The Standard Answer

Managing exceptions to your QMS rules

Published: Sunday, July 11, 2004 - 22:00

We all love exceptions. They afford us unfettered permission to break the rules. They are the vehicles we use to get around “things”—whatever those things happen to be.

For those of us who attended elementary school in the sixties, the tradition of exceptions reaches deep down to our grammatical roots. Your earliest recollection is probably wrapped around some bizarre bit of nostalgia associated with the recitation of a grammar rule like: “I before E, except after C, and except when pronounced like A.” And that’s the point of this article: even exceptions have rules.

Exceptions are an acknowledgement that not everything fits neatly into the less-than-tidy constructs that we use to define and navigate through our world. They are concessions that things aren’t perfect, but we still have to deal with them.

Failure to have plans (rules) to deal with exceptions pertaining to quality management processes and requirements is an avoidable cause of some of the nonconformances that arise during audits. Too often an auditee will attempt to rationalize away the non-fulfillment of a requirement by saying: “But that’s an exception. We only do that for one customer,” or, “We are just doing it that way until we use up the old inventory.”

As an auditor, I understand that there are exceptions. Yes, I do understand that unusual circumstances do arise. “But,” I have to ask the auditee, “do you understand that you still need to control this process?”

Exceptions tend to fall into two general categories:

• Processes that occur infrequently (or products that are manufactured rarely)
• Temporary deviations to products or processes brought on as the result of change

It’s easy to understand why an organization would not want to expend limited resources to develop work instructions for a process that only happens once a year. There are also times when changes happen so rapidly that it becomes necessary to deviate from a documented procedure because the approval cycle for the revisions could cause you to miss a delivery to your customer. Too often organizations will turn a blind eye to these anomalies because they know it doesn’t make fiscal sense to write endless procedures or generate countless ECOs (engineering change notices). They just hope the auditors don’t have keener vision.

The solution is not to issue prohibitions against the exceptions or to ignore them in the adolescent hope that they will go away. The remedy is to develop efficient methods to control them.

ISO 9001:2000 requires that the organization ensures that the integrity of the QMS is maintained even in the midst of change. (Ref: Sub-clause 5.4.2)

Many of the exceptions revolve around documentation. For example, the organization may have a manufacturing procedure that defines requirements for a package of documents (specifications, drawings, forms, inspection criteria, bill of materials, etc.) to be included in all production folders. There may be rare occasions when very simple jobs come through that do not warrant the time it takes to assemble a complete package. Rather than waste valuable time generating meaningless paperwork, the organization could decide to place an exceptions note in the manufacturing procedure, which would allow a deviation under pre-determined conditions whereby an abridged alternative to the folder could be used to get one-time-only or very simple jobs through the shop. The alternate method could be as simple as a marked-up drawing with an authorization signature and a sheet for notes. Of course, these decisions are reliant on the nature of the industry and the criticality of the product. The important thing is to have a consistently applied rule to deal with one-of-a-kind situations.

Another source of exceptions is a temporary deviation to an established process. Typical cases include:

• Temporarily outsourcing a process because a piece of equipment is being repaired
• Suspending calibrations for instruments that aren’t being used
• Substitution of a component
• Special instructions from customers that diverge from established practice
• Interrupting the preventive maintenance schedule on equipment because the manufacturing area is being moved and it makes more sense to do the PM when the machines are set up in the new location

For large projects, like moving a production area, the authorization to suspend the PM or calibration schedules could be as easy as an authorization from top management communicated to all involved parties. The neat thing is that, if the organization is utilizing the PDCA cycle and their management review process, there will be evidence that:

• Effects of the move were reviewed by management
• Decisions based on the facts that emerged from the review were planned and implemented
• The plans were communicated via e-mails, notes, minutes of meetings and memos
• The implementation was carried out in such a way as to maintain control of QMS processes, thereby ensuring continued ability to fulfill customer requirements
• There are records of documented approvals and authorizations

The temporary change would allow for continued, albeit different, control while the deviation was in effect.

Exceptions can be handled with general guidelines that define alternate practices, identify authorization, establish communication, create means of generating records and provide for traceability.

The difference between an exception and a nonconformance may very well be as simple as having a rule.

About The Author

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.