ISO 9001-2008 Lead Auditor 2

Quiz 6

Conforming Or Nonconforming?

Read the following scenario and determine if there is conformance or nonconformance.

Your examiner will notify you of your score.

After you have answered the questions/statements following the scenario, click on the "Submit" button to send it to us.

Note:  You will not be allowed to move to the next page until you answer all of the questions/statements on this page.

Where you have a question/statement that requires no answer, place "N/A" in the box.

Scenario

All customer requests for new or modified product come through the Sales department. The salesperson is responsible for carefully documenting the needs and expectations of the customer and applicable regulatory requirements. This information is then passed to and reviewed by the Engineering Manager. The Engineering Manager develops a project plan that identifies the assigned engineer and a timing chart. The plan and progress of design activities are reviewed at weekly department meetings. The plans are updated as the design evolves.

Upon completion, the design is reviewed by the Design Engineer to verify that it meets all input requirements. Acceptance criteria for production and special characteristics are identified. A prototype is made and tested to ensure it meets customer requirements. The design is released for production after compliance to requirements is validated by the Design Engineer and a review of pertinent design records is completed. The Engineering Manager has the final authorizing release for a design.

1.   Is there a nonconformance?

Yes?

No?

   This is correct

2.   If there is a nonconformance, what clause of the standard did it violate?

N/A

 OK

3.   If there is conformance, make a list of the objective evidence of conformance.

1)The firm determines the expectation and needs of the customer
2)It also determines regulatory requirements applicable to the requested product
3)Design activities progress is reviewed by representative from various design functions in weekly departmental meetings
4)Product design is verified by the engineer immediately after its completion
5)It also verified that the product design adheres to pertinent input requirements
6)Tests are conducted on a prototype to confirm all customer requirements are met
7)Production commences only after the engineer validates that the design complies to all requirements
8)Related design records are reviewed and maintained

 OK

4.   If there is a nonconformance, what is the objective evidence?

N/A

 OK

5.   If there is not a nonconformance, explain why not?

The product quality and realization process adopted by the firm complies fully with the requirements of the standard on customer-related processes; particularly clause 7.2 (ASQ-E, 2008). The firm accurately determines all requirements related to the product, reviews the design, validates compliance and maintains accurate design records.

OK

6.   If there is not a nonconformance, what should the auditor do next?

The auditor should closely scrutinize the firm's product quality and product realization processes to identify areas for improvement and make comments on how the process's efficiency and conformity to the standard can be enhanced.

 We can’t consult.