Appendix B–Pre-Audit Questionnaire
SECTION F - QUALITY ASSURANCE & QUALITY CONTROL Regulatory Standards and Compliance: |
| Are quantities and measures controlled in accordance with legislative requirements in the country where the product will be sold? | Yes/No |
| Are records maintained to demonstrate finished product complies with all regulatory requirements in the country where the product will be sold? | Yes/No |
| Factory Practices |
| Are there documented process flow charts identifying key areas of risks? | Yes/No |
| Are storage areas for components/raw materials/chemicals and finished products appropriate so as to not compromise safety,legality and quality of the product? | Yes/No |
| Does the factory have product design and development procedures? | Yes/No |
| Process Control |
| Are work instructions/procedures available for use by production staff? | Yes/No |
| Are visual reference standards/samples used and effectively controlled? | Yes/No |
| Are reference samples of incoming materials retained from each batch and appropriately stored? | Yes/No |
| Are rejected products and components suitably segregated and their re-use/disposal suitably controlled/authorized? | Yes/No |
| Inspection and Testing: |
Are product quality hazards and risks monitored onall relevant line operations?
| Yes/No |
Are there Hazard and Risk Inspectors appointed?
| Yes/No |
Are defect classifications and acceptancetolerances clearly defined?
| Yes/No |
Does the supplier carry out a statistical samplingmethod to check functionality and fitness for purpose?
| Yes/No |
Are processes in place to review packaging andassembly instructions as part of the quality process?
| Yes/No |
Are components and products inspected at each stageof production according to set inspection criteria and reference samples?
| Yes/No |
Does the factory have its own laboratory?
| Yes/No |
If so, is the laboratory accredited? | Yes/No |