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Equipment – Checklist

No.
Question
Options
1
Are all the Equipment Installed correctly as per the manual and guidance?
Yes
<10% not ok
>=10% not ok
No
N/A
2
Are all the Equipment Operate correctly as per the manufacturer’s guide?
Yes
<10% not ok
>=10% not ok
No
N/A
3
Are all the Equipment Performing correctly as per the manufacturer’s guide?
Yes
<10% not ok
>=10% not ok
No
N/A
4
Are all the Equipment grounded, if needed?
Yes
No
N/A
5
Is checking done that surfaces that contact components, in-process materials/products are not reactive, additive, or absorptive to minimize the growth of bacteria or contamination?
Yes
No
N/A
6
Are all the Equipment clean and maintained?
Yes
<10% not ok
>=10% not ok
No
N/A
7
Are predefined procedures for maintenance and cleaning updated and available to the cleaning staff?
Yes
No
N/A
8
Are all the Equipment that requires cleaning and maintenance are recorded and reported?
Yes
<10% not ok
>=10% not ok
No
N/A
9
Are Written Protocols and Records about equipment cleaning details and related staff responsibilities available?
Yes
No
N/A
10
Is any program for calibration of Equipment used?
Yes
No
N/A
11
Are all the results of Calibration recorded?
Yes
No
N/A
12
Are all main equipment marked with Identified Numbers?
Yes
<10% not ok
>=10% not ok
No
N/A
13
Are all open equipment, like mechanical Belt, pulley, etc. equipped with Safety guard?
Yes
<10% not ok
>=10% not ok
No
N/A
14
Are Qualification, Validation, and Calibration programs are available for all the equipment used for Quality Control Heating Ventilation, Production, HVAC, etc.?
Yes
<10% not ok
>=10% not ok
No
N/A