- 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 |
