Articles Tagged with ''auditing''

Remote audits may have sounded unconventional at this time last year. But 2020 is shaping up to be a memorable year for all kinds of reasons. 

The importance of auditing should not be overlooked. As longtime Quality columnist Jim Smith writes, “It’s rare that managers, or even most quality auditors, discuss how closely tied the findings of manufacturing audits are to the long-term ability of their companies to compete in this highly competitive market.”

As a full time auditor for the past six years for one of the large management system registrars, I start every interview, from production personnel to the CEO, with the question: “Given all of your job responsibilities at this company, what does the word ‘quality’ mean in your work?” 

When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

One of the requirements for management system standards is that internal audits be conducted of the processes of the management system. 

Daniella Picciotti still remembers her first auditing experiences. On a supplier audit with more senior colleagues, it was difficult to determine her role.