03.30ISO 9001 Myth #2 – “Say What You Do & Do What You Say”
A second myth that plagues ISO 9001 implementation efforts is the cliché “say what you do and do what you say.” While the first myth is responsible for misconception regarding the amount, structure, and format of documentation needed for ISO 9001 certification, Myth #2 misleads organizations as to the purpose and true intent of ISO 9001. In a nutshell, if a company isn’t effectively meeting customer expectations and isn’t achieving its other business goals and objectives, then saying what it does and doing what it says is irrelevant.
Believing they must write down everything they do, many companies engage in a massive documentation exercise. “Say what you do and do what you say” has led companies to the misconception that their mission in implementing ISO 9001 is to document everything that everyone does; and that the resulting documentation will adequately and even impressively represent how the business operates. While implementing ISO 9001 is a time to document how you do business, it’s not a time to illustrate every possible detail of the company’s daily activities.
The fact is, having every activity in the company documented (e.g. detailed work instructions) doesn’t ensure these activities are actually performed effectively, efficiently or even consistently. Paper is not a replacement for motivated, competent, and capable employees who work within a well-designed process.
Furthermore, by assuming “say what you do and do what you say” implies that more documentation is better; companies often paint themselves in a corner. Frequently they develop sets of procedures that actually stifle the creativity and flexibility of a talented workforce. In our ISO 9001 consulting practice, we typically see this scenario at clients that have an ineffective human resource development process (e.g. training, competency development, etc.) and have tried to compensate by developing detailed work instruction and other documents for every activity.
A successful ISO 9001 implementation should begin with the identification and rationalization of KEY business processes (not procedures). Developing an ISO 9001 quality management system presents a company with the occasion to bring key business processes to light and represent them in a way that is understood clearly by everyone in the company. To put it simply, you need to be focused on value-added content when creating your ISO 9001 documentation, not just large amounts of content.
To begin with, the minimum requirement for ISO 9001:2008 is a quality manual, six documented procedures (I call these support processes), and 21 records. This requirement does not assume any particular organizational size or complexity, so it stands to reason that even large organizations could potentially develop a fairly lean set of documents. It’s also possible for a smaller organization to have fairly complex operations, resulting in more documentation. In my experience, every company will exceed the minimum ISO 9001 documentation requirement.
Keep in mind that many processes and systems in your business are not unique. How you manage them and their interaction with unique processes defines your business operating system. The ISO 9001 quality management system simply provides the foundation and structural framework on which to build your business operating system.
ISO 9001 doesn’t require a high level of detailed documentation. Instead, the intent of ISO 9001 is to first accurately describe the processes which make up your business operating system and demonstrate their relationship to and interaction with one another. The second intent is to demonstrate that your business operating system is effective at exceeding customer expectations and meeting internal business objectives. If you cannot clearly and positively demonstrate that you have fulfilled these two intents, then saying what you do and doing what you say does not matter.
Please stay tuned for my next installment in this ISO 9001 Myth series: “ISO 9001 Myth #3 – Failing ISO 9001 Certification.”
Kirill Liberman, President
Kirill,
Thank you for contributing to the better understanding of the intentions behind the ISO 9001. I completely agree with the fact that “say what you do and do what you say” principle is not sufficient for a correct QMS implementation, is often interpreted literally and used as the implementation guideline.
My interpretation was that the phrase was a guide for basic integrity. The QMS documentation should be a truthful representation (not necessarily “overburdened with detail”) of all processes within a QMS and the processes should be executed according to the documentation. Perhaps a better formulation would have been “Do not say what you do not do and do at least what you say”.
February 11th, 2010 at 11:34 am
Thanks for the thoughtful comment, Eugene.
I think one of the problems that companies face is the lack of understanding the difference between a process and procedure. ISO 9001 contributes to this problem by using the word procedure, when it really means process.
If one focuses on the process, then he/she can clearly assess when/if a detailed procedure/work instruction is really needed.
Great to hear that you are beyond this problem.
February 11th, 2010 at 12:16 pm
You started my morning with a good laugh. We supply material to a major diagnostic kit manufacturer that has indeed painted themselves into a corner.
We recently received a flurry of e-mails and phone calls regarding product stability, testing procedures, etc. for a product we have supplied one customer for nearly 20 years. It was subsequently revealed at a scientific meeting that their manufacturing protocol references an additional testing procedure that could not be located in paper or electronic form. Production had continued for months (or perhaps year), records were signed and reviewed, and material released, with no evidence that this “required” procedure was followed. I know this scenario is not unique to this specific company and occurs throughout the diagnostic and pharmaceutical industries (a frightening thought).
Document bloat hinders response time to effectively address changes in processes. Employees do not wish to initiate necessary changes (or point out errors) due to the bureaucracy required to track all the current and broken document links. It is easy to blame such situations on poor training, but the reality is counter intuitive. It is the documentation overhead (in effect, over-documentation) that provides an environment where activities are not performed effectively, efficiently, or consistently.
Thank you for pointing us down the right path last year!
February 11th, 2010 at 12:27 pm
What a great example, Greg. Thanks for sharing it.
I had a similar laugh this week when I provided a Lean QMS demonstration to a perspective client. I began the demo with my usual debunking of the ISO pyramid (see Myth #1). But then I found out that this company already has the whole pyramid in place and only wanted Pinnacle to do a gap analysis against ISO 9001. I am still trying to get my foot out of my mouth. They literally stated that they already had thousands of documents. Although I showed them a better way, they can not consider it because the burden of dealing with the “documentation overhead” is too great. What do you think I am going to find during the gap analysis? (rhetorical question)
February 11th, 2010 at 12:47 pm
Yet another reason of why boiler templates to meet ISO certification are cumbersome and overbearing with documentation since most of them do apply this cliché.
It’s true that many companies initially implement ISO documentation overload when the true intent of ISO certification is to improve the business not burden it.
A document heavy system can be very difficult to maintain and train fellow employees. Not to mention the time vortex for the Quality Manager.
February 11th, 2010 at 3:25 pm
Great point, Dave. I still wonder how companies can afford to keep such systems and continue to pay for having them certified.
February 11th, 2010 at 3:36 pm
Hi Kirill
A nice piece of “MythBusters” presentation. I’ve audited many companies with hundreds of 1-2 page procedures. One example I remember was a company with 12 one page procedures for purchasing. One page to do this and one page to do that, etc. Trying to line these one page procedures together for a systematic flow was next to impossible. Each person had their own procedure for what they did, almost unmindful to each other in the department. They basically couldn’t see the forest for the trees. This clearly showed that mgmt did not understand the interactions (cause and effect) of how a key process worked. If they understood how the total purchasing process worked / interacted, this could have been an easy one 5 page document, and if they did a detailed flowchart, this could have been a one or two page glance, understand, and go procedure.
To get a better understanding of your concepts, any chance of you sending me a (what you call good) copy of a Quality Manual?
Chuck
February 12th, 2010 at 8:01 am
Great example, Chuck. I also see this often.
I also see many clients that have a lot of text-based documentation that actually says very little that is really useful or actionable. This is common when clients either buy a canned ISO 9001 documentation package or use a consultant that uses a canned “cookie cutter” approach. It seems to me that this stems form ISO 9001 certification being driven by a marketing need. Some companies fist get into ISO 9001 implementation just to get the certificate and view it as overhead or “cost of doing business.” Years later most discover that they missed an opportunity to get a value added management system. This is when Pinnacle’s consulting and Lean QMS come in. Perhaps I should be thankful for all the myths and misconceptions. 🙂
As for an example of my Quality Manual, you can see one here: http://www.pinnacleeg.com/sspqms-lean-qms-curriculum.php/page/services/service/leanqmscurriculum#leanqmsmap
February 12th, 2010 at 8:24 am
Hi, Kirill.
I’ve had personal experience with a quality system that has massive documentation. It might “say what you do and do what you say,” but even FINDING what you said you did could be problematic! I much prefer lean systems – they allow, even encourage, the natural changes that occur in any organization. The traditional, Draconian systems of “say what you do and do what you say” too often become “we do it that way because that’s the way we’ve always done it.”
February 12th, 2010 at 11:13 am
“we do it that way because that’s the way we’ve always done it” is a great quote, Mary Lynn. Another good one would be “we do it that way because that’s what it says to do.” Never mind that it does not work.
Thanks.
February 12th, 2010 at 11:19 am
Hi Kirill,
As an ISO 9001 QMS Lead Auditor for a major registrar, I may be able to shed some light on this issue that is very close to my heart. You see, after more than 15 years of conducting external audits for ISO 9001, I have found that, in general, most companies at best “tolerate” the need to document their processes but do not “celebrate ” that they get to document their processes. Frankly, it is somewhat sad that the senior managers of these companies still have not fully captured the benefits of documenting all core and support processes. As a result, I have found that the majority of the documents that they “tolerate” (for ISO 9001 certification) become old and dusty shelf-ware that nobody reads (unless they are cramming for another audit). Hardly, do I find that they have come to embrace the documents as part of their company’s DNA and see them as a strategic value tool for the company. This bodes well for true-blue Pinnacle clients that, from an auditors standpoint, can see and appreciate running an operation with a Lean QMS format. I really believe that we have come to a time that, to be honest with ourselves, we cannot and should not expect great companies to desire a lot of text (old school) procedures that do not even come close to depicting reality of the processes. At today’s pace, and the need for 100% on time delivery performance and perfect quality products, who has time to read old and dried up procedures that I would not allow my old grandfather to read. As an auditor of the Lean QMS documentation, I believe that this kind of product is what every company needs as it does not waste people’s time and somehow manages to live up to the title of this topic – “say what you do” and “do what you say”! The good news is it is affordable and like me most auditors actually prefer it.
Tim
February 19th, 2010 at 3:24 pm
Hi Tim and welcome back to the blog.
Thank you so much for your contribution. It is so important to hear your perspective as an ISO 9001 Lead Auditor.
I am also frustrated by the missed opportunity I see at so many companies. I am even more frustrated by fellow consultants that inflict their misinterpretation and misapplication of ISO 9001 on unsuspecting clients.
I hope you will comment on the next installment of this series called “ISO 9001 Myth 3 – Failing ISO 9001 Certification.” It will deal directly with the misconception that ISO 9001 Lead Auditors are in the business of failing their customers. I am sure readers of this blog would appreciate hearing your first-hand perspective.
Thanks again.
Kirill
February 25th, 2010 at 1:26 am
As a registration auditor it concerns me that people are still thinking that if there is a full detailed step by step procedure in place they will be a more successful company. To date I have never seen a company hire an unqualified person without any experience in to a job, give them the “procedures/work instructions” without any other support or direction and then expect them to do a great job.
Procedures are intended to be what is necessary to support the process. They vary from company to company, industry to industry. As is identified above there is a limited base requirement of what needs to be addressed in a written document (procedure/work instruction) but the system is to focus on the process’s customer satisfaction. This means that the only way to say that documentation is not adequate is by reviewing the process measures, if the process is constantly failing to meet it’s objectives than one possible, potential cause “may” be that documentation “may” need to be addressed.
Documentation does not assure success, processes that prevent failure assure success.
June 20th, 2011 at 10:36 am
You make another great point, Dan. Thank you again for your perspective. It is so important to hear form objective and experienced ISO 9001 Lead Auditors like you.
All too often ISO 9001 certification is not much more that a documentation exercise. I cannot count how many times I have encountered clients, consultants, and auditors that simply have not made the mental shift to a true process focused management system. To this day, I even work with Fortune 500 companies that have embraced Lean Six Sigma process improvement methods, while still maintaining ISO 9001 Quality Management Systems that are traditional documentation pyramids. Even these companies often fail to make the link between there ISO 9001 based management system platform, their true business operating system, and the culture of continual improvement. This was the subject of my “Improvement Initiatives Are Like Diets” and “Integrated Management System” articles.
Kirill
July 17th, 2011 at 11:03 am
I would comment on one thing:
“The second intent is to demonstrate that your business operating system is effective at exceeding customer expectations….”
The intent is to “meet” expectations, not to exceed. This is an important distinction, as it is an unachievable long-term goal (quantifier and qualifier model) and leads to unnecessary increase in costs. When I go to McDonalds and order a hamburger, I am not expecting much, but if I get what I expect – I’m happy.
February 1st, 2012 at 11:59 am
Thank you for the comment, Kevin.
The stated requirement of ISO 9001 is to “meet” expectations. However, if you peel the onion on ISO 9001 clauses 7.2 and 8.2.1, the intent is to exceed them. Even in a retail example like McDonald’s your expectation are not that simple. Sure you can get a burger, but if you got a treat, a smile, and a pleasant atmosphere, your expectations would be exceeded without you even knowing about it. It is a matter of stated vs. implied requirements. McDonald’s knows this. This is why, when it relates to the burger, they only care about the consistency of the taste (not the quality). But they focus much more on the McDonald’s experience.
ISO 9001 clasue 8.2.1 specifically requires a compnay to measure customer “perception.” This is an important word becasue a customer’s “perception as to whether the organization has met customer requirements” cannot be measured with indicators like rejects, complaints, and returns. These are meausres of customer dissatisfaction. I think we can all agree that there is more to customer satisfaction than what is stated in the PO or contract. So while we must at least “meet” the specifications in the PO or contract, we must also strive to “excueed” the unstated cusotmer expectations (requirements).
I hope you will come back to the blog and share your perspectives again.
Kirill Liberman
February 1st, 2012 at 3:02 pm
While I agree with the fact that this “Say what you do, do what you say” meme is flawed and dangerous, this article does not clarify the process approach, and instead may add more confusion.
At one point you say that “key business processes (are) not procedures.” Then you say the six documented procedures are “support processes.” Finally, you say “ISO 9001 contributes to this problem by using the word procedure, when it really means process.”
You have three cases where you cannot seem to agree whether you think a process and a procedure are the same thing, or something entirely different. And this problem plagues the industry, and has since 2000.
As a member of the US TAG that wrote the standard I can tell you that processes and procedures are two different animals entirely.
First, note that wherever the ISO 9001 standard uses the word “procedure” in does so as a two-word phrase: “DOCUMENTED procedure.” Therefore, any time the standard references a “procedure” it means a document.
This is not true of the word “process” which is an activity… it is invisible, conceptual. “Production” may be an idenfitied process (because it occurs), and I might then choose to support it with a number of documented procedures; but even beore I ever write a procedure, the Production process exists regardless.
Processes may be supported by a documented procedure, or not. You may require a procedure for how to train new employees in support of a key process called “Training.” But you may not require a documented procedure on how to file the records, since filing is such a mundane task, it hardly requires a document telling someone how to put papers in a drawer.
Process are identified, typically as a list or set of maps, in the Quality Manual, with their sequence and interaction. Processes then must be mangaed in accordance with 4.1, including the establishement of methods to measure and analyze them, and to apply resources.
They are a higher-level concept than a procedure, which requires none of those things. Procedurs instead are managed under 4.2… not 4.1.
In short, procedures are written documents developed to support “conceptual” processes, which are activities — not documents.
May 1st, 2012 at 2:08 pm
Welcome to the Blog, Christopher. Thank you for your comments.
I welcome and appreciate your constructive criticism. I hope you will take my response, in the form of an article titled “ISO 9001 Myth #5 – Process vs. Procedure,” in the constructive spirit it is intended.
Thank you also for your volunteerism on the US TAG. In the spirit of keeping the information on this blog factual, I must note one correction. US TAG did not write ISO 9001, as you claim.
I noted that the tagline for you consulting practice is “Rapid ISO 9001 & AS9100 Implementation Services…” Perhaps after you review the Myth #5 article and some of the other information on our website, you will conclude that speed is not the main goal of a value-added ISO 9001 consultant. We can get our clients ISO 9001 registered fast, but without sacrificing the value of a QMS and the true potential of an ISO 9001 platform.
I hope you will visit and contribute again. Perhaps we can both broaden our perspectives.
Kirill Liberman
May 10th, 2012 at 6:22 pm
Myth 2, writing things down, is not an outcome, its a means to an end. Especially in organizations that don’t write anything down, or don’t do it when they should, doing so can have enormous benefits. Just because overdoing it has downsides does not erase the benefits of doing it properly. I’ve personally seen what occurs when something as simple as writing down specifications brings out important issues, conflicting definitions and distinctions that people had for decades and were never expressed or resolved and were clearing holding back progress. Six Sigma does a nice job of organizing the “voice of the customer”, key performance indices and other elements of making improvement happen. Process mapping is also a useful exercise which helps under stand how that is different from a procedure.
August 3rd, 2022 at 12:25 pm
Thank you for contributing to our blog, Dan. Your comments are very helpful. I hope you will visit and contribute more often.
Kirill Liberman
August 3rd, 2022 at 12:36 pm