by Denise Robitaille
We’ve all heard the expression from managers and supervisors about their desire for a “clean audit.” It usually refers to a registrar’s surveillance audit or some other third-party assessment. A few days prior to the visit they gather the troops, give a pre-game pep talk, and end with a rousing exhortation to have a clean audit.
So, I’m wondering. If there is a clean audit, is it all possible to have a dirty audit? And if so, what would characterize such an audit? Would the auditors make a mess of the calibration area? Would there be disorganized files strewn across the sales manager’s desk? Would the production floor be awash in blood? Would the audit report be peppered with slanderous accusations, profane language, and naughty illustrations? Or… even more horribly…would the audit report include the dreaded and vile nonconformity?
Based on the reaction one generally gets, one would expect a dictionary definition to read something like this: “Nonconformity—An event of putrefying and soul-sucking proportion, purported to end careers and cause ISO 9001 certificates to spontaneously combust.”
What is it with people and nonconformances? Bosses look upon them as a personal indictment of their managerial competence. The president of the company views them as some kind of barometer of organizational stability and individuals perceive them as the report card from hell that will get them fired.
Let’s take a deep breath and recap just what it means to receive an audit report that includes a finding of nonconformity—even a major nonconformity.
The auditor has identified that there has been the “nonfulfillment of a requirement.” That’s the definition of nonconformity as found in ISO 9000:2005. Evidence supports the finding that a product was not made in conformance to specification, a process was not conducted in accordance with documented procedure or some other requirement has not been met. For example, it may be that a procedure states that appointments for auto glass replacement must be confirmed between 8:00 and 8:30 on the morning of the technician’s scheduled visit. The auditor observed that the customer service representative was doing the confirmation calls in the late afternoon on the day prior to the appointment. There’s obviously a nonconformance. However, it may be that the company figured out that confirming the appointment the day before made a lot more sense and modified the process without revising the documented procedure.
The question is not about who screwed up, but why the process and the documentation don’t match. The genuine concern here, and the real reason that this should be addressed, is that the organization must ensure that individuals aren’t changing processes without addressing the corresponding documentation. It’s a bad habit that, if perpetuated, leads to a proliferation of uncontrolled documents and processes. Eventually, no one knows what the right thing is supposed to be and mistakes are inevitable.
Clean audit misconceptions: Errors and improvement
Errors and degradations in process control evolve over time. They result mostly from change. Individuals retire, get promoted, or leave. Their replacements aren’t as conversant in the details of the process and the older documentation isn’t so helpful. Or, customers’ requirements change. What used to be acceptable is now rejected, because they’ve tightened up dimensional tolerances or some other product attribute. New equipment is purchased that eliminates the need for tedious steps that had been laboriously described in wordy work instructions that never got updated. Tooling wears and becomes less accurate. And, then, there are the actual cases where someone simply failed to do the right thing. There was an operator error.
In so many instances, things change and we’re just not paying attention. So, isn’t it a great thing to have audits that catch process nonconformities before they result in product defects? Isn’t it more advantageous to address problems before they become catastrophes?
Upon being “dinged” (another questionable expression that has crept into our quality management system lexicon) with a nonconformity, we proceed to investigate the root cause and figure out how to address it. We revise the process, fix the documents, do some training, and end up with an improved practice and a more enlightened work force. Overall, not a bad outcome from a process steeped in fear and loathing.
Richard Bach wrote: “There is no such thing as a problem without a gift for you in its hands. You seek problems because you need their gifts.” How interesting it would be if we accepted audit findings in the same spirit.
About the author
Denise Robitaille is the author of several books on various quality topics. She’s an internationally recognized speaker who brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates, she has helped numerous companies in diverse fields to achieve ISO 9001 registration and to improve their quality management systems. Robitaille is vice chair of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She’s also a RABQSA-certified lead assessor, an ASQ Certified Quality Auditor, and a fellow of ASQ.
Her books include The Corrective Action Handbook, The Management Review Handbook, The Preventive Action Handbook, Root Cause Analysis, Managing Supplier-Related Processes, and Document Control, all published by Paton Professional. She also co-authored The Insiders’ Guide to ISO 9001:2008.
Her newest book, 9 Keys to Successful Audits, is available now.
Tags: clean audit.