内蒙古省MedAccred —AC8121电子电缆和线束组件的审核标准 （23）

5.2.4 © Is there evidence that initial process validation is being done per the procedure? YES/NO

5.2.5 © Is there evidence that acceptance criteria was established prior to execution of the validation?YES/NO

5.2.6 © Is there evidence of a sampling plan that demonstrates establishment of the process, as well as the rationale for that selected sample size? YES/NO/NA

Audit Note: NA would be acceptable if customer determines the sampling size and the Supplier/Contract Manufacturer accepts that sampling size for adequacy of demonstrating their confidence in consistently producing the part.

5.2.7 © Is there evidence that indicates by operating at worst case processing parameters the product will still meet all predetermined requirements? YES/NO

Audit Note: “Worst Case” is a combination of variables that will provide the most difficult challenge to the process, ensuring a quality outcome.

5.2.8 © Is there evidence that Environmental Testing is a part of the validation to demonstrate product’s ability to withstand decontamination environment (for Biocompatibility, Cytotoxicity, etc.)? YES/NO/NA

Audit Note: NA may be included depending on the critical process being audited. NA applies when there are no customer defined requirements other than IPC/WHMA-A-620.

5.2.9 © Is there evidence that risk control mitigation is in place for product and processes (e.g., pFMEA)? YES/NO