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The Future of Quality Management Is Business Success, Part 8

Risk and liability are the result of continual improvement done poorly

Published: Monday, August 24, 2020 - 11:02

Each article in this series presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS). They will help implementers evolve quality management to overall business management. In this article we look at the clauses and subclauses of Section 10 of the standard.

10 Improvement

Define “improvement.” In quality parlance it typically means reducing defects and making processes more efficient and mistake-proof. For the CFO it might be improving the return on investment numbers on the financials. For the marketing director it might be expanding market share. For the CEO it might be exceeding the expectations of the board of directors.

The theme of this series includes “presents new tools for increasing return on investment (ROI), enhancing customer satisfaction, creating process excellence, and driving risk from an ISO 9001:2015-based quality management system (QMS).” To conclude the theme, we will look at Clause 10 from a more holistic perspective.

10.1 General

10.1 and excellence

The wording of this subclause begins with “The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.” That is hardly a compelling mandate for excellence. In fact item “c)” implies that the intent of the clause is to improve the QMS not the overall organizational goals.

If quality professionals are to become true champions of continual improvement, we first must determine what “improvement” means to all of the C-level officers of the company, to other departments, to the board of directors, and to other interested parties.

In my last assignment in corporate America, I was manager of training and development for a large multinational company. In the first year, we increased manufacturing production efficiency by more than 30 percent by creating self-directed work teams that were accountable for their own work and to each other.

One fine day, I was summoned to the division manager’s office expecting more accolades about how we had lowered the labor cost in production and test. Instead, I was informed that my job was being eliminated and headquarters had mandated that manufacturing would be outsourced. I began by pointing out the improvements we made that had recently been highlighted in the corporate quarterly newsletter. He leaned over the desk and asked if I knew how much labor cost was compared to overall cost of the product. That question had never occurred to me. It turned out to be 5 percent. All the process improvement in the world would have no consequential bearing on the final cost of the product.

The lesson was that I saw my job through the lens of a quality professional, not as a member of a complex organization that had different definitions of continual improvement.

As I have encouraged several times in this series, the quality policy needs to be replaced by the vision, mission, and values of the principals of the organization. Instead of having process flow charts and quality metrics, there needs to be an organizational flow chart that defines each operational area within the company, how they interact, and how they affect the key performance indicators important to the principals.

Until we, as a profession, move beyond our paradigms and take the initiative to understand how the entire organization operates and how we can contribute more than process improvement to the continual improvement of the company, we will become as much relics as quality control of years past.

10.1 and risk

As part of improvement, 10.1 requires that we reduce undesirable effects. I define the role of improvement as defining foreseeable risk in every process within the organization. For every process step there is opportunity for introducing undesirable effects. Defining them and eliminating them is the essence of effective improvement.

10.2 Nonconformity and corrective action

As with the other composition inconsistencies in the 2015 revision that I have pointed out in this series, I cannot find the logic in “nonconformity and corrective action” being placed in the clause on “improvement.”

10.2.1 and excellence

The content of this subclause defines the reactive mechanics of dealing with nonconformities within business processes. It is certainly good business practice to define the steps of identifying defects, dealing with them, and affecting corrective action to prevent recurrence.

What it lacks is the mandate to mine the treasure trove of information that led to the nonconformity. Whether you call it root cause analysis or the “5 Whys,” even the most trivial nonconformity is the result of a sequence of events that led to an undesirable outcome. Breaking the chain of events down to their component actions is the only way to achieve improvement.

There is inevitably some process step or training element that is not as effective as is necessary for defect prevention. To achieve excellence, each opportunity must be eliminated, not improved.

Early in my career I ran a small electronics manufacturing shop. The assemblers stuffed printed circuit boards with components, soldered them, and then the boards went on to inspection and test. The most common nonconformity was incorrect value resistors being placed. As the parts kits were prepared, they were placed in small envelopes with their ohmic value noted on the envelope.

Carbon resistors are marked with color bands to indicate their value, and it’s easy to misread the bands. I called the assemblers together to brainstorm the problem. In just a few minutes they suggested that instead of writing 100 ohms on the bag, write brown-black-brown on the bag indicating the color code for that value resistor. That way, the assembler would not have to convert color code to ohmic value; they would just look for the correct series of color bands. The nonconformity did not recur. This is a very innocuous example of the difference between corrective action and problem avoidance leading to excellence.

10.2.1 and risk

In the example above, the nonconformity cost time and money to correct. The final testing process would have flagged the board as out of tolerance, and it would not have reached a customer.

In another example, an oilfield service company ordered a replacement valve for a well head. The distributor shipped the valve and the technician installed it believing it to be the correct part. After the explosion that killed the technician, it was discovered that an incorrect valve was in the box. The valve was rated for water pressure not high-pressure oil. The technician did not recognize that the new valve did not look exactly like the old one, threads did not match but installed the valve anyway. That is an example of foreseeable risk combined with incomplete training.

If we are to be the champions of risk avoidance in our organizations, we must learn the concepts of foreseeable risk and incorporate them into every process step and metric.

10.3 Continual improvement and excellence

In my many years of attending and presenting at quality conferences, one of my most memorable recollections was sitting in on a breakout session on continual improvement. Its memorable because at least 30 minutes of the discussion was on why TC 176, the technical committee responsible for the development of ISO 9001, changed the word from “continuous” to “continual” in one of the revisions of ISO 9001. One discussion was that continuous referred to a river that was always flowing and continual was an ongoing activity, but not nonstop. Another theory was that it did not translate well contextually in other languages.

That experience was the beginning of me concluding that many of my colleagues were so invested in the language of ISO-babble and the essence of the requirements that they did not realize what we were trying to accomplish for the good of the organization.

Continual improvement should be defined as constantly raising the quality and reliability of the products or services to the level desired by the principals and demanded by the customers.

10.3 and risk

Risk and liability are the result of continual improvement done poorly. Clause 10.3 is two sentences long and talks only of improving the QMS. Continual improvement must be enterprisewide to avoid risk and liability, not to improve it.


About The Author

Tom Taormina’s picture

Tom Taormina

Tom Taormina is a subject matter expert in the ISO 9000 series of standards, having written 10 books on the beneficial use of the standards. He has worked with more than 700 companies and was one of the first quality control engineers at NASA’s Mission Control Center during the Gemini and Apollo projects. He also is an expert witness in product liability and organizational negligence.