- OBJECTIVE :
- To provide a system for initiating a new SOP and to update an existing SOP.
- RESPONSIBILITY :
- The Department Head/Section In charge shall ensure that all SOPs pertaining to their department are prepared/updated and routed for approval.
- Procedure :
- Submission of new SOP :
- The request for a new SOP shall be initiated by the operating executive of respective department.
- The initiator of the SOP shall prepare a legible copy of the proposed SOP and write “New SOP submission” at the top of the proposed SOP.
- The initiator shall forward “New SOP submission” to the Department Head/Section Incharge.
- The Department Head/Section Incharge shall have the “New SOP Submission” routed to Department Head/Plant Head, Q.A. Manager and Division Head with comments.
- The approvers shall signify their agreement or disagreement with comments by signing with date on the “New SOP submission”.
- A disagreement response from any one of the approvers shall stop any “New SOP Submission” until all approvers come to an agreement with the proposed new SOP.
- A disagreement response requires that the approver disagreeing shall discuss with the person who initiated the new SOP and explain the reason for disagreement and the possible remedies to gain the approval.
- If the “New SOP Submission” is approved, QA Manager shall have the SOP printed on SOP format.
- QA Manager shall issue the SOP, approved and authorised in accordance with SOP (SOP on SOP).
- Submission of changes to existing SOP :
- The person requesting the change shall :
- Hand write the changes requested on a separate sheet “Change Request” and attach the same to the most recent revision of the SOP.
- Sign and date the change request.
- Submit the change request to the Department Head/Section Incharge.
- The Department Head/Section Incharge shall have the “Change Request” routed to Department Head/Plant Manager, Q.A. Manager and Division Head with comments.
- Department Head/Plant Manager, Q.A.Manager and Division Head shall individually review the requested change(s), taking into account all aspects that will be affected by the change(s).
- The approvers shall signify their agreement or disagreement, with comments by signing with date on the “Change request” sheet.
- A disagreement response from any one of the approvers shall stop any “Change Request” until all approvers come to an agreement with the requested change(s).
- A disagreement response requires that the approver disagreeing shall discuss with the person who initiated the changes and explain the reasons for disagreement and the possible remedies to gain the approval.
- If “Change Request” is approved, Q.A.Manager shall have the changes made to SOP and print the same on SOP format.
- Q.A. Manager shall issue the new SOP, approved and authorised in accordance with the SOP (SOP on SOP) showing the recent revision number.
- Forms and Records (Annexures)
- Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision – 00 New SOP
