Risk assessment for Quality-by-Design and 3 Reasons why FMEA fails

1. Risk Assessment for QbD:
3 Reasons Why FMEA Fails
IFPAC 2014
Sun Kim, PhD
www.linkedin.com/in/kimsunkist/

6. We Are Not Alone
12 Likes
21 Comments
34 Shares

7. 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”

8. 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

9. Agenda
Story
1. Why Risk Assessment is Critical to QbD
2. Why FMEA is inappropriate for dev. proj.
3. a modified QFD Approach to Risk Ass.

10. 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

11. Why Risk Assessment determines
success and failure of QbD
1. First step & planning stage of QbD
a.
b.
c.
Scientists hate these types of meetings
If this doesn’t go well, the momentum fizzles
Links QTPP-CQA-CPP-CS

12. Why Risk Assessment determines
success and failure of QbD
1. 1st step & planning stage of QbD
a.
b.
c.
Scientists hate these types of meetings
If this doesn’t go well, the momentum fizzles
Links QTPP-CQA-CPP-CS
2. Output: Control Strategy
a. Prioritized list of projects or experiments

13. Why Risk Assessment determines
success and failure of QbD
1. 1st step & planning stage of QbD
a.
b.
c.
Scientists hate these types of meetings
If this doesn’t go well, the momentum fizzles
Links QTPP-CQA-CPP-CS
2. Output Control Strategy
a. Prioritized list of projects
3. Precursor to Design Space studies
a.
Links to Design Space

14. FMEA (Failure Mode Effects and Analysis)
Goal: “Identify all possible failures...prevent…”
Ref: ASQ

15. 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

16. 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

17. 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

18. 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.

19. Linear Approach
QTPP
(C)QA
(C)QA
(C)PP
(C)PP
Occurrence

20. Link: from QTPP to (C)QA
(C)QA
QTPP
Impact

21. Link: from (C)QA to (C)PP
(C)PP
(C)QA
Impact

22. Occurrence
Probability
(C)PP
Occurrence

23. Linking it Together
QTPP
(C)QA
(C)QA
(C)PP
(C)PP
Occurrence
Control
Strategy

24. (Hi-Res) Control Strategy
Different Strategy for different Types of Risk
High Occurrence,
Low Impact
Low
Risk
pH
@ Cation Exchange
High
Risk
High Impact
Low Occurrence,
Filter
Condition @
Form. Buffer

25. 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

26. Further Details?
QbDWorks.com