when the rubber meets the road |
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when the rubber meets the road |
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October 2000
An updated version of this essay appears in the Nothing but the Truth about Quality manualJames O. Westagrd, PhD, FACB
I know the title is a mixed metaphor. It's a mix of Ford's motto "Quality is Job 1" and an expression that questions the relationship between truth and reality, principles vs practice, words vs deeds, etc. In the case of quality, the question is whether our quality assurance programs really assure the quality of our products and services. That's when the rubber meets the road.
There is a very public lesson on quality unfolding in newspapers and on television today as a result of the Ford/Firestone problem with crashes of sports utility vehicles. It is reported that there have been a hundred traffic deaths in the US from crashes allegedly due to failure of the tires. A gigantic recall of 6.5 million tires is underway. On September 21, 2000, the CEO's of Ford and Firestone appeared again at a congressional hearing to answer questions about what they knew about the problem, when they found out, and what they did or didn't do about it. Automobile safety is important, and evidently there's a lot of political mileage as well!
I can't help but think back to November 1999 report from the Institute of Medicine that medical errors may cause from 44,000 to 98,000 deaths per year in hospitals in the US [http://www.ahrq.gov/qual/errback.htm]. In presenting this information to the public, quality is discussed in terms of "patient safety." The association with safety helps patients understand that medical errors could be hazardous to their health. It also implies that prevention or up front actions need to be taken to reduce consequences later on. This means that resources, including money, need to be invested up front to minimize costs later on. Safety provides a good analogy for quality
One would think that a safety problem of potentially 100,000 deaths/year would have generated a lot more concern than the Ford/Firestone problem of 100 deaths. While there have been congressional hearings, I don't recall that officials of healthcare businesses were summoned to appear and answer questions about their quality systems, what they knew, when they knew it, and what they did about it. But, I have a pretty good idea what they would say if asked!
- CEO of a hospital: We've been inspected and accredited by the Joint Commission for Accreditation of Healthcare Organizations (JCAHO), therefore our quality systems are well documented (meaning there are stacks of paper available to show the inspectors).
- CFO of a pharmaceutical company: All our products have been extensively tested in clinical studies to obtain FDA approval, therefore the quality of our products is well documented (meaning they've demonstrated at least one good effect and disclosed the many possible adverse side effects that are known at the time).
- Director of a clinical laboratory: We've been inspected and found to be in compliance with the Clinical Laboratory Improvement Amendments (CLIA-88), therefore our quality systems are okay (meaning that the laboratory runs at least 2 controls most days and has records to prove it).
- President of a diagnostic company: Our products and product labeling have been reviewed and approved by FDA, therefore there are no quality problems with our systems (meaning that experimental data has been collected, analyzed statistically, and claims for product performance are consistent with the data, rather than demonstrating that product performance satisfies defined quality requirements).
- CEO of a diagnostic supplier: We've been certified to be in compliance with the International Standards Organization (ISO) series 9000 quality standards, therefore our manufacturing processes and systems are documented to be of high quality (meaning they hired a consulting company to help them document their processes, then paid again to have the documentation inspected, and then documented that their documentation was in compliance with the ISO documents).
- Head of a government agency: We've become customer oriented now, have new policies and procedures that are more customer-friendly, and have higher satisfaction ratings from our customers (meaning quality is satisfying customers, particularly those who are politically powerful).
Everyone is in compliance with some accreditation standard, regulatory requirement, consensus standard, international standard, or government policy. Everyone has documentation to show that everything is okay when things are working right, but no one knows what will happen when their processes aren't working right. "Working right" has no definition in relation to the quality because none of the quality management guidelines require that the desired quality be defined for the product, nor do they require that process specifications be related to desired quality. It follows that a "problem" can not be defined in quantitative terms either, which also means there is no way to assess whether the quality system can identify or detect a critical problem. In short, today's quality management practices are arbitrary, rather than objective, even when they adhere to published guidelines. Everyone does what is accepted as good practice (which means doing what everyone else is doing) in the hopes that quality will happen.
Quality management should be concerned with developing production processes that meet defined requirements for quality and controlling those processes to guarantee that the products and services achieve the desired quality.
- Compliance does not equate with quality. The reality is that compliance, at best, is only an indicator of the minimum or lowest quality that is tolerable. Whether it's a professional standard, regulatory standard, or international standard, by the time the standard has been published it has been watered down through compromise in order to gain approval. If you want to be average, compliance is your ticket.
- Excellence is the opposite of compliance. You don't become excellent by doing the minimum that is needed to get by; you get better by doing more than is needed to be in compliance. You set your own standards for performance to provide high quality products and services.
- Documentation of past events doesn't prevent problems in the future. The old addage if "you didn't write it down, you didn't do it" should be replaced by "if you can't assure quality, you shouldn't do it." The detection and prevention of problems is where it's at; the documentation of problems is where we've been.
- Customer satisfaction does not equate to quality. Ford's Explorer is a highly successful product with many satisfied customers. Customer satisfaction does not take into account technical aspects of quality because the customer can neither understand nor measure those technical characteristics. The provider must take responsibility for assuring the technical quality of a product or service.
- Supplier quality can't be assumed. It appears that Ford didn't do it's own performance studies on the Firestone tires - they just assumed the quality would be okay. Sounds a lot like what is going on in laboratories today when we try to buy quality off the shelf. We assume that the manufacturer provides the quality and all we have to do is perform the tests and report the results. Instead, we should take responsibility for validating the quality of the analytical instruments, systems, kits, and reagents that we purchase. We are still responsible for the quality of the test results that are reported.
- Quality is not inherent in the business model. Deming's contributions to the Ford quality program and the success of the Ford Taurus in the 1990s seems to have been short-lived. Management's commitment to quality and to "create constancy of purpose toward improvement or product and service" [1] does not occur just because there's a competitive marketplace. Quality is a value and strategy that has to be imposed on the business model.
- Problems with quality can only be solved by management. The corollary is that quality is not a worker problem. There clearly was a hostile work environment in the Firestone plant in Illinois and there were job actions during the time these tires were being produced, but management made the decisions to continue production and release new product. Look at the working conditions in healthcare that have resulted from turbulent mergers, implementation of new management and organizational structures, effects of "cost-reduction" programs, and the increasing complexity of patient treatment protocols. Doing more with less is a management strategy that causes problems for workers. Medical errors are an outcome of poor management decisions.
- Near perfect may not be good enough! If you look at the defect rate on these Firestone tires, there have between 100 and 2000 failures (the range between the death count and the number of accidents reported) in 6.5 million tires. If we use the larger number, that's a defect rate of about 300 per million, which is 0.03%. In comparison, laboratory errors are estimated to be in the 1-3% range - a defect rate that is two orders of magnitude larger. Errors in pre and post analytical steps are thought to be several times higher than the laboratory error rate. And, laboratories are probably the best performing unit in a healthcare organization! What does that say about medical quality? Quality improvement is needed in all aspects of the testing process if laboratories are to become as "good" as Firestone.
- Quality is determined by the worst component in a product or process, not the best! Laboratories are probably the best performing unit is a healthcare organization. Often the weak link in the chain isn't in the lab, but in higher management where a critical decision cripples the ability of the laboratory to deliver the proper results. No one should be surprised at the findings about medical quality. When bad management happens to good laboratories, poor quality results.
Medical errors reflect the compliance of healthcare organizations with regulatory policies and administration procedures. Compliance equals complacent. If you are happy being in compliance, you have become complacent with your work, your working conditions, or the organization for which you work. In contrast, frustration is probably an indicator that you are unhappy with today's compliance mentality and compliance management. Many clinical laboratory scientists today are very frustrated with their work, which is a good sign. That means there is still hope for getting things done right. But, where to start?
- Become active in your professional organization. This single act is the easiest action for many individuals. Join and support their professional organization. You need the support of others who care about quality. In turn, others need your support. The best chance to find that support is with professionals like yourself. Initiate, encourage, and participate in discussions of the real issues that are important in your work.
- Improve your quality management skills. You can do this through your professional organization, through self-study or continuing education, and through the training materials and tools on the Internet, such as found on this website. Quality doesn't just happen; it must be achieved through hard work, knowledge, and skills.
Take advantage of your technical training. Laboratory scientists are the only people who can assure the analytical quality of laboratory tests. You have a unique and essential role to play if your organization is to deliver quality services. Begin by defining the quality needed for each test. Make sure your analytical methods and systems have the necessary analytical performance. Make sure your QC procedures can detect medically important errors. Extend your work to the pre-analytic and post-analytic parts of the testing process. That's doing your job as only you can do it. That's how you can provide quality where the rubber meets the road.
- Deming WE. Out of the Crisis. Cambridge MA, MIT Center for Advanced Engineering Study, 1986.
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