Follow
1. Departmental Organogram
2. Job responsibilities for newly joined employees are available
3. Adequate number of personnel is available
4. Prohibited in working area for Smoking, Chewing tobacco, Eating
5. Access to area is restricted
6. SOPs i) Sop available for carrying out all the important activities in the department, ii) SOPs are updated and properly maintained, iii) Adequate documentation is available for compliance of SOPs
7. Document/ data storage i) Documents/data are stored in a manner to prevent misuse and damage, ii) Documents are stored in a manner, which helps easily retrieval
8. Gowning i) Proper gowning practices are followed by Engineering Personnel working in the production floor, ii) People working in clean rooms are correctly attired as per the relevant SOP, iii) Adequate safety gears are used during working
9. Preventive maintenance i) Preventive maintenance schedules and SOPs are available for all critical production equipments and utility system, ii) Preventive maintenance is regularly done as per the schedule and records available for the same
10. Maintenance of equipment/building i) Records are available for all maintenance work done on production equipment/utility systems, ii) Building maintenance records are available
11. Calibration
i) Calibration programs are available for all the gauges, measuring instruments used in the plant and being followed,
ii) SOPs are available describing in details how to perform calibration of gauges and what is to be done incase gauges, measuring instruments are out of calibration,
iii) Adequate documentation of calibration is available,
iv) Calibration is done by using equipment, which has traceability to National standards, and certificates to that effect are available,
v) Adequate corrective action is taken incase any gauge, measuring instruments is out of calibration limit and the same is documented
12. Lubricants i) Approved list of food grade lubricants is available, ii) Food grade lubricants are used wherever there is possibility of product contact
13. Equipment qualification i) Are all critical equipments and utility systems are qualified and reports are available?
14. Equipment numbering system i) Equipment IDs are available with all equipments, ii) Master lists are available
15. Records for critical systems i) Records for operation, breakdowns and maintenance are maintained for all critical systems like HVAC system, Air conditioning plant, Air compressors, Water system, boiler etc. are in proper order, ii) Are records shown compliance to operating parameters mentioned in the respective SOPs?
16. Layouts/Drawings, i) SOP available, ii) Format of layouts/drawings as per the SOP, iii) Signature columns are completed
