1./2./19. Review customer requirements/specificat requirements/specification ion and initiate FMEA
3./20. Is characteristic special?
4./13. Select samples from Significant Product Run
Note #s appearing in shapes in the process flow on the left are references to the Requirements/Guidelines Requirements/Guidelines listed below:
10./13. Conduct measurement systems analysis
No
1.
No
Yes
5./18. Determine methods for evaluation/measurement, evaluation/measurement, list technique & any measurement device(s) selected
2. 3.
6./16. Do MSA results meet acceptability criteria?
3. Establish control plan noting the characteristic and process parameters / product tolerances
15. If a device can it discriminate 1/10 of expected process variation?
ISO/TS 16949:2009 Links to “Core Tools”
4.
5. Yes 11. PerformYes dimensional verifications
No
12. Conduct material/ performance tests 6.
Yes
13./21. Is process capable or customer approved corrective action plan?
5./6. Note measuring devices under evaluation/measurement evaluation/measurement technique in control plan
7.
8. 7./8. Select qualified internal/ external laboratory for PPAP inspection/testing
Yes
14. Identify one or more of the parts as a "master sample" and retain
Yes No
7./8. Is the inspection/test on the Laboratory's scope?
9.
10.
4. Confirm PPAP requirements have been met
11. 12.
Yes
No
13. 12. Conduct material/ performance tests
4. PPAP Approved ? No 14.
1. Agree/con firm process 1. Agree/con capability or performance requirements w/customer
Yes
No
13. Has the level of initial process capability or performance been determined? Yes
13. Schedule significant production run and conduct initial process study: ·Ppk - Special causes of of variation present and/or less than 100 readings from consecutive parts. ·Cpk - No special causes of variation and at least 100 individual samples. Notify customer of unstable processes that exist or if not enough data available (<100).
15.
9. Verify on-going process capability
16. 17.
No
5. Is characteristic unstable or noncapable?
Yes
5. Initiate reaction plan, develop corrective action plan, review with customer if required
18.
19.
20.
21.
**ISO/TS 16949:2009** (requirements) 7.2.1.1 The organization organization shall demonstrate conformity conformity to customer customer requirements for designation, documentation and control of special characteristics. 7.3.1.1 - development and review review of FMEAs, FMEAs, including including actions to reduce potential risks 7.3.2.3 The organization organization shall identify identify special characteristics characteristics and include include all special characteristics in the control plan. 7.3.6.3 The organization organization shall conform with a product approval procedure recognized by the customer. customer. This product and manufacturing manufacturing process procedure shall be applied to suppliers. 7.5.1.1 The organization organization shall - develop control control plans plans (see Annex A) - have a control plan for pre-launch pre-launch and production production that takes into account the design FMEA and manufacturing manufacturing process FMEA outputs - list controls used for manufacturing manufacturing process process control control - include methods for monitoring monitoring of control exercised over special characteristics characteristics defined by both the customer and the organization - initiate the specified specified reaction plan when the process becomes unstable or not statistically capable. Update and review control plans when change occurs … or FMEA (see 7.1.4). 7.6.1 7.6.1 Statist Statistical ical studi studies es shall shall be conducte conducted d for each each type of of measuring measuring and test equipment system system referenced in the control plan. Methods and acceptance criteria shall conform to those in cu stomer reference manuals or be otherwise approved by the customer. 7.6.3.1 The organization's organization's internal internal laboratory shall shall have a laboratory laboratory scope that includes its capability to perform the required inspection, test or calibration services and the laboratory scope shall be included in the QMS documentation. 7.6.3.2 External/commercial/i External/commercial/independent ndependent laboratory facilities facilities shall shall have a defined laboratory scope that includes its capability to perform the required inspection, inspection, test or calibration services and either provide evidence that it is acceptable to the customer or that it is a ccredited to ISO/IEC 17025 or national equivalent. 8.2.3.1 The organization organization shall maintain maintain manufacturing manufacturing process capability capability or performance as specified by the customer part approval process process requirements. **PPAP** Fourth Edition (requirements) 2.2.8 2.2.8 The organi organizati zation on shall shall have have applica applicable ble Measure Measurement ment System System Analysis studi es, e.g., g age R&R, bi as, linearit y, stability, … . 2.2.9 2.2.9 The organi organizati zation on shall shall provid provide e evidence evidence that dimen dimension sional al verifications … indicate compliance with specified requirements. 2.2.10 2.2.10 The organiza organization tion shall shall have records records of material material and/or performance test results for tests specified on the design record…. 2.2.11.1 The level level of initial process capability capability or performance performance shall shall be determined to be acceptable prior to submission for all special characteristics … The organization organization shall obtain customer customer concurrence on the index for estimating initial process capability prior to submission. 2.2.15 The organization organization shall retain retain a master sample sample for for the same period as the production part approval records… . **MSA** Fourth Edition (guidelines) Pg 74 The instrum instrument ent should should have a discri discrimina mination tion that that allows allows onetenth of the expected process variation variation of the characteristic to be read. Pg 78 Over Over 30% error error - consi consider dered ed not accep acceptab table le.. **APQP** Second Edition (guidelines) Pg 34 The specifi specified ed monitorin monitoring g and measuring measuring devices devices and methods methods should be used to check the control plan identified characteristics characteristics to engineering specification specification and be subjected to measurement system evaluation during or prior to the production trial run. Pg 53 Evaluati Evaluation on measuremen measurementt technique. technique. This This could include include gages, gages, fixtures, tools and/or test equipment required to measure the part/ process/manufacturing process/manufacturing equipment. **FMEA** Fourth Edition (guidelines) Pg 2 FMEA FMEA is an an analyt analytical ical methodolo methodology gy used used to ensure ensure that that potenti potential al problems have been considered and addressed throughout the product and process development process (APQP). Pg 91 Where Where a special special character characteristi istic c is identifie identified d with a severity severity of 9 or 10 in the PFMEA, the design responsible engineer should be notified since this may affect the engineering documents. **SPC** Second Edition (guidelines) Pg 20 To be acceptabl acceptable, e, the process process must must be in a state state of statistic statistical al control and the capability (common cause variation) must be less than the tolerance.
PPAP and the APQP, FMEA, M SA, SPC Reference Manuals are Copyright of Chrysler Corporation, Ford Motor Company, General Motors Corporation
File: CoreTls.vsd Rev. 09/01/2013
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