TUTCRIS - Tampereen teknillinen yliopisto


Managing Safety-Related Compliance of Machines in the Global Market



KustantajaTampere University
ISBN (elektroninen)978-952-03-1315-9
ISBN (painettu)978-952-03-1314-2
TilaJulkaistu - 22 marraskuuta 2019
OKM-julkaisutyyppiG4 Monografiaväitöskirja


NimiTampere University Dissertations
ISSN (painettu)2489-9860
ISSN (elektroninen)2490-0028


In global trade, a machine manufacturer must manage a large variety of safety
requirements, conformity approvals and product liability issues in order to avoid the possible losses caused by undesired events related to their products. Incorrect or insufficient knowledge of regulations in different market areas may hinder business and weaken competitiveness of machine-manufacturing companies with global operations. Especially outside of European Economic Area (EEA), European manufacturing companies may face difficulties in gathering and managing all local information and anticipating new requirements. This dissertation studies the process of managing compliance with product safetyrelated requirements in a global context. In here, the requirements cover external demands that an organisation has to comply. These may also be defined as external parties’/stakeholder requirements. The existing process of compliance management is studied from two perspectives: from globally operating manufacturing companies’ and from external parties’, such as legislators, standardisers and supervisory authorities, which have an essential role in effecting, demanding and/or supporting the management of compliance in companies as a whole. The results of the qualitative study base on prior literature and semi-structured interviews of six large machine manufacturing companies’ representatives (n=37) as well as twelve Finnish (n=40) and six European (n=13) external parties’ views of practices and problems in managing compliance. The results of literature review and the empirical findings of the interviews were applied in the construction of new approaches to manage
compliance with safety-related requirements more systematically. The empirical results of this study show that the European integration has clarified the companies’ operations significantly within the European Union (EU). However,
varying practices, requirements and their enforcement cause difficulties for
companies. From the external parties’ point of view, the regulatory system requires improvements in the EU. Especially market surveillance is unequal in different EU member countries. Nevertheless, the companies seem to have more difficulties related to achieving compliance in other market areas. The required information about another market is typically gathered with help of company’s local units, customers, dealers as well as by external benchmarking. Company makes a decision of whether it strives to comply with the requirements of all the market areas simultaneously or if the products are customised to different markets. The customisation may also be carried out in a local unit. However, central problems for companies are the lacking comparison of the requirements among different market areas and that the existing information does not cumulate to one place in the companies. In addition, the participating companies seem to desire more external help for official interpretations of requirements. However, this kind of advice is not easily available. Overall, according to the findings of this research, there is a need to clarify the process of managing compliance with safety-related requirements in a global context. The existing models and guidelines do not provide appropriate solutions for the identified needs. The constructed new approaches support to structure operations around managing compliance and provide new perspectives for understanding societies’ activities. These approaches consist of a model for managing compliance with safety-related requirements and safety concerns in product delivery strategies. The main part of these approaches is the model, which consists of essential issues related to the phases of managing compliance with requirements from discovering and following requirements up to evaluation and ensuring compliance of a product with the valid requirements. The model considers product-based requirements. In addition, it covers issues both from companies’ and from specific external parties’ perspectives. This dissertation emphasises European legislation and practices. Nevertheless, the proposed approaches are generic and should be of interest for a wider audience. This dissertation produces scientific contribution by providing an overview of the problems and practices in managing safety-related compliance from the industrial
perspective. In addition, it provides several external parties’ expectations, role and possibilities in supporting and controlling companies’ management of compliance. The results and constructed new approaches of this study combine several theoretical areas around compliance management, supply chain management, product liability and decision-making. Further, this study adds a novel aspect of safety in areas where it has not been covered in the earlier studies.

Tilastokeskuksen tieteenalat