Hi All
Hope everyone has submitted their compliance report ok and on time.

The compliance report asks the question in section H relating to CAPA
Does the incident/adverse event/deviation procedure specify an expected timescale for investigation and closure of investigations?
What is the timescale?
please give number of investigations (As at 1/12/2018) that remained 'open' and exceeded the expected closure date by:

At our most recent inspections, we adopted the approach as suggested by the inspector, for when the CAPA is to be considered closed. We have since developed two KPIS:
1) identification of Root cause and identification of the Corrective actions required (7 days)
2) Closure of corrective action against identified designated target date. (default is 28 days but subject to assessment)

Given this, the compliance report is asking two questions and doesn't quite fit with the question(s) we are trying to answer. From a BCR report point of view, at what point is the CAPA closed ie remaining open?
The second issue is our corrective action closure is not set at the same time but dependent on the actions required.

Its caused a bit of discussion here as the Quality view is always that until the Corrective has been implemented the capa isn't closed.

I also think it would be really useful for more extensive guidance notes on the completion of the BCR, so all HBB are answering consistently and therefore enabling MHRA to do a consistent assessment across the UK. For example, at what level is a change considered significant?

Any advice appreciated.