Evolution of Risk Management in Quality Systems
For me, quality management isn’t just a profession—it’s a passion. My journey began during the 1980s military surge, where I served in defense, nuclear, and aerospace sectors. Over time, I’ve witnessed the ebb and flow of quality processes in various industries. My entrepreneurial spirit led me to launch a total quality business in 1989, coinciding with the rise of ISO standards like ISO 9001, 9002, and 9003 in North America.
Previously, companies juggled multiple quality manuals, each catering to a distinct certification agency. How times have changed! Today, businesses streamline their processes, integrating customer demands through systems like ISO 9001 and AS 9100.
Our focus back in the 1980s was on statistical tools like x̅ and R charts, and the fish-bone method for problem-solving. Intriguingly, these foundational techniques are making a comeback, now under the umbrella term “Risk Analysis.”
Ask any employee today about x̅ and R charts, and you might be met with blank stares. But mention ISO 9001 or Risk Analysis, and recognition is immediate. It’s intriguing to draw parallels between then and now, to observe the growth and change of methodologies. While the 1980s emphasized problem identification and resolution, our modern approach is more proactive. We address potential hiccups right at the onset, thus keeping the proverbial “horse before the cart.”
But why did the 80s techniques not seal the deal? Three reasons:
- Skyrocketing costs due to repeated errors.
- Time constraints affecting customer retention.
- Ever-evolving production processes.
Fast forward to today—our world is teeming with smart devices, robotic manufacturing, and shifting global economies. Still, quality remains a challenge. We’ve recognized that as technology advances, processes evolve. Hence, the pivot from reactive “quality control” to proactive “quality management.” This transition is most evident with the inception of Risk Analysis, sparked by the new ISO9001:2015 standard.
Could our age-old tools from the 1980s be repurposed for today’s challenges? Understanding our operations, pinpointing risk factors, and establishing precise metrics will facilitate better quality control.
Let’s envision a system reminiscent of homeland security: a green-orange-red alert system. The goal? To develop a mathematical model tailored for each process. This isn’t about finding the perfect solution but about consistency in application.
ake the fish-bone diagram, for instance. Combining this with Internal Process Auditing Techniques, we can both identify and quantify potential risks in a process. This methodology can be enhanced through software, such as CIS Continuous Improvement Software integrated with ChatGPT, which we offer.
Incorporating a risk rating method, like the one suggested above, is just one step. The dynamic nature of industries means that our risk assessments will remain fluid. Routine audits, corrective measures, and subsequent evaluations can lead to improvements in the overall risk profile of a process.
In summary, coupling time-tested tools like fish-bone diagrams with advanced software can meet the rigorous demands of standards like ISO 9001:2015 and AS 9100. For efficient real-time assessments, I recommend platforms like CIS Continuous Improvement Software, which dynamically showcases an organization’s risk status.
About the Author
Peter Sanderson is the founder of TQMS Inc. and creator of CIS Software. With over 30 years of experience in ISO 9001 and quality management systems, he specializes in helping organizations implement practical, results-driven continuous improvement processes. His work has been featured in Quality Magazine, Quality Digest, and IWLA publications.
