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Denise Robitaille



Within a quality management system

Published: Friday, July 11, 2008 - 06:23

A few months back, I wrote about the choices an organization makes regarding its quality management system (QMS). At that time, I talked about the overall system, with particular focus on management’s investment and support.

Today I’d like to spend some time talking about the choices within the requirements of the quality management system. Once you’ve decided that you are going to conform to the requirements of ISO 9001 or a comparable QMS standard, you still have many options to consider. It’s not just a matter of whether or not you’ll conform to ISO 9001, but how you’ll do it. How will you implement your system?

The answer is encompassed in two sentences that carry within them challenge and constraint. “It depends.” and “You decide.” The method of implementation is dependent on the multiple variables of your unique organization. And the application is the outcome of your decision-making process, based on an assessment of those variables.

You have the obligation and the right to select how requirements will be applied in your organization. Once you’ve agreed that you’ll utilize a QMS model, you get to choose how it’ll manifest itself. But you also have to devote adequate resources to that decision making process.

This involves a lot more work than delegating the project to one individual and expecting a world class outcome. It requires the active participation of process owners and key players. The question is no longer “if” something should be done. It’s now “how” you’re going to do it. So you need the input of those most familiar with the processes and activities that make up your system.

This is the wonderful point at which your creativity can flow. Instead of looking at some of the requirements as arduous paper exercises, seize the opportunity to approach a perennial constraint from a new angle. Rather than saying: “That won’t work here,” you can come up with a method that will allow it to work in your environment—a way to do something that will go beyond conformance to create real value for your organization.

The decisions made are based on established criteria, which are in turn based on a balanced assessment of criticality and constraints. These create the rationale that justifies your actions. If, for example, you opt to implement a dock-to-stock program for procurement of generic components, you need to determine what risk is assumed if parts are bad. Would they pose a risk of damaging product or introducing defects into materials and would the resulting cost of such an incident wipe out any perceived financial benefit?

If the answer is that there are adequate fail-safes to prevent defects (like supplier audits or well monitored performance metrics), then the requirements for subclause 7.4.3 are met by controlling the process, thereby ensuring “… that purchased product meets specified purchase requirements.” In short, you don’t have to inspect everything.

Equipment maintenance is another good example. If the production machinery software has prompts that indicate when filters need to be changed, parts greased or other maintenance needs to be performed, having a monthly schedule to please an auditor is a waste of time and money. However, if the OEM recommends a complete overhaul once a year, you can’t ignore it—especially if the equipment’s failure could shut down your operation.

Control of measuring and test devices is constantly confused with calibration. ISO 9001 doesn’t require organizations to calibrate everything. Some things can’t be calibrated. In some industries, tolerances are measured to the nearest ¼ inch. If the reading on a rule is off by one line on the average scale, it’ll probably represent a variance of 1/16 inch or less, which is still within acceptable tolerance limits. In that case, having rules and tape measures calibrated or even verified is silly. The polar extreme to that scenario is one in which the customer needs you to hold a tolerance to +/- .0001. Here, the slightest maladjustment to a micrometer would invalidate any reading, justifying the need for a rigorous calibration process. It depends.

Every manufacturing process doesn’t need a work instruction. Detailed routers (production papers) with illustrations or photos are probably easier for operators to understand. Design review can be accomplished through e-mails and teleconferencing and doesn’t necessarily require meetings. You get to decide.

The commonality in all cases should be that the process is effective and that it doesn’t engender unacceptable risk. Once both of those criteria are met, there’s a good chance that you’ve also conformed to the requirements of the ISO standard.

About the author Denise Robitaille has helped companies in diverse fields achieve ISO 9001 registration. She's an RAB-certified lead assessor, ASQ-certified quality auditor and senior member of the American Society for Quality. Robitaille is also a member of the U.S. TAG to ISO/TC 176, the committee responsible for updating the ISO 9000 standard series. She's the author of numerous articles, as well as The Corrective Action Handbook, The Preventive Action Handbook, The Management Review Handbook, and Managing Supplier-Related Processes, all published by Paton Professional.


About The Author

Denise Robitaille’s picture

Denise Robitaille

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.

She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.

As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.