How is your compliance policy? Is it an all-consuming mission at your organization?

It can seem like a difficult balancing act to produce high-quality products and still be in compliance with standards and regulations.

“Ideally, compliance is part of your strategy, but not your entire strategy,” writes Diane Murray of LNS Research. “It's not enough to produce a safe product that works as intended, and meets regulatory requirements. Today’s quality leadership must contribute to the firm’s reputation, competitive standing, profitability, and growth.  Adding to the burden, your company’s industry, target market, role in the supply chain, size, and so many other factors intensify the pressure.”

The world continues to change in new and unexpected ways. As 2020 has made clear, it’s important for your organization to be agile and prepare for unforeseen challenges. Compliance is no longer enough to succeed. Instead, you must have plans in place to manage risk, innovate and seek out new solutions to problems.

In some cases, the pendulum can swing too far towards compliance, at the expense of quality and innovation. If you’re working on a medical device, for example, being in compliance is tantamount to being in business. Without compliance, your product is sunk. But this doesn’t mean it should be the only goal.

“Why Is Quality Focusing on Compliance?” asks Daniel R. Matlis, founder and president of Axendia, for MedTech Intelligence. Matlis writes, “Research shows that most organizations continue to identify the primary role of QA as compliance—ensuring documentation and adherence to regulatory requirements and with internal policies and procedures. However, the true focus of QA should be on improving product quality. Closing the loop allows quality and compliance events to influence the product engineering cycle in a timely fashion.”

One way to ensure your business remains compliant—and successful—is to use a methodology like Six Sigma. According to ASQ, “Using Six Sigma tools for continuous improvement (CI) is a proven method for meeting or exceeding FDA requirements for medical devices. Optical Integrity Inc., a manufacturer of medical devices, used the Six Sigma define, measure, analyze, improve and control (DMAIC) process to comply with the FDA’s concept of current good manufacturing practice (cGMP) and ISO 9001 requirements. The manufacturer’s achievement demonstrates the synergy that can exist between CI and cGMP requirements. Adopting a Six Sigma philosophy provides a compliant quality management system and a means for meeting both the regulatory requirements and international quality standards.”

Of course, Six Sigma is not the only solution. Using lean or your own production system can be another method to get results.


Compliance Strategy

Quality professionals understand compliance is important. But maintaining compliance and the highest levels of quality require a thoughtful approach to both.

“Meeting the challenge of manufacturing regulatory compliance requires establishing a consistent top-down strategy, process and tools that ensures compliance across the enterprise,” writes Joe Barkai. “Although regulations and compliance laws do not show special leniency towards SMBs, small organizations do have certain advantages: they have smaller data sets and fewer personnel with access to that data. On the other hand, SMBs may not have the necessary compliance expertise and focus, and IT personnel to manage and secure the data repositories.”

In some cases, smaller businesses have been in a better position because of recent government programs in response to the pandemic. But larger companies may have a deep well of expertise to rely on for compliance issues. So you’re in a decent place to start either way.

No matter which strategy you use, audits are no doubt a part of this process. Compliance audits are no doubt a familiar feature at your company, but consider how a performance audit might help your quality as well.

According to ASQ, there are a few things to consider with various types of audits. While a performance audits may not be as high a priority as a compliance audit, it still can provide tremendous value.

ASQ says, “Value-added assessments, management audits, added value auditing, and continual improvement assessment are terms used to describe an audit purpose beyond compliance and conformance. The purpose of these audits relates to organization performance. Audits that determine compliance and conformance are not focused on good or poor performance, yet. Performance is an important concern for most organizations.

A key difference between compliance audits, conformance audits, and improvement audits is the collection of evidence related to organization performance versus evidence to verify conformance or compliance to a standard or procedure. An organization may conform to its procedures for taking orders, but if every order is subsequently changed two or three times, management may have cause for concern and want to rectify the inefficiency.”

In other words, being in compliance doesn’t mean you’re necessarily using best practices. Improvement may not always go hand in hand with quality standards. You have to take the next step to get results.

It’s a difficult prospect to seek out new ways to improve your operations. But it is also a necessity.

 “The quality and compliance industry is ready for change,” according to Forbes. “After decades of seeing money poured into the industry with little to no tangible benefits to show for it, it’s time for technology to provide departments with the tools they need to succeed.”