The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future.
The first roundtable dinner event in Boston was a huge success. Panos Boudouvas, CEO of ZenQMS, and Scott Myers, Principal of Tunnell Consulting teed up a heated dialogue amongst the attendees regarding the best practices for scaling your quality management system (QMS) as your business moves through the clinical stages in preparation for commercialization and how to build a business case for quality internally.
Attendees included a diverse mix of regulatory experts and quality leaders representing all clinical/commercial phases such as Baim Institute, Bill and Melinda Gates Medical Research Institute, Apic Bio, Elevate Bio, Carmody Quality Solutions,ThermoFisher, Axcella Pharma, Tracelink and and others. The topic was “Scaling Your Quality Systems to Drive Business Growth” and centered largely on the topic of how to build a strong Quality Culture using a risk-based approach. With this in mind, it’s no surprise that no one advocated for a one-size fits all approach to quality activities/components by phase-- just a pragmatic approach based on thoughtful risk assessments.
What is a quality culture?
Life sciences companies today are under tremendous pressure to simultaneously increase profits, reduce the cost of consumer products, and successfully comply with an ever-changing regulatory environment. Some businesses will remain in survival mode- ‘treading’ to keep their heads above water (so to speak) and exhaust their resources quickly. Other businesses have demonstrated that implementing a culture of true quality across the business is the key to unlocking business growth, customer loyalty, and often a smoother path to commercialization.
How do you go about developing a ‘true’ quality culture?
The quality leaders and regulatory experts at the Boston Quality Leaders Forum event had some valuable insights to share with regards to their experiences implementing a quality culture within their own organizations- or that of their clients’.
Amy Card, Senior Director of Quality Operations at Brammer Bio, stressed the importance of developing a quality culture for your business and embedding it throughout the organization. Ms. Card explained:
The Quality team does not own the totality of quality in an organization. A key enabler to instilling a sustainable culture of quality throughout an organization is imparting ownership of quality performance upon all functional areas. And a quality system is only one aspect of the culture- safety, employee engagement, and data integrity are also critical for success as QMS scales to support business growth.
Danielle Feingold of the Baim Institute added to Ms. Card’s advice above and stressed the importance of establishing shared quality KPIs with other lines of business. Feingold suggested that “Building a culture of quality requires accountability and and an eQMS has been helpful in establishing and enforcing the quality KPIs.”
The majority agreed that many early stage life sciences companies fall onto a dangerous path to becoming a reactive, box- checking quality culture.
Judy Carmody, an independent Quality Consultant, believes that “The huge misnomer is that Qualification is just validation light. Every emerging life sciences company with the exception of one that will go through a phase 1 program should aim to exceed the expectations and quality standards required of a phase 3 company in order to develop a true risk-based approach and avoid the box-checking culture.”
Kirsten Peterson of Tracelink suggested that a quality manual is a key deliverable that sums up a company’s current approach to quality, it’s applicable to all stages and it should be required reading for all staff. Others echoed the sentiment-- likening it to a corporate mission statement.
Debra Weiss from the Bill and Melinda Gates Medical Research Institute indicated that even at early stages good practices start to drive culture-- for instance a basic policy/hierarchy for document provides organization and control that all employees grow accustomed to organically, which is preferable to trying to switch to formal approach after years of freedom. And even an approach that documented Quality Technical Agreements with critical vendors/contractors and even between internal sites again provide good structure and signalling to your intent. These aren’t difficult to deploy but pay dividends later.
Is a quality culture mandated?
The answer here is a strong MAYBE. While the FDA (2018) policies state that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues”- interpretation is left to the discretion of the company itself. The guidance document by its own admission “contains nonbinding recommendations” and states that “the use of the word ‘should’ in Agency guidances means that something is suggested or recommended, but not required.”
Hence, for the time being, it is up to the leadership team to partner with the Quality leaders in the organization to determine what entails a quality culture for their unique business and how best to implement it, measure success, and scale it for growth.