by Denise Robitaille
One of the enduring challenges for auditors is getting people to understand the importance of documents and records and their implicit communication. This is especially daunting for very small companies where instructions can be yelled across the room or where a salesperson can run out on to the production floor to deliver a last-minute change order. The oft-cited explanation, “But we all know that” is difficult to refute. The other standby is, “I’ve been doing this for years and I know where everything is.” Typical examples of shortcuts and omissions include:
- Lack of documentation concerning customer-specified requirements for packaging
- Random scattered e-mails as the only evidence of a customer’s concession to product that doesn’t meet requirements
- Nonexistent design reviews and/or records of actions taken to address issues that arose during a review
- Purchase orders with scant or incomplete information
The fallback explanation for these situations is that someone somewhere in the organization knows all about it or has the pertinent details in his or her personal files. When I come across these excuses in an audit, my first inclination is to become pedantic and point out that there are specific requirements in ISO 9001 (and in most of the sector-derived standards) relating to all of these things. I want to blurt out: “You have a certificate on the wall, as well as a signed quality policy stating that you conform to the requirements of the standard. It doesn’t say, ‘Except when we decide to rely on our memories.’” But that’s a bit flippant for an auditor and definitely unprofessional.
On top of that, it’s not helpful. Part of the auditor’s role is to facilitate the auditees’ understanding of requirements. It supports their endeavor to sustain a QMS that is effective and meaningful to the organization. Saying “ISO says so” just doesn’t work. In fact, it can be alienating.
When I encounter one of the stock clichés about something being common knowledge, I ask, “What happens when you win the lottery?” It lightens the mood, often evokes a laugh, and invariably gets them thinking. It’s infinitely kinder than pointing out that someone could die—an eventuality that as mere mortals we all have to contend with.
Almost a decade ago I was scheduled to do the recertification audit for an organization that was transitioning to ISO 9001:2000. For those of you who remember, it was a big change from ISO 9001:1994. The client was being uncharacteristically silent. Around the third e-mail I got the sad reply. Bob, the ISO management rep, had died suddenly. He was a diligent worker who assumed perhaps too much responsibility for the company’s QMS. As a result, upon his untimely demise, there were scores of documents and records that no one could find. It took them almost two months to retrieve information and recreate documents to be ready for the audit.
There are a lot of reasons why people become unavailable: illness, loss of a loved one, jury duty, military service, vacation, off-site training, relocation—or winning the lottery. In each instance, the organization is diminished by the temporary absence or permanent vacuum created by the loss of that individual’s talent and knowledge.
There are examples that don’t even require absence. There’s the verbal OK from the outside salesman of a concession from a customer that was not intended. Several years ago I had a client who manufactured more than $20,000 worth of product based upon the assumption that the customer had agreed to one exception that had been cited on the quotation—all of this based on the word of a salesman.
In regulatory environments, a lack of documentation can have dire consequences. Inability to prove sign-off of a medical device history carries the potential risk of a product recall. There are no good reasons for circumventing good documentation practices.
The next time a client tells you “I know where those files are,” ask him “What happens when you win the lottery?”
About the author
Denise Robitaille is a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She is committed to making your quality system meaningful. Through training, Robitaille helps you turn audits, corrective actions, management reviews, and processes of implementing ISO 9001 into value-added features of your company. She’s an Exemplar Global-certified lead assessor, ASQ-certified quality auditor, and ASQ Fellow. She’s the author of numerous articles and several books, including The Corrective Action Handbook, The Preventive Action Handbook, and her latest book, 9 Keys to Successful Audits, all published by Paton Professional.