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There's More to Risk Management Than That

I was slightly discouraged by Les Schnoll's "Standards Outlook" column on risk management ("Ensure Medical Device Safety," February 2003, p. 73). The line underneath the headline read, "A comprehensive risk management process is required," but I do not believe Schnoll presented a comprehensive process. He fell into the same trap many companies fall into--he forgot the rest of the story. Risk includes manufacturability and business risks.

Performing a manufacturing process and business risk analysis could be just as important as performing a patient harm risk analysis. I am not saying injury to a user is equal to or less important than the cost of the product, but manufacturing processes and business do play a roll in the mitigation of all risks. Did you make a safe product that can be manufactured at an acceptable cost, produce acceptable yields and reduce the liability exposure of the company?

You need to consider not only what happens if something fails during use, but also whether an employee can get injured building the product or whether the device is harmful even though it's being used correctly.

Many safety risks to patients can be mitigated by changing the design of the product, but these changes have a direct impact on the product's manufacturability. If the risk is mitigated by a change in the design that stops you from being able to make the product, then the risk mitigation was not accomplished.

I just want to make sure quality professionals don't lose sight of the rest of risk management. A comprehensive process should involve a review of the risks to the patient, user, production floor, lawyers and upper management.

F. DAVID ROTHKOPF
MEDIcept
Ashland, MA
drothkopf@medicept.com

Auto Manufacturers Not Focused on Real Change

As a quality professional who has worked in the automotive field with many different suppliers, I believe it is no mystery why the ISO 9001, Q-101 and Targets for Excellence standards have not produced the improvements needed (Roderick A. Munro, "Roadblocks to Quality," February 2003, p. 49). I have worked with all the major American manufacturers, and none have approached quality improvement in a rational way.

Take Ford, for example. Radley Smith was instrumental in developing the QS-9000 standard. Since then, he has made millions of dollars off the standard he forced down the throats of the supply base.

Is Ford in better shape than before QS-9000 came along? I don't think so. The automakers focus on getting reams of paperwork done, not on fixing problems. When I would try to get Ford engineers to participate in preparing a failure mode and effects analysis, they weren't interested.

Ford also made it virtually impossible to improve things. If we submitted a request for something we thought would improve the process, one of two things happened. Either we were told Ford did not have time to validate the change, or Ford wanted to keep all the savings.

There was also no incentive for suppliers to work on improvement activities. Thousands of man-hours go into filling out forms. Just think of all the problems that could be solved if those man-hours were devoted to true problem solving activities. The results would be incredible!

ALLEN HUFFMAN
Ridgid Products
Orange, VA
ahuffman@ridgid.com

Automotive Article Refreshingly Candid

Roderick A. Munro's article was refreshingly candid, especially his statement, "Everyone knows what a certified public accountant is, but few people know what a certified quality engineer is."

He goes on to point out one of the misgivings many of us members have noted in the past: "Even within our own Society the sheer number of certifications we offer has seemingly diluted the promotion of CQE as the top status of our profession. It has gotten lost in the crowd."

I understand certifications are revenue generators for the Society, but maybe we should rethink the overall value of having so many certifications.

TED MATTIS
ASQ Senior Member
Traverse City, MI

 

'Quality Progress' Just Keeps Getting Better

I would like to compliment you on the continual improvement of your magazine. The graphic design, organization and content just keep getting better.

The February 2003 issue was outstanding, especially the article "Boost Stock Performance, Nation's Economy" by Claes Fornell (p. 25). This was a well-thought-out and written article. It was clear, concise and got to the heart of the issue. This article should be mandatory reading for all college business majors, especially those in economics or finance classes. Fornell makes a compelling case and documents his premise with simple and easy to understand graphs and data.

"The Loyalty Elephant" by Steve Hoisington and Earl Naumann (p. 33) should be mandatory reading for college students taking marketing courses. There are many aspects to marketing, but one should never forget one of the primary purposes of a business. A business needs to make a profit, and a major contributor to profit is customer loyalty, particularly as it relates to cost and price.

These two articles will go a long way to improving the business knowledge and quality of present and future business leaders.

KENNETH G. SHIPMAN
NISH (formerly the National Industries
for the Severely Handicapped)
Vienna, VA
kshipman@nish.org

ISO 9000 Registration Doesn't Guarantee Quality

"Roadblocks to Quality" was a well-delivered critique of the auto industry. I have been concerned for years about the number of companies I have dealt with that made comments about being ISO 9000 registered and implied it automatically made them producers of top quality.

Management needs to be told again and again that if being registered to ISO 9000 or QS-9000 meant automatically perfect parts, there would be no need to require continual quality improvement under that registration.

GLENN WILSON
Packaging quality
and productivity consultant
Woodstown, NJ
glennwn@iopener.net

Satisfaction Index Reacts To Random Noise in Data

I have followed the various press releases on the American Customer Satisfaction Index (ACSI) with great interest over the past years, and there seems to be a continued pattern of reaction to random noise in the data, at least based upon the statements about percentage change in the indicators. If you stack up the various releases, they contradict each other from year to year and appear to do a poor job of offering a prediction of the future.

Claes Fornell says the point of the ACSI was to "analyze the data using newly developed software that would sort out the typical random noise one finds in all surveys and establish cause and effect patterns, and update with new data on a regular basis." To me, there does not appear to be any fact or evidence in the article to support that statement.

In response to my request for the statistical basis behind the ACSI declarations of changes, I was given a report that indicated the reporting criteria are to cite percentage changes from datum to datum that exceed a 90% confidence level.

If this is the case, then any certified quality engineer should be able to predict the outcome: One in every 10 industries will be reported as having a significant change of such and such percentage. No long run monitoring of the data (such as through a control chart) appears to be performed.

Considering another article in the very same issue laments that many managers and engineers still do not understand or apply the concepts of variation reduction or trend analysis, ASQ ought to be in the forefront in establishing knowledge of variation and trend analysis. A good place to start would be with the ACSI.

STEVE PREVETTE
Fluor Hanford
Pasco, WA
steven_s_prevette@rl.gov

 

Contact 'QP'

We welcome your letters. Send them to EDITOR, ASQ/QUALITY PROGRESS, 600 N. PLANKINTON AVE., MILWAUKEE, WI 53203-3005; or e-mail them to editor@asq.org. Please include address, daytime phone number and e-mail address. All letters will be published on the QP Discussion Board, or you can post your comment on the QP Discussion Board directly at www.asqnet.org. We reserve the right to edit letters for space and clarity.


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