LTR 85: The problem with CAPA problem statements

“If you frame something in a certain way, you can influence the perception of its cause and the solution. ”

In this Let’s Talk Risk! conversation, Jack Garvey cautions against starting a CAPA with a problem statement first. Rather, he recommends the analysis to initially begin from a factual review of both technical and situational context leading up to a CAPA, and then defining a specific problem statement appropriately to guide the subsequent investigation of root cause(s) and identification of corrective/preventive actions.

Starting with a problem statement, as required by many of the current computer-based tools, leads to bias that can influence the perception of causes and potential solution. Conformity bias, subjectivity, and over-generalization

Listen to this Let’s Talk Risk! conversation with Jack Garvey, we cover a range of topics related to CAPA and risk analysis. Jump to a topic of interest using the timestamps below.

00:01:02 Introduction

00:02:35 A quick recap of top issues in FDA inspections

00:05:50 Why not to start your CAPA with a problem statement

00:10:00 How to conduct good investigations in CAPA

00:17:00 Analyzing risks in a relative context and diversity of risk flow

00:24:10 Why training is necessary for appropriate use of FMEAs for risk analysis

00:29:10 Closing comments and key takeaways

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Suggested links:

LTR: 5 blind spots to check in your CAPA process.

LTR: A risk-based approach to CAPA.

Compliance Architects: Writing for compliance.

About Jack Garvey

Jack Garvey is currently the managing partner at Compliance Architects, LLC providing services in compliance and quality consulting, outsourcing, staff augmentation technology-related services to companies regulated by the US FDA. In a career spanning over 30 years, he has held a variety of roles ranging from engineering to regulatory attorney, and leadership roles in Quality and Regulatory functions. Jack holds a Bachelor’s degree in Chemical Engineering, and Juris Doctor in Environmental Law. He has been admitted to practice law in NY and NJ since 1991.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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