The Situation:

As part of a global enterprise, our client needed to conform to quality management processes, as prescribed by their global head o�ce, 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;• Con�gure 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.

Challenges faced in the QMS transformation project were:

• Complicated global requirements required to �t 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.

Case StudyFacilitating corrective and preventive actions to reduce non-conformances by 36%

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14 Non-conformances7 Man hours

Post- intervention9 Non-conformances4 Man hours

36% Reduction

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9 Non-conformances4 Man hours

Pre- intervention

Post- intervention

36%

43%

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 speci�c �elds were con�gured;

• Checklists were created in accordance with CAPA phases & requirements, and included initiation, investigation (evaluation/non-conformance assessment), plan (investigation and CAPA), implementation, veri�cation of implementation, e�ectiveness check, and closure;

• Checklist templates were created to accommodate root cause analysis methodologies and included the “�ve whys” and cause mapping process;

• Documents were created to record the basic work�ow 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 signi�cantly reduced the number of manual processes required – leading to a 43% reduction in man hours spent on CAPA;

• Module functionality was con�gured 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 identi�ed on an individual basis.

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Case StudyFacilitating corrective and preventive actions to reduce non-conformances by 36%

Learn how our solutions can help you meet your objectives at www.ariscu.co.za

Ariscu makes it easy to achieve a high-functioning system so you can spend less time inputting data and more time on monitoring and improving the SHEQ management at your worksites. We provide an easy-to-use,modular solution, suited to the size of your operations -guaranteeing superior performance.

Post- intervention9 Non-conformances4 Man hours

43% Reduction