Root Cause Analysis in Regulated Industry - Tools and Approach to Ensure Effective Corrective and Preventive Actions

Overview:

Identifying plausible reasons for undesirable effects in process/product is termed root cause analysis (RCA). When appropriately and efficiently executed, RCA can prevent and solve underlying issues systemically.

Why you should Attend:

Quality / Compliance Specialist, manufacturing engineers and quality professionals overseeing the product safety and compliance should be versed with risk management principles. This involves the systematic identification, control, and prevention of potential failures that could pose hazards to users. It also entails identifying associated risks and, if they reach an unacceptable level, notifying developers to mitigate them to an acceptable level or below.  

Areas Covered in the Session:

Webinar will focus on an approach to address the expectation of regulated industries to conduct an effective investigation in determination of root cause of the nonconformity:

• How to document a non-conformance problem statement based on data and relevant evidence
• Determine factors that caused the nonconformity
• Identify causal factors leading to the potential root cause
• Determination of corrections/corrective actions to eliminate the nonconformity and prevent it from recurring
• How to evaluate Verification of Effectiveness checks

Who Will Benefit:

• Quality Managers
• Production Managers
• Quality /compliance Leads/Specialist
• Manufacturing Engineers
• Service Engineers