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 |