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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thank you!