Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances

Root Cause Analysis (RCA) in the Laboratory – Addressing Non-Conformances is organized by Webinar Compliance.

Category: Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics
Presenter: Michael Brodsky
Scheduled On: February 16 2022 12:00 pm US/Canada (Eastern Time - ET)

Who Should Attend:
• Microbiology QA Managers
• Microbiological QC Analysts
• QA/QC Managers/Supervisors
• Laboratory Managers/Supervisors
• Personnel responsible for QC and resolving non-conformances

Description:
How would you approach a non-conformance in the laboratory?

Do you start treating the symptoms right away? Or, do you take a moment to analyze and consider if there’s actually a deeper problem that needs your attention?

Root Cause Analysis (RCA) is one of the most commonly used techniques that helps people answer the question of why the problem occurred in the first place.

If you only fix the problem and symptoms – what you see on the surface without actually digging deeper to understand the problem – the problem will almost certainly happen again. This will lead you to fix it, again, and again, and again. If, instead, you spend time to analyze why the non-conformance is occurring, you can fix the underlying systems and processes once and for all ensuring similar problems do not creep up again.

Areas Covered in the Session:
• Defining the Problem
• Examining the Data
• Identifying Possible Causal Factors
• Identifying the Root Cause(s)
• Taking Corrective Action
• Verifying the effectiveness of the corrective action