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(4 minute read)
The Situation:
As part of a global enterprise, our client needed to conform to quality management processes, as prescribed by their global head office, which included Corrective and Preventive Action (CAPA) requirements. A Quality Management System (QMS) transformation project was initiated to implement these requirements.
The main objectives of the QMS transformation project were to:
- Align a SHEQ management system to global CAPA requirements;
- Configure the system to accommodate prescribed processes for non-conformance management; as well as implementation, maintenance and sustainability of due operating processes and procedures; and
- Train all users on CAPA requirements, as well as roles and responsibilities within the required CAPA framework.
The Challenges:
Challenges faced in the QMS transformation project were:
- Complicated global requirements required to fit within a South African context;
- Standard operating procedures not aligned across various departments within the organization; and
- Continuous changes to procedures and processes and lack of standardization or stability in the execution and adherence to the prescribed requirements.
The Solution:
Align Ariscu to our client’s global CAPA requirements:
- A non-conformance template was created for the organization in which CAPA and non-CAPA specific fields were configured;
- Checklists were created in accordance with CAPA phases & requirements, and included initiation, investigation (evaluation/non-conformance assessment), plan (investigation and CAPA), implementation, verification of implementation, effectiveness check, and closure;
- Checklist templates were created to accommodate root cause analysis methodologies and included the “five whys” and cause mapping process;
- Documents were created to record the basic workflow process (including guidelines relevant to the application on Ariscu and CAPA); and
- Training was conducted on CAPA requirements, non-conformance report process and procedures, and Ariscu access and functionality as a QMS tool.
The Result:
- The Ariscu system facilitated compliance to global CAPA requirements and non-conformance report management, and significantly reduced the number of manual processes required – leading to a 43% reduction in man-hours spent on CAPA;
- Module functionality was configured to implement, maintain and sustain operating processes and procedures;
- All relevant stakeholders became knowledgeable on processes, expectations, roles and responsibilities as standard practice within the required CAPA framework;
- Training reduced the number of non-conformances by 36%; and
- The Ariscu system encouraged performance observation, allowing focus areas to be identified on an individual basis.
