No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketplace, it can all fall apart without a strong handle on your organization’s training needs and ability to effectively manage a training program. Ensuring that your staff is properly trained to do their work is a basic expectation for regulatory bodies in the life science industries. In order to manage this extremely important activity, your organization must:
Properly identify and maintain training requirements
Manage all associated training activities
Identify, provide, and manage training materials and locales
Be able to successfully report on an individual’s training history
Ensure outstanding training needs are being completed in a timely manner
Ensure training is effective
Implementing a best-practice solution for training management is essential to help an emerging life science company ensure compliance and quality. Regulatory agencies in the life science industries demand that your company has proper controls in place that ensure your staff, employees and non-employees are properly trained, that their training is documented, and that changes that require re-training are properly maintained, communicated, and rolled out, resulting in auditable documented training.
Utilizing an electronic training management system is preferable, but regardless of the system, there are a few things one must begin to compile to be ready to implement a structure that helps a training organization or human resource staff successfully manage training. Another important goal here is the ability to create an environment where a change to a training requirement results in an immediate and logical set of training tasks to be assigned to affected trainees. This is essential in ensuring ongoing quality within your organization’s training environment.
So how does one begin creating such an environment? The first step is understanding your own organization’s training landscape. Your organization has a number of people, each may play multiple roles (this is especially true with start-ups), and, as such, each role has its own training needs and requirements. Also contained in this landscape are many training elements that need to be managed. These include documents and courses that might be required. You will need to gather this information and get it into a structure that allows the easiest management as changes occur. Also, it is imperative that you have a good idea of how changes will be handled as they will inevitably occur and also to identify how these changes will be communicated.
Once you have a good understanding of your current landscape, the next step is to follow a four-step process to identify and structure the data so as to be ready to manage the training for your organization. Let’s take a look at each step:
Requirement Building. The goal of this step is to identify and document all training elements (documents and courses) that are required to achieve a specific requirement (e.g. Manager Requirements, Sterile Cleaning requirements, General Human Resource requirements, etc.)
Role Identification. The goal of this step is to identify the roles/major activities that are present in your organization (e.g. Shift Manager, Line Operator, Employee, etc.)
Role-to-Requirement association. The goal here is to take the defined requirements and assign them to the Roles identified. Note that some roles have multiple requirements to complete. For example, the “Shift Manager” may have both the “Sterile Cleaning” requirement and “Manager” requirements assigned to him/her
Identify employee’s role(s). The goal here is to assign the identified role (or roles) to the individuals, showing which roles they perform for our company. (For example, John Smith serves in the “Shift Manager” and “Employee”)
When completely implemented, if a new training document (for example) is added to a requirement, all employees whose role incorporates that requirement will now be required to be trained. Or if a person changes roles within an organization, the act of assigning that role to that person will trigger the need for new training and assign it to that person.
This four-step approach provides you with a very powerful way to manage training in your organization. It helps you organize training by roles for an employee or contractor, but it also helps you organize requirements for those roles. In effect, you are now able to manage your complete employee and contractor training in a grouped fashion.
Importance of Automation:
At first, glance, to manually manage these lists in a spreadsheet or other common office tool can be very overwhelming. That is where implementing a training management solution, configured to handle training management particularly, helps out tremendously. Advantages of using a training management solution include:
Immediate email notification whenever new training is required (triggered by adding or changing of roles, requirements, courses, or documents)
Ensure timely staff training (due dates tracked and charted, reminders sent)
Ensures appropriateness of staff training (only those affected get training notification)
Easily manage to change training requirements
Quickly identify “who-needs-what” training
Easily identify outstanding delinquent Training and escalate to management, if necessary
Automatic training notifications generated as a document revision becomes available for training
Overall paper reduction
Ensures user is accessing and training on the current version of the document
Training documents can be provided online via a “click” (potentially minimizes users need to hide old versions of documents)
Bottom line: if implemented accordingly, using this four-step approach within a best practice training management system results in an environment where people are trained to do the job they have been hired to do.
Note on resources:
Many start-ups and emerging companies in the life science industries are constrained in a number of ways — notably in funds and resources. This can present many hurdles in trying to get a useful training management system in place. In order to minimize costs and expending copious resources, some options to consider include: selecting a solution that can effectively address multiple business or quality needs to increase ROI, a solution that provides a lower cost option of hosting off-site (e.g., cloud-based solution), one that utilizes non-proprietary infrastructures, and one that can be configured without requiring programming resources.
Other items to be aware of:
A best practice approach for implementing an electronic training management system also includes these other important attributes. They are true needs that best of breed quality management systems will provide:
Communication: Automatic assignment of training when requirements change and then communicates those assignments effectively. Notification to users of coming-due uncompleted training tasks, and course registrations.
Client experience: The electronic system should incorporate end-user functionality that increases performance and acceptance such as: including built-in instructions within the process itself as well as visual hints or cues that make it obvious to the user where the document is in the process and what to do next. Also, it’s preferable to use dashboards displaying only data pertinent to the user.
Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures. Also, control of business processes is key. The system should provide seamless integration and flow to other quality and/or business processes, such as document management, or provide CAPA generated re-training tasks.
Compliance: The electronic system must meet all applicable regulatory requirements (e.g. 21 CFR Part 11). Also, implementing reminders and escalations when tasks are due (or late!) helps you to stay in compliance with objectives and agreed-upon timelines.
Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.