Browsing by Subject "internal audit"

In pharmaceutical industry GMP compliance and quality of operations can be ensured with quality management system (QMS). QMS is an operational system, which consist of multiple different elements depending on the size of the company and nature and complexity of its operations. For the QMS to be functional, documented and defined operations need to be managed and monitored systematically. Conducting internal audits has been considered necessary with regard to QMS, though it has not always been perceived as adding value or seen as an opportunity to utilise more fully. Internal audits are mainly utilized to control compliance to requirements. However, there are possibilities to utilise it more in improving and developing operations, preparation to external audits, quality risk assessment, finding out the best practices, basis for decision making, learning experience as well as the assessment of functionality and effectiveness of the QMS. The aim of this study was to examine the utilisation of internal audits in Orion (Espoo) and find solutions to improve the utilisation of internal audits with QMS. The focus was on how internal audits can monitor and guide QMS and what is required from internal audits for monitoring and guidance of QMS. These aims were approached qualitatively by conducting semi-standardized open-ended interviews. Interviewees (n=9) were selected from both auditor and auditee side and they had their background in quality assurance or production. Data compiled from these interviews was analysed mainly by qualitative methods, using also some quantitative analysis. Monitoring of the QMS can be looked at as the starting point to guide QMS. Valuable information can be gathered with internal audits with regard to QMS. By utilising this information, internal audit process and QMS can be improved and the quality of operations can be ensured. Based on this work internal audits can be utilised to monitor and have the potential to guide QMS under certain conditions. Internal audit topics need to be systematically selected, QMS needs to be monitored and guided based on the internal audit findings, flow and distribution of information needs to be efficient and flexible, and internal audits should be better utilised and managed. Further research is needed on the development and deployment of tools to aid better utilisation of internal audits in the control of QMS. Also ways to measure the effects of internal auditing should be further investigated.