How to maintain and improve quality management while working remotely

 


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The COVID-19 pandemic impacted every organization differently, with some companies speeding up, others slowing down, and still others rapidly pivoting their entire focus (e.g., producing hand sanitizer and PPE products exclusively).

At the same time, some organizations transitioned to remote work completely while others adopted a hybrid approach to keep workers safe and keep manufacturing lines running smoothly.

These significant shifts forced quality teams to rethink their approach to quality management overnight. After all, few organizations had the luxury of putting operations on pause or walking away until the pandemic was finally over.

While the pandemic may be subsiding with the arrival of vaccines, its effects will likely be long-lasting — and perhaps even permanent.

If there’s a silver lining of COVID-19, it’s the fact that companies had no choice but to invent the airplane mid-flight, so to speak — and many rose to the occasion.

Keep reading to learn more about what distributed quality teams need to keep in mind to ensure their programs continue to deliver strong results even while working remotely.

When you shift to remote work, things change.

You need to take a step back and look at what critical internal processes are operating smoothly and which have been broken by the shift.

For example, if you’re a small start-up managing processes through a contract manufacturer, you might determine that you need to open up more channels of communication because you lack visibility into your partner’s production lines.

Similarly, if you have manufacturing in-house, you need to look at what’s running properly and what needs to be changed.

To illustrate, when COVID-19 first reared its ugly head, manufacturers had to enforce social distancing measures, and quality teams needed to determine the impact those changes had.

After this assessment, if you determine processes and operations need to change from a quality perspective, figure out how those changes would impact training.

Your team might have to implement new procedures to get everyone up to speed quickly with a new way of working, and you need to be prepared.

Bottom line? Apply risk management thinking across your operations, determine the impacts, and figure out what you need to do to mitigate them. Once you’ve done that, make sure that you capture every change you make in your documentation to keep auditors happy and ensure regulatory compliance.

 

Step #1: Assess your internal processes 

 

When you’re working remotely, you can’t pop over to the next cubicle or workstation, ask an informal question, and then officially document the course of action. It’s just not possible.

In remote environments, communication becomes even more important. Quite simply, it takes on a whole new level of criticality to keep teams working together productively while maintaining compliance.

First and foremost, you need to make sure that all communications related to quality issues are captured in the appropriate channels. If there’s a problem on the production line, the last thing you want is a never-ending email thread where everyone is speculating about what might have happened and what should be done next.

Remember, everything you put into writing is discoverable during litigation. In the worst-case scenario of a lawsuit, you need to have the confidence that you’re disclosing everything upfront, and that there isn’t any email thread that might come to light later on. The best approach is to hop on the phone to have important conversations instead of creating a chaotic back-and-forth email chain. Once you’re off the phone, you can send a follow-up email to document the content of the conversation.

Better yet, ditch email and plug that information directly into your electronic quality management system (eQMS). With an eQMS in place, you can implement formal communication policies around quality issues and ensure that everything gets documented every time. As a result, you will be able to capture all information that’s important while mitigating potential risks down the line.

 

Step #2: Assess your external processes

 

Any changes you make internally can impact your external processes.

On the flipside, any changes your suppliers make externally will impact your internal processes. After you’ve assessed your in-house landscape, it’s time to take a broader look at your supply chain and identify any potential disruptions and what the associated impacts might be.

During COVID-19, quality teams had to determine what parts and components were available, whether shipments could still be on schedule, and what delays might look like. Once they had that information, they then needed to determine what sorts of issues might impact scheduling and day-to-day operations moving forward.

What’s more, even if teams were fully adjusted to working remotely, they could only be as prepared as their suppliers were in certain situations. Without the ability to visit facilities in person, teams adapted to the task at hand by setting up Zoom meetings for audit-related activities — like taking virtual tours of facilities. Of course, considerations also had to be made around potential responses from regulatory bodies.

While organizations working on COVID products might have had accelerated timelines and faster 510k approvals, companies not working on those products were more likely to experience delays.

Understanding these impacts can help quality teams readjust priorities accordingly. Whether you’re shifting to remote work or building a remote quality team from scratch, you need to consider how your decisions will impact your relationships with suppliers, auditors, and regulators.

And, once again, no matter what processes need to change, you need to make sure that your quality team is documenting every adjustment.

 

 

Step #3: Look for optimization opportunities

 

Shifting to a remote working environment is a great opportunity to streamline your processes and accelerate workflows.

For example, if you’re requiring nine different signatures on a change control item, perhaps you could make do with five to speed things up while remaining compliant and maintaining quality standards.

As many companies demonstrated during COVID-19, sometimes it takes an emergency to really look at a system as a whole and see how big and bloated it’s gotten.

Whether you’re moving to a remote environment because you want to or because you have to, it’s a great time to look for places to unlock additional efficiencies. If a checkbox isn’t really necessary, maybe it’s time to get rid of it.

During your transition, don’t underestimate the importance of maintaining a well-trained team. This is a good opportunity to examine your training procedures to make sure records are up to date and determine whether your current materials are effective. Regulators are increasingly looking at training effectiveness; use this opportunity to make sure your team is aligned around expectations.

Moving to remote work is a great time to look at your riskier processes and consider what additional controls might need to be in place. You should also invest some energy in making sure your development plans, objectives, and metrics align with your overall goals and strategy.

 

Step #4: Get audit-ready

 

When the pandemic began, on-site audits simply weren’t possible. On one hand, it was nice. Teams didn’t have to worry about logistical issues, like helping a customer find a hotel. On the other, it completely changed the way organizations prepared for audits.

Through the lens of documentation, customers were outlining scope asks and scope specificity up front. In a normal audit process, it might have been easy to grab a copy of the quality manual and the procedures list from the filing cabinet.

During the pandemic, this became a massive challenge for organizations relying on paper-based quality management systems. An eQMS can solve this problem, enabling companies to give auditors remote access to documentation.

Otherwise, companies found out the hard way that they’d have to figure out how to scan and upload files — or, worse yet, store them in a shared drive and hope for the best. In the event you need to audit a supplier via video, you also need to ensure you’re able to capture all the relevant information you uncover during the virtual tour.

An eQMS makes it easy to take pictures of the process and attach them to your audit report, thereby ensuring you’re capturing potential risks and protecting your company.

 

Step #5: Assess your information streams

 

When you’re starting remote work, you’ll also need to figure out what messaging tools work best for your team. Maybe it’s Skype, maybe it’s Slack, or maybe it’s Teams.

Whatever you decide to do, beware of sprawl; when you have too many communications tools, it’s easier to miss messages — making it that much harder to achieve compliance and ensure quality.

Pro tip: More messaging apps isn’t a good thing. Keep things simple.

 

While some teams may be able to make do with old-fashioned paper-based quality management systems when they work in the same building, legacy QMS solutions simply don’t cut it in remote environments.

This is why more and more organizations have adopted eQMS solutions like Qualio in the wake of the pandemic. Qualio helps you achieve the fastest eQMS implementation possible. We are also the highest rated solution on the market, and we’ve been voted the easiest eQMS to use.

On top of that, we’ve been a remote company for years, and we successfully got our own ISO 9001 certification with zero non-conformances all while working remotely.

To learn more about why leading life science companies rely on Qualio to ensure regulatory compliance in remote environments, request a demo today.