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Article CommentaryCommentary

Probability Concepts in Quality Risk Management

H. Gregg Claycamp
PDA Journal of Pharmaceutical Science and Technology January 2012, 66 (1) 78-89; DOI: https://doi.org/10.5731/pdajpst.2012.00801
H. Gregg Claycamp
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Abstract

Essentially any concept of risk is built on fundamental concepts of chance, likelihood, or probability. Although risk is generally a probability of loss of something of value, given that a risk-generating event will occur or has occurred, it is ironic that the quality risk management literature and guidelines on quality risk management tools are relatively silent on the meaning and uses of “probability.” The probability concept is typically applied by risk managers as a combination of frequency-based calculation and a “degree of belief” meaning of probability. Probability as a concept that is crucial for understanding and managing risk is discussed through examples from the most general, scenario-defining and ranking tools that use probability implicitly to more specific probabilistic tools in risk management. A rich history of probability in risk management applied to other fields suggests that high-quality risk management decisions benefit from the implementation of more thoughtful probability concepts in both risk modeling and risk management.

LAY ABSTRACT: Essentially any concept of risk is built on fundamental concepts of chance, likelihood, or probability. Although “risk” generally describes a probability of loss of something of value, given that a risk-generating event will occur or has occurred, it is ironic that the quality risk management literature and guidelines on quality risk management methodologies and respective tools focus on managing severity but are relatively silent on the in-depth meaning and uses of “probability.” Pharmaceutical manufacturers are expanding their use of quality risk management to identify and manage risks to the patient that might occur in phases of the pharmaceutical life cycle from drug development to manufacture, marketing to product discontinuation. A probability concept is typically applied by risk managers as a combination of data-based measures of probability and a subjective “degree of belief” meaning of probability. Probability as a concept that is crucial for understanding and managing risk is discussed through examples from the most general, scenario-defining and ranking tools that use probability implicitly to more specific probabilistic tools in risk management.

  • ICH Q9
  • Quality risk management
  • Probability judgment
  • Expert judgment
  • Pharmaceutical manufacturing
  • © PDA, Inc. 2012
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PDA Journal of Pharmaceutical Science and Technology: 66 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 1
January/February 2012
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Probability Concepts in Quality Risk Management
H. Gregg Claycamp
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 78-89; DOI: 10.5731/pdajpst.2012.00801

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Probability Concepts in Quality Risk Management
H. Gregg Claycamp
PDA Journal of Pharmaceutical Science and Technology Jan 2012, 66 (1) 78-89; DOI: 10.5731/pdajpst.2012.00801
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  • Article
    • Abstract
    • Introduction
    • Concepts of Probability
    • Probability in the Language of Risk
    • Probability for the Measurement of Uncertainty
    • Probability Implementation in Various Quality Risk Management Tools
    • Qualitative, Hierarchical Methods
    • Ranking Methods
    • Quantitative Methods
    • Challenges in Probability Judgments
    • Conclusion
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