Plan Ahead for Preventive Action
It’s interesting that so many companies resist any formal effort to address preventive action. Just to satisfy auditors, some organizations will even search through their corrective actions to find a few issues to characterize as preventive. But preventive action isn’t working on problems that have already happened. Rather, it’s looking ahead to 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 because preventing every problem and nonconformity is exorbitantly expensive. Organizations typically don’t apply preventive action at the optimal stage in a quality management system’s development or management. They don’t think about preventive action until long after it’s ceased to be an effective alternative.
ISO 9001:2000 makes a number of references to planning. Clause 5.4 tells us to develop quality objectives and then plan the quality system to meet those objectives and customer requirements. Clause 7.1 requires that we plan product realization and determine how we’ll ensure that 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 that we plan the production and service delivery processes so that they’re conducted under controlled conditions. The message should be clear: Well-planned processes are key to a successful quality management system.
The most appropriate time to consider preventive action is during planning. Clause 8.5.3 states: “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.” Organizations have three different ways in which they can develop preventive actions during the planning process:
 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. In terms of preventing nonconformity or undesirable process performance, it’s worthwhile to consider simplifying processes.
Manage risks of failure. First, organizations can use techniques such as failure modes and effects analysis as well as process failure modes and effects analysis to assess the risks of future failures of new products and processes. With such tools, risks are prioritized to help assess which ones offer the most economical applications. Risk-assessment tools are useful in evaluating and making cost and performance tradeoffs for products, and mitigating risk associated with product performance.
Anticipate and manage uncertainty. Uncertainty can be characterized as one of four types: process variation, foreseen uncertainty, unforeseen uncertainty and chaos uncertainty. (DeMeyer, Arnould; Loch, Christoph H.; and Pich, Michael T., “Managing Project Uncertainty: From Variation to Chaos,” MIT Sloan Management Review, Winter 2002.) In any organization, all of 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 very difficult, but developing strategies for the other types is certainly a good use of planning time.
For example, we can plan to use statistical process controls to control uncertainties due to variation. However, if foreseen uncertainty is dominant (as it is, for example, for organizations requiring FDA approval of new drugs), then 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 PERT charts are relatively useless; using iterative external scans of the environment to uncover potential opportunities and threats would prove more effective. The information could then be incorporated quickly into strategy and tactics.
Organizations must be innovative during quality planning to get the most from the preventive action concept.
This article is based on chapter 7 of Unlocking the Power of Your Quality Management System: Keys to Performance Improvement, by John E. (Jack) West and Charles A. Cianfrani (ASQ Quality Press, 2004).
John E. (Jack) West is a consultant, business advisor and author with more than 30 years of experience in a wide variety of industries. He is chair of the U.S. TAG to ISO TC 176 and lead delegate for the United States to the International Organization for Standardization committee responsible for the ISO 9000 family of quality management standards.
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