浙江省MedAccred —AC8121电子电缆和线束组件的审核标准 （22）

5.1.7 (P) A requirement to define process parameter ranges, such as process extremes (e.g., worst case), and testing documentation to confirm those ranges will produce acceptable quality product or services. Examples might include: setup conditions, operating ranges, sequence, material handling requirements, etc.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.

5.1.8 (P) A requirement for Environmental Testing as part of the validation to demonstrate product’s ability to withstand the decontamination environment? 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.

5.1.9 (P) A risk control mitigation procedure for product and processes (e.g., pFMEA)?

5.2 Compliance (C)

5.2.1 (C) Is there evidence that the applicable Regulatory and Customer - OEM requirements are being met? YES/NO

5.2.2 (C) Is there evidence that a Validation Master Plan (e.g., qualification plan, Validation Master Plan, Validation Project Plan, etc.) is reviewed and updated at pre-defined frequencies?YES/NO

5.2.3 (C) Is there evidence that changes, such as new product introduction, new processes, or process changes are assessed for risk and validation requirements, which may include the need to validate or revalidate? YES/NO