7 CAD / CAM DATA N/A
7.1.P Is there a procedure for CAD/CAM data processing? YES/NO
CAD / CAM DATA COMPLIANCE
7.1.C Is the procedure for CAD / CAM data processing being followed? YES/NO
8 ELECTROSTATIC DISCHARGE (ESD) N/A
8.1.P Are there procedures for the control of Electrostatic Discharge (ESD) which meet the requirements of at least one of the following; ANSI/ESD / S20.20, or EN61340-5-1 & EN61340-5-2 and defines: YES/NO
a.P - Handling, Storage and transportation of ESD sensitive components / products? YES/NO
b.P - ESD protective containers / packaging? YES/NO
c.P - Training program of personnel? YES/NO
d.P - Instruction and restrictions for visitors? YES/NO
e.P - Soldering iron, equipment and systems tip resistances?YES/NO/N/A
Audit Note: N/A applies if soldering tools are not used.
8.2.P Is there a preventive maintenance plan which includes cleaning, calibration, verification method, audit frequency, coverage and depth of audit of all aspects of the protection methods declared in the procedure? YES/NO
8.3.P Is there a procedure that defines actions to be taken when the humidity level falls below 30%? YES/NO
ELECTROSTATIC DISCHARGE (ESD) COMPLIANCE
8.1.C Are ESD Protected Areas (EPA) clearly identified, according to the procedure? YES/NO
8.2.C Are ESD sensitive items protected from ESD damage during transport outside the EPA by use of approved ESD protective packaging / containers? YES/NO
8.3.C Are the ESD sensitive items removed from the ESD protective containers / packaging only within a designated EPA? YES/NO
8.4.C Are the ESD protective containers / packaging clean? YES/NO
8.5.C Are all non-essential insulators removed from the designated EPA, including packaging waste, document holders, etc.? YES/NO
8.6.C Do the manufacturing personnel meet the requirements for ESD protection as defined in the procedure? YES/NO
8.7.C Do the personnel working within the defined EPA test and record the stated personal ESD grounding methods daily as per the procedure? YES/NO
8.8.C Is there objective evidence that personnel have been trained to understand the principles of ESD control and how to effectively use ESD protective equipment? YES/NO
8.9.C Does the supplier assure that visitors entering the EPA are using the stated ESD protection methods? YES/NO
8.10.C Are the visitor’s ESD protection methods tested are recorded as per the procedure? YES/NO
8.11.C Are visitors instructed in the behaviors expected of them prior to entering the EPA to ensure they meet the requirements of the procedure? YES/NO
8.12.C Are equipment, workstations and tooling in the EPA checked in accordance with the preventive maintenance plan? YES/NO
8.13.C Is the equipment used to test ESD protection compliance calibrated according to at least one of the following: ANSI/ESD / S20.20, or EN61340-5- 1 & EN61340-5-2? YES/NO
8.14.C Is the procedure to address situations in which humidity levels fall below 30% being followed? YES/NO
8.15.C Are there chart recorders or electronic data collection files for the humidity
readings? YES/NO
8.16.C Are tip resistances being verified in accordance with the procedure? YES/NO/N/A
Audit Note: N/A applies if soldering tools are not used.
8.17.C Has the EPA been setup and verified as per the procedure? YES/NO