Introduction of a Quality Management System at an Industrial Enterprise: Problems and Risks
Lebedynets V. O., Prokhorenko O. V.

Lebedynets, Viacheslav O., and Prokhorenko, Olena V. (2020) “Introduction of a Quality Management System at an Industrial Enterprise: Problems and Risks.” The Problems of Economy 4:177–186.
https://doi.org/10.32983/2222-0712-2020-4-177-186

Section: Economics and Enterprise Management

UDC 006.015

Abstract:
The purpose of the article is to substantiate a sound plan to design and implement a quality management system (QMS) at a typical domestic industrial enterprise: from the pre-design phase to obtaining a conformity certificate; to highlight problems that arise during the implementation of QMS, and to suggest sound recommendations for their solution. The introduction of QMS is considered as a project with the appropriate stages: the initiation stage, which means making decision on introducing QMS and appointing the project manager and task group; the planning stage, which means training the task group, defining the mission, vision, and policy in the field of the company quality, and designing the structure of QMS processes; the implementation stage, which means creating and publishing QMS documents and those of the pre-certification internal audit cycle; the completion stage, which means implementing all the documented procedures designed, and obtaining a certificate of their compliance with the requirements of ISO 9001 standart. The stages of such a project, their sequence, the estimated duration and distribution of responsibilities between the persons involved are offered. Possible problems arising at various stages of such a project are considered, namely: the conflict of QMS processes structure with the existing organizational set-up; unification of terms in the QMS processes structure due to the terminology already existing in the internal documentation; vague definition or lack of performance indicators; difficulties with the creation of the documentation system. Among the causes of these problems are: lack of motivation, unprofessionalism and / or lack of time among the developers, attempts to adapt to the existing system, the inconsistency of the actual goals of the organization head with the declared ones. It is recommended to divide the problem areas into three groups: by the performers (personal ones), by the system (systemic ones) and by the management of the company (administrative or leadership ones). A number of measures to eliminate or minimize the risks of problems arising during the introduction of QMS are suggested, and the responsibility areas as for taking these measures are determined.

Keywords: ISO 9001 standard, quality management system (QMS), QMS implementation project, QMS performance, risks in QMS implementation.

Fig.: 3. Tabl.: 1. Bibl.: 14.

Lebedynets Viacheslav O. – Professor, Professor, Department of Management, Economics and Quality Assurance in Pharmacy, National Pharmaceutical University (53 Pushkіnska Str., Kharkіv, 61002, Ukraine)
Email: v.o.lebedynets@gmail.com
Prokhorenko Olena V. – Candidate of Sciences (Economics), Associate Professor, Associate Professor, Department of Management and Taxation, National Technical University «Kharkiv Polytechnic Institute» (2 Kyrpychova Str., Kharkіv, 61002, Ukraine)
Email: a_prokhorenko@meta.ua

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