1. Conducting Effective CAPA Following an Audit
43rd DIA Annual Meeting, Atlanta
GCP/QA
June 18th from 1:30 - 3:00 pm

2. Presentation titles and speakers
Corrective and Preventative Actions –
Theoretical and Practical Aspects
Valerie Willets, ASKA Research, Vancouver, Canada
How to Achieve and Maintain Compliance –
A Site Perspective
Yvonne McCracken, Carolinas Research Associates, NC
An Auditor and Audit Client Perspective
Barbara Schnurr, Harrison Clinical Research, Germany

3. Learning Objectives
Discuss, structure, control and assess the follow-up process
Understand various strategies of CAPA
Effectively improve systems within an organisation

4. When does the audit end? At the close-out meeting? or
When the auditor says so? or
When the audit client says so? ?

5. When does the audit process end?
„The audit process is completed
when the follow-up process is completed and
when auditor / audit client have confirmed completion in writing

6. Essential phases of the audit follow-up process
Writing of audit report
Structuring of follow-up actions
CAPA
Corrective Actions & Preventative Actions
Confirmed completion

7. Structuring of follow-up actions
Audit client can assign overall responsibility for supervising the follow-up process to
Internal person/entity
Operative unit within the organisation
QM team member, or
Auditor
Increasingly common scenario for contract auditors

8. Structuring of follow-up actions
Audit client
Defines follow-up action process
Assigns responsibilities for
Overseeing follow-up progress
Carrying out the specified follow-up actions
Setting dates for action initiation and completion
Managing timelines
Submitting written response to auditor
Confirms that suggested follow-up actions are appropriate

9. Audit follow-up actions – an auditor‘s perspective
Upon decision of the audit client, the auditor‘s involvement …
may cease with the release of the audit report, or …
may continue through coaching and supporting the CAPA process until close-out

10. Audit follow-up actions – an auditee‘s perspective
Suggests actions required to respond to audit findings (CAPA: Corrective Actions Preventative Actions, improvement actions)
Undertakes agreed actions within a defined timeframe
Keeps audit client informed of status of these actions
Ensures timely submission of follow-up report to auditor

11. Essential phases of the audit follow-up process
Writing of audit report
Structuring of follow-up actions
CAPA
Corrective Actions & Preventative Actions
Confirmed completion

12. CAPA CAPA must be documented, controlled and assessed in order
to derive the best possible learning effect
to realise the potential for improvement
Metrics should be applied
to standardise findings
to detect systematic errors / weaknesses
to allow „before-after CAPA implementation“ comparison

13. CAPA – reporting and controlling
Can be
Non-computerised = paper-based
Computerised = electronic database
Influenced by
Size of organisation (S, M, L)
Number of audits performed
Volume of findings

14. Current handling of CAPA: Survey results
Questionnaires sent to 120 companies in Feb 07
Questions regarding
Audits
CAPA systems
CAPA implementation
Results of CAPA
Efficiency of CAPA
CAPA in their organisations

15. Essential phases of the audit follow-up process
Writing of audit report
Structuring of follow-up actions
CAPA
Corrective Actions & Preventative Actions
Confirmed completion

16. Compliance or non-compliance / formal close-out
Auditor / audit client determines
Adequacy
Effectiveness
Timeliness
of CAPA taken on reported audit findings
Compliance or non-compliance?
Positive compliance assessment ⇒ formal audit close-out

17. Accountability of auditors and audit clients
Auditors and audit clients should be accountable for
The quality of the audit service
The benefits realised for the organisation

18. Summary End of audit = end of problem identification phase
End of audit process = end of corrective actions (CA) = end of preventative actions (PA) ≠ end of improvement phase

19. Thank you!