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As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.
When something goes wrong at a facility, the first and easiest explanation is often operator error. But experts say that is rarely the real reason. Today, a growing number of FDA warning letters find that some facilities are not maintaining or following written procedures, whether for process or equipment operation, validation, or quality control testing.
Experts trace this problem to a need for more human-centered documentation and training practices, and approaches that empower staff and encourage their active involvement in problem solving and improvement. “Anywhere there is a person-machine interface, there is an opportunity for error” says Jim Morris, executive director of the Health Sciences division of NSF International, a global consulting group that focuses on training, testing, and auditing for pharmaceutical and medical device companies. “The information that operators have about how a process works becomes all the more important,” he says. The more that such information can be provided succinctly and clearly, the greater the chances that procedures will be carried out correctly.
Generally, operations that involve bioprocessing equipment come with a high level of complexity, says Morris. However, the highest bar for operators is in sterile operations, he says, due to the nature of the operations and the risk of microbiological contamination. Equipment vendors have responded by developing isolators and enclosed systems that minimize operator contact with the product.
Use of lean manufacturing and operational excellence techniques has also shown results by reducing waste and errors, and boosting overall productivity. Vetter, a contract development and manufacturing organization, recently implemented such a system for its aseptic filling operations, and realized an overall improvement in production flexibility and efficiency (1).
Outside of biopharma, changeovers for continuous oral solid dosage (OSD) form processing are extremely complex, says Morris, often involving more than 1000 components to disassemble, clean, and reassemble. Ideally, changeovers should take a day or two, but for continuous OSD facilities, they can require a week or more, depending on the complexity involved (2). Equipment vendors are working on simplifying designs, in projects that involve industry and academia, but work remains to be done.
Operators are the best source of insights on how to improve documentation and processes, and proactive companies are setting up processes that get the operators and technicians who are actually doing the work to provide feedback on procedures and training to see how they might be improved.
Seeking input from staff requires creating an open culture in which individuals feel safe bringing up problems and highlighting practices and areas that may need to be improved. “There is a need to move from blame and fear, and to shift the emphasis from a reactive to a proactive culture that provides a nurturing environment [for employees],” says Nuala Calnan, principal of the consulting firm BioPharm Excel, professor at the Technical University of Dublin, and co-leader of the International Society for Pharmaceutical Engineers’ (ISPE’s) and PDA’s quality culture program.
But even voicing the idea of employee empowerment can be challenging in a business environment that is constantly changing and focused on reducing costs. In 2019, the pharmaceutical industry saw $278 billion in mergers and acquisitions, 12% of the world’s total, according to Bloomberg analysts (3). Each change in company ownership brings changes in priorities, focus, systems, and procedures.
“Where you have a lot of structural and management changes and pressure on costs, change filters its way down to how work is conducted. It’s difficult to work with a lot of continuity, and people will be more prone to error,” says Morris. “The key to improving performance is to set up systems and people for success. Reducing complexity through user-focused documentation systems and risk-based quality systems are key components of success,” he says.
NSF advances an approach, discussed in a 2019 webcast (4), that is based on triage, or prioritizing efforts based on the severity of potential risks of failure. “Not all events are created equal,” Morris said on the program, “but many sites don’t triage very well, as attested to by poor investigations, a large number of open root cause investigations, and open CAPAs, recurring compliance issues, and high levels of stress.”
Successful triage requires establishing clear risk thresholds to distinguish between low-, medium-, and high-level risks and treating them so that staff effort devoted to an event or investigation is a function of the level of risk involved, he said. Training should also be designed so that crucial tasks (particularly the fundamentals of current good manufacturing practices [CGMPs] such as gowning, batch recordkeeping, and data logging) are practiced often and become embedded as habits.
At the same time, standard operating procedures (SOPs) should be made easier for operators and technicians to understand and follow, Morris said. Many pharma and biopharma SOPs still contain unnecessary or redundant information or appear as straight text, which can make them difficult to refer to quickly in a busy work environment where individuals are multi-tasking and frequently interrupted, Morris said on the program.
It is also important to address the user-friendliness of SOPs, which are meant, not to satisfy regulators or to function as training aids, but to standardize processes and provide consistency, as Martin Lush, global vice-president for pharma and biotech at NSF International has pointed out (5). At a typical pharmaceutical facility, Morris said on the webcast, there may be 800 SOPs and 200 work instructions in place, where the ideal situation might be to have the reverse (i.e., 200 SOPs and 800 work instructions).
In addition, each individual SOP can exceed 50 or 75 pages and can be very difficult to follow, Morris said. He suggested using smart labels, for example, to convert a full page of text into a label that provides built-in instructions, and to use arrows and flowcharts to describe sequential tasks, adding photos and call outs to improve explanations.“We need to make sure that SOPs are well designed so that the information they present is relevant and written so that people can follow it, and this needs to be an area of focus for most, if not all, pharmaceutical companies today,” he says.
Morris sees a potential role for virtual and augmented reality, especially in setting up risk-free learning environments, so workers can get close to the environment without posing any contamination or other risk. Embedded video will be especially useful in optimizing SOPs for complex and unique operations, says Morris.
He blames inadequate planning for many operations and compliance problems. “In some cases, companies haven’t invested enough in understanding variability, and how a process will perform at scale in their operations. Some don’t spend enough time ensuring that people are prepared for the new way of working before they bring changes online. As a result, they suffer from nonconformances that need to be investigated,” he says.
Empowering those employees closest to problems to solve them is a win-win, freeing managers up for more strategic work, says Calnan. “All too often in a CGMP facility, individuals must operate almost as if they are in a straightjacket within the restrictions of SOPs, regulations, and processes that are in place,” she says.
In these situations, the leader may handle all the directing and make all the decisions, says Calnan. “We need to enable qualified workers to make as many of those decisions as close to the call space as possible with all the support that they need,” she says.
Calnan also advises setting up polices that reward people for preventing or predicting problems. One example, would be rewarding good catches (e.g., discovering whether any crucial documentation is missing before product release) as part of batch documentation. In the end, senior management support is essential for shifting from a reactive to a proactive culture and empowering employees. “Quality culture comes from leaders, and you won’t get that crowdsourcing of problem solving and proactivity from the ground floor up if it isn’t sponsored from the top down,” she says.
1. G. Buerkle, “Applying Operational Excellence to Improve Injectable Production,” PharmTech.com, June 24, 2019.
2. J. Markarian, “Oral Solid Dosage Continuous Manufacturing Strategies,” PharmTech.com, April 2, 2019.
3. G.M. Burnett, “Analysis: Pharmaceutical M&A Accounted for 12% of all Global Deals in the Third Quarter of 2019,” bloomberglaw.com, October 15, 2019.
4. J. Morris, “Implementing a Simplification Strategy,” youtube.com, April 10, 2019.
5. M. Lush, “SOP Simplification, Part 1,” youtube.com, May 31, 2017.
Vol. 44, No. 1
When referring to this article, please cite it as A. Shanley, “Human-Centered Work: How Pharma Can Move to a Blame-Free Culture” Pharmaceutical Technology 44 (1) 2020.