VDA Potential Analysis [PDF]

Zitiervorschau

Potential Analysis VDA 6.3 2010 Organisation (Supplier):

Location:

SupplierNo.

Date:

Customer:

Order-No:

###

Reason for Order: Pro. No

Project, Product, Process

Evaluation

GREEN RED

Blocked Supplier

YELLOW Controlled Supplier GREEN

Approved Supplier

Assessment / Requirements: Process description

Order placement is not possible Order placement only possible with additional actions Order placement possible

Risk assessment:

NOTE: As part of the up-qualification-agreement, controlled suppliers are obligated to cooperate with a consultant, approved by the customer after receipt of order. The costs are paid by the supplier.

Potential assessment: Audit history / Certificates

Audit basis

Date

Application

Result Further processes:

Participants

* Participants

xxx yyy

1. Appointment Improvement Plan:

Auditor

Lead Supplier Evaluation

1/13/1900

Actions see"Improvement program"

Signiture Supplier / Candidate

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog VDA 6.3*

Questionnaire potential analysis (P1)

Question

2.1

2.2

1.1

1.2

Project Management Is the project organisation (projectleader) established and the responsebilities in addition with the comptetence of the projectleader and the team members settled?

Are resources planned for the project handling and will changes be anounced to the customer?

0

Requests / Details mark with x The project management is able to fulfill the customer requirements. A process to implement project management incl. resource-planning exists. Permissions of project managers and team members as well as the organisation is definded and contain all necessary competences for realization. Suppliers are consistently integrated in the project management.

Evaluate!

The resource-planning considers customer requirements regarding the contract of the project. A resource-planning (cross-departmental, interdisciplinary team) for project management is implemented. The necessary project budget is planned and approved. The requirements regarding personal qualification and providing goods must be determined before every project start and documented in the project plan. The involved personal resources, with according qualification, are provided by departments on time. The workload of the employees is considered while planning. Project changes must be displayed on time and discussed with the customer before realization. On changes (date, scope of development,...) in the project, a validation of the resourceplanning, possibly adjustment of demands. This relates to customer changes, as well as internal changes or changes by suppliers. The resource-planning also considers subcontractors. In particular, the critical path is considered in the resource-planning.

The project plan fulfils the specific customer requirements. All internal and customer milestones are completely implemented in the project plan and are adapted regularly on changes. By changes of the project plan the internal communication is ensured by a defined mailing list. Changes which are not released by the customer, are discussed with the customer. The project plan considers critical scope of delivery. The critical path arises from the project * Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 2 plan. 2.3

1.3

Evaluation

Evaluate!

Is a projectplan existing and verified with the customer?

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The project plan fulfils the specific customer requirements. Is a projectplan existing and All internal and customer milestones are completely implemented in the project plan and are 9.3 Potenzialanalyse verified with the (P1)customer? als Auszug aus dem VDA 6.3 Fragenkatalog adapted regularly on changes. By changes of the project plan the internal communication is ensured by a defined mailing list. Changes which are not released by the customer, are discussed with the customer. The project plan considers critical scope of delivery. The critical path arises from the project plan. To the defined milestones in the project plan a review is carried out, with the verification, whether all planned activities are carried out and the required maturity level is reached.

2.4

2.5

2.6

1.4

1.5

1.6

Is the change management in the project secured by the project leader?

The change management of the project fulfils the specific customer requirements. The feasibility check of changes is carried out and documented. Changes are indicated on time and discussed with the customers. All changes are documented with the help of a defined process. By changes which influence the product quality significantly the risk must be valued with the customer. The suppliers (critical scope of delivery) are actively integrated In the change management. The moment for change stops is defined and kept. Deviatoins are recorded in written form between the customer and supplier. Period of changes before SOP does not endanger the product quality. The realization of the changes must be valued together in dependence of the remaining time before SOP.

Are the responsible persons in the organisation and also at the customer involved in the change management?

Responsible persons as well as their representatives for the change management to the customer, in the organization and the suppliers are defined. There is a regulation for handling changes (distribution, process time, escalation path). The customer requirements regarding handling of changes are performed or regulated specifically and documented. A regulation for responsible persons regarding changes is defined.

Is a qualityplan in the project implemented and monitored?

In the project plan a Q plan which contains all relevant activities for the Q planning must be integrated. The Q plan is performed according to customer requirements / contract and contain internal and external product assurance-criteria The responsible persons for generation and maintenance of the Q plan are defined and deployed. The Q plan considers the dates of the whole project. The Q plan contains critical scope of delivery. All product-und process specifications are considered in the Q plan on verification and validation. The realization of the Q plan is monitored regularly regarding compliance with and reaching of the targets. In case of deviatons to the targets an escalation process is initiated in which the customer is integrated.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

3

Evaluate!

Evaluate!

Evaluate!

Evaluate!

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In the project plan a Q plan which contains all relevant activities for the Q planning must be Is a qualityplan in the project integrated. implemented(P1) and monitored? 9.3 Potenzialanalyse als Auszug aus dem 6.3according Fragenkatalog The Q plan isVDA performed to customer requirements / contract and contain internal and external product assurance-criteria The responsible persons for generation and maintenance of the Q plan are defined and deployed. The Q plan considers the dates of the whole project. The Q plan contains critical scope of delivery. All product-und process specifications are considered in the Q plan on verification and validation. The realization of the Q plan is monitored regularly regarding compliance with and reaching of the targets. In case of deviatons to the targets an escalation process is initiated in which the customer is integrated.

2.7

1.7

Is an escalation process settled and activ regulated?

In case of deviations of the maturity level, which affect the whole time schedule, an escalation process must be defined. An escalation process is described for the project and is implemented. Specific customer requirements are considered. The criteria for the escalation are defined, responsibilities and permissions are regulated. The effectiveness of the function (escalation) is proved by a suitable documentation.

Evaluate!

Evaluate!

Planning product and process development 3.1

2.1

Are the product-, and processrelated requirements known?

All requirements to develop the product are known. The supplier has implemented a process to identify general QM requirements of the customer as well as development and process requirements. Contract documents are checked. In case of nonconformances regarding the requirements, these requirements must be communicated to the customer or deviations must be "released" / be agreed by the customer (in case of an order). Requirements of the customer according the choice of subcontractors or prematerials must be documented. Special characteristic must be identified on the basis of own requirements, customer requirements, legal demands, manufacturing technology and characteristics which arise from the intended purpose of use of the product.

Is the feasibility based on the product and the process requirements evaluated?

A procedure to evaluate the feasibility must be defined. Contract and inquiry documents must be checked according completeness and feasibility. A process must be implemented which ensures that all requirements for the product are determined, additionally those which are not given explicitly by the customer (e.g., legal demands) Experiences (Lessons learned) and expectations must be considered. The release process, before an offer is presented to a customer, must be defined. * Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 4 confirm the feasibility of the customer requirements All responsible / involved parties must (sales, development, production planning, production, Q planning, logistics...). 3.2

2.2

Evaluate!

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A procedure to evaluate the feasibility must be defined. Is the feasibility based on the Contract and inquiry documents must be checked according completeness and feasibility. 9.3 Potenzialanalyse product and the (P1)process als Auszug aus demmust VDA 6.3 Fragenkatalog A process be implemented which ensures that all requirements for the product are requirements evaluated? determined, additionally those which are not given explicitly by the customer (e.g., legal demands) Experiences (Lessons learned) and expectations must be considered. The release process, before an offer is presented to a customer, must be defined. All responsible / involved parties must confirm the feasibility of the customer requirements (sales, development, production planning, production, Q planning, logistics...). Necessary capacities for sample construction, prototype construction, are alreaddy considered in the offer phase. The requirements from P7 "Customer Service/Customer satisfaction" are considered.

Evaluate!

Realisation Product and Process development 4.1

3.1

In the development phase is to be made sure by means of FMEA that the product and the Are the Design-FMEA and process corresponds to the requirements of the customer concerning function, reliability, etc. Process-FMEA generated and Changes in the product and process must be revalued. If necessary a new analysis is to be updated during the project initiated in agreement with the FMEA team and the project manager. including the corrective actions? After taking actions a new evaluation of the possible appearance and the possible detection is necessary with the focus on verification / validation of the Design-FMEA process of the project. The FMEA must be a content of the developing plan. The start phase, interfaces to the Prozess-FMEA, update loops,... are contained in it. The realization of FMEA's must be defined. Interfaces to the customer / supplier as well as internal interfaces are defined. Possible evaluation guidelines of customers are documented and applied. Production planning and the prospective producing plant are members of the FMEA team. With the generation of the Produkt-FMEA the manufacturing location is to be involved. Special characteristics are identified, marked in the FMEA and assured by defined actions. The effectiveness of the actions is to be proved. The interfaces of design and process FMEA are defined. A control circuit for updating the FMEA (frequency and trigger) exists.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog 4.5

3.2

Are the feasibility verification and releases according the project phases available?

The releases / suitability proofs are to be proved for all individual parts, assemblies and supplied parts according to the developing time schedule. Regular status reports of the project referring to the project plan or the milestones of the customer are provided. The evaluation guidelines / measuring dimensions including escalation criteria must be defined. Before the first delivery under series conditions a production process release and product release must be available with all requested documents. The PPF procedure should prove before SOP that agreed requirements in drawings and specifications are fulfilled. The finished PPF proves that customer requirements, specifications and other requirements (e.g., laws, norms,...) are understood correctly and are applied. Therefore the PPF is the final verification of the product, production and transport-planning process and leads with positive result to series release.

Evaluate!

Verification and validation for product and process are ensured.

4.9

3.3

Is the project transfer from the development to the serial process regulated (start up securing)?

A process for the structured handing over of the responsibility between developing team and production must be defined. Customer requirements are taken into consideration. Before the first delivery under series condition an internal production process release must be available. A production test according to customer requirements at the production location is carried out. Necessary actions due to the production test are performed in time. Machine capability tests (MFU) are proved for all relevant characteristics. Provided tools, inspection and measuring equipment are available in the necessary amount. A procedure to ensure the the start-up-run must be described and installed to shorten the high run phase and to ensure a robust production process. A start-up-run-approach must be carried out for all new parts and changed parts which require initial sampling.

Supply Managment Are only approved and qualified subsuppliers used?

Before defining the supplier the QM system (Certification / audit) must be evaluated. The accurately timed planning for the choice and evaluation of new suppliers on the basis of the project plan of the customer is to be proved. In case of series application it must be ensured that only suitable suppliers are used. In case of deviations to own criteria the further procedure must be defined. Experiences from evaluations of quality performances of existing suppliers must be taken into consideration. Risks in the supply chain must be determined and be valued as well as reduced by suitable actions (emergency strategy) In all phases process audits or comparable methods with commissioned suppliers are to be * Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 6 planned and to be carried out. (depending on the risk classification of the component) Sufficient capacities must be ensured at site of subcontractors. 5.1

4.1

Evaluate!

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Evaluate!

Are only approved and qualified Before defining the supplier the QM system (Certification / audit) must be evaluated. 9.3 Potenzialanalyse subsuppliers(P1) used? als Auszug aus dem VDA Fragenkatalog The accurately timed 6.3 planning for the choice and evaluation of new suppliers on the basis of the project plan of the customer is to be proved. In case of series application it must be ensured that only suitable suppliers are used. In case of deviations to own criteria the further procedure must be defined. Experiences from evaluations of quality performances of existing suppliers must be taken into consideration. Risks in the supply chain must be determined and be valued as well as reduced by suitable actions (emergency strategy) In all phases process audits or comparable methods with commissioned suppliers are to be planned and to be carried out. (depending on the risk classification of the component) Sufficient capacities must be ensured at site of subcontractors. This also applies on changes of quantity.

5.2

5.4

5.5

4.2

4.3

4.4

Are the custom related requirements considered in the supply chain?

Are the necessary releases available for all supplied series products?

Is the quality of the purchased parts assured?

The suppliers in the supply chain must be controlled and monitored concerning the order / project. (depending on the risk classification of the component) In this process the interfaces to the suppliers / subcontractors must be recognized and be ensured. The responsibilities at supplier-site must be defined. The transfer of customer requirements must be regulated and be traceable. The change management is to be considered.

Evaluate!

Evaluate!

For the whole scope of buy-parts a release must be carried out for new / changed products / processes before series application takes place. If not agreed separatly, the supplier of modules has the full responsibility of the quality control to all single components. Therefore, an continuous change management from the customer to the subcontractor is to be proved.

Evaluate!

The abilities and performances of a supplier must be checked in defined time periods, listed part-specific (supplier catalog) and be evaluated. In case of negative results qualification programs are to be defined. The realization of actions is to be proved. For the control of the quality of the scope of buy-parts, regular tests are carried out, documented and evaluated. Inspection options (lab equipment and measuring equipment) must be installed in the company (own know-how, short response time in case of problems). With saftey-related components specific agreements with suppliers are made regarding the use of processes and tests, as well as the recording and storage of the results. Requalification tests according to customer requirements are carried out. Inspection and measuring equipment is stored properly and the test workplace are designed

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 7 appropriately. (Damage, Soiling, climate control, lighting conditions, ordering, cleanness, noise)

Evaluate!

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Is the quality of the purchased The abilities and performances of a supplier must be checked in defined time periods, listed part-specific (supplier catalog) and be evaluated. In case of negative results qualification 9.3 Potenzialanalyse parts assured? (P1) als Auszug aus dem 6.3 Fragenkatalog programs areVDA to be defined. The realization of actions is to be proved. For the control of the quality of the scope of buy-parts, regular tests are carried out, documented and evaluated. Inspection options (lab equipment and measuring equipment) must be installed in the company (own know-how, short response time in case of problems). With saftey-related components specific agreements with suppliers are made regarding the use of processes and tests, as well as the recording and storage of the results. Requalification tests according to customer requirements are carried out.

Evaluate!

Inspection and measuring equipment is stored properly and the test workplace are designed appropriately. (Damage, Soiling, climate control, lighting conditions, ordering, cleanness, noise)

5.6

4.5

Are purchased materials sotred appropriatly

Delivered prematerials are stored according to the release status against damage and mixture. "Suspicious" / locked products are to be stored clearly with no access. Evaluate!

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

6.1.1

6.1.3

5.1.1

5.1.2

Production analysis Process-Input Is the project transfer from the development to the serial process regulated /start up securing)?

Are products and components appropriately stored and are the transport means and packaging equipment coordinated with the specific characteristics of the products and components?

A process for the handing over of the responsibility between developing team and production must be defined regulated. Before the first delivery under series condition an internal production process release and a product release must be available with all requested documents. The PPF procedure should prove before SOP that agreed requirements in drawings and specifications are fulfilled. The finished PPF proves that customer requirements, specifications and other requirements (e.g., laws, norms,...) are understood correctly and are applied. Therefore the PPF is the final verification of the product, production and transport-planning process and leads with positive result to series release. The requirements to release the series phase are agreed with the customer. A procedure to ensure the the start-up-run must be described and installed to shorten the high run phase and to ensure a robust production process. A start-up-run-approach must be carried out for all new parts and changed parts which require initial sampling. A production test according to customer requirements is carried out and evaluated positive. Necessary actions due to the production test are performed in time. Means of prodution / new parts are sampled positive. A process to develop process- / product-FMEA further is defined and regulated. Machine capability tests (MFU) are proved for all relevant characteristics. Provided tools, inspection and measuring equipment are available in the necessary amount.

Evaluate!

Customized packaging regulations must be taken into consideration / performed consistently (also in the production segments). The components must be protected against damage and soiling during manufacturing and the in-plant transport by suitable transport unities. Storage area/workplace/containers must comply with the ordering / cleanness necessary for the component / product. The part / material supply at the workplace / assembly line must ensure proper handling Predefined storage times as well as built-in times for special materials / components must be monitored by suitable methods (maximum, minimum storage times, prescribed interstorage time). Critical auxiliary and operating materials for machines and systemes which have direct influence on the product / the product quality must be monitored accordingly. Parts/pre material/critical auxiliary and operating materials are to be protected against environmental and climate influence.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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Are products and components Customized packaging regulations must be taken into consideration / performed consistently (also in the production segments). 9.3 Potenzialanalyse appropriately(P1) stored alsand Auszug are theaus dem VDA Fragenkatalog The components must6.3 be protected against damage and soiling during manufacturing and transport means and packaging the in-plant transport by suitable transport unities. equipment coordinated with the Storage area/workplace/containers must comply with the ordering / cleanness necessary for the component / product. specific characteristics of the The part / material supply at the workplace / assembly line must ensure proper handling products and components? Predefined storage times as well as built-in times for special materials / components must be monitored by suitable methods (maximum, minimum storage times, prescribed interstorage time). Critical auxiliary and operating materials for machines and systemes which have direct influence on the product / the product quality must be monitored accordingly. Parts/pre material/critical auxiliary and operating materials are to be protected against environmental and climate influence.

Evaluate!

Work content / Process-Flow

6.2.1

5.2.1

Based on the control plan, are the relevant details fully completed and adhered to in the production and inspection documents?

Product guidance plan, working plan, manufacturing advices must be available at the workplace. The process parameters which have impact on the product characteristics /-quality must be stated completely. Process parameters and inspection characteristics are to be stated along with tolerance specifications. The manufacturing documents and test documents must be available at the work-/test station. Insepection characteristics, test equipment, test methods, test frequencies / cycles must be described and defined in these documents. The operator intervention borders in process guide maps must be defined, be recognizable and reasonable. Deviations and initiated actions according to process guidelines / targets and test characteristics must be documented.

Evaluate!

Data of machines/tools/auxiliary materialsl (tool and machine-no.) for critical products and processes must be stated in the work plan/product guidance plan/test instruction.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog 6.2.3

5.2.2

Does the available production equipment and tooling ensure that the quality requirements for the product are met due to the customer?

It must be proved that the processes can be performed according to customer requirements with the used manufacturing equipment and that the resulting products correspond to the customer specifications. The manufacturing equipment, machines and systems must be able to meet the tolerance stated by the customers for the respective characteristic. For important product and process characteristics the process capabilities are to be determined and proved continuously. For the short-term process capability (machine capability tests) and the preliminary process capability Cmk / PpK> = 1.67 must be reached. The minimum target Cpk> = 1.33 applies to the long-term process capability Cpk. Customer specification / requirements for the capability proof of special characteristics must be considered. 100 % check is necessary for important characteristics for which capability cannot be proved.

Evaluate!

Cleanness requirements for production are defined and applied in dependence of the product risk.

6.2.4

5.2.3

Are critical or specific characters in the production guided under control?

Special product and process parameters are marked in the product guidance plan and are monitored systematically (SPC). Intervention borders are defined. In case of deviations effective countermeasures are taken. Documentation about deviations and remedial actions is gathered. The deviations which have impact on the quality of the product must be approved by the customer. Manufacturing processes are controlled and actionable. Documentation for special characteristics is available (archiving duration, -method) and discussed with the customer. For characteristics with special need of archiving the customized requirements are to be taken into consideration.

6.2.5

5.2.4

Are scrap, rework, set-up parts and excessive material conscientiously separated and identified?

Evaluate!

Parts, which are not released yet, defective parts or parts with nonconformances must be separated, documented and extracted safely from the manufacturing process. Containers for failures and rework must be marked appropriately. Quarantine store and areas must be marked clearly (unauthorised access must be avoided). The storage of set-up parts/reference parts and tools must be marked clearly. The amount of in-plant excessive material must be gathered, marked and stored appropriately.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog 6.2.6

5.2.5

Is the material and parts flow secured against mixing and intermingling, and is traceability ensured?

By a suitable / optimum flow of material and parts must be ensured that a mixture or mistakes in taking similar components is avoided, possibly by Poka Yoke. A wrong built-in part must be immediately recognizable and must be removed from the manufacturing process. Suitable tests and actions must be initiated which ensure a fastestpossible recognition and removal of wrong built-in parts. According subjects and actions must be contained in the Prozess-FMEA and possibly in the construction-FMEA and must be noticed. A process to reprocess excessive material, separated parts (e.g., wrong identified parts due to disruption of machines / systems), reworked parts, reused parts from product audits, test parts, etc... must be defined cleary. Containers / parts must be marked sufficient and suitable. Process status and test status must be clearly evident. Expiry dates and maximum storage times of materials / respectively components must be considered.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog Process support / personal resources 6.3.2

5.3.1

Are the employees qualified to For every workplace a job description and job profile must be available. Necessary training must be determined for every employee individually in relation to the task complete the defined tasks and and a suitable personnel development planning must be made. It must be documented who is their qualification maintained? is qualified for which tasks and activities. This documentation must be considered for personnel placement planning. The employees are trained regarding the processes and know potentially appearing manufacturing errors. All employees are trained about the results of wrong working execution (e.g., product training, what happens if the product was assembled wrong). Instruction about working safety and the environmental aspects relevant for the work takes place regularly. For the handling and the treatment of 'components / products with special proof' the employees must be instructed appropriatley. Carried out instructions, qualification certificates must be documented. Special proof of suitability for the respective task must be (stacker's driving license, welding, soldering license, visionl test, hearing test, etc.). Initial training plans for new employees, spare workers and subcontracted workers must be available. Initial training phases must be proved.

Evaluate!

Material resources 6.4.1

5.4.1

Is the service and maintenance of tools, equipment and machinery part of the advanced maintenance planning?

Systems, equipment, machines and tools which are necessary for smooth key processes are determined and planned with suitable preventive servicing (maintenance) intervals. Resources for the realization of necessary maintenance actions are available. Necessary maintenance actions are planned systematically and carried out. Preventive maintenance actions for machines, systems and tools are carried out, documented and controlled (maintenance system) The availability of spare parts for the production equipment, especially for key processes and processes which reflect the critical path is ensured. Clean working environment and clean workplaces are a component of a comprehensive investment maintenance. A process to analyse and optimize downtimes, machine utilization and tool lifetime is applied efficiently.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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Is the service and maintenance Systems, equipment, machines and tools which are necessary for smooth key processes are determined and planned with suitable preventive servicing (maintenance) intervals. 9.3 Potenzialanalyse of tools, equipment (P1) als and Auszug aus demforVDA 6.3 Fragenkatalog Resources the realization of necessary maintenance actions are available. machinery part of the advanced Necessary maintenance actions are planned systematically and carried out. Preventive maintenance actions for machines, systems and tools are carried out, maintenance planning?

documented and controlled (maintenance system) The availability of spare parts for the production equipment, especially for key processes and processes which reflect the critical path is ensured. Clean working environment and clean workplaces are a component of a comprehensive investment maintenance. A process to analyse and optimize downtimes, machine utilization and tool lifetime is applied efficiently.

6.4.2

5.4.2

Can the quality requirements be effectively monitored with the measurement and inspection equipment used?

The used inspection and measuring equipment is suitable for the purpose and the use in manufacturing and are stated in the production guidance plan. Systematic and accidental causes of measuring mistakes are excluded. Employees are trained in handling the measuring equipment (exclusion of measuring mistakes). Capability investigations for the used measuring equipment are carried out. The measuring accuracy of the used inspection and measuring equipment are suitable for the application and the appropriate characteristic. Proof of the calibration of inspection equipment (inspection plate) and measuring equipment exists. A process for periodical monitoring of inspection and measuring equipment is installed and applied. A marking (identification) system for inspection and measuring equipment is installed which manages the inspection and measuring equipment based on the marking. Accessories for measuring equipment and test equipment which has an influence on the measuring accuracy or the measuring result are monitored in the same way.

6.4.3

5.4.3

Are the work and test stations laid out according to the process requirements?

Evaluate!

Evaluate!

The workplace and environmental terms (also for rework) are adjusted to working contents and the products in order to prevent and avoid soiling, damage and part mistakes / wrong interpretation. In addition, the workplace is adapted according to the working task ergonomically. Evaluate!

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog 6.4.4

5.4.4

Also tools, equipment and test equipment which are not in use and/or not released, must be Are tools, facilities, and properly and be administered. inspection, test and measuring stored All tools, equipment and test equipment are marked with the respective status as well as equipment stored appropriately? change status (released, repaired, repair necessary, blocked). Storage without damage and protection against environmental influences is ensured, as well as ordering and cleanness. The release and use is defined and documented.

6.5.1

5.5.1

Process efficiency Are targets set for the product and proces and is their achievement followed up?

Evaluate!

Process and product performance indicators are defined and gathered to control and monitor the corporate processes. A target performance comparison is carried out on a regular basis. Targets are defined and realizable, the actuality is ensured. Specific process targets are defined, monitored and communicated (produced number of parts, quality performance indicators like failure rates, audit results, processing time, failure costs, process performance indicators (cpk). Deviations are analyzed and deposited with suitable actions which lead to product and process improvement. Necessary special actions must be defined and applied. The potential of improvement must be determined continuously due to previous knowledge about quality, costs, service. The monitoring of the performance indicators are ensured by regular management-reviews and is reported in appropriate committees.

6.5.3

5.5.2

Are nonconformities to product and process requirements analyzed for root causes and the corrective actions checked for effectiveness?

In case of product / process deviations suitable immidiate actions are to be carried out to comply with the requirements until the error root cause is eliminated and proof of effectiveness of applied corrective actions exists. The methods which are used for the cause analysis are defined and applied. Corrective actions are defined, their realization is monitored and the effectiveness is verified. Production guidance plan and FMEAs are considered and possibly complemented and updated. The status of these actions is transparent and communicated

Audit plans (process / product audit) must be available for the product and its manufacturing process. Reasons for audits can be: - New projects / processes / products - Proof of complaince with quality requirements - Highlight improvement potentials. Deviation reports must be forwarded * Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 15to the responsible persons, the improvement actions must be monitored. 6.5.4

Evaluate!

5.5.3

Evaluate!

Are processes and products regularly audited?

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Audit plans (process / product audit) must be available for the product and its manufacturing Are processes and products process. 9.3 Potenzialanalyse regularly audited? (P1) als Auszug aus dem VDAcan 6.3 Reasons for audits be: Fragenkatalog - New projects / processes / products - Proof of complaince with quality requirements - Highlight improvement potentials. Deviation reports must be forwarded to the responsible persons, the improvement actions must be monitored. In case of non-compliance with the quality requirements (internal/external) , additional eventrelated audits must be performed. Product audits are carried out and documented in the manufacturing process after finished manufacturing steps and on the end product periodically. Customer requirements and relevant functions including easy and safely built-in are considered. Execution failures in development and production are highlighted, valued by the customer and appropriate actions are initiated.

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

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Evaluate!

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog Process result (Output) 6.6.1

5.6.1

Are customer requirements fulfilled regarding product and process?

All requirements are considered which appear in the supplier assessment of the customer. Specific for process targets (possibly prescribed by the customer) must be defined (produced number of parts, quality performance indicator like failure rates, audit results, processing time, failure costs, process performance indicators (cpk). Customized special characteristics (D characteristics) must be marked. Customer requirements must be audit internal. A process which regulates the handling with provided products is implemented. This refers to products (set parts), tools, inspection equipment and packaging. For inspections (also endurance tests), inspection regulations must exist, the testing methods must be agreed with the customer and must be documented. In case of a delivery stop, a process must be described and implemented which informs all appropriate areas like storage / part supply / shipment and the customer.

Evaluate!

Customer Service/Customer satisfaction 7.1

6.1

Are the customer requirements regarding QM- System and product fulfilled before delivery?

All requirements, especially those which appear in the supplier evaluation of the customer are considered. Consideration of the certification of the QM system in accordance with customer requirements. If appropriately, special characteristics are to be proved with an audit. The customer requirements like spare part supply before, during and after the series phase, as well as the return of parts and their recycling must be performed and be considered. The spare part supply must be planned in addition to series delivery with the required product variations and changes and must be considered concerning the necessary resources. The packaging must fulfil the requirements of the customer concerning suitability, mounting, cushion and marking.

Evaluate!

Product requalification are carried out according to customer requirements. The compliance with laws must be ensured.

Is the delivery to the customer Concepts incl. assurance of emergencies to ensure the supply are defined. In the supply phase of series parts the update of these concepts is ensured. secured? * Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; In this case, own processes as well17 as the processes of the suppliers are to be taken into 7.3

6.2

consideration.

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9.3 Potenzialanalyse alscustomer Auszug aus dem 6.3ofFragenkatalog Concepts incl.VDA assurance emergencies to ensure the supply are defined. Is the delivery(P1) to the secured?

In the supply phase of series parts the update of these concepts is ensured. In this case, own processes as well as the processes of the suppliers are to be taken into consideration. Procedures must be installed which ensure that the organization informs the customer immediately in case of recognizing supply shortages. The information contains the prospective duration and the extent of the supply shortage, the reason and the initiated actions. The actions must be initiated / performed according to the customer requirements in time. Evaluate!

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

18

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog Amount of Evaluations:

0

0

0

35 Questions in Total Not-evaluated questions must be justified. This has a negative impact on the comparability of the results.

Rating criteria

Notice: Maximum amount of not-evaluated questions is limited to 3

Approved supplier Controlled supplier Support via audit team

Blocked supplier Order placement is not possible

Overall Rating GREEN The question can be answered with yes without any doubt. No potential risk.

[GREEN] Requirements fulfilled

[YELLOW] Requirements fulfilled in The question can not be answered with yes without any doubt. The target (product / process) is only achievable with additional actions. parts [RED] Requirements not fulfilled

The question can only be answered with no. The target (product / process) is not achievable. There is potential risk of failure .

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

19

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog Remarks

1.1

1.2

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben; 1.3

20

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog 1.3

1.4

1.5

1.6

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

21

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

1.6

1.7

2.1

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

22

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

2.2

3.1

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

23

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

3.2

3.3

*4.1 Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

24

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

4.1

4.2

4.3

4.4

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

25

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

4.4

4.5

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

26

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.1.1

5.1.2

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

27

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.1.2

5.2.1

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

28

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.2.2

5.2.3

5.2.4

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

29

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.2.5

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

30

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.3.1

5.4.1

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

31

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.4.1

5.4.2

5.4.3

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

32

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.4.4

5.5.1

5.5.2

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

33

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.5.3

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

34

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

5.6.1

6.1

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

35

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

6.2

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

36

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9.3 Potenzialanalyse (P1) als Auszug aus dem VDA 6.3 Fragenkatalog

Too many questions are missing

* Weitere Erläuterungen sind im VDA 6.3 Fragenkatalog beschrieben;

37

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Prozessaudit

Improvement Program Potential Analysis Supplier:

0

Date: Order-No.

Pos.

filled out by auditor Questi on No.

Weakness / Recommend Actions, Determination

12/30/1899 0

filled out by auditee Actions and Error Cause Analysis of the Organisation

Date

Responsibility

Project Management

1.1 1.2 1.3 1.4 1.5 1.6 1.7 Planning product and process development

2.1 2.2 Realisation Product and Process development

3.1 3.2

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VDA QMC

Prozessaudit

Improvement Program Potential Analysis Supplier:

0

Date: Order-No.

Pos.

filled out by auditor Questi on No.

Weakness / Recommend Actions, Determination

12/30/1899 0

filled out by auditee Actions and Error Cause Analysis of the Organisation

Date

Responsibility

3.3 Supply Managment

4.1 4.2 4.3 4.4 4.5 Production analysis 5.1.1 5.1.2 5.2.1 5.2.2 5.2.3 5.2.4

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VDA QMC

Prozessaudit

Improvement Program Potential Analysis Supplier:

0

Date: Order-No.

Pos.

filled out by auditor Questi on No.

Weakness / Recommend Actions, Determination

12/30/1899 0

filled out by auditee Actions and Error Cause Analysis of the Organisation

Date

Responsibility

5.2.5 5.3.1 5.4.1 5.4.2 5.4.3 5.4.4 5.5.1 5.5.2 5.5.3 5.6.1 Customer Service/Customer satisfaction 6.1 6.2

DRX_A_12.05.07_E D1_004

VDA QMC

Prozessaudit

Improvement Program Potential Analysis Supplier:

0

Date: Order-No.

Pos.

filled out by auditor Questi on No.

DRX_A_12.05.07_E D1_004

Weakness / Recommend Actions, Determination

12/30/1899 0

filled out by auditee Actions and Error Cause Analysis of the Organisation

Date

Responsibility

VDA QMC

Prozessaudit

Effectivity

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VDA QMC

Prozessaudit

Effectivity

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VDA QMC

Prozessaudit

Effectivity

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VDA QMC

Prozessaudit

Effectivity

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VDA QMC

Overview Evaluation Potential Analysis

Order: 0

Supplier:

0

P2 Projectmanagement 1.1

0 0 0

Projectleader Project team

1.2

0 0 0

Project resources

1.3 Poject plan

0 0 0

1.4 Change management

0 0 0

1.5 Changes Customer / Supplier

P3 Planning product and process development 0 0 0

2.1 Customer requirements

0 0 0

0 0 0

1.7 Escalation process

0 0 0

P4 Realisation Product and Process Development

0 0 0

2.2 Feasibility

1.6 QM-Plan

3.1 FMEA Product FMEA Process

0 0 0

3.2 Eignung Release

0 0 0

Projecttransfer

0 0 0

Flow of Material

0 0 0

Storage Work-/

3.3 Start-up series

0 0 0

P5 Supply Managment 0 0 0

4.1 Released suppliers

4.2 Customer requirement Supply chain

0 0 0

4.3 Procurement Release product

0 0 0

4.4 Procurement Quality product

0 0 0

4.5 Storage Incoming goods

0 0 0

P6 Process Analysis / Production Production analysis / Input 5.1.1 Projecttransfer Development / series

0 0 0

Work content / Process-Flow 0 0 0

5.1.2 Storage Prematerial

5.2.1 Production guidance plan

0 0 0

5.2.2 Production systems

0 0 0

Process support / personal resources 5.3.1 Employee Qualification

0 0 0

Target product Target process

0 0 0

5.4.1 Maintenance Servicing

0 0 0

5.5.2 Analysis, Cause Effectivity

characteristics

0 0 0

5.2.4 Identification marking parts, defective parts

5.2.5

0 0 0

Material resources 0 0 0

Process efficiency 5.5.1

5.2.3 Specific

5.4.2 Measuring Testing

0 0 0

5.4.3 Workplace Test location

5.4.4 inspection equipment

0 0 0

Process result (Output) 5.5.3 Process / Product Audits

0 0 0

5.6.1 Compliance Customer requirements

0 0 0

P7 Customer Service/Customer satisfaction 6.1 QM-System Delivery

Amount evaluated Question

0

0 0 0 RED YELLOW GREEN

0 0 0

6.2 Part supply

0 0 0

Blocked supplier: Controlled supplier: Approved supplier:

(1X red or min. 15X yellow) (max. 14 X yellow and 0 X red) (max 7X yellow und 0 X red)

Rating

GREEN DRX_A_12.05.07_E D1_004

Prozessaudit

47/47

Qualification Time Schedule 0

Order:

0

Time Schedule Supplier Actions: Improvement program received

Date: 12/30/1899

I. Concretization and scheduling of the improvement program (14 days )

1/13/1900

II. Realization of the improvement program ( 12 weeks after order placement ) III. Self audit VDA 6.3 ( only if evaluated "GREEN" or "YELLOW" with order placement ) Description: The actions must be applied on a short-term basis. For extensive improvement programs it can be divided in several realization phases. Self audit: In order to get a knowledgeable evaluation of the self audit, we ask for information about the time spent for the audit (man-days) and the qualification of the deployed auditors. We assume that the time spent on the audit equals the time of a certification audit at a minium. The self audit must be performed in the project phase of the 0-series (Parts from series tools and systems). After receipt and proof of these documents, we define, if the result is "Level A", an appointment for our audit. In case of a result "Level B", we ask for a reasonable date for achieving "Level A". We expect the transmission of the following audit report without any additional request by DRX. Up-Qualification-Agreement: As part of the up-qualification-agreement, controlled suppliers are obligated to cooperate with a consultant, approved by the customer after receipt of order. The costs are paid by the supplier.

Auditor

Auditor

Signature Supplier

DRX_A_12.05.07_E D1_004