Responsibility of QA and QC

Quality Control
1

Who is responsible for log in the OOS No. in Log Book QA or QC?

2

OOS should be initiate by the initiator, I.e. QC personal, who performed the analysis after confirmation with supervisor. OOS should be issued by Qualified QA personal, I.e as per respective OOS sop. Log entry also as per sop. If sop mentioned initiator, initiator should be logged OOS. If sop mentioned issued person, issuance person should be logged. However, log book entry who done OOS, that person name entry is available and also in oos form description part, analyst should be filled.

1 Like
3

It depends on your written SOP… it can be the OOS initiator or the Head of QC or QA

4

Mostly QA responsibility.

Thanks

5

Standard operating procedure for oos.
You only do as per your sop.

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Typically the QC lab (or testing area) has to initiate the OOS investigation and inform inmediately to QA and affected area(s) following SOP requirements. It is important to clearly establish the originator responsability, since time zero begins as soon as initial OOS is discovered.

7

Good answer

8

So how about the code of Document? It should be for QA or QC

9

thanks for claritty.

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