Addressing Non-Conformances using Root Cause Analysis (RCA)

Why Should You Attend:

RCA assumes that systems and events are interrelated. An action in one area triggers an action in another, and another, and so on. By tracing back these actions, you can discover where the issue started and how it grew into the problem you're now facing.

Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem occurred in the first place. If you only fix the symptoms – what you see on the surface – the problem will almost certainly happen again, which will lead you to fix it, again, and again, and again. If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the non-conformance occurred in the first place.

Learning Objectives:

Learn to determine the Root Cause origin of a problem. You will learn a specific set of steps, with associated tools, to find the primary cause of the problem, so that you can:

• Determine what happened
• Determine why it happened
• Figure out what to do to reduce the likelihood that it will happen again

Areas Covered in the Webinar:

• 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

Who Will Benefit:

This webinar will provide valuable assistance to:

• Microbiologists
• QA managers
• Laboratory managers
• Laboratory supervisors
• QC practitioners

Michael Brodsky
Lead Auditor, Canadian Association for Laboratory Accreditation

Michael Brodsky has a post-graduate degree from the University of Toronto, School of Hygiene and Tropical Medicine. He has been an Environmental Microbiologist for more than 49 years, as a research scientist and Laboratory Director in both the public and private sectors. He currently operates as the President of Brodsky Consultants. He is a Past President of the International Association for Food Protection (IAFP), the Ontario Food Protection Association (OFPA) and AOAC International. He serves as co-Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC OMA and the AOAC Research Institute, as a reviewer for Standard Methods for the Examination of Water and Wastewater and as a chapter editor on QA for the Compendium of Methods in Microbiology. He was also a technical assessor in microbiology for the Standard Council of Canada and a lead auditor/assessor for the Canadian Association for Laboratory Accreditation (CALA).

Frequently Asked Questions:

1. How do you determine to amount of time or frequency to assess?
2. What do you recommend for Verification of Effectiveness sample size?
3. In order to close a CAPA event, we must define a time point at which Quality reviews the effectiveness of the CAPA.
4. Like how to determine how many samples of verification is enough?
5. How many times should you test post correction in a clean room excursion?

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