How to investigation and take CAPA ? Deviation, Lab incident, OOS

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

1. Mistake/ Atypical / abbarent observation (eg 4ml pipet instances 5 ml pipet taken)

When to investigation

1. Planned /unplanned deviation.
2. OOS/OOT/OOE
3. CHANGE CONTROL
4. AUDITS
5. COMPLANTS
6. PRODUCT RECALL
7. CHALLENGES (EXSITING & FUTURE)
8. INFORMATION FROM THE MARKET
9. Investigation
10. Subject matter expert team
11. Define scope cautiously