ISO 13485 audit checklist about control of nonconforming product
ISO 13485 audit checklist about control of nonconforming product
Clause 8.3
1. How do you ensure that nonconforming products are identified and controlled to prevent unintended use or delivery?
2. Can you show me a documented procedure defining the controls for dealing with nonconforming product?
3. Does it show responsibilities/authorities?
4. When you have nonconforming product, what methods do you use to deal with it?
5. Can you show me records of the identity of personnel authorizing concessions?
6. Can you show me records of NC material and any actions taken?
7. Are there any records of concessions obtained?
8. When nonconforming product is corrected, can you demonstrate that it is re-verified to ensure it conforms to requirements?
9. When nonconforming product is detected after shipment, what actions are taken, such as containment?
10. Can you show me rework work instructions approved by same authority as the original work instruction?
11. Can you show me records of determination of adverse effects of rework?
12. Was the determination made prior to authorization of the work instruction?
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