In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators of multiple categories of emerging issues. Companies need to be reminded that speaking up itself isn’t the problem; it is when employees stop speaking up that is an indicator of the erosion of culture.
Forms of Speaking Up
A speak-up program cannot be described as a single process. The best-in-class programs are a series of processes, some not directly in a company’s QMS. Some examples include:
- Anonymous hotlines and digital portals for reporting quality concerns
- Non-punitive deviation reporting systems
- Quality councils and cross-functional forums
- Incentive programs to encourage discovery or reporting of known issues
- Transparent risk management
These practices are designed to empower employees at all levels, including personnel not directly employed by the company.
Regulatory Views
The FDA has emphasized the importance of speaking up as part of a robust quality culture in its own internal programs or in past communications.
- The FDA’s Quality Management Maturity (QMM) program encourages manufacturers to go beyond compliance by fostering employee empowerment and open communication. It recognizes that speaking up is essential to reducing human error and improving product reliability (Office of Pharmaceutical Quality (OPQ) White Paper: Quality Management Maturity: Essential for U.S. Supply Chains of Quality Pharmaceuticals).
- The FDA’s OPQ highlighted the need to not only encourage speaking up but also implement an enhanced ethics program during a 2022 presentation (Culture of Quality: Data Integrity and CGMP Compliance).
- The FDA’s Data Integrity and Compliance with Drug CGMP: Questions and Answers: Guidance for Industry Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry explicitly provides, in question 15, a direct email to the FDA for reporting data integrity issues as an additional form of speak up.
Cultural Challenges in Speaking Up
Despite its benefits, speaking up faces significant cultural barriers:
- Fear of retaliation or blame: This fear can hinder the best speak-up programs.
- What is wrong or right: The propagation of poor training can lead to unconscious poor behaviors.
- Testing the absence of data: The old phrase “no news is good news” is a bad practice when seeking signals of a good culture.
- Language and cultural diversity: Multinational teams may struggle with communication norms, translation, or regional cultural norms.
Overcoming these challenges requires deliberate cultural transformation, starting with leadership commitment, training, and systems that reward transparency.
Strengthening Quality Culture
Speaking up is not just a regulatory expectation, it’s a moral imperative in regulated industry as the products are intended to address unmet public health needs. It strengthens quality culture, protects patients, and builds resilient organizations. Regulatory bodies, like the FDA, increasingly recognize their role in enhancing quality maturity, and companies must invest in systems and behaviors that make speaking up the norm, not the exception. Enlightened leaders use speak-up as a differentiator between good culture and great culture.
Lachman Consultants has a track record of identifying blind spots in quality culture, but are you an enlightened leader who wants to know? Reach out to us at LCS@LachmanConsultants.com to discuss how we can help your firm achieve a speak-up culture.
