Breakdown Maintenance Procedure of the Equipments and Machines

  • Objective :To lay down a procedure for Breakdown Maintenance of the Equipment’s and Machines.
  • Scope :This Standard Operating Procedure is applicable for the formulation plant of Pharmaceutical company.
  • Responsibility
    • The Concerned Technician shall follow the Breakdown Maintenance Procedure as per this SOP.
    • Head-Concerned Department / Area Incharge shall be responsible for intimating the Engineering Department on the breakdown of the equipments/machines, through Maintenance Work Order as per this SOP.
    • Head-Engineering/Designee shall ensure the compliance of Breakdown Maintenance Procedure as per this SOP.
  • Accountbility:Head-Engineering and QA shall be accountable for the implementation of the procedure as per this SOP
  • Abbreviations and Definitions

SOP :  Standard Operating Procedure

Maintenance Work Order :  A pre-printed book enclosing a form in Duplicate, for the request of maintenance, comprising of three colour sheets i.e. in white and in pink colour.

  • Procedure:
  • As the breakdown occurs in equipment and/or machines the Concerned Department shall inform to the Engineering Department through the Maintenance Work Order by filling its .
  • Maintenance Work Order shall be numbered by eight characters.
    • The First character shall be ‘M’ denoting Maintenance Work Order.
    • The Second character shall be a slash, (/).
    • The Third and Forth character shall denote the Department Code. The following Department Codes shall be used.
    • Department Name                                        Department Code
    • Quality Assurance                                                      QA
    • Quality Control                                                           QC
    • Production                                                                  PR
    • Warehouse                                                                 WH
    • Administration and Housekeeping                               AH
  • The Sixth character shall be a slash (/).
  • The Seventh, Eighth and Ninth characters shall be the running serial number of the Maintenance Work Order that shall start from “001”.
  • Describe in detail the problem with the equipment in the space provided in Maintenance Work Order.
  • Indicate clearly in Maintenance Work Order if the problem is an emergency and will affect productivity.
  • Requesting Department shall retain the pink copy and send the Maintenance Work Order( White copy) to the Engineering Department
  • Engineering Personnel shall acknowledge the request and contact the Requesting Department regarding problem mentioned in Maintenance Work Order.
  • Engineering Personnel shall perform the repair work and after completion of work, fill the Maintenance Work Order (White), indicating the description of work done.
  • After completion of repair work the requesting department shall give his acceptance on (white copy) and Maintenance Work Order shall be submitted to QA Deptt for approval.
  • Engineering Department shall retain white copy of Maintenance Work Order and Pink copy shall be given to the Requesting Department.
  • All work details shall be recorded in History Card as per SOP ( titled “Preventive Maintenance”).
  • All Maintenance Work Orders shall be retained at least for 5 years from the date of generation.
  • 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.
  • Forms and Annexure
  •  Maintenance Work Order : Annexure – I  
  • Distribution
  •  Master Copy : Documentation Cell (QA)
  • Controlled Copies:  Engineering, Production, Quality Assurance,Warehouse , Quality Control, Administration and Housekeeping.
  • History
Date Revision Number
Reason for Revision
00 New SOP

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