9.8 C- If external calibration sources are used, is the source an approved supplier?
YES/NO
10.PREVENTATIVE MAINTENANCE
10.1 P- Is there a procedure to ensure periodic maintenance of all required production and testing equipment? YES/NO
10.2 P- Is there a system in place to identify late maintenance activities?YES/NO
10.3 P- Is there an escalation process based on prior maintenance records?YES/NO
10.4 C- Do records indicate that maintenance has been performed in accordance with defined schedules?YES/NO
11.FACILITY ENVIRONMENTAL MANAGEMENT SECTION NA
Audit Note: NA applies if there are no customer, part, or specification requirements for environmental management.
11.1 P- Is there a procedure that defines necessary parameters such as temperature, humidity, air quality, etc.? YES/NO
11.2 C- Are facility environmental parameters maintained within defined parameters?YES/NO
11.3 Cleanroom Conditions SECTION NA
11.3.1 P- Is there a procedure which defines the maintenance, monitoring, and control of the following cleanroom conditions:
11.3.2 P- Air quality, particulates, etc.? YES/NO
11.3.3 P- Access and proper gowning?YES/NO
11.3.4 C - Is there evidence the procedure for cleanroom conditions is being followed?YES/NO/NA
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