Sustainability Report 2012 Lek d.d.

43 Environment Lek HSE systems By organizing appropriate training programs, we provide our employees with a level of HSE qualification sufficient for them to manage HSE aspects of their work. In cooperation with unit heads, the HSE unit prepares annual training plans and se- lects training topics for inclusion in the Training and Education Catalogue. Training programs are organized into the following clusters: onboarding, continuing education, and training for promotion. We also encourage direct interaction of employees in diffe- rent roles, functions and units beyond the formal HSE func- tion organization. For this purpose, the Re:act Initiative was launched, creating opportunities for the employees to provide ideas, regardless of how insignificant they might appear at a first glance, to positively impact employee well-being, save valuable time and natural resources, and contribute to safety and quality. Environmental impact and risk assessment In accordance with legal requirements, all Lek sites have acquired environmental permits for operation (see Com- pliance with laws and standards). When planning an intervention and its potential impact on the environment, an impact and stress admissibili- ty assessment is made. The assessment is carried out in accordance with legal environmental guidelines, data from public sources, monitoring and studies carried out by authorized institutions, the current environment status and pollution, anticipated emissions resulting from the planned activities, and applicable environmental regulations. Im- pacts of the anticipated intervention are evaluated accor- ding to individual elements of the environment, and sepa- rately for the construction time and the operation time. If any environmental impact has been identified, mitigation measures are proposed. Pursuant to the Decree on the Prevention of Major Acci- dents and Mitigation of their Consequences (OG of RS, Nos. 71/08 and 105/10) Lek, with the exception of the Menge‰ production plant, is characterized as a negligible source of risk. At the Menge‰ production plant, classified as a source of minor environmental risk (mainly due to the presence of flammable substances at the site), hazardous substances were detected as anticipated. By applying the measures planned for emergency cases which may result in large-scale emissions, fire or explosion, and by means of response measures, the necessary action was taken to prevent major incidents. Being a minor environmental risk plant, we filed an application for an environmental permit with the relevant Ministry. The permit is due by the end of 2015, as major risk sources are given priority. Measures for risk prevention and mitigation Risk assessment is carried out using various methods. The choice of an appropriate method depends on its suita- bility for the area subject to assessment and on the quali- fication level of the associates involved. Risk assessment is made for: • Risk Portfolio, • Workplace Health Risk Assessment (WHRA), • Capital expenditure projects: with priority use of the ZHA (Zurich Hazard Analysis) method or the Hazard and Operability Study (HAZOP) in the project quali- fication phase, • Facilities and production lines: the Zurich Hazard Analysis (ZHA) or the Process Risk Assesment (PRORA), • Introduction of new products and production proces- ses: Process Risk Assesment – PRORA, • Assessment of product quality risks: priority use of the FMEA method. Figure 1: HSE organization Areas of expertise HSE Areas of expertise Occupational health and safety Chemical safety Environmental protection Occupational medicine BCM* / NEM** Secutiry Protection and rescue Ionizing radiation safety Fire safety Biological safety Transport of hazardous goods Explosion safety Energy management Development SCM Quality Support functions Quality Quality Biopharmaceuticals API development Linex Quality Packaging Center Lendava wastewater treatment plant * BCM: Business Continuity Management ** NEM: Novartis Emergency Management HSE Solids HSE Steriles HSE Penicillins HSE API Production HSE Antiinfectives