GMP is about People: Culture as a Performance Multiplier
Chapter 1 - From Compliance to Behaviour: why Culture determines GMP Outcomes
Let us begin with what we mean by "culture". In this article, the term culture refers to the shared values, behaviours and unwritten norms that guide how people act, interact and communicate. Culture is found in everyday actions, conversations, decisions, leadership behaviour and team routines - not in posters or policies. It is the human operating system beneath the GMP systems.
In GMP, we usually speak in the grammar of systems: SOPs, CAPAs, validations, data integrity controls and audit trails. These are essential foundations. Yet the recurring pattern across many operations and product types is sobering: robust systems exist, but performance still fluctuates - deviations persist, investigations are repeated and audit observations reappear. The cause is often diagnosed as a technical gap. In reality, the cause frequently lies in the culture.
A simple equation captures this:
(organisation + systems) x culture = performance
Systems set the ceiling; culture sets the floor.
Under stress, organisations fall back to their floor. A fearful, disengaged or cynical culture makes strong procedures brittle. People become less willing to raise uncertainties, challenge decisions or admit mistakes. Where, on the other hand, trust, transparency and psychological safety are cultivated, even imperfect systems function more reliably because people exercise judgement, speak up early and collaborate across boundaries.
The human factor explains why good people sometimes do the wrong thing. If we use the Fraud Triangle (opportunity, pressure, rationalisation), we can see how well-intentioned professionals in regulated environments may be tempted to take shortcuts. GMP controls reduce opportunity, but pressure and rationalisation are cultural phenomena. When the prevailing climate normalises heroics and punishes openness, rationalisations flourish. When the climate places integrity above speed, employees challenge the shortcut - even at 5:00 am when a QC result is late.
The hidden costs of a weak culture are substantial: normalisation of data integrity risks, under-reporting of deviations and near misses, superficial CAPAs, a declining Right First Time rate, rising turnover, erosion of tacit knowledge and - most importantly - increased patient risk. Each of these signals tells us something deeper: that people do not feel safe, supported or sufficiently accountable to do the right thing when nobody is watching or when the SOPs do not precisely fit the moment.
Psychological safety is the invisible enabler of GMP performance. When it is safe to say, "I am not sure", the operating system beneath our procedures remains stable. Leadership behaviour - asking questions before giving answers, acknowledging dissent, modelling vulnerability - matters as much as any checklist. In a culture where it is safe to excel, problems are identified earlier, corrected faster and translated into deeper learning.
The bottom line: compliance is necessary, but culture is the multiplier. Without the right culture, good systems break down. With the right culture, people carry the systems through ambiguity, pressure and time-critical decisions.
Recommendation
Hamburg, Germany3/4 November 2026
Quality Culture
Chapter 2 - Governance and Leadership: Designing the human Architecture of GMP
Culture is shaped by how power is distributed and exercised. A useful metaphor for governance is Montesquieu's "Checks and Balances". Applied to GMP:
- Quality sets and interprets the rules (SOPs, standards and policies).
- Operations executes the rules (manufacturing, documentation and discipline in practice).
- Independent oversight (regulators, auditors and QA review) tests assumptions and decisions.
When this balance tilts - when QA exercises control instead of building partnerships, when operations management bypasses oversight, or when auditors are feared rather than treated as a source of learning - behaviour becomes distorted. People begin to hide errors, approvals become performative, and investigations chase symptoms rather than causes. Restoring balance is therefore not a diagramming exercise, but a cultural intervention.
Practical mechanisms include shared ownership of common KPIs, rotating facilitation of reviews, QA and operations jointly leading improvement work, and decision logs that are transparent from the outset (who decided what, why, and on the basis of which values).
Leadership style is decisive. Under pressure, style becomes the system. Three common archetypes unintentionally degrade culture:
- The Enforcer (command and control): creates fear and hidden errors.
- The Pleaser (conflict-avoidant): leads to inconsistent standards and silent frustration.
- The Hero (over-functioning): creates dependency, causes burnout and suppresses ownership.
What GMP sites need are Builders: leaders who empower, provide clarity and are guided by values. Builders develop judgement ("What do you need to solve the problem?"), speak last in decision reviews and recognise integrity publicly. They create routines in which employees can demonstrate courage safely - daily meetings with a dedicated window for speaking up, CAPA reviews that include a devil's advocate role, and investigation debriefs that prioritise learning rather than finger pointing.
Team dynamics are the everyday place where culture either unfolds or breaks down. In many GMP teams, collaboration quietly fails behind the scenes long before obvious problems appear - precisely what Patrick Lencioni describes in his model "The Five Dysfunctions of a Team" (2002), which identifies the fundamental behaviours that promote or hinder successful teamwork. Applied in the GMP context, the five dysfunctions can be recognised as follows:
- Absence of trust -> unreported errors and defensive investigations.
- Fear of conflict -> stamped risk assessments and superficial CAPAs.
- Lack of commitment -> signatures without ownership.
- Avoidance of accountability -> recurring deviations and finger pointing.
- Inattention to results -> vanity metrics rather than meaningful outcomes.
Inverting the pyramid - building trust through vulnerability, normalising constructive challenge, ritualising commitments and holding one another accountable - reduces surprises and strengthens release decisions. This is not "soft" work; it is risk control through human behaviour.
The bottom line: governance that distributes power and leadership that builds people are not optional extras. They are the human architecture of GMP. When QA, Operations and Oversight share accountability for outcomes, and leaders reward integrity rather than speed, culture aligns with quality and performance follows.
Recommendation
Hamburg, Germany10-12 November 2026
GMP-Auditor Practice
Chapter 3 - Making Culture operational and durable: Trust, Systems, Metrics and Scale
Values endure when they are embedded in daily systems. Posters do not change behaviour; procedures, training, induction and feedback loops do - when they make integrity easy and shortcuts difficult.
Begin every GMP training session and onboarding module with the why (patient, product, safety). Use scenario exercises to practise values-based decisions under time pressure. Treat onboarding as cultural imprinting: pair newcomers with a culture mentor; walk through real decision logs that show not only what was decided, but why.
Embed cultural cues in SOPs. Procedure texts should communicate expectations beyond the individual steps. Put values in the header ("This SOP supports our no-compromise principle"), add decision trees for grey areas (if data are incomplete -> pause and escalate), and review the language for empowering rather than punitive tones. Written this way, SOPs train judgement, not just compliance.
Ensure feedback loops exist and are used. After deviations, audits and change controls, hold values retrospectives: Which value was upheld or threatened? Which behaviour will we reinforce next time? Recognise stories of integrity as visibly as output.
Cultural KPIs that explain technical KPIs. If culture determines performance, measure it with similar rigour:
- Speak-up / signal rate - frequency of concerns, near misses and improvement ideas.
- Psychological safety index - short impulse items (for example, "It is safe here to admit a mistake").
- Cross-functional CAPA involvement - percentage of CAPAs in which QA, Operations and Technical are involved in root-cause analysis.
- CAPA effectiveness - recurrence rates plus qualitative notes on behavioural and system changes.
- Decision transparency - percentage of key records with clear rationales linked to values.
These indicators do not replace traditional metrics; they explain them. If the Right First Time rate falls, first ask: has the speak-up rate also fallen? If so, you have not only a documentation problem, but also a speaking-up problem.
Scaling and sustaining culture. Strong cultures begin in rooms; durable cultures live in systems. To scale across sites and generations of leaders:
- Codify non-negotiable values in a concise culture charter.
- Localise the expression so that every site feels authentic while remaining aligned.
- Connect sites through culture forums, ambassador exchanges and shared decision logs.
- Measure centrally with a culture dashboard reviewed alongside quality and output.
- Prepare leadership transitions with a continuity kit and assess cultural alignment after 90 days - not just output.
In summary, culture is not a feeling; it is a system. Develop it, measure it, review it and improve it - just like any other critical GMP process. When trust is built into the infrastructure, appropriate SOPs, disciplined rituals and meaningful measures, people carry quality through uncertainty, pressure and time-critical decisions. That is the human factor in GMP. And it makes the difference between merely passing audits and consistently doing the right things.
Further Sources
- Donald Cressey: Other People's Money - A Study in the Social Psychology of Embezzlement (the Fraud Triangle).
- Marlous van der Hooft: From Compliance to Culture: How to Improve your Quality Culture in GMP Environments.
About the Author
Marlous van der Hooft is the owner and consultant at "Qualificiency Consulting", with more than 20 years experience in various senior operational and project management positions in the radiopharmacy and medical technology sectors. She is also the author of the book "From Compliance to Culture: How to Improve Your Quality Culture in GMP Environments".
