Assessment of the risks affecting the business continuity of Ukrainian pharmaceutical enterprises
DOI:
https://doi.org/10.24959/uekj.20.13Keywords:
business continuity system, risk management, pharmaceutical enterprises, standard ISO 22301, standard ISO 31000Abstract
Modern pharmaceutical enterprises (PE) must provide themselves with the conditions of continuous functioning as a strategic enterprise for the country. Domestic enterprises may benefit from the experience of leading pharmaceutical companies and the recommendations of the International Standards Organization, as described in the provisions of EN ISO 22301:2014 Societal security. Business continuity management systems. Requirements.
Aim. To identify steps for implementing a business continuity strategy. Particular attention in the article has been given to the issues of identification and assessment of the magnitude of risk for groups of events or conditions that alone or taken together may call into question the validity of the assumption of continuity of pharmaceutical activity.
Results. The article contains the results of the study on the classification of existing and potential business threats, methods of risk assessment that affect the activities of Ukrainian pharmaceutical companies and the possible methodological approach to implementing risk management in building a business continuity assurance system (BCMS) in the current conditions of the pharmaceutical market. The article presents the steps that are necessary to implement the risk management strategy of the BCMS with the justification of the distribution of the criticality of the risks that affect the continuity of the PE activity. The steps are based on the practical experience of a number of enterprises in our country that have already had experience in dealing with various incidents, for example: hacking attacks, changes in the law regulatory field, physical destruction of production facilities and others.
Сonclusions. А provide recommendations for identifying and separating all adverse events that may occur at domestic enterprises, assessing the risk of BCMS in accordance with established events and conditions that, individually or in combination, may result in the termination of the entity’s activities. We have also offered a list of relevant documents describing and recording activities at each step of the risk management of the BCMS.References
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