Quality Magazine logo
search
cart
facebook twitter linkedin youtube
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Quality Magazine logo
  • NEWS
  • PRODUCTS
    • FEATURED PRODUCTS
    • SUBMIT YOUR PRODUCT
  • CHANNELS
    • AUTOMATION
    • MANAGEMENT
    • MEASUREMENT
    • NDT
    • QUALITY 101
    • SOFTWARE
    • TEST & INSPECTION
    • VISION & SENSORS
  • MARKETS
    • AEROSPACE
    • AUTOMOTIVE
    • ENERGY
    • GREEN MANUFACTURING
    • MEDICAL
  • MEDIA
    • A WORD ON QUALITY PUZZLE
    • EBOOKS
    • PODCASTS
    • VIDEOS
    • WEBINARS
  • EVENTS
    • EVENT CALENDAR
    • IMTS
  • DIRECTORIES
    • BUYERS GUIDE >
      • Supplier Insights
    • NDT SOURCEBOOK
    • VISION & SENSORS
    • TAKE A TOUR
  • INFOCENTERS
    • Digital Quality Management Systems
    • NEXT GENERATION SPC & QUALITY ANALYTICS
  • AWARDS
    • ROOKIE OF THE YEAR
    • PLANT OF THE YEAR
    • PROFESSIONAL OF THE YEAR
  • MORE
    • Expert Columns
    • NEWSLETTERS
    • QUALITY STORE
    • INDUSTRY LINKS
    • SPONSOR INSIGHTS
  • EMAG
    • eMAGAZINE
    • ARCHIVES
    • CONTACT
    • ADVERTISE
  • SIGN UP!
Management

Compliance Today

No matter what is going on in the world, you can feel prepared.

By Michelle Bangert
Office Workers
June 1, 2020

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.”

KEYWORDS: compliance manufacturing regulations safety in manufacturing supply chain management

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Qm0520 clmn editnoteguest author michellebangert 0520

Michelle Bangert is the managing editor of Quality Magazine. She can be reached at [email protected]

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • 2024 Quality Rookie of the Year Justin Wise 1440x750px banner with "Quality Rookie of the Year" logo inset

    Meet the 2024 Quality Rookie of the Year: Justin Wise

    Justin Wise is an exceptional individual who has been...
    Aerospace
    By: Michelle Bangert
  • Man with umbrella and coat stands outside while it rains at night looking at a building.

    Nondestructive Testing: Is there an ethics problem?

    I was a whistleblower who exposed fraudulent activities...
    NDT
    By: Dale Norwood
  • Unraveling Deflategate: Football stadium with closeup of football on field

    Unraveling the Tom Brady Deflategate

    The Deflategate scandal erupted following the 2014 AFC...
    Measurement
    By: Greg Cenker and Henry Zumbrun
Manage My Account
  • eMagazine Subscriptions
  • Newsletters
  • Online Registration
  • Subscription Customer Service
  • Manage My Preferences

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Quality audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Quality or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Key Takeaways for Quality Leaders
    Sponsored byComplianceQuest

    Key Takeaways for Quality Leaders from the 2026 Gartner Magic Quadrant™ for QMS

  • This image shows a person seated next to a Bobcat T66 compact track loader.
    Sponsored byPolyWorks by InnovMetric

    Supercharging Digital Gauging at Bobcat North America

  • Dorsey Calibration Lab photo by Tom LaBarbera Picture this Studios
    Sponsored byDorsey Metrology International

    Ensuring Product Quality in a Competitive Manufacturing Landscape

Popular Stories

iStock-1352825159-jpg.jpg

U.S. Should Substantially Boost Support for Manufacturing USA Program, Issue National Industrial Manufacturing Strategy, Says New Report

Dorsey Calibration Lab photo by Tom LaBarbera Picture this Studios

Ensuring Product Quality in a Competitive Manufacturing Landscape

Visions Sensors Ebook

eBook | How AI-driven Vision Systems Are Transforming Automotive Quality Control

2026 Quality Professional of the Year!

Events

June 22, 2026

Automate 2026

Automate is North America's largest robotics and automation event — and the best place to take your ideas from insight to impact.
 
Our show floor features the world’s leading automation solutions, from AI and robotics to motion control, vision systems, and more. Plus, our educational conference is second to none, led by the brightest minds in automation today.
 
Ready to transform the way you work? Take the next step at Automate.
July 14, 2026

Quality Leaders Forum: Better Communication, Better Quality Data

The Quality Leaders Forum is a quarterly, editor-moderated fireside chat series hosted by Quality Magazine, featuring candid conversations with senior manufacturing and operations executives shaping enterprise-level quality.

View All Submit An Event

Products

Lean Manufacturing and Service Fundamentals, Applications, and Case Studies

Lean Manufacturing and Service Fundamentals, Applications, and Case Studies

See More Products
Rookie of the Year Custom Content

Related Articles

  • Woman with tablet

    Quality Beyond Compliance

    See More
  • Guest Column

    Manufacturing Today

    See More
  • Quality Magazine: Training that meets the needs of today's manufacturers. Image of people being trained.

    Training is Required to Meet the Needs of Today's Manufacturers

    See More

Related Products

See More Products
  • What Lean Means DVD

  • The Handbook for Quality Management, Second Edition

See More Products

Related Directories

  • Bluestreak Compliance

    Bluestreak Compliance is a CMMC-RPO: Within the Cybersecurity Maturity Model Certification (CMMC) ecosystem, a Registered Provider Organization (RPO) is critical in guiding organizations toward CMMC compliance. Bluestreak Compliance™ can provide you with all the answers and guide you through this complicated process to help you become NIST 800-171 compliant and well on your way to becoming CMMC certified.
×

Stay in the know with Quality’s comprehensive coverage of
the manufacturing and metrology industries.

Newsletters | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Manufacturing Division
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • Newsletters
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Market Research
    • Reprints
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • YouTube
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2026. All Rights Reserved BNP Media, Inc. and BNP Media II, LLC.

Design, CMS, Hosting & Web Development :: ePublishing