Quality Assurance: Are We Doing a Good Job?

When I started in this industry in 1984, I was amazed to find out that there wasn't any federal or state oversight in the production of orthoses or prostheses. You had to be state licensed to cut hair or even drive a hearse, but not to make a prosthetic leg. The federal government had some regulatory oversight of just about every industry I had ever been involved in—electronics manufacturing, food services, and even the auto body repair business. It seemed odd to me that an industry that is so central to the health and well-being of our patients and presents so much potential for injury would just be "winging it." Fast forward to 2012, and the lack of regulatory oversight still seems odd to me. Over the past few years we have started to hear rumblings about possible U.S. Food and Drug Administration (FDA) involvement; Medicare Pricing, Data Analysis and Coding (PDAC) rules that may or may not affect us; and a host of other potential changes. As a business owner, I have to keep an eye on these changes and do my best to adapt quickly. Some of the potential impacts can appear onerous and some of them downright ridiculous, but I am still stunned it has taken this long for regulatory scrutiny to be instituted. I favor some level of governance: I think our patients deserve to know that the devices they rely on for activities of daily living or mobility have been manufactured to meet certain minimum safety requirements. However, I think it would be beneficial to our industry as well as to our patients if we developed those quality-assurance standards ourselves. Nobody wants a boilerplate set of standards that interfere with the normal workflow but have little net positive effect on actual quality. Quality assurance parameters should be concise, offer a clear benefit, and be manageable for even a small facility. The American Society for Quality defines quality assurance (QA) as "the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled." It is the systematic measurement, comparison with a standard, monitoring of processes, and an associated feedback loop that confers error prevention, according to various sources. Doesn't this sound like something we should do? Implement a system that says, "This is how we do it," then measure everything we do against it. If it doesn't measure up, we learn why, fix it, and let everyone who may have been affected know about it as soon as possible. That is, of course, easier said than done. The basics of QA are to make sure the patient is protected, ensure a smooth workflow, analyze failures, and contribute to good business operations. By focusing on these primary factors, we make sure every job is done as efficiently as possible and that when a problem does occur we can minimize the potential impact. Most of these efforts are things we already do in some form or another; the trick is to make sure we have a written plan of action and we train our staff to ensure it becomes a part of our company culture. To protect the patient, we have to make sure that we have the information we need to complete the job successfully, that we complete the job following a standard procedure, and that we document the output. By developing a system that allows us to document our input, fabrication, and output, we know the device was fabricated in a thorough, safe, and efficient manner. Most importantly, it allows us to track any problems that might arise and, in the event of a product malfunction, to advise any other patient who might have received a similar product of the potential for failure. Instilling a culture of quality is the best way to smooth workflow. We know for a job to be completed in a profitable manner we have to produce as few in-house errors as possible. Any time a job has to be restarted or a process has to be repeated but the device doesn't leave the facility, we consider it an in-house error. Even though these errors have no immediate impact on the patient, they cost us as a company. Wasted man-hours and wasted materials impact the profitability of a company and, most importantly, they increase the amount of time required to get a device to our patient. Nobody likes to admit when he or she has made a mistake, but admitting and examining mistakes is part of a continual process improvement, and everyone benefits. Any time an error does occur I have found it is most often the result of poor process or poor training. By installing a checklist for every process, you can often thwart the potential for mistakes. It is also beneficial to document errors. Write them down so that you can easily see where mistakes occur in your processes and make whatever changes need to be made to reduce the potential for the same failure occurring in the future. Running a business well is essential. That goes beyond just paying the bills; it means making sure you have plans in place to train your employees in the basics of safety, fabrication, and inner-office systems and that there is a continuous, clear pathway to advancement. Everyone you work with wants to do a good job. They want to be known for producing safe, high-quality products and know what else they can do better to help the company grow. Most of the time when people speak to me about QA it is coming from the standpoint of potential government oversight, and it is rare that anyone is enthusiastic about it. Let's face it, this stuff takes time and energy, and most of us are doing okay without it, so do we really need it? Well, yes, I think we do. I know there are a lot of things I would rather do than fill out forms, spend hours and hours reviewing employees, or conducting fire drills or safety meetings, but these things need to be done to move the business of central fabrication forward. The extra effort is necessary to make sure this industry lives up to the claims of being a real science and a viable manufacturer of health-related items. We have to take a hard look at how we operate. I can imagine at some point the people who assembled airplanes thought it was silly to put lot numbers on all of the components or go through Federal Aviation Administration (FAA) inspections, but those processes have made that industry one of the safest in the world. And I, for one, appreciate that. I can't help but think when the same mindset is applied to O&P fabrication, our patients would appreciate it as well. Tony Wickman, CTPO, is the CEO of Freedom Fabrication, Havana, Florida. He can be reached at tony.wickman@@freedomfabrication.com

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