1. 1© M G Gibson 2010RSS Destructive Testing MSA1 ISO/TS 16949:2009(E) and AIAG MSA 4 th edn. (2010) Martin Gibson CStat, CSci, MSc, MBB AQUIST Consulting gg1000@waitrose.com

2. 2© M G Gibson 2014RSS Destructive Testing MSA2 Making sense of MSA  Do you know how accurate and precise your measurement and test equipment are?  Do you suspect that good work is sometimes condemned as bad simply because of uncertainty in the measurement system; is bad work ever released as good?  Do you know the cost of non-capable measurement systems?  Do you realise how important it is to understand measurement systems uncertainty?  Does your auditor share your understanding of measurement systems?  What can you do about it?

3. 3 ISO/TS 16949:2009(E) 7.6.1 Measurement System Analysis  Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. ... applies to measurement systems in the control plan. ... analytical methods and acceptance criteria used shall conform to those in customer reference manuals on MSA.  Other analytical methods and acceptance criteria may be used if approved by the customer. © M G Gibson 2014RSS Destructive Testing MSA3 Questions:  What is the operational definition of statistical studies?  Do organisations, auditors, quality mangers understand statistical studies?  Why do auditors ask?, “Can you show me GR&R studies for each type of measuring and test equipment system referenced in the control plan?”

4. 4 ISO/TS 16949 Scheme Update IF SMMT Webinar, 5 Nov. 2013 Common problems found in ISO/TS16949 audits  Calibration and MSA (7.6 and 7.6.1)  Definition of Laboratory scope  Control of external laboratories  Traceability to national or international standards  MSA not done for all types of measuring systems  MSA only considering gauge R and R © M G Gibson 2014 RSS Destructive Testing MSA 4 Questions: 1. Why is MSA regarded as GR&R?

5. 5 Ford Motor Company MSA requirements (2009) 4.35 (ISO/TS 16949 cl. 7.6.1) All gauges used for checking Ford components/parts per the control plan shall have a gauge R&R performed in accordance with the appropriate methods described by the latest AIAG MSA to determine measurement capability.  Variable gauge studies should utilize 10 parts, 3 operators & 3 trials  Attribute gauge studies should utilize 50 parts, 3 operators & 3 trials © M G Gibson 2014RSS Destructive Testing MSA5 Questions: 1. Are some Customers leading the thinking? 2. Why just limited to products? 3. What are your Customer expectations?

6. 6© M G Gibson 2014RSS Destructive Testing MSA6 Measurement System Variation Reproducibility Repeatability Accuracy Stability Precision Bias Linearity Gauge R&R Calibration Measurement System Variation Observed Variation = Process Variation + Measurement System Variation

7. 7 AIAG MSA 4 th edn. (2010)  Accuracy, Bias, Stability, Linearity, Precision, Repeatability, Reproducibility, GR&R  Attributes, Variables, & non-replicable data considered  Variables GR&R study  10 parts, 3 operators, 3 measurements  Parts chosen from 80% of tolerance  Destructive testing requires 90 parts from a homogeneous batch  Three analytical methods: 1. Range – basic analysis, no estimates of R&R 2. Average & Range – provides estimates of R&R 3. ANOVA – preferred, estimates of parts, appraisers, parts*operators interaction, replication error due to gauge © M G Gibson 2014RSS Destructive Testing MSA7 Question: 1. Do organisations, auditors, quality mangers understand MSA?

8. 8© M G Gibson 2014RSS Destructive Testing MSA8 AIAG ANOVA Models  Crossed vs. Nested  Y ijk = μ + Operator i + Part j + (Operator*Part) ij + ε k(ij)  Y ijk =  + Operator i + Part j(i) +  (ij)k  Crossed vs. Nested?  See Barrentine, Moen, Nolan & Provost, Bower, Burdick, Skrivanek  Fixed vs. mixed effects models?  Software?  MTB V16+ includes fixed, mixed effects, enhanced models, pooled standard deviation approach not included.  SPC for Excel – fixed effects  Other software packages? Question:  Do organisations, auditors, quality mangers understand ANOVA?

9. 9  % Contribution  Measurement System Variation as a percentage of Total Observed Process Variation using variances (additive)  % Study Variation  Measurement System Standard Deviation as a percentage of Total observed process standard deviation (not additive)  % Tolerance  Measurement Error as a percentage of Tolerance  Number of Distinct Categories (ndc)  Measures the resolution of the scale  % Contribution  % Study Variation  % Tolerance  ndc  < 1% Good  2-9% Acceptable  > 9% Unacceptable  < 10% Good  11-30% Acceptable  > 30% Unacceptable  < 10% Good  11-30% Acceptable  > 30% Unacceptable  > 10 Good  5-10 Acceptable  < 5 Unacceptable GR&R Variables Data Acceptance Criteria  Do organisations, auditors, quality mangers understand the metrics?

10. 10 Non-replicable GR&R case study (Anon, 2002)  Ensure that all the conditions surrounding the measurement testing atmosphere are:  defined, standardized and controlled  appraisers should be similarly qualified and trained  lighting should be adequate and consistently controlled  work instructions should be detailed and operationally defined  environmental conditions should be controlled to an adequate degree  equipment should be properly maintained and calibrated, failure modes understood, etc.

11. 11 Non-replicable GR&R case study (Anon, 2002)  If the overall process appears to be stable & capable, and all the surrounding pre-requisites have been met, it may not make sense to spend the effort to do a non-replicable study since the overall capability includes measurement error – if the total product variation and location is OK, the measurement system may be considered acceptable.  Ironically high Cp / Cpk gives poor ndc! Question: 1. Do organisations, auditors, quality mangers understand this concept? AIAG FAQs response:  If your process is stable and capable, the spread of this acceptable process distribution includes your measurement error. There may be no need to study your measurement error from a purely "acceptability" viewpoint.’

12. 12© M G Gibson 2014RSS Destructive Testing MSA12 Questions for Making sense of MSA  What is the operational definition of statistical studies?  Do organisations, auditors, quality mangers understand statistical studies?  Why do auditors ask for GR&R studies?  Why is MSA regarded as GR&R?  Are (some) Customers leading the thinking?  Why is MSA limited to products?  Do you know your Customer expectations?  Do organisations, auditors, quality mangers understand?  MSA, ANOVA, crossed vs. nested, fixed vs. mixed models, metrics, high Cp/Cpk gives low ndc?  Is MSA seen just as a QMS requirement or a true part of continuous improvement?

13. 13 References  AIAG Measurement System Analysis, 4 th edn., (2010)  Anon. Non-replicable GR&R case study, (circa 2002)  Barrentine, Concepts for R&R Studies, 2 nd edn., ASQ, (2003)  Bower, A Comment on MSA with Destructive Testing, (2004) ; see also keithbower.com  Gorman & Bower, Measurement Systems Analysis and Destructive Testing, ASQ Six Sigma Forum Magazine, (August 2002, Vol. 1, No. 4)  Burdick, Borror & Montgomery, A review of methods for measurement systems capability analysis; JQT, 35(4): 342-354, (2003)  Burdick, Borror & Montgomery, Design & Analysis of Gauge R&R Studies, SIAM, ASA, (2005)  Moen, Nolan & Provost, “using a Nested Design for quantifying a destructive test” in Improving Quality Through Planned Experimentation, McGraw-Hill; 1 st edn., (1991)  Skrivanek, How to conduct an MSA when the part is destroyed during measurement, moresteam.com/whitepapers/nested-gage-rr.pdf

14. 14 Example crossed vs. Nested (5x2x2 for brevity)