1.0 OBJECTIVE
1.1 To lay down the procedure for Handling of Deviation.
2.0 SCOPE
2.1 This procedure is applicable for the handling of process and system deviations.
3.0 RESPONSIBILITY
3.1 Initiator/Concerned department Executive or above shall raise the deviation form.
3.2 Head of Initiating Department shall evaluate and authorize the deviation.
3.3 Head-Quality Assurance or designee shall approve the deviation and ensure compliance.
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance /designee
5.0 PROCEDURE
5.1 Deviation: A deviation is an activity performed differently and/or modified than that specified in an approved document. Deviations can be classified into two categories.
5.2 Planned deviations: Planned deviations, which are described, and pre-approved Deviation from the current operational document, covering a specified period of time or number of incidences. They should be approved before execution.
5.3 Unplanned deviations: Any unplanned deviation shall be handled as per the current version of SOP No QA........ .“Reporting, Investigation, and Disposition of Incidents”.
5.4 Routing of Deviation
5.4.1 The initiating department Executive or above shall raise the deviation form in deviation report format (Annexure 1).
5.4.2 The duly filled deviation form shall be sent to Department Head for further evaluation.
5.4.3 Department head of the initiating department shall review the content of deviation and shall make an opinion as ‘Approved’ or ‘Rejected’. The Department head shall send back the format to the initiator in case of additional information is required on the deviation.
5.4.4 After review department head shall make the comments on the deviation and send them to QA for further evaluation.
5.4.5 On receipt of the deviation, Head-QA or designee shall allocate a number to the deviation report as per point no. 4.6 and shall enter the details in the Deviation Log (Annexure 2).
5.4.6 Head-QA shall evaluate the deviation and send the deviation format to other departments, as applicable for their opinion.
5.4.7 All the deviations shall be routed through the concerned Department for their comments before QA approval.
5.4.8 Respective Department Heads shall write their comments on the deviation report by evaluating the impact of deviation.
5.4.9 After filling the deviation format by the respective department(s) the format shall be sent back to Head-QA.
5.4.10 Head-QA shall evaluate the deviation report along with the opinion of the other Department Heads for the impact of deviation.
5.4.11 On the complete evaluation of the content of the deviation, Head-QA shall either approve or reject with comments.
5.4.12 If approved, one copy of the deviation report shall be forwarded to initiating department for their reference and execution of the activity. Original copy of the deviation report shall be filed in the QA department.
5.4.13 Where necessary, additional documentation shall be issued to carry out the deviation and proposed controls.
5.4.14 If the deviation is planned for a batch it shall be ensured that the act committed is not extended beyond that batch.
5.4.15 While indicating the corrective and preventive actions it shall be ensured that the actions committed are with timelines.
5.4.16 Deviations shall be reviewed every 15 days for closure of deviation report.
5.4.17 On confirmation of the corrective action as mentioned in the deviation report by QA personnel, Head-QA, or designee shall close the deviation, and the same shall be recorded in the Deviation Log (Annexure 2).
5.6 Numbering system of Deviation Report
5.6.1 The numbering system shall be a unique number consisting of 11 alphanumerical characters for e.g. the first deviation report in the Production department in the year 2021 shall be numbered as DVD/21/001.
5.6.1.1 The first two alphabetical characters ‘DV’ denote Deviation.
5.6.1.2 The third and fourth characters represent the department code e.g. ‘PD’ for Production
5.6.1.3 The fifth character ‘/’ is a forward slash as a separator.
5.6.1.4 The sixth and seventh characters indicate the last two digits of the current year 2021.
5.6.1.5 The ninth character ‘/’ is a forward slash as a separator.
5.6.1.6 The last three numerical characters are serial numbers starting from 001 for the year and continuing serially in increments of one unit.
5.7 Documentation
5.7.1 The completed and closed reports and related documents shall be filed with Documentation Assurance.
6.0 ABBREVIATIONS
6.1 e.g. - Example
6.2 No - Number
6.3 SOP - Standard Operating Procedure
6.4 AR - Analytical Report
6.5 HOD - Head of the Department
7.0 REFERENCES
7.1 Nil
8.0 ANNEXURES
8.1 Annexure: 1 - Format for Deviation Report
8.2 Annexure: 2 - Format for Deviation Log
8.3 Annexure: 3 - Flow chart for Handling of Deviations
END OF THE DOCUMENT
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