Strategic Approach Better for ISO 9001

Albena Iossifova and Kingshuk Sinha are exactly right in “Consultant’s Style: Sometimes Less Is More,” (December, p. 49). In my 18 years of experience with ISO 9001, the tactical approach has always resulted in systems that are merely cost burdens and morale destroyers.

From what I’ve seen, fewer than half the organizations that use the tactical approach eventually become registered, and only at significant ongoing cost. Even if an organization eventually does pass the initial registration audit, customers will recognize it as that same old lousy supplier because nothing has changed. That is why many folks say ISO 9001 based quality management systems are ineffective.

When the strategic approach is used, the registration effort not only does a keen job of establishing logical and effective systems based on the way the organization worked before the registration project began, but it also identifies places where improvements are possible and how to fit them into a revised system effectively.

In 14 years of consulting, I’ve helped about 25 organizations register using the strategic approach, and in each case we discovered and implemented at least one very significant improvement during the project. Such improvements then lead to others, because the first one almost always uncovers small problems formerly hidden by the big problem. All of the clients I’ve helped using the strategic approach became registered and realized enhanced profits.

CHIRP Associates
Kennett Square, PA

Management Must Team With Consultants

Being a management systems consultant, I was very interested in “Consultants’ Style: Sometimes Less Is More.”

A consultant’s approach to documentation development must combine strategic and tactical levels. Unfortunately, many organizations approach implementation of ISO 9001 based systems tactically, meaning senior management involvement (strategic) equates to delegation. Personnel working with the consultant often are lower level managers.

The authors point to research that shows “almost 50% of organizations that used consultants to develop their procedures had to modify the manuals to reduce the size and simplify the procedures.” The research they’re referring to is from November 2000. Let’s be fair—the data aren’t based on ISO 9001:2000. They’re based on the 1994 version, in which organizations and consultants produced hernia style documentation, often through 20 procedures.

Also, shame on management if companies are “very satisfied” with a consultant’s service when the consultant did 75% of the documentation writing. If managers had to “redo their management system” for practicality, it’s obvious managers had no role in the process and did not validate or conduct a reality check with the consultant.

Let’s stop solely blaming consultants. Effective operating systems and documentation require a team effort by the management and the consultant. Never rely on a consultant using a canned approach; and management should acquire process knowledge of the system they’re paying to improve before putting a consultant to work.

Sustaining Edge Solutions Inc.
Tucson, AZ

“30,000-Foot” Full Of Problems

Quality Progress needs to review articles carefully before publishing them. My concern is that people reading about the new Six Sigma Smarter Solutions approach to statistical process analysis and control will accept it as valid. Unfortunately, part of the credibility for this approach has been that it was published in Quality Progress, putting ASQ’s official endorsement on the method and the reasoning of author Forrest Breyfogle.

Below are my comments on Breyfogle’s series of Quality Progress columns, “Control Charting at the 30,000-Foot-Level” (Nov. 2006, Nov. 2005, Nov. 2004, Nov. 2003), which promotes the Six Sigma Smarter Solutions approach.

1. Breyfogle argues there is a difference between Walter Shewhart’s definition of special causes and W. Edwards Deming’s.

I wrote to Donald Wheeler and asked him to comment on this because he taught seminars with Deming from 1981 to 1993. According to Wheeler, Deming said “an assignable cause is a special cause and a special cause is an assignable cause.” You can find this quote in chapter 17 of Wheeler’s The Six Sigma Practitioner’s Guide to Data Analysis along with an excellent discussion on the myths associated with the faulty understanding of special causes.

2. Breyfogle’s example includes both random and systematic causes. The mean control chart is unstable, which indicates that a search for assignable causes is justified. A major part of the unexplained variation observed in the system has been caused by, let’s say, different suppliers. The functional relationship appears as a step function from one lot to the next. The autocorrelation coefficient is high (r = 0.8), indicating the lack of independence between observations. The mean control chart clearly indicates the process is unstable and unpredictable.

Breyfogle says that, in his view, this is common cause variation, which it was before it was determined to be due to different suppliers. It is easy to continue to believe it is common cause variation because this was discovered after it was assigned. However, the instant the cause was assigned it became a special cause. That is, the observed variation moved from the set having unexplained common causes to the set of having explained special causes.

Readers should look at the definition of special causes (see www.wikipedia. org/wiki/common_cause_and_special_cause). This is a cause that was not understood in the system that is now understood and assigned—in other words, a special cause.

3. Breyfogle argues that the X-chart of means is in control and we can therefore make performance predictions and assess process capability.

In reality, the X-bar chart tells us that the process is out of control. It is well known that fraction nonconforming estimates of process capability cannot be made from an X-bar chart. Simply plotting the means on an X-bar chart does not solve the problem. We can talk about past results (which Breyfogle does), but this is no indication of future performance.

Cupertino, CA

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