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