Discuss, Using Examples From Your Experience, How W.E. Deming’s 14 Points: Quality Management, GMIT, Ireland

QUESTION 1

(a) Discuss, using examples from your experience, how W.E. Deming’s 14 points and the 4 elements of his System of Profound Knowledge, could impact how organizations might develop a positive quality culture – incorporating quality and quality-thinking in all they do.

(b) Describe, briefly, 5 ways in which a Quality Culture can be undermined in an organization.

QUESTION 2 

Discuss, using examples how each of the Clauses 4 to 10 might be implemented and its subsequent impacts, but also addressing how certifying to the ISO9001:2015 standard does not guarantee quality.

“The objective of TQM is being customer-centric and doing things right the first time, consistently, freeing up organization time that is wasted, fixing poor work and failed product and service implementations. TQM uses strategy, data and communication channels to integrate 8 TQM principles into the organization’s activities and culture.”

QUESTION 4  

Explain the concept of CAPAs, addressing:

1. what they do,

2. how/when do they arise?

3. what guidance does ISO13485:2016 provide in relation to their role in complaint management and the management of non-conformities?

4. how does ISO 9001:2015 propose they should be treated?

QUESTION 5 

Explain the CE Marking concept and the role of the NSAI and Notified Bodies in the process.