Many businesses falsely believe that having a robust Quality Management System (QMS) only requires that they ‘check the boxes’ in order to meet the minimal requirements of the regulations. However, those companies that embrace quality and elevate it to be a strategic business imperative will invest in developing a true culture of quality that penetrates every level and department of the organization.
According to Kip Wolf, Principal at Tunnell Consulting, “Defining quality culture is challenging- it’s easier to explain what it isn’t vs. what it is. It is not something that is static- we can’t measure it and give you a binary result. Quality cultures are very dynamic and evolve over time.” And this is because quality cultures are defined and maintained by people/ business leaders. The FDA (2018) even goes so far as to state very directly 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.”
Regulated businesses that fully appreciate the value of implementing a quality culture throughout their organization would be remiss not to take advantage of technology and innovation that can reinforce the principles and enable the processes. Watch the video below featuring Kip Wolfe to learn more about the role of an eQMS in a quality culture:
Kip Wolf is a principal at Tunnell Consulting, where he leads the data integrity practice. Wolf has more than 25 years of experience as a management consultant, during which he has also temporarily held various leadership positions at some of the world’s top life sciences companies. Wolf temporarily worked inside Wyeth pre-Pfizer merger and inside Merck post-Schering merger. In both cases he led business process management (BPM) groups — in Wyeth’s manufacturing division and in Merck’s R&D division. At Tunnell, he uses his product development program management experience to improve the probability of successful regulatory filing and product launch. He also consults, teaches, speaks, and publishes on topics of data integrity and quality systems. He can be reached at Kip.Wolf@tunnellconsulting.com.