Opinion by Mike Richman
You don’t need me to tell you that these are strange and challenging times. 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.
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. That might mean developing testing protocols, protecting the supply chain, or researching a vaccine or other effective prophylaxis. 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? Simple—rigorous auditing to ensure compliance. It’s critically important that the auditors who ensure organizational compliance to various longstanding standards, schemes, and protocols do their job to protect output.
I realize that this is easier said than done. The temptation to cut corners and accept substandard processes has rarely been greater. But the risks of doing so are equally as great.
Consider the search for a vaccine for the novel coronavirus. Until this vaccine is developed, everyone who has yet to be exposed to the virus—meaning most human beings on the planet—will be susceptible to infection. Some unknown percentage of those that get infected will become severely ill, and some will of course perish. The stakes are high, and thus it is imperative that a vaccine is discovered as quickly as possible.
But “as quickly as possible” comes with a caveat: The vaccine that is ultimately developed must do more good than harm, and the only way to be sure of that fact is to audit procedures, audit output, audit data, and audit people. Only through auditing everything, repeatedly, first in the research phase and then through clinical trials, can we all be assured that the vaccine will be safe and effective.
This process, we are told, could take a year or more. Sadly, people will die of COVID-19 in that period of time who might have otherwise been saved with an effective vaccine. However, an ineffective vaccine won’t save anyone, and an unsafe one might kill more than a safe vaccine would save. This is the stark and insomnia-inducing reality that confronts researchers.
No one intentionally gambles with millions of lives, but the reality is that protocols are sometimes loosened when time is so clearly of the essence. Those in the trenches of this war, chasing the vaccine day after day, are not the ones who can uphold protective standards. It’s simply too much to ask anyone with such an emotional investment in the outcome to ensure compliance, so calmer heads must prevail. The auditing process, rational, cool, and orderly, is the companion to the single-minded passion of the scientist in a fight against a deadly enemy. Without someone to confirm that the checks are in place and that procedures are being followed the risks of bad outcomes are too high to bear. Thus, auditors have a key role to play in this crisis.
There’s little glory in being a person who says, “No.” However, if that “No” can help avoid an even worse tragedy than the one we are living through right now, then it is a heroic role, indeed. When the history of this era is written, the words will say that COVID-19 was defeated by the insight and persistence of swarms of scientists in labs all over the world. Those of us in this sector of industry, however, will acknowledge, with a quiet spark of pride, the role of the auditor in making it happen.
Now more than ever, auditing has a key part to play in protecting our health and safety.
About the author
Mike Richman is the principal of Richman Business Media Consulting, a marketing and public relations company working with clients in the worlds of manufacturing, consumer products, politics, and education. Richman also hosts the web television program NorCal News Now, which focuses on social, economic, and political issues in California. He is a contributor to (and former publisher of) Quality Digest.