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Denise Robitaille
Published: Tuesday, July 11, 2006 - 22:00 Still, they’re just numbers. Suggesting that they have any significance beyond tidiness perpetuates the notion that the language of “ISO-speak” supersedes the spirit of the standard. People are sometimes surprised at those of us who can spout the clause numbers. I’m an auditor; it’s my job to know. The auditee’s job is to know his or her job and to do it well. I don’t expect them to be able to rattle off chapter and verse of the ISO standard or any other document. I’d rather they didn’t, because the numbers are secondary. As an auditor, I need to see that they comprehend the linkage between their jobs and the fulfillment of the customers’ requirements. I have to ensure that the users are qualified and able to perform requisite tasks and that they can access and use the documents that relate to their work. The numbering system, therefore, needs to work for them—and not the other way around. The numbers contribute to the process by making documents more readily accessible and facilitating linkage between families of like work instructions. In days gone by it was common to find manufacturing work instructions (in ISO-speak, we call these “tier threes”) numbered W4.9.1.2, W4.9.1.3, etc. To the authors the logic was clear. All 4.9 documentation related to manufacturing. It’s a simple and clever methodology. Except, it isn’t necessarily how the company organizes processes in the real world. In actuality, the company probably puts together a job package that includes items such as a traveler (also called a router or shop order), drawings, barcode labels, blank inspection forms, assembly instructions, machine settings, a bill of materials for inserts supplied by the customer and a purchase order for outsourcing a secondary operation. Under ISO 9001:1994, that means attendant documented procedures describing activities and requirements would have numbering something like: 4.9.1, 4.5.1, 4.8, 4.10.2, 4.9.1, 4.9.2, 4.7, 4.6.3. The numbers don’t really mean anything to the people who are using them. All they know is this is the stuff that relates to Job # XX. To them the job package is incomplete if certain items are missing. That’s all. Re-numbering the documents to reflect the 2000 revision of ISO 9001 would probably not increase their understanding of their process or of the entire quality management system, or so I thought. But on two different occasions in recent months, I heard comments that gave me pause to reflect. Internal auditors need all the help they can get in relating their organization’s system to the ISO 9001 requirements. They want to understand how this all fits together. If they are to comprehend the process approach, then they need to relate their company’s documentation and practices to that model. The numbering system of the standard helps them to do that. Being able to reference the standard more quickly, because the numbers are identical, also helps them to determine more quickly if they’re in conformance with their own procedures and with the standard. Using the numbers augments the effectiveness of the audit by giving the auditors the means t more precisely zero-in on the requirements. By matching their procedures to the standard, they can ascertain not only whether the company is doing what they say they do but if what they are doing is working. The language of the ISO standard directs the reader to consider the purpose of a requirement. For example, clause 8.3 relates to control of nonconforming product. An organization may have a document that simply says defective material will be tagged. The ISO standard clearly states: “… to prevent its unintended use or delivery.” Will it prevent someone from grabbing it off the shelf and using it, despite the tag? An auditor can decide if the tagging of the defective product is adequate to fulfill the purpose. So, it’s fair to say that having numbers that mirror the ISO standard can be useful at times. Getting process owners to adopt the spirit of the standard is greatly increased when they can clearly see how the requirement relates to their work. It diffuses the notion that this is just another fad. You can say to the scheduler: “When it says in 7.2.2 b that the organization ‘… shall ensure that… the organization has the ability to meet the defined requirements,’ that means that no one can promise a customer that they can improve a delivery you have quoted without checking with you first.” That can be pretty powerful. I also found individuals new to an ISO 9001 environment who sincerely wanted to understand the standard. I was able to teach them the relationship between what they do and what the standard says. It would be nice to think they could go back and review what they learned after I’d left. That, too, would be easier if the numbers were the same, I suppose. But, I still can’t resist saying, “They’re just numbers.” Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, 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.What’s in a Number?
Actually, quite a bit
I have long maintained that renumbering procedures from the defunct ISO 9001:1994 standard to reflect the numerical scheme of ISO 9001:2000 is an exercise of questionable value. After all, aren’t they just numbers? What difference can it possibly make if your purchasing procedure is numbered 4.6 or 7.4? While I still haven’t changed my opinion, recent conversations with clients have led me to concede that I have perhaps underestimated the significance that others place on the ISO clause numbers.It seemed to me that companies (especially those registered to ISO 9001:1994) already had a grasp on the requirements of the standard. Most of the requirements are really just formalized, codified good practices embedded into a generic matrix—things like purchasing, order processing, resources management and whatever activities an organization develops to bring their product (including service) to market. The clause numbers are the construct in which they are arranged. The 2000 version of ISO 9001 does a much more creditable job of arranging them logically than its predecessors did.
With the aforementioned model, inspections would all go under 4.10s. This in turn perpetuates the notion that things like incoming and in-process inspections are a quality control activity and totally unrelated to other processes like purchasing and manufacturing.
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Denise Robitaille
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