7.4.1 Are assembly, processing, and inspection operations and tests performed in accordance with
approved written instructions? (Observe actual conformance to posted and systematic instructions)
7.4.2 Are statistical methods used to analyze process and product improvment opportunities?
7.4.3 Is a “real time” process control system used to allow adjustment of processes to prevent the
manufacture of nonconforming product? (Look for batch based control charts and logs. Verify
operator understanding of requirements and machine start up. Look for how operators continually
verify control of critical variables and outputs)
7.4.4 Is there a documented procedure for the identification, handling, and disposition of
nonconforming product? (Verify nonconforming product is identified, classified, and kept
separate from first quality product and that records are kept.)
7.4.5 Is “good housekeeping” maintained, and are storage facilities and procedures used to
safeguard product quality between final acceptance and shipping? (Look for evidence of 5S
protocols)