To lay down a procedure for Management of Equipment.
This SOP is applicable for Management of Equipment.
Respective heads of user departments shall be responsible of this procedure.
Department Head & QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
Equipment : An instrumentality needed for an undertaking or to perform a service.
In this SOP, term equipment shall be commonly used for all Machines, Instruments and Equipments installed in all departments.
- All new Equipments shall be procured through Materials Management through a qualification process where in user requirement specifications, design qualification may be done as part of impact assessment process on the product quality.
- Equipment numbering of the Equipments shall be assigned by respective department heads as per SOP No. BF-QA-001. Equipment number shall be displayed prominently on each equipment.
- The equipments shall either be commissioned as per Goods Engineering Practices or qualified through Installation Qualification, Operational Qualification and Performance Qualification.
- All equipments installed in manufacturing area, shall have a user log as ‘Machine Log Sheet’, which shall include duration of machine usage, machine cleaning, breakdown and preventive maintenance as per the Annexure-1.
- For the chain of equipments placed in a single area depicting a single work station jointly and are supposed to be used on a single product at a time, a single Machine Log Sheet with details of all equipments with their identification number can be used.
- Equipments in routine use shall be maintained through intermittent calibration, preventive maintenance program and revalidation procedure.
- Practice of appropriate labeling on equipment shall be maintained depicting the ‘status’ of equipment. Besides ‘status’ the label shall include the other information like equipment ID number, its location, Signature & Date.
- Spare machines shall be labeled as ‘Not in Use’ and shall be placed in the designated area.
- Routine calibration of the critical parameters of the equipments shall be stopped during the ‘Not in Use’ period, until the equipment is made functional.
- If any equipment is redundant or not for use or damaged beyond any repair, the same shall be labeled as ‘Rejected’ and shall be removed from the site with proper authorization from QA. Equipment list shall be updated accordingly. Written records thereof shall be maintained.
Forms and Records (Annexures)
Machine Log Sheet : Annexure – 1
Master Copy – Documentation Cell (QA)
Controlled Copies – Production, Quality Control, Stores, Engineering, Administration and Housekeeping
|Date||Revision Number||Reason for Revision|
MACHINE LOG SHEET
Area/Room Name/No. Equipment Name Equipment No Month and Year
Write “-“where not applicable