湖南省MedAccred _AC8121电子电缆和线束组件的审核标准 （32）

13.10 C- Are documents, including customer-supplied documents, readily retrievable on site and at the latest revision?YES/NO

13.11 C- Is there evidence that a formal First Article Inspection is conducted for new product introductions and engineering changes?YES/NO

13.12 C- Are the shop floor instructions in a form understandable by the operators?YES/NO

13.13 C- Are processes planned and defined for production up to the shipment of parts including:

13.13.1 C- Main manufacturing, inspection and test phases? YES/NO

13.13.2 C- Identification of internal and outsourced processes?YES/NO

13.14 C- Are internal non conformances and customer rejections used to develop root cause analysis and corrective actions within a defined timeframe?YES/NO

13.15 C- If required by customer, are process key characteristics identified, controlled, monitored and actions taken when out of limits?YES/NO/NA

13.16 C- If required by customer, are process key characteristics identified, controlled, monitored and actions taken when out of limits?YES/NO/NA

13.17 C- Have quality tools, such as control plans, FMEA been completed and subsequent risk mitigation actions adopted and enforced?YES/NO/NA

13.18 C- Is the procedure for introduction of new product being followed?YES/NO

13.19C- Are there records of manufacturability issues formally communicated to the customer as per the procedure?YES/NO

13.20 C- Is there objective evidence that product travelers are used and filled out correctly?YES/NO