Example of a true preventive action for 2021

Описание: Today’s video is an example of a true preventive action that you can implement if you have Canadian Licensing. If you don’t have Canadian Licensing, you can apply the same method to any regulatory requirement changes (MDR, IVDR, etc.).

It is only a true preventive action if you identify changes to regulations BEFORE your auditor (1st, 2nd, or 3rd party auditor). The preventive action is to create a quality plan for implementation of the quality system changes prior to the required deadline for compliance with the new regulation. There are five simple steps to the plan:

1 - Review regulations periodically (a documented schedule in your Management Review procedure is recommended)
2 - Identify new regulations (e.g. pages 66-75 of the CMDR “Amendments Not in Force”)
3 - Develop a draft quality plan and present during Management Review
4 - Initiate Preventive Action
5 - Perform Internal Audit of the individual processes updated for compliance with CMDR (need a qualified auditor trained on the CMDR...may be documented self-training)

If the internal auditor finds gaps, you initiate corrective actions for the gaps. If your MDSAP auditor finds gaps, you initiate corrective actions for the gaps and for the internal audit that missed the gaps.