“Do We Have To?” by Denise Robitaille ( InsideStandards, http://qualitydigest.com/IQedit/QDarticle_text.lasso?articleid=12554) was an interesting and accurate evaluation of many quality management systems (QMS). I am currently working with a small machine shop in Blanchester, Ohio, that used a consultant who simply filled in a computer-generated quality manual. It is most certainly a disappointment that there are still those in the consulting business who care only about completing a portion of their responsibility. If the organization cannot see a productive value in their QMS, then someone lacked the ability or desire to instruct them properly.
I sympathize with clients who ask me this question. As a consultant I’ve taken many clients through registration, and I’ve had to deal with registrars’ interpretations of ISO 9001. Unfortunately, in past years, instead of adding value to the process, I’ve had to spend resources making sure that the auditor was happy. There’s a lot in the standard that is positive in providing organizations with templates of structure and discipline in achieving consistency, efficiency, and customer focus. However, there is also a lot of interpretation of the standard that lends itself to focus on insignificant detail while allowing significant opportunities to continue unaddressed because they are not on the auditor’s radar.
Recent changes in the approach of auditors are very positive. I particularly like the “readiness review” required by the ISO/TS 16949 standard. Here the focus is on the customer issues and not whether the training form is properly filled in.
Reducing cycle time is a business objective. Measuring whether you have met the target is a management objective. Yes, somewhere in ISO 9001 it says that you should be setting objectives and meeting them, but it couches it all in terms of quality objectives, not business objectives. It words it in terms of producing this report and that record, and it audits evidence, not results. So perhaps the question should not be, “Why do companies try to avoid meeting requirements of the quality standard?” but “Why is the standard couched in such a way that companies see it as divorced from their business objectives, and thus see the cost and not the benefit?”
Regarding the article “Six Sigma Lessons from Deming, Part 1” (Anthony Burns, InsideSixSigma, http://qualitydigest.com/IQedit/QDarticle_text.lasso?articleid=12541), I have noticed a general decline in customer service since customer value is no longer a key component of the QMS when using Six Sigma. Deming brought the human element to quality and specifically focused on the customer and processes.
A stronger and more robust QMS offers a balance between requirements, tool sets, and assessments. An ideal QMS would use ISO 9001 for business requirements, Six Sigma or lean as the tool set to accomplish the quality goals, and the Baldrige award as the assessment tool to determine the adequacy of the QMS. The larger companies specified in this article would benefit from this overall approach.
I never understood how the proponents of Six Sigma could consider the 1.5 sigma mean shift as an unavoidable product of the process. In reality, if a process is drifting that much, it is probably due to a special cause that should be investigated. Control charting will clearly identify when this has happened.
I think that the author is off base on the source of “sigma” (3.4 defects per million opportunities) found in Six Sigma. He should look to Deming’s boss at Bell Labs (Walter A. Shewhart) as the definitive source of the math. To see where Six Sigma limits came from, read Shewart’s 1931 book, Economic Control of Quality of Manufactured Product. This is the definitive text that is the source of Deming’s trending/SPC work, TQM, and Six Sigma. The basis for the control strategy is described in the book in very dense mathematical terms.
To make the story very simple, the strategy is to stop overcontrol of processes by only making adjustments when a significant change has occurred.
For a more modern description of the source of the math behind Six Sigma, try the works of Donald Wheeler. Wheeler was a protégé of Deming and he writes quite clearly about the basis for the numbers behind statistical process control and Six Sigma.
In “Quality Conversation with Dr. Tomas Gonzalez” (“News Digest,” February 2008), Dr. Gonzales has underplayed his achievements related to the Six Sigma initiatives undertaken at his hospital. Though medical methodology uses something akin to Six Sigma in diagnosing and managing the patients, Six Sigma initiatives in a hospital environment generally take a longer time to get the doctors or clinicians on board. If you can enthuse them to the point that Dr. Gonzalez has done, that by itself is a great achievement and also half the battle won.
--Dr. Harish Nadkarni
What [is the health care system] doing to improve the health care of anyone before patients are admitted to the hospital? Having been a patient in a “quality” health care system, I can tell you first hand that the No. 1 problem in health care is the inability of staff at any level--physician, nurse, medical assistant, etc.--to listen to the patient first. How is Six Sigma going to improve the listening skills of those providing care?