by Denise Robitaille
I’ve occasionally spent time in these columns discussing how to audit some of the more elusive and amorphous “shalls” in ISO 9001. Let’s face it: Some requirements are a no-brainer. “The organization shall maintain appropriate records of… training… (6.2.2)” or “Records shall indicate persons authorizing release of product… (8.3).” Look for the record and you’ve got the evidence; check it off and move on.
There’s no disputing the importance of these requirements. They address aspects of a quality management system (QMS) that can definitely affect an organization and its ability to fulfill other important requirements. But how helpful are they in assessing the effectiveness of its entire QMS? In short, they beg the question: “Who cares?”
There’s one set of “shalls” peppered throughout ISO 9001 that often gets ignored during an audit: the multiple requirements relating to quality objectives. They are mentioned more than a dozen times in ISO 9001. They relate to management’s responsibility to ensure that quality objectives are established and communicated. Various references to quality objectives also direct the organization to ensure that there are appropriate measurable objectives for products and processes. They make note of the need for monitoring and periodic review.
So, what’s the big deal with quality objectives? They are directly related to the organization’s commitment to improvement. How do you know if you’ve improved if you don’t know where you started from? How do you know how much progress you’ve made toward a goal? You need to know the current status of the process or product and what the target—the objective—is. The degree to which you succeed in attaining or approaching your goal is the measure of the effectiveness of your QMS. It should also be a measure of the effectiveness of your QMS in achieving the organization’s goals—customer satisfaction and sustainable success.
The established quality objectives should relate to measures top management cares about. They generally care about satisfying customers so that the company can continue to be a successful enterprise. Therefore, if one is monitoring the progress in the attainment of quality objectives, one could also be very well monitoring the success of the organization.
What, then, should auditors look for when auditing the multiple requirements relating to quality objectives? Where is the evidence to be found? What objectives have been established for processes? If the objectives are to decrease scrap and to improve on-time delivery, the auditor should look for a measurable value for the desired goal. There should also be metrics showing the present status or progress toward the goal. Additionally, there should be action items or allocation of resources to assist in attainment of the objective. The objectives and the progress toward the goal should be effectively communicated to the individuals in the organization who are in a position (usually as part of their jobs) to affect the desired change. The auditor should, therefore, ask them about the objectives and the role they play in their fulfillment.
Look to the design process for objectives relating to products. What objectives have been established for the product? They may relate to speed, tensile strength, durability, or lubricity—any attribute of a product. As an auditor, it’s appropriate to ask: Have the objectives for the design change been established and communicated? Are they measurable? Has the organization allocated the necessary resources and defined the action items within the design process to ensure that the product objective can be met? For example, has the purchasing function been involved in the qualification and selection of suppliers that can provide raw material capable of producing a part with the desired attribute? Does the organization have the requisite instrumentation to validate the improved product?
The point with auditing requirements for quality objectives is not to simply check that they’ve been established. It’s to determine if the organization is implementing the necessary activities that will drive the improvement initiatives that naturally accompany a well-deployed objective. There are multiple improvements that will ensue from the establishment of quality objectives. They may relate to communication, increased understanding, greater efficiency, or better products.
As elusive as this collection of “shalls” appears to be, auditing them effectively could be one of the best assessments of the overall health of the organization: Its ability to innovate, respond, remain relevant in a rapidly changing world, and sustain itself into the future.
About the author
Denise Robitaille is the author of a dozen books on various quality topics. She’s an internationally recognized speaker who brings years of experience in business and industry to her work in the quality profession. As the principal of Robitaille Associates, she has helped numerous companies in diverse fields to achieve ISO 9001 registration and to improve their quality management systems. Robitaille is vice chair of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 family of standards. She’s also a RABQSA-certified lead assessor, an ASQ Certified Quality Auditor, and a fellow of ASQ.
Her books include Root Cause Analysis, The Corrective Action Handbook, The Management Review Handbook, The Preventive Action Handbook, Managing Supplier-Related Processes, and Document Control, all published by Paton Professional. She also co-authored The Insiders’ Guide to ISO 9001:2008.
Her newest book, 9 Keys to Successful Audits, is available now.