Determination of the approaches to estimation of personal qualities of auditors of the pharmaceutical quality systems

Authors

DOI:

https://doi.org/10.24959/sphhcj.18.119

Keywords:

quality management, pharmaceutical quality system, audit, personal qualities, auditor's competence

Abstract

Aim. To determine the approaches to estimation of personal qualities of auditors of the pharmaceutical quality system.

Materials and methods. The object of the study was the personal qualities of internal auditors of the pharmaceutical quality systems. The empirical and theoretical methods of research were used, in particular the method of comparative analysis of scientific literature in the field of research, the method of structural-logical modelling. Provisions of normative documents and materials published in the open scientific professional literature were the information base.

Results. It has been proven that the characteristics of the personal qualities of internal auditors are of great importance for providing the effectiveness of quality system audits; therefore, it is necessary to determine and estimate the personal qualities when selecting auditors. It has been substantiated that the criteria for assessing the personal qualities of internal auditors should be established taking into account the recommendations of the ISO 19011 standard and using psycho-diagnostic methods.

Conclusions. The list of the basic personal qualities of auditors of the pharmaceutical quality systems has been chosen and interpreted. The rationality of application of the methods selected has been scientifically substantiated. These methods allow selecting specialists with the most acceptable qualities for auditing. The methods for assessing the personal qualities of auditors can be applied by pharmaceutical companies of different profiles.

Author Biographies

T. V. Karamavrova, National University of Pharmacy

graduate student

V. O. Lebedynets, National University of Pharmacy

Doctor of Pharmacy, associate professor, Head of the quality management department

L. V. Plyaka, National University of Pharmacy

Candidate of psychological sciences, associate professor, practical psychologist of the highest category

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Published

2018-08-22

Issue

Section

Organizational and socio-economic bases of pharmaceutical activities