1. Does the Bill of Material (BOM) exist and is checked before mass-production? (i.e., list of components or raw material)
2. Is there an organization to prevent mixing of components during the production
3. Is mass-production under control and responsibilities well defined? (Start of the production…)
4. Are samples of pilot run carefully reviewed to see all Quality aspects are being met?
5. Are the quality criteria clearly defined and available at the work station? (e.g.: acceptance and rejection limits, range board of defects…)
6. Are in-process inspections performed during the mass production (by inspectors or operators)?
7. Does factory use international or other approved standards to carry out in-process inspection? Are there records?
8. Are there clearly written criteria/instructions/procedures available for inspection to follow? (e.g.: tests to perform, sample size, result interpretation, approved samples…)
9. Is there a clearly written procedure in case of process deviation or non conforming products? (E.g. specific flow for rejected products; set up or stop on line, checking new started production, etc.)
10. Do records reflect the action taken on the lines and on rejected products?
11. Are rejected products well identified and segregated from accepted products or immediately destroyed?
12. Are there clearly written criteria/instructions/procedures available for treatment on segregated products?
13. Are there clearly written instructions/procedures available for inspection on segregated products after treatment? (e.g.: tests to perform, sample size, result interpretation, approved samples)
14. Is the testing equipment calibrated accurately and is it sufficient for In-process control?
15. Are there In-process control report detailing inspection? (e.g.: tests performed, results…)
16. Are the inspection defects charted, analyzed, and monitored to improve on the problems encountered?