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Miriam Boudreaux

Quality Insider

The Abominable Quality Manual, Part One

Repeating a standard verbatim isn’t very useful for continual improvement

Published: Thursday, April 3, 2014 - 10:59

Have you ever seen a quality manual that didn't look exactly like the ISO 9001 standard? Not lately, probably. Nowadays, most quality manuals I see look like mirror images of an ISO standard or the American Petroleum Institute (API) Specification Q1 or Q2. I often wonder what value there is in a document that paraphrases these standards without telling me anything I don't already know.

Some auditors will tell clients that unless their quality manual is an exact replica of standard, they risk having a nonconformity for missing the word "input" in front of "design and development"—even if they refer to inputs as "feedback" within their company. Can you relate to this?

Do I hear an echo… echo?

I feel queasy every time I see a quality manual that simply repeats the relevant standard. What was meant to be a valuable document that could tell me a lot about a company's culture has been transformed into a zero-value-added document that only does a great job of replicating the standard. If you write your quality manual the way we will suggest in part two of this series, you will at least get some value from it.

I have to admit, though, that we, too, have given in to the demands of this new wave of narrow-minded auditors. The irony is that the ISO 9001 standard itself tells us exactly what a quality manual should consist of, and nowhere does it say the manual should repeat—word-for-word, bullet-by-bullet, and item-by-item—the words of the standard. So how did well-meaning companies get to this point?

What the standard requires

ISO 9001 makes it very clear that it requires only three things within a quality manual:
• Scope of the quality management system (QMS), including details justifying any exclusions
• Documented procedures established for the QMS, or a reference to them
• A description of the interaction between the processes of the QMS

API Specification Q1 requires the following four things from a quality manual:
• Scope of the QMS, including justification for any exclusions to specific QMS elements
• A description of the sequence and interaction between the processes of the QMS
• Identification of processes that require validation
• Reference to documented procedures that control the QMS processes

API Specification Q2 also requires four items but varies from API Specification Q1:
• Scope of the QMS
• Description of the interaction between the processes of the QMS, including references to documented procedures
• Allowable exclusions and the basis for claiming those exclusions
• Identification of legal and other applicable requirements to which the organization claims compliance

As you can see, they all pretty much ask for the same things. So, I ask myself, by what stretch of the imagination did we convert those three or four requirements of a quality manual into a need to replicate the standard in its entirety? When was it decided that it must be audited with the assumption that it should say word-for-word what the standard says?

How did the quality manual come to mirror the standard?

Way back when, quality manuals used to have the following elements:
• A picture of the process map (to satisfy the sequence and interaction of the processes)
• The scope statement (there were no exclusions)
• A register of the procedures (they linked to the real procedures)

These elements met the requirements of the standard itself and were valuable to employees because the links took them to the actual procedures. When customers asked for a copy of the quality manual, they would get a printed copy of the process map, the scope statement, and of course, all the procedures. What better way to show them what the processes really were? Instead of giving them a document that paraphrased the standard, they were told exactly what the company did and how it was done—through the procedures. Quality manuals were clear, transparent, and had nothing to hide.

Summarizing into a single document

Eventually, it became a bit time-consuming to print out an increasing number of quality manuals for customers. Not only that, but auditors got headaches when they weren’t presented with what they called “the norm.” So it became convenient to create a quality manual that summarized procedures, so they didn’t have o be printed out for every request. This version of the quality manual was still a valuable tool for managers and employees because it helped them become more familiar with the company.

At this point, the manual didn’t simply repeat each clause of the standard. Instead, it told users enough of the processes and procedures to be valuable—without getting into so much detail that it could potentially contradict the procedures. You don’t want to spell out every procedure in its entirety there. Otherwise, when you update the procedure, you might very well forget to update the manual or vice versa.

Mirroring the standard’s clauses

One day, somewhere, somehow, a new breed of follow-the-formula auditors began having trouble relating to the requirements of the standard in the quality manual. The auditors went from having minor headaches to major brain freezes. They didn’t want to read the procedures; instead, they wanted to see each clause and subclause of the standard perfectly imitated and laid out in the manual. Never mind that our procedures were very detailed and met all the requirements of the standard—in fact they met the requirements of many standards at once because at one point the facility was certified to ISO 9001, ISO 14001, QS-9000 and TL 9001. But for some strange reason, if we missed item d of subclause 6.2.2, even though the procedure explained it, we were nailed with a nonconformity.

“Parrot-phrasing” the standard

And so the era of repeating the standard began. I found that even when I summarized all the bullets into a few sentences, there would always be one auditor who would suggest putting the content back into bullet format. Or if we combined two bullets into one, an auditor would have a brain freeze because he couldn’t find bullet “e.” Finally, we gave in to auditors’ stay-inside-the-lines demands. Nowadays we advise our clients that because we don’t know what kind of auditor they will get, they had better write the quality manual line-by-line, word-for-word, just like the standard, and then plug in their procedures as reference.

The most ironic part of this is that a quality manual that repeats the standard word-for-word, while not providing much value, may fare better in an audit than a quality manual that perfectly addresses the standard yet still presents valuable information about a company’s procedures, culture, and processes. Where is the value-added with these auditor-driven manuals? What a beautiful thing it is to read a manual where I can learn about the company, truly have a glimpse at its processes and understand what it is all about.

Don’t touch my procedures

Having a quality manual that mimics the standard seems to have appeased most auditors, but we’re seeing that some of them are starting to move in another direction: They now want to see procedures also paraphrase the standard.

As a simple example, let’s look at one requirement of control of records. Both ISO 9001 and API Spec Q1 and Spec Q2 require that records be legible, readily identifiable, and retrievable. If I explain in my manual that records will be legible, readily identifiable, and retrievable and then on my procedure I declare that all my records are kept on the software in which they were generated, wouldn’t I be complying with the requirement? But I have seen auditors wanting my procedure to say, “Records would be readily available.” How is that adding value or complying with the standards? The point is not to paraphrase; the point is to do. Show me how you do it. Don’t show me that you can say what the standard wants you to do.

It makes no sense to lose information about a company’s culture, industry jargon, and process names just because an auditor wants to impose a flawed interpretation of the standard, along with procedures that parrot-phrase the standard.

What year is this, 1994? The standard changed in 2000 for the better, and it must continue in that direction.

So, should you concede?

I can truly say that in our company I live the standard, and I live the QMS—as an auditor, management representative, and a consultant who coaches clients what to do day in and day out. The standard is there for us to follow so that we can improve, and that doesn’t mean repeating what it says but rather doing, in our own way, what it says. I know that the standard was never meant to be regurgitated but not followed. So for those of you who believe there’s no value in paraphrasing the standard, I hear you.

In part 2 I will describe how to put together a quality manual that meets the requirements of narrow-minded auditors while still providing value to your company and its employees.

Discuss

About The Author

Miriam Boudreaux’s picture

Miriam Boudreaux

Miriam Boudreaux is the CEO and founder of Mireaux Management Solutions, a technology and consulting firm headquartered in Houston, Texas. Mireaux’s products and services encompass international standards ISO and API consulting, training, auditing, document control and implementation of Web QMS software platform. Mireaux’s 6,500 square foot headquarters, located in the northwest area of Houston, houses their main offices as well as their state-of-the art training center. Mireaux itself is certified to ISO 9001:2015 and ISO 27001:2013. To get in touch with Miriam Boudreaux, please contact her at info@mireauxms.com.

Comments

Outstanding

Wow, what a fantastic article! Very well written. The very first company I worked for that received ISO 9001 certification (back in 1994), did it with pre-written, standard-based documentation--as did many. This documentation was widely available in books at the time. So, it's nothing new. But it's something that needs to be overcome. I look forward to Part Two. Part One is dead on!

Auditors

Miriam, I appreciate the nuances you've described here, and you don't come across as combative. I am, however, and I have a low tolerance for fools. There's certainly much value in having a roadmap of a QMS, and a company should do all it can to make its QMS user-friendly; but in the end it's meant to serve the company, not the auditor. I understand why no-one wants to rile up an auditor, but companies pay good money for certification audits and deserve to expect some competence and professionalism from auditors, which is the opposite of what you're describing here. I await the sequel to your article.

Auditors

Should a competent, professional auditor expect any QMS to be defined according to ISO 9001 requirements ?

to Dan

No; only the QMSs meant to comply.

Auditors

Does a QMS defined (and procedurally structured) according to the requirements of ISO 9001 demonstrate a process approach as is required of the standard?