Featured Product
This Week in Quality Digest Live
Standards Features
Harish Jose
Using OC curves to generate reliability/confidence values
Phanish Puranam
Instead of blindly adopting industry best practice, companies can pilot new organizational designs
William A. Levinson
All is not gold that glitters
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Megan Wallin-Kerth
MasterControl’s Matt Lowe talks competition, data, and what quality does for a company

More Features

Standards News
June 6, 2023, at 11:00 a.m. Eastern
Ensuring product consistency, quality, and adherence to federal and state standards
Omnex webinar on May 11, 2023
Digital Twin Consortium’s white paper guides strategies for building owners and stakeholders
Copper, titanium, and 304L stainless-steel powders from Desktop Metal have qualified for production
Webinars cover Automotive SPICE and carbon neutrality standards
Creates one of the most comprehensive regulatory SaaS platforms for the industry

More News

Denise Robitaille


Preconceived Notions Can Stifle Innovation and Sidetrack Audits

Beware the single-definition paradigm

Published: Tuesday, August 31, 2010 - 06:00

Trepanning is the process of drilling a hole in the skull. It was practiced as far back as 10,000 years ago. Archaeological artifacts lend credence to the lore that the process was used by some cultures to expel evil spirits. Apart from that occult-ish application, the process has been used for centuries to ease headache pain and other ailments. Scientists suspect that in some cases it may have actually been beneficial in relieving pressure on the brain.


That’s the definition of trepanning with which I’m familiar. As a matter of fact, until a year ago, it was the only definition I knew.

Sometime last year I was working on a new project, helping a manufacturer of machined composite components establish an ISO 9001-compliant quality management system (QMS). I was touring the manufacturing area as we discussed the sequence of various machining processes. You can imagine my astonishment when they offered to direct me to the area where they did the trepanning. About all I could blubber out was a slightly choked, “I beg your pardon….”

They led me over to the station where the trepanning operation was done. Turns out trepanning is a standard boring operation using a tool called a trepanner. In all the years I’d been touring machine shops, I’d never come across the term before.

Needless to say, when I explained the alternate use of the term “trepanning,” it was my client’s turn to register surprise. The hilarity of the situation was priceless. The lesson it imparted, of equal value.

We, as auditors, consultants, process engineers, and standards developers often get comfortable with one way of doing things. We migrate from this snuggly cocoon without appreciable notice through several layers of stasis and progressive inflexibility until we discover (usually too late) that we’re in a rut. We find ourselves wedged into this rut where everything is relatively stagnant and our desire or ability to change is stunted. We become the recalcitrant stick-in-the-muds whose manifesto is, “We’ve always done it that way.”

What does all this have to do with your QMS? Lots. When we get set in our ways, we fall into the trap of thinking that there’s only one way to do things.

For auditors, this can result in a narrow-minded approach to the application of a requirement. We blur the line between the strict language of the standard and interject our own preconceived notion as to how an organization fulfills the requirement. The organization may have developed an ingenious method that the auditor has never encountered before. If it’s substantially different from the norm, auditors will sometimes err on the side of experience rather than spend the extra time to ascertain if the practice does indeed (perhaps unconventionally) fulfill the requirement. The result is an unwarranted nonconformance. The fallout can lead to resentment and a devaluing of the certification process as the organization gets punished for innovation by a shortsighted auditor.

Consultants should be ever mindful of the distinction between offering good ideas and usurping an organization’s right (and mandate) to make its own choices about its QMS. We need to advise the company what the requirements are without recreating the organization to suit our preconceived notions. Give companies good guidance and let their creativity take over. They’ll come up with great practices, and you’ll end up learning something.

Root cause analysis, corrective actions, product design, process development, innovation, and continual improvement are all stifled by the single-definition paradigm. “That can’t possibly be what caused the failure.” “That solution will never work.” “The product can’t be improved.” “This is the only way to achieve the desired results.”

Surprisingly, as often as we work ourselves out of this rut, we find ourselves time and again snuggly settled into our complacent surety that we’ve got the best and only answer. We all have to periodically shake ourselves out of the comfort zone where there’s only one way to do things. We need to occasionally remind ourselves of the words of great bard of Avon: “There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.”

I wonder if trepanning has an effect on dreams.


About The Author

Denise Robitaille’s picture

Denise Robitaille

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.

She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.

As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.


Paradigm Paralysis

It's fascinating that the very necessary skill of creating a paradigm to understand our world can work against us when trying to improve our understanding.

It's the quintessential catch 22 that without paradigms we couldn't learn, and yet if we don't challenge our paradigms we can't learn.

And to make it worse, paradigms make us feel comfortable, and challenging our paradigms force us into the unknown, which is uncomfortable.

I guess learning takes a little courage by its very nature.

David Smithstein, Founder and CEO