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Training Material on ISO/TS 16949: 2002Internal Auditing

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TRAINING MATERIAL
ON
ISO/TS 16949:2002
INTERNAL AUDITING

116-A, JWALAHERI MARKET, 11nd FLOOR, PASCHIM VIHAR, NEW-DELHI-63


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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 2. Table of Content :

Chapter
No.

Chapter Name

1.

Cover Page

2.

Table of Content

3.

Introduction

4.

Advantages of ISO/TS 16949

5.

Questionnaire

6.

Definitions

7.

Types of Audit

8.

Steps in Auditing Process

9.

Specimen Copy of Audit Schedule

10.

Auditor Friends

11.

How to write Non-conformance Report

12.

Flow of Non-conformity closure

13.

Attributes of Non-conformance statements

14.

Tips to Auditee

15.

Tips to Auditor

16.

Process Audit Questionnaire

17.

Case Studies

18.

Opinion & Feedback

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 3 Introduction :
This course material has been prepared for the Internal Auditors of an organization. The Internal
Auditing is a very important tool in the hands of the management to find out suitability ,
effectiveness, efficiency and improvement in the Quality Management System and not finding
faults.
The auditors must believe in the Quality Management System and be systematic themselves.
Above all, they must be able to convince the auditees and other members of the organization in
correctly interpreting the requirements of the standard and motivate the individuals in following
the system.
In order to achieve this objective, the auditors must be thoroughly knowledgeable in the
requirements of the standard and its implications. Hence, we have designed this program to help
the participants to understand the standard requirements through a questionnaire, which will be
followed by the training on the process of auditing and concluded with case studies which the
participants will solve.
The auditing process should identify problems which points to the unsuitability of the system or
the inadequacy of the system. These problems should be analyzed to find out the root cause and
then corrective and preventive actions are taken to prevent their recurrence and occurrence.
There should be a firm belief that all problems can be traced back to the system and the audit
process should be utilized to correct the system and make it more and more useful. The
management review process after the audit is an important process in that direction.

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 4 - Advantages of ISO/TS 16949 :
Better customer satisfaction due to consistency in Quality of the companys products and
services.
Opportunity to gain global customer acceptance for the company and its products.
Reduction in the costs of poor quality.
Organization will become system dependent and not people dependent.
More effective use of managerial time.
It creates plantwide awareness to quality and customers requirements through its inherent
correction and / or internal audit feature.
It streamlines material handling and storage through all stages of production.
It helps effective work in progress management by streamlining identification and storage
through all stages.
It streamlines house keeping, cleanliness and improves the whole work atmosphere.
It streamlines the calibration system with systematic analysis, which directly reflects on to
the quality of products.
It complements the organizations efforts towards Just in Time concept, better
manufacturing and marketing management and Total Quality Management.
It streamlines experience retention and improves predictability and consistency of
organizational behaviour.
It helps the management in identifying training needs of employees and orientation towards
continuous improvement.
Improves internal commitment as well as enhanced Customer confidence.
It provides the means for identifying and resolving problems and preventing their recurrence,
thereby improving conformance.
In general, ISO/TS 16949 certification bears testimony to overall quality of a organizations
products and its services.

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Training Material on ISO/TS 16949: 2002Internal Auditing

Chapter 5 Questionnaire :
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.

To whom does the ISO/TS 16949 Requirements apply ?


Who has developed the ISO/TS 16949 Quality System Requirements ?
What are the supplementary manuals referenced in the ISO/TS 16949 Standard ?
Differentiate between Responsibility and Authority ?
For which areas authorities have to be defined as per the standard ?
Is it required to have personnel in charge of quality in all the shifts?
What are the activities for which Multi-disciplinary approach has to be used?
Which are the functions / departments included in your companys Multi Disciplinary
Team (MDT) ?
Is it sufficient to review only Internal Audits and Corrective and Preventive Actions
during the Management Review Meeting ?
Is the documented business plan is a requirement of ISO/TS 16949:2002?
Give four examples of ISSUES which needs to be covered in the Business Plan?
Give five examples of company level data for your organisation.
Is it mandatory to determine Customer Satisfaction at a defined frequency ? If so, what is
the frequency adopted by your organisation ?
To determine the customer satisfaction W.R.T. product supplied, what are all the
parameters considered in your organization?
Specify any two measures adopted by your Organisation for the motivation of
employees?
How do you interpret the term Special Characteristics and when special characteristics
are identified ?
Specify some of the situations ,where FMEA needs to be reviewed?
What are the stages for which Control Plans are to be prepared ? Which are the situations
that will lead to review a update of control plans ?
List 5 requirements (as per ISO/TS 16949 standard) which have to be reviewed during
Contract Review.
List atleast 5 skills required for Design Engineer.
Which are the requirements, that have to be reviewed in the Design input ?
Define Product life, reliability, durability and maintainability.
Is it mandatory to have CAD / CAE system for Design ?
Is comprehensive prototype program mandatory ? which are the tests to be included as
part of Performance Test ?
How do you differentiate between Design Verification and Design Validation ?
What is the symbol used by your organisation for identifying the Special Characteristics ?
How do you interpret the term Documents of External Origin ?
What is the system adopted by your organization to ensure the latest version of External
Origin Documents?

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29.
30.
31.
32.
33.
34.

35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.

What is the system adopted by your organisation for identifying the date of
implementation of customer change ?
Is it mandatory to have your supplier certified for ISO/TS 16949 Requirements ?
Is it mandatory to review the Delivery performance of your Supplier ?
What are the Purchase commitments to be provided by your organisation to the supplier?
Does the customers representative have the right to visit to your supplier for verification,
as per ISO/TS 16949 standards ? If so, mention the applicable clause ref.
Which of the following is customer supplied product :

A Gauge given by the customer.

Packaging material supplied by the customer, but paid by your organisation.

Floppy diskette containing a set of drawings.


Name atleast four Governmental, Safety and Environmental regulation to be complied
with your organisation?
How do you differentiate the terms Preventive Maintenance and Predictive
Maintenance ?
Is it mandatory to correlate SPC data with Preventive Maintenance activity ? If so, how
do you propose to do this activity ?
How do you interpret the terms Preliminary Process Capability and Ongoing Process
Performance ?
Is it mandatory to do conduct preliminary process capability study for all characteristics ?
Which are the techniques that can be used for conducting process capability study for
non-normal data?
What are the elements to be covered as part of Reaction Plan ?
Is it required to do last off part comparison ?
Is it mandatory to record the details of Process Changes ?
How do you interpret the term Appearance Item ? Which are the appearance items in
you company ?
The Quality Plan (Control Plan) for receiving inspection specifies the AQL value as 2.5.
Is it acceptable ?
How do you define Layout Inspection ? What is the frequency for layout inspection
followed by your organisation ?
How do you interpret the terms Bias, Linearity, Repetability, Reproducibility ?
What are the different studies used for attribute gauges?
For which measurement and test equipments, R & R study is required ?
Does the location of product in the normal production flow constitute suitable indication
of inspection and test status ? explain.
How do you define Disposition Action? What are the different disposition actions
possible?
Is it mandatory to re-inspect the reworked product ? If so, it should be done on
what basis ?
Is it required to provide instructions for Rework ?
Define SPECIAL PROCESS?

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55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.

77.
78.
79.

State three techniques used for disciplined problem solving.


Differentiate between corrective and preventive action.
What are the sources of information to be used for initiating preventive action ?
Differentiate between Storage and Preservation?
What are the measures you would use to optimize the Inventory system?
Is the protection of material mandatory till delivery?
What should be the basis for doing production schedule?
Is 100 % on time shipment a mandatory requirement? Explain.
Is it mandatory that the external laboratory which is used for calibration or Testing
purposes need to have NABL accreditation?
Can records received from suppliers be included as quality records?
What are the criteria for deciding the retention period for the Quality records ?
The Quality Manager audits the Calibration Incharge. Is it acceptable as per the
Standard?
What is the basis adopted by your organisation for determining the schedule for Internal
Quality Audits ?
What are the three different audits that are to be conducted as part of Internal Quality
Audit?
Is it mandatory to identify the training needs of CEO ?
On what basis, do you propose to identify the training need of your subordinate ?
Describe how your company may be able to assess training effectiveness in a way that
would meet the requirements of ISO/TS 16949.
Is it mandatory to document a procedure for identifying the need for Statistical
Techniques ?
How do you interpret the terms Variation, Stability, Capability and Overadjustment ?
Is it required to give awareness training on the statistical concepts to all employees in the
organisation ?
How would statistical methods apply to the Marketing Group ?
Select the best choice :
A Production Part Approval is granted for
Part Number
Engineering Change Level
Manufacturing Location
Material Sub-contractor
Production Process Environment
All the above included.
How many possible submission levels are there in PPAP. Which one applies if there is no
prior customer agreement regarding submission levels.
What is the purpose of doing PPAP ?
What are the situations for which production part approval is always required prior to
first production shipment ?

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80.
81.
82.
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85.
86.

87.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
100.

List out three situations for which production part approval is required unless the
customer part approval activity has specifically waived the requirement.
List out atleast five documents / items to be completed by the supplier for production part
approval.
Differentiate between Corrective Action and Continuous Improvement ?
How would a company show evidence of a Comprehensive Continuous Improvement
Philosophy ?
List out atleast five techniques that can be used for continuous improvements ?
List out atleast five continuous improvement projects being undertaken by your
organisation.
A continuous improvement plan for quality assurance department specifies the following
activity as one of the projects :
Improvement of Cpk value from 0.7 to 1.33 for Process-A, Is it acceptable ?
Is it required to adopt MDT approach for facilities and equipment planning ?
What are the factors to be considered for evaluation of the effectiveness of existing
operations ?
How do you interpret the term Mistake Proofing ?
Explain atleast one mistake proofing methodology used by your organisation during
process planning.
Is it mandatory to carry out full dimensional inspection of the tool ?
Customer Supplied Tooling was identified through a sticker ? Is it acceptable ?
How do you interpret the term Perishable Tool ?
Is it mandatory to have a system, in case tool maintenance activity is out sourced ?
What is the purpose of Advanced Product Quality Planning ?
Which are the Five Phases of APQP ?
How do you define feasibility review ? What is the system for feasibility commitment in
your organisation ?
Which are the requirements to be covered before quality planning sign-off ?
What is the purpose of Design FMEA and what is the purpose of process FMEA ? When
DFMEA is conducted and when PFMEA is conducted ?
How do you define and calculate RPN ? What is Severity, Occurrence and Detection ?

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 6 Definitions :
1.

Auditee : Person to be audited.

2.

Auditor : A person who has the qualification and is authorized to perform all or any
portion of a quality system audit.

3.

Non-conformity : The non-fulfillment of specified requirements.

4.

Major Non-conformance :

5.

Absence or Total breakdown to meet the requirements of the standard.


A number of minor non-conformances against one requirement

Minor Non-conformance :

A failure in some part of the suppliers documented quality system relative to the
Standard.
A single observed lapse in following one item of a company quality system.

6.

Quality Audit : A systematic and independent examination to determine whether quality


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

7.

Objective Evidence : The qualitative or quantitative information records or statements


of facts, pertaining to the quality of an item or service or to the existence and
implementation of a quality system element or documented requirement, that is based on
observation, measurement or test and which can be verified.

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 7 - Type of Audit :
Internal (First Party) : Performed by a company or department on itself.
External (Second Party) : Performed by a Customer on its supplier.
Extrinsic (Third Party) : Performed by a Registration body.
Adequacy Audit : Examination of the Documented Quality System to verify whether the
requirements of the Standard are addressed in relation to the Companys product, process,
system.
Compliance Audit : Examination to verify whether the Documented Quality system is being
implemented.
Follow-up Audit : Audit conducted to verify the implementation and effectiveness of the
corrective actions taken on the non-conformances.
Surveillance Audit : Audit conducted by the Certification/ Registration body on a defined
frequency after Registration.

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 8 - Steps in Auditing Process :
Audit Schedule

Contact Auditee

Collect Information

Develop Check List

Opening Meeting

Auditors Meeting

Conduct Audit

NCR/CAR Meeting

Closing Meeting

Internal Audit
Report

Corrective Action
& Follow Up

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 9 - Specimen copy of Audit Schedule :
Organization Name : ______________
Internal Audit Schedule
Audit No. : _____________
Sl.
No.

Date

Time

Date : _________
Department

Auditee

Auditor

Scope of
Audit

Management Representative :
Page No. ___ of ___.
Circulation to :

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Chapter 10 - Auditor Friends :
Five W and One H
(Who, What, Where, When, Why and How)
Who
1.
2.
3.
4.
5.

Who does it ?
Who is doing it ?
Who should be doing it ?
Who else can do it ?
Who else should do it ?

What
1.
2.
3.
4.
5.

What to do ?
What is being done ?
What should be done ?
What else can be done ?
What else should be done ?

Where
1.
2.
3.
4.
5.

Where to do it ?
Where is it done ?
Where should it be done ?
Where else can it be done ?
Where else should it be done ?

When
1.
2.
3.
4.
5.

When to do it ?
When is it done ?
When should it be done ?
What other time can it be done ?
What other time should it be done ?

Why
1.
2.
3.
4.
5.

Why does he do it ?
Why to do it ?
Why to do it there ?
Why to do it then ?
Why to do it that way ?

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How
6.
7.
8.
9.
10.

How to do it ?
How is it done ?
How should it be done ?
Can this method be used in other areas ?
Is there any other way to do it ?

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 11 - How to write Non-conformance Report ?
1. What is the Non-conformance ? ( WHAT)
2. Objective evidence to substantiate the non-conformance. (WHERE)
3. Reference to document or relevant standard. i.e. Attribution ( WHY)
Example :
Responsibilities and Authorities for all personnel performing work affecting quality not always
been defined (NC)
For example, no job description exists for Purchase dept. personnel (OE)
Refer Procedure No. 30, Job Description Which states that the responsibilities and authorities
of all personnel will be defined in job descriptions. (Attribution)

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Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 12 - Flow of Non-conformity Closure :

Responsibility

Activity

Auditor

Non-conformity

Auditee
Disposition Action

Auditee
Root Causes
-

Auditee and MR
Corrective Action

Auditor / MR

Verification of Implementation
and Effectiveness

MR

MR

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Close Non-conformity

Summary

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Document
Introduction / Change
Awareness / Training to
personnel
Introduction /
Upgradation of
Resources

Training Material on ISO/TS 16949: 2002Internal Auditing


Chapter 13 - Attributes of Non-conformity Statements :

N o n - c o n fo r m it y
A dequacy
N o t a d d re s s e d

N o t R e fle c t e d

N o t L in k e d

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C o m p lia n c e
N o E v id e n c e

N o t u p d a te d

T w o S ta te m e n ts

N o t F o llo w e d

N o t A v a ila b le

N o t A u t h o r is e d

N o t F ile d

N o t In d e x e d

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Chapter 14 Tips to Auditee :
Before Audit :
Plan well in advance.
Decide if there are any products or activities that you want to exclude from the audit and
why.
Get to know about your assessor. Even witness him auditing another site, if possible.
Find out the assessors policy on Implementation time (Experience-time) for new systems.
(Some say six months, others say only a few weeks.)
Know your procedures and where they are located.
Remove all obsolete documentation.
Ensure all uncontrolled documentation that you are working with are properly stamped
Uncontrolled destroy after initial use.
Do not leave piles of documents around waiting to be processed or filed.
Label all your filing cabinets and files.
Do not leave on view neglected libraries of catalogues, standard software, etc.
Ensure all productive material is identified by number and status.
Ensure all material are stored in authorized areas.
Eliminate all unused, scrap / suspect material from around machines & work stations.
Scrap / Non-conforming material must be segregated and clearly identified.
Eliminate inappropriate stacking of boxes and goods.
Keep transport and fire lanes free.
Uniforms and attire must be clean and appropriate for area.
No obvious breaches of specified security areas.
Re-check that the calibration on your gauges and test equipment is in order.
Check your records are up to date.
Ensure all process controls are tamperproof.
Check that all workplace documentation on view is up to date and readable.
Check that everyone knows :
Brief details of standards (ISO / TS 16949)
The Quality Policy
The external auditors company name
What their objective is.
Do not over-communicate and make people nervous. The system is being tested not them.
Be prepared for the audit team to split up and audit separately.
Have an audit communication centre set up.
Do not forget cover all shift patterns.

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Remember, it is not good enough to say that you do a certain thing in the performance of
your job you must be able to prove it with documentation.
Document the rationale of the things you do not do. Document it in procedures and
instructions or exclude it from the scope.

During Audit :

Be punctual and courteous.


Make everyone aware that the auditors are likely to ask up to six questions :
What is your Quality Policy ?
Tell me how do you do your job.
Show me where in your system it tells you to do this.
Can I see some evidences ?
What action do you take if you have problem ?
What training have you received to help you to do this job ?
Be honest in your answers.
Do not brag : they are not customers. You do not have to impress them with the past or
future, just what happens now.
Do not volunteer additional information. Just answer the question asked and stop. Do not
ramble on.
Do not use terms like usually or generally. They invite further questions.
Do not fill in space between questions. If there is a gap, let the auditor fill it.
Do not be afraid to say, I dont know, but I shall get back to you.
Do not rush or divert the auditors. They are responsible for their own schedule.
Note any non-compliances observed in as much detail as possible.
Do not point fingers at someone else in front of the auditors. Internal conflicts are for
another time.
Do not challenge or argue to excess. Make your point then stop.
Do not be panic.
After Audit :

Do not argue at the exit meeting. It is too late.


Do not rush into hasty corrective action. Do it properly.
Remain polite, even if you did not do well. It is not the auditors fault, it is your organization
that failed. Shooting the messenger will not change a single thing !

Most Organizations fail external independent audits for one or more of the following reasons :

Identification of material
Documentation control

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Insufficient corrective action


Lack of evidence.

You have been warned!


Chapter 15 Tips to Auditor :
Before starting each audit, explain briefly to the Auditee why you are there and what you are
doing.
Emphasize that it is the system assessment and not the individual being assessed.
Be open and try to be seen be positive.
Use open questions e.g. Please explain this process to me.
Be objective Record facts not opinions.
Try to follow a logical trail.
Use the triangle, i.e. Question Observe Check.
Use time carefullyKeep to scheduleCover everything you are supposed to.
Try to maintain a natural flow i.e. Dont keep stopping and starting.
Give feedback to encourage auditee to talk freely and to put them at ease.
Use Show Me regularly to verify what you are being told is actually the case.
Thank auditees for their time and co-operation.
Dont leave loose ends on trails.
Use Check lists as aide-memoir only Dont let them take over the audit.
Bear in mind that smaller companies need less sophisticated systems.
Be flexible.
Listen carefully, to what auditees actually say and where appropriate base the next question
on their last answer.
Refer any major issues to lead assessor.
Be assertive, not aggressive or passive.
Talk to the person who actually performs the task being assessed.
Do not get into an argument.
Remember you are a Guest.
You are an Auditor; Not a Dictator
You are trying to help them out; not catch them out
Test your understanding to confirm that you have the correct information.
Make notes detailing exactly where non-conformances are found so they can be followed up
at a later date.
Only give advice / consultancy it is allowed by your organization.
Be professional in manner and appearance.
Be prepared to be unpopular if it is necessary.
Give criticism in the correct manner.

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Chapter 16 Process Audit


Definition :
Onsite verification activity used to :
-

Verify conformance to specified requirements, such as Control plan, Work Instructions


Ensure that Quality objectives are met
Verify that specified requirements for process capability/ performance are met
Assess the effectiveness of activities and related results

Process Audit Questionnaire


Product Realisation process :
Product Design and Development:
1.
2.
3.
4.
5.
6.

Are the customer requirements available?


Is a product development plan available and are the targets maintained?
Are the resources for the realisation of product development planned?
Have the product requirements been determined and considered?
Has the feasibility been determined based on the available requirements?
Are the necessary personnel and technical conditions for the project process planned/
available?
7. Is the design FMEA raised and are improvement measures established?
8. Is the design FMEA updated in the project process and are the established measures realised?
9. Is a Control plan prepared?
10. Are the required releases/ qualification records available at the respective times?
11. Are the required resources available?
Process Design and Development
1.
2.
3.
4.
5.

Are the product requirements available?


Is a process development plan available and are the targets maintained?
Are the resources for the realization of regular production planned?
Have the process requirements been determined and considered?
Are the necessary personnel and technical preconditions for the project process planned/
available?
6. Is the process FMEA raised and are improvement measures established?

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7. Is the process FMEA updated when amendments are made during the project process and are
the established measures implemented?
8. Is a Control plan prepared?
9. Is pre-launch carried out under production conditions ?
10. Are the production and inspection documents available and complete?
11. Are the required resources available?
PRODUCTION
Personnel/ Qualification
1. Are the employees given responsibility and authority for monitoring the product/ process
quality?
2. Are the employees given responsibility and authority for production equipment and
environment?
3. Are the employees suitable to perform the required tasks and is their qualification
maintained?
4. Is there a personnel plan with a replacement ruling?
5. Are instruments to increase employee motivation effectively implemented?
Production Material/ Equipment
1. Are the product-specific quality requirements fulfilled with the production equipment/ tools?
2. Can the quality requirements be monitored effectively during serial production with the
implemented inspection, measuring and test equipment?
3. Are the work and inspection stations appropriate to the needs?
4. Are the relevant details in the production and inspection documents complete and
maintained?
5. Are the necessary auxiliary means available for adjustments?
6. Is an approval for production starts issued and are adjustment details, as well as deviations
recorded?
7. Are the required corrective actions carried out as schedule and checked for effectiveness?
Transport/ Parts Handling/ Storage/ packaging
1. Are the quantities/ production lot sizes matched to the requirements and are they
purposefully forwarded to the next work station?
2. Are products/ components appropriately stored and are the transport means/ packaging
equipment tuned to the special properties of product/ components?
3. Are rejects, rework and adjustment parts, as well as internal residues strictly separated and
identified?
4. Is the material and parts flow secured against mix ups/ exchanges by mistake and traceability
guaranteed?
5. Are tools, equipment and inspection, measuring and test equipment stored correctly?
Fault analysis/ Correction/ Continual improvement

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1. Are quality and process data recorded complete and ready to be evaluated?
2. Are the quality and process data statistically analysed and are improvement program derived
from this?
3. Are the causes of product and process nonconformities analysed and the corrective actions
checked for their effectiveness?
4. Are product and process subject to continual improvement?
5. Are target parameters available for product and process and is their compliance monitored?
Chapter 17 Case Studies :
Following are the incidents that occur during a third party audit of a supplier XYZ India are
described. They contain the situations for which a non conformity report (NCR) may be required.
Examine each incident carefully, then take one of the actions.
1. If you think that there is sufficient objective evidence of non conformity, then you should
complete a nonconformity report
Case 1 Department : Production (Production Supervisor)
Auditor :
Explain your Quality Policy and Objectives ?
Auditee :
.thinks.thinks.
Auditor :
Get a copy from MR. Please read and try to understand.
Case 2 Department : Management Representative
Auditor :
How many management review meetings you have conducted ?
Auditee :
Three management review meetings have been conducted so far.
Auditor :
Show me the summary status and minutes of all the meetings
Auditee :
Presents to the auditor.
Auditor :
Verifies the minutes of second management review meeting and asks the
auditees to show the action no. 4, 5, 6 review results in 3rd meeting minutes.
Auditee :
No need to cover in the 3rd Management review meeting
Case 3 Department : Engineering in drawing room (Engineering Head)
Auditor :
Auditor picks a drawing. Is it included in Master List of Drawing ?
Auditee :
Searching in the master list.. No it is for development product.
Auditor :
How you are identifying the status of various drawings ?
Auditee :
By part no.
Auditor :
Please show me the Quality Planning file.
Auditee :
Submits Quality Planning file.
Auditor :
Searches and not able to find out for the above case.
Case 4 Department : Production
Auditor :
Is customer supplied product applicable to you ?
Auditee :
Thinks.. No.

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Auditor :

Auditor verifies the various sections and its activities in the shop floor.
In servicing department Why these products are lying here ?
Auditee :
These are received from customer for servicing.
Auditor :
Show me any document, which is explaining about verification and control
throughout the process.
Auditee :
Searches ..No it is not defined in any procedure.
Case 5 Department : Production
Auditor :
Verifies the copper pipe bending process being carried out by the operator.
Calls another operator, shows him pipe after the bending process and asks, is it
accepted ?
Operator :
No Not accepted and he explains his views.
Auditor :
Asks same question to third operator.
Operator :
Yes, it is accepted.
Auditor :
Finally Production Supervisor says accepted to the auditor.
Case 6 Department : Production (in shop floor with operator)
Auditor :
Show me document / instruction for this process ?
Auditee :
Shows the process sheet with drawing.
Auditor :
Verifies the revision status of the drawing revision against the Master List of
Drawing held by the Design department.
The master list says revision status 04. Where as the drawing copy received from
operator shows revision no. 02.
Case 7 Department : Production (Process Crimping)
Auditor :
Can you show me document / instruction for this process ?
Auditee :
Shows the work instruction to the auditor.
Auditor :
Tell me how, you will ensure the withstanding pressure ?
Auditee :
Explains the method.
Auditor :
Verifies the work instruction, which is not in line with the statement of the
operator but the auditor feels that method explained by the Operator can also be
applied.
Case 8 Department : Management Representative
Auditor :
Show me the master list of document with the latest revision ?
Auditee :
Shows the master list which indicates the latest revision.
Auditor :
Verifies the Work instruction held by Production against the master list. He
ensures that the revision status is same.

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Case 9 Department : Quality (Incoming Quality Section) During inspection of a Subcontractor Team.
Auditor :
Show me the inspection reports of this item xxx.
Auditee :
Shows the inspection reports file.
Auditor :
Verifies the inspection report with the Quality Plan. Some of the parameters are
outside the specification limits but are still accepted.

Case 10 Department : Quality Control


Auditor :
What are all the statistical techniques identified for the different application ?
Auditee :
Explains with the list of the techniques and applications.
Auditor :
Show me any documents / records with respect to one technique
Auditee :
Explains one technique with relevant records.
Case 11 Department : Quality Control
Auditor :
Show me the inspection reports of the different stages.
Auditee :
Gives the Inspection reports of different stages.
Auditor :
Finds deviation in the inspection report and verifies with the Non-conformance
register.
Can you show me where this non-conformance is reflected in the nonconformance register.
Auditee :
No this is before our system effective date.
Case 12 Department : Store
Auditor :
Verifies the raw material in the store and its condition, storage area.
Auditor finds that Roof is leaking and chemical items are stored near the
window. Window is not covered.
Case 13 Department : Quality Control
Auditor :
Verifies the calibration certificates and records.
What is the operating range for the temperature controller ?
Auditee :
He says 200 300 degree.
Where as that is calibrated for the range of 300 400 degree.
Case 14 Department : Quality Control
Auditor :
Verifies the out of calibration certificates and records.
Tell me what further actions were taken ?
Auditee :
Instrument scrapped.
Case 15 Department : Quality Control

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Auditor :

Verifies the Calibration records.


Auditor finds that History card of Adjustable Snap Gauge No. XX/23 says,
Before calibration Not OK and After calibration found OK.

Case 16 Department : Purchase


Auditor :
Is there an approved list ?
Auditee :
Approved Vendor List is presented.
Auditor :
Auditor observes that the basic raw material suppliers are marked (*) and there
is no evidence to substantiate their selection and capability. (*) Indicates that
Existing prior to the existence of the system.
Case 17 Department : Quality Assurance
Auditor :
How is final inspection carried out ?
Auditee :
As per the Quality Plan to Drawing No. XXX.
Auditor :
Can you please present the Quality Plan and Drawing.
Observation.
Drawing XXX specifies for Torque test, Frequency Test and Destructive test
which is not incorporated in the Quality Plan.
Case 18 Department : Production
Auditor :
A plating component is questioned for its process.
Auditee :
The plating is sub-contracted.
Auditor :
Is it identified as a special process ?
Auditee :
No, since it is being sub-contracted.
Auditor :
Observes that it is not identified in the Quality Manual also.
Case 19 Department : Quality Assurance
Auditor :
Observes an inspection report no. 123 has a disposition on a non-conforming
product as rework. There is no evidence of re-inspection.
Case 20 Department : Quality Assurance
Auditor :
Observes an inspection report with dimension having 4th decimal being measured
by a Micrometer no. 023. Requests the Micrometer for observation.
Auditee :
Presents the Micrometer
Auditor :
Observes that the Micrometer is capable of measurement to an accuracy of third
decimal place only.
Case 21 Department : Management Representative
Auditor :
Observes that a Non-conformity report was written as follows :
It may be necessary to develop an additional work instruction for the process

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.being practiced.
Case 22 Department : Lab
Auditor :
How is the chemical composition of the component X checked for various
percentages ?
Auditee :
Presents an IS No. XXX which has no document and data status.
Auditor :
Observation.
The standard was supposed to be issued by the Engineering but not so. An
independent copy was being held by the Lab Incharge.
Case 23 Department : Quality Assurance
Auditor :
Observes that a Pin Gauge is lying in the standards room without any status.
Asks clarification with the auditee.
Auditee :
States that calibration is not required for the Pin Gauge, since it is not being used
for any measurement of critical dimensions.
Case 24 Department : Quality Assurance
Auditor :
Observes that an inspection report was corrected from rejected to accepted.
Auditee :
States that it was first rejected. Later on accepted with the verbal permission of
Quality Assurance Manager.
Case 25 Department : Purchase
Auditor :
Observes a file containing Purchase Orders.
1. To present the file, the time taken by the auditee was 8 minutes.
2. File is haphazardly arranged.
3. All files are kept on the table in which only some of the files are identified.
Case 26- Department : Operation : Balancing :
Auditor :
Show me Control plan for the balancing operation
(Auditor Showing to the auditee)
Auditor :
Observing the control plan CP 1310 the RPM of the speed shaft defined as
3200 + or 22 RPM.
Show me the calibration report of tachometer TM 3011
Auditee :
Showing the Calibration report / records
Auditor :
Observed that the calibration done for the range of 4251 to 19189 RPM
Certification no : Y / SPL / 99-98 / TM-02
Case 27- : PART APPROVAL PROCESS
Auditor :
Auditee :

Reviewing the PAP file for the products 2217 / 98


Show me the Measurement System analysis part ?
Showing the same to auditor

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Auditor :

Found that the appraiser variation (AV), Equipment Variation and (R&R)
are compared against Tolerance in place of total variation.

Case 28 Department QA
Auditor :

Auditor observed the Corrective and Preventive action trend of OD section


process. CAPA No.123 / 98.
Auditor :
Observing the trend of rejection :
Rejection Trend :
Month
% Rej

March 03
12

Auditee:
Auditor :
Auditee:
Auditor :
Auditee :
Auditor :

We have taken corrective and preventive action in the month of May


Why in the month of July it has been increased ?
We are facing new failure specifically taper issue
What is your further action with respective to system ?
We are planning to go for some innovative solution
Observing the customer survey reports & records
How many times are you recording the survey ?
My management will decide as and when required.

Auditee:

April 03
11.95

May 03
11.79

June 03
6

July 03
14

Case 29 : PPAP
Auditor reviewing the PPAP for the part NO. 26544 98 Sr. NO.68146
During the review, auditor finds all the MSA, SPC, INSPECTION REPORT, WARRANT are
available.
Auditor :
Auditee :

Finds for the part no. 27538 (S), No inspection report submission warrant.
It is a subcontracted item

Case 30 : PPAP
Auditor :
Auditee:

During the IQA audit dated on 20.06.98, auditor looks the product
catalogue for the current year. He is asking the PPAP for the part number
for the 96587 9 (0) which is introduced 12th December 97.
PPAP are disposed already because the product is not active.
(Assume the two situations and write answers)

Case 31 :

MRM

Auditor :

Observes that the agenda of review meeting included all elements of


quality system and the same has been discussed in review meeting for
the month of July98.

Case 32 :

MRM

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Auditor :
Auditee :

Case 33 :
Auditor :
Auditee :

Reviews the minutes of Management Review meeting no. 01 & 02 and


observes that the action items 4,6& 8 of meeting 01 were not reflected in
minutes no.02.
Since the items is completed, it was not reviewed.

QA
Observes that increasing trend in internal rejection, he asked do you have
any analysis and action plan ?
Shows the analysis details only.

Case 34 : QA
Auditor :
Auditee :

Observes that the vendor rating received from Chrysler in July98


indicates Needs Improvement . He asked that what are the actions you
had taken on receipt of this report?
We are analyzing the problem.

Case 35 : MARKETING
Auditor :

Observes that the customer satisfaction survey form is designed to get a


descriptive feedback from the customer.

Case 36 : FMEA
Auditor :

Case 37 :
Auditor :

During the review of APQP timing chart and the process FMEA auditor
observes that KEY DATE of FMEA is decided as 14.07.98 & production
date is 07.07.98.
ENGINEERING
Observes that the customer ABC has identified three spl. .characteristics
in their drawing. The supplier XYZ has identified the same
characteristics in the drawings, control plan etc. using suppliers
equivalent symbol.

Case 38 : PRODUCTION
Auditor :

Observes that the reaction plan for drill hole in control plan of drilling
operation is mentioned as Adjust & reset

Case 39 : PRODUCTION

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Auditor :

Observes that the reaction plan is written as Adjust & reset for the
parameter which is controlled through X bar & R Chart.

Case 40 : FMEA
Auditor :

Auditor observes that in Process FMEA, the OCCURRENCE ranking is


assigned for the failure mode dia U/S is 3. The existing rejection rate for
the same failure mode is 2%.
The SEV rating for the effect cannot fit is assigned as 9.
The recommended actions considered was Increase Inspection to
100% After the action is taken the ratings for SEV, OCC, DET were
changed.

Case 41 : MANUFACTURNG CAPABILITY


Auditor :
Auditee :
Case 42 :
Auditor :
Auditee :
Auditor :
Auditee :
Auditor :
Auditee :

Observes that the plant layout is modified as a part of improvement


activity. What are the activities you had carried after this change ?
We had verified the change as per the lay out.
MAINTENANCE
Recently you had shifted or refurbished any machine ?
Yes Sir, we had completely refurbished the M/c 1012 a week before.
In that M/C any Special Characteristics are created/ changed ? (Verifies
the control plan )\
Yes.
What are the activities had carried out after refurbishment ?
We had checked few samples to check the process is as per
specifications (showing the inspection report).

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Chapter 18 - Opinion and Feedback


1.

6.

Were all the requirements of standard understood ?


A. Completely Understood
B. Partially Understood
C. Still not clear.
Was the questionnaire conducted to understand requirements of standard (100
Questionnaires) is :
A. Adequate
B. More than needed
C. Not adequate
Was the Group Discussion helpful in understanding the requirements of the standard ?
A. Very Helpful
B. Helpful
C. Not so very helpful
Was the Clause 8.2.2 and its requirements understood ?
A. Very Clear
B. Just Clear
C. Not clear at all
Was the auditing process and how to conduct audit explained clearly ?
A. Very Clear
B. Just Clear
C. Not clear at all
Are you clear now how to write a non-conformance ?
Yes / No

7.

Was the explanation adequate ?


Adequate / Not Adequate
Is disposition and corrective action distinguished clearly ?

02.

3.

4.

5.

8.

9.
10.

Clear / Not clear.


Are the case studies helpful ?
A. Very helpful
B. Not very much helpful
C. Not at all helpful
Was the auditors training helpful ? Yes / No.
How do you rate the training programme overall ?
A. Excellent
B. Very Good
C. Good

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D. Bad
Suggestion : How do you like to put in your suggestions for improvement ?
Name :
Designation :
Department :
Organization :

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Signature :
Date :

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