DMAIC Applied to

Risk Reduction

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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.

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Background

Company Background

$600M Chemical Manufacturer

5 Plants in U.S. Canada
3 Plants in Europe
Primary Operations: Chemical
Compounding and Packaging

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Goal

Goal as received from leadership

team:
Implement an effective Quality
Management System to prevent
product recalls.
Why is this important?

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Product Recalls and Safety Issues Can be Devastating

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Product Recalls and Safety Issues Can be Devastating

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Product Recalls and Safety Issues Can be Devastating

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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)

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Define

Define
- Needed a metric linked to recall
prevention
- Held a 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 Priority Number as the Metric
Outcome: Use PFMEA Risk
RPN = Severity x Occurrence x Detection

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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 RPNs below 250 in 12
months

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Analyze

Analyze
Pareto analysis of high risk process steps
revealed four major causes behind high risk
process steps
1. Process requirements (SOPs / 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
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2015
DMAICTools.com All Rights Reserved
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

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Control

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

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Control: CIP Audit

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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

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