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Tom Taormina

Customer Care

The Future of Quality Management Is Business Success, Part 7

Clause 9 of the standard can truly quantify business excellence and risk avoidance

Published: Monday, July 27, 2020 - 12:03

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 9 of the standard.

Clause 9—Performance evaluation

Clause 9 is the part of the standard that we can use to truly quantify business excellence and risk avoidance. I will propose paradigm shifts that will make the outputs of this clause more informative for senior management and will include actionable recommendations that can contribute to the success factors that are immediately palatable and implementable for the leadership.

9.1.1 Monitoring, measurement, analysis, and evaluation—General

9.1.1 and excellence
This subclause requires that the organization must establish what needs to be monitored, measured, analyzed, and evaluated.

Process metrics and personnel-competence evaluation typically are compared to control limits and minimum performance standards. Processes operating within control limits reduce variability and should prevent nonconformities. This is an opportunity, however, to go back to 9.1.1 and recast the metrics to measure performance to continual improvement goals. In the evaluation and analysis process, the data must yield challenges for the process owners to continually hone their practices, include the tenets of risk avoidance, and raise the bar of excellence.

When measuring personnel performance, the roles and responsibilities must include the title of the role and the responsibilities of the person performing the job. The responsibilities are the minimum acceptable outcome, but they, too, should be analyzed for raising the expectations to excellence rather than conformance. Most important is that every individual performing that role needs to be evaluated and confirmed as competent to perform the job. Individuals may have many roles they can perform, but training should drive the level of performance in a continual positive direction.

The most productive environment for process excellence is having incentives for process improvements and consequences for nonconformities. The most productive personnel-reward system has a base salary tied to learning a new skill as the only basis for raising base salary. That is complemented by individual and group incentives that only get reward if there are zero nonconformities.

9.1.1 and risk
Again, we need a paradigm shift when determining monitoring, measurement, analysis, and evaluation to include foreseeable risk. Although launching the space shuttle Challenger in temperatures that were below the control limit is the most dramatic example of the disastrous outcome of ignoring foreseeable risk, each process within your organization has the potential to create risk and liability. Process operators must be trained on what foreseeable risk is, and their operational procedures must include scrutinizing outcomes for foreseeable risk.

9.1.2 Customer satisfaction

9.1.2 and excellence
The standard devotes only two sentences to what is perhaps the most meaningful metric of business success: Satisfied customers are what keeps you in business and on your success path.

Score cards from your customers are not the answer to becoming better at your craft. Neither are golf outings or customer appreciation parties. Least effective is feedback from the sales force.

Within your organization, there needs to be a specific role of voice of the customer (VOC). That role includes researching customers and how they use your products and services. Then, the VOC rep should schedule face-to-face interviews with customers, asking questions just as you would for an internal audit.

The questions should elicit customers’ evaluation of your products or services as well as their suggestions for improvement. In companies that lead their field, some that I have audited also invite their customers to design review meetings and product development sessions. I discussed this in some detail in part 6 of this series in the section under 8.2.1.

The data generated from VOC efforts are akin to a bar of gold in terms of their value to your organization.

9.1.2 and risk
The VOC rep is also the first line of defense for defining potential liability. Customers that will not participate in the VOC program may be dissatisfied with your organization or, worst case, be getting ready to sue you.

During the interviews with willing companies, you may find potential risk opportunities that have not yet materialized and take corrective action to avoid risk.

9.1.3 Analysis and evaluation

9.1.3 and excellence
This subclause requires your organization to analyze and evaluate appropriate data and information arising from monitoring and measurement. We covered what data to collect in 9.1.1 and how to collect it. How we analyze it requires a clear focus on how it contributes to business excellence.

Analyzing and evaluating the effectiveness of the QMS is only meaningful if it is contributing to the organization’s overall strategic goals. The same is true of the other six requirements of 9.1.3.

9.1.3 and risk
Foreseeable risk must be included in every aspect of analysis and evaluation. Those doing the assessment must be skilled in identifying unforeseen risk opportunities in their processes.

One case I worked involved a boom box that caught on fire and caused the deaths of several people. As with most appliances, the main power was on all the time to allow the remote controls to work. The root cause was traced to the power supply circuit board. The AC power cord was terminated in crimped eyelets. The eyelets were then soldered to the circuit board.

From my experience teaching 40-hour soldering school classes at NASA, along with the electrical expert, we concluded that soldering a crimped connection destroyed the integrity of the crimp by heating the eyelet. Eventually a resistive joint formed inside the eyelet until the carbon buildup reached combustion temperature. That was just poor engineering.

The foreseeable risk opportunity for the manufacturer was not finding an overt risk prospect staring them in the face. The circuit board was mounted vertically. In evaluating the fire-retardant properties of circuit boards, vertical flame tests are performed. If the board had been mounted horizontally, the catastrophic outcome would likely have been avoided.

9.2 Internal audit

9.2.1 and excellence
I have written extensively about and taught that the ISO 9001 internal auditing scheme is the most effective tool an organization can implement. Proactive and nonconfrontational “interviews” with process owners and operators, conducted on a mutually agreed-upon time and place, yields a wealth of knowledge on process effectiveness and opportunities for improvement.

My books on internal auditing and my classroom curricula focus on how to mine process effectiveness data and how to keep the audit nonconfrontational. One opportunity for making internal auditing a more robust tool of business excellence is to include an evaluation of operator competence during the audit. That assessment and feedback must also be nonjudgmental and included as praise for exemplary performance or as a note if improvement is needed.

9.2.1 and risk
Developing the skills of detecting foreseeable risk should be included in auditor training. An effective auditor will detect obvious risk factors that are cited as nonconformities. The critical observation skills of risk avoidance can prevent an opportunity for liability.

9.3.1 Management review—General

9.3.1 and excellence
Ah, the dreaded management review meetings. The standard’s requirements for this are extensive and rigorous. As with the requirements for design and development, most implementers turn management review requirements into verbatim process steps. Senior management and department heads typically must be dragged into the meeting and bribed with lunch to stay the course. For some, the best possible outcome is not to receive a corrective action request after the meeting. It is understandable that those outside the quality group see management reviews as a time-consuming requirement of ISO 9001 to assess the performance of the QMS, not the overall organization.

I have run across very few organizations that implemented management review as an opportunity to objectively evaluate the effectiveness of their business, take steps to fix processes that are not effective, and find opportunities for strategic business improvement.

To turn management reviews into opportunities for excellence, first rename the event as organizational status reviews. The agenda is for every attendee to contribute to the inputs with her own unique issues. Then, the requirements of 9.3.2 can be recast to add agenda items for each department.

Instead of a presentation format, encourage participants to offer critiques and suggestions. The outputs specified in 9.3.3 are essentially the same, but they don’t include action plans and timelines for implementing the corrective actions and improvement plans, including before-and-after metrics. Tearing down walls and silos between departments is a gift for business excellence.

9.3.1 and risk
Add the tenets of foreseeable risk to the agenda as we do in root cause analysis by asking “why” five times or until the true cause is identified. Ask, “What could possibly go wrong?” until you have drilled down to the risk and liability issues’ roots.


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.


QMS applied in University set up for both academic and non

Dear Dr Tom,

Find this illustration very true and useful

What are yo thoughts and guidance when QMS is applied to a University. My institution is an International Sci & Tec type, and we really need to attain global status - whatever that means via partly through ISO certification for ISO 9001"2015

Kind regards