Building a durable and forward-looking pharmaceutical quality culture
Quality culture in the pharmaceutical industry is first and foremost about ensuring products reach patients safely, that they are efficacious, and that they get to the end consumer when expected.
The discussion about building and sustaining a strong quality culture permeates well beyond the pharmaceutical industry. The “why” behind this is quite simple: understanding what the consumer needs, and meeting that need as expected, the first time, will lead to customer satisfaction and a more sustainable business strategy.
Assuring that all business objectives, decisions, and actions align with this “why” is essential. Interpreting this for the pharmaceutical industry requires assuring safe, efficacious medicinal therapies reach patients and when expected. Aligning all business objectives, decisions, and actions around this focus is the answer to building a strong quality culture in biopharma. So, how do we get there?
What does a strong quality culture look like?
To say that quality culture is influenced from the top down is appropriate. Quality culture is shaped by the behaviour and decision-making hierarchy established by the leadership. This includes setting the goals, strategic objectives, and metrics against which the performance of the organisation is assessed. A strong quality culture focuses on understanding the risk to patient safety across every aspect and every decision the company takes, not just within the quality department.
Consider the following business decisions and the impact these may have on patient safety:
Table 1: Patient Safety Decision Examples
|Decision||Potential Patient Safety Impact||Primary Owner|
|Changing to a less expensive corrugate vendor||Validated shipping studies assure the product reaches the patient in usable form. Vial breakage or cracks due to change in protection by corrugate packaging.||Procurement|
|Selecting a pest control provider||Change in chemical exposure at the facility is possible. Product contamination potential.||Facilities|
|Changing pallet vendors||Could allow pests or chemicals into the facility to migrate into the product.
(Reference Tylenol recall circa 2009)
Any of the scenarios listed above could result in a product recall. Unfortunately, a recall generally occurs after patient safety exposure or impact has been realised. Many companies have processes in place for quality department review of changes, like those listed in Table 1, if these are recorded as GxP changes. However, this requires all functions to think of the potential patient safety impact during their daily functional decisions to ensure submission of proposed changes for extensive evaluation prior to implementation.
A strong quality culture is one where people are educated about the patient safety risks that relate to the outcome of the job and function they are performing, and all organisational functions are accountable for the assessment of patient safety as the primary risk factor in daily decisions.
What is management’s role?
While every function needs to have accountability, management must set the tone for a strong quality culture. How management behaves, what is rewarded, what is prioritised, how team members are expected to engage with each other, and the decision-making hierarchy all contribute to the quality culture.
Management must “Walk the Talk”, meaning setting goals and objectives that align with building and sustaining the quality culture. Also, rewarding the behaviours or how things are accomplished is key to assuring the proper processes that force risk-based and cross-functional decision making. The number of batches or activities performed in a given period should not be rewarded in a vacuum. Rather, the number of batches or activities completed right the first time, with all proper controls and checks executed as expected, is what is best for patient safety.
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 accountability 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 organisation.
Management must empower personnel to stop any process that could impact patient safety. When people feel empowered to speak up, the root causes of issues can be fixed promptly and patient safety risks mitigated more quickly. Due to the complexity of operations within biopharma, mistakes will happen, and management should focus on rewarding the diligent identification and reporting of mistakes, along with suggestions for potential solutions. Enabling this empowerment requires management support for continuous education on patient safety risks within the operation.
How do we hire and educate for a strong quality culture?
The emphasis should be on building a solid foundation of quality culture competency. Start by defining the critical skills needed at hiring. Job descriptions should include core critical skills that match the organisation’s quality culture aspirations. Examples of these skills include critical thinking, continuous improvement mindset, and cross-functional thinking.
Build an assessment tool to better understand the potential candidate’s skill level. It may also be helpful to ask quality culture-related questions during candidate interviews. For example:
- Describe what quality culture means to you.
- Describe an example of when you made a patient safety decision in your previous role.
- What was the patient safety impact of your prior role?
While it starts at hiring, focus on quality culture should continue through onboarding and continuous training initiatives, including the sharing of patient stories. GxP training should be approached from the perspective of explaining the patient safety risk behind each of the requirements. Provide GxP training specific to each function by explaining the patient safety risk element(s) targeted by each of the functional area GxP requirements.
Train new hires to come into the organisation, looking for error traps and patient safety concerns, and have a safe pathway for sharing these discoveries. Expect new hires to aid in error-proofing the processes and reward such contributions. As part of continuous training, share lessons learned when things do not go as planned. Specifically, focus on the patient safety concern associated with any issues and the risk-based thinking that should be applied in any similar future situations.
Patient safety should be the primary focus of all who are engaged in the business of producing medicinal therapies. Patients are reliant on the biopharma industry to provide safe, efficacious usable products at the time these are needed. Having a strong, enduring quality culture will help to achieve that objective, while also building a resilient business and educated workforce.