Firms will commonly espouse the virtues of a robust company culture as it relates to Quality. I’ve frequently heard the chant that “culture trumps strategy” when addressing the need to drive quality improvement plans. There’s a lot of credence with such a statement as culture is addressing (at a high level) a collective belief with this endeavor and I think we would all agree that success is far more likely when we all believe in the end goal.
But how would you know whether you had a robust company culture as it relates to matters of Quality when it comes to the laboratory? What would you look for in a laboratory as an indicator of a strong culture? And, as a laboratory manager, how would you encourage a robust culture?
With such questions, there is no single simple answer and, as such, one needs to evaluate in the collective. However, one of the most important considerations as it relates to culture is the firm’s senior management’s responsibility, and this is recognized by the regulatory agencies. An example is in Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations where there is a section dedicated to management’s responsibility as it relates to a successful, robust quality system. Under Part IV(A)(4) of this guidance document, it states:
“Under a quality system, senior management should incorporate a strong commitment to quality into the organizational mission.”
So, the company’s mission statement should commit to the highest level of standards of quality and recognize that this is a continual journey. This is obviously a critical component of establishing a company culture, but it does not stop there. Departments should consider having department-specific mission statements that dovetail with the overall company mission statement, and these department mission statements should also address quality commitments. However, such department statements should be a little more granular as they relate to how a high-quality output is demonstrated for that department. It would be expected that, for a laboratory, the mission statement would center on the quality of data that is generated by the laboratory and that laboratory management would drive a culture within the laboratory to realize this mission statement.
Laboratory management should then ensure that there are systems/processes/procedures/practices that strive to generate data with the highest quality and, with that, it’s obviously critical that the laboratory workforce see management “walk the walk” and not just “talk the talk” when it comes to matters of quality; management should be seen to embrace and champion those same systems/processes/procedures/practices as they relate to the laboratory generating data with the highest level of quality. So, what does that mean? This can be demonstrated in many ways, such as management celebrating and encouraging laboratory initiatives that result in improvements in data quality. That is, management celebrating when individuals raise potential data quality concerns and then encouraging robust corrective actions (rather than just putting a band-aid on them). Another example is having lab meetings during which there is a standard agenda item discussing “matters of quality”; for example, there could be a review of recently issued health agency citations (that are publicly available) and promoting a discussion of risk to determine whether one’s lab is at risk of similar citations.
This is far from an exhaustive list of ways that management can drive such a culture and, ultimately, there is no magic “lever to pull,” but a combination of actions/practices should be employed. Another consideration is ensuring that there are laboratory metrics that can aid in assessing the “health of the laboratory culture.” Again, it would not be a single metric but rather a collection of metrics, e.g., a percentage of invalidated OOSs, repeat deviations, use of preventative actions, effectiveness of Gemba walkthroughs, timeline adherence/number of extensions.
If you have any questions related to quality culture in the laboratory or would like to discuss how to implement best practices in your organization, please reach out to us at LCS@LachmanConsultants.com.
