Establishing a Culture of Quality: What Every CMO Should Know

Leaders at biopharma companies often ask us, “What is a culture of quality and how do you build it?” Simply put, a culture of quality is an environment focused on transparency and continuous improvement through effective and repeatable processes and outcomes. By forging a collaborative culture of quality, a company is better positioned to enhance their performance, credibility, and sustainability.

Embarking on the establishment of a culture of quality is no simple measure. It requires a collective vision established by executives, alignment on organizational goals across the company, and continual focus on collective responsibility for continuous improvement and innovation that sustains the culture.

Companies that do not prioritize a culture of quality or don’t see its value incite us to ask, ‘why not?’ If you find yourself in this situation, we encourage you to challenge your perception because the payoff is significant. Ultimately, cultivating a culture of quality positions companies to have greater control of their organizational risk and risk tolerance, which enables their team members to focus on pursuing continuous improvements where it matters most.

In a recent presentation at The CMO Summit, Halloran shared insights on “Establishing a Culture of Quality: What Every CMO Should Know.” Now we share these insights with you.

In this article, we identify the key elements in a culture of quality, how to enable a culture of quality, and the benefits and impact. As a Chief Medical Officer, and/or an acting executive of your company, you have an opportunity to help shape your corporate culture for the better.

Five Key Elements in a Culture of Quality

It’s our experience that many companies will review their progress towards the end of their clinical research lifecycle, much like an audit, uncovering issues that have already occurred, requiring them to be reactive. Instead of reacting, we need to shift to a different mindset – as an industry and as executives – where we acknowledge that it is likely that issues will still arise, but by proactively assessing risks, and having the right controls in place, we can proactively identify potential issues and apply corrective actions before they take place. Additionally, this proactive approach from the beginning enables an organization to pivot when unforeseen issues arise because they have established better control and operational strategy up-front.  

It is this infrastructure that will allow companies to understand their parameters, see where risk is too far on the tolerance spectrum, and then execute on planned responses.

Arriving at this culture requires five key elements that will need to be established at any biopharma company, and they include:

• Culture is driven by senior leadership
  • Leaders have to be seen as valuing the quality of any output, and that quality is owned by every individual that is engaged in clinical research rather than it be owned by a single function or department. This includes a commitment to investing in the infrastructure (people, process, data, and technologies) necessary to enable a culture of quality so that teams have the resources they need to execute on job responsibilities. Teams will look to their leaders to set the tone, so it’s important the commitment to quality at a leadership level is prioritized and communicated clearly and often
• Organizational goals contain a quality lens and quality is embedded in organizational goals
  • This shows leaders are committed and believe that is not just the ‘what’ but also the ‘how’ that matters. When organizations are collectively responsible for achieving organizational goals, this instills the mindset that quality objectives require the entire organization’s commitment to be successful
• Focus on continuous improvement
  • By proactively focusing on the quality of output, organizations allow real-time insights into what is working and improvements to be made. Additionally, this focus enables an organization to constantly learn and improve their processes and outputs
• Establish mechanisms for proactive risk, issue, and emerging trend review
  • When risks are assessed and controls are in place, organizations may shift their focus from “firefighting” to proactively identify issues, remediate them, and embed continuous improvements from any lessons learned
• Share commitment to quality by all internal and external stakeholders
  • When all stakeholders, both internal and external are committed to quality, it begins to drive a culture of trust and transparency

Four Strategies to Enable a Culture of Quality

Establishing a culture of quality from the top of an organization down to each and every employee will require four essential strategies:

• Management sets the tone
• Every employee owns the quality of their work
• Strong focus on innovation and continuous improvement
• Increase in organizational risk tolerance

When an entire company is focused on quality, they can detect clinical research problems earlier, experience fewer deviations and costly remediations, and protect their product and their brand. As you can see, creating a culture of quality requires a strategy that includes organizational structure support, quality standards, support from all levels at the company, and ensuring that business decisions include quality as part of major business decisions.

Important Benefits and Impact of Culture of Quality

There are two main important benefits to a culture of quality. The first is that it enables a proactive focus on errors that matter. As a CMO, for example, you have a number of competing priorities, but focusing on errors that matter, such as errors that impact patient safety and data integrity, allows you to prioritize your time and energy and adds value where it matters most.

Secondly, this culture provides space for organizational advancement. If errors that matter are identified before clinical research begins, and risk management controls are in place, companies are given the comfort and space they need to propel their development forward because they have built their guardrails that tell them when and where they might drift off track. Companies may then embrace opportunities to innovate, explore the benefits of new technologies, and pursue operational excellence to support their culture.

Ultimately, where does this all land? The impact is significant because a culture of quality:

• Builds efficiency and resiliency into pipelines
• Instills confidence in regulators
• Drives attainment of organizational objectives
• Delivers on commitments to patients, investors, and stakeholders

If you don’t have this culture in place, the big question is ‘why not?’

Halloran provides GxP quality support for clients of all sizes including the development and implementation of quality system design, GxP quality Leadership and support, quality as a culture, quality and compliance, and ad hoc quality support.

Ready to discuss your processes? Contact our team.