Is Inspection Dead?
When ISO 9001:2000 was published, there had been a significant move by many organizations away from inspecting product to establishing process capability. Many of us thought that the process focus of ISO 9001:2000 would encourage organizations that hadn't made this shift to do so. We were correct.
ISO 9001 subclause 8.2.4 requires organizations to monitor and measure product characteristics "… to verify that product requirements have been met…." It also requires that this verification "… be carried out at appropriate stages of the product realization process…."
ISO 9001 subclause 4.1 requires organizations to identify and manage processes, which include monitoring and measurement activities. ISO 9001 subclause 7.5.1 requires that organizations "… plan and carry out production and service provision under controlled conditions…" and provides a list of items needed to achieve this, such as using suitable equipment, as well as monitoring and measuring devices. The capability and effectiveness of these process-control activities should determine the extent of monitoring and measurement of the products and services themselves.
To many, it seemed that these ISO 9001: 2000 revisions meant that the demise of inspection was on the immediate horizon. At the very least, it was assumed that most future inspection would be automated. However, this thinking was wrong.
Entire industries have yet to achieve full process capability and may never make the necessary shift that will enable them to reduce or eliminate product inspection. The nature of some of the industries prevents this in many instances. For example, many processes in the construction industry are hard to standardize and control. In fact, some are still manual-labor processes in which the only controls are the instructions provided and the competence of the worker. In such situations, it's often more economical to inspect or test the product than put forth the tremendous effort required to achieve process capability.
The story doesn't end there. Signs indicate that inspection might return to the world of high technology, where new materials are being created for which no process-control criteria exist and where inspection techniques are still in their early stages. This is seen in such areas as superconductivity and nanotechnology. We're also looking at a future when producing products and services may well go beyond "mass customization" to accommodating the individual whims of each purchaser through advanced product design and production techniques. Of course, such a system of product realization must be "capable," but it will be you and I--the customers--who will "inspect" our own products, verifying that our individual requirements have been met.
Thus, we may well come full circle and return to the protocols of the 1930s, when the only real means of quality control was through product inspection. Industries that have never shifted toward process capability will be unaffected because they essentially do what they've always done: They carry out a process and inspect the result. Organizations with emerging technologies don't have the benefit of this history. Many know that it's better to control the process than inspect the product after the fact. Process control is often difficult, and in some cases the solution is to accept whatever process capability is possible and forego inspection entirely. Naturally, this is a prescription for disaster in a competitive, rapidly changing marketplace. Some high-tech organizations aren't aware of the economic consequences of opting for product inspection rather than spending the time and money to achieve a capable process. Often, they don't understand the consequences of no inspection when process capability is poor.
We've made the changes required to shift from product inspection to process capability, and our standards now reflect that shift. Can we really afford to go through this cycle again? The challenge for quality professionals is to develop standards for process management that can serve emerging technologies. To do this, we must re-emphasize the correct application of product inspection and related sampling standards. ISO TC 69, which considers applications of statistical methods, has spent a great amount of time during the past few years validating, updating and improving the array of international standards on statistical sampling. Many of us were critical of this effort because we thought sampling and inspection were both dead; we were wrong. We're going to need inspection and statistical sampling, perhaps in new and creative forms. Future technologies will depend on it.
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.