VDA 6.

3 process audit
 VDA 6.3 process audit

Whats about?

Nearly all suppliers in the automotive supply chain are maintaining a quality system
according to different standards (e.g. ISO 9001 or IATF 16949).

This is generally required by the OEMs (original equipment manufacturer).

While the quality system is securing the capability of a supplier to produce a defined
level of product quality, the processes of an organization are the main base to
guarantee the performance of an organization and secure its successful future.

The VDA 6.3 process audit is a standardized procedure to conduct process audits
within a quality management system and assess their capability and performance.

The VDA 6.3 is unique procedure without any comparable approach worldwide.
 VDA 6.3 process audit

Qualification of VDA 6.3 process auditors.

To conduct high quality process auditors the auditors must be

qualified according to the following issues:

Acceptable work experience within the processes they would

like to conduct process audits

Attend successfully a VDA 6.3 training session.

Pass the VDA 6.3 process auditor exam

Monitor, review and update the knowledge of process

auditors, if they are conducting process audits.
 VDA 6.3 process audit

Benefit for the organization.

The process audits, internally or at the suppliers, are clearly identifying the
weaknesses, risk and strengths within the audited processes.

The process audit report will provide an excellence analysis of the audited process, so
that effective improvement activities could be created.

The potential risks identified by a process audit will help to avoid costs of warranties.

The process audit will support the identification of waste and losses of a process to
increase the efficiency of it.

VDA 6.3 process audit will fully fill the requirement to conduct process audits due to
customer specifics and IATF16949 in a most effective and efficient manner.
 VDA 6.3 process audit

Customer specific requirements BMW AG:

BMW AG do require the VDA standards as additional requirements according

to their customer specifics.

Each supplier must conduct process audits, because it is also required by the
IATF 16949.

BMW AG itself conduct process audits based on VDA 6.3.

 VDA 6.3 process audit

Customer specific requirements Volkswagen AG:

Volkswagen AG do require the VDA standards as

additional requirements according to their customer
specifics.
This is mentioned in the Formel Q capabillity (page 4):

Base of the process audit is the VDA 6.3 part B serial

production including an assessment of all processes
and procedures of the current production. (page 29)
The self assessment of a supplier has to be
conducted according to VDA 6.3 followed by a product
audit (page 23)
The self assessment must be carried out minimum
once a year (page 23)
 VDA 6.3 process audit

Customer specific requirements Daimler AG:

Daimler AG do require the VDA standards as

additional requirements according to their customer
specifics.

Each supplier must allow Daimler AG to conduct

process audits also at their sub-suppliers.

Daimler AG require a analysis of structure and risks

within their processes.
 AGENDA

Structure of Automotive Quality Standards and link to

VDA6.3
Overview of the content of VDA6.3
The assessment scoring methodology
Analysis of results
Auditing a new supplier
Questions
 DEVELOPMENT OF AUTOMOTIVE
QUALITY MANAGEMENTSTANDARDS
1999 2000 2002 2008 2009 2015 2016

VDA 6.1

ISO/TS 16949 ISO/TS16949 ISO/TS16949

2nd
3rd Ed
Ed.

QS-9000 3rd
Edition

ISO 9001:
ISO ISO ISO
9000:1994 9000:2000 9001:2008 2015
 ISO 9000 QUALITY MANAGEMENT SYSTEMS

ISO 9000 Basic Principles and definitions

Definition of terminology for QM systems

ISO 9001 Requirements ( for Certification)

Need, proof of ability

ISO 9004 Managing for the sustained success of an

organization
A quality management approach
DESCRIPTION OF THE STRUCTURE OF THE
9001 PDCA CYCLE
 Automotive Specific Requirements for Quality Management

VDA range of publications

Procedures, operations & Q techniques
VDA 1
Documentation and providing evidence International requirements ISO 9001
VDA 2
Securing the quality of supplies
VDA 3 (Parts 1 & 2)
Ensuring reliability with automobile Legal requirements
manufacturers and suppliers
VDA 4 ring binder & VDA 4.3
VDA publications &
Securing quality before the start of Automobile sector requirements
full production IATF 16949
VDA 5
Suitability of test & inspection planning
VDA 6 Customer-specific requirements
Fundamentals for quality audits
VDA 6.3
Process audit
VDA 6.4
QM system audit, production facilities
Manual
System overview
VDA 6.5
Product audit
VDA 6.7
Process audit single production
VDA 10
Customer satisfaction Who, what, when
VDA 13
Development of software-based
systems
VDA 19 How
Technical cleanliness
VDA RGA
Ensuring maturity for new parts
VDA RPP Results; evidence of
Robust production processes
Note: This list is not exhaustive ! effectiveness
(see VDA QMC Webshop)
 TYPES OF
AUDITS

System audit Process audit Product audit

To verify the overall To verify the effectiveness of the product To verify that product
effectiveness of the realisation processes conforms to defined
Management System specification
throughout the
manufacturing and
dispatch processes
M = Material
T = Tool
I = Inspect:
gauges
measure

ISO/TS16949 VDA6.3 VDA6.5

or VDA6.1
OVERVIEW OF THE STRUCTURE AND
CONTENT OF VDA6.3
APPLICATION OF PROCESS ELEMENTS
WITHIN A SPECIFIC PROJECT
SCOPE OF APPLICATION IN THE SUPPLY
CHAIN
PROCESS ORIENTED APPROACH FOR THE
IDENTIFICATION OF RISK
QUALIFICATION OF INTERNAL
AUDITORS
Audits the internal process chain without considering the interfaces
to suppliers and/or customers.

Good knowledge of quality tools and methods (e.g. VDA-MLA, DoE,

FMEA, FTA, PPA, SPC, SWOT, 8D Method)

Knowledge of the relevant customer specific requirements

Knowledge of the relevant management system requirements (e.g.

ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA
6.1)

Specific knowledge regarding the product and process

QUALIFICATION OF SUPPLIER
AUDITORS
Audits the complete supply chain,the auditor carries out internal and
external process audits with interface to suppliers and/or customers.

Excellent knowledge of quality tools and methods (e.g. VDA-MLA, DoE,

FMEA, FTA, PPA, SPC, SWOT, 8D Method)

Auditor qualifications (negotiation, conflict management, audit procedure)

Knowledge of the relevant customer specific requirements

Knowledge of the relevant management system requirements (e.g.

ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA 6.1)

Specific knowledge regarding the product and process

CODE OF CONDUCT FOR AUDITORS
Process auditors must use their professional skills and judgement, while respecting the
law and upholding the principles of honesty and integrity.

Process auditors must continually develop their expertise. They maintain their
knowledge and skills with respect to audit procedures, QM systems, products and
processes as well as specialised methods, procedures and relevant standards. They
must be knowledgeable about the quality requirements for products as well as the
specific process risks and the possible impact on the manufactured products.

Process auditors must at all times behave in a way that does not endanger the image
and reputation of their own organization.

Process auditors must not accept assignments that would cause them a conflict of
interests.

Process auditors must not accept assignments that they cannot carry out properly
because of lack of knowledge.

Process auditors are bound to secrecy regarding confidential information that they have
acquired through their professional activities.
VDA 6.3 APPROACH TO THE
AUDITING

Close-d
Assessment questions
questions
answered? Assessed by auditor alone
yes / no

Audit questions
Open question 4
Open question 1

Open question 3
Open question 2

Open questions asked

during the audit
 POTENTIAL ANALYSIS
Evaluation of potential new, unknown supplier ( Contender)

Evaluation of new locations or new technology or new products

Classification of the potential for product development and

production
 POTENTIAL ANALYSIS
Evaluation of a potential analysis

Each question is evaluated in terms of consistent compliance with the requirement

under review and the risk involved.

If a question is not answered (shown as n. a.), a reason for this must be stated. A
maximum of 3 questions may be marked n. a. It should be noted that the comparability
of results and the mutual acceptance of audit results from other parties may no longer
apply.

The assessment is marked, using the traffic light system of "red", "yellow" or "green"
(see below).

Assessment of individual questions

The requirement of the question is not met. R

The requirement of the question is partially met. Y

The requirement of the question is met. G

If a question is marked "red" or "yellow" the reasons and the relevant evidences must be
documented.
POTENTIAL ANALYSIS
POTENTIAL ANALYSIS
 SCORING
Assessing the individual questions:
Points Assessment of compliance with individual
requirements
10 Full compliance with requirements
8 Requirements mainly* fulfilled; minor deviations

6 Requirements partially fulfilled; significant

deviations
4 Requirements inadequately fulfilled; major
deviations
0 Requirements not fulfilled
Points Evaluation of the compliance of the individual requirements

Risk assessment from Risk assessment from the Systematic view;

the perspective of the perspective of the prod- abstract
process/process step; uct; specific
specific

10 Technical requirements No product defects, the Requirements are

and specifications for the product meets the technical completely met
process are fulfilled standards

8 Small deviations in the Some product defects but Requirements are

process which do not no influence on the function, mainly fulfilled;
affect compliance with use or further process steps minor deviations
the customer specifica-
tions or have an effect
on following process
steps

6 The process does not Product non-conformities do Requirements are

always meet the defined not affect the function; how- partially met;
requirements. This has ever the failure has a nega- significant deviations
an impact on the cus- tive impact on the use or on
tomer or following pro- further process steps
cess steps

4 The process does not Product non-conformities Requirements insuffi-

meet the defined re- have an impact on the func- ciently met;
quirements and has a tion, the failure leads to us- major deviations
significant impact on the age restrictions, significant
customer or following impact on the following pro-
process steps cess steps

0 The process is not ca- Product non-conformities, Requirements are

pable of ensuring com- no function, the use of the not met
pliance with the defined product is considerably re-
requirements duced, further process steps
are not possible
 OVERALL LEVEL OF
ACHIEVEMENT

Classification Overall level Description of

of the
achievement classification

A 90% Quality Capable

B 80- 89% Conditionally

quality capable

C < 80% Not quality capable

 RULES FOR
DOWNGRADING

Downgrade from A to B, despite an achievement level of EG 90%

Process elements P2- P7 or process stage E1 En achievement level < 80%

Sub-elements process analysis, production EU1 EU7 achievement level < 80%
At least one * question assessed as 4 points
At least one question assessed as 0 points

The rules for down-grading are used by the audit team.

The audit report must state the down-grading rule which has been used.
 RULES FOR
DOWNGRADING

Downgrade from A or B to C, despite an achievement level of EG 80%

Process element P2- P7 or process stage E1 En achievement level < 70%

Sub-elements process analysis production EU1 EU7achievement level < 70%
At least one * question assessed as 0 points

The rules for down-grading are used by the audit team.

The audit report must state the down-grading rule which has been used.
 IMPROVEMENT
PROGRAM

Generally
P7 Customer support / Customer satisfaction /
Service
7.1 x Are the customer's requirements satisfied regarding QM 6 Delivery performance target not being met. Contingency
system, product (on delivery) and process? plan
not effective in the event of machine breakdown.
7.2 Is customer support ensured? 10 no weakness identified
7.3 x Is the supply of parts ensured? 10 no weakness identified
7.4 If there are deviations from quality requirements, are failure 8 Out of the 4 complaints sampled, 3 have been effectively
analyses carried out and corrective actions closed. Complaint A45679, the root cause analysis had
implemented effectively? not been effectively completed
7.5 Is there a process which ensures that analysis of defective 10 no weakness identified
parts is carried out?
7.6 Are personnel qualified for the various tasks and are 10 no weakness identified
responsibilities defined?

to be
complete
to be completed by auditor d by
organizat
i on

Points
Ques Weaknesses / Actions and root cause analysis Respon
Pos.

Timing Effectivenes
. recommended -
No. activities, finding sibility
Customer support / Customer
P7
satisfaction / Service
Delivery performance target not being 6
met. Contingency plan not effective in
7.1 the event of machine breakdown.
7.2 no weakness identified 10
7.3 no weakness identified 10
Out of the 4 complaints sampled, 3 8
have been effectively closed. Complaint
A45679, the root cause analysis had
7.4 not been effectively completed
7.5 no weakness identified 10
7.6 no weakness identified 10
32
While auditing the development of product and processes, we will
first look at the guidelines of Red Book. We will give due
importance to star questions. Thereafter, we will use Turtle
Diagram to identify process specific risks.
After covering the specific requirements of the Red Book, we will
look at some of the commonly discovered risks which are
revealed by the Turtle diagrams & which need to be added to
the auditors basket of open ended questions and assessed
additionally, by the auditing team.

(This series of presentations will give you an idea of what is

involved in these audits. However the expertise can come, only
after undergoing an authorized training, followed by sufficient
practise.)

33
P2 Project management

7 questions incl. 1 new (2.5)

2 STAR Questions different allocation
All questions=> Potential analysis
Revised content
Questions about change management are combined in one
question
new: question about procurement activities in project
management
QM-Plan changed to Advanced product quality
planning

34
2.1) Is a project management established with a project
organisation?
o Project Org Chart;
o Involvement of Suppliers in Project Management;
o Evidence of Specialists and Technologies;
o Verification of their qualifications.

2.2) Are all resources required for the project development planned and
available and are changes shown?

Takes into account customers requirements;

Includes identification;
Availability & capacity (workload wise) of in-house expertise;
Changes in the project plan & organisation (interface with customer) are
reported;
Use of PERT & CPM; concurrent engineering practices.

35
2.3) Is there a project plan and has this been coordinated with the
customer?
Product realization and Timing control plan;
Review of milestones;
Country specific certification requirements;
Detailed activities concerning procurement.

2.4) Is the Advanced product quality planning implemented within the

project and monitored for compliance?

Verification and validation of the product and process Requirements;

Customer requirements in regard to quality plans & their adequacy.

36
2.5*) Are the procurement activities of the project implemented and
monitored for compliance?
Ensure that only approved and quality-capable suppliers are used;
Supplier selection and award criterial;
Award amount and delivery target date;
The suppliers for facilities, machinery, tools, test and measurement
systems and services (such as development, laboratories and
maintenance etc.) are integrated.

2.6*) Is change management within the project ensured by the project

organization?
Evaluation must include the risk assessment for the product quality as
well as the
deadlines;
Changes must be discussed with & agreed upon by customer;
Controlled procedure for change management.

37
2.7) Is there an escalation process established and is this effectively
implemented?

Project risks are identified, assessed and reduced through appropriate

measures;
Special risks of technologies, suppliers & supply countries are taken
into account during escalation management;
Identification of contact persons & decision makers in the escalation
process.

38
Additional risks likely to get discovered thru Turtle Diagram

Project Planning activities are done without real involvement of

suppliers.
Actual time available for specialists to support the project, could be
inadequate.
Activities which are supposed to have been done by CFT, are in reality
done by a single person, though names of all team members are
mentioned.
Country specific regulations of Safety and Environment are not fully
considered during planning. Waste management plans are inadequate.
PERT and CPM analysis is not done / adhered to.
Concurrent engineering teams are not used.
Risk assessment & qualification of all components under
development is not done as expected by VDA.
Evidence of escalation process in case of major delays.

39
P3 Planning the product and process development

5 questions incl. 1 new (3.4)

One STAR -Question
2 questions for potential analysis
new: Activities to ensure customer care
Questions about procurement scope moved to P2
Embedded Soft Ware considered (in questions 3.1,
3.2, 3.3)

40
 3.1) Are the specific product and process requirements
available?
Contract review;
Customer requirements (Legal requirements);
Purchasing conditions & QM specific requirements;
Logistic planning.

3.2*) Can the manufacturing feasibility be evaluated according to the product

and process requirements?

o Manufacturing feasibility of technology, function, quality, logistics, software,

etc;
o Also for Buildings, premises, CAM, CAQ, Product / process innovation;
o Inter-divisional manufacturing feasibility analysis (for example, sales,
development,
purchasing, production planning, production, QM planning, logistics);
o Requirements from P7 also need be considered.

41
3.3) Are the activities for the product and process development planned
in detail?

Milestone planning aligned with customers;

Evidence of QFD, DoE;
Product / process FMEA etc;
Planning for reliability testing and functional
testing.

3.4) Are the activities for customer support / customer satisfaction /

customer service planned?
The customer requirements are taken into account for failure analysis;
NTF Processes;
Inspection Planning for standard and stress testing;
Safeguard for emergencies.

42
3.5) Have the necessary resources been taken into account for the product
and process development?

Controlled procedure for planning resources should include Qualified

personnel, budgets,
infrastructure, test equipment, lab facilities, machines, plant etc;
And outside processes/ services;
Demand analysis and Bottleneck identification;
Use of problem solving techniques.

43
ADDITIONAL RISKS LIKELY TO GET DISCOVERED THRU TURTLE DIAGRAM

Project Planning activities are done without real involvement of

suppliers..
Actual time available for specialists to support the project, could be
inadequate.
Activities which are supposed to have been done by CFT, are in reality
done by a single person, though names of all team members are
mentioned.
Country specific regulations of Safety and Environment are not fully
considered during planning. Waste management plans are inadequate.
PERT and CPM analysis is not done / adhered
to. Concurrent engineering teams are not
used.
Risk assessment & qualification of all
components under development is not done
as expected by VDA.
1
3
P4 Implementation of the product and process development

8 questions including 2 new (4.5, 4.7)

3 STAR -Questions
3 questions for the potential analysis different allocation Product and
process in one question
Embedded software (4.1, 4.4, 4.5, 4.8) Infrastructure themes in 4.3
to material resources Control plans = production and testing
requirements Purchased products in 4.1
Project transfer to the series = 4.8
4.1, 4.2 and 4.8 (2010) combined in one question (4.1.)

45
46
4.1*) Are the actions from the plans implemented for product and process
development?

When carrying out the product FMEA the proposed manufacturing

site for the production shall be included;
QFD, DoE, FMEA, Poka Yokes, SPC, Statistical trial planning; Environmental
simulation,simulation testing (e.g. salt spray test);
Planning of project sequence including trials. The out-sourced products and
services are services are taken into account;
Fitment trials & system testing;
Risk analysis to ensure customer requirements in the development phase

4.2) Are human resources available and are they qualified to ensure the
start of the series?
o Personnel resources qualified for the relevant tasks, are planned ; Training
need identification, proof of training, training effectiveness; (This also
applies to the staff of external service providers.)
o Analysis is carried out of bottlenecks and additional demands;
o Knowledge of foreign languages.
4.3) Are the material resources available and suitable to ensure the
start of the series?

Availability of test equipment, laboratory equipment, machinery;

equipment, and the utilization of machinery and equipment;
Outsourced processes are considered;
Process Development;
- Facility planning, layout, Machinery and equipment planning
- Quantities and throughput times, Transport routes, containers, storage
- Supporting processes for example from logistics and IT

48
4.4*) Are the required approvals and releases for the product and process
development available?

PPAP report with signed PSW & PPAP lot sample;

The actions from the FMEA have been confirmed in their effectiveness;
Product Development
- Specifications, drawings, requirement specifications, FMEA IMDS,
- Product testing, installation inspection, function / endurance testing,
environmental simulation
- Confirmation with legal requirements
- Development releases from customers.
- Logistics concept (e.g. suitability of packaging through sample shipping)
- Proof of capability of special characteristics
- Capacity studies
- Tool approvals
49
4.5) Are the manufacturing and inspection specifications derived from the
product and process development and are they implemented?
The manufacturing and inspection characteristics contain all characteristics
from the
product and process development (including special characteristics);
These must take into account all the components, assemblies,
subassemblies, parts, software and materials including manufacturing
processes that are part of the product;
Product audits, layout inspection and a functional verification plans;
Process development;
- Risk analysis (FMEA, FTA etc.)
- Production control plan (pre-series, series)
- Product inspection / audit plan & Response / reaction plan
- Layout inspection / functional verification plan
- Series release (first and last piece) & Testing within the series

50
4.6) Is a production trial run carried out under series conditions for
the series release?
Quality capability of the entire production process is given under serial
production conditions (tools, equipment, cycle time, personnel
manufacturing and inspection specifications, I,M & TE);
Identification of bottlenecks & quality issues thru this run;
- Equipment and infrastructure are ready for start of series (measurement
reports)
- Work/inspection instructions
- Production tests according to customer schedule
- Packaging requirements

51
4.7) Are the processes established for securing customer care / customer
satisfaction / customer service as well as the field failure analysis?
Customer requirements for the supply of parts during the product
lifecycle are established. The planned processes for the continuous series
supply including safety margins for emergencies are available;
The analysis process for 0-km and field complaints is established taking
customer
requirements for field failure analysis into account;
If external sites are used for analysis, the interfaces are defined and
evidence of the presence of the required equipment and capacity is
available;
Initiation criteria must be agreed with the customer for the NTF.

52
4.8*) Is there a controlled method for the product handover from
development to serial production?

A process exists for transferring work results from the project to the
production;
The material resources include buildings, test facilities, laboratory facilities,
equipment, facilities, etc. These are available and have been released;
- Customer requirements
- Handover protocols/ checklists with handover criteria
- Acceptance reports
- Production metrics such as OEE, rejects
- Experience from the ongoing project
- Measurement capability

53
Additional risks likely to get discovered thru Turtle Diagram

1. Process specific measures from Product FMEA

2. Establishing & marking of special characteristics
3. How is the inspection / test plan generated.
4. Is acceptance criteria very clear
5. Checking suitability of packaging by trial despatch
6. Establishing production rate as per takt time.
7. Process parameters like Pressure, temp, time, etc.
8. Information on current non-conformities if relevant
9. Analysis of OEE.
10. Testing plans for software.
11. Are pending actions from Hand over sign-off completed in
timely manner.

54
55
While auditing the Serial Production, we will first look at the
guidelines of Red Book. We will give due importance to star
questions. Thereafter, we will use Turtle Diagram to identify
process specific risks.
After covering the specific requirements of the Red Book, we will
look at some of the commonly discovered risks which are
revealed by the Turtle diagrams & which need to be added to
the auditors basket of open ended questions and assessed
additionally, by the auditing team.

(This series of presentations will give you an idea of what is

involved in these audits. However, the expertise can come, only
after undergoing an authorized training, followed by sufficient
practise.)

56
P5 Supplier management

7 questions
2 Star Questions
5 questions for potential analysis
Minor changes only in the content of the
requirements

57
5.1) Are only approved/released and quality capable suppliers
selected?
An evaluation as per documented procedure of the qualification
capability of the supplier must be available.
Audits done by CFT and also by other OEMs.
Upgrading programs for non performing suppliers; Also applies to suppliers
of research and development , prototype, software, equipment, machinery,
tools, Service providers (eg. Sorting companies),
External testing labs, Suppliers in outsourced processes

5.2) Are the customers requirements taken into consideration in supply chain?

o The communication of customer requirements must be regulated and

traceable.
o Change management must be audited;
o QAA (quality assurance agreements)
o Legal, regulatory requirements

58
5.3) Have target agreements for the delivery performance been agreed with
supplier & implemented?

Measurable targets for quality, delivery quantity (batches), punctuality, must

be checked
and evaluated within a defined period.
QM agreements includes escalation mechanisms.

5.4*) Are the necessary releases / approvals available for out sourced products
and services?

Approvals, releases, PSW & PPAP for build samples & trials.
Evidence of change management from Customer to sub-supplier.
Compliance with EU safety data sheets, MSDS, IMDS & REACH.

59
5.5*) Is the quality of the outsourced products & services ensured?

Deviations from the supplier quality;

Evaluation of main failures, ppm evaluations,
8D reports,
testing in accordance with ISO/IEC 17025) for raw materials (material
certificates) and finished parts.

5.6) Are incoming goods stored appropriately?

FIFO, Identification & batch traceability, no wrong identification,

Labelling (traceability / test status / work sequence / use status);
the transport and storage conditions must be defined and verified;
Secure storage for suspect & quarantined products.

60
5.7) Are personnel qualified for the various tasks & responsibilities
defined?
Qualification requirements rather than training requirements must be
determined for each employee;
Knowledge must be available Of previous complaints regarding out sourced
material,
Product / specifications / special customer requirements,
Foreign language.

61
Additional risks likely to get discovered thru Turtle
Diagram
Evidence of supplier discussions & regular support.
Supplier audit must actually be done by a CFT & not by a single
person.
Inspection and measuring records of improved components.
Workshops, reducing defects & inventory.
Information flow in case of non-conformity
or loss.
Emergency strategy in case of supply
bottlenecks Kanban, Pull system, JIT, FIFO &
traceability
Safety against mix ups.
Audits, statistics, 8-D methods & Customer satisfaction.

62
P6 Process analysis production

Total of 26 questions in 6 groups 6.1, 6.2, 6.3, 6.4, 6.5 &

6.6
8 Star Questions
15 questions for potential analysis
Transport and handling of parts is separately evaluated
No structural changes in the elements only adjustments to
content

63
P6.1 Process analysis => Input to the process
5 questions
1 Star Question different allocation
1 questions for potential analysis
Content revised
Allocation for evaluation of transport and handling of parts
unchanged
Embedded software (6.1.5)

64
6.1.1) Has the project been transferred from development to serial production
and is a reliable start guaranteed?

A complete production process / product release must take place

All un-resolved issues must get closed before the first production shipment;
PSW is signed
Process transfer sign off is available.

6.1.2) Are the necessary quantities / production batch sizes of incoming materials
available at the agreed upon time and at the correct storage / work-station?

o The correct incoming product, quantity, packing, with the correct

documentation, at the agreed time and at the agreed place.
o Evidence of PULL system with FIFO, return of the residual quantity after the
batch gets
over,
o Change status indication &
o Special requirements (ESD protection etc.) of packaging for the product.
65
6.1.3) Are incoming materials stored appropriately and are the means of
transport means / packing facilities suitable for the special characteristics of the
incoming materials?
How is the suitability of Store areas /work-stations / containers ensured?
Are suitable transportation units used to protect the products from
damage and contamination?
Storage times & Use-by dates.

6.1.4) Are the necessary identifications / records / approvals available

and allocated appropriately to the incoming materials?

Customer specific regulations for the identification & traceability,

Documentation of special releases,
Test results of characteristics with special requirements regarding
documentation

66
6.1.5*) Are the changes to the product or the process in the course of serial
production
tracked & documented?

Management of ECR & ECNs,

Ensuring at all times the correct design level is used also for
software,
Up-dates of the FMEA (Product and Process)

67
Additional risks likely to get discovered thru Turtle
Diagram

Sufficient & suitable transport means.

Minimal / no intermediate storage, management of holding stores
& quarantine
Only transfer of satisfactory parts.
Labels, tags & latest revision number.
Likelihood of environmental influences.

68
P6.2 Process analysis=> Management of Process

5 questions
2 Star Questions different allocation
4 questions for potential analysis different allocation
Allocation for evaluation of transport and handling of parts not
changed
Content revised
Question 6.2.3 (2010) suitability of manufacturing facilities
moved to 6.4.1
Embedded software (6.2.5)

69
6.2.1) Are the requirements of the control plan complete and have they been
effectively implemented?

Process parameters & Tolerances influencing product characteristics and/or

quality must
be fully stated in control plans;
The production and test/inspection documents are complete and available
and based on the production control plan;
Required action plan for process disturbances are known, initiated and
documented.

6.2.2*) Does a repeat release for the restart of production take place?

o Defined criteria for triggering a production repeat release;

o Deviations and measures taken are documented;
o Tooling layout / master parts / setting pieces / red rabbit.

70
6.2.3) Are special characteristics managed in the production?

SPC / pre control charts for critical & significant characteristics,

Cpk, Cmk, machine capability checks
Records of deviations with action taken;
Proof of inspection process with Inspection results.

6.2.4*) Are non-approved and / or defective parts managed?

Scrap and parts for reworking are separated and safely removed;
Labelling of scrap, rework & setting parts and also for the quarantine
area;
Reworking criteria / testing are defined, known and approved by
customer.
Setting pieces & masters are labelled and protected against accidental
use.

71
6.2.5) Is the flow of materials and parts secured against mixing /
wrong items?
Material and parts flow;
Risk Analysis,
Poka Yoke against mix ups.
The reuse of residues, separated parts, reworked parts, reusable parts
from audits, inspected items, outsourced processed (e.g. sorting
service) etc. must be clearly defined (including regulations for
traceability).

72
Additional risks likely to get discovered thru Turtle
Diagram
Inspection frequency, Red Rabbit validation frequency,
Confirmation of process parameters like Pressures, timing,
temperature and CNC programs
Tool layout, sister tool compatibility and tools pre-setters Tool
inserts their grades & geometry.
Changed production parameters.

73
P6.3 Process analysis => Personnel resources

3 questions
1 Star Question
2 questions for potential
analysis
Content revised and
reorganised

74
 6.3.1*) Are the employees able to fulfil their given tasks?
Authorities, responsibilities, job description
Qualification matrix for all.
Induction training & knowledge of problems and their effects,
Evidence of qualifications & capabilities like forklift driving license, welding
certificate, soldering certificate, vision test, hearing test;
Applies to internal and external temporary employees.
6.3.2) Do the employees know their responsibilities and authority in the
monitoring of the product and process quality?
o Responsibilities, duties and authority of the employees like
process release, employee self-inspections, stopping the
process;
o Tasks / function of the product and what happens when it
malfunctions.
o Employees receive regular information on the current quality, both
internally and
with the customer.
o Applies to internal and external / temporary employees
6.3.3) Are the necessary personnel resources available?

Shift plans with balance of qualification matrix.

A scheme exists for supporting areas that are not continually in use like
laboratory,
standards room etc.
Fluctuations in on call staff and through absences (e.g. illness, holidays,
training) are taken into account in the schedule.

76
Additional risks likely to get discovered thru Turtle
Diagram
1. Co operation & contribution to improvement
programs,
2. Interpretation of control charts & control plans.
3. Ability & authority to stop production.
4. Tidiness, cleanliness & 5 S.
5. Participation in JH pillar of TPM.
6. Instructions for handling products having special
requirements.
7. Quality circles & their effectiveness.
8. Self assessments.

77
P6.4 Process analysis => material resources

5 questions
2 *-Questions
4 questions for potential analysis different allocation
Content revised
No questions to transport and handling of parts
New question: Suitability of manufacturing facilities previously in
6.2 (2010)

78
 6.4.1*) Can the product-specific requirements from the customer be met with
the manufacturing equipment?

Do the products meet the customer specifications;

Evidence of machine / process capability for spl. characteristics / process
determining
Parameters (e.g. pressure, time, temp.);
Layout and condition of the equipment, tools, fixtures and handling
facilities meet the requirements under real production conditions;
Capability of replacement tools / reproducibility of fixtures, specifications.
6.4.2) Is the maintenance of the mfg. equipment & tools controlled?

o Scheduled / unplanned maintenance activities have been carried out &

analysed for improvements;
o Process for analysing & optimization of utilization of machine tools etc;
o Key processes and critical equipment are identified and preventive as well as
proactive
maintenance activities are carried out;
o Tool life and conditions are monitored; 79
6.4.3*) Can the quality requirements be effectively monitored with the
measurement and testing facilities in use?

The test, inspection and measurement facilities used are suitable & as per
control plan;
The test, inspection and measurement facilities used are suitable;
Proof of the capability of inspection equipment and Processes;
Identification & calibration system of the equipment;
Comparison of in-house results with those at customers.

6.4.4) Are the work and inspection stations appropriate for the needs?

Ergonomic suitability of work stations;

Lighting, Cleanliness and tidiness, Climate control, Noise pollution;
Clean rooms;
The work-place layout is adapted ergonomically to the process;
Also applies to permanent and temporary established rework, sorting and
inspection stations
6.4.5) Are tools, equipment and testing equipment stored
properly?
Tools, equipment and testing equipment (including gauges, tools,
equipment and test equipment not in use or not yet released) must be
stored and managed properly.
Change history,
Defined storage location;
Status identification.
Identification showing customer's property, products /tools / devices
provided on
loan.

81
Additional risks likely to get discovered thru Turtle Diagram

Monitoring of MTBF / MTTR and steps taken for their

improvement.
Maintenance of conveyors, chutes, trolleys & trucks.
Health & safety at work.
Standstill of the process / equipment, its analysis, corrective and
preventive action.
Managing 5 S & Visual workplace.
Revision to PM plan after major breakdown.

82
P6.5 Process analysis => Effectiveness, efficiency, waste
avoidance

4 question
1 Star Question
2 questions for potential
analysis
Content revised

83
6.5.1) Are there targets set for the manufacturing process?

Target requirements are defined, agreed, achievable based upon Customer

requirements and up-to date.
Targets include Number of parts produced per unit of time; Rework, scrap,
production runs
with no reworking, first time through quality, first pass yield;
Quality metrics include failure rates, audit results;
Process metrics (process capability);
Reduction of waste of energy and process materials).
Audit of A, P & Q factors of OEE.

84
6.5.2) Is quality and process data collected and
analysed?
o Defect frequency cards; Control charts; Special characteristics;
o Process parameters (temp, time, pressure);
o Factory data collection, Special incidents are documented in shift /
equipment book.
o Fault signals like plant standstill, power failure, programme error
message;
o Parameter changes are analysed for improvement.
o SPC, Pareto analyses, Cause & effect diagrams, Risk analysis (FMEA, FTA).
o Wherever applicable, FMEA is revisited & cascading document changes
take place.

85
 6.5.3*) In the case of deviations from product & process requirements, are
the causes analysed and corrective actions checked for effectiveness.

Corrective & preventive actions for failures are immediate, effective and
known to all
concerned;
Knowledge & successful use of Cause & effects diagram- Taguchi,
Shainin - 5 W method;
Nonconformities that affect the properties of the delivered
product are communicated to the customer.
6.5.4) Are processes & products audited regularly?

The process and product audits carried out effectively at regular frequency;
Root causes are analysed for deviations discovered;
Process audits cover parameters and capabilities;
Product audit to cover specified characteristics, Labelling, packaging;
Capacity of the test equipment, Software version.
86
 Additional risks likely to get discovered thru Turtle
Diagram

Data acquisition & use of I O T. Recorders & their

status / adequacy,
Analysis Corrective / preventive action for Plant Standstill / Power off.
Cost of poor quality
Cost optimization and control of 7 wastes.
Re-occurrence of same NCs in subsequent audits. Auditor
qualifications.

87
P6.6 Process analysis => Result/Output

4 questions
1 Star Question
2 questions for potential analysis
3 questions to transport and handling of parts (separate
evaluation)
Content revised

88
6.6.1) Do the quantities/production batch sizes match needs and are they
systematically directed to the next process step?

Audit of D type characteristics

Dock audits for customer requirements; audit Millipore ratings,
Tests, checks and inspection procedures are agreed with customer and
documented,
Audit of Endurance tests and of Production tests under peak production
conditions.
Communication in the event if shipment is blocked / hold.

89
6.6.2) Are products/components stored in an appropriate manner and are
transport facilities/packing arrangements suitable for the special
characteristics of the products/components?

o Internal packing instructions are known and implemented (not only

customer-specific),
o Parts must be protected against environmental and climatic influences
during storage and transport.
o Audit of ESD protection to electronic parts.
o Monitoring of storage periods / quantities stored;
o Customer specific packaging instructions (inc. packing supplied by the
customer); Information on available stock levels;
o Substitute packaging, Requirements for cleaning packaging.

90
6.6.3) Are the necessary records / releases
retained?
Customer requirements for the labelling of the release status on containers
/ batches / carriers / components and also on reworked parts must be
implemented and documented;
Customer specifications, Customer's identification requirements;
Customers requirements for archiving time limits, Archiving requirements/
regulations (EDP, paper, fire protection, legibility, Last piece inspection;
Identification of special releases.

91
6.6.4*) Are the customer requirements met at the delivery of the final
product?
If deviations occur, corrective actions are defined and
implemented;
Quality agreements with the customer;
Customer specific requirements;
Customer requirements for the identification of special
characteristics;
The planning of the shipping audit;
Storage / recall processing / parts supply / shipping, Target
agreements,

92
Additional risks likely to get discovered thru Turtle
Diagram
1. Evidence of Communication process in the event if shipment of product is
blocked /
hold
.
Defined storage / holding locations availability.
2.
Packing WI
3.
Customer requirements for identifying reworked
4. parts.
5. Special releases/ deviation approvals, product
traceability

93
P7 Customer care, customer satisfaction,
service
5 questions
2 *-Questions new allocation
4 questions for potential analysis
Failure analysis as a general requirement is integrated into complaints
management (specific question removed)
Question 7.1 has been redefined

94
 7.1) Are all requirements related to QM System, Product and
Process fulfilled?
Quality agreements with the Customer is fulfilled.
Layout inspection and a functional verification concept e.g. carried out
product audits,
function tests, endurance tests
Supply guarantee after serial production
Inclusion of sub-supplier for the supply of spare parts & Supply guarantee
after serial Production
Certification of the QM system

7.2) Is customer service guaranteed?

o Competent contact personnel ensure communication in accordance with
the customer specifications
o Knowledge of the product application and of problems with the product and
complaints regarding the product or Transport
o Access to customer portals in accordance with the customer specific
agreement is ensured.
o World-wide customer service
7.3*) Is the supply of parts guaranteed?
Concepts to ensure supplies including in emergency are available
Contingency plans including for alternative production, suppliers, transport
in line with VDAs standard for Robust Production processes, are available.
Capacity and reaction time for sorting actions & Use of external capacity
Procedures must be in place which guarantees that the organisation informs
the customer immediately when supply shortages are detected.
Regulations covering authority to make decisions & escalation paths.
7.4*) If there are deviations from quality requirements, are failure analyses
carried out and
corrective actions implemented effectively?
Processing complaints & 8D process also for 0 km and field complaints.
Procedures for failure analysis are defined.
Internal / external analysis facilities (laboratories, comprehensive testing
facilities,
personnel) & Use of problem solving methods
Testing concept for defective parts in the field (standard test/ stress test/
NTF test) And NTF guidelines
96
7.5) Are personnel qualified for the various tasks and are
responsibilities defined?

Responsibilities, duties and authorisations each employee in Org Chart

The employees know the product and the consequences of faulty
workmanship for the
supply of parts and the quality of the final product.
Failure analysis
- Evaluation methods (e.g. audits, statistics)
- Quality techniques (e.g. Pareto, 8D Method, cause and effect diagram,
Ishikawa)
- Foreign language skills

97
Additional risks likely to get discovered thru Turtle
Diagram
1. Quality agreements
2. Agreed inspection & testing procedures.
3. Record of customer visits & deriving measures,
4. Implementation of new requirements
5. Possibilities for plant modification
6. Use of 8 D & verification of effectiveness
7. Customer packing requirements (CSR, Packing Wi),
8. Spare part production plan for after the end of serial
production.
9. NTF (No trouble found) guidelines- Procedure
10. Regulations covering replacements -after sales who deal with
customer)

98
THANK YOU FOR
ATTENDING