Is Your QMS Robust Enough to Withstand the Long Term Effects of the Recent COVID-19 Pandemic?


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Boy, what a year! Who would ever have thought this world would go through a pandemic such as the one we are living through now? As I look back at everything that has been happening over the past six months, I realize how critical it is to have a robust, flexible quality management system (QMS) with appropriate tools for support of your business. I expect we will see some of the recent actions taken in the industry stay in place for the long term. One thing I can say is how grateful we should be for the changes implemented by the International Organization for Standardization (ISO) over the past several years. If properly implemented, your business systems should be more resilient to the catastrophic issues we have seen over the past several months, and ensure you’re prepared for the future. Let’s take a look at some of the challenges we are currently facing in more detail:

  • Documentation – electronic vs. paper, easy access, remote access.
  • Production facilities working with limited capacity and staff.
  • Key resources working remotely.
  • Virtual audits and inspections.
  • Suppliers unable to meet requirements and/or demands.

The recent issues with the COVID-19 pandemic demonstrate the criticality of integrating the QMS with the organization’s business continuity plan. When government mandates were issued causing organizations to shut down, leadership teams kicked their business continuity plans into high gear.

Many production lines were identified as essential to keep products getting to market. After all, we still need food, medical products, and other supplies to live. How do you keep the operations going with all of the restrictions currently in place? Fortunately, technology has advanced to provide new platforms for virtual communications. With Zoom, Webex, Team, Google Docs, Go to Meeting and others, we now have tools and venues to facilitate working remotely. As a result, many of the support staff are now working from home. We have to continue to find creative ways to work remotely AND ensure we maintain compliance to regulations and conformance to standards.

While these new work conditions have benefits, let’s look at three of the biggest challenges and how you might address them.

1. Working Remotely

It’s true that more people are working from home, remotely. In fact, I understand that many organizations will continue this practice even when the pandemic is over. Individuals are doing every day work remotely from home as well as participating in meetings, trainings, and audits being performed. In addition to the increase in remote access for industry, more individuals are using the same services for family gatherings and activities. While this access is amazing and a great way to operate, the increase activity is putting a strain on bandwidth, overall access and system performance. Some things to consider when scheduling these events include time of day for event, number of participants and use of camera vs. no camera.

2. Accessing Information

The QMS sets the foundation of processes to support this production. As a result, a robust, simple system is critical for success in times of crisis. In my humble opinion, the biggest challenge I have encountered over this period of time is the necessity for virtual tools and processes. This includes access to critical documentation and processes through remote systems. While many organizations have implemented software solutions to support document management, there are still issues with remote access from homes or remote location. Additionally, many organizations are still using some sort of manual processes for review, approval, and/or distribution. Now is the time to adopt the right technology, and eliminate these issues.

3. Keeping Up

While the pandemic and other issues linger, regulations in different parts of the world continue to change. As such it is important to keep current with the change and continue with training and/or educating your organization to understand the changes and requirements. Most organizations offer virtual training opportunities. Courses have been modified and instructors are available for public as well as private classes. These can be done from home or work. Don’t fall behind, this is a great time to get updates on what’s happening in the quality/regulatory space.

The key to success here is to evaluate your current systems and documentation to ensure they are effective and as simple as possible. Integrate the QMS requirements into business continuity planning. If you have already done so, there should be minimal disruption to the operations. Consider completing a risk assessment or retrospective analysis of the impact the pandemic has had on your operations over the past six months or so. Are there any key lessons learned because of the challenges of the pandemic? Are there things you would have done differently?

Prepare yourself and your organization for the fact that some of the changes we are seeing may be here to stay. People will need to adapt to working from home, getting access to critical documents, staying up-to-date on industry trends. As we learn to navigate this new terrain, it’s most important of all keep things simple. Don’t get overwhelmed. Leverage your QMS to provide the infrastructure and support to the operations.


christine_park

Christine Park is a solution-focused, results-oriented Business Executive with extensive Business Development/Quality Systems/Regulatory Affairs Executive. An independent consultant and experienced trainer she has demonstrated success and business acumen to integrate quality into daily business activities while reducing costs. She takes a pragmatic, common sense approach to defining and establishing good business practice to achieve goals with quality and assurance to regulatory compliance. Christine has experience with Medical Device, Pharmaceuticas, Biologicals, Food Safety as well as general quality management systems. See more information on her website.


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