Guidance on Quality Culture Standards

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

Q: How can the new document from the Parenteral Drug Association (PDA), PDA/ANSI Standard 06-2025, help manufacturers and laboratories improve their culture and processes?

A: PDA/ANSI Standard 06-2025 is a consolidation of guidance documents, tools, and models to assess and improve quality culture. Companies have probably seen how the state of the quality culture can impact an organization positively or negatively. This document is a great tool to research the key aspects of culture, assess the status of your culture, and create a strategy to maintain and improve the quality culture of your organization.

Q: What is a quality culture and what does the term refer to?

A: Quality culture is something seen and felt everyday as an employee and as a consumer in our everyday lives. It is hard to put into words, but it is defined well in the PDA/ANSI 06-2025 standard as “the overriding attitude, both expressed and implied, of an organization towards quality” (1).The document breaks it down into two distinct elements: a culture of shared values, beliefs, expectations, and commitment toward quality and a structural/managerial element with defined processes that enhances quality and coordinates individual efforts. It is the cross-functional ownership of quality at all levels, as well as the beliefs and systems that drive our actions each day.

Q: What factors of a quality culture are important in the pharmaceutical industry?

A: The document has so much information on the key factors of a good quality culture.The consistent themes that stand out are:

Leadership commitment—quality accountability, recognition, feedback loop, Gemba, visionary, strategic, enablers, respect your team, humility, trust

Employee engagement and ownership—mission focused, striving for excellence

Consistent standards and expectations —all sites, all teams aligned and striving for the same outcome, courage to do what is right, communicate the behaviors that you expect

Collaboration and communication—together, sharing, learning from each other, planning

Technical excellence—which was a newer way to group concepts that companies are familiar with, such as mature systems, competence, organizational learning, technology/innovation, and agility.

Q: Can you talk about the application of these factors in a laboratory setting and how it may differ from that of a manufacturer?

A: All of the above attributes apply and are critical for a laboratory’s quality culture, but in the authors’ opinion, some items are even more critical for a testing laboratory to succeed.In a laboratory, the main resource is people, not machines or facilities. Scientific competence and a good understanding of why things are done a certain way is paramount to producing quality results and solving problems for customers. Good leadership and employee engagement can make a huge impact on quality culture and the results achieved for clients.

Q: To what extent is the customer perspective incorporated into quality decision making?

A: The customer perspective must be embedded in strategic planning, quality systems, and day-to-day activities. The customers’ product end-users, along with their regulators, determine what good quality looks like in any particular setting. If contractors are not viewing their work through their clients’ eyes, they will miss the mark on quality. Aligning employees’ responsibilities with customers’ expectations, particularly in the pharmaceutical industry, creates employee engagement as they get excited about what customers are doing. This also creates partnerships with customers that are based on achieving mutual success. What customer doesn’t want to be understood by the provider to whom they are going for a solution?

Reference

1. PDA. PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools (PDA, February 2025).

About the authors

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company.

Article details

Pharmaceutical Technology®
Vol. 49, No. 5
June 2025
Page: 34

Citation

When referring to this article, please cite it as Cushing, M. and Schniepp, S.J. Guidance on Quality Culture Standards. Pharmaceutical Technology 2025 49 (5).