Change is constantly occurring across industries. This can be a change in staffing, management theory, equipment, and regulations. Pharmaceutical manufacturers experience frequent changes, especially as they adopt new technologies in the manufacturing process. As new and different treatments emerge, such as those designed to combat non-communicable diseases, it means that the technologies used to aid in the production of these drugs tend to also need to be updated. New equipment and better testing procedures can help labs more quickly develop formulas that might treat diseases, improve quality of life, and bolster profits. However, changing equipment requires environmental, health and safety (EHS) professionals to manage key aspects to ensure that lab safety and regulatory compliance are maintained.
So how can management of change software aid in the introduction of new technologies within a lab setting or hospital? In order to answer this question, an understanding of management of change (MoC) is necessary.
What is Management of Change?
At its simplest, MoC refers to a process to ensure that changes are properly reviewed before they are implemented to avoid, minimize, or mitigate key environmental, health, and safety risks and ensure that people within an organization who have to adopt these procedural changes are properly trained before and after the changes are made. Generally, MoC processes cover new technology, equipment, employees, and regulations. Once management has decided to introduce something that requires change at an organizational level, then it is necessary to begin a top-down approach to ensure that this change is managed effectively and according to all environmental, health, and safety regulations. Throughout this change, regulatory compliance must be maintained. In any change management situation, there are competing priorities, such as implementing the change on time and budget, providing training to impacted employees, and effectively communicating changes up and down the organization, which can make the MoC process challenging to manage using spreadsheets, homegrown solutions, and email chains.
This is where management of change software becomes the best tool an organization can utilize. These solutions are designed to centralize and standardize the change management process thereby helping to ensure that action plans are easily understood and followed by all staff members. While the processes will differ from industry to industry, the overall goals remain the same: employee safety, efficient implementation of the changes, and risk mitigation. The pace of technological advancements within the healthcare sector, especially pharmaceutical manufacturers, is leading to a shift in the production of life-saving drugs. But new equipment means that there can be room for error if employees are not properly trained, or they are resistant to the change.
What Management of Change Software Can Do For You
MoC software is designed to centralize and standardize your processes and simplify the approval process from the shopfloor to the C-suite. Let’s take a look at how this process works:
- First, the change is entered into the application.
- Second, in accordance with EHS processes, potential risks can be assessed and addressed before equipment is ordered. This level of review ensures that unapproved equipment is not ordered, which can save the company a lot of aggravation and money. Within the application, all of the requisite forms are automated within the application, which means they can be filled out, filed immediately, and sent for the necessary reviews and approvals.
- Third, operations and the EHS team can begin to assess the regulatory demands of the new piece of equipment and determine if new permits are needed and/or additional employee training is required. This step helps identify and avoid, minimize, or further mitigate risks.
- Fourth, perceived risks can be explored and mitigated through the formation of action plans that are managed by health and safety workers and administered through the system. All of this is occurring before the change happens.
- Fifth, training programs can be created to ensure that employees are trained on how to use the new equipment in the lab setting, monitor it for failure, and perform routine maintenance.
- Lastly, automated notifications and reminders are put into place throughout the entire MoC process to keep the approval process moving forward, which can shorten the time frame it takes to implement changes going forward, while ensuring that employees have completed any required training, all risks have been identified reviewed and mitigated, and management have reviewed and approved all items related to the change request.
In theory, this is all pretty straightforward but in practice it can be much more complex. The key is people: they must be active participants in the process, which means they need to foster an environment where communication is transparent. Software solutions can improve the process only so much, there must be a culture that embraces the technology to make the process work.
The Introduction of Collaborative Robots in a Lab Setting
The world of clinical testing is one in which change is constantly taking place in the form of new regulations, techniques, and equipment. To compete on the world stage and be at the forefront with cutting edge drugs, means that advanced technologies have to be adopted, such as robotics.
Some employees balk at the idea of this change out of fear that their jobs may become obsolete as more and more of the manufacturing process is automated. However, automation does have its benefits, such as freeing up lab techs to take on other tasks that they had less time for. Let’s take a look at how MoC software could be utilized for the introduction of a new piece of lab equipment: collaborative robots or ‘cobots’.
The first step in the action plan would be the formation of the change itself. Before a piece of new tech, such as a cobot, is introduced or ordered the EHS team must assess the potential risks that could occur with this new piece of equipment. Various risk assessments must be conducted on the introduction of this new technology within the lab setting in order to identify the risks that have to be mitigated. It is important that before the cobot is ordered that regulatory measures are met or adjusted for, an action plan created to address any and all potential risks, and the necessary training modules developed.
Once the lab knows that cobots are going to be introduced into the lab, safety training must be provided to employees who will be working and interacting with them. Compliance management software can also be used in conjunction with MoC to ensure that all regulations and EHS requirements are identified and included in the action plan. Once this is in place, then the cobots can be ordered and installed, and training with the new pieces of equipment can proceed.
Train on the New Equipment
Training will be required for any employee who will use, and maintain the cobots, or be present in the lab to ensure that they know what to do if there is an event or accident. To ensure that risk is managed and mitigated, training can be delivered through the software solution or through your company learning management system (LMS) and an automated record of completion can be sent to the MoC solution to note who has and hasn’t taken the required training courses. Before the cobots even arrive, employees should embark on an extensive training program to understand all of the risks they may pose, such as dropped contaminants and improper handling of tools. Anything that could go wrong needs to be planned for, even if it seems infinitesimally unlikely. Remember, training is designed to help to avoid, minimize, and mitigate known risks.
Training, regulatory reviews, and related documentation associated with the equipment can be stored directly in the software, which provides users with a ‘single source of truth’ that can be used for internal and external audit reviews, regulatory reporting, and continuous improvement projects. The entire training and safety process should be assessed on an ongoing basis as the change is implemented. Further, safety equipment may need to be purchased and understanding the mechanisms involved with the new cobots may also require hands-on training. Cobots are designed to make tasks easier and eliminate human errors, proper training ensures that they are used at an optimal level.
Damaged mechanisms mean that a service technician may need to repair the cobot, or a cobot repair specialist may need to be employed by the organization so you have an on call person. Third-party companies and certified technicians can be added to the action plan in case they are needed. Planning and training for every eventuality needs to be a component of change management.
Documentation and Compliance
Leveraging an MoC solution to centralize and standardize the entire change management process, including risk assessments, approvals, documentation, and any regulatory changes, has tremendous benefits to a company. By using an MoC solution, you can manage and monitor changes on a continual basis and measure the value of your change management program. If it becomes clear that the change is not being implemented as smoothly as possible then this can be addressed and updated within the system for further study. Everyone wants to prevent errors that can lead to incidents, and the best way to do this is through the standardization of processes.
Management of change is crucial within every industry, from energy generation to pharmaceuticals. The practices used by both may be different, but the end result is the same: that the change is implemented efficiently, effectively, and in accordance with regulations. To help ensure these goals are met, leveraging software solutions that centralize and standardize the change process from beginning to end are invaluable.
Imagine having to have binders full of paperwork to be approved by managers. Communication amongst management and employees would be minimal and possibly lead to a lack of transparency, which could in turn lead to poor decision-making, added risks to employee health and well-being, and added costs to the company that impact the bottom-line. Staying relevant and thriving in a fast-paced industry, like the pharmaceutical industry, means constant change and therefore the need for constant adaptation. Don’t just update equipment, update the processes and the technology used to institute them. An EHS system with a MoC module is just another tool in the proverbial arsenal.