1. Copyright 2015 DMAICTools.com All Rights Reserved DMAIC Applied to Risk Reduction

2. Copyright 2015 DMAICTools.com All Rights Reserved Goals for this Presentation 1.Share how the DMAIC approach helped a team through a challenging assignment. 2.Introduce PFMEA as a powerful prevention tool.

3. Copyright 2015 DMAICTools.com All Rights Reserved Background Company Background $600M Chemical Manufacturer 5 Plants in U.S. Canada 3 Plants in Europe Primary Operations: Chemical Compounding and Packaging

4. Copyright 2015 DMAICTools.com All Rights Reserved Goal Goal as received from leadership team: “Implement an effective Quality Management System to prevent product recalls.” Why is this important?

5. Copyright 2015 DMAICTools.com All Rights Reserved Product Recalls and Safety Issues Can be Devastating

6. Copyright 2015 DMAICTools.com All Rights Reserved Product Recalls and Safety Issues Can be Devastating

7. Copyright 2015 DMAICTools.com All Rights Reserved Product Recalls and Safety Issues Can be Devastating

8. Copyright 2015 DMAICTools.com All Rights Reserved Initial Thoughts on the Project “Implement an effective Quality Management System to prevent product recalls.” Initial Thoughts We were already ISO 9001 registered An across-the-board effort strengthening all QMS areas would likely not address causes behind recalls DMAIC advantages for this project - - Structure (metrics / proven roadmap) - Root-cause focus - Prevention tools - Control plan Financial Impact: Recall Prevention (2012 recall cost was $1.7M for one incident)

9. Copyright 2015 DMAICTools.com All Rights Reserved Define -Needed a metric linked to recall prevention -Held a ½ day “Define Kaizen” (1) Root cause analysis -A major product recall -Other major “quality surprises” in the marketplace over the prior two years (2) Agree on a valid measure of recall risk Outcome: Use PFMEA Risk Priority Number as the Metric RPN = Severity x Occurrence x Detection

10. Copyright 2015 DMAICTools.com All Rights Reserved Measure Team agreed on standard definitions for Severity, Occurrence, Detection scoring (example lower left) Baseline Results One “very high risk” process step (RPN > 500) identified and addressed (mixing kettle rinse water handling in one facility) 114 “high risk” process steps (RPN > 250) identified Goal: all RPN’s below 250 in 12 months

11. Copyright 2015 DMAICTools.com All Rights Reserved Analyze Pareto analysis of high risk process steps revealed four major causes behind high risk process steps 1.Process requirements (SOP’s / standard work) insufficient – methods not defined 2.In cases where requirements were documented, operator understanding of process requirements was lacking 3.Critical-to-quality process steps were not highlighted in any way 4.Plant ISO audit processes were too general, did not focus adequately on the first three bullets

12. Copyright 2015 DMAICTools.com All Rights Reserved Improve Process requirements for high risk process steps reviewed and updated Training processes put in place requiring supervisor verification for high-risk process steps In some cases, additional process controls were added to increase chances of detection RPN values re-assessed as changes were made, process steps above 250 RPN reduced from 114 to 37 in nine months

13. Copyright 2015 DMAICTools.com All Rights Reserved Control Team developed a Critical Inspection Point (CIP) Audit CIP = high risk process step requiring proper SOP, training, and internal audit Audits are conducted quarterly and plants are scored based on nine criteria for each CIP

14. Copyright 2015 DMAICTools.com All Rights Reserved Control: CIP Audit

15. Copyright 2015 DMAICTools.com All Rights Reserved Outcomes Initial CIP audit scores were in the 30% - 50% range for all plants After three quarterly audits, plants progressed to the 80% + range Critical customer complaint count from 42 avg per month to 19 High risk process steps from 114 to 37 Quarterly CIP audits represent the control phase and will switch to twice/year when plants reach 95% CIP audit scores