As leaders in the life sciences, we are focused on providing various necessary services/ products in the interest of public health. In doing so, we are expected to clearly manage and understand risk, but at times we are faced with doing it right vs. doing it quickly, and/ or doing it right and quickly, but at the expense of our teams.
Misplaced priorities can intentionally or unintentionally force organizations to make decisions outside of what would typically occur without various, and sometimes self-imposed, pressures. These pressures can run the gamut from both internal and external influences, such as business and quality-related metrics, supply chain demands, regulatory expectations, client demands for CROs/CDMOs, drug shortages, and patients’ needs, to name just a few. At times, these pressures may cause a company to rush through quality processes to move product along the supply chain. In these pressurized situations, decisions can be made that are solely focused “on the numbers,” and how they are interpreted and/or reported. As the product moves through the supply chain, the added pressure to release or make different decisions creates and/or exacerbates weakened links in the supply “chain.”
Bottom line, we all must do what’s best for our business, our teams (people), and, ultimately, the patient in a compliant manner. So, what happens if you prioritize one over the other?
For some organizations that are business-focused only, the numbers rule the roost. Metrics and reporting often drive leaders to make decisions that ensure that the numbers are at or above anticipated levels. This can be further complicated by having the undue pressure of numbers that are not realistic. In this dynamic, you can lose sight of regulatory commitments, rush to complete non-robust investigations, release batches with improper reviews, or get “creative” with moving batches through the system. You can also lose sight of your greatest asset — your people. Producing many units and having inventory are overshadowed by cost if those units cannot be released, which causes further issues with the supply chain.
Some would ask, “What concerns could there be that focus solely on compliance?” The quick answer is that focusing on any one thing too much allows the development of “blinders” and impacts continuity from the other business and personnel perspectives. A site must also be mindful of perpetuating the stigma of a divide between the operations and quality teams. This can have a major impact on the site’s culture and can be difficult to repair.
Evaluate the metrics and determine whether they are measuring the right things. For example, if you are focused on driving down the number of open deviations past 30 days, and you have critical deviations open for over a year and the potential assessment of impact to product on the market has not been completed (e.g., same product family, equipment train, raw materials), then you should reconsider how you are prioritizing resources to determine whether a FAR (field alert report) or potential recall is required.
Ensure that the individuals who are a part of these teams are familiar with the overall processes. It is not intended for them to become SMEs, but it would help in understanding impact and identifying potential concerns that the operations team may not see. Leaders of these teams should stay close to those less senior to help them determine when situations are black and white, and when situations may be gray.
Look at the performance of the site or departments over the past three years and determine a reasonable expectation for site performance. One good year or quarter does not necessarily support exponential growth without having shoredup resources and assessed the sustainability of the site’s infrastructure and quality systems.
Make sure that the compliance team has a seat at the table, and allow an environment for both favorable and unfavorable news. However, it is not ok to inflict pressures that are perceived as potential threats to individuals being the bearers of bad news.
Allow time for compliance-related activities while ensuring a fully imbedded, quality-minded culture. Oddly, some sites only allow time for quality- related activities during “convenient” times (e.g., during plant shutdowns, weekends, after regulatory pressures). Not embedding a constant quality culture within the organization can cause knee-jerk reactions and ineffective decisions.
Ensure you have the right SMEs to give you accurate information for decision-making. This will ensure engagement and ownership of the plan for better success of execution.
It is important to have timely and accurate communication with the relevant team to minimize the additional strain on the organization that comes from a change in business priorities.
Having operations and compliance teams working toward the same goal and vision — and comfortable bringing ideas and information to the table — will make you the most successful.
As mentioned earlier, people are the greatest asset of any organization. One focus that should be considered about people is that there is a difference between having people as a resource vs. having people as a team. There will be times where the balance needs to shift to focus on people, especially during an intense cultural change. However, it is important to communicate these needs to the appropriate executives to ensure support from the business and compliance perspective. This will help alleviate the additional pressures that may tempt a shortening of training or managing clients’ expectations for CROs/CDMOs.
Take the time to understand the daily activities and challenges of the individuals with whom you interact. This goes hand in hand with having a level of understanding and appreciation for everything that goes into completing the goals and fulfilling the vision.
Maintain open lines of communication to maintain a pulse of the organization. If during those communications, you, as the leader, take action, timely follow up is required. Do not overcommit, and it’s ok to say, “I don’t know.” The team will appreciate honesty over hollow words. Overall, be a part of the successes and the failures. Own them both.
Training takes time and should be seen as an investment. Cross-training across groups takes even more time but is a great way to become very familiar with each group. It also helps build a rapport across the teams, and it supports personnel development.
Management of the internal and external pressures that come from these groups can be difficult. Balancing among them is even trickier. Communication will be the greatest tool in doing so. Understanding the processes, having realistic expectations, driving a quality culture, having the right people at the table, and maintaining open communication can help you be successful in this venture.
NATASHA HOWARD was an independent consultant with Quality Executive Partners, Inc. (QxP). Natasha had 22 years of experience in the pharma industry, with a focus on managing personnel and complex projects, coordination of operational activities, and design and qualification of equipment and facilities. Natasha passed away unexpectedly several weeks after submitting this article to Life Science Leader. We are publishing it posthumously in memory of the contributions Natasha made to the field of pharmaceutical manufacturing.
Link to original article in Life Science Leader: https://www.lifescienceleader.com/doc/leadership-pressures-causing-an-imbalanced-organization-0001