Each pharmaceutical manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA). And the procedures must ensure all requirements of CAPA subsystem are met.
CAPA Subsystem in Context
- Production & Process Controls
- Material Controls
- Equipment & Facility Controls
- Design Controls
- Records, Documents, & Change Controls
- Inspection/Test Data
- Nonconforming Material Reports
- Equipment Data
- Scrap/Yield Data
- Rework Data
- Returned Product
- Internal Audits
- Process Control Data
- Acceptance Activities
- Field Service Reports
- Legal Claims
- Warranty Claims
- External Audits
- Medical Device Reports (MDRs)
CAPA Process Steps
1. Analyze Data
Ensure all quality data sources are defined and analyzed to identify existing product and quality problems. Analysis of data should also include a comparison of the same problem type across different data sources.
Common Statistical Techniques Used for CAPA Management
- Pareto charts
- Run charts
- Control charts
- Mean and standard deviation
- T tests for comparisons
- Experimental design (DOE)
- Graphical methods (fishbone diagrams, histograms, scatter plots, spreadsheets, etc.)
2. Investigate Cause
Typical Investigation Steps include:
- Identify problem and characterize.
- Determine scope and impact.
- Investigate data, process, operations and other sources of information.
- Determine root cause, if possible.
Possible Root Causes:
- Change Control
- Purchasing/Supplier Quality
Commonly used root cause analysis tools:
- Fishbone diagrams
- 5 “whys”
- Fault-tree analysis
Many manufacturers tend to overuse training as a corrective action and do not adequately address the systemic corrective action.
3. Identify Action
Identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems is a critical step of CAPA process. We can follow the below sequence:
- Identify solutions.
- Develop action plan for corrective action and/or preventive action.
- Should consider the risk posed by the problem.
– Not all problems require the same level of investigation and action.
– It is appropriate to “elevate” some issues at the expense of others.
A Preventive Action is NOT required for all situations; however, a Corrective Action to prevent recurrence is required.
4. Verify and Validate Effectiveness
Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
CAPA Effectiveness Verification Checklist
- Criteria applies based on case or nature of CAPA
- Plan of effectiveness check is specific to CAPA
- Early detection points are identified to monitor for recurrence/occurrence
- The solution works
- No other potential non-conformances generate