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.

References

Bakotic, D., Rogosic, A. (2017). Employee involvement as a key determinant of core quality management practices. Total Quality Management & Business Excellence, 28 (11–12), 1209–1226. doi: 10.1080/14783363.2015.1094369.

Bewoor, A. K., Pawar, M. S. (2010). An empirical study of the motives and benefits of QMS/ISO implementation among Indian SMEs. International Journal of Productivity and Quality Management, 6 (3), 379–406. doi: 10.1504/IJPQM.2010.035122.

Rajan, D. (2015). Motivation and job satisfaction: a study of pharmacists in private hospitals. Samvad, 9, 87–100.

Ramlall, S. (2004). A review of employee motivation theories and their implications for employee retention within organizations. Journal of American Academy of Business, 5 (1/2), 52–63.

Kotvitska, A. A., Lebedynets, V. O. (2015). Orhanizatsiia vnutrishnikh audytiv systemy upravlinnia yakistiu pidpryiemstva z vyrobnytstva likarskykh zasobiv. Kharkiv : NTMT, 28.

Lebedynets, V. O., Karamavrova, T. V. (2017). Sotsialna farmatsiia v okhoroni zdorov’ia, 3 (3), 58–65. doi: 10.24959/sphhcj.17.85.

KMU. (2016). Postanova No. 929 “Pro zatverdzhennia Litsenziinykh umov provadzhennia hospodarskoi diialnosti z vyrobnytstva likarskykh zasobiv, optovoi ta rozdribnoi torhivli likarskymy zasobamy, importu likarskykh zasobiv (krim aktyvnykh farmatsevtychnykh inhrediientiv)”. Available at : https://www.kmu.gov.ua/ua/npas/249579316.

MOZ Ukrainy. (2016). Likarski zasoby. Nalezhna vyrobnycha praktyka: ST-N MOZU 42-4.0:2016. Kyiv, 334.

Derzhspozhyvstandart Ukrainy. (2003). Nastanovy shchodo zdiisnennia audytiv system upravlinnia yakistiu (ISO 19011:2011, IDT): Natsionalnyi standart Ukrainy DSTU ISO 19011:2012. Kyiv, 24.

Sistemy upravlinnia yakistiu. Vimogy. (2016). (ISO 9001:2015, IDT) : DSTU ISO 9001:2015. Kyiv: DP “UkrNDNTs”, 22.

Halii, L. V. (2008). Farmatsevtychnyi zhurnal, 5, 12–16.

Halii, L. V. (2011). Dr. dissertation (Pharmaceutical Science). National University of Pharmacy. Kharkiv, 363.

Karamavrova, T. V., Lebedynets, V. O., (2017). Proceeding of Upravlinnia yakistiu v farmatsii : materialy Х naukovo-praktychna konferentsiia, (Kharkiv, 19 travnya, 2017). (pр. 72–75). Kharkiv: NUPh.

Tauseef. A. (Ed.). (2012). Total Quality Management and Six Sigma. London : InTech, 296. doi:10.5772/2559.

Ugarak, J., Korcok, D., Vuksanovic, D. (2015). The effectiveness of internal audits and their impact on system improvement. International Journal of Scientific and Research Publications. 5 (4), 1–6.

Kovalchuk, K. F., Friman, Ye. M., Friman, I. M. (2009). Naukovi pratsi Kirovohradskoho natsionalnoho tekhnichnoho universytetu. Ekonomichni nauky, 15, 3–10.

Pliaka, L. V., Tiurina, V. O. (2009). Proceeding of Molodizhna polityka: problemy i perspektyvy : materialy VI mizhnar. naukovo-praktychna konferentsiia (pp. 135–137). Drohobych : Redaktsiino-vydavnychyi viddil DDPU im. Ivana Franka.

Shliakhetko, V. V. (2014). Naukovi zapysky Ukrainskoi akademii drukarstva, 4, 122–129.

Raihorodskyi, D. Ya. (2007). Psykhodyahnostyka personala. Metodyka i testy. (Vol. 1). Samara : Bakhrakh-M, 440.

Shamlian, K. M. (2014). Problemy suchasnoi psykholohii, 23, 707–719.

Published

2018-08-22

Issue

Section

Organizational and socio-economic bases of pharmaceutical activities