Taylor Brown, a certified lead auditor for ISO 13485 at Greenlight Guru, highlights the importance of quality automation tools.
In the medical device industry, any error — big or small — can not only create device flaws but also negatively impact patients and other end users. To mitigate these mistakes, we must first look at where they originate. Broadly speaking, 75-80% of mistakes are a result of human error. To decrease the risk of error, medical device manufacturers need efficient and automated training practices.
Training, while critical to preventing errors, currently happens using legacy quality management tools and inefficient manual processes that fail to focus on the downstream impact of errors on device quality. They’re cumbersome and require substantial effort to capture valuable insights.
Aside from reducing the risk of human error, training is a crucial component in helping medical device companies meet compliance standards and produce high quality devices for end users. Medical device quality management systems that allow users to demonstrate closed-loop traceability can assist in automating the training process and connecting internal processes, documents and data. Here are three ways quality automation tools can help you mitigate risk and improve medical device quality:
Simplify the training process
Siloed quality system processes, including those used to manage training, form a barrier between trainers and trainees. When managers are required to physically assign training tasks, then monitor the status of those individual tasks for each trainee, there’s a heightened risk of missing something that can affect your medical device’s quality down the road. In highly regulated industries such as ours, where human lives are on the line, we must ensure that we are operating under systems which keep our personnel well-trained with the necessary competence.
A purpose-built medical device QMS incorporates every training process into your system as you so choose. Managers can easily assign training activities and let the system’s automation capabilities do the rest — from notifying trainees to tracking progress. Trainees can sign into the software platform and view their individual dashboards which house their specific assignments and training activities. Once tasks are completed, managers can evaluate trainee performance for specific training tasks at the document level or by individual or group.
A medical device quality management system with closed-loop traceability eradicates the barriers standing between people and the information they need to succeed in their roles. This type of solution streamlines and improves the training management process while paving a smoother path to compliance.
Enhance training activities
Measuring the impact and efficiency of your training activities is challenging if you’re relying on an antiquated quality system. Trying to establish the connection between employee performance and training processes can be quite difficult with these outdated systems and oftentimes is neglected.
Integrating training management activities throughout all quality system processes using an automated tool can help managers better track their training program’s efficacy, too. Instead of trainers manually signing off on each training activity, automation can complete this process. These steps can be done electronically while following 21 CFR Part 11 requirements and provide proof to regulatory authorities that sufficient training has been conducted.
When training activities are conducted through a quality system with closed-loop traceability, trainers and trainees gain insights into connected processes within the total quality ecosystem. Training data within a closed-loop traceability quality system can be leveraged by managers to gain insights on how to adjust and improve training activities on an ongoing basis.
Enable proactive approaches to audits
Over the past few years, there has been a heightened focus on training requirements during inspections and audits. Sufficient training is no longer a “bonus” but is crucial if you want to successfully pass an audit or inspection. Yet, many managers keep relying on legacy tools that make locating, managing and monitoring records difficult. That leaves your organisation vulnerable to costly mistakes.
Take advantage of traceability and automation capabilities that come equipped in a modern QMS solution built for medical devices. A well-connected, easily accessible and traceable system can allow you to produce and maintain training records that go beyond checking off boxes. With the right quality system in place, you can store compliance records, create detailed trainee reports and auto-generate logs — all of which is done automatically by the system and requires no manual effort from training managers.
Streamlined, dedicated workflows create a comprehensive audit trail, confirming that training occurred in the time frame allotted and was executed effectively. In fact, this type of training management solution has assisted 95% of medical device QMS users in feeling confident they could pass an unannounced audit today, according to our recent 2021 State of Medical Device Report.
Error within the medical device industry must be avoided where possible to provide our patients and end users with safe and efficient medical devices. We need error reduction and efficiency maximisation, and we now have the systems available to accommodate these needs. To avoid error, mitigate risk and ensure the delivery of high-quality products, we should sustain the foundation of our organisation, which is formed through proper training.
