Corrective and preventative actions require a flexible tool that will help you determine the root cause of non-conformities or other undesirable situations and prevent their recurrence.
- Supports a teamwork approach to corrective actions with assignments of specific activities, to include a CAPA Manager, Investigators, Action Plan Implementer, Action Plan Reviewers, and Reviewers after the action plan is complete to ensure the follow up results justify the completion of the corrective or preventive action. This supports the Mentor/Mentee dynamic lean experts describe as being one the critical success factors at Toyota. Having at least two people involved improves brainstorming, problem solving and accountability.
- Triage system to encourage CAPA input from everyone without bogging down CAPA system with improvements that don’t need to be managed in the CAPA system. The Employee Feedback module can act as the preliminary input for CAPA requests. The Management Rep can use this as a teaching tool to weed out corrective/preventive actions from anomalies that should just be recorded and fixed. (“Corrections” vs. “corrective actions” – see The Corrective Action Handbook for more details).
- Fields for the key information needed to describe the initial problem, the Nonconformity, the Requirement, the Evidence, and the Risk or Concern that justifies why the CAPA is needed. Both Mike Micklewright and Denise Robitaille support the use of these fields when describing a nonconformity.
- Multiple root cause analysis tools such as the 5-Why process as well as the A3 format used at Toyota. The Corrective Action Handbook also provides an excellent list of areas to consider when performing a root cause analysis that is also supported within the CAPA Module.
- Links to other records within The Lean Machine that support the CAPA record. These can include documents, audits, nonconforming material reports, metrics, parts, customer complaints, customers, vendors, equipment, and management review meetings. All of which are alligned with the requirements of ISO 9001:2008 and other ISO standards for quality systems.
- Action plan management tools to both describe and manage the action plan, including attachments, and the ability to automatically create a new event record specifically designed as a CAPA action plan, which supports assignments, due status, completion status.
- Accountability support through dashboard links to all CAPA records based on their stage and assignment so that all users involved with the CAPA have direct links to their CAPA responsibility as soon as they log into the software. Accountability is also supported through robust reporting tools and the teamwork approach described above.
The CAPA module also includes useful features such as:
- Extensive reporting and trend analysis capabilities
- The ability to E-mail the corrective action to a vendor or a customer
- MS Outlook integration to export due dates and the description of actions needed your MS Outlook calendar
- Linking the Corrective Action module to your own released procedure on corrective actions
- Chronology tracking to have The Lean Machine automatically log the significant user actions as the CAPA record is completed