3/17/ The FDA Group (508) Improving Efficiency and Quality of a CAPA Program. The FDA s Perspective Management's Perspective.

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1 Perspectives: CAPA and FDA Improving Efficiency and Quality of a CAPA Program The FDA s Perspective Management's Perspective. 33 rd Annual Meeting of the Society of Quality Assurance National Harbor, Maryland March 29, 2017 J. Lawrence Stevens, RAC Senior Regulatory/Quality Consultant 1 2 1

2 CAPA and FDA Symptoms of an Ineffective CAPA System Management Perspective Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems. Recurring issues Inability to manage the many sources of quality data to understand early trends and issues More reaction than prevention Resources ($$$) are spent on handling failure rather than learning from it and preventing more of the same Field issues CAPA is an efficient and valuable system for identifying problems early and institution effective corrective actions to prevent recurrence of the problems. CAPA must be well defined and accountable through metrics. 2

3 Pleasing FDA Pleasing FDA CAPA Inputs FDA s unwritten CAPA regulations Proper CAPA inputs Root cause determination Effectiveness checks Collect and analyze data to identify nonconforming product, incidents, concerns or other quality problems that would be worth the effort to correct What Inputs does FDA expect? Management Review Non conforming product trends Complaint trends Internal Audit Findings Supplier Performance Environmental Monitoring Process Controls Servicing 3

4 Integrate CAPA with Risk Management Your risk management file must be used during CAPA assessments The basics of risk management should include: Severity Frequency Detectability Determining Root Cause Determining Root Cause TOOLS The five whys, a simplistic approach exhausting the question Why?. Fishbone diagram, a cause and effect diagram also known as the Ishikawa diagram. Pareto analysis, the 80/20 rule premised on a predefined database of known problems. Fault tree analysis, a quantitative diagram used to identify possible system failures. Failure modes and effects analysis (FMEA), which lists all potential failure modes and the potential consequences associated with each failure mode. 4

5 Identifying the Corrective Action Effectiveness of the Corrective Action Effectiveness Assessment FDA expects the root cause to be the gauge for success of the corrective action. Verifying or validating the corrective and preventive action to ensure that such action is effective. Immediate containment and interim controls may be necessary. What does FDA consider an appropriate method of validating the corrective action? Monitoring complaints is not an acceptable method. Quantitative analysis of the corrected situation is desireable 5

6 Making Changes Are You Ready for FDA? Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems. What does FDA expect regarding appropriate changes, and documentation regarding those changes? Complete CAPA Procedure Evidence of effectiveness for each CAPA Monitor CAPA processing QUESTIONS? Internal Audits 6

7 What are resources for Validation and Data Integrity The FDA Group is a global leader in GxP auditing, remediation, and quality system resourcing. We utilize a proprietary talent selection process of former FDA & industry professionals, amplified by a corporate culture of responsiveness and execution. Headquartered in Westborough, Massachusetts, The FDA Group has more 19 than 355 specialists (60 of whom are Thank You Contact the experts at The FDA Group (508) info@thefdagroup.com TheFDAGroup.com 7