ORGANIZATIONAL CULTURE - Assessing Quality Culture: Five Key Elements

INTRODUCTION

There is sufficient passive endorsement of the idea that build­ing and sustaining a strong quality culture is linked to enhanced business efficiency. Whether it is early detection and resolution of issues, or proactively avoiding the issues altogether, the results are not only an improvement in compliance, but also actual busi­ness efficiencies. So why hasn’t a strong quality culture permeated the pharma Industry?

It takes some effort to define, improve, and quantify Quality Culture. Breaking down this term to try to define it seems to complicate the issue. Focus on the term Quality conjures thoughts of product/material testing or rote execution of compliance requirements. Focusing simply on the term Culture leads us to review behavioral aspects which, by nature, are qualitative and intangi­ble. Neither of these terms, when taken separately, guide us to a better understanding of the target. Without formal definition and measurements, outlining the actions needed for improvement or monitoring is perceived as a non-productive use of business re­sources.

Let’s start with a definition. Many describe Organizational Culture as how an organization behaves. Just like a community, each organization has known rules of engagement that include how to lead, communicate, interact, make decisions, reward, or recognize members and teach the next generation. Quality Cul­ture within the pharma industry requires entrenching patient safety as the core foundation of the organizational culture. A strong Quality Culture is demonstrated through an everyday awareness, at all levels of the organization, of the impact our ac­tions and decisions have on the ability of patients to safely consume the therapeutic products we make. The organization must incorporate consideration of patient and patient safety into all culture aspects of the business execution. There are five key pri­orities to consider when assessing the strength of your Quality Culture. This article explores these in detail.

MANAGEMENT OWNERSHIP OF QUALITY CULTURE

Management must set the tone and take ownership for a strong quality culture to endure. How management behaves, what is prioritized, and how team members are expected to en­gage with each other contributes significantly to the quality cul­ture. Management influences these aspects everyday through their actions and both formal and informal communications. The entire organization is looking to the senior management team to understand what is expected within the organizational culture.

It is critical that all members of the C suite understand their influence and demonstrate their commitment to patient safety in everything they do. This does not usurp the importance of finan­cials, strategy, technology, etc, however, failure to keep patient safety at the core of those critical activities goes directly against the mission statements of most companies to serve patients and to improve the quality of life of those patients.

Management is responsible for Walking the Talk, meaning management behavior should align with expectations the management team has for how the rest of the organization behaves. This is realized by setting realistic goals and objectives that align with building and sustaining a strong quality culture. Goals should be based on resources available (or commitments to en­hance resources) to accomplish those goals. Stretch goals can be great for the company bottom line, but if these are impossible to accomplish with the current resources, then patient safety may be at risk.

Another important consideration is management visibility and empowerment of personnel directly responsible for daily operations decisions. Leaders should be aware of the complexity of the operations and understand the patient safety impact. This is aided by visits to the operations fa­cilities and learning the processes in place.

Management must be approachable and open pathways for concerns to be communicated. When people feel empow­ered to speak up, the root causes of issues can be fixed promptly, and patient safety risks are avoided, or mitigated more quickly.

EMPOWERMENT & TEAM DYNAMICS

The decision-making authority for daily operations concerns related to pa­tient safety impact also highlights the strength of the quality culture. If all deci­sions require escalation to senior manage­ment, how does that occur when management is not available? Will the tac­tical operators executing production be able to actively identify issues as they occur or are they likely to become passive since authority is with the management team only? Decision-making as it relates to pa­tient safety, or raising concerns about pa­tient safety, should be required, and enabled across all levels of the organiza­tion.

One way to identify a strong quality culture is to determine who is making the decisions when things don’t go quite as planned. In a strong quality culture, every­one understands the risk to patient safety in everything they do and therefore can make the decision to stop the process if there is a perceived patient safety impact. It is also an environment where people are encouraged to speak up immediately when mistakes are made. Mistakes will happen in a production environment, and in an organization with a strong quality culture, mistakes are considered learning opportunities.

Rewarding the behaviors, or how things are accomplished, is key to ensur­ing the proper processes. All team mem­bers notice how others are managed when a non-conformance is noted. Is there a focus on removing the error traps to aid compliance or are operators and analysts expected to “do better”? In a strong quality culture, the operators and analysts associ­ated with an error help identify contribut­ing factors and are expected to aid in the implementation of the solution, based on their knowledge of everyday operations.

Team dynamics also factor into quality culture. Of course, team dynamics develop as a result of interpreting what is expected and rewarded within the work operations. Rewards and recognitions based on team successes drive a desire for team members to work together to accomplish a common goal. This does not mean that everyone contributes equally, but everyone should be expected to contribute to the best of their abilities. This requires a supervisor to monitor the dynamic and execution of the work. Everyone knows one bad seed can spoil the bunch. Those not contributing to the team outcome as expected need to be identified and managed quickly and prop­erly to keep the rest of the team motivated.

QUALITY RISK MANAGEMENT

An immediate indicator of patient safety focus is the use of proactive versus reactive Quality Risk Management (QRM). The expectations provided in ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System) guide­lines are for product owners and manufac­turers to proactively use QRM principles to identify patient safety risks. Marketing Au­thorization Holders and manufacturers will have the most detail about the product, production, and monitoring capabilities for specific products. This goes beyond complying with the formal regulations; this requires an in-depth knowledge of product and process, and using that to assess po­tential patient safety risks.

A sure sign of a poor quality culture is where a high volume of risk assessments are completed retrospectively in an at­tempt to justify something that is already done. This is particularly concerning when it is applied to the acceptability of a batch for release to the market. The perception is that the more a company invests in the production of a batch – and that can be very high costs of materials and compo­nents for biologics and gene therapies – the more you’re biased to keep going or accept the batch because of the extreme costs (sometimes exceeding $1M). It is not always possible to avoid these retrospec­tive risk assessments, especially in early phases when the process is still evolving. It is essential in those cases to preset the risk question, criteria for scoring risk, and ac­ceptance criteria before starting the analy­sis. It is also helpful to utilize an independent facilitator for these assess­ments.

A mature QRM program is an effective indicator of a strong quality culture. It is achieved through the integration of risk identification and risk management within all areas of the quality system. There are several fundamental proactive risk assess­ments that should be in place to ensure patient safety. For example, contamination control and material/supplier quality risk assessments should be in place for all pharma manufacturing sites. Ultimately, the goal of quality risk management is to mitigate potential risks to the patient be­fore these come to fruition. Conversely, retrospective risk management already has risk(s) posed and is dependent on unbiased decision-making to protect the patient. Therefore, minimizing the de­pendence on retrospective risk manage­ment is a more robust approach to protecting patient safety.

USE OF DATA & METRICS

Use of data and metrics can enable a strong quality culture. Pharmaceutical manufacturing produces an abundance of data. This can be overwhelming and dis­tracting if there is not a strategy for collec­tion and use of that data. Not all data has the same value. A strategy for data collec­tion and monitoring should focus on the intended use of the data; what we hope to learn by using the data. For instance, will the data indicate that we are getting better or remaining within a state of control? Is the data collected in a meaningful way so that we can take actions based on the re­sults? Is the data collected at a point that allows for preventative actions if trending in an adverse direction?

Part of the data strategy within a pos­itive quality culture is the use of metrics. Defining metrics and setting metrics tar­gets should prompt action. Metrics targets need to drive the right behavior, or at least avoid driving the wrong behavior. For ex­ample, the number of batches or activities completed within a given period should not be rewarded in a vacuum. Rather, the number of batches or activities completed right-first-time, with all proper controls and checks executed as expected, is what is best for patient safety. You don’t have to be a statistician to know that it’s possible to “play” with numbers to attain the ac­ceptable result you want. This could mean not counting some events for a certain rea­son or including additional data to dilute an effect. It is important to define how data will be collected and calculated for each metric to ensure consistency and accuracy in assessing status of the quality systems.

Table 1 lists some suggested exam­ples of setting metrics that aid in quality culture improvements.

KNOWLEDGE MANAGEMENT & CONTINUOUS LEARNING

Finally, we cannot underestimate the contribution of knowledge management and continuous learning opportunities to quality culture. Along with the data gener­ated through production activities, there are new learnings with additional experi­ences with the product and process. Or­ganizations with a strong quality culture maintain the practice of updating and sharing process and product knowledge in an efficient manner. There is ownership of the process knowledge and a responsibility for the owner to improve the monitoring and controls based on newly acquired in­formation.

A continuous learning environment is one in which sharing of information is sup­ported. Due to the complexity of opera­tions within Bio/Pharma, mistakes will happen, and management should focus on rewarding the diligent identification and reporting of mistakes along with sug­gestions for potential solutions. To prevent repeat occurrences of the same errors, sharing these events as lessons learned is good practice. This includes setting specific time aside to review lessons learned on a consistent basis.

SUMMARY

Quality Culture requires a continuous focus on patient safety. This goes well be­yond establishing a compliance culture that abides by the regulations. A strong quality culture requires engagement from everyone from the operations floor to the C suite to understand the impact their role has on patient safety. It requires the estab­lishment of processes that support both addressing known potential risks proac­tively and identifying new risks real time with an expectation of action. A continuous focus on patient safety requires a robust data collection and monitoring strategy.

Londa Ritchey is currently a Quality Director at PharmaLex with 30 years of experience in pharma/biopharma/ATMP quality assurance, emphasizing sterile drug substance and drug product operations. Her experience includes quality risk management, aseptic quality operations, quality systems design and implementation, contamination risk management, supplier quality management, training program design, and inspection readiness. Her educational background includes degrees in Microbiology, Biostatistics, and an MBA.