Why investigation?
To identified error
Random error
Impacts precision (Weight error dilution error injection to injection error Example document error, document error
[ note : Precision show random error which is not control for us] +- positive and negative error possible Limit(+- 2)
Systematic error
Impact accuracy
(if Assy result 90 % – 100% show consistence 92 % meet every time )
Gross error
- Mistake/ Atypical / abbarent observation (eg 4ml pipet instances 5 ml pipet taken)
When to investigation
- Planned /unplanned deviation.
- OOS/OOT/OOE
- CHANGE CONTROL
- AUDITS
- COMPLANTS
- PRODUCT RECALL
- CHALLENGES (EXSITING & FUTURE)
- INFORMATION FROM THE MARKET
- Investigation
- Subject matter expert team
- Define scope cautiously