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Abstract

Self-inspection is a requirement of most Quality Management Systems. Within an organisation, it is a key process for self-assessing compliance to regulatory requirements. Done well, it can be a very informative system – highlighting gaps and driving improvement. However, these audits can vary in effectiveness and the contribution of the programme can be difficult to assess and measure. Ensuring that there is an effective system in place is challenging. This paper assesses how the effectiveness of self-inspection programmes is currently measured and reviews the expectations of quality system regulations and standards. Based on this research, a Self-Inspection Programme Effectiveness Assessment (SI-PEA) tool was developed. SI-PEA is a risk-based method for assessing effectiveness of the self-inspection programme, verifying compliance to current quality system regulations, and identifying if there are opportunities to improve the programme. The tool ultimately assigns a risk score to the programme’s overall effectiveness. The tool was developed for application in a pharmaceutical quality system but is suitable for application within any quality management system. The developed SI-PEA tool has been successfully piloted across two companies to prove its functionality.

DOI

https://doi.org/10.21427/w3nm-mx76

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

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