Effectiveness: confusion around the term (QMS: CAPA)

[travis-kalypso]

Effectiveness

There is a lot of confusion around the term effectiveness, this is amplified by the fact that it is represented in both the CAPA action tasks as well as the overall CAPA effectiveness. Recommend changing the action effectiveness task to ‘Verification of Implementation’.

[travis-kalypso]

The overall Effectiveness life cycle state (post implementation) should be renamed to Verification of Effectiveness (VoE) to avoid confusion.  Including this last critical VoE step must be set as a preference which doesn’t match industry expectations.

Also, OOTB there is no action task to verify that the proposed CAs/PAs will not adversely affect the safety, performance, and ability to meet regulatory requirements. The recommendation is to have this review and approval done by the MRB team during the plan approval prior to implementation. The actions (safety, performance, regulatory check) will likely be handled in the engineering change process in a PLM system. Adding a few attributes to the approval task will confirm the reviews are accurate and complete. After implementation, the VoI task will be used to confirm that the outputs of the engineering change and CAs/PAs did not adversely affect the safety, performance, and ability to meet regulatory requirements.

 

For the proposed process change to work, there are some attributes that will need to be changed because they affect work flow. In the plan state, before you create actions, you can choose whether a plan approval is required. The recommendation is to change this attribute to “Is Verification of Actions Required?” which will create the plan approval package. Secondly, when creating actions, both the VoI task and approval are optional. In order for the process to work, a task requiring a VoI task, should require the VoI approval.

[olivierlp]

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