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Subscribe NewsletterRoot Cause Analysis – Starting at the Beginning
Product Id
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600094
Overview: Root Cause Analysis (RCE) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.
It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. As such RCA is a major element of cGMP compliance, and key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.
It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. As such RCA is a major element of cGMP compliance, and key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators brains be engaged by the use of such simple yet powerful tools? Use RCA to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.
Areas Covered in the Session:
- Regulatory "Hot Buttons"
- 4 Basic Steps to Problem Solving
- An Investigation Template
- ID / Document the Problem
- Investigation / Analysis – Methodology and Tools
- Find the Solution(s)
- Monitor for Effectiveness
- Lock In the Change
- Close the Loop
- Take It to the Next Level
Who Will Benefit:
- Senior management, project leaders, internal / external consultants
- Regulatory affairs
- Quality systems personnel / QAE
- R&D and engineering staff
- Production personnel
- Personnel involved in Lean and Six Sigma Initiatives
- New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
- Risk management, complaint and CAPA personnel desiring to minimize post-production / life cycle, and other costly problems.