Task:
Maintenance of a CAPA (Corrective and Preventive Actions) system within the Quality Management System (QMS). Previously, CAPA projects within the organization were merely managed without proper resolution. Root cause analyses were lacking, and human errors were often identified as the sole cause, with retraining being the only measure taken.
Objective:
To improve the situation by raising awareness among responsible employees and management about the benefits of thorough CAPA resolution. Management should also provide the necessary resources to conduct comprehensive analyses, tests, and experiments.
Milestones:
- Adjustment of the process to align with organizational philosophy
- Definition of a responsible role for the CAPA process
- Sensitization to awareness and responsibility
- Introduction of tools for effective CAPA project resolution
Approach:
Initially, stand-up meetings were introduced to conduct root cause analyses within the team. This approach revealed several causes that were not attributable to human error. Management realized that reducing errors could lead to cost savings. Consequently, the CAPA process was thoroughly revised, and the role of CAPA Coordinator was established to lead CAPA projects. Affected employees and management were trained according to the new SOP (Standard Operating Procedures) and processes.
Conclusion:
A new CAPA process was introduced within the organization, incorporating SIX SIGMA and SCRUM methodologies. A responsible role for CAPA projects was established to coordinate projects, delegate tasks, and oversee implementation. Paper-based documentation was partially digitized, allowing documents to be electronically signed.
