Clinical Researcher—June 2023 (Volume 37, Issue 3)
Londa Ritchey, MS, MBA
Understanding the needs of your customers and getting them right the first time builds customer satisfaction and a sustainable business strategy. That seemingly simple objective is at the heart of a strong quality culture.
For the pharmaceutical industry, this means ensuring medicinal therapies reach patients in accordance with the elements of safety, efficacy, and timing that are expected. To achieve that and build a strong quality culture, organizations must align all business objectives, decisions, and actions around this overarching focus.
A strong quality culture focuses on assessing patient safety in all aspects and decisions of the company, not just within the quality department. Patient safety should be paramount in all decisions, big and small. For example, a seemingly simple change of secondary packaging components can result in vial breakage or cracks and could result in a product recall. GXP changes such as these require all functions within the organization to consider the potential patient safety impact from their daily processes and decisions.
Why Management Matters
A strong quality culture is influenced by its leaders. As such, management should “walk the talk,” setting goals and objectives aligned with building and sustaining that culture.
Quality culture is defined by the behavior and decision-making hierarchy outlined by the company leadership. This includes setting the goals, strategic objectives, and metrics on which the performance of the organization is assessed. Rewards for accomplishment are key to assuring the proper processes that force risk-based and cross-functional decision-making. As an example, rewards should be based on identifying and communicating issues early or completing activities correctly the first time, with all proper controls and checks executed as expected.
Quality culture puts processes in place to allow decision-making when senior management is not available. Will the tactical operators be able to actively identify issues as they occur, or will they become passive if accountability is with the management team only?
Team members across all levels of the organization should be capable of making decisions on patient safety or raising concerns about it.
Complex operations within biopharma and cell and gene therapy mean missteps will occur. To mitigate the impact of this, personnel should be empowered to speak up if they identify any issues that could impact patient safety. Empowering and rewarding team members for diligent identification and reporting of mistakes, and for offering potential solutions, helps to mitigate risks to patient safety. This empowerment requires management to support continuous education about patient safety risks within the operation.
Recruiting the Right People
A cross-company quality focus depends on having people with the right skills. That begins with hiring by defining the skills needed and ensuring candidates’ skills match the organization’s quality culture objectives. Job descriptions should include core critical skills the organization requires. These include skills related to a strong quality culture, such as critical thinking skills, continuous improvement mindset, and cross-functional thinking.
Once hired, employees should receive continuous GxP training related to their specific function. Patient safety risks associated with the function must be at front and center of that training. To ensure the quality culture shapes the business at every level, employees must also be trained to identify potential patient safety risks within their functions and know how to escalate these for visibility and remediation.
Potential team members should be made aware of the organization’s emphasis on building a solid foundation of quality culture competency.
Build an assessment tool to better understand the potential candidate’s skill level, including their quality culture acumen. Quality culture–related discussion points during candidate interviews, for example, could include “describe your understanding of quality culture”; “provide an example of when you have made a patient safety decision”; and “explain the patient safety impact of your previous role.”
A Quality Education
Focus on quality culture should continue through onboarding and continuous training initiatives, including the sharing of patient stories and dealing with unplanned outcomes.
Teach new team members to look for error traps and patient safety concerns and to feel safe sharing these discoveries. Expect them to assist in error-proofing the processes and reward such contributions.
As part of continuous training, share lessons learned when things do not go according to plan. Focus on the patient safety concern associated with any issues and the risk-based thinking that should be applied in any similar future situations. Use examples of noncompliance concerns other companies are experiencing within industry by utilizing shared internet resources. Share these as lessons learned to proactively avoid the same issue.
Personnel must believe management expects and rewards learning and sharing ideas to strengthen quality culture. This requires building training time into the daily schedule. Additionally, performance metrics should link to on-time training completion for core-function training requirements.
Patient safety must be integrated into everything a pharmaceutical company does. Having a strong, enduring quality culture will help to achieve that objective while also building a resilient business and workforce.
Londa Ritchey, MS, MBA, is Quality Director with the Quality Management and Compliance group at PharmaLex.