When audit findings become opportunities
POMEX’s intervention in a medical analysis laboratory
A clinical biology laboratory needed to address major and minor findings from an external audit.
These non-conformities had to be resolved for the laboratory to continue meeting the current practical directive requirements. Here’s how POMEX turned this situation into an opportunity.
01. Context and Challenge
The laboratory, operating in clinical biology analysis, needed to resolve several non-conformities following an external audit. These major and minor findings highlighted the need for improvements in their quality system. Faced with these challenges, the laboratory urgently needed to develop and quickly implement an action plan to correct these issues and ensure continuity of operations.
02. POMEX’s Role
It was in this context that POMEX was called upon to provide its expertise. Our mission was clear: support the quality manager in drafting, implementing, monitoring, and executing an action plan that meets the audit requirements. In close collaboration with all support teams, management, and laboratory technologists, we strengthened the quality team and established good practices in line with current standards.
To do this, it was crucial to quickly understand the laboratory’s internal operations for implementing actions. A detailed analysis of existing processes allowed us to develop a precise action plan, prioritising the necessary interventions to resolve the non-conformities.
03. Implemented Solutions
The various stages of our intervention involved developing specific solutions tailored to the laboratory’s resources and infrastructure. We introduced new practices, particularly in quality management, and established formalised processes to ensure the sustainability of improvements.
Each proposed solution was carefully evaluated in terms of feasibility and impact. We worked with the teams to plan and execute the necessary actions. Communication played a key role throughout this process, ensuring that every team member understood the objectives and steps to follow.
04. Achieved Results
The results of our intervention were quickly evident. Adhering to the deadlines in the action plan allowed the laboratory to renew its accreditation, ensuring the continuity of its activities. Beyond this immediate success, our intervention evolved and strengthened the laboratory’s quality system.
The quality system was completely redesigned to meet the expectations of the third-party organisation. This overhaul also strengthened the quality cell within the laboratory, making it more robust. The staff began to see the quality service not as a constraint but as a valuable ally to improve their daily work.
05. Long-Term Benefits
The good practices we implemented not only resolved immediate issues but also laid the groundwork for continuous improvement. The quality staff, now better supported, can maintain and enhance these practices over the long term.
To ensure the sustainability of these results, a complete transfer of knowledge was carried out between POMEX staff and the client. Thus, the laboratory now has the tools and skills necessary to continue on this path of continuous improvement.
06. Adaptability
The mission we deployed for this laboratory is adaptable to many other contexts. The analysis of “input-output” processes, identification of non-conformities, implementation of action plans, and change management are approaches that can be applied in various industries.
POMEX has already demonstrated the success of these methodologies in other projects, showing that they can be adjusted to meet the specific needs of different companies. The key lies in adapting solutions to the standards and benchmarks specific to each sector.
Conclusion
This experience reaffirmed the importance of communication and change management in the success of any intervention. By making the teams actors of change, we not only resolved the non-conformities but also transformed the laboratory’s quality culture.
POMEX has proven that with a structured and collaborative approach, it is possible to turn a specific situation into an opportunity for renewal. We are proud to have contributed to this transformation and are ready to help other companies successfully tackle their quality challenges.
