Process Audit Requirements

No. TS Question (VDA 6.3)

P2 Project management
2.1 7.1 Is the project organisation (project
management) established and are
tasks & authorities specified for the
team leader and team members?

2.2 7.1 Are the resources required for the

7.1.1 project development planned and
available and are all changes
displayed?

2.3 7.1 Is there a project plan and has this

7.1.1 been agreed with the customer?
7.2.1
7.2.1.1
7.2.2
7.2.2.1
7.2.2.2
7.2.3

2.4 7.1.4 Is change management in the

project ensured by the project
organisation?

2.5 7.1.4 Are the responsible personnel

within the organisation and in the
customer's company involved in the
change control system?

2.6 7.1 Is there a QM plan for the project?

7.1.1 Is this implemented and monitored
regularly for compliance?

2.7 Is there an established escalation

process and is this implemented
effectively?

P3 Planning of the product- and process development

 Process Audit Requirements

No. TS Question (VDA 6.3)

3.1 4.2.3.1 Are the product and process-
7.2.1 specific requirements laid down?
7.2.3

3.2 7.2.2 Has manufacturing feasibility been

7.2.2.2 assessed in a cross-functional
7.2.3 manner, based on the requirements
which have been determined for
product & process?

3.3 7.1 Are there plans for the product and

7.1.1 process development?

3.4 6.2.2 Have the necessary resources been

6.3 taken into account for the product
and process development?

3.5 7.4.3.2 Is QM planning arranged for

sourcing bought-in products and
services?

P4 Carrying out the product- and process development

4.1 7.3.1.1 Have the Product FMEA / Process
7.3.2.3 FMEA been drawn up? Are they up-
7.3.3.1 dated as the project progresses and
7.3.3.2 are corrective actions laid down?
7.3.4
 Process Audit Requirements

No. TS Question (VDA 6.3)

4.2 7.3.1 Are the stipulations arising from the
7.3.6.2 plans for product and process
development put into effect?

4.3 6.2.2 Are the personnel resources in

place and qualified?

4.4 6.3 Is the infrastructure in place and

appropriate?

4.5 7.3.2.1 Based on the requirements, are the

7.3.3 necessary evidence and releases
7.3.3.2 available for the various phases?
7.3.5

4.6 7.5.1.1 Are the productions control plans

used for the various phases and are
production, test and inspection
documents derived from them?

4.7 7.3.6.3 Has a pre-production run been

carried out under serial production
conditions to obtain production
approval / release?

4.8 Are the planning activities

associated with sourcing outside
products and services implemented
effectively?
 Process Audit Requirements

No. TS Question (VDA 6.3)

4.9 Is the transfer of the project to
production controlled in order to
secure the product launch?

P5 Supplier management
5.1 7.4.1 Are only approved/released and
7.4.1.2 quality-capable suppliers selected?

5.2 7.5.1.6 Are the customer's requirements

taken into account in the supply
chain?

5.3 7.4.3 Have target agreements for delivery

7.4.3.2 performance been agreed with
suppliers and put into operation?
5.4 7.3.5 Are the necessary
7.3.6 approvals/releases available for the
out-sourced products and services?

5.5 7.4.3 Is the quality of the out-sourced

7.4.3.1 products and services ensured?

5.6 6.2.1 Are incoming goods stored

6.2.2 appropriately?
7.5.5.1

5.7 6.2.2.2 Are personnel qualified for the

various tasks and are
responsibilities defined?

P6 Process analysis / Production

6.1 What goes into the process ? (process input)
6.1.1 7.3.6.3 Has the project been transferred
from development to serial
production?
 Process Audit Requirements

No. TS Question (VDA 6.3)

6.1.2 7.4.2 Are the necessary quantities /
production batch sizes of incoming
materials available at the right time
and at the right place (stores; work-
station)?

6.1.3 6.2.1 Are incoming materials stored

6.2.2 appropriately and are transport
7.5.5.1 facilities / packing arrangements
suitable for the special
characteristics of the incoming
materials?

6.1.4 7.4.3.1 Are the necessary identifications /

7.5.3 records / approvals available and
allocated appropriately to the
incoming materials?

6.1.5 7.3.7 Are changes to the product or

process in the course of serial
production tracked and
documented?

6.2 Work content / Process sequence (Are all production processes controlled)
6.2.1 7.3.3.1 Are all the relevant details listed in
7.3.6.3 the production and test/inspection
7.5.1.2 documents, based on the
7.5.3.2 production control plan?

6.2.2 7.5.1.3 Are production operations checked /

approved and are setting data
logged?
 Process Audit Requirements

No. TS Question (VDA 6.3)

6.2.3 7.5.2 Can the customer's specific product

7.5.2.1 requirements be satisfied with the
production facilities used?

6.2.4 7.3.2.3 Are significant characteristics

7.5.1.1 controlled in production?

6.2.5 8.3 Are scrap, rework and setting parts

8.3.2 kept separate and identified?
8.3.3

6.2.6 7.5.3 Is the flow of materials and parts

7.5.3.1 secured against mixing / wrong
8.3 items?

6.3 Process support/ Personnel resources

6.3.1 5.5.1.1 Are operators given responsibility
and authority to monitor the quality
of product and process?
 Process Audit Requirements

No. TS Question (VDA 6.3)

6.3.2 6.2.2.2 Are the operators able to carry out
6.2.2.3 their allotted tasks and are their
qualifications kept up-to-date?

6.3.3 6.2.2.2 Is there a personnel employment

plan?

6.4 Material resources

6.4.1 7.5.1.4 How are the maintenance and
overhaul of production facilities /
tools controlled?

6.4.2 7.6.1 Can the quality requirements be

8.2.2.3 monitored effectively with the test,
8.2.3.1 inspection and measurement
facilities employed?

6.4.3 6.4 Are the work-stations and

6.4.2 test/inspection areas suitable for
requirements?

6.4.4 7.5.1.5 Are tools, equipment and

7.6 test/inspection facilities stored
correctly?

6.5 Process effectiveness (integrate effectiveness, efficiency, elimination of waste)

 Process Audit Requirements

No. TS Question (VDA 6.3)

6.5.1 8.2.3.1 Are target requirements set for
8.2.4 product and process?

6.5.2 8.2.3.1 Are quality and process data logged

8.2.4 in such a way that they can be
assessed?

6.5.3 8.3 In the case of deviations from

8.5.1.2 product and process requirements,
8.5.2 are the causes analysed and the
8.5.2.1 corrective actions checked for
effectiveness?

6.5.4 8.2.2 Are processes and products audited

8.2.2.2 regularly?
8.2.2.3
8.2.2.4
8.2.2.5

6.6 What should the process produce ? (process result / output)

6.6.1 8.2.2.3 Are the customer's requirements
8.2.4 met in terms of product and
8.2.4.1 process?
 Process Audit Requirements

No. TS Question (VDA 6.3)

6.6.2 7.5.1.6 Are quantities / production batch
sizes aligned with requirements and
are they forwarded to the next
process stage in a targeted
manner?

6.6.3 7.5.5.1 Are products / components stored in

an appropriate manner and are
transport facilities / packing
arrangements suitable for the
special characteristics of the
products / components?

6.6.4 4.2.4 Are the necessary records /

releases carried out and stored
appropriately?

P7 Customer support / Customer satisfaction / Service

7.1 8.2.2.3 Are the customer's requirements
8.2.4 satisfied regarding QM system,
8.2.4.1 product (on delivery) and process?

7.2 7.1.4 Is customer support ensured?

7.2.3
7.5.1.7
8.2.1
8.2.1.1
8.5.2.4

7.3 6.3.2 Is the supply of parts ensured?

7.4 8.2.3.1 If there are deviations from quality

8.3 requirements, are failure analyses
8.5.2 carried out and corrective actions
8.5.2.1 implemented effectively?

7.5 8.5.2.4 Is there a process which ensures

that analysis of defective parts is
carried out?
 Process Audit Requirements

No. TS Question (VDA 6.3)

7.6 6.2.1 Are personnel qualified for the

6.2.2 various tasks and are
6.2.2.2 responsibilities defined?

TS: ISO/TS 16949

 Process Audit Requirements

Requirements

• The project management is in a position to meet the customer's requirements.

• A process for establishing the project management exists.
• The authority of the project leaders and team members is specified, together with links to the organisation.
All the expertise required for implementation is established.
• The suppliers are engaged in the project management.

• Resource planning takes account of the customer's requirements, based on the contract covering the project.
• Resource planning (a cross-functional, interdisciplinary team) for project management is established and
implemented.
• The necessary project budget is planned and released.
• The technical personnel, with the relevant qualifications, are provided at the right time by the specialist departments.
• The work load on personnel must be taken into account in the planning.
• Changes in the project must be notified at an early stage and agreed with the customer before they are implemented.
• If changes occur in the project (timings; extent of development, etc.) a check is made on resource planning and
nchanges are made if necessary. This applies to changes caused by the customer, to i nhouse changes and changes by
suppliers.
• Resource planning also takes account of suppliers.
• In particular the critical path is taken into account when planning resources.

• The project plan meets the customer's specific requirements.

• All in-house and customer milestones are fully included in the project plan and are regularly adjusted to take account
of changes.
• A specified distribution system is in place to ensure that changes in the project plan are communicated internally.
Changes to the project plan not initiated by the customer are discussed and agreed with the customer.
• The project takes account of critical delivery items. The critical path is generated from the project plan.
• The QM plan must be part of the project.
• A review is carried out at the milestones defined in the project plan to check that all planned activities are carried out
and that the level of maturity required is achieved.

• Change management within the project meets the customer's specific requirements.
• Manufacturing feasibility checks on changes are carried out and documented.
• Changes are highlighted at the right time and agreed with the customer.
• All changes are documented using a defined process.
• Changes not initiated by the customer are discussed and agreed with the customer.
• Where changes have an influence on product quality the risks must be assessed with the customer.
• Suppliers are actively involved in change management (for critical aspects).
• Timings for changes to stop are defined and complied with. Any deviations from this rule are agreed in writing
between customer and supplier.
• The period for changes before SOP does not jeopardize product quality.
• The implementation of changes must be assessed jointly, depending on the time remaining before SOP.

• Persons responsible for change management and their representatives, in the organisation, in the customer's
organisation and at the suppliers are defined.
• There is a regulation covering dealing with changes (distribution, time permitted for processing and escalation paths.
• Customers' requirements for handling changes are complied with or specifically controlled and documented.
• There is a defined regulation covering persons responsible for changes

• A QM plan must be integrated in the project plan, covering all activities relevant to QM planning.
• The QM plan is drawn up in accordance with the customer's requirements/contract and contains both internal and
external product securitisation criteria.
• The persons responsible for drawing up and maintaining the QM plan are defined and in place.
• The QM plan takes account of the timings in the overall project.
• It also contains critical delivery items.
• The QM plan takes account of all product and process specifications for verification and validation.
• Regular checks are made to ensure that the QM plan is implemented and achievement of the targets is monitored.

• There must be an escalation model for deviations within the project which threaten the overall timing plan (risk
management). An escalation process for the project is described & established. It takes account of specific customer
requirements.
• The criteria for escalation are specified and responsibilities & authorities are regulated. The effectiveness of the
function (escalation) is demonstrated by appropriate documentation.
• If special risks have been identified for technologies, suppliers and supply countries, this must also be taken into
account in escalation management.

t- and process development

 Process Audit Requirements

Requirements
• All requirements regarding the product to be developed are known.
• The organisation has implemented a process for identifying the customer's general QM requirements and also
development and process requirements.
• Enquiry and contract documents are checked to make sure they are complete.
• If the requirements cannot be achieved, the customer must be informed. Deviations may be "released" / agreed by
the customer (in the event of a contract).
• Customer requirements regarding the choice of sub-suppliers and/or materials to be used must be documented.
• Special characteristics must be identified on the basis of in-house requirements, customer requirements, legal
requirements, production technology and characteristics arising from the application/use of the product.
• There are interface agreements for suppliers (set suppliers) specified by the customer.

• The procedure for assessing manufacturing feasibility must be controlled.

• Contract and enquiry documentation must be checked for manufacturing feasibility.
• A process must be implemented which ensures that all requirements relating to the product are determined, including
any not explicitly stated by the customer (e.g., legal regulations) ·Experience (lessons learned) and forward looking
expectations
must be included in the study.
• The release process before a quotation is issued to a customer must be controlled.
• All areas involved/with responsibility must confirm the feasibility of the customer's requirements (Buying,
Development, Production Planning, Production, QM Planning, Logistics, ...).
• Consideration capacity required for making samples, prototypes, etc. must be taken into account in the quotation
phase.
• The requirements set out in "P7" : "Customer support / customer satisfaction / service“ are taken into account.

• At a level below the project plan, specific plans are drawn up for the development of the product and process. These
plans contain details of timing dates and periods for certain development and planning activities, milestones,
production tests, etc.
• The milestones are aligned with the customer's milestones.
• Metrics (RFA) are laid down for the individual milestones and the critical path is identified.
• The internal development plans are aligned with the relevant project timing plan, particularly with regard to metrics for
the individual milestones. It is ensured that development plans are always up-to-date.
• QM planning must be integrated in the development plans, including test/inspection planning, the planning of test and
inspection facilities and risk analyses.
• In the development phase, suitable methods must be used to secure the product development so that when the
product goes into serial production it fulfils the installation conditions (function, reliability, safety, security).
• Product & process FMEAs are part of the QM planning.
• Experience in technology for serial production is demonstrated.
• External processes and services are an integral part of the project planning.

• A procedure for determining resources must be controlled. This includes determining the availability of qualified
personnel, budgets, infrastructure, test equipment, laboratory facilities, machines, plant, etc. (loading on machines and
plant).
• Personnel qualification requirements and the facilities to be made available must be determined and documented
before starting any development. Capacities for building prototypes, samples, 0-production, production tests and serial
production must be planned.
• Regular demand analyses must be carried out during the development regarding possible bottlenecks & additional
demand.
• Resource planning must be adapted regularly to changes in the project. Outside processes and services must be
taken into account.

• A process must be implemented to plan and check essential supplier activities. This also includes the strategy for
awarding the contracts, the extent of the contracts and the target date for the contracts.
• Potential suppliers are known, including those already across the various departments.
• Suppliers of plant, machinery, tools, services and procedures are integrated in the process development.
• It must be possible to trace the awards of contracts to suppliers via appropriate documentation. Timing dates for
awarding contracts, reviews and acceptance checks are included in the process development plan.

ct- and process development

• In the development phase it must be ensured by means of FMEAs that the product and process meet the customer's
requirements in terms of function, reliability, etc.
• Changes to the product and process must be evaluated afresh.
• If appropriate, a new analysis should be carried out in agreement with the FMEA team and the project manager.
• pOnce actions have been completed, and u pdated FMEA is required in regard to the probability of occurrence and the
probability of detection, with the focus on the verification / validation of the Product in the project.
• The FMEA must be part of the development plan.
• The start phase, the interface to the Process FMEA, updating loops, etc. must be clear from the Product FMEA.
• The execution of FMEAs must be controlled.
• Interfaces to customer and suppliers are defined.

• Any evaluation requirements set by the customer are documented and applied.
• Personnel from production planning and the future production location are members of the FMEA team.
• When drawing up the Product FMEA the proposed production location must be involved.
• Special characteristics (SCs) are identified, highlighted in the FMEA and secured by appropriate actions.
• The effectiveness of the actions must be demonstrated.
 Process Audit Requirements

Requirements
• In the development of new products and processes, quality planning takes account of installation requirements for the
product from the very earliest stages.
• The methods set out in the development planning for product developments are used so that, after accumulated
experience has been implemented and the product has gone into serial production, it will meet the specified installation
conditions in terms of function, reliability, and safety/security.
• The QM planning must include a trailing plan for the parts, sub-assemblies and materials, including the manufacturing
processes from the prototype and pre-production phases.
• There is a QM plan (to DIN EN ISO 9000) for the prototype and pre-production phases.
• There are records of knowledge gained from the prototype phase and pre-production phase, to be taken into account
in the serial production phase.
• The planning of test, checking and inspection equipment is part of the QM planning. Requirements covering this
equipment have been laid down and implemented.

• There must be a process covering general personnel planning.

• The personnel resources must be planned and available at the specified timing dates.
• Personnel must be qualified for the relevant tasks. This also applies to the service personnel employed in the product
development process. Appropriate certification must be available.
• Determining resources is associated with the availability of qualified personnel.
• During product development a regular analysis must be carried out of possible bottlenecks and additional demand.
• Outside processes and services must be taken into account.
• There is capacity to achieve the prototype build, sample build, 0-production, production test and serial production.

• There must be a controlled process for the structured transfer of responsibility between the development team and
production.
• The customer's requirements are taken into account.
• An internal production process release check must have been carried out in full before the first shipment of production
items.
• A production test has been carried out at the production location in accordance with the customer's requirements.
Actions arising from the production test have been completed on time.
• Proof is available of machine capability studies to cover all special characteristics.
• Tools, test, measurement and inspection equipment are available in sufficient quantities.
• A procedure to secure the launch must be described and installed in order to secure the launch phase and a robust
production process.
• A check on launch security must be carried out for all new and modified parts which need to be submitted for initial
sample approval/release

• The production control plan must contain the parts, subassemblies, assemblies, and materials, including the
manufacturing processes which are associated with the product.
• The production control plan must be drawn up for the following phases:
- Prototype phase (if required by the customer)
- Pre-Production phase
- Serial Production phase

The question is not relevant for product development.

• A pre-production / production test must be carried out in order to assess all production factors and influences at the
appropriate time and make any necessary corrections.
• It should be possible to prevent bottlenecks and quality problems in serial production.
• The planning of a pre-production run and the agreements for executing a pre-production run are set out in P4.9 and
P6.1.1.
• Critical product features are taken into account.
• Proof that the agreed quantities can be achieved has been provided.
• Peak demands and agreed flexibility are taken into account.

Note: Depending on the phase at which the audit is carried out, certain production tests may still be in the planning
•stage.
The organization must monitor regularly the progress at the suppliers' premises with the execution of the project.
•The
Appropriate milestones
question is andfor
not relevant check-lists are included in the project management of suppliers.
product development.
• Tracking activities at the suppliers' premises are carried out, deviations are detected and suitable actions are
introduced.

• Process development must define and verify the status of the products and processes to be used in the various
phases.
• There must be a controlled process for the structured transfer of responsibility between the development team and
production.
• The customer's requirements are taken into account.
• An internal production process release check must have been carried out in full before the first shipment of production
items.
• A production test has been carried out at the production location in accordance with the customer's requirements.
• Actions arising from the production test have been completed on time.
• Proof is available of machine capability studies to cover all special characteristics.
• Tools, test, measurement and inspection equipment are available in sufficient quantities.
• A procedure to secure the launch must be described and installed in order to secure the launch phase and a robust
production process.
• A check on launch security must be carried out for all new and modified parts which need to be submitted for initial
sample approval/release.
 Process Audit Requirements

Requirements
• There must be a controlled process for the structured transfer of responsibility between the development team and
production.
• The customer's requirements are taken into account.
• An internal production process release check must have been carried out

• Before suppliers are specified, an assessment of the QM system (certification / auditing) must be obtained.
• Evidence must be provided of the timely planning for selecting and assessing new suppliers, based on selection
criteria meeting the customer's project plan.
• For serial production, it must be ensured that only suitable suppliers are used.
• If there are deviations from the organization's won selection criteria, the further procedure must be decided on.
Experience from evaluations of quality performance assessments must be taken into account for existing suppliers.
• Risks in the supply chain must be determined and assessed and must be reduced by appropriate action.
• Process audits or comparable methods must be planned and executing in all phases for the suppliers selected
(depending on the risk classification of the product).
• It must be ensured that the suppliers have sufficient capacities - this also applies to changes in quantities.

• Suppliers in the supply chain must be controlled and monitored in terms of their engagements and performance
(depending on the risk classification of the product).
• Interfaces are recognized and secured.
• The forwarding of customer requirements must be controlled and traceable.
• Change management must also be taken into account.

• Target agreements must be agreed and implemented with suppliers to cover delivery performance, to ensure the
continuous improvement of products and processes.
• In the event of discrepancies, actions must be agreed and their implementation monitored, including timing dates.
• An approval/release must be issued for all out-sourced products and services before they are used in serial
production.
• In the case of modules (unless otherwise agreed), the supplier has full responsibility monitoring the quality of all the
individual components.
• Evidence must, therefore, be provided of comprehensive change management, for the customer to the sub-supplier

• The capabilities and performance of a supplier must be checked at defined intervals and the results must be logged
and evaluated in a report (supplier listing). In the event of negative results, qualification programs must be laid down.
Evidence must be provided that the actions have been implemented.
• To monitor the quality of the out-sourced goods and services, regular checks are carried out, documented and
evaluated.
• For safety-relevant parts, specific agreements must be made with the supplier regarding the handling of processes
and tests / inspection, as well as archiving the results.
• Requalification checks are carried out to the customer's requirements.
• Test, inspection and measurement equipment must be stored in an orderly manner and associated work-stations
must be laid out appropriately (to prevent damage, contamination noise and to ensure good lighting conditions,
tidiness, order and, if relevant, air conditioning).

• Incoming materials and goods containers must be placed in stores in accordance with their release status so that
they cannot be damaged or mixed up.
• "Suspect" and quarantined products must be stored securely to prevent access to them.
• FIFO and batch traceability are ensured when the materials and goods are processed further.
• Material stock figures in the stores administration system agree with this quantities actually in stock.

• A description must be provided of what responsibilities, tasks, and authority the employees have in their relevant task
areas.
• A job description must be available for functions.
• Training needs must be determined for each employee in terms of the task and qualification must be provided
accordingly.
• Knowledge is available of previous complaints regarding relevant out-sourcing requirements

duction
? (process input)
• A process is defined for transferring responsibility between development/production & is controlled.
• A complete production process/product approval/release with all the documentation required must take place before
the first production shipment.
• The PPAP is the final verification of the product, production and transport planning process and a positive result lead
to approval/release for serial production.
• Conditions for serial production release are agreed with the customer.
• Reference parts from sample submissions must be retained in accordance with the customer's instructions.
• The process for securing the launch of production is described/installed, in order to shorten the run-up phase &
ensure a robust production process.
• A process to secure the launch must be carried out for all new parts/modified products requiring initial sample
submission/approval.

• A production test has been carried out to the customer's requirements & assessed positively. Actions arising from the
production test have been completed on time. Production facilities/new parts have been sampled with positive results.
• A process for the further development of the product and process FMEAs is defined and controlled.
• Evidence of feasibility investigations has been provided for all special characteristics.
• Tools, test, inspection and measurement facilities are available in sufficient quantities.
• Responsibility for serial production has been transferred from the project team to the production plant.
 Process Audit Requirements

Requirements
• The right product (incoming material, part, component…) must be provided to the agreed quality, in the right quantity
and the right packing, with the right documentation, at the agreed time and at the agreed place.
• Parts/components must be available at defined store locations/work-stations.
• This process must be controlled (KANBAN, JIT, FIFO).
• Order quantities/batch sizes must be taken into account in order to ensure that parts/materials are available to meet
demand at the relevant work-place and must be aligned with upstream processes.
• The return of unwanted parts (residual quantities) after the order has been completed must be controlled, including a
count of the parts involved.

• Customer-specific packing regulations must be taken into account / implemented throughout (including in production
processes).
• During manufacture and internal transport and also when being transported to and from service companies, suitable
transport units must be used to protect the products from damage and contamination.
• Stores areas, work-stations and containers must be appropriate for the tidiness and cleanliness required for the
parts/products.
• Cleaning cycles are defined and monitored.
• The supply of parts/materials at the work-station/on the assembly line must provide for safe handling.
• Specified storage times and use-by-dates for special materials/parts must be monitored by appropriate methods
(max. and min. storage times; specified intermediate storage times).
• Critical operating and auxiliary materials for plant and machinery with a direct effect on the product/product quality
must be monitored accordingly.
• Parts, incoming materials, critical operating and auxiliary materials must be protected against environmental/climatic
influences.

• Released incoming materials must be clearly identified and recognizable. The release status must be clear from the
identification.
• The release identification on bundles, batches, load containers and parts must be specified.
• Customer-specific regulations for the release of products must be taken into account.
• It must be ensured that only released materials/parts are forwarded to production/the next process and used.
• Traceability of releases must be ensured.
• The traceability of the units produced must be ensured within a reasonable framework (e.g., documentation covering
the use of batches).
• Depending on the product risk, traceability must be guaranteed across the entire process chain, from sub-supplier to
the customer.
• Customer identification and traceability requirements must be taken into account.
• Special requirements for the identification of spare parts must be taken into account.
• Legal requirements and the product liability act must be observed.
• Characteristics subject to special documentary and archiving requirements must be recorded accordingly.

• The progress of a change from the initial change request through to implementation must be clearly described and
responsibilities must be controlled.
• A process regulating the change release must be implemented.
• Changes must be agreed, approved and released with the customer. If necessary a new PPAP must be produced.
This refers both to product and process changes.
• Documentation of change levels must be fully traceable throughout.
• This requires the implementation of a suitable system which controls the defined process sequence.
• This applies equally in the supply chain.
• The effects of changes must be analyzed, documented and assessed, before the associated changes are
implemented (risk analysis, production control plan,...).
• Conformance with the customer's requirements must be checked before the change is released and implemented.

• It must be ensured that, at all times, the correct design level of the incoming materials is used and the correct design
level of the finished product is manufactured and shipped to the customer.
• Characteristics subject to special documentary and archiving requirements must be tracked and documented
accordingly.
• It is ensured that only current/valid documents are present at work-stations.

quence (Are all production processes controlled)

• The production & test/inspection documents (production control plan, work plan, manufacturing instructions) must be
available at the work-place / inspection station. Checking/inspection characteristics, facilities, methods, frequencies
(cycles) and requalifications must be described & defined in these documents.
• Process parameters influencing product characteristics and/or quality must be fully stated. Tolerances must be stated
for process parameters and checking/inspection characteristics.
• The control limits in process control charts must be specified, recognizable and traceable.
• Non-compliances & actions taken regarding process requirements & inspection characteristics must be documented.
• Data regarding machines/tools/auxiliary aids (tool and machine numbers) for critical products and processes must be
stated in the work plan, production control plan/inspection instructions.
• Conditions governing rework are specified & secured within the process (parts identification; fresh
checks/inspection,...).
• The quality checking/inspection concept complies with the customer's requirements/agreements made with the
customer.

• "Approval / release for serial production" is the contract-related initial and repeat release for the start of production.
The approval / release is required for product and process and must be issued in writing by authorized personnel,
based on acceptance criteria. At this point problem areas detected in previous serial production must be eliminated.
The approval / release checks must be carried out to clear checking / inspection instructions to ensure repeatability.
• If production is to recommence after parts have been taken for test/inspection, the products must remain quarantined
until these parts have been approved/released. Rework must be include in the approval / release processes. To
ensure the constant quality of parts produced, fresh evidence must be produced of a secure production process after
any break in production (e.g., night-time shut-down in the case of a 2-shift operation, a change of tool, material, batch
or product).
 Process Audit Requirements

Requirements
• Corrective actions are also regarded as a break in production. A repeat release must always be carried out for the
product and also for the process. Special processes (gluing, welding, soldering, ...) are controlled and require
appropriate documentation in addition to the release. Responsibilities for the repeat release are specified. The repeat
release for production must be documented and the quantity required for release must be defined.
• If it is not possible to carry out the release process immediately after a break or problem in production, access must
be assured to all parts produced until the repeat release has been carried out. Setting plans (setting data, programs,
etc.) product-specific setting-up plans and setting aids/reference parts must be available at the work-place/at the
station. For comparison purposes, inspection and limit samples must be available at the relevant work-place.
• Non-compliances and actions taken are documented.

• It must be shown that the processes are implemented to the customer's requirements with the existing production
facilities and that the resulting products comply with the customer's specifications.
• The production facilities, machines and equipment must be able to maintain the specified tolerances for the relevant
characteristics.
• Process capability must be determined for significant product/process characteristics and continually demonstrated.
• For short-term process capability (machine capability studies) and provisional process capability, a figure of Cmk /
Ppk >= 1.67 must be achieved. For long-term process capability (Cpk), the minimum requirement is Cpk >=1.33. Note
must be taken of customers' regulations, requirements for proof of capability of significant characteristics.
• In the case of significant characteristics where no capability level can be demonstrated, 100% inspection is required.
• Cleanliness requirements for production are defined and implemented by reference to the product risk. There is
sufficient production capacity, taking into account levels of scrap and rework.

• Significant product characteristics and process parameters are identified in the production control plan and are
monitored systematically (SPC).
• Control limits are defined and effective control action is taken in the event of deviations.
• Records are maintained of non-compliances and corrective actions. Non-compliances affecting the characteristics of
the product must be approved by the customer.
• Production processes are controlled and process-capable.
• Quality records are specified for significant characteristics (type and duration of archiving) and are agreed with the
customer.
• In the case of characteristics subject to special documentary and archiving requirements, customer-specific
requirements must be observed.

• Non-released parts, defective parts and/or parts with defective characteristics must be separated and documented.
They must be securely removed from production operations.
• Containers for scrap and rework must be appropriately identified.
• Quarantine stores and quarantine areas must be clearly recognizable (unauthorized access must be prevented)
• The storage and retention of setting parts, reference parts and tools must be displayed and identifiable.

• An appropriate and optimum flow of parts and materials must ensure that mixing / confusion between similar items
cannot occur. Poka Yoke or other methods may be used for this. The use or fitment of an incorrect part or material
must be immediately detectable and must not proceed further in the value creation process. Suitable checks/actions
must be carried out to guarantee early detection and filtering out of items wrongly installed items. Associated subjects
and actions must be included and examined in the Process FMEA and, if appropriate, in the Product FMEA.
• There must be a clearly controlled process for handling residual quantities, parts which have been separated out (for
example, stacked up because of a machine problem), re-used parts from product audits, checking parts, etc.
• Containers and parts must be adequately, appropriately and securely identified.
• The process and/or inspection status must be clearly visible.
• The use-by date and longest storage time for materials must be observed.
• Internal residual quantities must be logged by quantity and suitably identified and stored.

l resources
• A description must be provided of what responsibilities, tasks and authority the operators have in their individual
areas of operation: who is responsible for process releases and checks on first-off parts and who can distribute these.
• Checks carried out by the operators themselves must be describe: when, how many, how often, with what, where,
documentation.
• A description must be provided of who maintains the quality control charts and who has what authority in the event of
non-compliances (authority to quarantine parts, stop the line, etc...).
• The quality-consciousness of operators must be encouraged and maintained regularly by suitable means.
• All operators are trained in the consequences of carrying out work wrongly, as parts of product training (what
tasks/functions does the product perform and what happens if these cannot be guaranteed because of incorrect
assembly, etc.).
• A process must be implemented to determine to what extent personnel are aware of the significance and importance
of their tasks.

• Employees regularly receive information on current quality levels achieved by the customers.
• Operators are engaged in the continuous improvement process.
• Feedback is provided on suggestions for improvements.
 Process Audit Requirements

Requirements
• There must be a job description for each work-station, including a requirements profile.
• Training needs must be determined individually for each operator based on the task and an appropriate personnel
development plan drawn up. A record must be kept of who is qualified for what tasks and activities.
• This documentation must be taken into account when planning the use of personnel.
• Employees are trained in the processes and know of production errors which can potentially occur.
• All employees are trained in the consequences of carrying out work incorrectly (e.g., product training, what happens if
the product is wrongly assembled; using checking / inspection equipment,...). Training in health & safety at work and
work-related environment aspects is provided regularly. Instruction must be given to employees regarding the handling
and dealing with "components/products requiring special documentary evidence".
• Training, instructions and qualification evidence must be documented.

• There must be evidence of suitability to meet requirements regarding activities (e.g., fork-lift driver license; welding
certificate, soldering certificate, eye test, hearing test, etc.).
• Induction plans must be available for new employees, replacement and temporary personnel. Induction phases must
be demonstrated.
• Training/instruction is given and documented in the event of changes to the product/process.

• When planning the employment of personnel, the qualifications of the employees must be taken into account
(qualifications matrix).
• Absentee levels (sickness, holidays, training) are included in the employment planning.
• In the case of replacement personnel and personnel transferred on loan, it is important to ensure that they have the
necessary qualifications.
• Rules regarding deputies are documented and are derived from the qualifications matrix for the relevant production
operations.

• Plant, equipment, machines and tools required for the problem-free operation of key processes are identified and
appropriate preventive maintenance intervals are allocated to them.
• Resources to carry out essential maintenance work are available.
• Essential maintenance work is systematically planned and carried out.
• Preventive maintenance of machines, plant and tools is carried out, documented and controlled (maintenance
systems).
• Availability is assured for spares for production facilities, particularly for key processes reflecting the critical path.
• Clean working surroundings and work-places are integral to an overall care for the facilities (GAB).
• A process has been effectively implemented to analyse and optimize down-times, machine loadings and the life of
tools.

• Tools are covered by a tool management system containing the following points:
- identification of usage status (OK, NOK, under repair)
- tool tracking card with all the changes made to the tool
- tool operating times
- protection from damage
- ownership details for the tool

• The test, inspection and measurement facilities employed are suitable for the purpose and for handling in production.
They are included in the production control plan.
• Systematic and random causes of measurement errors are eliminated. Employees are trained in the use of
measurement equipment (exclusion of measurement errors).
• Capability studies (MSA's) are carried out on the measurement devices and measurement systems employed. ·The
accuracy of this equipment is appropriate for the purpose and from the characteristics to be checked.
• Certification is available covering the calibration of the inspection equipment (inspection plates).
• A process for the periodic monitoring of measurement and inspection equipment is installed and implemented
(responsibility for collection and return is defined). This process also takes into account the calibration of process-
integrated measurement technology with an influence on the product characteristics.

• There is an identification system for measurement and inspection equipment. Administration of this equipment is
based on the identification.
• Measurement and inspection equipment accessories having in influence on measurement accuracy and the
measurement result are monitored in the same way.

• Conditions for the work-places and their surroundings (inc. rework areas) are appropriate for the products and the
work carried out, in order to prevent / eliminate contamination, damage, mixing-up of parts and misinterpretations.
• In addition, the work-place layout is adapted ergonomically to the work to be carried out.

• Even tools, equipment and test/inspection devices not in use and/or not yet released must be stored and managed in
an appropriate manner.
• All tools, equipment and test/inspection devices are identified with their current status and change level (released;
under maintenance; maintenance required; quarantined).
• Storage is provided where the equipment is protected against damage and environmental effects, and cleanliness
and tidiness are ensured.
• The issue and use of this equipment is controlled, specified and documented.

grate effectiveness, efficiency, elimination of waste)

 Process Audit Requirements

Requirements
• Process and product metrics are defined and logged in order to control and monitor the organization's processes.
• A regular comparison is made between specified and actual results.
• Target requirements are agreed and achievable; they are guaranteed to be up-to-date.
• Process-specific targets are laid down, monitored and communicated (quantities produced; quality metrics such as
failure rates, audit results, through-times and process effectiveness figures (Cpk).
• Non-conformances are analysed and subjected to suitable action leading to improvements to the product and
process.
• Essential special action must be specified and implemented as necessary.
• The potential for improvement must be determined continuously from previous experience regarding quality, costs,
and service.
• Monitoring the metrics is ensured through regular management reviews and reported in associated committees.

• Full quality data and process data must be available to demonstrate compliance with requirements and targets. The
data must be capable of assessment. Special events must be logged (in a log book). Events and problems must be
allocated to the areas responsible, where the associated improvements are generated and implemented. Quality
control charts and monitoring charts are in use and are maintained in accordance with requirements. Process data
and parameters (SPC) are monitored and used for the control of processes.
• In the event of a problem or non-conformance, corrections are made automatically and/or an associated report is
issued.
• Essential actions (action plan) for process problems are known and are introduced and documented by the
responsible personnel.
• Non-conformance with approved/released processes with an effect on the characteristics of the product must be
approved by the customer. Process capabilities are checked regularly.

• Types and frequencies of failures are logged and assessed and actions are derived. The effectiveness of the actions
introduced is verified.
• Failures resulting in a change to the process or product are also documented in the relevant FMEA with the
associated actions.
• Failure costs are logged against those causing them (amount of scrap; rework items & consequences) and actions
are allocated.

• If deviations from product and process requirements occur, immediate containment actions must be taken to comply
with the requirements, until the causes of failure are eliminated and evidence has been provided of the effectiveness of
the corrective actions.
• Methods used for the analysis of causes are defined and in use.
• Corrective actions are derived, their implementation is monitored and effectiveness is verified.
• In this, production control plans and FMEAs are taken into account and are extended and up-dated if required.
• Functioning quality control circles are implemented in production within the organization.
• The status of the actions is transparent and communicated.

• Audit plans (process audits, product audits) must be available for the product and its production processes.
• Reasons for an audit are:
- New projects, processes and/or products
- To provide evidence of compliance with quality requirements
- to indicate the potential for improvements
• Deviation reports must be issued to those responsible and improvement actions must be tracked.
• If the quality requirements are not met (internal/external) additional audits referring to the specific event(s) must be
carried out.
• Product audits are carried out and documented in production, after production operations have been completed.
They are carried out periodically and examine the finished product. Account is also taken of customer requirements
and relevant functions, including ease and security of fulfilment.
• Deficiencies in engineering and production are displayed, assessed from the customer's standpoint and appropriate
actions are introduced.

roduce ? (process result / output)

• Account must be taken of all requirements included in the customer's supplier assessment.
• Process-specific targets (from the customer's requirements, if appropriate) must be laid down, including quantities
produced, quality metrics such as failure rates, audit results, failure costs, through flow times and process metrics
(Cpk).
• Significant characteristics specific to the customer ("D" type characteristics) must be identified.
• Customer requirements must be audited in-house (shipping audit, ...)
• A process is implemented, regulating the use of products supplied by the customer. This refers to products (setting
parts), tools, inspection equipment and packaging.
• Test/checking/inspection instructions must be available (also covering endurance testing). Procedures must be
agreed with the customer and documented accordingly.
• A process must be described and implemented, explaining how the areas of stores, scheduling, parts provision,
shipping and the customer are informed in the event of a block on shipping.
 Process Audit Requirements

Requirements
• Parts/components must be forwarded to defined storage/holding points using suitable means of transport. In this,
attention must be paid to the order quantity/batch size so that only the required quantity of parts/materials is moved to
the next work-station (the "pull" principle).
• Logging and assessing quantities (number of OK parts, parts to be reworked and scrap parts) must be controlled and
traceable.
• Parts identification must be specified (OK parts, rework parts and scrap). The identification must also indicate the
current change status.
• It must be ensured that NOK parts cannot be forwarded or processed further.
• Customer requirements for the identification of reworked parts must be implemented and documented
(quantity/volume, identification, list history, and usage).

• Parts must be protected from damage by suitable storage and packing.

• Customer-specific packing instructions must be available in shipping/goods outwards department and
observed/implemented throughout (also in the various production operations).
• The positioning of parts must ensure secure storage at the work-place, including handling.
• Storage points/containers must meet essential requirements for cleanliness & tidiness. This includes the parts at the
work-place itself (no over-filing).
• Specified storage times must be monitored (specified maximum, minimum, and intermediate storage times).
• Parts must be protected against environmental and climatic influences during storage and processing.

• Releases for the shipment of products to the customer or the next process must be identifiable and documented.
• Special releases and releases under deviation must be traceable by appropriate identification and documentation.
The documentation must cover the period and/or quantity of parts involved. These details must also be included in the
parts life-history, including the identification method.
• Traceability of releases, including documentation, must be generally guaranteed. Traceability of the parts produced
must be ensured to a reasonable degree.
• The customer's requirements must be taken into account in determining archiving regulations and periods.

stomer satisfaction / Service

• Take account of all requirements, particularly those included in the supplier assessment system used by the
customer. Take account of the certification of the QM system in accordance with the customer's requirements. If
appropriate, include evidence of significant characteristics when carrying out audits.
• Customers' requirements for the supply of spares before, during and after serial production must be implemented and
observed, including the acceptance and recycling of returned parts. The supply of spares must be considered in
addition to serial production, including variants and changes, in terms of the resources required.
• Packing must meet the customers' requirements regarding suitability, fixing, cushioning and identification.
• Product requalifications are carried out to the customers' requirements.
• It must be ensured that the product conforms with legal regulations.

• It must be ensured that competent contact personnel are available for the various areas in the customer's
organization.
• Communication in a language which the customer understands is essential.
• Customer support is also a measurement of active creative cooperation. The supplier has the obligation to examine
his products at all stages of the creation and implementation stages and to improve them in agreement with the
customer.
• A procedure is agreed with the customer for ensuring the security of new product/process launches.
• Concepts are in place, including security for emergencies to ensure supplies.
• These concepts must always be kept up-to-date in the serial production delivery phase. In this, consideration must be
given to in-house processes and also the suppliers' processes.
• Procedures must be in place which guarantee that the organisation informs the customer immediately when supply
bottle-necks are detected.
• The information must include the expected duration and extent of the bottlenecks and the actions which have been
taken.
• The actions must be taken at the right time and in accordance with the customer's requirements

• Independent detection and analysis of deviations from quality requirements, with the rapid introduction of corrective
actions including evidence of effectiveness are requirements demanded of the quality control circle.
• Timings agreed with the customer following complaints or rejects must be maintained. Non-conformances must be
communicated.
• Deviations and the associated corrective actions must be placed in order of priority and integrated in existing risk
analyses (e.g., FMEAs).
• Introduce special actions to ensure the supply of products correct to specification (e.g., 100% inspection).

• The process for analysing the defective parts from the field is implemented and described throughout the
organization.
• Customer-specific requirements are agreed.
• Test/inspection planning must be carried out for standard checking and checks involving debit charges.
• Initiation criteria must be agreed with the customer for the "NTF" (no trouble found) process. The characteristics to be
checked and the specification for the checks must be documented and agreed with the customer. Capable checking
equipment and the associated resources must be planned.
• Communication must be maintained with the contact personnel involved in analysing field failure returns. Personnel
responsible for the findings, the NTF process, the reporting system and for controlling the failure elimination process
must be clearly defined.
 Process Audit Requirements

Requirements
• Metrics for the field failures analysis process must be tracked in order to measure effectiveness. The standard
reporting system for reporting on analyses (8D) and quality reports must be agreed with the customer. The
effectiveness of the failed parts analysis is ensured by a continuous improvement process.

• A description must be provided, setting out the responsibilities, tasks, and authority of personnel in their respective
task areas.
• A job description, including requirements profile, must be provided for each function.
• Training needs must be determined for each person, depending on the task and appropriate personnel development
planning must be drawn up and implemented.