copyright 2015 dmaictools.com all rights reserved dmaic applied to risk reduction

Copyright 2015 DMAICTools.com All Rights Reserved

DMAIC Applied to Risk Reduction


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.


Background

Company Background

• $600M Chemical Manufacturer• 5 Plants in U.S. Canada• 3 Plants in Europe• Primary Operations: Chemical

Compounding and Packaging


Goal

Goal as received from leadership team:

“Implement an effective Quality Management System to prevent product

recalls.”

Why is this important?


Product Recalls and Safety Issues Can be Devastating


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)


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


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


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


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


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


Control: CIP Audit


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

copyright 2015 dmaictools.com all rights reserved dmaic applied to risk reduction

Documents

rights reserved dmaic

rights reserved goals

rights reserved goal

devastating slide

rights reserved measure

quality process steps

risk reduction slide

high risk process steps