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SOP on Breakdown Maintenance

OBJECTIVE
To describe the procedure for Breakdown Maintenance of the equipment’s and machines.

SCOPE
This procedure applies to the engineering department in the Pharmaceutical Manufacturing Facilities of Pharmasky Limited.

RESPONSIBILITY
The engineering staff is responsible for implementation of the process.
The engineering in-Charge or his designee has to ensure the compliance.

PROCEDURE
  • As the breakdown occurs in equipment / machines, the concerned department shall raise maintenance work order to intimate to engineering about the breakdown.
  • User Dept. personal shall mention basic details of equipment i.e. equipment location, block, equipment ID no. and description of breakdown along with name, sign, date and time along with possible reason of breakdown for raising work order.
  • QA comments may be taken on maintenance work order depending upon the criticality of the breakdown.
  • If work order route through QA department, then QA department shall write their comments in work order and tick in YES or No for repair affects a critical process.
  • QA department reviewer shall write their name with sign and date.
  • User dept. person shall get acknowledge the work order from engineering dept. person by taking signatures on the maintenance work order logbook (White Copy)
  • Engineering person remove white copy of maintenance work order after receiving the work order by signing on it from the work order log book.
  • Engineering person shall attend the breakdown within 24 Hrs. after receiving of work order and mention the details of job carried out to rectify the problem and also mention if any spare part is used to attend the breakdown. (In Pink and Yellow Copy).
  • User dept. person shall then verify the work done by engineering person and sign in the checked by column in the maintenance work order. (Pink and Yellow Copy)


  • After taking final comments from QA personnel (If Pre Approval for QA is Yes then final approval is required) engineering person take out the pink copy of work maintenance work order, from the logbook and file it with the white copy of the maintenance work order.
  • Yellow copy dully signed by QA, engineering and user dept. personnel shall remain in maintenance work order logbook with user dept. for future reference.
  • Breakdown maintenance activity related to equipment’s/systems shall be recorded in machine history card
  • Maintenance work order serial no. shall be pre-printed on the logbook.
  • QA dept. shall issue the work order logbook to every user dept. by mentioning the serial no. in continuation on each work order in triplicate.
  • QA dept. shall maintain record of which serial no. logbook is issued to which dept.
  • User dept. person shall tick mark in the work order whether the work order is related to any equipment or it is related to any general work i.e. door problem, paint/putty requirement etc. or any other maintenance work related to building and facility.
  • Any major repair or replacement of any critical part which affects the performance of the machine (or having direct impact on product quality), shall be undertaken through change control procedure as per SOP of change Control

ABBREVIATION(s)
Q.A : Quality Assurance
Q.C : Quality Control
SOP : Standard Operating Procedure
No. : Number
Hrs : Hours

ANNEXURE(s)
Nil.

REVISION CARD
Nil.

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