Training Record Management Today
Training record management is a major element of quality management, compliance, and regulatory practices as well as employee safety. Although often a lower priority, without training record management automation, manufacturers are prone to compliance challenges and unnecessary administrative costs. The result could be regulatory penalties and fewer resources for creating products.
Auditors focus on compliance around your training record management system when assessing your company’s ability to follow its documented business processes. For example, the training process is typically the first place an FDA auditor
will look when assessing a medical device company’s current Good Manufacturing Processes (cGMPs). If a company is found noncompliant, the FDA can issue a Warning Letter, which could result in a company shutdown.
ISO 9001:2015 and ISO 13485:2016 (and therefore MDSAP) emphasize risk management thinking to all quality processes, including training. The first step is to determine the required competence for personnel performing a role (ISO 13485 Section 6.2.a, ISO 9001 Section 7.2.a). Then, act to acquire the competence, in other words, provide training to achieve and maintain competence (ISO 13485 Section 6.2.b, ISO 9001 Section 7.2.c). For ISO 13485, training includes building awareness of the “relevance and importance of their activities and how they contribute to the achievement of the quality objectives” (ISO 13485 Section 6.2.d). Next, ensure the personnel are competent or evaluate the effectiveness of the training, which can be accomplished with a quiz administered after the training activity (ISO 13485 Section 6.2.c, ISO 9001 Section 7.2.b and 7.2.c). Your organization must maintain records of all employee education, training, skills, and experience to serve as an official record in the event of an audit (ISO 13485 Section 6.2.e, ISO 9001 Section 7.2.d).
For medical device companies
, CFR 21, Part 820, Quality System Regulation has parallel requirements. The FDA specifically mentions that training should include awareness of the “device defects” that can result from incorrect work. And they note that employee training should include the specific “defects and errors” they can encounter as part of their job.
OSHA requires safety training for all employees. Safety training includes everything from knowing the nearest exit locations to the potentially harmful chemicals on-site to how to operate specialized machinery. Some of these safety topics affect all employees while some address only certain job requirements.
FDA and ISO Findings Related to Training Record Management
For FDA regulated companies, violations resulting in 483 Observations or Warning Letters can cause serious impact to a company’s business and financial goals. Many companies are not meeting the requirements set forth by the FDA. This list shows the FY 2017 FDA findings related to training procedures, training records, and whether training occurred.
||21 CFR 820.25(b)
||Training – Lack of or inadequate procedures
||Procedures for training and identifying training needs have not been [adequately] established.
||21 CFR 820.25(b)
||Personnel training is not documented.
||21 CFR 820.25(1)
||Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs.
Although ISO does not publish a list of companies and findings, several ISO consulting companies list the top findings in their area of practice. ISO auditors find problems with training procedures, records, and execution when they audit a company for ISO 13485 or ISO 9001 compliance.
Today’s fast changing world demands all companies train employees to current operating procedures as they incorporate new technologies, meet new challenges, and encompass new practices. All companies need training, whether your company requires compliance with the FDA, ISO, or other standards. With the emphasis that regulating organizations put on these issues, as well as material consequences for noncompliance, having a strong training record management system that utilizes the latest technology is a smart investment.
Where to Start Automating Your Training Record Management
The first three steps to automating training record management are:
1. Define training plans per employee or employee role
2. Assign employees to roles
3. Track training statuses
Training record management software can help you with these first steps. Look for systems with periodic (e.g., annual) or event-based (e.g., when new or revised training content is released) notifications for the employees. Additionally, companies need reporting to assist with progress tracking as well as internal and external audits. Manufacturing companies benefit greater when training plans and assignments are tied to the product record. Most training record management systems do not do this. Medical device companies need a solution with CFR 21 Part 11 electronic signature capability and assistance in validation
In the training content itself, be sure the content is compliant. For example, the FDA requires that the employee understands the potential problems with doing the job incorrectly. And employees need guidance as to what defects and errors might be revealed in inspection.
7 Big Wins with Training Record Management Automation
The benefits gained from implementing these three steps of training record management automation are realized quickly, span across cross-functional departments, and aren’t limited to just audits. This list shows 7 big wins you will see from implementing a training record management software solution.
1. Simplify Audits
The rigor of training record management automation helps you better manage training records and pass audits for regulating bodies. A modern system will simplify, expedite, and improve your training process.
2. Improve Product Quality
As employees understand the latest standard operating procedures (SOPs) then they also better understand the quality implications of not following the latest SOPs, leading to an improvement in product quality
3. Increase Workforce Flexibility
When training records are linked to product records, management gets more workforce flexibility. Product line managers know who is trained on, for example, an assembly instruction or a test procedure so they can handle absences or job changes.
4. Reduce Administrative Overhead
With search capabilities and automated notification through the training record management software, your colleagues can spend less time administrating. For example, they need to track new employee training and periodic employee retraining. The admin also must track training required with new or revised procedures, standards, and work instructions. Finally, your admin must remind those who have not yet completed required training. With the manual, spreadsheet-based alternative, these tasks are time consuming and mundane.
5. Improve Visibility
With employees’ training plans and training records online, and linked to relevant procedures, work instructions, and standards, you can be confident your training records are accurate, up-to-date, and easy to access
6. Reduce Compliance Risks
By ensuring employees are always trained on the latest policies, SOPs, and work instructions (WIs) you reduce compliance related risk. This is accomplished completely when training content changes are controlled and linked with training plans and records.
7. Improve Employee Safety
Safety for employees is improved when they are trained on the latest safety policies and procedures.
How Arena Does It
Arena recognizes the impact that employee training has on your product quality and regulatory compliance. Earlier we discussed the three steps towards automating your Training Management, now you can read how Arena Training Management
enables you to set up all three:
Define the training plans
, both by employee and employee role using Arena Training Management. Some training plans are required for all employees in a given role. Other training plans are designed specifically for an employee, or a group of employees, that do not correspond to role (job title or function). For example, all employees responsible for final assembly must know the standards and policies for the final assembly workstation. However, only some of them need to learn the assembly instructions for a particular product within a larger product portfolio. This can all be done easily and quickly within Arena Training Management.
Assign employees to roles
. Often, employees may be assigned to more than one role. With Arena Training Management, you have the flexibility to assign many employees to a single role or to assign one employee to many roles. Changing roles and employees in Arena Training Management is a straightforward task.
Track the progress of the employees’ training
. This is where Arena Training Management really shines. For each training plan, training managers can see how many people are assigned to a given plan, how many have completed the plan, and how many are late. You can then click on any of those categories to view the employees’ names. Each employee then gets an email whenever they are assigned to a training plan. The training plan is also visible on the employee’s dashboard in Arena for easy reference. When the employee has read the training material, they provide an electronic signature indicating they have “read and approved” the material; this process is all in compliance with the FDA’s 21 CFR Part 11 regulations. The employee’s training record is then electronically stamped with the time and date of completion.
Leveraging this simple process, Arena Training Management supports your evolving training record management needs — giving you the confidence that everyone is trained, and you are ready to pass any audits.
Arena Training Management is a unique training record management system because it links your employees’ training records to the product record. This approach provides many additional benefits to product companies. Arena Training Management keeps a record of who has “read and approved” materials, ensuring that everyone is trained on the latest revision-controlled policies, standard operating procedures (SOPs), work instructions, and other training materials. Because these training records are auditable, it’s easy to demonstrate to ISO, FDA, OSHA, and other auditors that you are fully compliant. As an example, Arena Training Management can help you maintain compliance with OSHA’s regulations. Any of your employees who work with hazardous materials are assigned to training plans that include all of the relevant material data safety sheets (MSDS). This eliminates the need to manually maintain spreadsheets that are disconnected from the product record.
Arena Training Management links employee training plans to documents associated with the product record (e.g., parts, documents, and assemblies) and automatically notifies users whenever a new revision of a document has been released. The notifications come in two forms, an email, and a dashboard update. Arena Training Management streamlines and automates many of the administrative tasks associated with maintaining a compliant training record management system.
An automated training management process simplifies these lesser-value administrative tasks, enabling your training managers to deliver more effective content — content you need to ensure employee safety, product quality, and regulatory compliance. How do you manage each employee’s training plan? How much time is your training staff spending recording and reporting who has taken a class with a spreadsheet? How often are documents revised without impacted employees’ awareness resulting in adverse conditions or substandard products?
For product companies, Arena Training Management can provide added workforce flexibility
. Workforce flexibility benefits come with better cross-training. When needed, you can easily identify all employees who are trained to perform a given function, like performing an incoming inspection or executing a test procedure. The employee’s training record is linked directly to the document(s) describing the SOP.
Arena Training Management is the training record management solution for improved product quality and regulatory compliance.
Too often many company’s training record management processes may not be executives’ top priority but putting automated basic functionality into place with a training management system can yield major improvements and avoid significant problems. Product companies should consider a training solution that links the training records to the product record. You’ll benefit from a system that is simple to implement, intuitive to use, yet robust, and scalable. When you adopt training record management software, you will accelerate audits, improve product quality, and maintain employee safety with minimal administrative overhead. With Arena’s training record management solution, you will have better—and safer—resources available to create products that change the world and you will be confident you are compliant.