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
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
Consider the following when setting a due date for the CAPA:
frequency of the related error
innovation level of the action (a solution you have never tried may generate variables that you cannot foresee)