CAPA (Corrective and Preventive Action)

  • Collect and Analyze Information based on appropriate Statistical Methodology as necessary to detect recurring quality problems
  • Identify and Investigate Existing and Potential Product and Quality Problems
  • Take Appropriate, Effective, and Comprehensive Corrective and/or Preventive Actions

Why is CAPA Important

Linked to many other requirements.
– 820.198 Complaint Files
– 820.90 Nonconforming Product
– 820.80 Acceptance Activities
– 820.200 Servicing
– 820.22 Audits
– 803 Medical Device Reporting (MDR)
– 806 Reports of Corrections and Removals (“Recalls”)
– ... And many more
-- Ensures problems are detected AND resolved.

The CAPA Process

CAPA Data Analysis – 21 CFR 820.100(a)(1)
How does your firm categorize and group data and perform the analysis?
  • Expect FDA to verify your firm is using appropriate analysis techniques
  • Analysis of data should also include a comparison of the same problem type across different data sources

CAPA Data Analysis – 21 CFR 820.100(a)(1)
  • Is the data received by the CAPA system is complete, accurate, and timely?
  • Trend analysis is one type of data analysis

CAPA Investigation – 21 CFR 820.100(a)(2)
  • Investigating the cause of nonconformities relating to product, process, and the quality system.
  • 21 CFR 820.198, Complaint Handling, also requires investigations for the device involved, but the CAPA requirement is broader to cover the process and the quality system.

Possible Root Causes
  • Training
  • Design
  • Manufacturing
  • Management
  • Change Control
  • Purchasing/Supplier Quality
  • Testing
  • Documentation
  • Maintenance

Many manufacturers tend to overuse training as a corrective action and do not adequately address the systemic corrective action.

Root cause analysis tools
Commonly used tools
– Fishbone diagrams
– 5 “whys”
– Fault-tree analysis
– Among others

Identify Required Actions – 21 CFR 820.100(a)(3)
Identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems

CAPA and Risk Management
Risk analysis allows a manufacturer to:
– Determine priorities
– Assign resources
– Determine the severity of impact
– Determine the depth of investigation

Common tools
– Hazard analysis
 -- Used early for potential problems
– Failure Mode Effects Analysis (FMEA)
 -- Bottom up
– Fault Tree Analysis (FTA)
 -- Top down

Identify Required Actions – 21 CFR 820.100(a)(3)
- Expect FDA to review the actions taken
- Be prepared to discuss the appropriateness of the action taken
 -- Why was corrective action taken?
 -- Does the corrective action extend to include any additional actions (component suppliers, training, acceptance activities, field actions) if necessary.

Verify and Validate – 21 CFR 820.100(a)(4)
Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.

Did my solution work?
Did it create other potential non-conformances?

Implement and Record Changes – 21 CFR 820.100(a)(5)
Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.

Disseminate Information – 21 CFR 820.100(a)(6)
Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems