Self Inspection Check List (Engineering)

Annexure –  V Self Inspection Check List (Engineering)

Sr. No.	Check Points	Yes / No	Remarks
General:
1	Does    Engineering have current copies of standard operating procedures [SOPs] and objective and principles of cGMP understood and applied?	Yes/No
2	Are cGMP training conducted as per training programme?	Yes/No
3	Whether the training record is available and updated?	Yes/No
4	Cabinet and cupboards are arranged properly.	Yes/No
5	Check the housekeeping, cleaning of followings a.  Floors, walls ceilings and high levels surfaces b.  Light fittings, windows c.  Air conditioning plant area d.  Dust Collection System Local / Central e.  Utility Area and equipments	Yes/No
6	Are all equipment's of Central Utility area identified and tagged properly	Yes/No
7	Do line diagram of HVAC and purified water system  available and updated with Engineering Department	Yes/No
8	Do department have mechanical drawings and maintenance manual of all manufacturing equipments	Yes/No
9	Do you have written well defined SOPs for preventive maintenance and schedule for all manufacturing plant equipments	Yes/No
10	Preventive Maintenance done as per schedule	Yes/No
11	Air handling system records maintained	Yes/No
12	Check the gauge indicators	Yes/No
13	Check the pre - filter cleaning schedule and record for HVAC	Ok / Not Ok
14	Check maintenance of tool box	Ok / Not Ok
15	Check the history records for key equipments like : a.    Air Compressor b.    ETP plant.	Ok / Not Ok
16	Are calibration records maintained and calibration tags placed on the every instrument?	Yes/No
17	Check the record for accidents and verify the action taken.	Yes/No
18	Is the list of fire extinguishers available?	Yes/No
19	Are the fire extinguishers filled, calibrated and, maintained periodically?	Yes/No
20	Are the ETP equipments listed?	Yes/No
21	Is the Water treatment, chlorination records available?	Yes/No
22	Are the raw water, feed water hardness records available?	Yes/No
23	Check the operation of water system (start up and shut down) is as per SOP.	Yes/No
24	Check the operation and sanitization log of water system.	Yes/No
25	Check the record of water quality.	Yes/No
26	Check for any leakage of water from the distribution phase.	Yes/No
28	Check that ducts of HVAC system are properly identified.	Yes/No
29	Check the filter cleaning record.	Yes/No
30	Checks that control in water and HVAC system are operating.	Yes/No