FDA reminds device companies that they must control environmental conditions for both products and manufacturing facilities, or risk tough regulatory penalties. “Clearly environmental controls are important, and FDA will and can take major regulatory action when environmental controls aren’t being adhered to,” FDA/QSR expert Kim Trautman told Elsevier’s “The Silver Sheet.”

Procedures to control environmental conditions are required under Quality System Regulations 21 CFR 820.70, Production and Process Controls; Environmental Control. Environmental control “is not just about a manufacturing facility being clean,” Trautman points out.

John Avellanet, managing director for Williamsburg, Virginia-based FDA compliance consulting firm Cerulean Associates LLC, recommends that manufacturers start by reviewing ISO 19011:2002, a standard created by the International Organization for Standardization (ISO). ISO 19011 provides guidance to auditors for conducting environmental management system audits, among other auditing topics.

The standard will “tell you what the auditor or the investigator is going to look at from an ISO perspective,” Avellanet said.

“Whether your company is ISO-certified or not, the important point is that this standard gives you a very broad base of all of the environmental control issues that the auditor is going to be checking for,” he said.

Controlling Environmental Conditions Depends on Communication

Communication is key for device manufacturers as they attempt to ensure that facilities meet FDA’s environmental control requirements.

At many firms the facility manager is in charge of environmentally controlling the facility. An official from the quality assurance department would make sure that person is appropriately handling those duties by conducting internal quality audits.

“Everybody that has a task associated with environmental controls – whether it’s electrical environmental controls, HVAC [heating, ventilation, and air conditioning], the clean room, pest control or any other facility-associated things – should get together and coordinate and talk on a regular basis,” consultant Avellanet said.

However, employees tasked with ensuring that facilities stay clean and pest-free sometimes become busy and unintentionally let problems slip through the cracks.

“The responsibility for keeping things clean ends up being delegated down the chain of command,” Avellanet told “The Silver Sheet.”

“There is the person who is in charge of the overall facility, and he knows that maintenance schedules, cleaning schedules, pest control schedules – all of those types of things – have to tie together,” he said.

“Once you delegate that down to the head of maintenance, and then the head of calibration, and then to the head of pest control, for example, those people aren’t seeing all of the other pieces and parts, and a lot of times they may not be sharing information that the other person might need,” Avellanet said.

For example, a firm where Avellanet once worked was infested with mice. “You really wouldn’t think this would be too serious of a problem because they found the infestation of mice, and they cleaned it up, and so forth,” he said.

Nevertheless, it became a larger issue because no one informed the person in charge of the HVAC system about the infestation.

“The HVAC guy said he wished he knew earlier about the infestation because his team had just changed the HVAC filters a week before and they weren’t going to be changed for another three weeks,” Avellanet said. “Had he known that they had uncovered an infestation of mice, he would have much more rapidly changed the filters.”

Avellanet related an environmental control communication problem that plagued another company: “We were doing work in the QC [quality control] lab that required very specific voltage and electrical power. Meanwhile, the project engineer for a building add-on was using many power tools. What happened during this very specific time during the day is that the environmental conditions associated with electricity were poor. We were getting all sorts of flaky results for two hours during a specific time of day, and we couldn’t figure out what was causing the problem.

“About a week later a person from the lab told the story to a facility employee during lunch,” he continued. “The facility employee said, ‘Maybe it was related to the fact that we were doing all of this construction about 30 feet from you on the outside of the building.’ That was the answer: Both were tied into the same electrical circuit.

“Those are the little things that happen when things are delegated down,” Avellanet said. “Things fall through the cracks because there isn’t a high level of cross-communication. It’s not because people are withholding information, but it’s because they don’t recognize that the information could have potential environmental impact.”

“Communication could just be in an e-mail to everybody,” Avellanet said. “For example, the e-mail could state: ‘I noticed a big patch of black mold on HVAC filter No. 4, which is right over the chemical storeroom. Bill, you’re in charge of the chemical storeroom, so I thought you should know this.’ That’s all it takes. You’d also obviously let the quality assurance people know, but the point is that you should keep folks informed.”

Slew of Standards for Environmental Control

Because FDA doesn’t specify how manufacturers should control their environment, firms typically turn to international standards to fill any gaps they may have in their processes and procedures.

“When you have an area like environmental controls that is standardized and regulated more heavily, then there tends to be an expectation of better industry compliance, especially when expectations in standards are laid out with clear-cut specifications,” FDA’s Trautman said.

Most industry standards related to environmental control are extremely specific to particular products or processes.

For example, “there is a USP [United States Pharmacopeia] standard for purified water. The FDA considers anything from USP to be good science and something to be relied on,” consultant Avellanet said.

“Or, depending on the type of disinfectant cleaner you’re going to use, there is USP 1072, which is a guidance on disinfectants,” Avellanet said.

Further, the U.S. Occupational Safety and Health Administration (OSHA) “has different standards for air filtration, depending on whether a building is an office, an open warehouse, etc.,” he said.

The challenge for manufacturers is not finding standards to use; rather, it’s determining which are applicable to their particular situations.

“If you go to ISO’s website and search ‘environmental controls,’ you’ll come up with hundreds of standards,” Avellanet said. “And that’s just ISO. You still haven’t gone to OSHA; you haven’t gone to USP; you haven’t looked at biomechanical engineering standards. There are so many standards that it can be overwhelming.”

Faced with so many choices, Avellanet said manufacturers can identify standard they need by carefully reviewing the controls and asking, “Are those the ones we need? Is it too much? Is it too little?” This is where bringing in someone with a broad base of independent experience can be helpful.

“That is a very good approach, but very few firms take advantage of that,” Avellanet said. “You can even do a pre-implementation audit such as a process and controls review, where you or someone outside the organization does review to their understanding of the process, the controls, and their experiences – and then compares that to the regulatory requirements.”

Under the consent decree, Cerulean will perform regular quality systems management reviews to ensure that Dr. Comfort’s manufacturing processes and controls meet the rules and regulations associated with diabetic footwear medical devices.  This review will help ensure compliance with the Medicare reimbursement rules and regulations.

“Our goal is to ensure Dr. Comfort’s compliance with HHS requirements,” said Cerulean’s Managing Director and Founder, John Avellanet. “And as with all of the firms we help, we want to make sure to strike a practical balance between compliance and cost. The key is to ensure all the terms of the corporate integrity agreement are met, and preferably in the least burdensome manner. This will help position Dr. Comfort products for success in the wider global marketplace and regulatory landscape.”

Much as with its other clients, Cerulean will rely upon a blend of qualitative and quantitative methods to assess compliance. The first step is to take a qualitative approach to analyze the manufacturing and reimbursement processes and controls. Such a review asks a simple question:  Should the processes and controls, as written, work?

The next step is to take a quantitative approach, reviewing records and data that serve as proof that the processes and controls did, in fact, work as expected. This approach uses record sampling to provide a 95-99% degree of confidence that the processes and controls are working as intended.

Cerulean’s blended approach to auditing processes and reviewing compliance controls provides enough information, and enough confidence in the reliability of that information, to make reliable judgements at reasonable costs.

About Cerulean Associates LLC

Cerulean offers expert FDA quality systems and compliance analysis, remediation and improvement consulting. Emphasis is on cost-effective compliance for device and drug companies. Cerulean employs only highly experienced industry professionals and experts to consistently prevent and solve compliance challenges with practical solutions. Cerulean is the only compliance consultancy to offer guaranteed results.

To solve your compliance concerns, contact Cerulean today