By James Morris, executive director, Pharmaceutical Services, NSF International
Investigations into tragic events often find fault in those closest to the incident (control room operators, plant personnel, etc.). However, thorough investigation often reveals that the root cause is found in the interplay between technology, the organization, and those closest to the event having to make split-second decisions.
In the life science industry, we are not often faced with situations where split-second decisions determine a person’s fate. However, decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?
In the book Behind Human Error, David D. Woods et al draw the distinction between what they refer to as the “blunt” and “sharp” ends of complex systems, like those found in the aviation, power generation, and healthcare industries. At the blunt end are upstream decision makers such as industry executives, policy makers, and technology suppliers; the sharp end is composed of practitioners, such as pilots, practitioners, and operators. Applying these concepts to life science organizations, we essentially need to determine how they should:
- maximize the effectiveness of decision-making at the blunt end of the organization, where choices are made regarding vision, policy, capital investment, and resource deployment, and
- ensure the effectiveness of decisions and actions at the sharp end of the organization. The “sharp end” refers to those in operating roles – first line supervisors, operators, analysts, etc. (Woods).1
In this article, I will touch on both “sides” of a life science organization and share several best practices at the operating level.
Decision-Making At The Blunt And Sharp Ends Of An Organization
The decisions at the blunt end of an organization are, to a great extent, a function of the quality of the leadership and the cohesiveness of the leadership team. Senior leaders decide which priorities are funneled to the rest of the organization. Their decisions as to what to do and what not to do, how they communicate priorities, and their decision-making under pressure resonate across the organization. An overly ambitious leader may pursue many parallel improvement initiatives simultaneously and risk overwhelming those at the sharp end who are managing day-to-day activity. The experienced leader will find the right balance, avoid initiative overload, and quickly recognize pivotal moments (a successful product launch, a product development failure in the clinic, or a product recall) — leveraging these moments to move the organization steps closer to realizing the company’s vision. Clearly, the sharp end is greatly influenced by company leadership, and building the right company culture at the sharp end starts with the blunt end of the company.
However, decisions and actions taken at the sharp end can make or break an organization. And, as is true for most organizations, manufacturing operations must constantly balance the conflicting demands of faster, better, and less expensive. This context will not change, so it is incumbent upon leadership to consider what can be done to maximize employee and work group effectiveness and reduce the risk that a poor upstream decision will have severe consequences downstream in the supply chain. Organizations can be messy, and therefore it is important to take the long view, to look for incremental improvements, and to get very good at two key activities: how we develop expertise and how we share information across the organization.
The training function and role of training is, sadly enough, undervalued in many companies. Most operations must constantly manage the complexity that comes with change and make decisions when things don’t go exactly right. Rather than ask why something went wrong, we should ask, “How did we get it right the majority of the time?” That is what makes us human, the unique ability to figure things out. But to keep the odds in our favor, personnel must be offered frequent and high-quality training, so they are prepared to make the right call when things do not go according to plan. Training and personnel development should be given the same measure of importance as any capital investment.
What is the right level of investment in personnel development and training? I recall a conversation with a well-respected head of global manufacturing. His comments went along these lines: “We expect our people to learn on the job, and we mentor people along the way,” implying that training away from the shop floor was not a priority. I agree that true learning takes place on the job, but with today’s technology and complexity, on-the-job learning must be supplemented with education that explains why things work the way they do — for example, why a bubble point test failure warrants careful investigation, why the air evacuation phase of a sterilization cycle must be within the validated range, and why a software change on a medical device requires thorough testing. How we impart that knowledge to those at the sharp end is what will ultimately determine company and/or unit operation success.
Most everyone is familiar with the “read and understand” approach to personnel training. The supervisor and their employees play a specific role (lab analyst, production supervisor, material handler, warehouse operator, etc.), and they are provided a list of standard operating procedures (SOPs) that they must read and understand. This is a check-box exercise and far from learning how to properly perform a task. We must move training at the sharp end away from the check-box mentality and embed the following principles:
- Role-based training: Encourage role-based training that is specific to those tasks the trainee must perform and to the related SOPs that explain how to carry out their tasks/roles. If a training curriculum includes a host of SOPs that are not essential to the trainee’s role, it is not the right curriculum.
- Training on demand: Training is delivered “on demand” or close to when the task is to be executed. If training was delivered in a classroom, there is a good chance additional training will be needed on the job.
- Competency-based training: Knowledge acquisition and competency must be verified by subject matter experts on the job. If competency is verified via a written assessment, it should be verified and re-verified as work is being performed. Learning is incremental, and how we transfer information from short to long to memory (learning) varies from person to person.
- SME expertise: Accelerate the development of subject matter experts (SMEs) in unit operations. The senior leader quoted above aptly noted that people “learn on the job . . . ,” but the context was that his company was extraordinarily good at succession planning, tapping experts across the company when problems arose and not moving people out of their roles too quickly. SME development was of high importance to his global manufacturing organization.
In addition to company leadership, the primary champion of the above principles is the learning and development (L&D) or training function within an organization. Viewed strategically, the L&D function is much more than the administrator of the learning management system. They play a vital role in how information (knowledge) is acquired, retained, and shared; how personnel are onboarded; how competency is measured; and how expertise is developed. Leadership that recognizes the strategic value of a proactive, innovative L&D function will ultimately maximize the quality of decision-making and action taken by those at the sharp end.
Information sharing at the sharp end must be practiced with rigor. Pre- and post-action reviews, 10-minute huddles, or other descriptors for the “micro-meeting” should be embedded in the routine of work, just as machine setup and teardown are embedded. It is through this regular communication that work is performed and errors are prevented. A reporting culture is a characteristic of a quality culture, where issues are raised and dealt with on a routine basis.
This way of working does not simply happen. Proactive companies embed the micro-meeting and develop people so that these skills are practiced until they become habits. People at the sharp end respect the comments and opinions of their peers because they understand success is the result of open-minded thinking. Training to better communicate happens through deliberate action taken at the blunt end of an organization.
In any industry, a tragic event leaves a lasting imprint, frequently precipitating legal repercussions and new regulatory requirements. Fortunately, what holds our attention most of the time in pharmaceutical operations are the vast number of day-to-day challenges necessitating investigation and corrective action. People at the sharp end are often blamed, though shortcomings at the blunt end are typically at the heart of many issues. Investing time and resources in the people closest to day-to-day operations — those at the sharp end — will offer a valuable payback that we may not see right away but that often takes the form of a problem avoided or a disaster averted.
- Woods, D., Dekker, S., Cook, R., Johannesen, L., and Sarter, N., Behind Human Error, CRC Press (Boca Raton, FL), 2000.
About The Author:
Jim Morris has over 25 years of pharmaceutical management experience in both plant operations and corporate offices in the U.S. and Europe. He has held positions as deputy director of QA/QC and regulatory affairs at Mass Biologics, director of QA/QC for the Biologics business unit of Cilag AG, and a number of quality assurance and manufacturing roles with Pfizer over a 16-year timeframe, culminating as the head of quality assurance in Latina, Italy. His areas of recognized expertise include: quality leadership development, supply chain auditing and managing audit programs; quality management systems; parenteral product manufacture and compliance; and OTC product manufacture and compliance.