Structuring progression of information for deviations, NC to CAPA.

Jean_B

Trusted Information Resource
What information structuring have the experienced folks of Elsmar seen/implemented that worked well for the amount of information (especially deviations) that is required to be processed according to regulations and standards?

I've noticed a lot of pre-filtering to occur to allow the formalized (but inefficient) system to be able to cope with the load imposed on it.
However, this means that the (fallible) human part of the system is in essence pre-filtering what the system will even be able to detect.
To my knowledge there are many factors that cause this, such as systems that do not deal well with uncertain or ill-defined information, restraints on capacity that is not seen to add value in the short-term, inability to train and equip everybody who observes events of interest to start up the chain of analysis, biases and incompetence in what is and is not reportable, and the need to play 50 shades of green as early as possible in the records for plausible deniability.

I'm looking for inspiration for improvement on this in any place I can find it. A form of the increasing complexity in the Sandia report is perhaps an option worth pursuing;
  1. have anybody write rudimentary information in little time (quality event),
  2. and select which of these events is investigated in depth (to determine whether it constitutes NC) and breadth (trend analysis),
  3. and then explained in basic information understandable by non-specialist for disseminating and resolving the issue at hand (disposition, and correction if deemed necessary),
  4. and perhaps continue to select for corrective/preventive action to prevent quality events in the future.
  5. (or adjust resources to be able to cope with the number of events in 1 to 3).
But the fear of having to defend the amount of events versus the ones you looked at might get enough of a subset of the auditors/inspectors iffy that it will be avoided to prevent compliance findings or human resource investments while it would be a viable risk-based approach perhaps preferable to a mistuned and overly precise system, of which the common stated cause is 'oversight'.
 
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