A paradigm shift, identified and coined by American physicist and philosopher Thomas Kuhn, is a fundamental change in the approach, concepts, and assumptions of a practice. 

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.”

To drive change in any business process you must first assess your existing program. Is it inclusive? Is the program delivering results? How can it be improved and how can success be measured?

Our industry is fraught with tales of quality audits from hell and other less than desirable places, usually the result of standards written by folks who know a little but expand it to encompass a lot.

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.

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.

Back in the 1980s, it was referred to as sabermetrics. Its name was derived from the acronym for an organization called the Society for American Baseball Research. 

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