should a incident or deviation be initiated in following two cases.
1) breakdown of equipment (preventive maintenance schedule)
2) a calibration date being missed. (delay in initiating & completion of calibration activity)
there are two situations,
1) where equipment is not used (after breakdown or delay in calibration)
2) where equipment is used; but no apparent effect on previous analysis.
now the option we are weighing is that,
A)
in case of breakdown:- is it adequate to include steps for impact-assessment in the breakdown-analysis/report (if impacted, then trigger an incident)
in case of calibration :- is it adequate to include steps for "not use the equipment" before completion of calibration. (if used, then trigger an incident)
B) or should an incident be triggered, just because there was a break down or delay in calibration schedule.
note :- this is for FDA/CGMP regulated laboratory/manufacturing unit
1) breakdown of equipment (preventive maintenance schedule)
2) a calibration date being missed. (delay in initiating & completion of calibration activity)
there are two situations,
1) where equipment is not used (after breakdown or delay in calibration)
2) where equipment is used; but no apparent effect on previous analysis.
now the option we are weighing is that,
A)
in case of breakdown:- is it adequate to include steps for impact-assessment in the breakdown-analysis/report (if impacted, then trigger an incident)
in case of calibration :- is it adequate to include steps for "not use the equipment" before completion of calibration. (if used, then trigger an incident)
B) or should an incident be triggered, just because there was a break down or delay in calibration schedule.
note :- this is for FDA/CGMP regulated laboratory/manufacturing unit
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