Deviation management at SEQENS
Quality, Production and operational excellence, a multidisciplinary team to improve the robustness and performance of the Quality Deviation process.
For nearly 4 years, the Seqens group has implemented a method and adapted tools for problem solving (D.M.A.I.C) within the framework of quality deviations on all its GMP sites. This approach was supported by a reorganization of roles and responsibilities between teams for greater clarity and efficiency.
Together, the Operational, Quality Assurance and Operational Excellence teams worked on a Lean organization supported by visual management and a single multi-service meeting (Supply Chain, Production, Quality Control, Maintenance and Quality Assurance) to monitor the processing of deviations in real time.
In a few months, the root causes of Deviations were better identified, and the solutions proposed and implemented (CAPA) enabled a considerable reduction in the number of deviations and a halving of the deviation processing time.
At the same time, this new process was digitalized using the DigiQual solution (the internal name given to the application) designed by Seqens with the support of Veeva Vault solution, which is progressively deployed at the group’s sites
These initiatives have enabled the Operational teams to increase their skills to become more autonomous and efficient. The robustness of the Seqens methodology has been praised during recent customer audits at our sites.
While fulfilling the requirements of the pharmaceutical industry, our sites are now more agile and ready to meet the challenges of tomorrow.