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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.
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
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?
Copyright 2015 DMAICTools.com All Rights Reserved
Product Recalls and Safety Issues Can be Devastating
Copyright 2015 DMAICTools.com All Rights Reserved
Product Recalls and Safety Issues Can be Devastating
Copyright 2015 DMAICTools.com All Rights Reserved
Product Recalls and Safety Issues Can be Devastating
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)
Copyright 2015 DMAICTools.com All Rights Reserved
Define
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
Copyright 2015 DMAICTools.com All Rights Reserved
Measure
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
Copyright 2015 DMAICTools.com All Rights Reserved
Analyze
AnalyzePareto 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
Copyright 2015 DMAICTools.com All Rights Reserved
Improve
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
Copyright 2015 DMAICTools.com All Rights Reserved
Control
ControlTeam 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
Copyright 2015 DMAICTools.com All Rights Reserved
Outcomes
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