By Tom Taormina
Editor’s note: This is the second of three articles in a series defining a new approach to quality management for conformity-assessment professionals. You can read part one here. Look for part three in the coming weeks.
In commonly accepted legal parlance, defining quality means “fitness for intended use.” Nothing more, nothing less. That definition is elegantly simple, yet we are disposed to attempt to qualify it with a myriad of modifiers and conditions. Let’s use that lens of “fitness for intended use” to examine the litany of definitions we throw around every day. A product or service that is of poor quality is unfit for intended use. A product or service that is of acceptable quality is fit for intended use. A high-quality product or service is still just fit for intended use.
In dispositions of detected nonconformities, “use-as-is,” “rework-to-print,” or “repair” define the product as fit for intended use. Scrap denotes that the product is not fit for intended use. A disposition of “accept with concessions” should be an alarm of foreseeable risk. Again, in legal terminology, “foreseeable risk” is when a reasonable person in any given situation should know that specific harm might occur because of their actions. Anything less than unqualified fitness for intended use takes us into the murky world of risk management and risk-based thinking. By definition, any process, product, or service that has a predictable risk is NOT fit for intended use.
The postulate to the definition of risk being “fit for intended use” is that no critical defect ever reaches a customer. Again, this flies in the face of conventional wisdom that zero outgoing defects is unattainable. If Shewhart, Deming, and Juran could have seen the future of technology and product complexity they might have extrapolated that process variability is a foreseeable risk and can be AVOIDED instead of managed. Again, the simply elegant solution to process variability is stopping defects from moving from one process to the next. The tool is replacing process conformance with process excellence and replacing risk management with risk avoidance. We will discuss this in detail later.
The call from an attorney
One day, about 20 years ago, I received a call from a local attorney. He was involved in a lawsuit that he presumed was precipitated by a quality control issue. He asked me to help determine if the defendant caused the defect to occur. After reading through mountains of documentation, I requested a copy of the quality manual for the plaintiff company. It quickly became apparent that I was performing a QMS desk audit, which I now define as a forensic business audit. It was clear that the plaintiff was not following their own procedures, specifically in supplier control, incoming inspection, and final inspection. In a federal court, the defendant was found not guilty of “an unacceptable standard of care” in manufacturing and selling their products. The term “unacceptable standard of care” simply translated as unfit for intended use.
Forty-plus cases later I have formulated my conclusions there is no such thing as an acceptable defect level. I have seen pictures of dead people who were using a product that was not fit for intended use when it was sold, yet it passed the manufacturer’s standards of product quality. Under the veil of an acceptable defect level, people died or were permanently injured because of ineffective quality management. In other cases, great human (not to mention financial) devastation was created by a product that fit the definition of acceptable quality level.
In part three we will present the new gold standard for the quality professions.
About the author
Tom Taormina, CMC, CMQ/OE, was one of the first quality control engineers at NASA’s Mission Control Center. He supported all 17 Apollo Moon Missions. He went on to run three manufacturing companies successfully replacing QC with self-inspection. Over the last 50 years, he has worked with more than 700 companies as a consultant, auditor, and trainer. He has trained scores of QMS auditors and conducted hundreds of audits. For 20 years, he has provided expert witness testimony in more than forty lawsuits. Taormina is the former Chair of ASQ QMD Quality Management Systems Committee. He has published 12 books on quality management.