This spring have presented no shortage of hurdles. While many industries are facing new challenges, for those in manufacturing, this may mean continuing production despite supply chain disruptions, health and safety concerns, and economic impact.
Of course, quality should never been dismissed even in the most nerve-wracking times. And with quality comes auditing. It’s just one aspect of our lives being affected by remote work.
In an April article for The Auditor, Mike Richman writes, “Whether you’re an auditor, an auditee, or anyone else in (or out) of the workforce, we’re all trying to figure out where we are, what we’re doing, and where we’re headed.”
He continues, “In following the news and observing the multi-front response to the COVID-19 pandemic, I can’t help but think of the quality function. So many of the processes that are front-and-center in the minds of government officials, doctors, and researchers touch on quality in one way or another… All of it, and much more, depend on adherence to management systems that are hopefully robust enough to stand up to an unprecedented amount of stress and speed.”
“But how does one know if the system is equal to the moment?” He asks. “Simple—rigorous auditing to ensure compliance.”
While rigorous auditing and compliance are always the goal, this may not be achievable at the moment. And that’s fine to let other goals take priority right now. Keeping your business going should be the bullseye that manufacturers are focused on during this unusual time. Pretending otherwise is just impractical.
As Julie Myers Wood wrote in Forbes, “Regulators have recognized, for the moment, that the world has changed significantly. A company’s first priority will be to survive the crisis.”
But beyond survival, it’s important to keep the future goals in mind. Letting go for the moment doesn’t mean giving up forever.
In-person audits may be on hold at the moment—one side effect of the crisis that you may not mind—but it doesn’t mean that the principles behind them should be abandoned.
And just as people have adapted to Zoom birthdays, companies can try remote audits. But like Zoom gatherings, there are some guidelines to make the best of them, and some advice on what not to do.
Tammy M. Pelnik describes ways to optimize remote internal quality audits despite the current climate in her April 2020 article for the Regulatory Affairs Professional Society (RAPS). She writes, “These types of events can render typical in-person, on-site internal quality auditing impractical or impossible. Nonetheless, for a company that is continuing critical operations, internal audits are an invaluable tool in maintaining assurances of consistent QMS compliance. Remote auditing can mitigate increased compliance risks of on-going delays in planned internal audits. Further, additional benefits from innovative audit scheduling approaches, expanded options for involving experts to augment auditor teams, and reduced overhead are possible with remote auditing methods regardless of periodic crises or world events. Adopting remote internal auditing can support ongoing operations and improve audit effectiveness both during unusual times and in the normal course of business.”
The idea that your operations will continue and thrive—“regardless of world events”—sounds promising. While this may not always be possible, it is a helpful way to view your compliance planning.
In some industries—such as the recently highlighted medical one—compliance can never take a back seat. FDA regulations do not go on pause. Before an FDA inspection, companies must be ready for the inspection and for the results. As stated in an article for Contract Pharma, authors John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao of BakerHostetler explained more about inspections today.
“In the face of such serious consequences for non-compliance with these FDA regulations, companies should be committed – and should have been committed even before COVID-19 – to bringing processes into compliance before an FDA inspection.”
But, they note, things are different today: “In the time of COVID-19, however, companies should make specific adjustments. This includes conducting internal audits of cGMP compliance and increased scrutiny in specific areas that may relate to COVID-19. For example, companies should consider training their employees on preventing the spread of disease and providing them regular updates on COVID-19 developments. It may also be necessary to institute stricter protocols for hygiene, employee health, equipment sanitation, and even employee quarantines.”
In other words, now is not the time to relax your stringent quality policies. Know that the inspections will continue in the future, and you don’t want to play catch-up once they do. Letting programs lapse or fall into disuse will not make the road back any easier.
Take heart that you are not the first to deal with a crisis, and we will all get through this.
Julie Bell Lindsay, executive director of the Center for Audit Quality, shared her perspective on the crisis with Compliance Week. “It’s unquestionable that the current environment has presented the profession with challenges and uncertainties they would not have thought of six months ago,” Lindsay said. “Surely it is making their job more difficult, but auditors have quickly adapted without ever losing their focus on audit quality.”