We know - people make mistakes.
We are convinced - deviations and accidents can be avoided.
With our innovative economic and helpful concepts for learning efficiently and sustainably from mistakes - Vision Zero turns into reality.“
Our customers have these
- the same mistakes happen over and over again
- a high rate of human errors
- considerable effort for root cause analyses and measures
- true root causes are not identified
- Corrective Actions and Preventive Actions (CAPAs) are not effective
- free of mistakes and accidents (right the first time)
- increased quality culture and increased safety culture
- lean systems for increased efficiency
- find and eliminate the true root causes
- effective CAPAs instead of useless solutions
What our customers say
Advantages of KU-Pharma:
less deviations* after only 2 months
*compared to the corresponding period the previous year
Achieved reduction in the number of deviations in a biopharmaceutical production plant with about 700 employees.
That speaks for itself:
of the projects of KU-Pharma* are follow-up projects or recommendations
*since our foundation in 2009
Expert consulting with systemic consulting, because implementation always involves people.
Innovative Process Quality by Design concepts: for robust processes and flawless products
Safety at work
Recognise and understand cause - trigger - consequence of incidents: to turn Vision Zero into reality
Risk-based approach: for learning efficiently and sustainably from mistakes
Root cause analyses without blame but with fairness in the case of mistakes and accidents: with our principle of the innocent trigger
Our services in detail
Our complementary (expert and systemic) consulting services help to ensure that all managers and employees can carry out their tasks correctly and safely the first time (“Do It Right The First Time”).
The consulting is based on the RIGHT concept developed by us:
the status quo of investigating deviations and incidents:
- classification and processing - mistakes, deviations, incidents, accidents
- root cause analysis - procedure, methodology, qualification, results, evaluation
- CAPAs- evaluation of effectiveness before und and after implementation, effectiveness checks
- metrics - usefulness, dealing with unattained goals
based on our expertise and our systemic understanding (30 years experience in the pharmaceutical industry, human resources and administration)
- information - recording the current general conditions for managers and employees to support error-free and safe working
- impulses - for dealing with mistakes fairly
- evaluations - identifying systemic causes and dependencies
In a GMP environment, all required processes and systems have usually already been implemented.
- That's why we think it's important -
to do the right things, and to do these things right.
- Therefore, we determine precisely the need for optimisation of effectiveness and efficiency.
Elaboration and implementation of powerful concepts and optimisation measures with regard to quality, safety at work and efficiency.
- Process optimisation for - risk-based approach, root cause analysis, CAPAs, metrics
- Workshops and training eg:
- Root Cause Analysis and CAPAs
- Learning efficiently and sustainably from mistakes
- Process Quality by Design
- Technical Writing
- Coaching for - managers and employees
- Creation of - documents (eg SOPs, URS) for the overall process and detailed steps
In our view - learning from mistakes is an ongoing task for all organisational levels and departments of a company.
- Sustainability - tracking and monitoring the implementation of holistic measures
to turn Vision Zero into reality.
Root Cause analysis for deviations and accidents
An example of our development results: our universal Root Cause Analysis Tool
5xWhy and the Ishikawa Diagram are the best known tools for root cause analysis.
"However, both methods are incomplete in our view and have particular disadvantages:
5xWhy easily tempts people to put the blame on someone. Both methods lack an inner logic for systemic dependencies of causes and triggers of incidents.
According to our findings, a complete tool for root cause analysis contains three necessary basic components. Based on this, we have developed a complete and universally applicable investigatory method. This supports even inexperienced investigators to quickly and efficiently identify those causes that lead to effective measures which prevent the incident from reoccurring."
This is how learning from mistakes turns into success.
Advanced Pharmacist for Pharmaceutical Analysis, Qualified Person
Our analytical, logical thinking specialist with 30 years pharmaceutical experience in small and medium-sized companies and conglomerates, develops pioneering concepts for efficient and sustainable learning from mistakes and constantly questions their status quo.
Efficient, error-free and safe working in the GMP environment turns into reality.
Master of Business Administration,
diploma as a business studies teacher
Our specialist for systemic consulting asks the right questions with sensitivity and creativity. She helps to recognise the correlation in processes rapidly, so that the people involved find solutions for their issues and that they are open-minded for change.
She is the right coach for us and also for you.