For Life Science Companies

Things Change - Plan On It
by Denise Robitaille, RABQSA-certified lead assessor, ASQ-certified Quality Auditor and Fellow of the American Society for Quality


Share This Article





This article was originally published by Quality Digest Magazine.

Can you think of a more rousing or appropriate quotation to justify the ISO 9001 requirements relating to monitoring and measuring? How about the requirements for periodic internal audits? Or management review?

Things change. How can we possibly expect reliable outputs when we've failed to recognize that the inputs may not be the same? Not only is it possible that the requirements (inputs) may have changed; it's equally likely that support processes, interrelated activities, and available resources may also have changed.

"The only man who behaved sensibly was my tailor: he took my measure anew every time he saw me, whilst all the rest went on with their old measurements and expected them to fit me."
--George Bernard Shaw

People often bemoan the requirements relating to monitoring and measuring. The general consensus is that it's a good idea to track error and defects, but to monitor that which appears to be running smoothly is a waste of precious resources. Within these tough economic times, that argument can't help but sway managers, unless a compelling counterbalance is offered. Time and again, quality professionals stake their justifications in "ISO says so" rather than in objective indicators.

The result is that actions are only taken in a reactive mode, after the problem has arisen—after the customer has complained or the material has been scrapped. When that happens, the inclination is to look for someone to blame. Someone has to be responsible for the mess. Unfortunately, this just perpetuates the culture of blame and band-aid fixes.

Let's pretend that we're tailors, and the great George Bernard Shaw is our customer. He orders a new suit, requesting that it be identical to the one he purchased from us last year. Of course, the playwright has neglected to inform us that he's gained one stone (that's 14 pounds) since last we measured him. And we, for our part, have neglected to verify his current dimensions. No matter how extraordinary we are in our profession and regardless of the sophistication of our sewing machines, the suit will not fit.

Or, perhaps the customer's physique hasn't changed at all. Instead, the last time he ordered a suit, we furnished it in one week. He's assuming the same turnaround time. However, our nimblest seamstress has gone to work for the competition, and the lead time for a three-piece suit is now 10 to 12 days. Alas, the suit will not be finished until three days after the opening of his new play.

Any number of variables can change without any perceptible degradation, but that may have an adverse affect on our ability to meet customer requirements. It's not that anyone screwed up; it's simply that things changed.

Regardless of the current economic climate, the return on investment should still be the overarching consideration for maintaining effective monitoring practices. Limited resources may cause you to streamline your methods, but they shouldn't force you to abandon effective monitoring practices.

Preaching the message is probably not going to get you much support—but diligence and consistency should. You need to show management the value of continuing the monitoring and assessment practices that have served the organization all along.

How can you bring the fruits of good monitoring and measurement to the attention of top management? Be deliberate in the selection of key indicators and assiduous in the implementation of your chosen monitoring methods. Bring good data to the management review table so that executives have the fodder they need for good decision making. Demonstrate the effect of the changes that have occurred in process, product, marketplace, and resources so they can take the action that will prevent costly mistakes or lost opportunities. Those changes could relate to a variety of different features of your organization that might have escaped notice without regular monitoring. Because many of the conditions weren't the result of a product defect, the need for action could only originate from the recognition that something had changed. Changes might include:

  • Increased availability of machine time due to streamlined process
  • Longer raw material lead times due to global shortage
  • Change in customer expectations resulting from newer technology
  • Need for refresher training
  • Revised statutory requirement
  • More linguistically diverse work force
  • Improved inventory turnover due to better forecasting

Any response to many of these factors couldn't have occurred had it not been for a commitment to the monitoring, measurement, and auditing practices that allowed these changes to come to light. If you want top management to support monitoring initiatives, that's the message that must be delivered. Properly presented, with reference to the monies saved, the continued value should be evident to managers. Without it, monitoring and measurement are just pointless exercises.

Denise E. Robitaille helps organizations implement and maintain ISO 9001 systems. She's an RABQSA-certified lead assessor, ASQ-certified quality auditor, and Fellow 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 and several books, including The Corrective Action Handbook and The Preventive Action Handbook. She is also a co-author of the newly released Insiders Guide to ISO 9001:2008, all published by Paton Professional.

Share This Article





Watch Related Videos

Download Free Resources
White Paper: ISO 9001-2000 Standards: Automating Quality Systems
White Paper: Change Control - Continuous Quality Improvement in FDA and ISO Environments
White Paper: Quality Audit - A Tool for Continuous Improvement and Compliance
White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments
White Paper: Effective Nonconformance Management Key to FDA and ISO Compliance