山西省MedAccred —AC8121电子电缆和线束组件的审核标准 （21）

4.18 C- Is there evidence of a regular review and disposition of non- conforming material? YES/NO

4.19 C- Is there evidence that customer and/or specification requirements have been captured and implemented by the supplier’s manufacturing system and documentation? YES/NO

5.PROCESS VALIDATION

5.1 Does the supplier have a formal detailed procedure (P) that defines the process validation requirements, including:

5.1.1 (P) A methodology that meets applicable Regulatory and Customer - OEM requirements? YES/NO

5.1.2 (P) A requirement for a Validation Master Plan (e.g., qualification plan, Validation Master Plan, Validation Project Plan, etc.) which is reviewed and updated at pre-defined frequencies? YES/NO

5.1.3 (P) 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

5.1.4 (P) A description of conditions that cause an initial process validation be completed? YES/NO

5.1.5 (P) A requirement that acceptance criteria is established prior to execution of the validation?YES/NO

5.1.6 (P) A requirement for 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.