When companies implement an enterprise quality management system (EQMS), one of the first places they often start is with a corrective action solution. This makes business sense when the compelling event is either an audit finding, an FDA 483 inspection observation, or a warning letter related to the corrective action process.
However, a best-practices approach is to deploy your document control system and employee training first, only rolling out other EQMS functions once those are up and running.
According to FDA 483 inspection observation data, lack of or inadequate procedures represented more than 60 percent of the total number of citations for medical devices in 2020. Furthermore, all required documentation and training standards and regulations across the globe are core quality processes with dependencies across the entire quality system.
Automating your document control processes creates a foundation for lasting change. However, launching an EQMS without a document management system in place can carry over errors and inefficiencies inherent in manual and siloed systems.
Bearing that in mind, this article explains why document and training management implementation strategies are powerful techniques for using your documents to understand your processes better.
Why Your Document Control System Should Come First
Documents are the foundation for everything you do. They allow you to assess compliance gaps, support training with instructions and work aids and form the basis for all processes you use. For example, if you’re using the EQMS to initiate a corrective action request, it won’t be effective if the procedures that govern it are buried in a three-ring binder.
Implementing EQMS solutions like corrective actions or employee training before document control is like building a house without a foundation. Instead, visualize your document control system as the hub, with documents requiring updates anytime you have changes to existing products, manufacturing processes, or even the EQMS itself.
Document control is interdependent with every other EQMS function, including:
- Corrective and Preventive Action (CAPA)
- Change Management
- Supplier Quality Management
- Complaint Tracking
- Nonconformance and Deviation Management
Successfully implementing and managing a quality management system with minimal resources is possible with up-front preparation, the right software, and effective processes that maximize the software’s capabilities.
1 Building on Document Control with Employee Training
Anytime a document is changed, for example, a specification or manufacturing process change, that triggers a subsequent task to update employee training documents. You can’t manage your processes without these two critical pieces, and every time there is a change, both will be affected.
This principle also applies to adding new processes in the EQMS. For instance, when you roll out an EQMS solution, you need to document the new process and create training on using the new tool.
Having your document control system linked to employee training before deploying other solutions forms the basis for a smooth process. Do it the other way around, and you’re still stuck sharing documents via email, servers, or paper, creating opportunities for lost information and quality escapes. In short, the exact opposite of what an EQMS is meant to provide.
2 What Your Documents Can Reveal About Your Processes
Organizations rarely use document management to strategically look at what’s happening within other quality processes. However, this approach can provide critical insights into hidden issues.
One technique for seeing what’s happening with your processes is to compare the date a document was originally created with the total number of revisions. The frequency distribution of this data can point you directly to processes that need updating or processes that change too much. Figure 1 provides a sample visualization that compares document age vs. history.
For example, suppose you have a document that was created a month ago and has already undergone several iterations. In that case, that should trigger questions on why you’re making so many changes to the process. As a result, you may want to look deeper to see if something unstable about that process needs to be addressed.
Conversely, if you have a document that was created ten years ago and is still on the first version, that would indicate the process may be in serious need of updating—or that the current document doesn’t reflect what’s actually happening on the manufacturing floor.
3 Remembering the Why and the Human Element
As you think about how you will roll out your EQMS to your organization, it’s important to remember why you’re doing all of this. Improving quality isn’t just about growing the business, although that is a key driver of value, especially regarding the EQMS.
A quality system aims to precipitate the manufacture of safe, high-quality products that protect customers, whether it’s a life-saving medical device or a brake pad that performs reliably on the road.
The recent headlines over 15 million wasted COVID-19 vaccines at a contract manufacturing facility underscores the importance of getting it right. The 483 inspection observation from the facility shows numerous people not following procedures, although this was a significant organization with the proper quality fundamentals in place.
The lesson for manufacturers is that an EQMS is a foundation, not the cure. It can’t fix problems with leadership or company culture. Nor can it make people genuinely want to follow the expectations set down in employee training. Instead, the understanding must be that individuals execute the protocols and safeguards they are trained on, with controls in place to ensure it happens. If not, that person, and in many cases, the company, are accountable per the operating procedures set forth.
Document control and training management processes are a great starting point when integrating an electronic QMS. Standardizing procedures and other information in the document management system and engaging users from the beginning with employee training establishes your quality expectations and creates awareness of the system. Of course, what comes after is also important, but only once you have these fundamentals in place are you truly prepared to move forward.