Description:
Most Corrective and Preventive Action (CAPA) programs suffer from poor documentation of non-conformances and poor root cause analysis and corrective actions plans. This one day seminar is designed to teach and remind auditors how to document nonconformances and to teach the recipients of nonconformances how to provide thoughtful root cause analysis and how to develop effective Corrective and Preventive Action plans. The seminar is conducted in four (4) workshops of up to 10 people each. Each workshop contains either auditors and those who issue requests for Corrective and Preventive Action or those who respond to requests to provide Corrective and Preventive Action Plans.
Documenting a Nonconformance :
- Accurately citing the requirement-quoting it
- Clearly stating the condition or event
- Stating why the condition event is a nonconformance
- Specific examples are used (both good and bad) along with those from your organization
Root Cause Analysis
- The 5 Whys?
- Fish bone diagrams
- The importance of determining the true root cause vs. citing an excuse
- The connection between root cause analysis and corrective and preventive action
Corrective and Preventive Action Plans
- Corrective vs. Preventive Action
- The Ultimate Goal: permanently correcting or preventing a nonconformance
- The connection between Corrective and Preventive Action and continual improvement
Who Should Attend?
Internal Auditors and Management Representatives who issue nonconformances and oversee the CAPA program and the recipients of Corrective and Preventive Action requests.
Prerequisites:
Participants should all be working within an existing Management System.
Duration: 1 Day (4 sessions of up to 10 people each, each session is 2 hours in duration)
Type: On-Site Training or via Digital Video Conference (DVC)
Price: $2500 plus course materials and travel expenses.