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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).
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
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
Each supplier must conduct process audits, because it is also required by the
IATF 16949.
VDA 6.1
QS-9000 3rd
Edition
ISO 9001:
ISO ISO ISO
9000:1994 9000:2000 9001:2008 2015
ISO 9000 QUALITY MANAGEMENT SYSTEMS
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
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
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).
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.
33
P2 Project management
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?
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.
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.
37
2.7) Is there an escalation process established and is this effectively
implemented?
38
Additional risks likely to get discovered thru Turtle Diagram
39
P3 Planning the product and process development
40
3.1) Are the specific product and process requirements
available?
Contract review;
Customer requirements (Legal requirements);
Purchasing conditions & QM specific requirements;
Logistic planning.
41
3.3) Are the activities for the product and process development planned
in detail?
42
3.5) Have the necessary resources been taken into account for the product
and process development?
43
ADDITIONAL RISKS LIKELY TO GET DISCOVERED THRU TURTLE DIAGRAM
45
46
4.1*) Are the actions from the plans implemented for product and process
development?
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?
48
4.4*) Are the required approvals and releases for the product and process
development available?
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
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.
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?
58
5.3) Have target agreements for the delivery performance been agreed with
supplier & implemented?
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?
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
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?
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?
66
6.1.5*) Are the changes to the product or the process in the course of serial
production
tracked & documented?
67
Additional risks likely to get discovered thru Turtle
Diagram
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?
6.2.2*) Does a repeat release for the restart of production take place?
70
6.2.3) Are special characteristics managed in the production?
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?
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?
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?
81
Additional risks likely to get discovered thru Turtle Diagram
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?
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
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?
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?
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
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
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