Part A2: General Organization

1. Is there any document available, which describes your organisation?

(Quality Assurance Manual; Organisation chart)

2. Is there an independent Quality Assurance department?

3. Production planning:

1. a. Is production planned systematically?
2. YES / NO
3. If so, by which means?
4. b. Are the delivery times planned and continually monitored?
5. YES / NO
6. b. Production planning and control system
7. Work Procedure Index Cards
8. Are the delivery times planned and continually monitored?
9. YES / NO
10. c. Do you inform the customer of delays?
11. YES / NO

4. Instructions:

1. a. Are there written work instructions for the production processes?
2. YES / NO
- For production
YES / NO
- For in-process inspection
YES / NO
- For final inspection
YES / NO
- For outgoing goods inspection
YES / NO
3. b. Are the inspection / work results documented?
4. YES / NO

5. Information on the business process:

1. a. On-Time delivery/delivery compliance for last or current business year (%)
2. b. Have you implemented a procedure which ensures that non-conforming products and/or services will be segregated?

1. Name:
2. Designation:
3. Signature:
4. Date: