Quality culture expertise · HAQK method
Quality experienced as a police officer, departments working in silos, a Quality team that decides out of fear, operators who apply rules without understanding them: quality culture can’t be decreed. We evolve it from leadership to the shop floor, with concrete everyday tools.
Quality culture is hard to measure directly, but its effects are very easy to measure: international studies show it, and so do our assignments.
83 sitesstudied by ISPE and McKinsey: the stronger the quality culture, the fewer repeat deviations and the more effective the CAPAs
350+ sitesanalysed by the University of St. Gallen: a significant link between quality culture and quality system effectiveness
−47 %human-error deviations in one year, with our proactive culture tools
−46 %human errors across two production units, driven by front-line managersSources: ISPE, Quality Metrics pilot programme, waves 1 and 2 (2015–2016), carried out with McKinsey & Company; University of St. Gallen, OPEX benchmarking database of pharmaceutical production sites. The last two figures were measured on our assignments, with weak signals, task observations and 15 minutes for Quality.
Changing the quality culture doesn’t mean changing the site director’s vision.It means showing how Quality will help achieve that vision.
Quality, a story of problems. Every day, we talk about quality problems and their costs, rarely about their benefits. The result: everyone sees Quality as the police officer, protecting patients for some and holding things back for others.
Every site, and every population within the same site, sits somewhere on this curve. The goal: move everyone towards a Quality that anticipates.
The TinkererEndureAlways ready to do their best, especially if it’s faster and without the rules.
The Cautious OneDefendFollows the rule, even when it blocks everything: “it’s not me, it’s the rule”.
The EnforcerDefend“Zero nonconformities” is their creed, but buried in paperwork, they have lost touch with the shop floor.
The CompetitorMasterKnows the rules and uses them to win: Quality is a tool for efficiency.
The VisionaryAnticipateLinks the rules to the site’s mission and brings others along: Quality becomes a collective driving force.
Changing a quality culture isn’t just talk: we combine awareness with concrete tools rooted in everyday work.
A 55-question questionnaire reveals the Quality profile of each population and its confidence in the system. A necessary eye-opener before any change programme.
questionnaire5 profiles
A common goal for the whole leadership team, then departmental objectives consistent with it. We break the “internal supplier, internal customer” logic to tear down silos.
leadership teamcommon goal
Quality teams discover the cognitive biases that distort their decisions and learn to decide without rushing. Quality comes first from organisation and the shop floor, not from documents.
cognitive biasesICH Q9
Inspired by safety culture, weak signals, task observations and 15 minutes for Quality deal with risky situations before they become deviations.
weak signals15 minutes for Quality
The Pharmaceutical Industry Fresk to understand, online learning paths tailored to each profile to learn, and the GMP Memory Box and GMP Gemba walks so nothing is forgotten.
FreskGMP Memory Box
One- or two-day training courses where people experiment rather than listen: participants are deliberately led into error to understand its mechanisms, then leave with ready-to-use tools.
hands-on trainingQuality teams
A weak quality culture in production and quality control, and a Quality team with little pragmatism. Assessment of the Quality vision, alignment of the leadership team, the Fresk and 15 minutes for Quality.
Major deviations that revealed a lack of understanding of Quality on the shop floor. One training day per group: the Fresk, hands-on experience of error mechanisms, the V.A.K. check and pre-job briefing.
A team of young pharmacists and Quality technicians who made decisions in a rush. Two days on cognitive biases, Quality decision reflexes and pragmatic Quality.
Each step is independent, but the project always starts with an assessment of the situation.
Questionnaires tailored to the site, data collection from as many employees as possible and profile analysis. About a month.
Alignment workshop, building the common goal and departmental objectives, then facilitation of the leadership team for four months.
Training and coaching for pragmatic Quality: cognitive biases, decision-making, risk management.
Weak signals, task observations, 15 minutes for Quality and the Fresk, run by your managers.
It’s the way everyone, from leadership to operators, experiences Quality day to day: as an imposed constraint, as a fear of error, or as a collective reflex that guides decisions and supports the site’s performance.
With a 55-question questionnaire, tailored to the site, which reveals the Quality profile of each population (Tinkerer, Cautious One, Enforcer, Competitor, Visionary) and their confidence in the quality system. It’s the basis of any approach: you can’t change what you can’t see.
Because a culture spreads from the top. If each department pursues conflicting objectives, Quality remains Quality’s business. We rework a common goal, then each department’s objectives in line with it, to break down silos.
Quality that defines ways of working that are genuinely applicable on the shop floor, while limiting risk, rather than “office” Quality that piles up documents. It relies on the risk management advocated by ICH Q9 and on rational decisions, made without rushing.
Yes: one day for operators and their supervisors, built around the Pharmaceutical Industry Fresk and a playful, hands-on exploration of error mechanisms, and two days for Quality teams, on cognitive biases, decision-making and pragmatic Quality.
The assessment takes about a month and leadership alignment a few months. The roll-out to Quality teams and the shop floor takes place over a year, with everyday tools that embed the changes for the long term.
Tell us about your situation in thirty minutes. We’ll tell you which level to start with.