Responsibility of Quality Assurance in Rejection.

1.0         Purpose     :       To provide instructions for responsibility of quality assurance in rejection.

2.0        Objective  :   To provide a documented procedure for role of quality assurance in the handling of rejection

   

3.0                 Scope  :  This procedure is applicable for the handling of rejection by quality assurance department.

4.0         Responsibility  :

·           Primary: QA-Officer

·            Overall: QA-Manager

5.0               Procedure:

·        Rejection of Raw Material:

Ø       Supply Rejected by QC

o       In case material does not meet specification parameters, QC raises an “Out of Specification (OOS)” report along with attachments like report of analysis etc. and forwards to QA for Approval, QA personnel will study available information / records / documents of the material.

o       If QA find that supply needs to be rejected, QA In-charge will approve the “Out of Specification (OOS)”. 

Ø       Rejection due to manufacturing activities

o       On receipt of “Online rejection note” from production department, inspect the rejection.

o       Approve the rejection by signing on “Online Rejection Note”.

o       If the quantity of rejection is very high, study the cause of rejection.

o       Based on study QA, suggest the corrective action.

o       If any corrective measures are required from the supplier, Inform to purchase department for corrective actions.