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First Step in QbD - How to Get it Right

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What is the most overlooked step in Quality by Design? QbD Risk Assessment - Learn the common pitfalls and how to prevent it. It's all about the relationship between your process parameter (CPP) and patient (QTPP)

Published in: Healthcare

First Step in QbD - How to Get it Right

  1. 1. First Step in QbD: How to get it Right ISPE 2014 Sun Kim, PhD
  2. 2. Are You ... 1. Starting a QbD project & want to skip common pitfalls? 2. Tried QbD but management and colleagues were skeptical? 3. undecided if QbD is for your organization?
  3. 3. QbD in 3 Steps 1. Risk Assessment: Build Relationships from QTPP, CQA to CPP (CMA) 2. Design Space 3. Control Strategy
  4. 4. You Are Not Alone. 17 Likes 47 Comments
  5. 5. 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”
  6. 6. 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
  7. 7. Agenda 0. Story 1. Why Risk Assessment is Critical to QbD 2. Why You shouldn’t blindly apply FMEA for QbD development projects. 3. A Smarter Risk Assessment Approach
  8. 8. Why Risk Assessment determines success and failure of QbD 1. 1st step & planning stage of QbD 2. Output is Control Strategy 3. Precursor to Design Space studies
  9. 9. Why Risk Assessment determines success and failure of QbD 1. 1st step & planning stage of QbD a. Scientists dread these types of meetings b. If this doesn’t go well, the momentum fizzles c. Links QTPP-CQA-CPP-CS
  10. 10. Why Risk Assessment determines success and failure of QbD 1. 1st step & planning stage of QbD a. Scientists hate these types of meetings b. If this doesn’t go well, the momentum fizzles c. Links QTPP-CQA-CPP-CS 2. Output: Control Strategy a. Prioritized list of projects or experiments
  11. 11. Why Risk Assessment determines success and failure of QbD 1. 1st step & planning stage of QbD a. Scientists hate these types of meetings b. If this doesn’t go well, the momentum fizzles c. 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
  12. 12. FMEA (Failure Mode Effects and Analysis) Goal: “Identify all possible failures...prevent…” Ref: ASQ
  13. 13. 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
  14. 14. 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
  15. 15. 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
  16. 16. Smarter Approach 1. Scientist-driven: Y=f(X), QFD=C&E + FMEA 2. Process Map: TRD (Technical Requirements Document), IMPD (Investigational medicinal product dossier) 3. Link how a CPP matters to the Patient (QTPP) 4. Risk = Impact x P(Occurrence) Yoji Akao, Quality Function Deployment: Integrating Customer Requirements Into Product Design, Productivity Press, 1990.
  17. 17. How will a Process Parameter affect a Patient? Linking QTPP-CQA-CPP/CMA
  18. 18. Linear Approach QTPP (C)QA (C)QA (C)PP (C)PP Occurrence
  19. 19. Link: from QTPP to (C)QA QTPP (C)QA Impact
  20. 20. Link: from (C)QA to (C)PP (C)QA (C)PP Impact
  21. 21. Occurrence (C)PP Probability Occurrence
  22. 22. Linking it Together QTPP (C)QA (C)QA (C)PP (C)PP Occurrence Control Strategy
  23. 23. Control Strategy: CQA Pareto
  24. 24. Control Strategy: CPP Pareto
  25. 25. (HD) Control Strategy: Impact x Occurrence
  26. 26. Lean QbD Software Demo LeanQbD.com
  27. 27. The First Step in QbD 1. Risk Assessment is the Blueprint of QbD. 2. Focus on building Y=f(x) for QTPP-CQA-CPP/CPP 3. Save time by using Templates and a simple rating system Recommendation: ● Use LeanQbD approach - Get it at LeanQbD.com ● More Tips from QbDWorks.com
  28. 28. More Tips from QbD Practitioners QbDWorks.com

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