2019

STANDARDS OUTLOOK

Spring Into Action

Use corrective, preventive approaches to get a jump on problems

by John E. "Jack" West

I recently had an opportunity many quality professionals would love to have: presenting the basics of ISO 9001 and Six Sigma to a group of business advisors, most of them former CEOs. I did my best to deliver an interesting and witty description of management systems, process management and improvement—the stuff ASQ members are all about.

My presentation was well received, and I got a lot of genuine compliments. But I also heard a disturbing but fascinating question from the former CEO of a major energy company: "We heard a lot about quality in the last two decades of the 20th century, but today it seems to have dropped off of the radar screen. Is that because business moves too fast today for quality processes to keep up?"

I was forced to agree and provided several reasons. The pleasant ones included the reality that many organizations have adopted quality processes into the way they manage for all kinds of results, not just product quality. In these cases, management processes are no longer recognized as having come from the implementation of quality management.

On the other hand, I pointed out that in a lot of organizations, quality is either a second-class citizen or thought of as "something we did 15 years ago." In these cases, quality is relegated to the status of a long-forgotten initiative the organization "finished."

In these latter cases, what should a quality professional do? My recommendation is to refocus on the corrective action and preventive action processes because these processes can be drivers of improved financial performance. Fewer internal problems mean lower costs. When customers have fewer problems with products or services, the organization can drive sales higher.

Quality professionals commonly say things such as, "The audit program is the centerpiece of our quality system," or, "Management review is the heart and soul of the system," or even "Customer satisfaction is the most important thing we manage."

Seldom do we hear that corrective action is as important. In the grand scheme of things, perhaps it isn’t. But it can be a key to a successful quality management system (QMS).

Not always the way

We improve our ability to meet customer needs by continually correcting the causes of things that go wrong. Unfortunately, corrective action does not even make it to the radar screen of quality managers when they think about important processes. One reason for this is that corrective action is not always the right thing to do. Let’s look at three examples:

1. You know the cause already. If you already know the cause, there’s no need to find it. But you may be able to list several possible cause-removal actions and decide whether any of these actions are a cost-effective correction of the cause. If there is such a possible action, you should take it.

2. There is no effective, efficient corrective action available. Perhaps the most economical action you could take is still too expensive to implement quickly. Maybe you need a capital investment to update technology to make the process capable.

Or, you might just consider the situation and decide that while you could address the cause of a certain problem, you have higher priorities. Perhaps there are other quality problems that are far more important to customers.

Do you just tolerate the effects of the problem? You probably shouldn’t. You can consider other actions, such as sorting the nonconforming items, installing a second process to correct nonconformities or installing a backup process if it is a problem related to a service. These should always be viewed as temporary or interim actions until a resolution can be implemented.

The difficulty with these temporary actions is they tend to become a permanent part of the organization’s process. Sometimes, they aren’t corrected when the process is revamped for a new model or product.

3. You have a bad situation but don’t need to know or correct the cause. Sometimes, bad things happen with a process you may never use again, so while you need to deal with the nonconforming situation, the cause is irrelevant.

Suppose, for example, you take a once-in-a-lifetime boat ride down a swift river. If you fall out of the boat, your immediate action needs to be focused on getting back in, not worrying about why you fell out. If you never intend to set foot on another boat, perhaps it is better to forget the incident rather than spending time figuring out why you fell out.

Making excuses

Because there are legitimate reasons for not addressing causes, some organizations go to great lengths to put real problems into categories that don’t require the cause to be addressed. They look for excuses not to take real corrective action.

But this is not the only reason corrective action is ignored. Another reason is that most of us have long held a narrow view of what corrective action is.

According to ISO 9000:2005, correction is "action to eliminate a detected nonconformity," while corrective action is "an action to eliminate the cause of a detected nonconformity or other undesirable situation."1

Many of us spent years in environments where the concept of correction was called corrective action. Yet corrective action has really meant "correction of cause" for several decades. I still encounter many people who do not understand the nature of true corrective action.

Real corrective action involves making changes to the conditions, processes and operations that cause nonconformities or problems. It corrects causes so the problem or nonconformities will not recur. The issue is not that organizations don’t correct causes; it’s that many organizations don’t do it often enough.

Other organizations are different. They think about correcting causes all the time. Every employee is encouraged to study the problems they encounter daily and propose changes that will eliminate problems—or even implement the changes if they’re authorized to do so.

Organizations should create an expectation that all employees will work on rooting out the causes of problems. Everyone needs to have the tools to determine and correct causes.

Organizations should also provide a structure to control changes and make managers accountable for results. More importantly, they should encourage everyone in the organization to think differently about how to find and correct causes rather than simply implementing stopgap measures that keep production going.

Shigeo Shingo described this thought process with an analogy, pointing out that implementing stopgap measures is similar to using ice to relieve the pain of appendicitis when what is really needed is an appendectomy to remove the affected part.2

At first glance, this comparison might seem to be overly dramatic because failure to get the appendectomy could result in death. But the failure to address real causes is just as dangerous to an organization.

Recognize also that many major problems and failures do not have a single root cause. Most serious failures are the result of a deadly chain of events. Interrupt the chain, and there is no failure. Because tiny changes can sometimes prevent a big catastrophe, it’s a good practice to teach everyone to look for potential links and remove them.

Preventing problems

Many companies resist any formal effort to address preventive action, defined in ISO 9000:2005 as "action to eliminate the cause of a potential nonconformity or other undesirable potential situation."3

Just to satisfy auditors, some organizations will even search their corrective actions to find a few issues to characterize as preventive. But preventive action doesn’t involve working on problems that have already happened. Rather, it’s looking toward what could happen in the future.

It seems obvious that an ounce of preventive action costs much less than a pound of corrective action. So why do organizations resist? Perhaps it’s the thought that, even under the best of circumstances, preventing every problem and nonconformity is exorbitantly expensive.

Organizations typically don’t apply preventive action at the optimal stage in QMS development or management. They don’t think about preventive action until long after it has ceased to be an effective alternative. But it should be at the forefront of their minds if they’re following ISO 9001:2008, which makes several references to planning:

  • Clause 5.4 requires you to develop quality objectives and then plan the quality system to meet those objectives and customer requirements.
  • Clause 7.1 requires you to plan product realization and determine how you’ll ensure requirements for the product are met.
  • Clause 7.3.1 provides rules for planning design and development processes, which means considering the interrelationship of design review, verification and validation with the various phases of the design work.
  • Clause 7.5.1 requires you to plan the production and service delivery processes so they’re conducted under controlled conditions.4

The message should be clear: Well-planned processes are the key to a successful QMS. In fact, the most appropriate time to consider preventive action is during planning.

Clause 8.5.3 of ISO 9001 says: "The organization shall determine action to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems."5

Plan to prevent

Organizations have three ways to develop preventive actions during the planning process:

1. Reduce complexity and the number of process interactions. Every step, resource or control adds new interactions to a process and increases its complexity. Because each step has at least two interactions—and often many more—with other steps and processes, the number of interactions increases much faster than the number of steps.

Complexity also increases the opportunities for things to go wrong. In terms of preventing nonconformity or undesirable process performance, it’s worthwhile to consider simplifying processes.

Process simplification is one of the most effective preventive action tools and is best addressed during process planning. It is much easier to find potential links in a deadly chain of events if the process is simple.

2. Manage risks of failure. Organizations can use techniques such as failure mode and effects analysis to assess the risks of future product and process failures. With these tools, risks are prioritized to assess which ones offer the most economical applications.

Risk assessment tools are useful in evaluating and making cost and performance tradeoffs for products, and for mitigating risk associated with product performance—for example, warranty claims and loss of goodwill—and liability exposure. The latter issue alone makes a compelling case for an aggressive preventive action process in many organizations.

3. Anticipate and manage uncertainty. Uncertainty can be characterized as one of four types: process variation, foreseen uncertainty, unforeseen uncertainty and chaos uncertainty.6

In any organization, these forms of uncertainty exist to some degree, depending on the nature of the organization, its products, its culture and the markets it serves. Obviously, managing unforeseen uncertainty would be difficult, but developing strategies for the other types is certainly a good use of planning time.

For example, you can plan to use statistical process controls to control uncertainties due to variation. But if foreseen uncertainty is dominant—for example, in organizations requiring the Food and Drug Administration’s approval of new drugs—emphasizing contingency planning, training or decision tree models might be more appropriate.

For organizations frequently facing unforeseen uncertainty—for example, an army conducting a military mission—conventional tools such as program evaluation and review technique charts are relatively useless. Using scans of the organization’s external business environment to uncover potential opportunities and threats might be more effective. The information could then be incorporated quickly into strategy and tactics.

Regardless of the type of organization, it’s important to be innovative and develop agile techniques for corrective and preventive actions. The focus needs to be on improving the organization’s ability to achieve sustained business results. That means rapid, continual action to make the needed improvements. The result will be better quality that drives costs lower and sales higher.


References

  1. International Organization for Standardization, ISO 9000:2005—Quality management systems—Fundamentals and vocabulary, 2005.
  2. Shigeo Shingo, Study of Toyota Production System From Industrial Engineering Viewpoint, 1981, Japan Management Association, pp. 107.
  3. International Organization for Standardization, ISO 9000:2005—Quality management systems—Fundamentals and vocabulary, see reference 1.
  4. International Organization for Standardization, ISO 9001:2008—Quality management systems—Requirements, 2008.
  5. Ibid.
  6. Arnoud DeMeyer, Christoph H. Loch and Michael T. Pich, "Managing Project Uncertainty: From Variation to Chaos," MIT Sloan Management Review, Winter 2002.

John E. "Jack" West is a member of Silver Fox Advisors in Bellaire, TX. He is past chair of the U.S. Technical Advisory Group to ISO/TC 176 and lead delegate of the committee responsible for the ISO 9000 family of quality management standards. He is an ASQ fellow and has co-authored several ASQ Quality Press books.


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