Abstract

In this research first time in Latvia a multidimensional risk assessment is carried out in a manufacturing enterprise in the pharmaceutical industry according to the only international risk management standard ISO 31000:2018. The key multisided risks were identified and prioritized in the manufacturing pharmaceutical enterprise by applying the common metrics method: obtaining evaluations of risk occurrence and impact severity, made by the two highest levels of enterprise management, i.e. Board and senior line managers. A Top 10 of key risks was created from identified 64 different risks and the convergence and divergence in the risk rankings, evaluated by the enterprise’s Board and senior line management were obtained and analyzed. The main conclusion is that manufacturing enterprises in the pharmaceutical industry have specifics regarding exposure to multisided risks, where the main key risk is a regulatory risk and not different financial risks. Different rankings of enterprise operational risks, investment assessment risks, technological innovations risks made by the enterprise Board and senior line managers are signalling that exactly in these directions of the enterprise’s business activities it is necessary to review the strategic and operational planning with the aim to mitigate the potential risk impacts.

Highlights

  • There is no overall accepted definition of enterprise risk and enterprise risk management (ERM)

  • There is no industrial enterprise in Latvia today, which has fully implemented ERM complying with ISO 31000:2018

  • In this research we have been concentrated on the second part of the whole ERM implementation process: risk assessment and quantification in manufacturing pharmaceutical enterprise

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Summary

Introduction

There is no overall accepted definition of enterprise risk and enterprise risk management (ERM). The only international ERM standard ISO 31000:2018 (2018) defines: “ERM is a comprehensive and integrated system for managing risks, that helps an entity to meet its business tasks and achieve its objectives by minimizing unexpected profit deviations and maximizing the value of the business.”. Implementation of ERM in compliance with ISO 31000:2018 standard in industrial enterprises has started only after global financial crisis (2009) mainly in USA and is not widespread in Europe. There is no industrial enterprise in Latvia today, which has fully implemented ERM complying with ISO 31000:2018. The risks to which industrial enterprise can be exposed are multisided (Hillson, 2016):

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