Quality compliance is crucial for success in the highly regulated pharmaceutical industry, and the importance of this compliance has led to the notion of a quality culture that supports compliance. But what happens when critical business needs and quality compliance demands collide? When stressed by competing priorities, a company’s quality culture may stand up and ensure compliance … or it may collapse under the pressure.
And in order to identify potential pressure points, it’s important for companies to understand not only their quality systems and procedures, but the belief systems embedded in their corporate cultures.
Client Business Situation
Executive leadership at one biopharma company — interested in ongoing quality improvement and enhancement, as well as concerned about some existing compliance issues — engaged Compliance Architects® to help identify compliance risks posed by the current culture, as well as advise on how to address issues found and make improvements. An evaluation of the manufacturing facility showed a robustly designed quality system and well-written procedures. But that didn’t mean the company never experienced any problems.
For instance, while overall successful in terms of quality compliance, this company’s facility had experienced repeated incidents of microbial contamination at its manufacturing facility. It was noted that, despite strong procedures and regular executive proclamations of the importance of training, some training materials showed some deviations from procedures important to preventing contamination.
The Quality Pulse® service helped the biopharma company determine whether its quality culture was playing a role in discrepancies like this. In essence, Quality Pulse® used a targeted survey of a broad swath of employees, cutting across divisions and levels of corporate hierarchy, to help determine where disconnects might exist between the corporate expressed values—for example, quality must be maintained at all costs—and underlying assumptions—such as prioritizing product release above all else. This is a normal tension that all biopharma companies face, Teresa Gorecki, practice director, said, adding that where customer service or product release are prioritized, there is a risk that this focus can lead to gaps in quality compliance.
“Companies must first recognize that there is always going to be a conflict when trying to meet business objectives or quality objectives.”
Quality Pulse® provides a model that allows close evaluation of how a company’s express messaging about its values compares to the underlying assumptions among workers, the informal rules that employees learn to follow. For example, the expressed value might be that quality comes first, but if the informal, underlying message is that product release takes priority, that can have a huge impact on quality culture and compliance.
By posing questions as common scenarios, Quality Pulse® surveys ask people to detail their behaviors, their experiences and what they see in daily operations. The scenarios aim to look at expressed values, underlying assumptions and quality structures, processes and systems. Employees must select answers ranging from totally favorable to totally unfavorable, with no neutral answers allowed. For example, a scenario might involve a scheduled batch release that occurs while a major inspection is ongoing and needs additional time to finish; the employees would answer the degree to which they would expect the boss to give them the extra time before releasing the batch.
These answers provide data in the form of scores for key quality-related values. Written text answers are also evaluated to provide even more specific feedback.
“Quality Pulse® provides the data to have difficult conversations.”
Client Business Pain
In the case of the subject biopharma company, the faulty training materials acted as a red flag that quality might not be the primary focus at all levels of the company. And further examination via the Quality Pulse® survey revealed that there were areas of disconnect where priorities other than quality—such as batch release or meeting customer milestones and deadlines—were rewarded in certain divisions more than strict adherence to quality standards.
“When there is not a balance between expressed values and underlying assumptions, when there is lack of congruence or alignment between those two things from the supervisor level all the way up to the CEO, there is no trust about quality-related matters,” Gorecki explained.
And the Quality Pulse® analysis revealed that the tension between getting batches out the door and adhering tightly to quality requirements had tilted, in some areas, too far toward the customer service side, leading to quality issues when staff were under production deadline pressures. The training materials, showing videos that included incorrect procedures or environments, were a symptom of that pressure.
This is a common issue in all types and sizes of pharma companies, from small CMOs to multinational corporations; the emphasis often is on shipping product out on time, no matter what. Unfortunately, if quality control doesn’t get equal focus, at all levels and in all divisions of a company, compliance issues are likely to arise, causing problems for the company.
Findings and Solutions Provided
The cause? Simple lack of trust in the corporate system. For instance, if the underlying assumption is that production deadlines trump quality, employees may be reluctant to bring forward a potential quality issue because they don’t trust that immediate supervisors will reward that behavior. In fact, they may fear penalties for doing anything that slows production. At the same time, quality staff themselves may come to distrust information about issues that are brought forward, concerned that employees may delay or avoid sharing needed information in the interest of protecting themselves from repercussions.
In addition to the finding that the company’s expressed values weren’t reflected in actions, other concerns found in the Quality Pulse® evaluation included concern that confidentiality would be broken, a history of no action being taken when employees did speak up about quality problems, and frequent justification for shortcuts taken, as well as a lack of alignment between written SOPs and work as it was done on a day-to-day basis.
Based on these findings, the company began action planning, as well as having Compliance Architects® make specific suggestions based on the Quality Pulse® data generated. To address these types of issues, Gorecki advised, “companies must first recognize that there is always going to be a conflict when trying to meet business objectives or quality objectives. The best advice is to make sure that this concept is included in value statements, that expressed values state that priorities are meeting customer service milestones and meeting quality objectives.”
“This forces everyone in the organization to be responsible for both quality and business outcomes,” she added. “If management is that explicit and willing to commit, culture problems will go away.”
Additional steps include investing in quality—including, for instance, manufacturing technology, process control technology, document management solutions and data capture systems—and training in the use of all those tools and in quality-focused procedures.
“When there is not a balance between expressed values and underlying assumptions, when there is lack of congruence or alignment between those two things from the supervisor level all the way up to the CEO, there is no trust about quality-related matters.”
Finally, making sure that quality leaders report independently and directly to the president or CEO of a company can avoid potential conflicts that can arise if quality officials report, for instance, to the supply chain or research leadership.
The benefits of these approaches to address the identified quality culture weaknesses lies in the trust-building transparency that improved communication consistency will provide, Kenneth Ray, Quality Pulse® practice lead, said. Once the points of breakdown are identified, they can more easily be addressed.
“Quality Pulse® provides the data to have difficult conversations,” he said.
That data helps companies to understand employee behaviors and operations that are harming quality culture, by helping leadership to better understand what the underlying assumptions—the unwritten messaging—really are, as perceived by the people doing the work. Additionally, the data can signal what the company is doing well and should continue.