Breakdown Maintenance Procedure of the Equipments and Machines

April 10, 2016September 14, 2024 Pharmaceutical Guidanace

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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Reason for Revision

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