Making Products Better
I‘m often told that ISO 9001 requires organizations to improve their quality management systems (QMS), but not the quality of their products. Certainly, when you read the clause about continual improvement, you could get that picture. In fact, the clause doesn’t refer to the product at all.
ISO 9001 subclause 8.5.1--”Continual improvement,” states: “The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.”
During the past several months this column has reviewed the requirements in ISO 9001 related to quality planning. If all of them are followed and the resulting plans are faithfully executed, the result should be consistently conforming product. But suppose the organization receives complaints that its product doesn’t consistently meet customer requirements, and suppose that these complaints are valid. Is product improvement required in such a case? In fact, from the customer’s perspective at least, the answer is a resounding yes . If the organization fails to consistently deliver conforming product, there is clear evidence that QMS effectiveness must be improved.
We should all agree that, at the very least, we must improve the effectiveness of the system if we find ourselves not consistently delivering product that meets customer requirements. Actions to improve the system could include adding inspections or cross-checks to make certain that the product or service conforms before the customer receives it. Or the improvements could be fundamental process changes that prevent nonconforming items from occurring. These requirements seem evident from the clause about continual improvement alone. When we look at the clause about corrective action, it becomes clear that the causes of such nonconformities should be addressed.
ISO 9001 subclause 8.5.2--”Corrective action,” states: “The organization shall take action to eliminate the cause of nonconformities to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered…”
But suppose the product design itself is the root cause? For example, a little-used but required feature of the product or service might not perform as specified. Suppose it isn’t possible to correct this situation by changing the product- or service-delivery process? What, then, are we required to do? A simple answer might be that the design itself must be improved so that the feature will function as required; however, some argue that the design itself isn’t part of the QMS but, rather, an output. With that view, it would be adequate to take corrective action on the design process to prevent future, similar nonconforming features.
What about customers who need the nonconforming feature to work? The corrective action clause doesn’t exclude issues related to nonconforming designs. What to do? ISO 9001 offers an answer by suggesting that such issues be handled during the management review process.
ISO 9001 subclause 5.6.3--”Review output,” states: “The output from the management review shall include any decisions and actions related to
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements , and
c) resource needs.”
This little subclause is the only place where ISO 9001 directly addresses improving the product itself and not just the QMS or its processes. It clarifies that there’s no intent in ISO 9001 to address improving the product beyond the point where all customer requirements are met. On the other hand, if the product itself doesn’t conform, it should be subjected to the improvement process.
Why, you might ask, would this issue be directly dealt with only in the clause about management review? It simply means that such issues are important enough that they should be brought to the attention of top managers for discussion and decision during the management review. Often problems such as infrequently used features that don’t work correctly are nearly impossible to fix, but the issue is left to lower levels for decision. Top managers may be unaware of it until a precipitous loss of market share drives the issue to the top.
So, are we always required to improve a nonconforming design? I would say we should do so if the improvement is feasible. In any event, ISO 9001 does drive the decision to the top, where such decisions belong. These decisions may have long implementation times and require significant investment of both human and capital resources ¾ decisions that, typically, are the domain of top management.
John E. (Jack) West is a consultant, business advisor, and author with more than 30 years of experience in a wide variety of industries. From 1997 through 2005 he was chair of the U.S. TAG to ISO/TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 series of quality management standards. He remains active in TC 176 and is chair of the ASQ Standards Group.
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