Creating Lean ISO 9001 - Quality System Procedures

Bizmanualz Solutions

In last week’s article I attempted to convince you of the value and sense of a Lean Quality Manual. But, how useful is a Lean Quality Manual if the Quality Management System (QMS) procedures are burdensome books with tons of detail and little value?

Understand the Requirements

The ISO 9001:2000 Standard requires six procedures; Document Control, Record Control, Control of Nonconforming Product, Corrective Action, Internal Audit, and Preventive Action. That is the minimum requirement, but even the leanest of Quality Management Systems will probably need a few additional procedures.

My personal opinion is that a company should always have a procedure for Competence, Awareness and Training to outline their training and skills program. I have found the contribution to the QMS by this procedure to be very valuable. After 25 years of auditing, I have come to the conclusion that the number one weakness of the various Quality Management Systems in North America is Competence, Awareness, and Training.

As I outlined in Part I of this series, other QMS procedures may be needed to bring emphasis to a company’s core business and processes. So for a very Lean QMS there should be six to ten system procedures. Before we discuss how to make the individual procedures more Lean; how about a story?

QMS Out of Control: A Case Study

In 2005 I audited a small manufacturing company in central Illinois who was a supplier for a large defense contractor (which I represented). It was a privately owned company of about 80 employees with the owner as President. This company had been ISO 9001 registered for about six years, initially to ISO9001:1994 and then to ISO9001:2000. After the Audit Opening Meeting and facility tour, I started the audit by checking system procedures.

The Quality Manager indicated that there were two sets of procedures, one set in administration and one set on the shop floor. “Well, let’s go check the set on the shop floor,” I told him. We arrived at a table that had a “procedure manual” that was about six feet long. It had a heavy, solid support on each end with three rods running between the supports where standard holes were punched in 8 ½ x 11 sheets of paper. Pages were placed back to back, and then inserted into a plastic page protector. The page protector was then inserted into the “procedure manual.” The Quality Manager proudly explained that as they added more procedures they could just add additional sections of the three rods to expand, thereby moving the support ends farther apart. Get the picture?

I quickly noticed that Procedures, Work Instructions, Part Drawings, as well as all kinds of other documents were included into this “procedure manual.” I asked the Quality Manager to show me the Document Control procedure. After some searching he could not find it! He told me he was sure it was there…somewhere. Next I asked him for the Internal Audit Procedure. He could not find that! Corrective Action? You guessed it. I asked him if there was any specific procedure that he cared to show me. His response was, “Well, if there was I probably could not find it either.” I did ask him if he understood that the procedures I had requested were required procedures. He said that he did.

We moved to the “procedure manual” in the administration area and I asked if there was someone else who might be able to find these required procedures. He returned with his assistant and informed me that she had been with the company for several years more than his two with the company. (It was Hail Mary time!). After some searching, the assistant could not find the requested procedures in the administration area “procedure manual” either. It wasn’t looking very good for this auditee, and it was only 10:00 in the morning.

Follow-up discussions revealed that they constructed their “procedure manual” under the premise that ISO 9001 requires everything to be documented. They thought their “procedure manual” was what the ISO 9001 Registration Auditor was looking for. Since they had not received any non-conformances to their QMS in six years, they assumed that they were doing the right thing. The fact was, however, that I could not find a single person in the company that used these “procedure manuals.” The belief of the company was that they had to have all those “useless” procedures because that is what ISO required, and they had to do ISO because it was what their customer’s required.

This company had some serious issues with their QMS. Not only did they have specific compliance issues to the ISO 9001 Standard, they had a system that did not provide any real value. They did not know how to use their Quality System, and they did not understand ISO 9001. Their most consistent response to me was, “Well, our ISO Auditor did not have a problem with that.”

Where is your Big Honkin’ Binder?

That was definitely one of the largest “Big Honkin’ Binders” that I’ve ever seen. Imagine, though, if the company had understood that ISO 9001 excellence does not come from lots and lots of procedures. What if they had grasped the concept of focusing on processes and had only six to ten QMS procedures? What if they had thought about providing value to the employees by issuing Work Instructions at the point of use? One thing is for sure; I would not have written nearly as many non-conformances to their QMS.

This story is a great illustration of how “less is more.” Fewer QMS procedures can actually provide more value to the QMS. The same concept also applies to the length of each procedure. The starting point should be to address the minimum requirements for the six required procedures in ISO 9001, and then build on the system as needed for benefit of your organization.

The ISO 9001 Standard does not specify the format of any procedure, nor does it specify a length. All an organization has to do is to meet the requirements given in the standard. Since no one wants to read a procedure “book” or page after page of procedure text, why write them? Why not write one, two or three page procedures? Why not use flow charts or process diagrams? Eliminate lengthy text in paragraph format - no one wants to read it anyway. Using flow charts, process maps, numbered lists, etc…, the information is brief and easy to understand.

A Document Control procedure for ISO 9001:2000 can be done in two or three pages using a flow chart, a document list, an approval block, and allow for revision history. The Records Control procedure can be in completed in three pages, including a Master Records List. The Internal Audit, Control of Nonconforming Product, Corrective and Preventive Action Procedures can all be two page documents

Try it! Change your paradigm and your organizational approach to Lean Procedures. This will reduce cost and you will see for yourself how easy it can be to follow and use System Procedures. You may be surprised that people will actually use the procedures.

Next, in Part III of this series we, will discuss other QMS documentation from a Lean perspective.

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