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World of CAPAs - part 2

Updated: Aug 10, 2023

In part 1, we discussed when it is worth to open CAPAs. Now, let's evaluate what we need to think through when we define the CAPA itself.


Define the true owner(s)


Before defining the CAPA details to be implemented, first identify who will actually do the work.

You should find the person who:

  • owns direct responsibility for the defined action(s)

  • understands the event and why the root cause was assigned

  • has the resources, or can obtain the resources, to implement the action


Define the activities to be done


Be clear on the required actions, and/or deliverables to consider the CAPA implemented, as to avoid surprises during implementation. If you exactly know, what to do and what documentation to update, you can also have a better scheduling for the CAPA, as well.


What you should think through with the future CAPA owner

  • exact activities to do

  • timelines

  • potential need of any change controls

  • investment need, if any

  • exact requirements to be able to implement the CAPA

  • potential barriers to implement the CAPA

  • key stakeholders to involve


Timelines


Consider the following when setting a due date for the CAPA:

  • resources required

  • frequency of the related error

  • innovation level of the action (a solution you have never tried may generate variables that you cannot foresee)

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