TASK Discuss and reach agreement as to which would be applicable to an observation, major or minor Non-Complaince or an Improvement for each of the scenarios below.

1. A company has processes which are temperature sensitive but it had not been established temperature settings to be specified for heating in the area.

2. The company had identified within its documented procedure a list of regulatory and legal requirements but there is no evidence that this information had been sent to managers.

3. Minutes from the management review meeting, which is held every six months, reported that 6 corrective actions from internal audit were not closed from an internal audit held 5 months earlier. 4. It could not establish that staff had any understanding of their responsibilities to achieve quality objectives.

5. The Sales Manager of the company admitted that the company had not carried out any survey to establish if customers were satisfied with the product. There had also been no customer complaint received over a year so a customer survey was considered unnecessary.

6. In the company, communication was generally good between staff throughout the organization but there were no details within the quality management system to ensure this occurred.

7. The company published information provided by clients but without client expressed permission.

8. When checking a number of items in a production process it was unable to tell if the item had been subjected to inspection or not from the accompanying information.

9. There was no documented record that processes continued to meet their specified requirements established when first set up.

10. There was no analysis of supplier's data.

11. Staff in the design and production departments, were not aware of contract change agreed one month earlier on a current project.

12. Inspection records did not indicate the authority responsible for the release of the product