How does robust process management help you control risk?

This article uses a flow of concepts to show how quality professionals can reduce risks. It includes references to help direct further learning.

First, why is this important? Because every manager needs to help control risk for the organization. Since 2015, ISO 9001 has emphasized risk-based thinking to build more robust quality systems. While a few managers may be asked to take calculated risks, most managers are fully engaged by reacting to issues already present.

This constant reacting forces managers to think fast all the time.[1] Thinking fast allows our hard-wired human biases to take over: seeing what we want to see, taking short cuts that create other issues and detour us, fixing only symptoms, etc. We need to shift our thinking to a slower mode and use questions.

A questioning attitude is part of what makes a good quality manager (or auditor, or engineer.) You see this attitude more often in experienced employees. They have been around and know that a question at the right time is better than 100 statements. Not all questions are useful, but asking no questions is a pathway to disaster. This means judgement is needed after the question is asked, and logic/ systems thinking[2] will help weed out the poor questions.

A method we use to reduce risk is to deny the existence of a specific risk. You see this all the time. Health care workers who smoke, experienced drivers who speed, bosses who brush aside concerns, we all do it. Some of us have been doing it so long we have built up a robust process of denial. Statements like “it has worked well for years” or “if it isn’t broken, don’t fix it” support this denial. It becomes a habit, part of the work culture. If denial is part of the culture, we often do not even notice it!

One way to find hidden risk to ask, “how can this fail?” There is a tool we use in quality management called Failure Modes and Effects Analysis, FMEA for short.[3] This uses an act of imagination by asking how a process or product may fail under common and/or atypical usage. This is a hard step to take, and you need the questioning attitude mentioned above to do it well. You may have other resources to identify modes of failure: if you have had past problems, look them up. Ask your long-term employees (especially those lower in the organization who are closer to the real work) and see what they remember. If you have a “lessons learned” file, use it! Also, there are creative thinking techniques that allow an FMEA team to anticipate a wider variety of problem situations. Missing a failure mode that occurs later can be costly.

FMEA will help you find and fix the worst future risks. It uses a prioritization matrix to find the most severe, the most common, and least controlled issues. Having a long but prioritized list lets the matrix sort out the ones you need to worry about. Then, work the list and mitigate issues from the worst downward until you feel you have done enough.

Next, you need to apply robust Root Cause Analysis (RCA)[4] on a regular basis to get at deep systematic causes of surfaced problems. We often stop problem investigations when we find physical causes, but the problem comes back when a different physical cause is driven by an unanticipated system cause. (Let us not even mention “human errors”, that is another article!)

This ongoing RCA effort may lead to improvement loops, like Plan-Do-Study-Act (PDSA.)[5] Some people know this from Six Sigma’s define-measure-analyze-improve-control (DMAIC.) PDSA goes a step beyond DMAIC by using a continuing loop. Once the fix is in place, you start the loop again. Six Sigma projects do not always continue the improvement. They are too often seen as projects with a beginning, middle and end.

Applied by empowered employees, PDSA loops let you grow your way out of problem swamps, using low cost and intelligently applied mistake proofing. The application of the Japanese idea of small- step improvement kaizen (not the American ‘tear- it- up- and- fix- it’ kaizen blitz events) allows continual process improvement with less disruption and reduced financial investment.[6]

There are few quick answers, and most quick fixes are probably wrong for your situation. Applied common sense and logic are the mature way to drive improvement. Any manager may do this, but a qualified quality manager will certainly do it. To see what a qualified quality manager should know, see the ASQ Certified Manager of Quality/Organizational Excellence body of knowledge.[7]

Finally, I believe there might be a problem with using the phrase ‘quality management.’ Traditionalists may disagree, but our concepts do evolve, and so should our language. ‘Quality control’ became ‘quality assurance’ then ‘quality management.’ As quality planning links to quality control, and then to quality improvement, we look more and more at process planning, process control and process improvement. What will happen if we start using the term ‘process management’ to refer to the activities we have been calling ‘quality management’? It is worth a thought.

[1] Kahneman, D. (2015). Chapter 1 "The Characters of the Story". In Thinking, fast and slow (pp. 24-30). New York: Farrar, Straus and Giroux.

[2] Senge, P. M. (1990). Chapter 4 "The Laws of the Fifth Discipline". In The fifth discipline: The art and practice of the learning organization (pp. 57-67). New York: Doubleday.

[3] Stamatis, D. H. (2003). Failure mode and effect analysis: FMEA from theory to execution. Milwaukee, Wisc., WI: ASQ Quality Press.

[4] Okes, D. (2019). Root Cause Analysis, Second Edition: The Core of Problem Solving and Corrective Action. Milwaukee, WI: ASQ Quality Press.

[5] Imai, M. (1997). Chapter 1 "An Introduction to Kaizen". In Gemba kaizen: A commonsense low-cost approach to management (pp. 4-7). New York, NY: McGraw-Hill.

[6] Duffy, G. L. (2014). Chapter 2 "Continuous versus Breakthrough Improvement". In Modular kaizen: Continuous and breakthrough improvement (pp. 15-25). Milwaukee, WI, WI: ASQ Quality Press.

[7] ASQ. (2019). CERTIFIED MANAGER OF QUALITY/ORGANIZATIONAL EXCELLENCE [Brochure]. Milwaukee, WI: Author. Retrieved July 09, 2020, from https://p.widencdn.net/9ujgls/cmq-oe-cert-insert