STANDARD OPERATING PROCEDURE HANDLING OF OUT OF SPECIFICATION

STANDARD OPERATING PROCEDURE

SUBJECT:                      HANDLING OF OUT OF SPECIFICATION

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date              : Next Review                : SOP REVISION           :

1.0              OBJECTIVE:

This SOP will establish a uniform means for handling out of specification results, investigation and release system.

2.0              POLICY:

2.1         It applies to analytical /chemical / physical / microbiological analysis performed on samples     

 received.

2.2       This SOP includes the minimum requirements to be included in handling of out of   specification.

2.3       This SOP describe the general procedure for handling out of specification (OOS) test results and minimum requirements / authorization needed for releasing OOS finish products, Raw Material and packaging Materials. 

3.0        PROCEDURE:

3.1       General policy:

3.1.1    All analytical OOS must be investigated & documented.

3.1.2   For minimum requirement of OOS handling specific investigation, Handling, Deposition & release follow the respective specifications.

3.2       Handling OOS on Laboratory Chemical / Physical analysis.

3.2.1        Procedure for handling OOS will be followed as per annexure-1 attached to the SOP.

3.2.2        Inform the concern department head and principal company site leader about the OSS.

3.2.3        All OOS investigation will be reported within 48 hours from the date of discovery if this not possible must be generated by lab detailing investigation to date, next step & Target date of completion. The investigation report should contain the root cause, action plan, owner and date of completion.

3.2.4        OOS results and investigations will be documented as per the annexure-1.

3.3       Release of OOS:

3.3.1    Release of OOS FG / RM / PM / INPROCESS:

3.3.1.1 The release of process for FG/ RM / PM and in-process will be followed as per the Annexure-1

3.3.1.2 Product release recommendation should be prepared containing all information including technical and business justification for release and corrective and preventive actions steps as per annexure-1

3.3.1.3 After getting all approvals from the principal company, plant QA may authorize the release or rejection of product as per the recommendation.

3.3.1.4 In case of e-mail approvals the copy of mail will be attached with the OOS document for future reference  

 3.3.1.5 ABBREVIATION:

Standard Operating Procedure (SOP)

Quality Assurance (QA)

Out of Specification (OOS)

4.0       FREQUENCY: As and when required.

5.0              RESPONSIBILITIES:            QA/QC Analyst, QA Executive, Manager and principal company.

6.0        REVIEW GUIDE: Out of Specification file.

7.0  ANNEXURE:

1. Format for Handling of Out of Specification.

           

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	√
General	x	x
Maintenance	x	√