Ensuring Regulatory Compliance In Technical Information

Regulatory Compliance can be a headache

Regulatory compliance represents a critical and oft-overlooked aspect of developing, managing and distributing technical information. A transaction doesn’t end with the product sale. In fact, post-sale is where some of the most important work happens, and the manufacturer’s greatest responsibility to the customer—providing accurate and transparent information about the product.

Technical information is the backbone of a company’s operation in more ways than one. When it comes to legal compliance, product information is key—and when it comes to product information, supplier expertise provides an important safeguard against potential fines or even launch delays.

“Failure to maintain regulatory compliance can result in lawsuits, fines, even market access restrictions.”

Every company is expected to ensure consumer safety, meet regulatory requirements and mitigate liability risks. In other words, every company is responsible for their own regulatory compliance.

Now more than ever, technical information requirements can be complex and many companies—this is doubly true of startups—can’t afford to make a mistake. A product information supplier forms the first line of defense against inadvertent noncompliance, something that’s more common—and dangerous—than many manufacturers might think.

Noncompliant technical information, even when the nonconformity seems minor, can have significant consequences, including lawsuits, fines, and even market access restrictions.

Look for Proven Regulatory Expertise

Technical information services should serve as an extension of a company’s compliance department. But content experts are not legal experts, so what role should these teams play in helping businesses navigate the conundrum of legal compliance?

FInes and repercussions related to regulatory compliance

We spoke with Gary Ragland, product expert, and Nick Horan, Director of Business Development, for their take on the subject.

“We take a holistic approach to content development,” says Ragland. “That means regulatory compliance with safety requirements and other general tech info regulations is just as important as maintaining technical accuracy.”

“We have the experience and knowledge of global homologation requirements for technical documentation,” says Horan. “With this experience, we’re able to develop market-specific content that’s compliant with various market homologation requirements. This puts a company that much further along when content gets submitted for approval by engineering and legal teams.”

In other words, each regulatory body has its own set of guidelines. A good content team should have the experience and know-how to help navigate those guidelines.

“Each regulatory body has its own guidelines. A good content team will help navigate those guidelines.”

“Staying up to date on regulatory compliance is a never-ending battle, but it’s vital to our customers,” says Ragland. “It entails staying engaged in the industry, attending workshops and webinars, and benchmarking against other manufacturers in the same field.”

Avoiding Accidential Noncompliance

Inadvertent noncompliance happens all the time. And, again, with regulations evolving in real-time even legacy brands might find themselves susceptible.

“Incorrect units of measurement would be the simplest example of inadvertent noncompliance,” says Horan. “For instance, in the U.S., we use SAE, but in other parts of the world, they use the metric system. If you use the wrong one, hardcopy information could be recalled. That’s a lot of expense for a seemingly minor act of noncompliance.”

The revision and updating of legal standards can have a significant impact on the way companies need to present product information. This year saw sweeping modifications to EU tech info regulations, modifications which impact the types of information a company is required to offer, how that information needs to be packaged, and the amount of time for which it must be made available.

Regulatory compliance warnings

“We keep our ear to the ground,” Horan says. “We’re part of several community groups that are relevant to our type of business, and we end up discovering new requirements that way. We also scrub websites and news articles covering things like FMVSS, CMVSS, NHTSA, CARB, ECE, and other regulatory bodies. Sometimes we’ll find out about new requirements via reviews with OEM legal teams. Due to the massive body of work we do in this space, we’re usually the first to find out about anything new.”

Regulatory Bodies Governing Automotive Technical Information

Every industry reports to a unique set of regulatory bodies. When it comes to the automotive space, there are a few big ones, which Nick mentioned, defining the standards a company must comply with.

FMVSS refers to Federal Motor Vehicle Safety Standards. This is a set of federal regulations specifying motor vehicle design, performance, and similar factors related to safety. The National Highway Traffic Safety Administration (NHTSA) writes and enforces these regulations, among others. 

legal requirements

Some key requirements under FMVSS include crashworthiness, which concerns the integrity of features like seatbelts and airbags, and crash avoidance, which looks at features like brakes, tires, and lighting.

Failure to meet the specifications these standards set forth can result in recalls, lawsuits, fines and market access restrictions.

CMVSS—Canada Motor Vehicle Safety Standards—is the Canadian equivalent of FVMSS. ECE—the Economic Commission for Europe—is the European equivalent.

CARB refers to the California Air Resources Board. This organization focuses on zero-emission transportation. Part of the Environmental Protection Agency (EPA), CARB defines emission standards that all vehicles must adhere to.

In total, that’s a good number of rules and regulations for siloed technical information teams to keep track of. So, what’s the smart way to manage all this?

The Road to Successful Regulatory Compliance

When it comes to managing the risks associated with ever-changing legal compliance requirements, one practice is key:

“Documentation, documentation, documentation,” Horan says. “It’s imperative for our operations to ensure we document all relevant homologation requirements, and work those into our development processes.”

Another crucial element? Collaboration. A good information partner will actively facilitate communication between cross-functional teams, like engineering, marketing, and legal, to ensure technical documentation meets both technical and legal requirements.

“We have a proprietary Review Management System [RMS] outlining who at each OEM is responsible for signing off on what content,” says Horan. “We capture that change, and our automatic workflows ensure that feedback goes directly to the correct author for that section. If applicable, once a change is made, the requestor will also get a copy of that change for record-keeping.”

Systems like these, which evolve to operate almost passively, are fundamental to proper risk management. As technical information evolves and adapts throughout its lifecycle, documenting each phase is crucial in avoiding missteps.

Working together to maintain compliance

And a team-oriented approach between partners creates an additional level of protection against noncompliance.

“This is a deadline-driven business,” Ragland says. “But there have been cases where we’ve had to work with our partners to evaluate deadlines and adjust accordingly due to compliance statements requiring verification. In the end, the content has to be correct, and it has to be compliant. You can’t really cut corners on this.”

Noncompliance poses significant threats to a company’s financial health, reputation, and long-term viability. That’s why it’s essential for businesses to prioritize compliance efforts and implement robust systems and processes to mitigate these risks.

For more information, check out the webinar Keeping Your Technical Information Out of Jail (or at Least Out of Trouble), hosted by Nick Horan and featuring Gary Ragland and Tony Smith (Canoo, Snap-On, Helm Service Bay Solutions). 

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