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

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

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

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