1.Objective:

To lay down the procedure for handling of Planned Modification System.

2. Scope :

This SOP is applicable to addition, deletion &/or modification of area, equipments, utility, system, machines.

3. Responsibilities :

User Department, QA, Engineering

4. Definitions:

• Planned Modification: A modification which is planned for the introduction, alteration, deletion, up-gradation, repair, replacement of equipment, facility, area, machine, utility, pipelines which may be due to breakdown maintenance or identified during preventive maintenance.

5. Procedure :

5.1 Issuance, Approval and Execution of Planned Modification Form :

• Engineering department and concerned department shall take the decision for the requirement of introduction, up-gradation, replacement, alteration, deletion, repair or up gradation of new equipment, machine, utility, pipelines, area, introduction or relocation of instrument.
• Concerned department shall intimate to QA for issuance of Planned Modification form.
• QA shall issue Planned Modification form to initiator Department and make necessary entries in to log.
• Each Planned Modification shall be assigned an unique identification no. by QA which is as follows :

PM-NNN/YY

Where PM stands for Planned Modification,

NNN stands for sequential no. as 001, 002 & so on, which changes every year on January 1^st,

YY stands for last two digits of current year (Ex. 19 for 2019)

• Based on proposed modification, engineering department head shall give tentative schedule time in consultation with initiator department and external party if required.
• Initiator shall circulate to impacted department head for impact evaluation.
• After impact evaluation, concerned department head shall review and give recommendation, if any. On the basis of that, Head shall approve it & after that it shall be circulated to the QA department for final comments.
• Finally, it comes with Quality Head & Site Head for the approval.
• In case, if the Planned Modification Form is rejected at any stage, the same shall be returned back to QA with justification & QA shall maintain record of all the Forms.

    5.2 Execution of Planned Deviation:

• On receipt of the approved Planned Modification, engineering department shall prepare the detailed specifications along with drawings like schematic drawing, area layout, isometric drawing etc.
• Approval shall be taken on the detailed specifications and drawings from the Quality head and Site head before proceeding with the modification.
• The final proposal shall be intimated to the concerned department head.
• In case, if any authority is not in agreement with the recommendations, a group meeting shall be organized by engineering and mutually agreed decision shall be finalized.
• On receipt of the approval on the specifications and drawing, engineering department shall prepare the cost estimation with tentative completion schedule in co-ordination within internal / external agency.
• Engineering head shall mention tentative time schedule for completion of modification in Planned Modification form.
• In case of any major modification, which requires approval from any external regulatory bodies, the same shall be taken before commencing the activity.
• Production activity / operation of utility or machine shall be stopped before starting execution of the modification activity.
• Necessary arrangements shall be made before starting modification activity in plant to avoid contamination & the same shall be documented in section “Clearance Prior to Start of Modification“.
• On completion of all the above requirements, contracts shall be granted to commence the work. The work shall be carried out under the strict compliance of approved proposal and schedule.
• On completion of the modification, concerned department and engineering department shall ensure that the modification is completed as per proposed approved specification.
• If there is any change or deviation noticed while physical evaluation of modification against approved proposal, the same shall be mentioned in remark section and shall be brought into notice of the quality head.
• Concerned departments shall ensure that all recommendations are completed after modification.

5.3 Validation / Qualification of the modified area / equipment / machine / utility:

• After completion of the modification activity, upon recommendations, equipment / utility / facility / area shallbe validated / qualified to confirm that the same is performing as per its intended use.
• Validation / qualification shall be carried out by concerned department in consultation with QA department and engineering department.
• All the supportive documents, protocols, reports, specifications, details of the modifications carried out during &/ or after the modification work & report shall be attached along with the planned modification form.
• The full set of the qualification / validation documents shall be submitted to
  QA department.
• If the modified facility does not meet the required specifications, re modification / rework shall be initiated by engineering with new planned modification form.
• Production activity / operation shall not start unless and until all the recommendations get completed.

• QA shall review and evaluate all the documents & shall ensure that all the recommendations have been completed

• Basedon physical verification of the site and evaluation of complete documents, Quality head shall give the clearance to carry out the production activity.
• QA shall initiate closure of Planned Modification Form based on final evaluation. QA shall maintain final completed records in their custody.

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