• 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)?