Prevent Defense

Take action to refocus your quality management system

by John E. "Jack" West

ISO 9001 has become a well-established baseline for quality management worldwide. Its requirements constitute the absolute basics of an acceptable quality management system (QMS). But, in these times of sparse resources, it is often impractical to devote equal attention to every part of the system. At the same time, many practitioners struggle with the clause on preventive action.

Now is an ideal time for organizations to revisit the preventive action concept using innovative thinking. Effective preventive action requires focus and attention, both of which can be addressed via a method that starts with prioritization and ends with improvement actions.

Considering failure

The process starts with two actions for each QMS process, followed by two actions for prioritizing high-risk processes. But, if you haven’t already, you should identify the QMS processes.

Ask how each process can fail and what the consequences of those failures are. One way to do this is to use the concepts of process failure mode and effects analysis (PFMEA), which gives us a method for managing the risks associated with potential process failures.

PFMEA is a technique for studying the causes and effects of failures before they occur. In addition to analysis of the potential failure modes and their effects, it is very common to analyze the criticality of each potential failure mode. This requires the following actions:

  • For each potential failure, list the possible failure modes.
  • For each failure mode, develop a description of the potential effects.
  • For each potential failure, estimate (on a scale of 1 to 10, with 10 being the worst) the severity, probability (or frequency) of occurrence and detectability (ability to detect the potential cause and prevent the failure).
  • Multiply the rankings to create a risk priority number that can be used to prioritize preventive actions.

Be careful not to make this a bigger project than it needs to be. Remember, all you want to do is determine the high-risk processes. This involves understanding process inputs, outputs, internal process measures (if any), process monitoring methods and expected process outputs. With the possible exception of measurement, all QMS processes should have each of these elements. If some elements are missing or insufficient, they should be noted. If any are missing for high-risk processes, fast action may be needed to rectify the situation.

Priority issues

What processes typically emerge from prioritization? They can be very different from one organization to the next, but regardless, the processes can be categorized using ISO 9001 clauses. The following clauses are used most often:

  • Clause 4.1, general requirements—outsourcing.
  • Clause 5.1, management commitment.
  • Clause 5.4.1, quality objectives.
  • Clause 5.6, management review.
  • Clause 6.1, provision of resources.
  • Clause 6.2.2, competence, training and awareness.
  • Clause 7.3, design and development.
  • Clause 7.5.1, control of production and service provision.
  • Clause 7.5.2, validation of processes for production and service provision.
  • Clause 8.2, monitoring and measurement (particularly 8.2.1, customer satisfaction; and 8.2.3, monitoring and measurement of processes).
  • Clause 8.4, analysis of data.
  • Clause 8.5, improvement.

After prioritization is complete, there are two more concepts to help assess the high-risk processes. They involve understanding how the process is operated, measured and controlled. You should be able to demonstrate that all high-risk processes operate continually in a state of control. It might be helpful to answer the following questions for each high-priority item:

  • Have criteria and control methods been determined for control of the QMS processes?
  • Is information available to support the operation and monitoring of the processes?
  • Are processes measured, monitored and analyzed, with appropriate actions taken to achieve planned results and continual improvement?
  • Is the QMS established, documented, implemented, maintained and continually improved?
  • Have provisions been made to ensure control of outsourced QMS processes?1
  • If the processes have not been previously mapped, doing so can prove useful at this stage (see Figure 1).2

Figure 1

More on measurement

This brings us to measurement, which is a part of the mapping process but is important enough to discuss in greater detail.

For many processes, particularly those that are capital-intensive, it may be critical to understand which process parameters are the causes of process performance. This concept is important when solving the basic problems that cause processes to miss targets. It is also important when developing new or reengineered processes because it helps establish which process parameters should be monitored or measured over time to ensure the process continues to meet requirements.

The concept is simple, but its power is often ignored. The idea is that most process output measures cannot be directly changed. Rather, they are response variables—that is, they respond to changes in other variables within the process.

These other variables can be changed and are called independent variables. To get better results out of the process, you must determine which of the many independent variables in the process affect process performance and learn to optimize them.

It is critical to remember that the process output results (response variables) are difficult to change unless you identify and change the independent variables. The best changes are likely to be those that foolproof the process and make occurrence of the possible failure all but impossible.

For example, you can’t make candy sweeter unless you determine what makes it sweet and change the amount of the ingredients that make it sweet. Likewise, it is not practical to improve a management review process by writing memos; you need to get the attention of the responsible top managers with real data.

For critical activities that must be completed correctly by employees to achieve a desired result, the controlling independent variables may be the effectiveness of training and amount of practice.

You may be wondering how to determine which of the many variables of your process are the ones that, when changed, will ensure the process will not fail. One way to determine that is to ask those working in the process. It is also useful to have the workgroup or process team develop a cause and effect diagram (also called an Ishikawa or fishbone diagram) to identify the likely candidates.

Some processes contain activities or steps that involve a great deal of uncertainty. For example, the process for managing a maintenance process will necessarily have a step in which the availability of a critical repair part is determined. No matter how well you have selected which parts should be hand, it is reasonable for the maintenance process team to consider including in the process a provision for the situation in which a critical part is not available. In other words, think through a plan B for key foreseeable uncertainties in the process.

Again, don’t make the mapping, measurement and improvement activities a bigger project than needed. All you want to do is determine the process activities you will need to change or foolproof to reduce risk. Go about it at your own pace. The key to making progress is to start, even if you need to start small. 


  1. Charles A. Cianfrani, Joseph J. Tsiakals and John E. "Jack" West, ISO 9001:2008 Explained, third edition, ASQ Quality Press, 2009, p. 19. )
  2. Charles A. Cianfrani and John E. "Jack" West, Cracking the Case of ISO 9001:2008 for Service, ASQ Quality Press, 2009, pp. 139-147.)

John E. "Jack" West is a management consultant and business advisor. He served on the board of examiners for the Malcolm Baldrige National Quality Award from 1990 to 1993. West is past chair of the U.S. Technical Advisory Group to ISO/ TC 176 and lead delegate to the committee responsible for the ISO 9000 family of quality management standards. He is an ASQ fellow and co-author of several ASQ Quality Press books.

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