1. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License Multi-State Advanced Manufacturing Consortium US DOL SPONSORED TAACCCT GRANT: TC23767 RELEASE DATE12/7/2015 VERSIONv 001 PAGE1 of 40 PRIMARY DEVELOPER – Janaina Gasparelo, Henry Ford College I NTEGRATED Q UALITY S ESSION 6 P ROFESSOR J ANAINA G ASPARELO H ENRY F ORD C OLLEGE J ANUARY, 2015 US D EPARTMENT OF L ABOR M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM

2. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949 – Key Principals – Quality Policy – Terminology – Audit Survival Core Tools (AIAG) AGENDA

3. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License Level 1: The international guideline ISO9001:2008 Level 2: The international automotive standard ISO/TS 16949 Level 3: The international automotive customer specific requirements ISO 9001 requirements PLUS additional requirements specific to automotive production. Mandates implementation of Customer Specific Requirements, which mandate the use of the AIAG Core Tools ISO/TS 16949: WHAT IS ISO/TS 16949?

4. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: WHAT IS ISO/TS 16949? Replaces US, and European Standards; QS-9000, VDA, etc. Document reflecting worldwide automotive requirements – US, Europe, and Asia. Customized for Semiconductor Industry with ISO/TS16949 Semiconductor Supplement.

5. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: SCOPE Scope: This technical specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions (such as design centers, corporate headquarters & distribution centers) form part of site audit but cannot obtain stand alone certification.

6. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: APPLICATION Application: This technical specification applies to all organizations, regardless of type, size and product provided. Any exclusions to the technical specification due to the nature of the organization and its product, must be agreed upon with the registrar prior to the registration audit.

7. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: GOAL GOAL: “The goal is the development of a quality management system that provides for; o continual improvement, o emphasizing defect prevention and o the reduction of variation and waste in the supply chain.” TS16949 section 0.5

8. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: CERTIFICATE HOLDERS, REMOTE LOCATIONS Who can hold a TS16949 certificate in this scenario? Manufacturing Site Sales, Design, Testing, Purchasing, Program Management and Quality Off-site Warehouse Manufacturing Site On-site Test Lab If an organization has a site or head quarters performing as support function Remote Location – must comply but will not receive stand alone certification. YES Usually NO lab would be treated as part of the mfg. location MAYBE Depends

9. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: EXPECTED BENEFITS Consistency in supplier development Reduction in multiple 3rd party registrations Common language between customers, suppliers & auditors Reduction in variation due to standard set of requirements Increased efficiency Improved product/process quality Additional confidence for global sourcing Focus on continual improvement

10. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: CLAUSES 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices 8 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of non-conforming product 8.4 Analysis of data 8.5 Improvement Introduction 1 Scope 2 Normative reference 3 Terms and definitions 4 Quality Management Systems 4.1 General Requirements 4.2 Documentation requirements 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review 6 Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment Click here to open a UNCONTROLLED Copy of the Standard

11. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 1. Process Approach - Define the organization’s processes. » Know your processes and follow as written. - Audit across the organization, not by element or item. Process – “any activity or set of activities that uses resources to transform inputs into outputs.” Inputs Design Results Testing Manufacturing Outputs

12. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 1. Process Approach Customers Requirements Satisfaction Continual improvement of the quality management system Input Product realization Product Output Measurement, analysis and improvement Management responsibility Resource management Key Value-adding activities Information flow TS16949, page xi

13. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 2. Management (Business) Review - Focus on Leadership & Top Management. - Review of process performance. (metrics, OEM scorecards, eQOS)

14. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 3. Human Resources and Competency - Encourages & measures employee motivation. - Define job competency requirements. - Measure effectiveness of training.

15. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 4. Objectives Deployment - Measure the out-put of the processes. What are your department metrics? - Continuous improvement. Inputs Outputs Process Results Suppliers Customers Stakeholders Product Information

16. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: KEY PRINCIPLES 5. Customer Focus Measure customer satisfaction (Surveys, PPM, NCTs) Understand Customer Requirements. Some Customers specify additional requirements which affect: Documentation Auditor qualifications Management Review items Design & Validation

17. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Audit: the systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. Audit Criteria: set of policies, procedures or requirements. Audit Evidence: records, statements of fact or other information, which are relevant to the audit criteria and verifiable. Audit Findings: results of the evaluation of the collected audit evidence, which are relevant to the audit criteria.

18. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Audit Conclusion: outcome of an audit, provided by the auditor after consideration of the audit objectives and all audit findings. Auditor: person with the competence to conduct an audit. Auditee: organization or person being audited. Audit Plan: description of the activities and arrangements for an audit.

19. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Audit Scope: the extent and boundaries of an audit. IATF (International Automotive Task Force): develops policies and procedures for the common IATF 3-party registration scheme to ensure consistency worldwide along with providing training. IOAB (Automotive Oversight Bureau): Coordinates with the IATF European Oversight Offices to ensure global consistency of the ISO/TS 16949 registration scheme

20. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Major Non-Conformance: − The absence or the total breakdown of the system or process. − A number of minor non-conformances against one requirement can represent a total breakdown of the system and thus may be considered a major nonconformity. − A long-standing minor nonconformance from previous assessments, or a collection of similar minor non- conformances indicating a widespread problem.

21. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Minor Non-Conformance: − A nonconformance that judgment and experience indicates is not likely to result in the overall failure of the process or negatively impact other downstream processes. − A single observed lapse in following one item of the company's business processes.

22. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Opportunity for Improvement (OFI) aka Observation: − Practices observed, which, while they are not in strict violation of the requirements, constitute poor or marginal practices. − Procedures that are complicated and wordy, making them hard to follow and unlikely to be read. – Responses to questions are dependent upon two key people, one of whom is near retirement. – There are several forms, all of a very similar nature, to handle different types of sales calls.

23. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: TERMINOLOGY Pass: − Practices observed comply with the defined requirements or audit criteria.

24. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL How can I help to ensure conformance to TS16949: Test Equipment / Gauges Are gage/equipment calibration(s) dates past due? Are calibration stickers present? Are calibration certifications available and in a known location?

25. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL How can I help to ensure conformance to TS16949: Training: Are you certified to run the equipment per the work instruction/test? If you are a trained operator, is your name on the training matrix? Are you following your processes/procedures/WI as written? Is there any past performance report that can be a record of your qualification(s) and training? Who holds your training records or certifications?

26. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL How can I help to ensure conformance to TS16949: Material Tagging and Identification: Do you have any unidentified material in your area? Documentation: Are all required forms at correct revision levels? Housekeeping: Is your work area clean and safe? Are parts at your area marked properly?

27. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL What can we do? How can I affect Quality? Process Control – what you do in your job assignment – Work to your Processes/Procedures/Work Instructions – Be familiar with the Customer Specifications – Know the emergency drills – Gages – know the calibration process (i.e. when, who, why) – Know your process inputs, outputs and metrics

28. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL What can we do? How can I affect Quality? Document Control – location and retrieval – Make sure you know the system that houses your Processes/Procedures/Work Instructions – Know the person of knowledge on processes / tests / operations – If a form needs to be filled out, know where that record is subsequently kept – Know your record retention policy

29. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL Employee Conduct Answer questions completely and honestly Give auditors what they specifically ask for, but no more Answer question with facts Comment ONLY on your area of control or expertise: Saying “I don’t know” is acceptable, direct questions to manager or appropriate area of expertise. Do not supply documentation from uncontrolled sources

30. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL Employee Conduct If you do not understand the question, please ask for further explanation If item cannot be located, ask to have a little time and supply to audit at a designated agreed time.

31. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License ISO/TS 16949: AUDIT SURVIVAL Employee Conduct Be professional Be orderly Be positive Be honest Be confident Relax You know your processes, teach the auditor what it is you do

32. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS What are Core Tools? Published by the Automotive Industry Action Group; AIAG Reference

33. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: APQP Advanced Product Quality Planning and Control Plan (APQP) The purpose of this manual is to communicate to internal and external suppliers, and to their subcontractors, the product quality planning and control plan guidelines developed jointly by the three automakers. Provides guidelines designed to produce a quality plan that will support the development of a product or service that satisfies the customer. The manual introduces and focuses on the five phases of quality planning and illustrates appropriate activities at each of these phases.

34. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: FMEA Potential Failure Modes and Effects Analysis (FMEA) Because of a company’s commitment to continually improve its products whenever possible, the need for using the FMEA as a disciplined technique to identify and help eliminate potential concern is as important as ever.

35. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: FMEA Potential Failure Modes and Effects Analysis (FMEA) Each failure mode gets a numeric score that quantifies (O) likelihood that the failure will occur, (D) likelihood that the failure will be detected, and (S) the amount of harm or damage the failure mode may cause to a person or to equipment. The product of these three scores is the Risk Priority Number (RPN) for that failure mode. RPN = S x O x D This reference manual retains the presentation of the FMEA preparation instructions to both Design and Process FMEAs.

36. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: MSA Measurement Systems Analysis (MSA) The purpose of this reference manual is to present guidelines for assessing the quality of a measurement system. Some of the topics covered by this manual are: - Bias Study - Linearity Study - ANOVA Analysis - Gage Repeatability & Reproducibility Study (Gage R&R) - Attribute Study Data set

37. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: PPAP Production Part Approval Process (PPAP) This manual defines generic requirements for production part approval, including production and bulk materials. The purpose of PPAP is to determine if all customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate.

38. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: SPC Statistical Process Control (SPC) This reference manual describes several basic statistical methods associated with statistical process control and process capability analysis. SPC is used to measure the effectiveness of the equipment used in manufacturing processes. SPC will help the supplier ensure that quality parts are being produced and help eliminate waste in the manufacturing environment.

39. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License CORE TOOLS: SUGGESTED INDUSTRY HIERARCHY Organization can prove with Evidences 1 Business and Quality Policy Manual 4 – forms, templates, tags, logbooks 3 – work instructions, handbooks 2 Automotive Common Procedures 2 Site Specific Procedures

40. M ULTI -S TATE A DVANCED M ANUFACTURING C ONSORTIUM 20151207_v001_msamc_courseware_quality_ppt620151207_v001_msamc_courseware_quality_ppt6 found in Resources by the M-SAMC Multi-State Advanced Manufacturing Consortium www.msamc.org is licensed under a Creative Commons Attribution 4.0 International License.www.msamc.org Creative Commons Attribution 4.0 International License Multi-State Advanced Manufacturing Consortium US DOL SPONSORED TAACCCT GRANT: TC23767 RELEASE DATE12/7/2015 VERSIONv 001 PAGE40 of 40 PRIMARY DEVELOPER – Janaina Gasparelo, Henry Ford College SAFETY DISCLAIMER: M-SAMC educational resources are in no way meant to be a substitute for occupational safety and health standards. No guarantee is made to resource thoroughness, statutory or regulatory compliance, and related media may depict situations that are not in compliance with OSHA and other safety requirements. It is the responsibility of educators/employers and their students/employees, or anybody using our resources, to comply fully with all pertinent OSHA, and any other, rules and regulations in any jurisdiction in which they learn/work. M-SAMC will not be liable for any damages or other claims and demands arising out of the use of these educational resources. By using these resources, the user releases the Multi-State Advanced Manufacturing Consortium and participating educational institutions and their respective Boards, individual trustees, employees, contractors, and sub-contractors from any liability for injuries resulting from the use of the educational resources. DOL DISCLAIMER: This product was funded by a grant awarded by the U.S. Department of Labor’s Employment and Training Administration. The product was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. RELEVANCY REMINDER: M-SAMC resources reflect a shared understanding of grant partners at the time of development. In keeping with our industry and college partner requirements, our products are continuously improved. Updated versions of our work can be found here: http://www.msamc.org/resources.html.http://www.msamc.org/resources.html