- 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.
- 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.
- 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
- Master Copy : Documentation Cell (QA)
- Controlled Copies: Engineering, Production, Quality Assurance,Warehouse , Quality Control, Administration and Housekeeping.
Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube