Digital quality management systems, also called “eQMS,” are becoming increasingly common, especially as the technology that supports them becomes more widely available and user-friendly. The COVID-19 pandemic has made remote access to information more important than ever and highlighted the shortcomings of traditional paper-based QMS, but the benefits of switching to an eQMS extend far beyond the unique challenges imposed by a global pandemic. Digital QMS allow for better accessibility, better document control, faster and more streamlined processes, and other advantages that affect both efficiency and company culture. The transition from a traditional paper system to an eQMS, however, requires a commitment of time and resources that often drives decision-makers to put it off for as long as possible. We collaborated with Tim Akin, an expert from the provider of our own eQMS, Qualtrax, to get an insider perspective on the process of transitioning from a paper to a digital QMS and how to make that process easier.
How do I know when it’s time to switch to an eQMS?
In most cases, there will not be one single, dramatic event that signals the end of your paper QMS; the inconveniences of maintaining it will simply become more burdensome over time. It can be hard to feel the true impact of an inefficient system on a day-to-day basis, but if you begin to take notes of every request you receive and how long it takes to complete, it may be striking to see how much time you lose over weeks or months. How often are you being asked for a signature, a copy of a manual or procedure, or the latest version of something? How long does it take you to track down that record for that audit you are performing? Even an informal record jotted on a notepad will give you a much clearer idea of how efficient your current system is.
Of course, those uncommon, dramatic events can’t be entirely written off either. It’s impossible to predict a major disaster like a flood, an earthquake, or even a global pandemic, but a web-based eQMS is much safer from loss or destruction compared to physical documents, and disasters or near-disasters can be a wake-up call for some people who were previously resistant to change.
What are the biggest challenges in switching from paper to digital?
Decision-makers are often paralyzed by the extremely loaded question of “where do I start?” and Tim’s best advice for people in that stage is actually counter-intuitive: start at the end. Consider exactly how your staff will use this system on a day-to-day basis once it’s in place. Consider how people will access the information they need and how it will be used to demonstrate compliance. Essentially, decide how you want the data to look at the point where you need it the most, and fill in the steps to create that result.
Another challenge to consider is adoption of the eQMS by your staff. “No matter how awesome your new digital system is, you’ll always have some people who embrace it, and others who resist it.” Tim explained, “For those who are resistant, do everything you can to demonstrate the ways in which the eQMS makes their process simpler, and reassure them that the core of the system is the same: they need approval from the same people, their corrective action process is the same, and so forth. Encourage dialogue, make your staff feel heard, and give them a reasonable timeframe and the training they need to adjust.”
Does a digital system make compliance easier?
A tool is only ever as good as its user, but an eQMS is a powerful tool that can help your processes run much more efficiently. Qualtrax and most other well-designed eQMS tools focus heavily on process automation. As we often illustrate in A2LA WorkPlace Training courses, a high percentage of audit findings are a result of documented processes being different from the processes being used in practice. Automation creates “paths” that restrict users from straying from the established process.
Another crucial aspect of compliance is demonstrating that compliance. Even if you do everything right, you must be able to show evidence of it. If an auditor has direct access to an eQMS, it eliminates all the potential problems and confusion associated with finding, duplicating, and organizing documents, then getting them in front of the auditor somehow. While many audits are currently being conducted remotely, this is almost equally important for on-site audits. Most digital systems will have measures built in to maintain a clear audit trail, flag errors, and prevent old documents being mistaken for current ones, minimizing the potential for human error.
“In a lab I once worked at, we had an entirely paper system for our documents and records.” Tim explained. “Every time we prepared for an audit, the managers would spend days pulling binder after binder from shelves and going through to check that the versions were up to date, pages and corrections initialed and numbered, records complete. Even after all that, we’d still have corrections and findings from the audit for people using out of date procedures, missing records, confusion about processes.”
Are there other reasons to consider an eQMS?
While there are plenty of measurable advantages to an eQMS, Tim pointed out how a more efficient system can have a psychological impact on your staff. “I think most people look at quality as a bit of a burden, as something they have to do,” he said. “But we find that when the QMS is streamlined and supports productivity, people embrace the processes more fully, and see the quality system as foundational to their work rather than something annoying and ungainly that holds them back and eats up their time. That’s when you really get a thriving culture of quality, where people proud of their organization’s capabilities.”
Isn’t my paper system or partly-digital system good enough for now?
Every organization is unique, so there is no one-size-fits-all approach to implementing a QMS. Sometimes, organizations that had a well-established paper QMS before digital options became available will retain portions of the paper system rather than fully making the transition. In some cases, this is a reasonable solution for a period of time, and in other cases it just creates confusion. The culture of an organization may come into play here: staff may be particularly resistant to change, and this barrier can’t simply be ignored. As mentioned before, widespread adoption of the new system is important to making it work the way you intended, so consider what it will take to get your staff fully on board before making a change.
“My recommendation with any new customer or organization looking for advice is to embrace it fully in either direction,” said Tim. “Realistically, the whole industry is moving inevitably toward eQMS, so whether you know you need more time to adjust to the idea or are ready to make a change now, use that to inform your goals. Most organizations I’ve worked with may start with a hybrid system and realize quickly they should have just ripped the band-aid off to get where they really want to be.”
Where can I get more information?
Perhaps you’re already considering an eQMS, but if you’re not ready to take the plunge, these questions of efficiency, accessibility, and compliance should be central to how you use and structure your QMS. At A2LA WPT, QMS design, implementation, and oversight are a key part of our consultancy services, so our staff has unique insight on challenges organizations face with an inefficient QMS. For more information on eQMS options, both from Qualtrax and in general, visit qualtrax.com. If you feel you may need support developing a QMS for your organization, regardless of its size, information about A2LA WPT’s consulting services is available here.