Responsibility of Quality-Assurance in Rejection SOP

 

1.0  OBJECTIVE:

To lay down the documented procedure for role of quality assurance in the handling of rejection.

2.0  SCOPE:

This SOP shall be applicable for the handling of rejection by quality assurance department.

3.0  RESPONSIBILITY:

3.1  All Q.A. Personnel.

4.0  ACCOUNTABILITY:

4.1  Head of Quality Assurance Department.

5.0  PROCEDURE:

5.1  Rejection of raw material:

5.1.1        Supply rejected by Q.C.:

5.1.1.1  In case material does not meet specification parameters, Q.C. raises an “Out of Specification (OOS)” report along with attachments along report of analysis etc. and forwards to Q.A for approval, Q.A personnel will study available information/ records/ documents of the material.

5.1.1.2  If Q.A finds that supply needs to be rejected, Q.A In-charge will approve the “Out of Specification (OOS)”.

5.1.2        Rejection due to manufacturing activities:

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

5.1.2.2  Approve the rejection by signing on “Online rejection note”.

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

5.1.2.4  Based on study Q.A, suggest the corrective action.

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

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

8.1  Not Applicable.

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

SOP

Standard operating procedure

&

And

No.

Number  

Ltd.

Limited

QA

Quality assurance

F

Format

QC

Quality control

OOS

Out of Specification

 

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