Chapter 13: Leadership

13.1 ISO 9000 Stewardship

Clearly, the QMS needs an organizational home ^[1]. It requires the following:

• Ownership and oversight by top management;

• A way to be created, controlled, and revised;

• Acceptance by all users;

• Evidence that it is worthwhile.

Unfortunately, for most users, the QMS is something that suddenly appears and is overwhelming with its unaccustomed vocabulary and demands. As a result, it is important to create a documentation system that

• Is worth reading;

• Contains phraseology familiar to the industry;

• Is relatively easy to work with (user friendly);

• Truly represents the policies, processes, procedures, and formats of the organization.

For example, in the case of the manual, we have assumed that the manual is actually distributed in such a way that all QMS users can obtain a copy if they so desire. We have found that this is not always the case. We believe it should be, especially as the rest of the documentation system is made available to those users who need them on a daily basis. I find it unfathomable that a document that states the strategic position of the enterprise should be considered not appropriate for the average user to read. Interestingly enough, Par. 5.5.3: Internal communication of the Standard requires that top management ensures that appropriate communication processes be established within the enterprise to alert users on the effectiveness of the QMS. What could be a more effective way to establish a framework for such discussion than a readable, reality-oriented manual?

Our intent is to make the QMS fully compliant with the Standard's clauses so that we gain the benefit of the inherent interplay, whereby one clause either supports or relates to another clause.

In particular, we wish to make the manual fully compliant with the Standard so that it drives all of the other documentation levels in this direction. We want the manual to reflect the organization's dedication to an integrated business/quality theme.

We have found an effective way to ensure that the manual is compliant and distributed appropriately and represents the organization's personality. This is to assign various staff members (stewards) with specific sections of the Standard so that they are responsible for the documentation, implementation, and demonstration of effectiveness of each ISO 9000 clause down through all operating levels of the system. The stewards may take on roles such as process steward, subprocess steward, and section steward. This approach is even more important than it had been in the previous revision because the Standard now requires that quality objectives be established at relevant functions and levels within the organization (Par. 5.4.1: Quality Objectives).

As a result, it is not just that top management establishes quality objectives, but that operational areas also establish objectives that support the top-level objectives.

Multilevel Quality Objectives We will now establish the various roles and duties assignable to the stewards. The requirement for documentation, implementation, and demonstration of effectiveness—that forms the three pillars of ISO 9000—is illustrated in Figure 1.3 and is based directly on Clause 4.1: General Requirements of the Standard, which directs us to create and implement a documented QMS and to continually improve its effectiveness.

The interpretation of this requirement, to the effect that the prime directive of ISO 9000 is documentation, has been the most maligned in both the 1987 and 1994 versions and is already going in the wrong direction for the 2000 version. It is patently not true that the prime requirement in ISO 9000 is documentation. Documentation now is, and has always been, at most, a third of the mandatory directives.

The total implementation of the QMS, and the demonstration that what has been implemented is effective in enhancing enterprise performance, has always been the prime directive. The 2000 version makes this point abundantly clear via its clearly stated requirement to continually improve QMS effectiveness.

From an engineering standpoint, the gain of the system (output divided by input) can be described quantitatively to some degree prior to certification by measuring how close we are to completeness. A gain of near unity (i.e., when we reach 90% of our documentation, implementation, and demonstration of effectiveness goals) can be used to successfully determine when it is time for the initial assessment by a registrar.

At the 90% point, the QMS is fully operational and ready for fine tuning. However, the fine-tuning process is never ending, so it is best to follow the rule of diminishing returns (i.e., move on to other tasks when it takes twice as much effort to go half as far as you previously traveled). When you reach this asymptotic behavior, the QMS needs to be shaken periodically to see what falls out, and that is done through the internal audit process. That is what "taking our temperature" is all about. It is the essence of Section 8 in the Standard, which contains, for example, both the internal audit and corrective and preventive action.

After certification, the gain can actually exceed unity and is based on how well we achieve our quality objectives, which are measured according to metrics that fit our industry. For example, assume that customer satisfaction is our gain measure and the metric is the dollar value of the contract awarded (for each new award) divided by the previous award's dollar value. We could see a dramatic increase in gain if the customer has shifted the previous percentage of awards from 20% to us and 80% to our competitors to 40% to us and 60% to our competitors based on our improved performance. Each enterprise will of course have its own appropriate gain measures and metrics. However, this is a two-way street, and the gain could be less than unity if our competitor is more interested in improved performance than we are.

^[1]Many companies prefer to use other terms such as champion rather than steward. Terms such as process champion and subprocess champion are used. The thought is equivalent—we must have clearly established and committed leadership.