Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis.
The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for resolution of the key underlying problem basically an inability to define, locate and resolve the basic problem(s) or root cause(s) using a repeatable system. Consequently, the most important area audited by the FDA is CAPA it assures the FDA that the company is in compliance without the Agency constantly auditing it. However, one of the most cited 483 observations is failure to resolve the key underlying problem and close out CAPA documents in a timely manner basically an inability to define, locate and resolve the basic problem(s) or root cause(s). FI and RCA also play a major part in successful V&V and other CGMP activities. Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to the reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
The FDA has faulted companies repeatedly for failure to identify, systematically investigate, resolve, and then verify/validate and monitor for resolution of the key underlying problem basically an inability to define, locate and resolve the basic problem(s) or root cause(s) using a repeatable system. Consequently, the most important area audited by the FDA is CAPA it assures the FDA that the company is in compliance without the Agency constantly auditing it. However, one of the most cited 483 observations is failure to resolve the key underlying problem and close out CAPA documents in a timely manner basically an inability to define, locate and resolve the basic problem(s) or root cause(s). FI and RCA also play a major part in successful V&V and other CGMP activities. Regular, defined, systematic use of a few simple but powerful tools can contribute greatly to the reduction of product liability, cost reduction efforts, less chance of recalls, and an improved bottom line.
Why you should Attend:
Accurate and thorough Failure Investigation and Root Cause Analysis is a key to successful CAPA, validation, and other problem-solving programs. It is also key to many other important cGMP activities Non-conformance/OOS resolution, Complaint Handling, Adverse Event Reporting and Resolution, other Verification and Validation activities, Audit corrective and preventive actions, et al. Simple tools and workflow are not understood, disseminated, and used, consistently. Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools will be presented and discussed as simple and effective means to accomplish FI/RCA. A breakdown in FI/RCA results in product failures, liability issues, scrap/waste/fall off, and needless recalls, which we see listed on the FDA's website daily. Avoid a 'shoot from the hip' approach. Define, then attack, and resolve root problems/causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of a 'closed-loop' CAPA system, and basic CGMP compliance.Areas Covered in the Session:
- U.S. FDA's Expectations
- FI and RCA's Role in a Proactive and Compliant CGMP System
- Accurate Description with A Sample Failure Investigation Template
- 7 Powerful Tools for Root Cause Analysis
- Investigation Detail - Root or Probable Cause
- Impact Analysis and Action Often neglected but of major importance
- Correction, Corrective Action, Preventive Action
- Effectiveness Determining and Monitoring
- Institutionalize vs 'Entropy'
Speaker
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
