sop for Break Down maintenance of Machine and Work Requisition

1.0 Objective
To lay down a procedure for Maintenance Work Requisition.
2.0 Scope
This SOP is applicable for raising Work Request by all users department in case of following situations to follow at formulation plants
Procedure for rectification of breakdown of equipment and other work request which shall be raised by the concerned department. The rectification of breakdown and other work request shall be carried by engineering department as per laid down procedure.
2.1 Requisition of civil repair related to plumbing/painting/door repairs.
2.2 Non performance of any system related to HVAC, Water, Air, and dust extraction etc.
2.3 Breakdown of utility equipments.
2.4 Rectification of electrical failures.
2.5 Any other work requisition related to process area.
3.0 Responsibility
3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/designee shall be responsible for the compliance of this SOP.

4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
DPI : Dry Powder Injection
TCA : Tablet capsules
No : Number
QA : Quality Assurance
IPQA : In Production Quality Assurance
5.0 Procedure
5.1 When there is any break down of Machine / Equipment/ System or civil related work like Plumbing, Painting and Carpentry etc. The concerned/user department personnel shall raise the maintenance work request as per the Annexure –1.
5.2 The QA/IPQA personal will see the nature of break down; anticipate the fault and corrective action should be planned in co-ordination with Engineering and the representative (Officer/ Executive) of the concerned department.
5.3 Types of breakdown
5.4 Non Critical Breakdown: Which causes deviation to standard operating condition, but do not have a potential to give an impact on product.
5.5 Critical Breakdown: The breakdown which has potential to effect the product, this type of breakdown should be intimated immediately to QA Head and Engineering Head. and
5.6 If the breakdown is critical than the deviation/change control should be initiated/filled by the department.
5.7 User department should specify that machine is available for maintenance or not. If machine is in running condition user department should specify the time when the machine will be available for maintenance for engineering department.
5.8 Engineer should accept the intimation and inspect the machine& assign the respective technician.
5.9 Concerned user department shall fill the maintenance work request and send it to Engineering Department/Hand over to engineering person.
5.10 The engineer should inspect the machine, & take proper safety precaution prior to starting rectification job. If the work requires spares/lubricants, the same should be taken from stores after submitting material requisition to Engineering stores.
5.11 The engineer should raise material requisition as per purchase requisition if spares are not available in engineering store for repair/rectification.
5.12 If the breakdown maintenance work requires the skill of external agency, engineer from engineering department should discuss the same with Engineering Manager. The Engineering Head will co-ordinates with the external agency for rectification of work.
5.13 The engineer should supervise and coordinate with the outside contractor, if Job is to be done by out side contractor.
5.14 Outside contractor shall carry out the repair / rectification work in consultation with Nominated engineer from engineering department.
5.15 On satisfactory rectification check machine for smooth operation and take trial, technician / engineer have to Complete Maintenance work request as per Annexure- I.

5.16 The concern officer shall make entry of equipment failure in the respective equipment log failure and after rectification.
5.17 Repaired / rectified machine / equipment / system are handed over to the officer user department with his acknowledgement signature.
5.18 Periodic review of maintenance history shall be carried out every yearly the periodic review shall be recorded as per Annexure – I. The periodic review shall be conducted for following parameters.
5.18.1 Nature of breakdown
5.18.2 Nature of repeated Breakdown.
5.18.3 Action taken for prevention of breakdown.
5.19 The Intimation request of the breakdown shall be filed & stored in the respective Equipment files by Engineering Department.
5.20 The record of maintenance work carried out shall be maintained in the log book as per annexure -2.
5.21 Engineering head can review the maintenance work done.
6.0 Forms and Records
6.1 Format for maintenance work request – Annexure-1
6.2 Machine History Card – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering Department.

sop for Break Down maintenance of Machine and Work Requisition

Leave a Comment Cancel reply