In 2007, a plant manager for Rockwell Medical overruled the facility’s QA manager and released a product that did not meet Rockwell’s own quality standards. The result of this encounter comes out in the Establishment Report (EIR), where the FDA stated, "Employees who manage, perform, and assess the work affecting quality have not been assigned the appropriate authority and responsibility to accomplish their work."

These two examples clearly show that the FDA will hold medical device manufacturers responsible for following regulations related to quality assurance and regulatory compliance. The key to that mandate is the need for QA personnel to possess the “independence and authority” that will enable them to monitor the manufacturing process and, if needed, stop products from going out the door.

The reasons for this regulatory state of affairs are well understood. Generally speaking, consumers can make informed buying decisions about a host of products, from automobiles to shoes. But healthcare consumers can’t always make the same knowledgeable determinations about the stents, heart valves, and other devices that literally affect their health and safety.

Regulatory agencies such as the FDA and notified bodies are there to hold device makers to safety and effectiveness standards. When the U.S. Congress passed the Pure Food and Drug Act in 1906, its intent was to protect the public from unhealthy, and possibly life-threatening, meat and other products. Two federal cases—U.S. v. Dotterwich and U.S. v. Park—later affirmed that intent and emphasized the legal obligations of FDA-regulated product manufacturers.

Well-run device makers understand the proper role of quality and regulatory professionals. Comment 13 of the Preamble to the Quality System Regulation states that companies must set up their quality systems to consider factors such as design complexity, operations, and the risk associated with a failed device. FDA regulation 21 CFR 820.20(b)(1) requires manufacturers to ensure that the quality assurance professional has the appropriate authority and resources.

Pam Weagraff, the former vice president of regulatory, clinical and quality for MediSpectra Inc. and now principal consultant with Quintiles (Research Triangle Park, NC), says device companies “are organized usually with more focus on their business needs. Understandably.” But, she adds, one aspect of that business orientation that has become “increasingly important over the years” is the appropriate role of quality assurance and regulatory compliance.

“Steven Niedelman, the former FDA Deputy Associate Commissioner for Regulatory Operations and chief operating officer and now a senior consultant with Crowell & Moring (Washington, D.C.), asserts that management should ensure that quality professionals have permission “to just say ‘no’ to prevent poor-quality product from being manufacturer or shipped,  or both.” For device companies “it is essential that QA managers have the appropriate sign-off authority to make decisions aside from other organizational priorities,” he says.

What steps should device companies take to ensure that a QA manager has the requisite independence in practice and not just in theory? “Follow the law,” says Virginia Perry, former corporate officer and vice president of regulatory affairs, quality assurance and clinical at Nellcor, and now a partner at Perry-D’Amico & Associates (Half Moon Bay, Calif.). Furthermore, she says, companies should establish the appropriate internal procedures to ensure that their reporting structure “supports that independence.” For example, they should not have a QA manager report to the manufacturing department.

“Companies should be cautious that individuals not only account to higher levels of management outside of the function they oversee,” says Frances Richmond, PhD, director of regulatory science programs at the University of Southern California. Companies also need to make “active efforts” to document the “rigor of the process,” meet the individuals, and be seen acting on recommendations, she adds.

Elaine Messa, the former FDA district director for the Los Angeles District and now director of medical device quality systems and compliance practice for Becker & Associates Consulting (Washington, D.C.), says that FDA regulations are quite clear about the need for quality assurance independence. “Quality system regulation under management control talks about the responsibility, and it is up to a company to ensure that their decisions management practices allow quality and other functions to be independent,” she says.

If that’s the case, how do firms get cited for not giving the quality function adequate authority? “I think some of it’s because of company culture from the top down,” Messa says. In addition, she says there’s “a natural tension that you’d expect to exist among the various branches or units of operations and regulatory” functions.

Niedelman says “competing priorities” between the quality and operations sides of the device business are the main barriers to smooth cooperation between the two. “Operations wants production to continue at all costs,” he notes. “It’s very metrics driven.” QA is the “gatekeeper” that ensures “production is consistent with policies and procedures and that manufactured product meets specifications.”

According to Richmond, device makers can overcome these obstacles by holding regular meetings, defining common objectives, and emphasizing long-range planning. Evaluating the risks posed by products of poor quality is an additional recommendation.

To relieve the tension, Weagraff recommends that qualify professionals be designated as the management representative. “In that capacity, the ideal reporting relationship, of course, is to the CEO.” She notes that case law supports that concept through judicial rulings stipulating that a chief executive can’t profess that she “wasn’t aware of the situation. That’s not an adequate defense.”

All this protocol isn’t helped by the fact that QA is one company expense that can be difficult to justify during an economic downturn. Bad times tempt management to trim staff and processes, which can be a mistake, according to Niedelman. “QA is frequently looked upon as overhead, because it’s not an income-producing function,” Niedelman says. “Firms have a tendency to pare back—sometimes getting too lean—and get in trouble” because of inadequate or inappropriate QA staffing.

“QA budgeting is tied to the bottom line,” Niedelman adds. “Unfortunately, QA is often one of the first organizations hit during budgetary [cutbacks], because it is seen as overhead.” He calls this approach short-sighted, because it can lead to more costly problems down the line, including recalls, increased liability, and erosion of reputation.

The importance of quality assurance is a critical message that should “cascade down” from top management, Niedelman says. Equally important, company leadership must send the message that “quality personnel have the responsibility and authority to take appropriate steps to ensure that safe and effective product is being manufactured and shipped.”

Is the appropriate level for the senior QA position director, vice president, or senior VP? “This depends on the size and complexity of the organization,” Niedelman says. “I’ve seen it be successful at all three of those levels—as long as the off-setting operations authority is at the same level and scope. Obviously, the higher the level position, the more seriously others will take the role and its importance. It’s increasingly difficult for a director of QA to overrule a VP or senior VP of operations if there’s a difference of opinion with similar line authority. If a director of QA has the autonomous authority to shut down a line, the corresponding operations folks should not have any higher position.”

When asked whether the quality manager has the authority to say, “No, we can’t send this device out into the world,” Weagraff exclaims, “Absolutely.” If a “cross-functional” team is involved in making the device, a regulatory body would look for sign-off on product requirements from the product manager, manufacturing, and R&D, she says. And “they’re going to look very carefully to make sure there’s a signature there from quality and regulatory as well. It would definitely raise some eyebrows [if there weren’t]. It’s a whole concept of checks and balances.”

“If they didn’t have the authority, the FDA is going to climb all over you,” says Mary Edwards, vice president at Minerva Surgical (Cupertino, Calif.). Having said that, she believes it’s “very important” that the quality assurance point person have systems in place that give him the “absolute authority to stop production going out the door.” However, bringing products back “has to be a team decision because it involves more than just quality. In a lot of organizations, quality, sales, or regulatory departments have that authority,” Edwards says, “because they’re looking at different aspects of whether the product is acceptable to the customer.”

Whatever the nature of the QA arrangement and the firm’s oversight of the manufacturing process, cooperation is the key. The QA manager needs to understand the company’s business needs and balance them against the QA responsibilities. Perry of Perry-D'Amico & Associates provides sage advice when she tells quality managers to “be a team member, not a police officer.”

A special thanks to the folks at Sparta Systems for their help with this article. I suggest you check out their blog page for opinions on similar topics.