Note I do mean capa as the full vehicle including problem definition, root cause analysis and action planning, not only the correction and corrective action.
Initiation is then problem definition being triggered within the capa process so it can be properly controlled and administrated instead of headless chicken behaviour with after the fact ratification and document scrounging.
Given the regulatory pressure to respond swiftly over quality, this is what you get. Just look at the tendency for such reports to use the simplest of RCA in depth and breadth, with sometimes ridiculously narrow 5-why being accepted or even preferred because it must be clear and agreed between not only your lead auditor but also peer reviewers hundreds of miles away. All while obviously fitting on an a4 sheet of paper, preferably no more than 2 sheets per nc.
Initiation is then problem definition being triggered within the capa process so it can be properly controlled and administrated instead of headless chicken behaviour with after the fact ratification and document scrounging.
Given the regulatory pressure to respond swiftly over quality, this is what you get. Just look at the tendency for such reports to use the simplest of RCA in depth and breadth, with sometimes ridiculously narrow 5-why being accepted or even preferred because it must be clear and agreed between not only your lead auditor but also peer reviewers hundreds of miles away. All while obviously fitting on an a4 sheet of paper, preferably no more than 2 sheets per nc.