QMS-Module 1 - Competency Unit-QM

QMS-Module 1 - Competency Unit-QMChapter 4
Quiz 1
Is there a nonconformance?
Yes, conformance relates to acting within the agreed rules regulations and procedures within the firm and in accordance with international standards, and there is non-conformance in this case, where there are changes without communication to the management.
If there is a non-conformance, what clause of the standard did it violate?
To determine where there is non-conformance during audition it is necessarily to look into the audit findings by comparing audit evidence to audit criteria (ISO, 2011). Similarly, when looking into non-conformance one highlights on the procedure adopted by the Manufacturing Engineer versus the set procedures. The changes violated i clause 7.3.7 under ISO 9001-2008 (ANS, 2008) Thus, one of the non-conformance issues is the adoption of a process, when implementing quality management systems. In this case, the Engineer did not do an evaluation, to determine how the process would affect the overall organization. The operator demonstrates the new method with the aim of increasing efficiency, but there is no evidence that this seeks to meet customer’s needs.
If there is conformance, make a list of the objective evidence of conformance.
There is also conformance in the tasks undertaken by the manufacturing engineer
The process instruction sheet is the evidence that there has been conformance in carrying out the duties.
The instruction sheet states about the plans adopted to improve on the process
Work instruction on how the new method operates
Testing the validity of records
Checking for documentary evidence and testing the new method.
 If there is a nonconformance, what is the objective evidence?
Objective evidence relates to attempts of facts that are documented, and the records may pertain to quantitative or qualitative information (ANS, 2008). The objective evidence in this case is that there is a need of physical evidence and this is collaborated with the documentary evidence. The change in the method is verifiable by the management, given that lack of physical evidence is unlikely to be accepted by the management. The objective evidence of the quality audit is to determine whether the organization can carry out internal audit to verify whether there has been compliance to the quality management system. There was no evidence that the new method had been tested before adoption, and hence it is necessary to highlight on this in the objective evidence. Even though, the Engineer has accepted the new method as being useful to improve on quality, there is little information to what extent the process will help to meet customer needs.
If there is not a nonconformance, explain why not?