Making the Quality Journey
Regulatory Pressures, New Standards Ignite Industry To More Carefully Consider Quality System Updates
Andy Teng - Editor
 Photo courtesy of B. Braun Medical OEM/Industrial Division |
Regulatory Pressures, New Standards Ignite Industry To More Carefully Consider Quality System Updates
As any medical device manufacturer knows, getting a product to market can at times be a Herculean effort. There is a plethora of obstacles, from brainstorming a successful design to winning FDA approval to securing reimbursement coding. That's why the linchpin of device manufacturing is sometimes overlooked.
Developing and maintaining a top-notch quality program-no small challenge in organizations of any size-should be a priority for all manufacturers. The reality, however, is that many companies fall short of fulfilling their obligations because of resource constraints, misunderstanding of regulatory requirements and just plain ol' complacency, according to a number of quality consultants who work with medical device clients.
As a result, many companies find out about gaps in their quality systems only after it's too late, like when an FDA inspector shows up at the door. Some have operated for years or decades a makeshift quality program that worked well until a problem occurred. Then there are the small and virtual firms that have simply focused all of their resources on product approval or funding and made quality an after thought.
Even large companies, especially those experiencing fast-track growth, can fall down on the job when it comes to maintaining a comprehensive quality program. Some firms grow so quickly that there just isn't enough time to adequately staff their quality team, some observers point out. Others have so many subsidiaries operating under so many regulatory agencies that their quality programs simply become unwieldy.
Small or large, though, what seems to be forcing medical device companies to pay more attention to their quality systems is rapid changes in regulations and enforcement of those rules.
Regulatory Pressure
"There has been clear regulatory pressure and [growing] awareness that quality systems are key elements of regulatory compliance," said Rene van de Zande, the president and CEO of Emergo Group, which provides quality consulting, training and other services to medical device manufacturers in the U.S. and Europe. "There is growing awareness because of the push from outside and domestically."
Van de Zande said the proliferation of medical device regulations in North America, Europe and Asia is forcing companies to sit up and take notice. Coupled with constantly evolving ISO standards, these rules have led many companies to more actively think about their quality programs. He and other observers point out that the industry today has come a long way from years past, when quality systems often sat in a manual on the shelf. Although many manufacturers still view the maintenance of their quality system as a once-a-year affair, others are beginning to understand that quality is an ongoing, dynamic process that needs constant attention.
For instance, Canada and Europe will adopt ISO 13485: 2003 next year. Medical device companies participating in those key markets must become certified in Canada by March 15 while in the EU the deadline is July 15. (Although the EU's Medical Device Directive (MDD) doesn't specify adopting 13485:2003, many companies opt to because it conforms with Annex II of the conformity assessment procedure.)
Because of these looming deadlines, many manufacturers have become more aware of the need to keep their quality systems up to date. Often, they call in consultants to perform a gap analysis and prepare them for internal audits, which are pivotal to any successful program. Additionally, they look for training assistance so that employees come up to speed with current standards, regulations and best practices.
"A number of companies are considering or conducting major renovations to their quality programs, asking such questions as, 'What is the status of our quality program? Do we have quality gaps?'," said Schuyler Ritter, executive vice president of marketing and sales for Beaufort Advisors in Norfolk, VA. "Managers realize how important quality is and how costly quality lapses can be. Things are changing so fast in this industry that business leaders are taking a hard look at their systems and asking if they are still current." Not staying current can have severe repercussions. As several U.S. companies can attest, not only are the FDA and federal and state prosecutors becoming more aggressive in pursuing violators, but the growing number of product liability and whistleblowers cases underscores the importance of maintaining a sound program.
"The FDA makes examples [of violators] as part of its enforcement. You hammer one company pretty hard and the others around them will pay attention," said Brent Noblitt, co-founder and senior partner of Irvine, CA-based Noblitt & Rueland, a firm that provides regulatory and ISO training and consulting. He said manufacturers get the message when they see others in the industry hit hard by warning letters, fines and seizures. And as the fines grow bigger, the message gets louder.
But it's not just fines that motivate companies to invest in quality programs. Just the threat of a 483 letter-the FDA notification which signifies problems discovered during a site inspection and a precursor to a warning letter if those problems aren't mediated immediately-can send quality managers scrambling to find a fix. They know that failing to shore up quality gaps can ultimately lead to the loss of their site registration.
That's what happened with one client of Plymouth, MA-based Quality Assessment Services, a consulting firm that helps companies build quality systems and provides other related services. Dan Whelan, the president of the company, said one of his clients lost its FDA registration because it had failed to maintain an adequate program.
Whelan, who is putting together his 20th quality program, said the challenge facing small and startup companies is that they just don't have the necessary resources. As a result, quality programs often suffer from neglect.
"Their primary responsibilities forces them to focus elsewhere," he said, adding that at times companies try to take shortcuts that can cause bigger headaches later on.
Ask most consultants and they'll say there are no shortcuts when it comes to building a sound quality system. That also means that management must make a commitment to actively update manuals, train personnel and perform audits.
Where to Start?
While most medical device manufacturers have quality programs in place, they often don't realize deficiencies exist until a problem creeps up, said Ron Johnson, executive vice president of Rockville, MD-based Quintiles, an international consulting firm. Johnson noted that although there is more emphasis on quality these days, many firms simply don't actively search out those deficiencies. More likely, they are only made aware when a recall occurs, a backlog of complaint investigations piles up or some other precipitating event unfolds.
"In our experience, there is some benign neglect," he said, adding that many companies call in the services of a consultant to help with resolving issues such as problems with the Corrective Action/Preventative Action (CAPA) portions of their system.
To help companies identify potential problems, consultants typically begin the task by performing a gap analysis. An initial examination of a manufacturer's quality policy, manual and processes can reveal shortcomings that can run afoul with regulators. They then compare actual practices against those stated in the manual or standard operating procedures to determine whether employees really adhere to their own policies. A plethora of issues should be audited, from complaint handling to employee training to outsourcing agreements. Many of these issues are often at the root of quality system woes, said Johnson.
A common mistake that companies make when they implement a quality program is to buy a set of procedures and make them fit their business. Often, these off-the-shelf manuals are not customized for a particular company's operations, so adopting them requires a lot more effort than anticipated. Dan Kamm of consulting firm Kamm Associates in Deerfield, IL said many firms also forget to follow the procedures once they have implemented them. "They are just trying to get by," he lamented.
For some of his clients, Kamm said he customizes commercially available procedures for each operation. This way, the companies can minimize costs while still implement quality procedures that fit their needs.
Training Considerations
One particularly thorny issue that many companies fail to address adequately is the training of employees, said Judy Andrews, manager of quality and compliance systems with Medical Device Consultants, Inc. (MDCI), a North Attleboro, MA-based consulting firm. She said regulators have become more concerned with manufacturers ensuring that their workers are adequately trained to meet the demands of their job.
"One of the issues that I think is catching a lot of people off guard is the training requirements," she said, pointing out that ISO standards such as 13485:2003 also address training requirements as part of quality. "Most notified bodies are looking for an active effort in making sure that people have the training they need and that the training works."
But the difficulty inherent with training is determining how much is adequate. Under FDA's Quality System Regulation, Part 820.25, section b (which addresses personnel issues), the agency vaguely mandates that training is required. It reads: Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
"It's very nebulous," Noblitt said of the language, pointing out that each manufacturer must determine what is considered "adequate" training.
He added that there are many facets to contemplate. For instance, should employees receive only enough training to function within their department or job responsibilities or should they have a broader understanding of related services? Also, not all training is the same. Understanding the requirements of a machine operator, for example, is vastly different from employees who may be involved in risk management, which requires more analytical skills.
Additionally, how companies follow through after training takes place is another consideration.
"You can grasp it, but unless you actually do something with it (the training), you can lose it," Noblitt added.
Some consultants point out that many of their clients' employees understand their jobs well, but there are gaps in their knowledge. That's why it's important for companies to promote continuous education-through in-house training by staffers or consultants, conference attendance or enrolling in courses.
Training is one of the issues covered under ISO 13485:2003, which will become the required standard in key foreign markets next year. Because the new standard is significantly different from the previous version, ISO 13485: 1996, and from QSR (which is procedure-based instead of process-based like 13485:2003), many companies are struggling to grasp and implement the new standards.
Because 13485:2003 more closely integrates regulatory compliance with quality programs, this shift has caused palpitations for some quality managers, said Pete Gonzalez, the business development manager for Lloyd's Register Quality Assurance (LRQA), whose Houston-based U.S. headquarters provides registration services to 13485 and European standards.
He pointed out that both European and Canadian regulators are also seeking a greater integration of quality programs with regulatory compliance. That's also one reason why both markets have mandated the adoption of ISO standards.
Andrews said many of her clients these days are trying to implement ISO 13485 into their systems, but there is much confusion in the industry. Some are uncertain about how this would affect their compliance with QSR.
"A lot of companies are 13485:1996 compliant. They are asking for help with the transition," she said. "It may be anything from doing an audit to companies saying, 'How do I do this?'"
Indeed, implementing new ISO standards is a difficult task because of myriad issues to consider. Gonzalez said a critical decision companies with multinational sites face is how to implement a registrar system for all of their facilities. Should one system cover all sites or is there less risk to using different registrations for different sites? These are the questions that device makers should ask themselves.
"Each [approach] has its own set of challenges and each has pros and cons," he said. "There's more of a drive for big companies to consolidate under one registration for cost reasons and consistency."
Outsourcing Concerns
One area of quality systems attracting much attention these days is the impact of outsourcing. Whether it's vendor audits or CAPA conformance, manufacturers can get in trouble if they fail to extend their quality system requirements to vendors, some consultants say. It's an issue that affects large and small companies alike.
"The finished device manufacturer has the responsibility to make sure there is a sufficient level of quality," said Johnson at Quintiles. "More often than not, we are working with the finished device manufacturers to get their suppliers in place."
Johnson, whose company is often called on to perform vendor audits, noted that contract manufacturers at times fail to understand that the QSR may apply to them as well. In fact, he added, one client came under FDA enforcement action for failing to ensure that its subcontractor met QSR obligations.
The benefit of becoming ISO certified is that auditors often look to review and possibly audit outsourcing agreements to make sure they comply with regulations, said Andrews, whose company also regularly performs audits of vendors for their clients.
"Those are the two issues you can get into trouble for-losing real control of your process and failing to monitor your contract manufacturers," she added.
With outsourcing growing in the medical device industry, OEMs are likely to increasingly address vendor issues in their quality manuals.
As updated standards come into effect and new regulations are issued, the medical device industry will need robust quality systems to meet these mandates. Although maintaining an effective program takes commitment and effort, manufacturers will almost certainly rather make the investment than become one of the examples made by the FDA and other regulators around the world.
