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As technology and automation transform pharmaceutical manufacturing, the human factor is often overlooked. New production equipment and manufacturing spaces may be cramped or inadequately designed, while work schedules and operating procedures often fail to consider workers physical needs and limitations. A common example of a mismatch between Installing standing platforms and adjustable-height isolators can make human abilities and equipment suitable for workers of all sizes. Photo courtesy of task design is when employees sit parallel AstraZeneca. to a filling or packaging line, instead of facing it. This position is usually taken because there isnt enough knee and leg space under the machinery, but sitting parallel to equipment results in twisting
and reaching, increasing the likelihood of stress or musculoskeletal disorders (MSDs). Ergonomics prevents situations like these, by evaluating worker abilities and limitations and taking them into account in designs. Key MSD risk factors include:
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All of these risks are commonplace in pharmaceutical manufacturing, and may affect the bottom line, by reducing productivity, morale and product quality. More manufacturers today recognize the importance of integrating proactive ergonomic solutions into their business processes (see BEST PRACTICES FROM AROUND THE WORLD, below). We used to be focused on training employees just to be aware of ergonomic issues, says Robb Patterson, ergonomics team leader at Pfizer Global Manufacturings Kalamazoo, Mich. site. Today, were getting our engineers to think about human factors during the design stage. The industry is moving from a reactive to proactive stance towards ergonomics, Patterson says. Good ergonomics foundations Successful ergonomics programs are systematic and sustainable, and put in writing. They include clear goals, focus on risk, and are integrated into existing processes and operations. They must be measurable, visible and focused on continuous improvement. More sophisticated workplace ergonomics programs share the following characteristics:
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management commitment and support extensive training on risk factors and ergonomics hazard analysis and control strong medical management regular program evaluation
If any ergonomics program is to succeed, it must be viewed, from top to bottom, as a good business decision. Ergonomics programs that operate as one-off fixes or grassroots initiatives fail to change the manufacturing culture. U.S. regulatory requirements for ergonomics are generally limited to the General Duty Clause. Except for a few state OSHA programs, ergonomics programs are recognized as a best practice by the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and other organizations. The preferred method for controlling risk factors is through engineering controls. Engineering controls involve a change in the physical features of the workplace, and might include reducing the weight of objects, changing work surface heights or purchasing lifting aids. When engineering solutions are not feasible, administrative controls are used. These controls are less effective than engineering controls because they dont eliminate the hazard. They include longer rest breaks, using more employees to perform lifting or certain tasks, and improving maintenance for tools and work areas.
Work practice controls such as personal protective equipment (PPE), are also used, but are the least effective methods, since the employee is still exposed to the risk factor.
Employees at Pfizers Kalamazoo site inspect and pack Gelfoam sponges, used for dental surgery. Previously (above), inspectors sat parallel to the pace belt and had to reach over the work area to grab product off the belt. Photo courtesy of Pfizer.
After a redesign (above), workstations are perpendicular to the belt, which has reduced worker reaches from 24 in. to about 6 in. Stations and chairs are also adjustable, allowing workers to stand or sit at preferred heights. Photo courtesy of Pfizer.
Ergonomics at Biogen Several years ago, Biogen Idec implemented a full-blown ergonomics program after it realized that most of its workers compensation costs stemmed from poor ergonomics. Key to the program, modeled after NIOSH and OSHA recommendations, is a written corporate policy that explicitly correlates ergonomics with the companys core values of worker safety and a high quality of work life. While regulations in specific countries or states may direct some aspects of the program, Biogen Idec has gone beyond minimum recommendations i.e., simply documenting a written program to create a Global Ergonomics Guideline for Office, Laboratory and Manufacturing areas. An Ergonomics Steering Committee identifies and addresses current issues in ergonomics and heads off future problems by making ergonomic principles a part of new projects, purchases and personnel hires. It also provides for ergonomics teams made up of plant workers and safety professionals to address specific ergonomics issues that arise. Workers are encouraged to contact designated experts in their global regions.
Where most companies still wait until after an injury has been reported to evaluate a manufacturing area or workstation, Biogen trains employees when they are hired on workstation requirements and hazards. During renovation or relocation, the Ergonomics Steering Committee reviews design plans and equipment for potential risk factors and provides input into heights, reaches, equipment use, accessibility and other aspects key to design based on a careful review with the end users and the design team. Welcoming informed workers In working with engineers, the steering committees goal is to ask the right questions: How much would that filter weigh when full? How do you propose to move it? Over time and with many successes achieved, plant and design engineers have become accustomed to the Steering Committees input and now often address ergonomics issues on their own. A culture has taken root that encourages all employees to report incidents and near misses, and to participate actively in creating viable solutions. Manufacturers often express concern that educating workers in risk factor identification and prevention will produce a barrage of complaints, and even lawsuits. Biogen has addressed this issue by creating an electronic system to record and manage all ergonomics concerns and requests for workstation evaluations. The system not only records all transactions and keeps an ongoing history of projects, but also provides immediate employee feedback and the amount of time that corrective action will take. The company has found that technology is an excellent way to sustain ergonomics at individual sites, and share best practices worldwide.
BEST PRACTICES FROM AROUND THE WORLD AstraZeneca: Ergopasses and Body Maps Ergonomics have always been high on the agenda at AstraZeneca, says Jan-Anders Kipping, an occupational hygienist who heads up the ergonomics program within AstraZenecas Global Safety, Health and Environment (SHE) Group in Sweden. AstraZeneca evaluates ergonomics and conducts risk assessments for a new site or production line in three stages in the concept stage, after blueprinting and equipment purchases, and yearly or halfyearly after startup. Even if you have a blueprint or 3-D computer model, its not the same as when an operator is standing there, Kipping says. Working heights or materials loading procedures may have to be modified. Sweden, where physiotherapists or SHE professionals are commonly found within plants, has influenced other AstraZeneca facilities, Kipping says. The Sodertalje site has instituted the Ergopass, a pamphlet into which employees ergonomics data, job procedures and physical needs, are recorded. In Reims, France, employees use body maps, onto which they mark areas of personal discomfort or pain. Summary body maps are then compiled for specific jobs and working environments, allowing managers to identify problem areas and implement changes.
AstraZenecas Asset Strategy for Packing (ASPac) team has undertaken a Bulk Tablet Container Project in order to share best practices and develop global standards. No tablet pack is heavier than 10 kilograms for smaller machines, and 50 kilos for larger machines. Standardization is a way to force people to use lifting equipment, Kipping says. Not all employees are receptive to changing their habits, he says, but when they have ergonomic problems, they are willing to listen. Pfizer: Old Sites, New Practices At Pfizer Global Manufacturings Kalamazoo site, ergonomics requirements are part of the capital approval process, says Robb Patterson, ergonomics team leader. Weve been able to justify many projects solely on ergonomics. Examples of this include automating end-of-line processes and purchasing new cartoners, case packers and palletizers. Kalamazoo strives to get all workers involved in ergonomics. When an ergonomics-related issue arises, ergonomics focus teams comprising four to six plant-floor employees are put together to brainstorm immediate improvements. Workers are also asked to critique their colleagues physical practices. In the injectable drug inspection area, for example, employees use checklists to gauge whether or not their colleagues are following sound ergonomics practices. Information from these checklists is input into a database that measures overall employee compliance with site ergonomics standards, or best known methods for given tasks. These methods are integral to employee training and development programs. The pride of ergonomics at Kalamazoo is the new manufacturing space for the companys Gelfoam product, a clotting agent for dental surgery. Height-adjustable equipment and chairs are being used to ensure that operators are able to perform all work within a 12- to 16-in. envelope. Ergonomics interventions have decreased the risk of injury and have improved the sites safety metrics. And without question, Patterson says, an attention to ergonomics has led to increased product quality, productivity and worker satisfaction. Global Integration at J&J With 120 sites worldwide, Johnson & Johnson has taken upon itself to be a trendsetter in ergonomics, and to share its best practices with regulators and industry. Unlike the EU, the U.S. does not have standardized regulations for ergonomics. In 2002, Johnson & Johnson approached OSHA about developing a partnership to further standardization within the pharmaceutical industry, and the agency was receptive. The partnership began in 2003 with a benchmarking activity at the Ortho Clinical Diagnostics facility in Rochester, N.Y. Today, the two continue to share ideas at regular meetings. The Puerto Rico Occupational Safety and Health Office (PR OSHO) is now also involved.
We opened the doors to OSHA, says Mnica Matlis, Johnson & Johnson's World Wide Manager for Ergonomics. Johnson & Johnson and OSHA expect to make some of their best practices documents available on OSHAs website later on this year. Johnson & Johnsons ergonomics program, ERGO, is a cultural program, Matlis says, so that everybody owns the process, not just the safety and ergonomics professionals. It includes a six-step Ergonomics Maturity Ladder (EML):
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Despite its initiative to standardize best practices among its global facilities, Johnson & Johnsons program remains sensitive to regional and cultural differences. Matlis offers the following suggestions for building a successful ergonomics program:
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Establish a track record and long-term commitment to ergonomics; Establish an ergonomics culture at the site, and buy in from the top and the ground floor; Consider local cultural issues when implementing ergonomics programs; Ask employees. Solutions without employee input are doomed to fail; Get middle managements firm commitment to ergonomics; Design ergonomic risk out of the process before it even touches the employee.