SOP for Review and Change Control of Formats
To lay down the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs).
This procedure is applicable for review and changes control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the SOP for better documentation practices.
Personnel of concerned department to initiate the Change Request Form ((CRF) Annexure -1
Head of concerned department to review and approve the CRF
Head – Quality Assurance (QA) to approve or reject the proposed change(s) and to ensure compliance
Officer – Documentation to complete the post approval requirements.
When ever a change becomes necessary or desirable to the formats of any SOPs of the user department, the concerned personnel of the department, shall raise a CRF outlining , the proposed change(s) and the reasons for change(s), attach supporting documents, if any and forward to the Head of the department.
Head of the department shall review and approve the change, if acceptable and forward to Head – QA with his comments.
Head – QA shall review the change(s) and approve the change(s), if acceptable and forward to Officer – Documentation, for implementation.
Officer – Documentation shall take the final print of the format and allot the revised format number for the new format.
Officer – Documentation shall assign effective date for the revised format, mention effective date on the specimen of the revised format as well as CRF and file the original CRF in ‘File for CRFs’.
Officer – Documentation shall take number of copies of the new format as required from the SOP issue register and he shall replace the old formats with new formats in the respective SOPs.
Officer – Documentation shall reconcile the superseded formats and destroy.
The superseded format of the Master copy shall be stamped as ‘OBSOLETE FOR REFERENCE ONLY’ and retain in the same SOP.
Forms and Records (Annexures)
Specimen format of “Change Request Form” – Annexure 1.
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
|Date||Revision Number||Reason for Revision|
Specimen format of “Change Request Form”
HANGE REQUEST FORM
- Format No. :
- Format Title :
- Proposed change :
- Reasons for change :
- Comments of Department Head :
- Change(s) acceptable:
- (Put Ö mark in the appropriate box)
- Comments of Head – QA :
- Change(s) Approved:
- Other connected SOPs (Nos.) :
- Superseded format(s) was replaced with the new format and superseded format(s) were destroyed.
- The stamped master copy of the superseded format with ‘OBSOLETE FOR REFERENCE ONLY’ in the respective master copy of the SOP.