Multi-faceted assessment of the ergonomics in medical device manufacturing
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
According to the National Safety Council (NSC) and the Bureau of Labor Statistics (BLS), in 2018, there were over 4,000 preventable injury related deaths (this does not include homicide or suicide at work) (Statistics, 2019). Likewise, in 2017, there were 4.5 million work-related injuries (Council, n.d). First aid injuries are injuries, according to OSHA that can be treated using items in a first aid box, near misses are injuries that almost happened (e.g., almost being hit by a swinging door), but did not, while recordable injuries are one that the employee has to receive medical attention for the injuries, and they have to be reported to OSHA. Companies reports every recordable injury to OSHA; however, the National Safety Council (NSC) emphasizes that that is not enough. The reduction of injuries before they occur will not only save an organization lots of money and time, but also save the life of a worker. This requires Mesa establishing a safety culture. OSHA emphasizes that safety cultures should consist of shared beliefs, practices, and attitudes that exist at an establishment. “Culture is the atmosphere created by those beliefs, attitudes, etc., which shape our behavior”(OECS, 2020). The purpose of this project was to assist a manufacturing facility, that manufactures Biological Indicators (BI), to ensure that the safety program was compliant with Occupational Safety and Health Administration (OSHA) regulations.

JSA. The overall sample size for one the Biological Laboratory department consisted of 13 employees and job functions that involves lifting heavy containers, sealing glass with gas induced flames, steam, chemical and heat related operations, there were 72 injuries in less than a year, categorized as first aid injuries (50), near misses (20) and recordable injuries (2).Job Safety Analysis (JSA), also called Job Hazard Analysis (JHA), is a great way to identify hazards before they occur, as it focuses on the worker, task, tools, and the work environment ((OSHA)). Because JSA breaks down a job function or description in a step-by-step process, it helps shed light on each task, like putting each task under a microscope to identify risks and hazards of the job. A template created by a lean expert consultant firm was utilized. The template highlighted the likelihood of an injury and the consequence of such injury in a risk matrix format. Although it is difficult to quantify risk, a severity section was included in the risk matrix to add a numerical value to the consequence of the risk and likelihood of an injury (or death).
This project focused on the Biological Indicator (BI) Laboratory and the Assembly and Packaging (A&P) areas. To complete the JSA, the employees and supervisors were interviewed and observed as they completed each process. As much as possible, employees were physically observed. When this was not possible (due to COVID-19 restrictions), a video recording device was used to capture the processes. Physiological data included pulse monitoring, and a pinch gauge measurement recorded for tasks that involved dexterity usage or continuous heavy lifting. Standard Operating Procedures (SOPs) created for job function per International Standard Organization (ISO) and Food and Drug Administration (FDA) regulations were reviewed for the requirement of the job functions (ISO, 2016).
Safety Consultant. A representative from OSHA/Environmental Compliance Systems (OECS) was hired by Mesa to perform a safety audit and inspection throughout the organization as a safety consultant. The consultant toured through the facility highlighting areas that were compliant with regulatory standards and identifying safety hazards and violations.
Safety Citizenship (Ownership and responsibility). When the risks are identified, the organization needs to ensure that the hazards are eliminated or reduced to an acceptable risk level. One of the ways this can be accomplished is to involve supervisors and employees who perform the tasks in the hazard identification and elimination phase. Laurent et al suggest that the role of a worker in eliminating safety hazards serves as a motivation for both the worker and others around them in promoting a safer environment and their safer behavior (Laurent, Chmiel, & Hansez, 2020). When a hazard was identified during the observation and interview process, the responsibility of the providing a safer environment was given to the employees and supervisors, with a deadline, so that they are made responsible and accountable for the safety of their areas.

The template provided a step-by-step breakdown of the process (job function), with the hazards and the rating of the hazard from ‘low’ to ‘very high’. For each process step, the hazard was identified, as well as the inherent risk involved in performing that task. A control measure was then put in place for process steps with risks higher than low to reduce the risk.
Upon completion of the JSA, it was found that some processes had tasks with ‘Very High’ inherent risks, but with control measures put in place, the residual risks were reduced to ‘low’ or ‘medium’.
The numerical severity was determined by using the risk matrix from the JSA template which is rated from 1-12, with 1 being low and 12 being extremely high, resulting in death.
The control measures or risk reduction measures put in place were done using the hierarchy of controls. The hierarchy of controls is a means of determining risk reduction measure that are effective and feasible (NIOSH, 2015). The physiological data recorded an average of 15% increase in the heart rate of technicians while unloading test tubes from Autoclave.
The safety consultant discovered about 20 safety violations and had several recommendations. These were rated based on severity according to OSHA and how the organization would be fined according to OSHA’s Risk Assessment Code (RAC). “A Risk Assessment Code (RAC) is a numerical prioritization method used to address which recommendation to address first, based on frequency/severity. Rating numbers reflect the likelihood of accident occurrence and potential for injury severity. RAC 1, for example, would be the highest combination of frequency /severity and should be one of the first recommendations to correct. RAC 15 is the lowest probability for an injury to occur where correction is not critical for immediate action. A recommendation with a lower probability number still needs to be addressed since the exposure may come into play with other accident potentials. The RAC is not intended to reflect the likelihood of receiving an OSHA citation or an insurance correction recommendation” (OECS, 2020). When hazards were identified during the process, supervisors and employees were informed immediately to assume responsibility and take ownership of providing a safer environment for everyone.

Job Safety Analysis is a great tool to identify safety hazards on a job site though job functions. This will prevent the injuries and keep companies compliant with OSHA, FDA and ISO regulations. by identifying safety hazards through Job Safety Analysis of a job function so they can be eradicated. Creating an atmosphere from top to bottom where a safety culture of safety responsibility and ownership is embraced will promote a safe and compliant environment This will enable a safety culture that is sustainable and interconnected into every task and area of the facility. This will also minimize preventable injury, loss of time and money and even death.