1. Define the term system.
2. What are the main differences between ISO 9000 and the MBNQA?
3. What are the key components of Six Sigma?
4. Discuss the differences between a first-party, second-party, and third-party audit.
5. Discuss the importance of data accuracy and integrity in a quality information system.
6. What are the purposes of quality documentation systems?
7. What would be the foremost characteristics of an acceptable sampling plan for critical defects?
8. A manufacturer approaches a customer and asks which of the 237 dimensions on the blueprint are critical. The customer replies that they expect the product to be in conformance to all of the dimensional specifications–therefore they are all critical. Is there a better approach the manufacturer could have taken with the customer? Discuss.
9. What are some of the categories of information which might be important to include on product packaging? When would it be appropriate and desirable to include this information on the product itself?
10. Why might lot traceability be more important in pharmaceutical manufacturing than in writing instrument manufacturing?