Quality Assurance: Fabricating the Best Device Every Time

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By Maria St. Louis-Sanchez

Paying close attention to quality assurance (QA) is a necessity for O&P central fabrication labs. Having a good QA process in place helps them produce consistently good work, be more productive, reduce waste from mistakes, and promote a good reputation and repeat business. Most importantly though, the experts say, is that QA helps ensure that patients can safely rely on the devices they depend on to remain active and perform activities of daily living.

"We're dealing with human beings and are making things that provide them structure or support," says Ronnie Graves, CO, BOCPO/L, RTP, president of Prosthetics Research Specialists (PRS), Bushnell, Florida. "We can't be making mistakes."

Labs are not currently required to adopt quality standards and processes, and as a result, a device made by one lab might be entirely different from a device made by another even when presented with the same patient data. This is a problem for the patient and the industry as a whole, the experts say.

"It's such a small field, and it's so scattered," says Alex Stein, cofounder of Motion Unlimited, New Hope, Minnesota. "Fabrication facilities vary greatly, from someone's garage to the larger companies. It would be nice to have something in place where it doesn't matter how small you are, but you still have a basic set of quality standards. Then the practitioner could sleep soundly at night." Adopting these standards is more than just good business sense. The technicians and business owners The O&P EDGE spoke with speculate that in the future, having a QA plan won't be optional.

"One day our industry will wake up and realize that the FDA [U.S. Food and Drug Administration] will demand this documentation from us, and it won't be a choice," says Graves.

Rachel Friddle-Johnson, CPO, president of Friddle's Orthopedic Appliance, Honea Path, South Carolina, says the transition is already happening. Medicare currently requires that custom spinal orthoses be approved by Medicare's Pricing, Data Analysis, and Coding (PDAC) system, and soon enough she thinks that Medicare will require fabrication labs to meet certain standards if they want to make devices for those patients. "We're already seeing Medicare get involved, and it's just going to be a matter of time before that involvement turns to other areas in the orthotics and prosthetics world," she says. "At some point Medicare is going to say that if you send this to a central fab, you have to send it to a fab that meets certain requirements."

While the experts all say that instituting a QA plan is necessary for fabrication labs, the challenge is creating systems with the resources the labs already have.

The Challenge

Making one quality, dependable device isn't the challenge, experts say. The challenge is turning out many custom devices quickly without wasting materials or manpower while ensuring that all of them are well made and safe to use.

Accomplishing that goal requires organization, a standardized system for how devices will be produced, and employee buy-in to follow the system while doing the work, says Greg Mattson, CTPO, CPA, CEO of Fabtech Systems, Everett, Washington.

"If you go to McDonald's and you order a hamburger, you are expecting the relatively same hamburger 100 percent of the time," Mattson says. "Imagine if every employee was making a hamburger the way they wanted to make it. When you are making things, each employee needs to be making what the company agrees to make. It's challenging for O&P because each person is different, and each device is slightly different than the last." Still, he says, the effort is worth it in the long run. The patients and practitioners are happy because they have good devices, and in the end, business has improved, he says.

"We saw massively improved fabrication times because things were standardized," Mattson says. "We were better able to schedule times to complete jobs because we knew how long they would take. You are not guessing."

While QA plans can vary greatly depending on the size of the lab and what is being manufactured, all labs should work toward these five goals:

  • Tracking everything
  • Standardizing every process that can be standardized
  • Testing throughout the process
  • Training employees well
  • Having open communication with practitioners

Track Everything

Stein and Jason Kimmel, also a cofounder of Motion Unlimited, aren't exaggerating when they say they track everything. From the moment they get a package from a practitioner, everything is documented. Their employees take digital pictures of the contents, the project is assigned a number, and everything is put in the same bin-where it will stay until the finished product is shipped out.

Before anything is fabricated, it is first built on paper with step-by-step instructions listed for the technicians to follow and check off as each step is completed. Once fully constructed, the device is examined and compared to the instructions before being shipped to the client.

At any point in the manufacturing process, Stein and Kimmel can tell you what stage the device is in and what kind of quality checks it has already gone through. For every device that has been shipped, they can tell you who made it, exactly how it was made, the products and materials that were used, and each step the device went through during the manufacturing process.

Sound like a lot? Yes, but they say it's the best way they've found to ensure that no device falls through the cracks and each is given the same thorough treatment.

"You have to remember that people depend on and use our devices day in and day out, so they have to be reliable," Stein says. "You make certain that your devices are reliable by ensuring that the processes you have in place are correct and repeatable."

It's even important to track when things go wrong, because that can point out potential problems that need to be addressed, Mattson says. When something goes wrong with a device from his lab, the cause of the problem is inputted into a database. He is then able to analyze the information and spot trends. For instance, if one employee tends to be at fault for mistakes more often than others are, then he or she might need additional training. If there's a recurring problem with materials from a certain supplier, then it might be time to rethink that relationship, he says.

Standardize Every Process Possible

Using the word "standardize" alongside the word "custom" in O&P may seem confusing, but it's necessary for fabrication labs to do just that. While the sizes and shapes of devices may change, many of the steps it takes to physically put them together can be standardized and perfected over time, the experts say. By figuring out the best materials for the various jobs and the best way to handle materials, there is less room for error and waste.

"Our company reviewed all of the processes that a device goes through, broke them down into their simplest forms (e.g., alignment transfer, plaster fill, etc.), and standardized each step," Kimmel says. "We deal with the variabilities as they arise while still adhering to our standards. This allows us to fabricate the devices the same way every time."

Graves cites another example of consistent procedures. Technicians at PRS have a standardized way to measure the resin they use for their products. If this weren't the case, then there could be problems. "Some technicians will use a scale and put in exactly 2 percent, and some will just grab the tube and squeeze it into a cup and they are estimating," he says. If each technician does it differently, then the molecular strength of the resin will change from device to device. He continues, "We have to prevent that from happening. We need to standardize it so we are always exact."

Test During Manufacturing, Not After

One of the worst mistakes a lab can make is to wait until a device is finished to ensure it was fabricated correctly, Mattson says. "Most companies check quality at the end, which is the wrong [time], because then you [could] have to start all over again." Instead he recommends a system of checks built into the manufacturing process. With this system, the technician can't move on until the check is completed, and if something does go wrong, time and money are saved.

"If there's a problem with the second step, then you are only going back two steps to fix a mistake instead of 20 steps at the end," he says.

Mattson suggests that labs have a standardized quality checklist for devices instead of individual ones for different types of devices. "You don't want to have 50 forms for 50 devices," he says.

Tony Wickman, CTPO, CEO of Freedom Fabrication, Havana, Florida, says that he is able to test products during the manufacturing process by having different technicians complete the different steps. "It's individualized, so things move from one group to another group," he says. "That way we are constantly checking the work ahead of us. If something goes wrong, we can figure it out and go from there. We don't have to start over from scratch."

Train Employees Well

Even if you have the best QA system in the business, it won't matter if employees don't stick to it. But getting technicians to follow a standardized system-instead of how they might think a device is supposed to be fabricated-can sometimes be a challenge, Graves says.

"Technicians are an individual breed amongst themselves," Graves says. "They are very independent and think their way is the only way. They can get insulted when you ask them to document."

To help get everyone on board, Kimmel says, he makes QA everyone's responsibility. Technicians are encouraged to come up with better and more efficient ways to make devices, he says. "When you involve them in the process, you will see that the technicians will start coming up with the improvements themselves," he says. Mattson says that quality improves if employees are allowed to contribute their ideas because they are the ones who work the closest with the devices.

"One thing I know as an owner is that I listen to my employees because they do a job that I don't do," Mattson says. "If an employee has a better way of doing something and can prove it, they have a way of changing the system."

The business owners we spoke with all agree that proper training is essential to technicians being able to do their best work. A good QA plan has standardized training to ensure all the technicians have the skills they need and know the processes of the lab in which they work, and to eliminate knowledge gaps from person to person.

Stein and Kimmel say they start newly hired technicians slowly and make sure they master one step at a time before moving to the next.

"Some of the more complex devices you don't see every day, and it can be overwhelming to tell someone to build it from the start," Stein says. "But when we break down the processes into smaller steps, we give the [less-experienced] technician a feeling of accomplishment."

In many cases, having a standardized system helps with training, Mattson says. Since all of the processes and how to execute them are somewhat similar, it's easier to train an employee to follow the steps. "Otherwise you are letting new employees come in with their own ideas and they might be trying to reinvent the wheel five times, and in the end you are paying for it," he says.

Ask the Practitioner

Having a system to track paperwork and devices isn't everything, the experts say. If the information the lab gets from the O&P practitioner is incorrect or lacks important details, then the device could be made incorrectly or different from the practitioner's expectations. It's important for the lab to follow up.

"You need to ask questions, and you cannot assume," Kimmel says. "Oftentimes, what the practitioner has in his head and what we have in our head can be two different things."

Wickman says there's a lot of information that can be incorrectly communicated or left out entirely, and labs need to ensure they know exactly what practitioners are expecting before they start to make devices. "The practitioner, as a general rule, is under fire, and they sometimes forget [to add certain details or instructions]," he says. "Most of the time when we pursue that information, they are glad we did. It's never a confrontation. It's an 'I forgot to put that on their form. Thanks for calling me.'"

That said, getting the necessary information is often one of the hardest jobs for the labs, Wickman says. His lab has what he calls a "triage person" who looks at what the practitioner has sent, makes a list of all of the information that is missing, and then calls for clarification. "Then the project is effectively on hold until we have everything we need," he says. "It's a drag, but it's better than doing it twice. It's a huge component of our job. We are on the phone most of the day."

Look to the Future

Sometimes, the best way to produce consistently quality products is to use the latest technologies.

For example, technicians at Friddle's use a computer-aided software program with a laser to scan the inside of a socket so the measurements can be kept on file without having to store a plaster mold. They use a machine to braid carbon fiber over a mold to lay it down properly and consistently with no waste. And technicians use a digital vertical alignment fixture, which not only allows them to record and save the alignment, but also allows them to save multiple alignments with the same fixture and to go back and make adjustments as needed.

Using this technology does not eliminate the need to have qualified employees, Friddle-Johnson emphasizes. "You still need people to do all of the parts and the process, it's just [that] we've been able to save and capture what's been done," she says.

While not all labs will be able to afford the latest technologies, that doesn't mean they can't take other steps to ensure that they manufacture quality devices. Indeed, the future of O&P fabrication labs may depend on the steps they take now to ensure they are producing the best work possible, she says.

"What we are fabricating is going on the patient, so there needs to be some kind of accountability for the facility to ensure they are operating under good business practices."

Maria St. Louis-Sanchez can be reached at .