Jon Speer, Founder, Greenlight Guru03.15.21
Error is the bane of medical device quality. Even minor mistakes can lead to serious flaws in products, potentially harming end users. The right training can greatly reduce the risk of making these kinds of errors, but when the quality system managing training is cumbersome and disconnected, it can do little to solve the problem at hand.
Training in the medical device industry often relies heavily on legacy tools, paper-pushing, and checking boxes, with little attention paid toward its downstream effects on quality. Trying to track training activities and records in this type of static system is burdensome and obscures valuable insights from being gained by even the most effective companies.
Yet, training is an integral part of your business. It not only will help you meet compliance requirements but also factors into overall product quality. Companies are developing their medical device quality management systems (MDQMS) to demonstrate closed-loop traceability of every system process, and training must be included in that effort. To help facilitate this, manual processes and legacy tools should be set aside in favor of quality automation tools. Following are three reasons why training and automation are essential if companies want to reduce risk and improve patient outcomes.
1. Make the Training Process Easier
Separating training from the rest of your quality system processes adds an unnecessary layer between trainers and trainees. If a manager has to manually assign training activities, set due dates, and update the completion status for every trainee, then there’s a much higher likelihood that something will slip through the cracks. When the training activities themselves can be a deciding factor of whether or not your product succeeds, that’s not a chance worth taking.
A purpose-built MDQMS can easily incorporate the small, but vital, pieces of the training process into a system that works for you. For example, managers can assign training activities with a few clicks and then rely on automated processes to notify trainees and track their progress. Trainees can then sign into a dedicated workflow within the software platform to view personalized dashboards, where they can find these assignments or outstanding training activities. When a training task is completed, managers can assess competence from the document level or by an individual or group. This eliminates the disconnect between people and information, streamlining and improving the overall training management process while simplifying compliance needs.
2. Improve Training Activity Development
How can you tell if your training activities are effective? With a spreadsheet or manual quality system, it’s much tougher to map the quality needs that your training intends to address back to your training activities and processes. And if those needs change, it’s even more challenging.
On a functional level, a modern MDQMS with an integrated training management workflow can help managers track the effectiveness of a training program. Each training activity can be set up to require a trainer sign-off, attesting competency of an employee, specifically for regulatory purposes. These secure electronic signatures are compliant with 21 CFR Part 11 and offer objective evidence that adequate training is being conducted.
Because all training is integrated within a closed-loop quality system, you also gain insight into connected processes from your overall quality ecosystem. If a subsystem of that ecosystem is faltering, training data can be used to shed light on creative solutions to adjust training activities in order to mitigate immediate and long-term problems. Visibility into the status of training activities increases overall efficiency and efficacy while ensuring you’re meeting the necessary quality standards.
3. Prepare Proactively for Audits
We’re seeing an increasing focus on training requirements during audits and inspections, meaning proper training and supporting documentation is no longer a nice-to-have, but a must-have for passing an audit. Still, training managers continue to struggle when using disparate systems to document and track who’s been trained on what. Without easy-to-navigate training records, you can be left exposed come audit time. For example, if your team implemented new processes or updated existing procedures, would you know who’s been properly trained and when that training took place? Is your only record a calendar event buried in months of other meetings?
A modern MDQMS leverages automation and traceability to produce and maintain meaningful training records. Instead of scouring your calendar for a training activity’s invite, your quality system can auto-generate logs, store supporting evidence needed by regulators, and generate details of trainees’ records without a manager lifting his or her finger. This streamlined system provides the much-needed assurance through an audit trail that confirms training occurred when it was supposed to and personnel have the competency required to do their job effectively. This valuable training management solution has helped 95 percent of MDQMS users feel confident they could pass an unannounced audit today, according to our 2021 State of the Medical Device Industry report.
High quality outcomes demand high quality training. To reduce the risk of errors and increase efficiency and efficacy, having the ability to incorporate training activities and records into your MDQMS has never been more important. These essential quality system functions will save you time and money while improving the quality, safety, and effectiveness of your medical device.
Jon Speer is the founder at Greenlight Guru, a medical device quality management MDQMS software. He is a medical device guru with over 22 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
Training in the medical device industry often relies heavily on legacy tools, paper-pushing, and checking boxes, with little attention paid toward its downstream effects on quality. Trying to track training activities and records in this type of static system is burdensome and obscures valuable insights from being gained by even the most effective companies.
Yet, training is an integral part of your business. It not only will help you meet compliance requirements but also factors into overall product quality. Companies are developing their medical device quality management systems (MDQMS) to demonstrate closed-loop traceability of every system process, and training must be included in that effort. To help facilitate this, manual processes and legacy tools should be set aside in favor of quality automation tools. Following are three reasons why training and automation are essential if companies want to reduce risk and improve patient outcomes.
1. Make the Training Process Easier
Separating training from the rest of your quality system processes adds an unnecessary layer between trainers and trainees. If a manager has to manually assign training activities, set due dates, and update the completion status for every trainee, then there’s a much higher likelihood that something will slip through the cracks. When the training activities themselves can be a deciding factor of whether or not your product succeeds, that’s not a chance worth taking.
A purpose-built MDQMS can easily incorporate the small, but vital, pieces of the training process into a system that works for you. For example, managers can assign training activities with a few clicks and then rely on automated processes to notify trainees and track their progress. Trainees can then sign into a dedicated workflow within the software platform to view personalized dashboards, where they can find these assignments or outstanding training activities. When a training task is completed, managers can assess competence from the document level or by an individual or group. This eliminates the disconnect between people and information, streamlining and improving the overall training management process while simplifying compliance needs.
2. Improve Training Activity Development
How can you tell if your training activities are effective? With a spreadsheet or manual quality system, it’s much tougher to map the quality needs that your training intends to address back to your training activities and processes. And if those needs change, it’s even more challenging.
On a functional level, a modern MDQMS with an integrated training management workflow can help managers track the effectiveness of a training program. Each training activity can be set up to require a trainer sign-off, attesting competency of an employee, specifically for regulatory purposes. These secure electronic signatures are compliant with 21 CFR Part 11 and offer objective evidence that adequate training is being conducted.
Because all training is integrated within a closed-loop quality system, you also gain insight into connected processes from your overall quality ecosystem. If a subsystem of that ecosystem is faltering, training data can be used to shed light on creative solutions to adjust training activities in order to mitigate immediate and long-term problems. Visibility into the status of training activities increases overall efficiency and efficacy while ensuring you’re meeting the necessary quality standards.
3. Prepare Proactively for Audits
We’re seeing an increasing focus on training requirements during audits and inspections, meaning proper training and supporting documentation is no longer a nice-to-have, but a must-have for passing an audit. Still, training managers continue to struggle when using disparate systems to document and track who’s been trained on what. Without easy-to-navigate training records, you can be left exposed come audit time. For example, if your team implemented new processes or updated existing procedures, would you know who’s been properly trained and when that training took place? Is your only record a calendar event buried in months of other meetings?
A modern MDQMS leverages automation and traceability to produce and maintain meaningful training records. Instead of scouring your calendar for a training activity’s invite, your quality system can auto-generate logs, store supporting evidence needed by regulators, and generate details of trainees’ records without a manager lifting his or her finger. This streamlined system provides the much-needed assurance through an audit trail that confirms training occurred when it was supposed to and personnel have the competency required to do their job effectively. This valuable training management solution has helped 95 percent of MDQMS users feel confident they could pass an unannounced audit today, according to our 2021 State of the Medical Device Industry report.
High quality outcomes demand high quality training. To reduce the risk of errors and increase efficiency and efficacy, having the ability to incorporate training activities and records into your MDQMS has never been more important. These essential quality system functions will save you time and money while improving the quality, safety, and effectiveness of your medical device.
Jon Speer is the founder at Greenlight Guru, a medical device quality management MDQMS software. He is a medical device guru with over 22 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
