Although this is my first post to this forum I have been reading this treasure trove of high quality information for a while now and want to express my gratitude to this community. Thank you for all your guidance and advice!
Then, onto my situation:
- we produce small LOT's (50 to 100 a batch) of disposable, sterile class IIa medical devices
- we have implemented a destructive sample check to verify the quality of these products after manufacturing & sterilisation
- we had implemented a ISO 2859-1 AQL based sample plan (so a inspection by attributes and AQL levels based on Risk Management) BUT we got feedback from our notified body that for design verification and validation a ISO 2859-2 LQL sampling plan linked to %Confidence/%reliability levels coming from Risk Management.
My question being:
From what I have understood the required sample size for a attributes inspection with c=0 (all samples should pass the test) can be calculated as:
n=ln(1-confidence)/ln(reliability)
(e.g. 95% confidence /90% reliability would result in n=29)
However: how as n is not linked to a LOT size how can one link this to LQL levels?
Then, onto my situation:
- we produce small LOT's (50 to 100 a batch) of disposable, sterile class IIa medical devices
- we have implemented a destructive sample check to verify the quality of these products after manufacturing & sterilisation
- we had implemented a ISO 2859-1 AQL based sample plan (so a inspection by attributes and AQL levels based on Risk Management) BUT we got feedback from our notified body that for design verification and validation a ISO 2859-2 LQL sampling plan linked to %Confidence/%reliability levels coming from Risk Management.
My question being:
From what I have understood the required sample size for a attributes inspection with c=0 (all samples should pass the test) can be calculated as:
n=ln(1-confidence)/ln(reliability)
(e.g. 95% confidence /90% reliability would result in n=29)
However: how as n is not linked to a LOT size how can one link this to LQL levels?