In recent history inadequate investigations has been the major deficiency sited by prominent regulatory bodies.
While every company deploys their best talents for investigations of their deviations/market complaints/ OOS etc. Also companies hires best of talent pool from peer companies but still silly mistakes leads for huge losses to organizations.
So what is so special in Investigations that lacunas are highlighted by regulators and not by technical teams.
A good investigator is one who can do a good criminal investigation as well.
Failure in investigation to find out the root cause is aften resulted due to poor oversight on technical issues. Manytime due to inadequate training of Investigators.
The reason is not only inadequate writing skill but also people failed to assess impact of incidence on ongoing production , previously manufactured batches and impact on patients safety.
Sometime poor investigation is the result of undue pressure from seniors to close opened cases.
Perhaps people just don’t want to stretch to other batches to avoid market recall .FINANCIAL PRUDENCE(?) leads for disasters in such cases.
Sometime people don’t understand the way out to ensure patients safety in affected batches. May be closing the eyes and avoiding well adopted strategies leads for voids.
Most accurate reason for poor investigation is because Investigators are concerned with only underlying issues but not the PATIENTS SAFETY.
A good investigator needs to think great Murphys law that if anything can go wrong , it will go wrong.
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