By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.
News about the company Immunomedics, which had a number of issues cited in an FDA Complete Response Letter (CRL) and Form 483, drove this point home recently. The news involved the FDA citing Immunomedics in January 2019 for data manipulation and breaches during an August 2018 inspection.
As a result of the CRL, a group of investors filed a class action lawsuit. The group included people or entities that purchased or acquired Immunomedics securities between Aug. 23, 2018 and Dec. 20, 2018. A February 2019 statement from the law firm Bragar Eagel & Squire noted, “The complaint alleges that throughout the class period defendants made false and/or misleading statements, as well as failed to disclose material adverse facts.”
I believe there is evidence that, based on the FDA observations made, components of a voluntary quality assurance (VQA) culture were missing. While the observations in the 483 individually note noncompliance issues, let’s examine the larger picture.
More troubling than the inadequate processes or nonexistent procedures are the apparent number and type of observations. Taken alone, they could be construed as minor; however, taken together, they indicate significant systemic quality culture issues. Building and maintaining such a culture is ultimately the responsibility of the C-suite, as is ensuring that appropriate resources and systems to support such a culture are in place.
To begin, here are the four pillars of a VQA culture:
- Education and Training
- Setting Quality Expectations
- Collaboration Not Confrontation
(For more detailed discussions of VQA culture, read my previous articles “The 4 Pillars Of A Voluntary QA Culture: How Does Your Company Measure Up?” and “How To Bulletproof Your Quality Training Programs.”)
Think of the pillars as complementing each other. They support each other and work in tandem. It is not a linear process, but an integrated one — if you do the work in one area, it has an effect in other areas.
In the case of Immunomedics, there is enough evidence to conclude that the company lacked a VQA culture. Let’s examine this pillar by pillar.
1. Education and Training
Training makes employees more engaged and aware of how their actions impact the quality of what they are doing, along with other functions. It provides skills that improve standards, reduce mistakes, and create the kind of environment where people understand how to build adequate systems and processes. Any investment in your employees’ skillsets is an investment in your company.
Several observations made in the 483 discuss how sampling and testing procedures, investigations, and implementations were deemed inadequate; it also notes the backdating of batch records. These examples point to a lack of training and education. There can be many reasons for this, but the outcome is typically the same. When people lack proper training, they don’t understand the components of an adequate procedure or how to properly execute tasks in a procedure. Not having proper training programs only sets employees up for failure. Properly training employees can reduce noncompliance and, as a result, positively affect performance.
2. Setting Quality Expectations
Setting specific and measurable expectations — usually communicated during training but reinforced throughout the management of the employee — allows employees to know what is asked and expected of them. Clear expectations allow people to understand critical success factors, so they can be more efficient, productive, and compliant.
When expectations are vague, it results in inadequate procedure execution and, as a result, noncompliant performance, as evidenced by several of the observations in the 483, specifically, the lack of sampling and testing of a critical raw material used in manufacturing, lack of quality agreements in place with critical vendors, and deviations not being closed on time, to name a few.
Engaging with employees to set realistic expectations makes them more informed, committed, and engaged. Setting specific and measurable expectations allows people to know what is expected and can result in greater efficiencies, productivity, and compliance. However, it is only the second step toward developing a VQA culture. Training and setting expectations can still result in noncompliance if people are not held accountable.
Holding people accountable shows that you care about them and what they are doing. It demonstrates that what they are doing matters and adds value and is important to the company. Human nature shows that when people feel as though what they are doing doesn’t matter, they are less likely to do their best or do it right. When people are accountable, research shows that people can identify and solve problems better and faster. Along with solving problems more quickly, when people are accountable, they are motivated and feel ownership. They also feel responsible for their own work and their own actions. Accountability empowers them to speak up and to identify issues before they become a crisis.
When an organization’s employees lack accountability, they are more likely to take less responsibility. They also are less likely to address problems or seek out solutions. When people are unmotivated, they are less compliant. It is apparent that there was a lack of accountability at Immunomedics, as seen in the observations related to closed deviations lacking critical information, deviations not being closed within the required time frame, and a lack of proper controls to prevent contamination.
When there is an obligation or willingness to accept responsibility and to account for one’s actions, people feel more empowered to make the right choices. Accountability communicates there is a level of trust and confidence in employees, which empowers and motivates them.
Keep in mind, however, that holding employees accountable without providing adequate training or setting proper expectations is a recipe for disaster and can be extremely demotivating, resulting in noncompliance. As stated earlier, this is a symbiotic process where all the components need to be in place to realize the true benefit — compliance.
4. Collaboration Not Confrontation
Collaboration is the pillar that has a clear presence in all the other pillars. It is a key factor to ensure value. Without it, the other three pillars cannot be effectively implemented. You need collaboration among functions to properly implement the other pillars. When quality departments and company leadership foster such an environment of openness and information sharing, they raise their profile and levels of confidence and trust among employees. This can create a “safe” environment to raise issues to further improve processes — and this breeds compliance. If something is going wrong and employees have a good relationship with quality, employees would feel comfortable raising issues and, together with quality, work to find root causes and solutions.
When collaboration is not there, there are more delays, waste, redundancy, and noncompliance because there is no focused group effort. As there were many instances of data manipulation and data integrity breaches at Immunomedics, one can make the case that collaboration between quality and other functions was lacking. As a result, the FDA cited several instances of inadequate investigations or improperly executed compliance procedures (i.e., corrective and preventive actions, deviation, nonconformance).
The ability to conduct appropriate investigations and resolve issues is a collaborative activity. Without such collaboration, there is a lack of openness and information sharing to raise the levels of confidence and trust among employees so they can work together to solve problems. This leads to issues within the organization, as well as with important external vendors and partners.
The Financial Fallout
When a company lacks a VQA culture, compliance and performance suffer. People remain isolated on their one task and fail to see how their actions impact others. There is a lack of accountability and collaboration to help address issues as they arise. People focus on affixing blame rather than working together to solve problems. As a result, procedures and processes don’t get followed or put in place properly, if at all. Systems are vague and unclear, and people do what they need to do to solve short-term issues without taking the bigger picture into account.
Regrettably, these issues are not exclusive to Immunomedics, as demonstrated in the most recent incident at Novartis subsidiary AveXis, Inc. Many leaders lack the understanding of how quality and a VQA culture can stave off noncompliance issues, as well as build a high-performing, innovative environment where success — financially or otherwise — is a direct byproduct.
It starts at the top with leaders who choose to be better-informed, patient, and open-minded and have the will to invest in such a corporate culture. When overlooked, these issues become compounded and grow out of control. Doing the right thing early on can prevent poor performance and noncompliance in the long term, protecting patients, integrity of the data, the bottom line, and the financial health of your company.
And it will help keep your shareholders happy.
About The Author:
Judy Carmody, Ph.D., is the founder and principal consultant of Carmody Quality Solutions, LLC (CQS). She has 20+ years of expertise in applied technology, bench chemistry, analytical development, validation, quality management, and senior leadership. She has built quality management systems for both startup and Fortune 500 companies.
Carmody founded Avatar Pharmaceutical Services, an FDA-registered contract research organization that provided quality, submission-ready, customized analytical services in compliance with cGMP. She grew Avatar to 25+ employees and more than 75 clients before it was purchased by a Boston-based pharmaceutical company in 2010. She holds a Ph.D. in analytical chemistry from Clark University in Worcester, Massachusetts. Please connect with her on LinkedIn.