The Standard Answer

Watch out for all or never: Quality procedure documents should say what they mean and mean what they say.

Published: Sunday, August 8, 2004 - 22:00

There’s a marauding infestation of adverbs and adjectives that infiltrate the text of quality documents and operating procedures, wreaking havoc wherever they are found. The leader of this menacing bunch is called “All.” Among his compatriots you’ll find “Never,” “Always,” “Every” and “None.”

When I come across a particularly virulent case of rampant absolutes during an audit, I’m tempted to violate the prohibition we auditors have against consulting. I want to scour the auditee’s documentation and point out the countless instances where they’ve used “all,” or one of the other offending words, without perceiving the full implication of what they have written.

I generally end up asking the auditee or process owner, “Do you really mean all?” The authors of the documents rarely give adequate consideration to the manner in which they express the requirements. This normally innocuous group of words can skew meaning, making the requirements absurd or impossible to achieve.

I’ve tried to sort out the reason there’s such a pervasive overuse of this small group of limiting modifiers. There are those who use the words casually and ubiquitously, almost like variations of common articles, to give some variety to monotonous text. They ascribed no substantive meaning to the usage of these words in a sentence. Others take great pains to deliberately insert these precise, all-encompassing words to communicate their unwavering resolve to the maintenance of the company’s quality system. Their intent is to reinforce the organization’s rigid commitment to consistency and control.

In both instances, the outcomes are markedly different from the original intention. In the first scenario, the document writer may have inadvertently altered the parameters that define process requirements. In the latter case, the use of “all” or “never” could so restrict process owners that they cannot avoid falling into some breach of a defined requirement.

One of the typical examples that I’ve seen relates to documentation. The document control procedure reads, “All documents are reviewed and approved by the vice-president of operations prior to issue.” This wouldn’t be such a big deal, if the only documents a company had were manufacturing work instructions. Unfortunately, the same procedure goes on to list what things are considered to be documents. These include drawings, customer purchase orders, internal audit schedules, the electronic corrective action database and all the documents of external origin. The likelihood that the V.P. of operations is going to review all these documents is slim to none. Furthermore, documents of external origin are generally just identified, verified and maintained—not usually approved. Assigning ownership for the review of all documents, even those he doesn’t read, begs the question: If the V.P. isn’t reviewing all the documents, then who is?

Other examples might include:

“All non-conforming material is placed in the MRB cabinet.” What happens if it doesn’t fit or the cabinet is full? “All obsolete copies are destroyed.” Can you keep one for reference or in the archives? “The valve is always opened before the unit is turned on.” What happens if you turn the machine on first? Does the device stall or does the building blow up? The answers to these questions demonstrate the appropriateness of “all” or “always.”

The auditee may feel I’m being capricious, picking away at miniscule findings in an attempt to beef up my list of nonconformance. In actuality, I would normally assess the risk that the language poses and make a determination as to whether this is a minor observation (an opportunity for improvement) or a minor nonconformance. I’ve never witnessed a case where it indicated a systemic breakdown of considerable magnitude.

Auditors don’t have the prerogative to decide when the organization really means “never” and when it intends to say, “…well, almost never.” The auditee or process owner is the best authority on the criticality of a process. Sometimes, it’s absolutely crucial to conduct a particular activity in a specified sequence. Sometimes, it’s a matter of regulatory compliance that a certain signature always precedes the release of a device for shipment. In those instances, “always” is the appropriate word to use in the procedure.

It’s often quite clear when “all” or “never” is intended to be rhetorical, as opposed to prescriptive. There are many cases, however, where the risks that are engendered by either complying—or failing to comply—with an overly restrictive requirement are less obvious, especially to an impartial observer. Note the valve example early in this article. There is also the risk of simply wasting resources through blind adherence to a poorly worded document.

The message: be judicious in the use of the word “all” and its cohorts (never, always, etc). Always—yes, I do mean always—maintain vigilance when writing and revising documents to prevent the proliferation of marauding mundane modifiers.

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.