CAPA—Common Pitfalls and How to Avoid Them

1. CAPA—Common Pitfalls and How to Avoid Them ASQ Las Vegas section 705 February 21, 2007 Presented by Michelle M. Johnston, RAC Advanced Quality System Solutions

2. Sources of Potential Problems • Root Cause Investigations • Management oversight (or lack thereof) • Procedural issues • Timeliness

3. What I’ve Encountered • < 10% of CAPA systems are effective • Most problems lie in implementation, not within procedures • Internal audits do not identify systemic problems related to CAPA • Timeliness is a common shortcoming

4. Differences in CAPA Requirements for Medical Device Manufacturers • Prescriptive with regards to sources of data • Traveler • Complaints • Nonconforming material • Service reports • Internal Audits • Returned product

5. FDA Enforcement • Nonconformities are cited during inspection, corrective action plan required. • Warning Letter– more serious, available to the public • Fines, stop product shipment

6. Differences in CAPA Requirements for Medical Device Manufacturers • Use of statistical techniques to detect quality problems • Verification and validation to ensure that device is not adversely affected by CAPA • Dissemination of information regarding quality problems to those responsible for quality

7. Root Cause Investigations We can’t solve complex problems using the same knowledge that created them.” -Albert Einstein

8. Root Cause - Common Pitfalls • Looking for a “Quick Fix” • Everything under the sun is attributed to employee training. • Narrow focus—don’t consider similar devices or processes • Insufficient technical expertise – assign root cause responsibility to CAPA Coordinator • Lack of training in tools of investigation • No reference to internal procedures or methods

9. Root Cause - Common Pitfalls • Getting side tracked – extraneous data and side issues. • Lack of documentation or information regarding root cause investigation (e.g., how did you get from point A to point B) • No traceability to product or processes • Assignment of blame • Actions taken are not aligned with or support results of investigation • Recommended actions are not implemented, no justification

10. Root Cause Investigation • Root cause is not always obvious, hence the difficulties • There can be more than 1 root cause • Root cause is NOT restating the nonconformity! (e.g., product packaging did not include expiry date) • Don’t rely on that next “epiphany”

11. Root Cause Investigation • Root Cause Investigations should be: • Appropriate to the problem — • commensurate with risk • Determine cause, not fix symptoms • Structured approach, problem solving methods to correct and prevent • What happened • How it happened • Why it happened

12. Root Cause Analysis • Root cause investigations should be a formal and structured process and not just thinking off the cuff • Appropriate root cause analysis tools and training • FTA • Pareto analysis • Fishbone diagram • 5 Whys

13. Root Cause Investigation • An inability to consistently determine root cause may point to procedural or investigative deficiencies. • Repeat CAPAs indicate • the root cause has not been identified ….. • Or a proper solution identified and implemented

14. CAPA Committees Help or Hindrance?

15. CAPA Committees - Common Pitfalls • CAPA seen as necessary evil • Try to solve the problem in committee • CAPA not a priority to management—meetings are not held as required • Members do not understand CAPA requirements • Difficulty in reaching consensus, hidden agendas • Insufficient documentation of meetings • Decisions are not always conveyed to those expected to carry them out.

16. CAPA Committee - Considerations • What exactly is their role? • CAPA Committee is usually cross-functional • Middle to upper management • Meet at defined intervals

17. Role of CAPA Committee • Identify and initiate CAPA • Assign priority • Assign resources • Review progress and address issues • Monitor timeliness • Verify effectiveness

18. CAPA Committee –Summary • CAPA committee only as good as the system • Not a requirement--if you have one, make it value-added

19. Does it make a difference? It depends.

20. CAPA Procedures

21. CAPA Procedure - Common Pitfalls • Responsibilities not clearly defined. Who does what? • Inputs not adequately defined. Are you considering all sources of data? • CAPA forms complex, not intuitive. If you need to explain how to fill out the forms, then they are likely too burdensome. • One size fits all approach. No consideration given to risk.

22. CAPA Procedure - Common Pitfalls • Decentralized CAPA system—local systems don’t talk to each other • Inadequate employee training. Many times, employees are simply required to read the procedure and depending upon their role, this may not be sufficient • Preventive action takes a back seat and is rarely addressed

23. CAPA Procedure - Common Pitfalls • Supplier related CAPAs: • Requirements not defined • Not adequately monitored • No evidence of internal review and acceptance

24. CAPA Procedure - Common Pitfalls • Verification of effectiveness is lacking or confused with verification of implementation. • What is the method? • What is the timeframe? • Who is responsible?

25. Considerations • Clear,comprehensive, flexible procedure • Easy to use documentation • Closed loop system • Clear lines of communication

26. Considerations • A robust CAPA system doesn’t exist in a vacuum • Appropriate linkages include: • Management Review • Risk Management • Post Market Surveillance • Internal Audit

27. Timeliness of CAPAs

28. Common Pitfalls • No aging data, timeliness not tracked • Arbitrary deadlines – not linked to complexity of the problem • Requests for extension routinely granted • Do you need this “contingency” clause? • Should be the exception, not the rule • Some requests are made after due date • Allocation of resources—one person responsible for multiple CAPAs

29. Timeliness of CAPAs Considerations • Expected CAPA closure should be commensurate with the nature and risk of the problem • Imposing arbitrary 30 day deadline may not result in a comprehensive CAPA investigation • Demonstrate timely, forward progress • Interim progress reports to keep due date on target

30. Summary • Review your CAPA process to make sure you avoid common pitfalls while ensuring problems are identified and corrected. • Properly investigating and identifying root cause • Providing meaningful and effective oversight of the CAPA process • Ensuring the CAPA procedure is understood and effective • Closing CAPAs in a timely manner, appropriate to the complexity of the problem

31. CAPA—Common Pitfalls and How to Avoid Them For more information contact: Michelle M. Johnston, RACT: 858.722.4471 E: mmjohnston@advqss.com Website (coming soon) www.advqss.com