Strive to convey what is intended in all communications

with the auditee.

5. BE PREPARED. If properly prepared, the auditor will learn the respect

of the auditee as he shows knowledge of what he is about to do.
 AUDIT ETHICS

 Be objective in judgment and pronouncement.

Know facts versus opinion.

 No surprises. Fully disclose findings.

 Be objective in obtaining facts and eliminate
personality conflict.

 Don’t divulge proprietary information. Don’t

discuss audit performance of other organization.
 UNDESIRABLE TRAITS OF AN
AUDITOR

1. ARGUMENTATIVENESS. The auditor needs to turn a

heated argument into a discussion.
2. OPINIONATED. When the opinions of the auditor
interfere with his ability to perform tasks, the auditor
will become ineffective.

3. LACK OF DESIRE. Recurrence of defects or issues can

be discouraging and bring about a lack of desire.

4. INFLEXIBLE. The auditor needs to bend, listen and be

flexible with the audit teams and all personnel he
interacts with.
 UNDESIRABLE TRAITS OF AN
AUDITOR (cont...)

5. JUMPS TO CONCLUSION. The auditor has to read

into things further before jumping to a conclusion
that may not be factual.

6. MR. NICE GUY SYNDROME. The auditor needs to

be strong, honest and fair. Being a Mr. Nice Guy
can hurt the results and overall credibility.

7. EASY TO INFLUENCE. The auditor must remember

to verify verbal information.
 BUILDING EFFECTIVE
RELATIONSHIPS

THE TRUST PYRAMID

TRUST LEVEL THREE

UNDERSTANDING LEVEL TWO

COMMUNICATION LEVEL ONE

COMMUNICATION SKILLS

 Verbal

 Body Language

 Style and sound of speech

 Facial

 Range of literacy
 AUDITING TECHNIQUES

LEVEL ONE COMMUNICATION

VERBAL * Try not to sound critical and

judgmental

* Ask questions and listen to

the answers

* Leave silences where appropriate

NON-VERBAL * Try not to use aggressive body

language

* Show interest

* Try not to show impatience or

frustration
LEVEL TWO UNDERSTANDING
* Summarize or paraphrase what person has
said to demonstrate that you are listening and
attempting to understand

* Achieve EMPATHY by seeing things from the

other person’s point of view, not just your own.

LEVEL THREE TRUST

* When one person really understands they

are far more likely to trust each other

* Trust in the audit context means that both

parties know what one is not out to “win” at
the other expense
 COMMUNICATION IS NOT EASY

Something said does not mean said correctly

Said correctly does not mean it has been heard

Heard does not mean it has been understood

Understood does not mean it has been agrees upon

Agreed upon does not mean it has been remembered

Remembered does now mean it has been applied

Applied does not mean we will keep on applying

TIPS IN COMMUNICATING EFFECTIVELY
L - Listen to what is being said
I - Internalize every sentences
S - See the person giving explanation
face to face (if necessary)
T - Tell the person up front if there is any
confusing statement
E - Ensure understanding by:
• repeating/rephrasing the statement
• explaining the what , why, who, when
and how of the instruction.
• demonstrating by example

N - Note and all the items discussed

TIPS IN ASKING QUESTIONS

WHY
WHY WHO
WHO WHAT
WHAT WHEN
WHEN WHERE

HOW

HOW
SHOW ME..
AUDIT PHASES
Auditing is a “system”
and follows the same
structure and philosophy
as ISO 9000 and ISO14001
PLAN DO Standards / Models.

ACT CHECK
Note : A system is a planned
way of achieving a desired
goal, hence the audit process
is a system for ensuring that
an effective audit is conducted.
AUDIT PREPARATIONS
OVERVIEW

Obtain Basic
Information

Select Audit Team

Members

Prepare Audit
Checklists

Release Audit
Schedule
 AUDIT PLANNING
The systematic determination of what should
be done. Scheduling is establishing the detailed
time table to do it.
ISO 8402:1994
QUESTIONS TO BE ASKED?

What is the purpose of the audit?

What are the boundaries of this audit?
What is the planned length or duration of the audit?
What expertise or technical support will be useful
to this audit?
What depth of investigation is anticipated?
What is the location?
What are the cost considerations?
DO

This is an on-site element of the audit where people are

interviewed and records and processes checked. There are
4 stages :
Introductory meeting
- Set “mood” for audit
- Important for Communication
- Identifies: What, When, Who, How
- 1st Party = casual
- 2nd / 3rd Party = formal
Audit
Audit Review (Sanction findings)
Feedback
DO

Auditor Tools :
- Look
- Listen
- Ask Question
- Silence
- Empathy
- Rapport

Interview basics:
- Always record objective evidence
- Always tell the auditee what you’re doing
- Always ask open questions
- Treat auditee as your equal
- Always think the auditee for their help
AUDIT TRAILS

- Follow process from start to finish

means

You see what actually happens,

not what procedure says should
happen

you keep on track

audit is more systematic/logical
less likely to miss stages
AUDITOR REVIEW INFORMATION

1. Quality assurance manual, procedures and instructions

that describe the management systems and methods of
implementing them

2. The auditee file - copies of previous audit reports or

maybe auditing rating

3. Inspection and field report - to assess the true quality

and fitness for purpose of product being audited

4. Contracts and QA specifications, standards and codes

5. The information sent by the auditee

6. Corrective action file - verify closed out corrective actions

 USEFULNESS of CHECKLISTS
For the Auditor
* Acts as a guide for the person performing the audit
* Provides objectives evidence that the management
audit was performed
* Provides information which helps the auditor prepare
for the closing meeting and the audit report

For the Auditee

* Reveals the auditor’s guidelines and helps the auditee
prepare for the audit
* Helps the auditee train his staff
* Provides objective evidence that the system has been
independently audited
 SOURCES OF ITEMS

 Requirements of external standards

 Key elements of internal procedures

 Key actions

 Quality records to be maintained

 Quality system documentation

required
 AUDITOR TOOLKIT

Hard surface to write on Notebook or

(e.g. clipboard) logbook

Copy of checklists Copy of audit plan

Report forms Copy of any

standard(s) used

NOTE : Use ESD and cleanroom friendly if to be brought

inside the line.
 AUDITING TECHNIQUES

AUDIT PREPARATION

* Participation by auditee personnel:

- escorts/guides
- attendance to pre-audit and post-audit meeting
- operate product or service being audited
* Office facilities
management audit was performed
* Devices/tools that will be used for verification
* Documents as requested to be prepared by the
auditor
* Other materials or accessories needed to access the
areas and activities
* Safety, regulatory and proprietary rights control
that will be met during the audit
 SAMPLE DEVIATION

DATE / TIME EMPLOYEE EMPLOYEE DEPT. /

ISSUE
ISSUED NUMBER SUPV. SECTION

04/24/03 /
ELVIE YLANAN DING SILLA SOIC1 / EOL
12:06

Atmel Colo lots for TFS are bundled in LTC and not placed in
magazine. Non-conformance to items 7.5 and 7.6 of Material
Handling Specs. 001-0938-3014