INTRODUCTION FOR CORRECTIVE & PREVENTIVE ACTION (CAPA) MANAGEMENT
Corrective action and preventive action (CAPA, also called corrective action / preventive action) are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards such as ISO 9001/13485/22000. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective actions (CA) are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit. Preventive actions (PA) are implemented in response to the identification of potential sources of non-conformity.
LEARNING OUTCOME
At the end of the seminar/workshop, the participants are expected to:
- Describe and implement the corrective & preventive action system in QMS
- Monitor the effectiveness of CAPA implementation within the organization QMS
COURSE CONTENT
DAY 1
- ISO Clause Corrective action
- ISO Clause Preventive Action
- Non-Conformance Report (NCR) Issuance
- NCR CAPA writing (Do’s & Don’t)
- Possible Root Causes identification in NCR
- NCR Follow Up/Timeline Development
- Case Study/Group Exercise on NCR Writing
DAY 2
- Effective CAPA writing/issuance
- Verification Methods for CAPA Effectiveness
- NCR/CAPA Microsoft Excel Based Database/Tracking
- How to provide effective CAPA?
- Samples of CAPA
- Workshop/Case Study
- Interactive Group Discussions
- Written Assessment/Quiz
WORKSHOP 1: CLASSIFICATION OF CORRECTIVE & PREVENTIVE ACTION
WORKSHOP 2: ROOT CAUSE ANALYSIS TOOL AND TECHNIQUES
Post-Training Written Knowledge Assessment
Course Wrap Up/Q&A
