Culture Eats Governance for Breakfast

Introduction

The adage “culture eats strategy for breakfast” encapsulates a fundamental truth in business: Even with the best strategy, a company is only as good as its culture.  The same is true for governance. 

Today, numerous “governance frameworks” exist for nearly every corporate function.  At its core, governance is the set of rules and processes that provide a structure for decision-making, addressing key elements like accountability, transparency, and efficiency.  Yet, even the best frameworks, SOPs, and policies look great only on paper.  If the organizational culture doesn’t support them, governance will fail, or at the very least, be ineffective.

In the end, culture eats governance for breakfast, too!

Why Culture Overrides Governance

In today’s corporate environment, stakeholders often demand speed and agility. This pressure can create a culture that whitewashes accountability, transparency, integrity, and quality, undermining the very purpose of governance. Instead of control, you get chaos or, worse, stagnation. Ultimately, having the best Quality Management System means little if the people using it don’t fundamentally believe in the principles of accountability, transparency, integrity, and quality.

Common Cultural Gaps

Where do cultural gaps in governance typically exist? They often appear in a few key areas:

• Leadership Silence. When leadership is silent on essentials like data integrity or a culture of quality, employees interpret it as a lack of importance. These subtle cues can quickly erode standards.

• Resistance to Change. Legacy processes and a fear of failure often sabotage governance initiatives. Effective governance requires continuous improvement; it’s a journey, not a destination.

• Fragmented Accountability. An "us vs. them" mentality between departments or teams makes it difficult to assign clear ownership, allowing critical responsibilities to fall through the cracks.

• Fear-Based Reporting. When employees are afraid to report mistakes, a culture of integrity is impossible to maintain. Instead, errors are hidden, leading to reactive firefighting through audits and CAPAs rather than proactive improvement.

Building a Governance-Ready Culture

As I discussed in my article, The Human Side of Data Governance, building a culture of accountability is key. A similar approach is required to create a Governance-Ready Culture, one built on the following principles:

• Visible leadership commitment (Set the Tone at the Top) – when leadership models open reporting and continuous improvement, employees see the commitment and can start to model the same behavior.

• Cross-function ownership (Break Down Silos) – by integrating QA, IT, and process owners, teamwork is fostered, and accountability becomes a shared responsibility.

• Normalize error reporting (Make Compliance Easier) – treat findings as opportunities, not punishment.  Companies still require the human component, and where there are humans, mistakes are made.  Learning from them and improving is the desired goal.

• Recognition programs (Recognize and Reward Good Behavior) – reward stewardship and integrity using awards and spot-bonuses.

• Educate your team (Educate and Empower Your Team) – Training is the foundation of a good corporate culture. Helping employees see the "big picture"—how their work contributes to quality and patient safety—aligns the entire organization and empowers them to make better decisions.

Case Examples: When Culture Eats Governance

You don’t have to look far to see how cultural blind spots undermine even the most detailed governance frameworks. Warning letters are full of them.

Quality Units Without Teeth

The FDA has repeatedly flagged pharmaceutical manufacturers where the Quality Unit (QU) lacked authority, independence, or both. In some cases, QUs allowed incomplete batch records to pass review or tolerated documentation that was torn. On paper, the governance model existed. In practice, a culture of “exceptions are okay” rendered it ineffective. [1]

The Glenmark Example

Glenmark Pharmaceuticals offers a sobering reminder of how culture perpetuates compliance risk. Despite multiple FDA citations over the years, the same deficiencies have resurfaced repeatedly—most recently in 2025. The FDA’s assessment was blunt: management oversight and control were inadequate across the organization. When the same issues recur, it’s not a process gap—it’s a cultural one. [2]

The Data Integrity “Repeat Offender” Problem

FDA enforcement data shows that data integrity issues appear in the majority of warning letters, year after year. Missing metadata, overwritten records, incomplete audit trails—these aren’t new risks, but they persist because many organizations still view data governance as “extra work” instead of a cultural expectation. Governance keeps writing rules; culture keeps ignoring them. [3]

Culture as the Real Root Cause

In fact, industry experts increasingly argue that the “core failure” in many FDA citations isn’t the technical observation at all—it’s the compromised culture underneath. If leadership signals that speed trumps transparency, or that reporting errors will be punished rather than learned from, employees adapt their behavior accordingly. Governance can’t survive in that environment. [4]

A Positive Contrast: W. L. Gore & Associates

Gore provides a vivid contrast: it builds governance on top of a deeply embedded culture of trust, autonomy, and accountability. Its structure is famously described as a “lattice” organization — flat, decentralized, and built on relationships rather than hierarchy.

At Gore, everyone is an associate, not a subordinate. Leadership is not assigned by title but emerges through influence and credibility. Four cultural principles guide decision-making:

• Freedom – associates are encouraged to pursue ideas, choose work, and innovate without unnecessary constraints.

• Fairness – treating others with respect and equity, ensuring collaboration is the norm.

• Commitment – individuals make and keep commitments, creating accountability without rigid oversight.

• Waterline – before making a decision that could significantly affect the company (“below the waterline”), associates are expected to consult peers to avoid sinking the ship.

These principles replace heavy-handed oversight with mutual accountability and cultural norms. Governance still exists, but it serves as a supportive framework rather than a top-down enforcer. Because culture is already aligned, governance works with — not against — the organization’s natural behavior.

This model demonstrates that when culture prioritizes openness, accountability, and ownership, governance becomes a natural extension rather than a burden. [5]

Closing Thought/Call to Action

Governance frameworks and SOPs are scaffolding. Culture is the foundation. When the foundation is weak, scaffolding collapses no matter how well it’s built.  With culture, governance evolves naturally into continuous improvement.  Instead of asking if your governance is built correctly, start by asking if your foundation is strong enough to support it.

References

1.       Investigations Quality. Quality Unit Oversight Failures: A Critical Analysis of Recent FDA Warning Letters (2025).
https://investigationsquality.com/2025/05/21/quality-unit-oversight-failures-a-critical-analysis-of-recent-fda-warning-letters/

2.       Glenmark Pharmaceuticals – FDA citations and company history.
https://en.wikipedia.org/wiki/Glenmark_Pharmaceuticals

3.       Food and Drug Law Institute. Update: FDA Data Integrity Enforcement Trends and Practical Mitigation Measures (2018).
https://www.fdli.org/2018/04/update-fda-data-integrity-enforcement-trends-practical-mitigation-measures/

4.       LinkedIn. Industry Insights: Learning from USFDA Warning Letter 320-25-104 (2025).
https://www.linkedin.com/pulse/industry-insights-learning-from-usfda-warning-letter-case-pharma-p61yc

5.       Classic Case: W. L. Gore & Associates, Inc.
https://www.researchgate.net/publication/260943692_CLASSIC_CASE_6_W_L_GORE_ASSOCIATES_INC