SOP for Deviation Control

1.0      Objective:

The objective of this SOP is to describe a procedure for in case of planned/unplanned deviation from established system and testing activity.

2.0       Scope:

This SOP is applicable to all Planned/unplanned deviation from approved testing procedures or activity.

3.0       Responsibility:

3.1       Head of department shall be:

Responsible to check the impact on the test results due to deviation.

Responsible for initiate the deviation control form as mentioned in the scope with justification.

3.3       GM Tech/ QA Manager shall be:

Review of the deviation control form and give the comment if any.

Responsible for Release or Rejection of the deviation.

4.0       Procedure:

4.1              Deviation: A deviation is an activity performed differently and/or modified than specified in an approved document. There are two types of deviation- planned and unplanned.

a)      Planned deviation: The planned deviation must be approved before execution by the concerned.

b)      Unplanned deviation: The unplanned deviation is the deviation, which already has occurred.

4.2              Concerned department should initiate deviation form in case of deviation from laid down procedure.

4.3               Fill the details like description of deviation, reason / justification for deviation, steps taken to resolve the deviation / suggested corrective action.

4.4              Initiator of the deviation must sign and date the deviation form.

4.5              Forward the deviation form to Technical Head for approval/ rejection.

4.6              Forward the deviation form to QA Head who evaluates the deviation and decides about approval/ rejection. He shall identify the root cause of the deviation jointly with head of the department and shall Asses the impact on the quality of the test result. Make the entry of the deviation details in the deviation log. QA department allots deviation control number.

4.7              After disposition by QA Head, forward deviation form to QA department, which retains the form. 

4.8              QA department send the photocopy of completed Deviation form to the initiating department. Initiating department shall file the photocopy of the approved deviation form with respective raw data of the analysis.

4.9              Responsible person of the initiating department must initiate the corrective action and follow up shall be carried out.

4.10          QA person must monitor the implementation of suggested corrective actions and sign and date in the verified column of deviation form.

5.0      Documents:

5.1      Annexure – 1         Format for Deviation control register         XXX/FRM/000

 6.0     History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

                                                             ANNEXTURE

                                                      Deviation Control Register

Sr. No.	Deviation details	Deviation Date	Initiate by (Department)	Deviation control No.

 SOP No.: XXX/SOP/000-00                                                   Format No. : XXX/FRM/000-00