A comprehensive set of standards provides a level playing field for your laboratory. Your technicians know what you expect of them, what to expect of you and what to expect of each other; everyone operates from the same handbook. Having standards paves the way for an efficient, well-run organization and is the foundation of a quality management system (QMS).
Implementing a QMS necessitates that you take a cohesive look at your operations and define and document all of your laboratory processes, including technical, administrative and managerial procedures. It doesn't dictate what your methods or quality level should be, but rather guides you in creating a quality assurance plan that's unique to your business.
In addition to helping you comply with the FDA's Good Manufacturing Practice regulations, documenting your operation's "best practices" is an effective business management tool that offers many benefits to your laboratory. Internally, it can result in a more streamlined operation, reduce costs, serve as a valuable training tool and clearly outline the responsibilities of your staff. Externally, it can ensure greater patient safety, increase customer satisfaction and even give you a marketing edge.
Here, LMT takes a look inside three laboratories that are using quality management systems to find out why they implemented them, how they did it, what they've gained and if they believe it was worth it.
FDA inspection prompts one lab to implement QMS
Laboratory owner Robbie Winans, CDT, Image Plus Dental Technologies, LLC, an 18-person laboratory in Dallas, Texas, was caught off guard when, with six days warning, he had an FDA inspection. For four days, the auditor went through a detailed checklist, talked with every employee and watched every fabrication step. The FDA auditor told him he had to get things in order and implement a quality management system to comply with the requirements of the FDA's Good Manufacturing Practices (GMP) and Quality System regulations.
Although the GMP requirements have been in effect since 1997, the dental laboratory profession has flown largely under the FDA's radar. However, the recent dramatic rise in offshore imports has prompted the FDA to take a closer look at dental laboratories and perform on-site—sometimes surprise—inspections to ensure compliance with its regulations.
The specific GMP requirements that are applicable to dental laboratories are outlined in Title 21 Part 820 of the Code of Federal Regulations—also referred to as "21 CFR Part 820" or "CFRs"—and these regulations specify that laboratories must have an established, documented quality system. (For more information, click here to visit the FDA website). However, since the FDA only outlines objectives for a quality system that ensure good manufacturing practices and doesn't specify methods that must be used to ensure compliance, it's largely up to the laboratory owner to figure out how to be in compliance—which is no easy task.
"It's very confusing dealing with the FDA. Their language is totally foreign," says Winans. "Basically, they want you to document everything—the lot number for each alloy and porcelain you use, your fabrication steps, all your remakes, company meetings—and even store prescriptions for 14 years." Since Winans had very little required documentation in place, he knew he needed help. "I felt the only way to come into compliance was to hire a consultant, someone who is familiar with working with the FDA."
Upon the recommendation of another lab owner who also had an FDA inspection, Winans is working with Carter Thompkins, vice president, client operations at Integrated Management Systems (IMS), a quality management system consulting firm. Winans has handed off much of the implementation process to his office manager, Kelli Arnold.
For the past three months, Arnold and Thompkins have been working together to write the procedure manual documenting all of the lab's operations including step-by-step fabrication and inspection processes; how it handles remakes, tracks cases, equipment maintenance and repairs, and maintains records; the responsibilities, authority and training of each staff member; and its quality objectives, and how it analyzes, measures and reviews those objectives. "Everything has to be documented and controlled," says Arnold.
Once these are complete, the owner and supervisors will review and revise the procedure manual until everyone is in agreement on the wording and content. Next, IMS will identify any additional areas that need to be addressed, help develop analytical methods to identify areas that need improvement, train selected staff on internal auditing and help the lab perform the first internal audit to ensure its FDA compliance. The lab can then be audited by an IMS-provided independent auditor and receive a letter that guarantees IMS' services for one year.
Arnold acknowledges that implementing a QMS is confusing at first but after a couple of months, it's all starting to come together. She estimates it will take another six months before every thing is documented and put into practice. "It's a lot of work; some days I spend a couple hours on it. But I think it will be beneficial to our laboratory in the long run. It puts everyone in an organized mindset."
Editor's note: Based on his experiences helping a few labs in Texas comply with the FDA's Good Manufacturing Practices, Thompkins has developed the Crown Program®, a QMS specifically tailored to meet the requirements of the FDA's 21 CFR Part 820. Offered by Integrated Management Systems, the program consists of two two-day seminars and corresponding handbooks, manuals and implementation tools; the cost is $650 for the first course and $450 for the second course. On-site consulting, verification auditing/training and support are also available. For more information, e-mail Thompkins at Carter.T@IMS-Quality.com or contact IMS at 972-671-9590.
ISO: paved the road to growth for New Jersey laboratory
In the late 90s, Kuwata Pan Dent was a 28-person laboratory in Florham Park, New Jersey, with a mission: to grow its business. "We wanted to make sure our growth was controlled and to do that, we needed a system in place that would ensure the consistency of our product and maintain our profitability as well as be used as a training tool as we grew," says Francine Ichijo, marketing manager.
The lab turned to ISO, a quality management system developed by the International Organization for Standardization, the world's largest developer of standards. The system is not specific to dental laboratories; instead, it provides generic guidelines for managing quality and customer satisfaction that can be applied to any type of organization, large or small. "ISO gave us the freedom to create our own system," explains Ichijo, who spearheaded the year-and-a-half-long implementation process.
She worked with a consulting company that put together a consortium of small business owners and managers in New Jersey, all of whom were trying to obtain ISO certification. She also received a grant from the Department of Labor which covered the cost of training and implementing the system. She met with the consortium for one day every three weeks during which she received instruction and shared ideas as to how to implement the system.
Her first step was to write a quality manual showing how the lab would operate in order to meet ISO standards. The manual defines the lab's quality policy, organizational chart and the staff's responsibilities and authorities. It also outlines how workflow and the customer's casework is controlled in the lab.
Next, the lab had to document all of its work procedures, including technical, administrative and managerial responsibilities. "We created a work instruction for every function in the laboratory, complete with diagrams, written instructions and physical samples showing, for example, what the metal should look like after degassing or after opaquing. We went into a lot of detail, definitely more than ISO requires, but we wanted to be able to use the documentation as a training tool down the road," explains Ichijo.
Determining a system of document control was one of the biggest challenges, according to Ichijo. ISO specifies that all controlled documents have to be clearly marked, identified if they have been revised, and easy to locate and retrieve. For instance, if there are three copies of a work instruction form in various locations in the laboratory, you need to know where each copy is at all times so that if changes are made, you can make the revision to all three simultaneously. Once the laboratory found software that is specific for ISO, controlling documentation became much easier.
ISO also provides guidelines for "handling nonconforming product," which—when applied to the dental laboratory setting--refers to how you handle remakes. The laboratory had to carefully examine the frequency of its remakes, pinpoint the causes and develop a plan to take corrective and preventive measures.
Kuwata Pan Dent was granted ISO 9002: 1994* certification upon successfully passing an independent audit by an authorized ISO auditor. In the six years since being ISO certified, the lab has almost doubled in size, sales have increased significantly and it recently purchased a new building that it will occupy next fall. It has seen a noticeable increase in the consistency of its restorations, an improvement confirmed by customer satisfaction surveys as well as a decrease in internal and external remakes.
Communication among staff members has also improved. "Implementing ISO forced us to define everyone's responsibility and authority. Now that these are clearly defined and every staff member knows he or she has the authority to stop a case if the quality is questionable, we have eliminated a lot of conflict," says Ichijo. "We have monthly meetings that include all of our employees, not just the managers, and everyone is made aware of our goals and objectives. Everyone is on the same page."
The lab's ISO certification is good for three years, but it also must have annual surveillance audits conducted by an independent auditor. This outside auditing process has proven to be a valuable tool in marketing to prospective clients. "Dentists worry that the first case will be done by the best guy and then it's downhill from there," says Ichijo. "With ISO certification, we can assure clients that we have a system in place so no matter who touches their cases, they will be fabricated the same way every time."
In addition, the lab conducts an internal audit of a different aspect of the company every three weeks; these audits are mandatory but the frequency, scope and methods are at the discretion of each individual company. Various staff members are trained as auditors; they examine the procedures, standards, documentation and supervision and talk to the relevant staff members to make sure they are complying with the ISO standards and working effectively. The internal audits are a good tool to help make sure the lab is prepared for its annual independent audit. It's also an opportunity to enhance communication among staff members, identify and correct problem areas and recognize employees who are doing something well.
"In the beginning, implementing the system was hard and a nuisance but now it's all worth it. Now that everything is in place, I only spend about four hours a week reviewing quality documentation and following up on corrective actions," says Ichijo.
Editor's note: For more information on ISO, visit www.iso.org.
*The International Organization for Standardization revised its Quality Management Systems requirements in 2000, placing greater emphasis on customer satisfaction and management commitment. All companies that were ISO 9002 certified were required to transition to ISO 9001:2000; Kuwata Pan Dent did so in February 2003.
DAMAS tightens operations at West Coast laboratory
When Mark Jackson decided to implement a quality management system (QMS) last year, he had one main motivation: marketing. Jackson simply wanted a leg up on his competition. "This industry has gotten more sophisticated and there's more competition than ever before. I wanted to differentiate myself from my competitors and be able to say, 'all other things being equal, my lab is held to a higher standard because a third party comes in to audit our quality management system'," says Jackson, owner of 35-employee Precision Ceramics, Montclair, California.
But as the FDA's scrutiny of our industry grows, Jackson says there's another advantage to being DAMAS certified. "If necessary, I can demonstrate to the FDA that I've done my due diligence and what's required to comply with their standards as we understand them to apply to the dental laboratory setting. If they come into my lab, I'm going to greet them with a cup of coffee and a donut and ask them what they'd like to see."
Jackson had experience with an ISO certification system during his years working for an implant manufacturer and felt it would be overprescriptive for a dental laboratory's custom-made products. Instead, he decided to use the Dental Appliance Manufacturers Audit Scheme (DAMAS), the NADL's laboratory-specific QMS which is based upon the quality management principles of ISO 9001:1994. "ISO is a general guidance program intended to help manufacturers of any products comply with the FDA's GMPs," says Jackson. "DAMAS was written solely to address the special needs and conditions found in the dental laboratory and I believe it satisfies FDA requirements, while not being overly intrusive for the laboratory." Originally developed by the United Kingdom's Dental Laboratories Association, the NADL has the rights to market and sell the DAMAS system in North America.
Jackson attended a DAMAS information session, and bought the system which consists of two manuals and a CD with templates for creating your own documentation. After reading through the materials, he decided to bring in a quality assurance expert, David Lawrence of Lawrence-Hall Consultants. "The materials use a lot of acronyms and a lot of it went over my head, so I decided to bring in help," says Jackson. "I asked David to go through the lab, look at everything we do here and help me with the parts I didn't understand. Basically, I said, 'I want you to do a mock inspection and anywhere I'm non-compliant tell me what I need to do to be compliant'."
For Jackson, this was the most stressful part of the process: not knowing how much work would be involved in documenting his operations. But he was in for a pleasant surprise. Since the lab already had documentation and a number of controls in place he simply needed to tighten those controls to meet the system's requirements. One key time saver was not having to document the lab's fabrication procedures: because he follows manufacturers' techniques to the letter, he can use the manufacturers' user manuals for all of the lab's step-by-step processes.
Here are some of the main areas Jackson had to address:
Purchasing: While the laboratory already had a comprehensive inventory and purchasing system, it needed to incorporate a method for inspecting and tracking incoming materials to ensure they matched the products ordered. "The solution was fairly simple and quick. Now, a person inspects the incoming shipment, then stamps the invoice and signs and dates it to verify that it was checked, and copies of the invoices are placed in a special file," says Jackson.
Case tracking: The lab needed to be able to track a case's "chain of possession," meaning it had to document which properly trained and qualified technician handled a case from the time it arrived at the lab until it went back out. The lab used barcoding software, but it allowed a technician to barcode a case even if the previous technician had failed to do so. To remedy this problem, Jackson contacted the software manufacturer and asked it to create an additional module that wouldn't allow a case to be barcoded out of sequence. The manufacturer e-mailed the module, the lab downloaded it and its DAMAS requirement was met.
Equipment maintenance: To show that his equipment is properly maintained, Jackson implemented a written equipment and maintenance calibration log that details when equipment is repaired or calibrated. This duty is now handled by the maintenance staff which is responsible for equipment repairs.
It took Jackson and his consultant a day to review his operations and implement solutions. Several weeks later, Precision Ceramics was audited and DAMAS certified by Anglo Japanese American (AJA) Registrars Ltd., the company responsible for conducting independent third-party DAMAS audits and granting certification. According to the NADL, there are currently three DAMAS-certified laboratories in the U.S. with 20 more expected by the end of the summer; Jackson's lab was the second to receive certification.
Overall, Jackson spent about $4,000: $150 for the DAMAS materials (the fee is $300 for non-NADL members); $1,300 for the consultant (he split the $4,000 fee with two other laboratories); $1,000 for the certification audit; and another $1,500 for the DAMAS information session, flight to the session and time invested in research. Every two years, he will spend another $1,000 for the audits necessary to maintain his certification.
So was the investment worth it? Absolutely, says Jackson, who notes that the quality system has resulted in a real boost to the lab's quality, consistency, customer service—and its bottom line. For instance, the new equipment repair log allows him to tell at a glance which pieces of equipment are becoming a drain on the budget. "Instead of continuing to repair and invest money in these problem pieces, we retire them and buy new equipment. I've replaced two porcelain furnaces, three handpieces and a model trimmer this way and I estimate that we'll save between $3,000 and $5,000 per year in equipment repair and maintenance," he says.
Customers also appreciate the changes they see. For example, the laboratory now uses a new packaging system that explains the restorations' indications and contraindications, preparation and cementation guidelines, the exact names of the materials used, the manufacturer of that material, and details on how to contact the manufacturer if they need further information. "We have gotten many, many calls because of this. Some clients just compliment us on our thoroughness, while others are surprised to learn they've been using the wrong technique to cement or bond a given restoration. It has improved communication greatly, and reassures them that they are getting the genuine product and not a cheap imitation," says Jackson. "This started as a marketing feather in my cap. I didn't realize what a huge benefit it would be for my lab."
Editor's note: For details on DAMAS, contact the NADL at 800-950-1150 or http://www.nadl.org.