• Are criteria for workmanship stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations)?
• Are product operations carried out in accordance with approved data?
• Are persons authorized to approve changes to production processes identified? Are changes documented?
• Are production equipment, tools and programs validated prior to use and maintained and inspected periodically according to documented procedures?
• Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement (This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered)?
• When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), does the organization establish and document controls for the media?
• Where traceability is a requirement, does the organization control and record the unique identification of the product?
• Is this identification maintained throughout the product life? In any assembly, the identity of its components and those of the next higher assembly are traced?
• Does the organization have a documented process for exercising care with customer owned/provided property while it is under the organization’s control?
• Does the organization preserve the conformity of product during internal processing and delivery to the intended destination?
• Does the preservation of product also include shelf life control and stock rotation?
• Does the organization maintain a register of Monitoring and Measuring Devices and define the process employed for their calibration including details of equipment type, unique identification, location, frequency of checks, check method, and acceptance criteria?