Risk assessment for Quality-by-Design and why FMEA fails
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Transcript of Risk assessment for Quality-by-Design and why FMEA fails
Risk Assessment for QbD:3 Reasons Why FMEA Fails
IFPAC 2014Sun Kim, PhD
www.linkedin.com/in/kimsunkist/
We Are Not Alone
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Sampling of LinkedIn Comments
“It is like a loop I always have to dealt with, everytime!” - S of Angelini
“The first part of your blog literally had me laughing out loud. This is so true and relevant.” -I of Teva
“I completely agree with you that FMEA, especially in the early development, is not the ideal tool” - F of PTM Consulting”
Sampling of LinkedIn Comments
“How refreshing to see this. Thank you so much for noting that the FMEA emperor may be missing some clothing.” - D, Statistician
“The formality of risk assessment should align with the level of product and process understanding. FMEA definitely has its place, but later in the development process.” - S of UpsherSmith
Agenda
Story1. Why Risk Assessment is Critical to QbD2. Why FMEA is inappropriate for dev. proj.3. a modified QFD Approach to Risk Ass.
Why Risk Assessment determines success and failure of QbD
1. First step & planning stage of QbD
2. Output is Control Strategy
3. Precursor to Design Space studies
Why Risk Assessment determines success and failure of QbD
1. First step & planning stage of QbD
a. Scientists hate these types of meetingsb. If this doesn’t go well, the momentum fizzlesc. Links QTPP-CQA-CPP-CS
Why Risk Assessment determines success and failure of QbD
1. 1st step & planning stage of QbDa. Scientists hate these types of meetingsb. If this doesn’t go well, the momentum fizzlesc. Links QTPP-CQA-CPP-CS
2. Output: Control Strategya. Prioritized list of projects or experiments
Why Risk Assessment determines success and failure of QbD
1. 1st step & planning stage of QbDa. Scientists hate these types of meetingsb. If this doesn’t go well, the momentum fizzlesc. Links QTPP-CQA-CPP-CS
2. Output Control Strategya. Prioritized list of projects
3. Precursor to Design Space studiesa. Links to Design Space
FMEA (Failure Mode Effects and Analysis)
Goal: “Identify all possible failures...prevent…”
Ref: ASQ
1. Most attributes become “Critical.”
A. FMEA’s definition:RPN (Risk Priority Number) = Severity x Occurrence x Detectability (or Controllability)
B. Classic definition: Risk Index = Severity x P(Occurrence)
http://plato.stanford.edu/archives/win2012/entries/risk/#DefRis
W. Gilchrist, ?Modelling Failure Modes and Effects Analysis,? International Journal of Quality and Reliability Management 10 (5), 16-23, 1993.
S. Kmenta, Scenario-based FMEA Using Expected Cost, A new perspective on evaluatng risk in FMEA, IIE Workshop,January 22, 2002.
S. Kmenta and K. Ishill, Scenario-Based Failure Modes and Effects Analysis using Expected Costs, Journal of Mechanical Design 126, 1027-1036, 2004.
D. Wheeler, ?Problems with Risk Priority Numbers,Quality Digest, 2011 Available at: http://www.qualitydigest.com/inside/quality-insider-article/problems-risk-priority-numbers.html
2. Inappropriate ordinal scale
At the development stage where scale-up details are not available, scientist do not yet understand the manufacturing process well enough to list realistic failure modes.
Recommendation: Use Low-Med-High or better yet, 0-1-3-9 scale
http://plato.stanford.edu/archives/win2012/entries/risk/#DefRis
W. Gilchrist, ?Modelling Failure Modes and Effects Analysis,? International Journal of Quality and Reliability Management 10 (5), 16-23, 1993.
S. Kmenta, Scenario-based FMEA Using Expected Cost, A new perspective on evaluatng risk in FMEA, IIE Workshop,January 22, 2002.
S. Kmenta and K. Ishill, Scenario-Based Failure Modes and Effects Analysis using Expected Costs, Journal of Mechanical Design 126, 1027-1036, 2004.
D. Wheeler, ?Problems with Risk Priority Numbers,Quality Digest, 2011 Available at: http://www.qualitydigest.com/inside/quality-insider-article/problems-risk-priority-numbers.html
3. Mediocre Control Strategy
Typical Examples:equipment maintenance, training or monitoring- feed control valves, steam traps, tank, flange, piping leaks
- pH, DO, backpressure monitoring
Ref: Pharmaceutical Engineering, May/June 2010, Vol. 30, No. 3, P.1-11
Alternative Approach: Modified from QFD
1. Scientist-driven
2. Process Map: TRD (Technical Requirements Document), IMPD (Investigational medicinal product dossier)
3. Link QTPP-CQA-CPP-CS
4. Risk = Impact x P(Occurrence)
Yoji Akao, Quality Function Deployment: Integrating Customer Requirements Into Product Design, Productivity Press, 1990.
Linear Approach
QTPP (C)QA
(C)PP(C)QA
Occurrence(C)PP
Link: from QTPP to (C)QA
QTPP
(C)QA
Impact
Link: from (C)QA to (C)PP
(C)QA
(C)PP
Impact
Occurrence
(C)PP
Probability
Occurrence
Linking it Together
QTPP (C)QA
(C)QA (C)PP
(C)PP Occurrence
Control Strategy
(Hi-Res) Control StrategyDifferent Strategy for different Types of Risk
pH@ Cation Exchange
Filter Condition @ Form. Buffer
High Risk
Low Risk
High Occurrence, Low Impact
High ImpactLow Occurrence,
Risk Assessment for QbD:3 Reasons why FMEA fails
1. Most Quality Attributes will be “Critical” because FMEA’s risk formula
inflates risk.
2. Scientists will waste time arguing over a meaningless evaluation
scale.
3. Control strategy will be mediocre.
Recommendation:
● Use QFD approach
● Further details at QbDWorks.com
Further Details?
QbDWorks.com