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4

                 Section:


Project management for product realisation
4.1.          Overview of manuals
       Manuals for the core tools of the automobile industry:

Topic:                QS9000 Manual: VDA Volume:
Advance Quality       APQP                 VDA4, VDA4.3
planning
Approval Process PPAP                      VDA2
Risk analysis         FMEA                 VDA4.2
Statistics            SPC                  VDA3.1-3.3
Spec.                 APQP / FMEA          VDA1
characteristics
Capability of test    MSA                  VDA5
equipment
4.2.       Field of application



  What for do I need it:

  “Guideline for support at
   launch of new products“



  With and without
  product development
4.2.           Field of application


Why do I need it?
 • It makes complex processes
 transparent
   and reproducible
 • It helps to prevent redundant activities
 • It offers a continous check in a project
 • It exonerates at product liabilities
 • It is a recommended demand of
   Daimler/Chrysler, Ford and General
   Motors (Opel)
4.2.     Field of application


Why do I need it?

                Are you sure
                   that our
                 calculation
                     was
                  correct??
4.2.        Field of application


        Reasons of customer
•In order to provide means which satisfy the
customer
•In order to identify necessary modifications as
early as possible
•In order to prevent late modifications
•In order to produce a quality product timely
with lowest costs
Goals
                Objective                     PLAN
                Supplement Information
                Standards
                Key persons Structure
                             Preparation
                             Meetings
ACT
                             Review
                             Closing

       Negative differences
       or corrective action plan
                                    Action plan
       or correction




                                                     DO
Positive differences
Stopp
Overtake benefits
Improve                   Plan conducted?
                          “Customer” happy?



                    CHECK
4.3.                Phase model

Concept Release Prototype          Pre-series   Series


   PLAN

      PRODUCT deve./engi.


        PROCESS development/engineering


                    PRODUCT & PROCESS validation



         Feedback, appraisal, corrections
4.3.            Phase model




        PLAN

          PRODUCT deve./engi.



INPUT      PROCESS development/engineering
                                                      OUTPUT
                       PRODUCT & PROCESS validation



            Feedback, appraisal, corrections
4.3.            Phase model


                 Dropped if no


         X
       PLAN
                 development responsibility
         PRODUCT deve./engi.


          PROCESS development/engineering


                      PRODUCT & PROCESS validation



           Feedback, appraisal, corrections
Customer
   Inquiry
               Whe
 New Product
                     n do
                         es i
  Contract
                             t   star
   review
                                      t   ?
    Offer


   Order



 APQP
4.4.             Development



  Definition according to QS9000:
  “If the supplier may compile or change specifications for
  the customer.“

Definition according to VDA6.1:
“If the supplier bears the written development
responsibility.“

  Supplement according to TS 16949:
  “Development then exists when the supplier specifies
  products in cooperation with the customer.“
4.4.                           Development


                  Supplier
                  Customer
                                    Idea


                                Specification
     Compiled
    by supplier                                  Compiled
  (Cooperation with customer
    or also in subcontract)
                                                by customer
4.5.          Basic prerequisites

Support of management
Capacities and means have to available; development order
placed in writing.
4.5.            Basic prerequisites
Overlapping team:
Employees of quality management, development
department, production, logistics, purchase, distribution, field
consulting, sub-suppliers and customers.
4.5.            Basic prerequisites
Define the volume!
•Define a team leader who keeps track of the planning
process.
•Defining of roles and responsibilities of each co-operating
sector.
•Define internal and external customers (interface matrix)
•Choose which methods, persons and sub-suppliers are
needed in the team and which not.
•Understanding of customer expectations
•Inspection of doability of provided design, reliability features
and manufacturing process.
•Costs, time and requirements have to be considered.
•Determine if support by customer is needed.
•Determine documentation process or method.
4.5.   Basic prerequisites




             Communication
4.5.        Basic prerequisites


SIMULTANEOUS ENGINEERING:

        ACTIVITY „A“

                    ACTIVITY „B“


                       ACTIVITY „C“


                    Total period
PLAN

  PRODUCT deve./engi.


   PROCESS development/engineering


               PRODUCT & PROCESS validation



    Feedback, appraisal, corrections
4.6.              Phase 1



The voice of the customer:
Complaints
Recommendations
Customer satisfaction analyses
Internal customer information
Market surveys
Warranties / liabilities
Quality analyses
Experiences of the team
4.6.                 Phase 1



Defaults of the business plan:
Market strategies
Timing
Investments
Budget
Customer areas
Turnovers
Competition
4.6.                 Phase 1



Product and process benchmarking:
Ascertain „best in class“
Define and understand deficiencies
Compile a plan in order to fill the gap
Repeat analysis
4.6.                Phase 1



Product and process assumptions:
Design concepts
Innovations
New techniques
Modern materials
4.6.                Phase 1



Product reliability analysis:
Repair
Spare part market
Endurance tests
4.6.               Phase 1



Customer information:
Information of next user (customer and end customer)
Needs and expectations
Inspections and tests of customer
Customer satisfaction bar
4.6.               Phase 1



Development targets:

                        Measurable
Customer expectations
                          values
4.6.                Phase 1



     Reliability and quality targets:
                           Reliability targets:
                           •probabilities
                           •confidence limits
•Customer expectations
•Benchmark analysis      Quality targets:
•Reports, statistics     •targets of continual improvement
•Repairs                 •e.g.: PPM. Reduction of rejects, error margins
4.6.              Phase 1


Preliminary process flow plan:


        •Material list
        •Product assumption
        •Process assumption
4.6.                        Phase 1

Preliminary listing of specific features:
 Definition:
 “Features which have effect on safety and/or fulfilment of
 legal restraints resp. are functional important.“


          •Given by customer.
          •Ascertained by supplier (at design responsibility).



 INPUTS: product assumptions, customer information, FMEA of similar parts
PLAN

  PRODUCT deve./engi.


   PROCESS development/engineering


               PRODUCT & PROCESS validation



    Feedback, appraisal, corrections
4.7.                Phase 2


Design FMEA:
“Methodical analysis of all possible potential errors of a
   design,
their effect and importance on the customer as well as
   planning
and operating of activities for risk reduction.“
4.7.             Phase 2


Design for manufacturing and
 assembly:

                           MANUFACTURING
       PRODUCT

                             ASSEMBLY
4.7.    Phase 2




       The activities of phase 1
       have to lead to this that
       the design result fulfils the
       design defaults
4.7.        Phase 2




         Design defaults              Design result
       (requirement specification,    (CAD, drawing,
             inputs phase 1)         specification etc.)
4.7.              Phase 2

Regularly Design Reviews:
Meetings in order to determine if the given plan is
observed:

•    Consider design/function
•    Reliability and confidence targets
•    Components, sub-systems and systems
•    Computer simulations, Benchmark
•    DFMEA
•    Checking of producibility and assembly
•    DOE methods
•    Test errors
4.7.                  Phase 2

“Control plans are written descriptions of systems which
serve for this to dominate parts and processes.“

It differs in:

•Prototype – A description of dimensional measurements, material
and performance tests which are carried out during prototype
phase.
•Pre-series – A description of dimensional measurements, material
and performance tests which are carried out after prototype phase
but before series.
•Series – A comprehensive documentation of product/process
features, process control inspections and measuring systems
which are carried out during mass production.
4.7.             Phase 2



Manufacturing of the prototype has to lead to this
  that…

•    the product fulfils the specification resp.
     provides required data.
•    specific product and process features have
     been considered.
•    data and information are used in order to define
     preliminary process parameters and packaging
     standards.
•    all doubts, deviations and influences are
     reported
     to the customer.
4.7.         Phase 2



Preparation of engineering drawing
          •Legal demands
          •Safety features
          •Determination of features for „fit & function“
          •Tolerated dimensions
          •Documented inspection of the drawing
4.7.         Phase 2



Preparation of engineering drawing

          Test equipment available for all features?
          Dimensions producible?
          CAD data compatible to customer?
4.7.               Phase 2


Preparation of technical specifications
       (can be included in engineering drawing!)

               Functional requirements
               Reliability requirements
               Features dependent on appearance

               (Kind of inspection, volume,
               frequentness and carrying out are
               defined in standards, specifications,
               test instructions and control plans,
               etc.)
4.7.               Phase 2


Preparation of material specification
       (can be included in engineering drawing!)


               Have to be tested with reference to:
               Specific features
               Physical characteristics
               Performance
               Environment (disposal)
               Handling
               Stocking (conservation)
4.7.                  Phase 2


        New equipment, tools
            and facilities
  Tools = Formative means of production
  Equipment = Constructive auxiliary means of production
  Facility = New areas, assembly line and plant extensions


  •Include into schedule
  •Tools and equipment have to be process-capable
  •Delivered and provided in time
4.7.                Phase 2


Discussion which specific features are determined
(basis is the preliminary determination of phase 1)



  •Find accordance (involve customers)
  •Consult attachment C of QS 9000 (determinations of features)
  •Include into control plan
  •Consider customer release procedure
  •Consider documentation requirements
  •Use auxiliary means APQP forms
4.7.            Phase 2




       Determination of
       requirements on all test
       equipment and teachings.
       => include into schedule and monitoring!
4.7.                  Phase 2

 Team doability declaration:
 The APQP team confirms in writing that the
 suggested design…
 1. can be manufactured
 2. can be assembled (if claimed)
 3. can be verified positively
 4. can be packaged
 5. can be delivered
 ... in satisfying quality and quantity as well as
      according to given costs.

Attention! Please use form „Team Feasibility Commitment“
PLAN

  PRODUCT deve./engi.


   PROCESS development/engineering


               PRODUCT & PROCESS validation



    Feedback, appraisal, corrections
4.8.            Phase 3


  Packaging standars are given by customer and
  have to be worked into the own QM-system.

Packaging specifications are
developed by supplier and
have to be worked into the
own QM-system. Thereby it
has to be considered how far
packaging has effect on
product quality (drop test,
conservation, etc.)
4.8.                 Phase 3


            Inspection of QM-system

•Inspection and practice of any modifications into the QM-manual
•Involvement of process and work instructions
•Regeneration of necessary documents and forms
4.8.            Phase 3


             Matrix of features


Appropriation of features (product and process)
to a process.

 •The more product features are influenced by a
 process the more important is the control on
 this process!
4.8.               Phase 3


Process FMEA:
“Methodical analysis of all possible potential errors of all
processes, their effect and importance on the customer as
   well
as planning and operating of activities for risk reduction.“

                     Basis:
                Process flow plan
4.8.           Phase 3




           Differences to series control plan:

           •     Higher frequented inspections
           •     More in-process and final inspections
           •     Statistical analyses
           •     Stronger audits (product and process)



       Comment: With pre-series SAMPLES are
       meant.
4.8.               Phase 3

Information at machines:
•    Name of process (relevant to process flow chart)
•    Name of part and number
•    Revision status
•    Tools, equipment and test equipment information
•    Material and disposal instructions
•    Demands on specific features
•    SPC requirements
•    Necessary norms / standards
•    Inspection and test instructions
•    Reaction plans
•    Visual auxiliary means
•    Tool change intervals and facility instructions
4.8.                  Phase 3

          Measurement System Analysis
                   (MSA)

 A measuring process contains diversifications

 Every ascertained measured value consists of
 •every real value and
 •measurement error.

 Measurement error is caused by
 •diversification influences of measuring equipment and
 •diversification influences of the inspector or the measuring
 method.

 Measurement error consists of
 a systematic error and
 a random error.
4.8.                Phase 3


          Statistical Process Control
                      (SPC)


Analysing of proceedings
with the target to dominate the process.
Determination of preliminary process capability
on real fabrication conditions.
Determination of continous process capability
on real fabrication conditions.
PLAN

  PRODUCT deve./engi.


   PROCESS development/engineering


               PRODUCT & PROCESS validation



    Feedback, appraisal, corrections
4.8.               Phase 4

PRODUCTION ATTEMPT
Production attempt should be carried
out as possible on close-to-production
conditions :
•Tool
•Equipment
•Environment
•Material
•Staff
•Plant areas
4.8.               Phase 4

PRODUCTION ATTEMPT
The quantity to manufacture has to be
clarified with the customer. Targets of
pilot production are:
•Preliminary process capability studies
•Evaluation of capability of measuring
 equipment
•Process inspection
•Production validation
•Production parts release
•Inspection of packaging
•„Sign Off“
4.8.              Phase 4


         Measurement System Analysis
                  (MSA)


 All in control plan listed measuring
 equipment is taken a inspection of capability
 of measuring equipment according to
 method MSA of QS 9000.
 Only test equipment for fabrication is
 allowed to put in which does not exceed
 demonstrably a maximum R&R value of
 30%.
4.8.              Phase 4

             Results of preliminary process capability
                               (SPC)
Only at features given by customer or own determination.
Arrange procedure with customer:

1.   Take parts
2.   Measure parts
3.   Determine standard deviation
4.   Determine PPK values
4.8.                           Phase 4

                            Production part approval process
                                        (PPAP)

  •Ensure that the supplier understands all customer
   requirements and can translate these in
  processes
   and products which meet customer
   requirements


Comment:
On the subject of PPAP, a separate course can be attended!
4.8.             Phase 4


Inspection of packaging


 •Stock test
 •Conditioning
 •Drop test
 •Road trial
4.8.                Phase 4



DEFINITION:

“A comprehensive documentation of product/process
features, process control inspections and measuring
systems which are carried out during mass production.“
4.8.               Phase 4



DEFINITION:

The quality planning team should ensure that all
process flows and control plans are realised.
It is recommended to carry out and document the
“sign off“ in the production plant.
4.8.               Phase 4



The „Sign off“ should enclose the following points:

1. Control plans should exist and be available at
   any time at locations which need these for
   realisation of contents.
2. It should be checked that all process
   instructions considered the specified specific
   features which are mentioned in the control
   plan. Recommendations of process FMEA
   should have been realised.
3. With special test equipment or in control plan
   mentioned test equipment, a successful
   inspection of capability of test equipment
   should be present.
PLAN

  PRODUCT deve./engi.


   PROCESS development/engineering


               PRODUCT & PROCESS validation



    Feedback, appraisal, corrections

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Apqp+english+version[1]

  • 1. 4 Section: Project management for product realisation
  • 2. 4.1. Overview of manuals Manuals for the core tools of the automobile industry: Topic: QS9000 Manual: VDA Volume: Advance Quality APQP VDA4, VDA4.3 planning Approval Process PPAP VDA2 Risk analysis FMEA VDA4.2 Statistics SPC VDA3.1-3.3 Spec. APQP / FMEA VDA1 characteristics Capability of test MSA VDA5 equipment
  • 3. 4.2. Field of application What for do I need it: “Guideline for support at launch of new products“ With and without product development
  • 4. 4.2. Field of application Why do I need it? • It makes complex processes transparent and reproducible • It helps to prevent redundant activities • It offers a continous check in a project • It exonerates at product liabilities • It is a recommended demand of Daimler/Chrysler, Ford and General Motors (Opel)
  • 5. 4.2. Field of application Why do I need it? Are you sure that our calculation was correct??
  • 6. 4.2. Field of application Reasons of customer •In order to provide means which satisfy the customer •In order to identify necessary modifications as early as possible •In order to prevent late modifications •In order to produce a quality product timely with lowest costs
  • 7. Goals Objective PLAN Supplement Information Standards Key persons Structure Preparation Meetings ACT Review Closing Negative differences or corrective action plan Action plan or correction DO Positive differences Stopp Overtake benefits Improve Plan conducted? “Customer” happy? CHECK
  • 8. 4.3. Phase model Concept Release Prototype Pre-series Series PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 9. 4.3. Phase model PLAN PRODUCT deve./engi. INPUT PROCESS development/engineering OUTPUT PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 10. 4.3. Phase model Dropped if no X PLAN development responsibility PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 11. Customer Inquiry Whe New Product n do es i Contract t star review t ? Offer Order APQP
  • 12. 4.4. Development Definition according to QS9000: “If the supplier may compile or change specifications for the customer.“ Definition according to VDA6.1: “If the supplier bears the written development responsibility.“ Supplement according to TS 16949: “Development then exists when the supplier specifies products in cooperation with the customer.“
  • 13. 4.4. Development Supplier Customer Idea Specification Compiled by supplier Compiled (Cooperation with customer or also in subcontract) by customer
  • 14. 4.5. Basic prerequisites Support of management Capacities and means have to available; development order placed in writing.
  • 15. 4.5. Basic prerequisites Overlapping team: Employees of quality management, development department, production, logistics, purchase, distribution, field consulting, sub-suppliers and customers.
  • 16. 4.5. Basic prerequisites Define the volume! •Define a team leader who keeps track of the planning process. •Defining of roles and responsibilities of each co-operating sector. •Define internal and external customers (interface matrix) •Choose which methods, persons and sub-suppliers are needed in the team and which not. •Understanding of customer expectations •Inspection of doability of provided design, reliability features and manufacturing process. •Costs, time and requirements have to be considered. •Determine if support by customer is needed. •Determine documentation process or method.
  • 17. 4.5. Basic prerequisites Communication
  • 18. 4.5. Basic prerequisites SIMULTANEOUS ENGINEERING: ACTIVITY „A“ ACTIVITY „B“ ACTIVITY „C“ Total period
  • 19. PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 20. 4.6. Phase 1 The voice of the customer: Complaints Recommendations Customer satisfaction analyses Internal customer information Market surveys Warranties / liabilities Quality analyses Experiences of the team
  • 21. 4.6. Phase 1 Defaults of the business plan: Market strategies Timing Investments Budget Customer areas Turnovers Competition
  • 22. 4.6. Phase 1 Product and process benchmarking: Ascertain „best in class“ Define and understand deficiencies Compile a plan in order to fill the gap Repeat analysis
  • 23. 4.6. Phase 1 Product and process assumptions: Design concepts Innovations New techniques Modern materials
  • 24. 4.6. Phase 1 Product reliability analysis: Repair Spare part market Endurance tests
  • 25. 4.6. Phase 1 Customer information: Information of next user (customer and end customer) Needs and expectations Inspections and tests of customer Customer satisfaction bar
  • 26. 4.6. Phase 1 Development targets: Measurable Customer expectations values
  • 27. 4.6. Phase 1 Reliability and quality targets: Reliability targets: •probabilities •confidence limits •Customer expectations •Benchmark analysis Quality targets: •Reports, statistics •targets of continual improvement •Repairs •e.g.: PPM. Reduction of rejects, error margins
  • 28. 4.6. Phase 1 Preliminary process flow plan: •Material list •Product assumption •Process assumption
  • 29. 4.6. Phase 1 Preliminary listing of specific features: Definition: “Features which have effect on safety and/or fulfilment of legal restraints resp. are functional important.“ •Given by customer. •Ascertained by supplier (at design responsibility). INPUTS: product assumptions, customer information, FMEA of similar parts
  • 30. PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 31. 4.7. Phase 2 Design FMEA: “Methodical analysis of all possible potential errors of a design, their effect and importance on the customer as well as planning and operating of activities for risk reduction.“
  • 32. 4.7. Phase 2 Design for manufacturing and assembly: MANUFACTURING PRODUCT ASSEMBLY
  • 33. 4.7. Phase 2 The activities of phase 1 have to lead to this that the design result fulfils the design defaults
  • 34. 4.7. Phase 2 Design defaults Design result (requirement specification, (CAD, drawing, inputs phase 1) specification etc.)
  • 35. 4.7. Phase 2 Regularly Design Reviews: Meetings in order to determine if the given plan is observed: • Consider design/function • Reliability and confidence targets • Components, sub-systems and systems • Computer simulations, Benchmark • DFMEA • Checking of producibility and assembly • DOE methods • Test errors
  • 36. 4.7. Phase 2 “Control plans are written descriptions of systems which serve for this to dominate parts and processes.“ It differs in: •Prototype – A description of dimensional measurements, material and performance tests which are carried out during prototype phase. •Pre-series – A description of dimensional measurements, material and performance tests which are carried out after prototype phase but before series. •Series – A comprehensive documentation of product/process features, process control inspections and measuring systems which are carried out during mass production.
  • 37. 4.7. Phase 2 Manufacturing of the prototype has to lead to this that… • the product fulfils the specification resp. provides required data. • specific product and process features have been considered. • data and information are used in order to define preliminary process parameters and packaging standards. • all doubts, deviations and influences are reported to the customer.
  • 38. 4.7. Phase 2 Preparation of engineering drawing •Legal demands •Safety features •Determination of features for „fit & function“ •Tolerated dimensions •Documented inspection of the drawing
  • 39. 4.7. Phase 2 Preparation of engineering drawing Test equipment available for all features? Dimensions producible? CAD data compatible to customer?
  • 40. 4.7. Phase 2 Preparation of technical specifications (can be included in engineering drawing!) Functional requirements Reliability requirements Features dependent on appearance (Kind of inspection, volume, frequentness and carrying out are defined in standards, specifications, test instructions and control plans, etc.)
  • 41. 4.7. Phase 2 Preparation of material specification (can be included in engineering drawing!) Have to be tested with reference to: Specific features Physical characteristics Performance Environment (disposal) Handling Stocking (conservation)
  • 42. 4.7. Phase 2 New equipment, tools and facilities Tools = Formative means of production Equipment = Constructive auxiliary means of production Facility = New areas, assembly line and plant extensions •Include into schedule •Tools and equipment have to be process-capable •Delivered and provided in time
  • 43. 4.7. Phase 2 Discussion which specific features are determined (basis is the preliminary determination of phase 1) •Find accordance (involve customers) •Consult attachment C of QS 9000 (determinations of features) •Include into control plan •Consider customer release procedure •Consider documentation requirements •Use auxiliary means APQP forms
  • 44. 4.7. Phase 2 Determination of requirements on all test equipment and teachings. => include into schedule and monitoring!
  • 45. 4.7. Phase 2 Team doability declaration: The APQP team confirms in writing that the suggested design… 1. can be manufactured 2. can be assembled (if claimed) 3. can be verified positively 4. can be packaged 5. can be delivered ... in satisfying quality and quantity as well as according to given costs. Attention! Please use form „Team Feasibility Commitment“
  • 46. PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 47. 4.8. Phase 3 Packaging standars are given by customer and have to be worked into the own QM-system. Packaging specifications are developed by supplier and have to be worked into the own QM-system. Thereby it has to be considered how far packaging has effect on product quality (drop test, conservation, etc.)
  • 48. 4.8. Phase 3 Inspection of QM-system •Inspection and practice of any modifications into the QM-manual •Involvement of process and work instructions •Regeneration of necessary documents and forms
  • 49. 4.8. Phase 3 Matrix of features Appropriation of features (product and process) to a process. •The more product features are influenced by a process the more important is the control on this process!
  • 50. 4.8. Phase 3 Process FMEA: “Methodical analysis of all possible potential errors of all processes, their effect and importance on the customer as well as planning and operating of activities for risk reduction.“ Basis: Process flow plan
  • 51. 4.8. Phase 3 Differences to series control plan: • Higher frequented inspections • More in-process and final inspections • Statistical analyses • Stronger audits (product and process) Comment: With pre-series SAMPLES are meant.
  • 52. 4.8. Phase 3 Information at machines: • Name of process (relevant to process flow chart) • Name of part and number • Revision status • Tools, equipment and test equipment information • Material and disposal instructions • Demands on specific features • SPC requirements • Necessary norms / standards • Inspection and test instructions • Reaction plans • Visual auxiliary means • Tool change intervals and facility instructions
  • 53. 4.8. Phase 3 Measurement System Analysis (MSA) A measuring process contains diversifications Every ascertained measured value consists of •every real value and •measurement error. Measurement error is caused by •diversification influences of measuring equipment and •diversification influences of the inspector or the measuring method. Measurement error consists of a systematic error and a random error.
  • 54. 4.8. Phase 3 Statistical Process Control (SPC) Analysing of proceedings with the target to dominate the process. Determination of preliminary process capability on real fabrication conditions. Determination of continous process capability on real fabrication conditions.
  • 55. PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections
  • 56. 4.8. Phase 4 PRODUCTION ATTEMPT Production attempt should be carried out as possible on close-to-production conditions : •Tool •Equipment •Environment •Material •Staff •Plant areas
  • 57. 4.8. Phase 4 PRODUCTION ATTEMPT The quantity to manufacture has to be clarified with the customer. Targets of pilot production are: •Preliminary process capability studies •Evaluation of capability of measuring equipment •Process inspection •Production validation •Production parts release •Inspection of packaging •„Sign Off“
  • 58. 4.8. Phase 4 Measurement System Analysis (MSA) All in control plan listed measuring equipment is taken a inspection of capability of measuring equipment according to method MSA of QS 9000. Only test equipment for fabrication is allowed to put in which does not exceed demonstrably a maximum R&R value of 30%.
  • 59. 4.8. Phase 4 Results of preliminary process capability (SPC) Only at features given by customer or own determination. Arrange procedure with customer: 1. Take parts 2. Measure parts 3. Determine standard deviation 4. Determine PPK values
  • 60. 4.8. Phase 4 Production part approval process (PPAP) •Ensure that the supplier understands all customer requirements and can translate these in processes and products which meet customer requirements Comment: On the subject of PPAP, a separate course can be attended!
  • 61. 4.8. Phase 4 Inspection of packaging •Stock test •Conditioning •Drop test •Road trial
  • 62. 4.8. Phase 4 DEFINITION: “A comprehensive documentation of product/process features, process control inspections and measuring systems which are carried out during mass production.“
  • 63. 4.8. Phase 4 DEFINITION: The quality planning team should ensure that all process flows and control plans are realised. It is recommended to carry out and document the “sign off“ in the production plant.
  • 64. 4.8. Phase 4 The „Sign off“ should enclose the following points: 1. Control plans should exist and be available at any time at locations which need these for realisation of contents. 2. It should be checked that all process instructions considered the specified specific features which are mentioned in the control plan. Recommendations of process FMEA should have been realised. 3. With special test equipment or in control plan mentioned test equipment, a successful inspection of capability of test equipment should be present.
  • 65. PLAN PRODUCT deve./engi. PROCESS development/engineering PRODUCT & PROCESS validation Feedback, appraisal, corrections

Notes de l'éditeur

  1. In der Einleitung der QS 9000 auf der Seite 1 sind Ziel und Zweck der QS 9000 deutlich erwähnt. Der Punkt der ständigen Verbesserung spiegelt sich in allen Bereichen der Elemente der QS 9000 wieder. Er spielt eine wichtige Rolle und wird ebenfalls noch als separates Element in Hauptabschnitt 2 erwähnt. Das gleiche gilt natürlich für die Fehlervermeidung, die schon in der ISO 9001 ihre Andeutung durch die dort erwähnten Vorbeugemaßnahmen fand, nach dem Motto - Vorbeugung vor Entdeckung. Die QS 9000 beschäftigt sich im Gegensatz zu der ISO 9000er Reihe stärker mit wirtschaftlichen Aspekten, wie z.B. die Verminderung von Streuungen in Prozessen und Minimierung von Verschwendungen innerhalb des Wertschöpfungsprozesses des Lieferanten. Der Zweck dieses Standards besteht darin einheitliche Forderungen von Opel, Ford, Chrysler (auch “big three” genannt) und Truck Herstellern an die Lieferanten weiterzugeben, um ein einheitliches Managementsystem zu schaffen mit dem Endziel eine dauernde Kundenzufriedenheit zu gewährleisten.
  2. (QS 9000 Seite 29 / 4.9.2) Als erstes müßen Sie prüfen, ob eine Normalverteilung Ihrer Meßwerte in Form einer Gaußschen Glockenkurve vorliegt entweder durch optische Tests oder statistische Berechnungsmethoden und ob Sie die Forderungen der vorläufigen Prozeßfähigkeit erfüllen. Ist dies nicht der Fall, ist Ihr Prozess nicht von Ihnen beherrscht. Berechnen Sie dann die Standardabweichung S, aber über die Einzelstandardabweichungen aller Stichproben, denn das ist der wesentliche Unterschied zum Cpk-Wert. Die Berechnung bezieht sich auf einen Zeitraum von mehr als 30 Arbeitstagen, d.h. man geht davon aus, daß ungefähr alle Einflußgrößen in dieser Berechnung mit einfließen. Berechnen Sie auf Basis der angegebenen Spezifikationswerte und der errechneten Standardabweichung den Cpk Wert, der dann >/= 1,33 sein muß.
  3. (QS 9000 Seite 19 / 4.4.9) Um zu gewährleisten, daß alle Lieferanten die Kundenforderungen korrekt verstehen, wurde das PPAP-Handbuch veröffentlicht, deren Einhaltung eine Forderung für TIER 1 Lieferanten ist. Zu den oben genannten Fälle (Neue Produkte oder Teile, Korrekturen an Produkten oder Teilen und Produkt- oder Teilemodifikationen) kommen folgende Situationen hinzu, bei denen das PPAP-Handbuch angewendet werden muß: *Benutzung von anderem Konstruktions- oder Rohmaterial *Produktion mittels neuen oder modifizierten Werkzeugen *Änderung in Prozeß oder Methode der Herstellung *Änderungen von Unterlieferanten *Produktionswiderbelebung nach Stillstand von mindestens 12 Monaten
  4. (QS 9000 Seite 29 / 4.9.2) Als erstes müßen Sie prüfen, ob eine Normalverteilung Ihrer Meßwerte in Form einer Gaußschen Glockenkurve vorliegt entweder durch optische Tests oder statistische Berechnungsmethoden und ob Sie die Forderungen der vorläufigen Prozeßfähigkeit erfüllen. Ist dies nicht der Fall, ist Ihr Prozess nicht von Ihnen beherrscht. Berechnen Sie dann die Standardabweichung S, aber über die Einzelstandardabweichungen aller Stichproben, denn das ist der wesentliche Unterschied zum Cpk-Wert. Die Berechnung bezieht sich auf einen Zeitraum von mehr als 30 Arbeitstagen, d.h. man geht davon aus, daß ungefähr alle Einflußgrößen in dieser Berechnung mit einfließen. Berechnen Sie auf Basis der angegebenen Spezifikationswerte und der errechneten Standardabweichung den Cpk Wert, der dann >/= 1,33 sein muß.
  5. (QS 9000 Seite 29 / 4.9.2) Als erstes müßen Sie prüfen, ob eine Normalverteilung Ihrer Meßwerte in Form einer Gaußschen Glockenkurve vorliegt entweder durch optische Tests oder statistische Berechnungsmethoden und ob Sie die Forderungen der vorläufigen Prozeßfähigkeit erfüllen. Ist dies nicht der Fall, ist Ihr Prozess nicht von Ihnen beherrscht. Berechnen Sie dann die Standardabweichung S, aber über die Einzelstandardabweichungen aller Stichproben, denn das ist der wesentliche Unterschied zum Cpk-Wert. Die Berechnung bezieht sich auf einen Zeitraum von mehr als 30 Arbeitstagen, d.h. man geht davon aus, daß ungefähr alle Einflußgrößen in dieser Berechnung mit einfließen. Berechnen Sie auf Basis der angegebenen Spezifikationswerte und der errechneten Standardabweichung den Cpk Wert, der dann >/= 1,33 sein muß.
  6. (QS 9000 Seite 29 / 4.9.2) Als erstes müßen Sie prüfen, ob eine Normalverteilung Ihrer Meßwerte in Form einer Gaußschen Glockenkurve vorliegt entweder durch optische Tests oder statistische Berechnungsmethoden und ob Sie die Forderungen der vorläufigen Prozeßfähigkeit erfüllen. Ist dies nicht der Fall, ist Ihr Prozess nicht von Ihnen beherrscht. Berechnen Sie dann die Standardabweichung S, aber über die Einzelstandardabweichungen aller Stichproben, denn das ist der wesentliche Unterschied zum Cpk-Wert. Die Berechnung bezieht sich auf einen Zeitraum von mehr als 30 Arbeitstagen, d.h. man geht davon aus, daß ungefähr alle Einflußgrößen in dieser Berechnung mit einfließen. Berechnen Sie auf Basis der angegebenen Spezifikationswerte und der errechneten Standardabweichung den Cpk Wert, der dann >/= 1,33 sein muß.
  7. (QS 9000 Seite 29 / 4.9.2) Als erstes müßen Sie prüfen, ob eine Normalverteilung Ihrer Meßwerte in Form einer Gaußschen Glockenkurve vorliegt entweder durch optische Tests oder statistische Berechnungsmethoden. Ist dies nicht der Fall, ist Ihr Prozess nicht von Ihnen beherrscht. Berechnen Sie dann die Standardabweichung S, aber über die gesamte Streuung aller Meßwerte, denn das ist der wesentliche Unterschied zum Ppk-Wert. Die Berechnung bezieht sich auf einen Zeitraum von unter 30 Arbeitstagen, d.h. man geht davon aus, daß noch nicht alle Einflußgrößen in dieser Berechnung mit einfließen. Berechnen Sie auf Basis der angegebenen Spezifikationswerte und der errechneten Standardabweichung den Ppk Wert, der dann >/= 1,67 sein muß.
  8. (QS 9000 Seite 19 / 4.4.9) Um zu gewährleisten, daß alle Lieferanten die Kundenforderungen korrekt verstehen, wurde das PPAP-Handbuch veröffentlicht, deren Einhaltung eine Forderung für TIER 1 Lieferanten ist. Zu den oben genannten Fälle (Neue Produkte oder Teile, Korrekturen an Produkten oder Teilen und Produkt- oder Teilemodifikationen) kommen folgende Situationen hinzu, bei denen das PPAP-Handbuch angewendet werden muß: *Benutzung von anderem Konstruktions- oder Rohmaterial *Produktion mittels neuen oder modifizierten Werkzeugen *Änderung in Prozeß oder Methode der Herstellung *Änderungen von Unterlieferanten *Produktionswiderbelebung nach Stillstand von mindestens 12 Monaten
  9. (QS 9000 Seite 34 / 4.10.5) Muster- und Funktionsprüfungen sind für alle Produkte in von Kunden vorgegebenen Frequenzen durchzuführen. Die Ergebnisse müssen den Kunden auf Forderung zur Einsicht vorgelegt werden.