Production Part Approval Process 4 th Edition

Production Part Approval Process 4 th Edition 13.01.2007 Seite 1 It s the goal of this lecture to to show you the basic content and the rules of the Production Part Approval Process and to explain the purpose and the background but this lecture will not save you from learning how to practically use this system 13.01.2007 Seite 2

Notes to This Lecture this lecture was created for training purposes only; it is not an extensive description, but a help for getting started view of contents, basic idea and goals The content of this lecture shall not be used as a reference for daily work Please make sure that you are working only with original latest level documents Creating this lecture, the valid standards of Dec 2006 were used This lecture does not refer to customer specific requirements, nor to special rules/requirements for bulk materials, tires, nor truck industry! Standards mentioned in this lecture can be obtained from the institutions listed in section 6. Internet Links 13.01.2007 Seite 3 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 6. Internet Links 13.01.2007 Seite 4

1. Introduction it is the purpose of advanced quality management to prevent that unreliable designs or processes are used in serial production therefore it is necessary to have one extensive, strict approval process for new or changed designs or processes inevitably this process causes some administration work but its worth while because it reduces the production of muda! 13.01.2007 Seite 5 Saving by taking advantage of the Rule Of The 10 : The cost of the remedy of a defect increases tenfold with every step, the project advances! Early identification of a defect EXPENSES...saves the major part of the cost! PROJECT TIME 13.01.2007 Seite 6

Savings by avoiding the 7+1 muda errors over production stock muda in the process muda unnecessary movement unnecessary transport waiting time Design ignoring the customer s expectations 13.01.2007 Seite 7 Too high stocks... take space raise assets employed require additional searching require additional administration require additional transport are a risk, because parts might exceed expiration date or become unsaleable are a risk, because parts might be damaged complicate the overview are often a consequence of a weak process cover weak process 13.01.2007 Seite 8

Requirement for low stocks... are controlled and capable processes and Total Productive Maintenance since all kind of process problems will cause delivery stops, if the stocks are low! lower stocks 13.01.2007 Seite 9 Advantages of controlled & capable production processes satisfied customers by good quality and avoided muda no scrap, no rework constant flow of material low stocks possible 13.01.2007 Seite 10

According to QS-9000... such an extensive and strict process is an obligatory requirement (cp. QS-9000, main section I) the name of this process is Production Part Approval Process its explanation is one QS-9000 reference manual QS-9000 13.01.2007 Seite 11 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 12

2. Content of the QS-9000 Introduction Section 1 General Section 2 Process Requirements Section 3 Customer Notification and Submission Requirements Section 4 Submission Levels Section 5 Part Submission Status Section 6 Record Retention Manufacturer Specific Requirements Will not be discussed here! are to be found in internet OEM Homepages or 13.01.2007 Seite 13 Appendicies Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Completion of the Part Submission Warrant Completion of the Appearance Approval Report, Dimensional Results, Material Test Results, Performance Test Results Bulk Material - Specific Requirements Tires - Specific Requirements Truck Industry - Specific Requirements Glossary 13.01.2007 Seite 14

Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 15 is, so to speak, the goal of APQP... APQP makes sure that all requirements are recognized before the Product Development is started that those special characteristics of the product are specified which influence these requirements that it is verified again and again that the planed design can safely meet these requirements, if the special characteristics are within tolerance that only those production processes are specified, which are controlled and capable according to SPC regarding these characteristics A test production and are used to validate that all processes are under control and capable the produced parts fulfil all requirements 13.01.2007 Seite 16

Purpose and Applicability It is the purpose of to define generic requirements for production part approval determine if all customer engineering design record and specification requirements are properly understood by the organization determine that the manufacturing process has the potential to produce the product consistently meeting these requirements during an actual production run at the quoted production rate Applicability (, Introduction) shall apply to internal and external organization sites supplying production or service parts, production materials or bulk materials. For bulk material is not required unless specified by the customer a supplier of standard catalogue production or service parts shall comply with unless formally waived by the customer 13.01.2007 Seite 17 Submission of The organization shall obtain full approval from the authorized customer product approval activity for: 1. a new part or product 2. correction of a discrepancy on a previously submitted part 3. product modified by an engineering change to design records specifications materials 4. any situations required by section 3 Note: If there is any question concerning the need for, contact the authorized customer representative. 13.01.2007 Seite 18

Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 19 (2.) 2. Process Requirements 2.1 Significant Production Run 2.2 Requirements 2.2.1 2.2.2 2.2.18 Requirements describing the details of documentation to be attached Will be discussed in chapter 4 of this presentation! 13.01.2007 Seite 20

(2.)2.1 Significant Production Run Products for shall be taken from a significant production run This production run shall be from one hour to eight hours of production, and with the specific production quantity to total a minimum of 300 consecutive parts, unless otherwise specified by the authorized customer representative This significant production run shall be conducted at the production, at the production rate, using the production tooling, production gaging, production process, production materials, and production operators. Parts from each unique production process, e.g. duplicate assembly line and/or work cell, each position of a multiple cavity die, mold, tool or pattern, shall be measured and representative parts tested 13.01.2007 Seite 21 (2.)2.2 Requirements the supplier shall meet all specified requirements as listed in this handbook and all customer-specific requirements Production parts shall meet all customer engineering design record and specification requirements including safety and regulatory requirements If any part specification cannot be met, the organization shall document their problem-solving efforts and shall contact the authorized customer representative for concurrence in determination of appropriate corrective action. 13.01.2007 Seite 22

View over the documentations to be created (see chapter 4 of this presentation for details) Warrant 13.01.2007 Seite 23 Content of the documentation to be created 1. Design Record 2. Authorized Engineering Change Documents 3. Customer Engineering Approval 4. Design-FMEA 5. Process Flow Diagram(s) 6. Process-FMEA 7. Control Plan 8. Measurement System Analysis Studies 9. Dimensional Results 10. Records of Material/ Performance Test Results 11. Initial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report 14. Sample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18. Part Submission Warrant 13.01.2007 Seite 24

Paperwork or EDP?? all forms mentioned in this document may be replaced by identical computer generated forms these documents have to be approved by the customer product approval activity before first submission at Adare Carwin a floppy with all forms can be obtained 13.01.2007 Seite 25 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 26

2.3. Customer Notification and Submission Requirements(, Section 3) 1. Customer Notification The organization shall notify the authorized customer representative of any planned changes to the design, process or site. Examples are indicated in Table 3.1 Notification of all changes to desing nad process is the the organization s resonsibility. Upon notification and approval of the proposed change by the authorized customer representative, and after change implementation, submission is required unless otherwise specified 2. Submission to Customer The organization shall submit for approval prior to the first production shipment in the following situations (see Table I.3.2) unless the authorized customer representative has waived this requirement. The organization shall review and update all applicable items in the file to reflect the production process, regardless of whether or not the customer requests a formal submission. The file shall contain the name of the authorized customer representative granting the waiver and the date. 13.01.2007 Seite 27 Table 3.1: Customer Notification Required 1. use of other construction or material than was used in the previously approved part or product 2. production from new or modified tools (except perishable tools), dies, molds, patterns, etc., including additional or replacement tooling 3. production following refurbishment or rearrangement of existing tooling or equipment 4. production from tooling and equipment transferred to a different plant location or from a additional plant location. 5. change of subcontractor for parts, non-equivalent materials or services (e.g.: heat-treating, plating) that affect customer fit, form, function, durability, or performance requirements 6. product produced after tooling has been inactive for volume production for twelve months or more 7. product and process changes that impact fit, form, function, performance, and/or durability of the salable product 13.01.2007 Seite 28

Table 3.2: Submission to Customer 1. a new part or product (i.e.: a specific part, material, or color not previously supplied to this specific customer) 2. correction of a discrepancy on a previously submitted part 3. engineering changes to design records, specifications, or materials for production product/part number(s) 4. bulk material only: process technology new to the supplier, not previously used for this product 13.01.2007 Seite 29 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 30

2.4. Submission Levels Note: The content of the documentation to be generated is always the same! The supplier has to retain everything (e.g.. as a copy)! the Submission Level just indicates what has to be submitted to the customer! 13.01.2007 Seite 31 There are five Submission Levels: 1. warrant only (and if applicable an Appearance Approval Report) 2. warrant with product samples and limited supporting data 3. warrant with product samples and complete supporting data 4. warrant with other requirements as defined by the customer 5. warrant with product samples and complete supporting data available for review at the organization s manufacturing location 13.01.2007 Seite 32

The customer decides about the submission level I want I need I wish...looking at: the status of the supplier (Ford Q1,...) his experience with earlier approval processes the know-how of the supplier concerning this product the importance of the part so the submission level might be different for every product 13.01.2007 Seite 33 S = submit retain a copy at an appropriate location, (including manufacturing) R = retain at appropriate locations (including manufacturing) has to be made readily available to the customer representative upon request * = retain at appropriate locations submit upon request 13.01.2007 Seite 34

LEVEL 3 IS THE STANDARD LEVEL" IT SHALL BE USED FOR ALL SUBMISSIONS UNLESS SPECIFIED OTHERWISE BY THE RESPONSIPLE CUSTOMER PRODUCT APPROVAL ACTIVITY Level 1 = just warrant and (if applicable) Appearance Approval Report Level 2 = standard minus process description and background information Level 3 = standard Level 4 = warrant, other requirements as defined by the customer Level 5 = the complete list, and everything will be checked at the supplier s site! 13.01.2007 Seite 35 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Requirements 3. Customer Notification and Submission Requirements 4. Submission Levels 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 36

After everything is ready, it will be submitted to the customer! namely at the responsible product approval activity the customer will inspect everything and notify the organization of the result using the Part Submission Status 13.01.2007 Seite 37 Part Submission Status ORGANIZATIONS MAY NEVER SHIP PRODUCTION QUANTITIES BEFORE CUSTOMER APPROVAL! Upon approval of the submission, the organization shall assure that future production continues to meet all customer requirements For those organizations that have been classified as self-certifying by a specific customer ( Submission Level 1), submission of the required organization-approved documentation will be considered as customer approval unless the organization is advised otherwise. 13.01.2007 Seite 38

Part Submission Status: A B C Approved Interim Approval Rejected 13.01.2007 Seite 39 Part Submission Status A = Approved indicates that the part or material meets all customer specifications and requirements the organization therefore is authorized to ship production quantities of the product subject to releases from the customer scheduling activity 13.01.2007 Seite 40

Part Submission Status B = Interim Approval Permits shipment of material for production requirements on a limited time or piece quantity basis. Interim Approval will only be granted when the organization has: clearly defined the non-compliances preventing approval; and, prepared an interim approval action plan agreed upon by the customer The organization is responsible for implementing containment actions to ensure that only acceptable material is beeing shipped to the customer. re-submission is required to obtain a status of Approved material covered by an interim approval that fails to meet the agreed-upon action plan either by the expiration date or the shipment of the authorized quantity will be rejected. No additional shipments are authorized unless an extention of the interim approval is granted. 13.01.2007 Seite 41 Part Submission Status C = Rejected Means that the submission does not meet the customer requirements, based on the production lot from which it was taken, and/or accompanying documentation In such cases, the submission and/or process (as appropriate) shall be corrected to meet the customer requirements. The submission shall be approved before production quantities may be shipped. 13.01.2007 Seite 42

Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Process Requirements 3. Customer Notification and Submission Requirements 4. Submission to Customer - Levels of Evidence 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 43 Record Retention and Sampling records, regardless of submission level, shall be maintained for the length of the time the part is active (in production or service) plus one calendar year the supplier shall ensure that the appropriate records from a superseded part file are included, or referenced in the new part file 13.01.2007 Seite 44

Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Requirements 3. Customer Notification and Submission Requirements 4. Submission Levels 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 45 3. Summary of the Process before delivering new or changed parts or changing the production processes the supplier has to document that he has successfully finalized all activities of to ensure that the product will meet all requirements that the processes are under control and capable These activities are mostly described in QS 9000 APQP the documentation consist of the Part Submission Certificate and the required attachments according to his Submission Level the supplier has to submit everything or just parts of it to the customer the customer checks the documentation and sets the Part Submission Status depending on that the supplier can start delivery or not 13.01.2007 Seite 46

Teamwork: How to judge about? Task: Assume you have received a Submission Level 3 from your supplier. Supplier has design responsibility. How to make sure whether or not the supplier worked carefully? but without leaving your desk! Time frame: Preparation 15 min. 13.01.2007 Seite 47 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Requirements 3. Customer Notification and Submission Requirements 4. Submission Levels 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 48

4. The Documentation and its Preparation Warrant 13.01.2007 Seite 49 Only English report forms have to be filled out and submitted to the customer! 13.01.2007 Seite 50

Content of the documentation to be created 1. Design Record 2. Authorized Engineering Change Documents 3. Customer Engineering Approval 4. Design-FMEA 5. Process Flow Diagram(s) 6. Process-FMEA 7. Control Plan 8. Measurement System Analysis Studies 9. Dimensional Results 10. Records of Material/ Performance Test Results 11. Initial Process Studies 12. Qualified Laboratory Documentation 13. Appearance Approval Report 14. Sample Production Parts 15. Master Sample 16. Checking Aids 17. Customer-Specific Requirements 18. Part Submission Warrant 13.01.2007 Seite 51 4.1 Design Records all design records for the saleable product e.g. CAD/CAM Data part drawings specifications including component drawings For parts identified as black box the design record specifies the interface and performance requirements The organization shall provide evidence that the Material/Substance Composition reporting has been completed and that reported data complies with all requirements Reporting and requirements as prescribed by the customer Reporting may be entered into International Materials Data System (IMDS), www.mdsystem.com/index.jsp 13.01.2007 Seite 52

4.1 Design Records / Where applicable, the Organization shall identify polymeric parts with the ISO symbols for plastics: 100g, see ISO 11469 / 1043-1 for elastomers: 100g, see ISO 11469 /1629 4.2 Authorized Engineering Change Documents all authorized engineering change documents, which are not yet recorded in the design record but incorporated in the product, part or tooling 13.01.2007 Seite 53 4.3 Customer Engineering Approval where specified by the customer, the organization shall have evidence of customer engineering approval 13.01.2007 Seite 54

4.4 Design-FMEA If the supplier is design responsible a Design-FMEA is required according to the customer-specific requirements e.g. QS-9000 FMEA (Potential Failure Mode and Effect Analysis) 13.01.2007 Seite 55 4.5 Process Flow Diagrams see QS-9000 APQP 13.01.2007 Seite 56

4.6 Process-FMEA according to the customer-specific requirements e.g. QS-9000 FMEA (Potential Failure Mode and Effect Analysis) 13.01.2007 Seite 57 4.7 Control Plan The Organization shall have control plan that defines all controls used for process control and complies with the customerspecified requirements, e.g. QS-9000 APQP QM-Plan according to QS-9000 APQP control plans for families of similar parts are acceptable if the new parts have been reviewed for commonality Note: Certain customers require control plan approval e.g. customer signature on the control plan, prior to submission. 13.01.2007 Seite 58

4.8 Measurement System Analysis Studies the organization shall have applicable Measurement System Analysis Studies (e.g. Gage R & R ) for all new or modified gages, measurement, and test equipment See QS-9000 MSA (Measurement System Analysis reference manual. 13.01.2007 Seite 59 4.9 Dimensional Results The organization shall provide evidence that dimensional verifications required by die design record and the Control Plan have been completed and results indicate compliance with specified requirements. The organization shall have dirnensional results for each unique manufacturing process, e.g. cells or production limes and all cavities, molds, patterns or dies The organization shall record, with the actual results: all dimensions (except reference dimensions), characteristics, and specifications as noted an the design record and Control Plan. 13.01.2007 Seite 60

4.9 Dimensional Results / The organization shall indicate the date of the design record, change level, and any authorized engineering change document not yet incorporated in the design record to which the part was made. The organization shall record the change level, drawing date, organization name and part number on all auxiliary documents (e.g. supplementary layout results sheets, sketches, tracings, cross sections, CMM inspection point results, geometric dimensioning and tolerancing sheets, or other auxiliary drawings used in conjunction with the part drawing). 13.01.2007 Seite 61 4.9 Dimensional Results / Copies of these auxiliary materials shall accompany the dimensional results according to the Retention/Submission Requirements Table. A tracing shall be included when an optical comparator is necessary for inspection. The organization shall identify one of the parts measured as the master sample NOTE 1: The Dimensional Results form in Appendix C, a pictorial, geometrie dimensioning & tolerancing [GD&T] sheets, or a checked print where the results are legibly written on a part drawing including cross sections, tracings, or sketches as applicable may be utilized for this purpose. NOTE 2: Dimensional results typically do not apply to bulk materials. 13.01.2007 Seite 62

13.01.2007 Seite 63 4.10 Records of Material/Performance Test Results The organization shall have records of test results for material tests performance tests for tests specified in the design record in the control plan 13.01.2007 Seite 64

4.10.1 Material Test Results The organization shall perform tests for all parts and product materials when chemical, physical, or metallurgical requirements are specified by the design record or control plan Material test results shall indicate and include: the design record change level of the parts tested; any authorized engineering change documents that have not yet been incorporated in the design record; the number, date, and change level of the specifications to which the part was tested; the date on which the testing took place; the quantity tested; the actual results; the material supplier s name and, when required by the customer, the customer-assigned supplier/vendor code. NOTE: Material test results may be presented in any convenient format. An example is shown in Appendix D. 13.01.2007 Seite 65 13.01.2007 Seite 66

4.10.1 Material Test Results / For products with customer-developed material specifications and a customer-approved supplier list, the organization shall procure materials and/or services (e.g., painting, plating, heat-treating, welding) from suppliers on that list. 13.01.2007 Seite 67 4.10.2 Performance Test Results The organization shall perform tests for all part(s) or product material(s) when performance or functional requirements are specified by the design record or Control Plan. Performance test results shall indicate and include: die design record change level of the parts tested; any authorized engineering change documents that have not yet been incorporated in the design record; the number, date, and change level of the specifications to which the part was tested; the date on which the testing took place; the quantity tested; the actual results. NOTE: Performance test results may be presented in any convenient format. An example is shown in Appendix E. 13.01.2007 Seite 68

13.01.2007 Seite 69 4.11 Initial Process Studies 4.11.1 General 4.11.2 Quality Indices 4.11.3 Acceptance Criteria for Initial Study 4.11.4 Unstable Processes 4.11.5 Processes With One-Sided Specifications or Non-Normal Distributions 4.11.6 Actions To Be Taken When Acceptance Criteria Are Not Satisfied 13.01.2007 Seite 70

4.11.1 General the level of initial process capability or performance shall be determined to be acceptable prior to submission for all special characteristics designated by the customer or the organization (sc,cc) the organization shall perform measurement analysis to understand how measurement error is affecting the study measurements (see Measurement System Analysis reference manual) for explanations about Cpk or Ppk see SPC (Statistical Process Control manual) 13.01.2007 Seite 71 Mean Value x Turning Point Standard Deviation s Gauß Normal Distribution 13.01.2007 Seite 72

Definitions Process under Control / Capable Process not capable capable under control not under control 13.01.2007 Seite 73 The Capable Process Example Process Capability Index Comment C p = Process Capability Index Shows proportion of the permissible tolerance interval to the scatter Scatter is measured in multiples of the standard deviation s If the scatter is with +/- 3 s within the tolerance, then C p =1 C pk = Critical Process Capability Index Supplementary considers the mean of the process not being equal to the middle of the tolerance interval Example 1 to 3 No capability High amount of scrap No capability If centered pretty exact, just about no scrap Very good capability Statistically no scrap No capability Not centered Scrap Good capability Process is centered enough Little scrap Process adjusted exactly to center of tolerance interval 13.01.2007 Seite 74

4.11.2 Quality Indices Initial process studies shall be summarized with capability or performance indices, if applicable. NOTE 1: The initial process study results are dependent on the purpose of the study, method of data acquisition, sampling, amount of data, demonstration of statistical control. etc. See the QS-9000 Statistical Process Control reference manual for additional information in understanding the basic principles of statistical stability and process measures (indices). For guidance on items listed below, contact the authorized customer representative. 13.01.2007 Seite 75 C pk and P pk C pk - The capability Index for a stable process. The estimate of sigma is based on within subgroup variation. C pk is an indicator of process capability based on process variation within each subgroup of a set of data. C pk does not include the effect of process variability between the subgroups. C pk is an indicator of how good a process could be if all process variation between subgroups was to be eliminated. Therefore, use of C pk alone may be an incomplete indicator of process performance. P pk - The performance index. The estimate of sigma is based on total variation (all of individual sample data using the standard deviation. P pk is an indicator of process performance based on process variation throughout the full Set of data. Unlike C pk, P pk is not limited to the variation within subgroups. However, P pk cannot isolate within subgroup variation from between subgroup variation. When calculated from the same data set, C pk and P pk can be compared to analyze the sources of process variation. For more information, see QS-9000 Statistical Process Control. 13.01.2007 Seite 76

Purpose of Initial Process Studies The purpose of the initial process study is to understand the process variation, not just to achieve a specific index value. When historical data are available or enough initial data exist to plot a control chart (at least 100 individual sarnples), Cpk can be calculated when the process is stable. Otherwise, for processes with known and predictable special causes and output meeting specifications, Ppk should be used. When not enough data are available (< 100 samples) or there are unknown sources of variation, contact the authorized customer representative to develop a suitable plan. 13.01.2007 Seite 77 Examination of the stability (Process control) process seems stable process seems instable examine capability continue with 4.11.3 Process may not meet customer requirements continue with 4.11.4 13.01.2007 Seite 78

4.11.3 Acceptance Criteria for Initial Study Capability Index for stable process Index > 1.67 1.33 Index 1.67 Index < 1.33 the process currently meets the acceptance criteria after approval, begin production and follow control plan the process may be acceptable contact the authorized customer representative for a review of the study results the process does not currently meet the acceptance criteria contact the authorized customer representative for a review of the study results 13.01.2007 Seite 79 4.11.4 Unstable Processes Depending on the nature of the instability, an unstable process may not meet customer requirements. The organization shall identify, evaluate and, wherever possible, eliminate special causes of variation prior to submission. The organization shall notify the authorized customer representative of any unstable processes that exist and shall submit a corrective action plan to the customer prior to any submission. NOTE: For bulk materials, for processes with known and predictable special causes and output meeting specifications, corrective action plans may not be required by the customer. 13.01.2007 Seite 80

4.11.5 Processes With One-Sided Specifications or Non-Normal Distributions The organization shall determine with the authorized customer representative alternative acceptance criteria for processes with one-sided specifications or nonenormal distributions. NOTE: The above mentioned acceptance criteria assume normality and a two-sided specification (target in the center). When this is not true, using this analysis may result in unreliable information. These alternate acceptance criteria could require a different type of index or some method of transformation of the data. The focus should be on understanding the reasons for the nonnormality (e.g., is it stable over time?) and managing variation. Refer to the Statistical Process Control reference manual for further guidance. 13.01.2007 Seite 81 4.11.6 Actions To Be Taken When Acceptance Criteria Are Not Satisfied The organization shall contact the authorized customer representative if the acceptance criteria cannot be attained by the required submission date. The organization shall submit to the authorized customer representative for approval a corrective action plan and a modified Control Plan normally providing for 100% inspection. Variation reduction efforts shall continue until the acceptance criteria are met, or until customer approval is received. NOTE: 100% inspection methodologies are subject to review and concurrence by the customer. 13.01.2007 Seite 82

4.12 Qualified Laboratory Documentation Inspection and testing for shall be performed by a qualified laboratory as defined by customer requirements (e.g., an accredited laboratory). The qualified laboratory (internal or external to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted. When an external/commercial laboratory is used, the organization shall submit the test results on the laboratory letterhead or the normal laboratory report format. The name of the laboratory that performed the tests, the date (s) of the tests, and the standards used to run the tests shall be identified. 13.01.2007 Seite 83 4.13 Appearance Approval Report (AAR) AAR = approval report for the appearance of appearance items concerning requirements on color, structure, or surface For completion of AAR, see instruction in, appendix B A separate AAR shall be completed for each part or series of parts for which a submission is required if the product/part has appearance requirements on the design record Upon satisfactory completion of all required criteria, the supplier shall record the information on the AAR since the Appearance Approval Report is a industry wide used form not all customers will require entries in every position 13.01.2007 Seite 84

4.13 Appearance Approval Report (AAR) / The completed AAR and representative production products/parts shall be submitted to the location specified by your customer to receive disposition AARs (complete with part disposition and customer signature) shall then accompany the PSW at the time of final submission based upon the submission level requested 13.01.2007 Seite 85 13.01.2007 Seite 86

4.14 Sample Production Parts The organization shall provide sample products as specified by the customer. 13.01.2007 Seite 87 4.15 Master Sample The organization shall retain a master sample for the same period as the production part approval records, or a) until a new master sample is produced for the same customer part number for customer approval, or b) where a master sample is required by the design record, Control Plan or inspection criteria. as a reference or standard. The master sample shall be identified as such, and shall show the customer approval date on the sample. The organization shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern, or production process unless otherwise specified by the customer. 13.01.2007 Seite 88

4.16 Checking Aids If requested by the customer, the organization shall submit with the submission any part-specific assembly or component checking aid. The organization shall certify that all aspects of the checking aid agree with part dimensional requirements. The organization shall document all released engineering design changes that have been incorporated in the checking aid at the time of submission. The organization shall provide for preventive maintenance of any checking aids for the life of the part. measurement system analysis studies, e.g. gage R&R, accuracy, bias, linearity, stability studies, shall be conducted in compliance with the customer requirements. See MSA (Measurement Systems Analysis reference manual). 13.01.2007 Seite 89 4.17 Customer-Specific Requirements The organization shall have records of compliance to all applicable customer-specific requirements. For bulk materials, applicable customer-specific requi rements shall be documented on the Bulk Material Requirements Checklist. 13.01.2007 Seite 90

4.18. Production Part Submission Warrant Upon completion of all requirements, the organization shall complete the Part Submission Warrant (PSW). Warrant A separate PSW shall be completed for each customer part number unless otherwise agreed to by the authorized customer representative. If production parts will be produced from more than one cavity, mold, tool, die, pattern, or production process. e.g., line or cell, the organization shall complete a dimensional evaluation on one part from each. The specific cavities, molds, line, etc., shall then be identified in the Mold/Cavity/Production Process line on a PSW, or in a PSW attachment. 13.01.2007 Seite 91 4.18. Production Part Submission Warrant/ The organization shall verify that all of the measurement and test results show conformance with customer requirements and that all Warrant required documentation is available and, for Level 2, 3, and 4, is included in the submission as appropriate. A responsible official of the organization shall approve the PSW and provide contact information. 13.01.2007 Seite 92

Part Submission Warrant consists of: Information about the part Some formal information Materials reporting Reason of the submission Requested submission level Result of the submission Declaration For customer use (result) 13.01.2007 Seite 93 Detail of Part Submission Warrant 13.01.2007 Seite 94

Dimension Results / Part Weight (Mass) The organization shall record on the PSW the part weight of the part as shipped, measured and expressed in kilograms to four decimal places (0.0000) unless otherwise specified by the customer. The weight shall not include shipping protectors, assembly aides, or packaging materials. To determine part weight, the organization shall individually weigh ten randomly selected parts, calculate and report the average weight. At least one part shall be measured from each cavity, tool, line or process to be used in product realization. NOTE: This weight is used for vehicle weight analysis only and does not affect the approval process. Where there is no production or service requirement for at least ten parts, the organization should use the required number for calculation of the average part weight. 13.01.2007 Seite 95 Contents 1. Introduction 2. Content of the QS-9000 1. General 2. Requirements 3. Customer Notification and Submission Requirements 4. Submission Levels 5. Part Submission Status 6. Record Retention 3. Summary of the Process 4. The Documentation and its Preparation 5. Summary 13.01.2007 Seite 96

The Attempt to Run without APQP! 13.01.2007 Seite 97 The Production Part Approval Process is an extensive strict approval process for new or changed designs or processes. Summary It is very formalized, so it inevitably causes some administration work, but it doesn t demand anything that makes no sense from an engineer s point of view! Later changes of the product or the process are expensive and take a lot of time. The prerequisite to fulfill demands is a carefully done quality planning according to QS-9000 APQP. 13.01.2007 Seite 98

6. Internet Links http://www.din.de http://www.iso.ch http://www.cenorm.be https://www.carwin.co.uk/qs/qs9000default.htm http://www.aiag.org http://www.iaob.org http:// www.vda-qmc.de 13.01.2007 Seite 99