QMS: What's the Problem?
We have spent considerable time talking about problems from Apollo XIII, the West Texas Fertilizer Plant, the Deepwater Horizon Oil Rig Gulf disaster of 2010, all the way to Wall Street and the JPMorgan Chase & Company driving our country into the Great Recession. Sometimes we need to get back to basics and ask ourselves what has been the purpose of all the object lessons? The whole point of creating an ISO 9000 quality management system along with its QMS Guide has been to find ways to deal with problems that haven’t occurred yet (risk). The idea of looking at risks is that we want to see what might become problems. And finally, having a QMS allows a business to have procedures in place to minimize the damage caused by a problem. One of the many systems available to minimize risk and problems is the Kepner-Tregoe system which we are not finished with. Companies need to develop their own risk assessment/problem solution systems iwthin their guides. We have been talking about that part of ISO 9000 because this is the place where lives, money or livelihoods can be lost. Let’s back up a bit and review the start of our path.--Tim
Quality pioneers W. Edwards Deming, Joseph M. Juran and Philip B. Crosby began their careers as quality practitioners and statisticians. As their experience grew, they shifted their attention from quality tools to leadership and creating an organizational culture in which quality can be nurtured and achieved.
You can read more about them in our new, free report Quality Management Systems Guide. Click here to download yours now.
Things haven’t changed since they were first starting out. Deming pointed out that the commitment of top management to quality and productivity is not enough. "They must know what it is that they are committed to—that is, what they must do. These obligations cannot be delegated. Support is not enough. Action is required." This includes:
- Communicating a well-thought-out, long-term vision for the future.
- Establishing and maintaining a culture for effective problem solving (see AIAG CQI-21).
- Developing strategic and tactical plans for accomplishing the vision.
- Allocating adequate competent resources for internal and supplier quality.
- Understanding and reinforcing the organization’s disciplined problem-solving process by asking the right questions and requiring its use by everyone.
- Empowering people to act within established policy, processes and procedures.
- Providing what Deming called constancy of purpose.
- Ensuring the problems are, in fact, solved—not just contained.
Notice the emphasis on problems and problem solving? Corrective action is another way of saying that. Recent data for ISO Technical Specification (TS) 16949 global certification audits show that clause 8.5.2, corrective action, is the one most frequently cited for major nonconformities, and it’s eighth on the list for minor ones.
In addition to the ISO 9001 requirements, ISO/TS 16949 requirements for this clause include sub-elements for:
- Problem solving.
- Error proofing.
- Corrective action impact.
- Rejected product test and analysis.
Clause 18.104.22.168 of ISO/TS 16949 requires that organizations "have a defined process for problem solving, leading to root cause identification and elimination."
Let’s look at problem solving a little closer:
Identification of the problem.
This is the hardest part in the process. Before creating a problem statement, it helps to collect evidence from where the problem was discovered or happened. The problem statement should properly identify the problem, not just its symptoms. Note that there is a difference.
Correction or containment actions.
Clause 3.6.6 of ISO 9000 defines correction as "action to eliminate a detected nonconformity." In a disciplined problem-solving process, however, correction or containment is better defined as immediate actions taken to address the symptoms of a detected nonconformity.
Containment is not problem solving. It is a form of putting out fires. The process must not stop with containment of the problem. Containment actions are necessary to stop the bleeding and to protect the customer. Containment actions taken also should be focused, temporary and extraordinary. Actions taken should stay in place until the effectiveness of the corrective actions is verified.
Often, the problem is a lack of information and resources available to properly complete the problem-solving process. As a result, practitioners move from problem to problem putting out fires because they only have time to address containment.
Top management must see that proper resources are available to give employees what they need to solve the problem. These resources might include adequate training and technical coaching, as well as sufficient time to solve the problem instead of having to hurry to contain it.
Root cause analysis.
This means figuring out what caused the problem. There are three kinds of root cause:
- Escape root cause addresses the question, "Why did the concern reach the customer or next operation?"
- Occurrence root cause addresses the question, "Why did the problem occur?"
- Systemic root cause addresses the question, "Why did the system or planning process fail to identify a concern?"
Missing or not doing this step correctly is one of the main reasons for many ISO/TS 16949 audit nonconformities.
If you need more information on the process of problem solving, we would be glad to answer your questions. And you can also read more about the general topic of ISO 9001 in our new, free report Quality Management Systems Guide. Click here to download yours now.
ISOCert Solutions was founded in 1990 in Sonoma County California by partner Tim Landerville and has grown steadily since its inception. It maintains its corporate office in Santa Rosa, California and others throughout the United States.
ISOCert Solutions specializes in Enterprise-class software that is made for scalability, high performance, quality management and robustness. Their software provides businesses with logic support functionality, enabling enterprises to improve product quality, services and productivity while providing efficiency gains. For more information please see: http://isocertsolutions.com/ or call (707) 570-5669 to discuss how to become ISO 9001 certified.