Sustainability Report 2013 Lek d.d.

47 Environment Lek HSE systems Environmental impact and risk assessment In accordance with legal requirements, all Lek sites have acquired environmetal permits for operation (see Compliance with laws and standards). When planning an intervention and its potential impact on the environment, an impact and stress admissibility 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 appli- cable environmental regulations. Impacts of the anticipated intervention are evaluated according to individual elements of the environment, and separately 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 negli- gible source of risk. At the Menge‰ production plant, clas- sified 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 explo- sion, and by means of response measures, the neces- sary 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 suitability for the area subject to assessment and on the qualification level of the associates involved. Risk assessment is made for the following: • Risk Portfolio, • Workplace Health Risk Assessment – WHRA, • Capital expenditure projects: with priority use of the Zurich Hazard Analysis (ZHA) or the Hazard and Operability Study (HAZOP Study) in the project qua- lification phase, • Facilities and production lines: the Zurich Hazard Analysis (ZHA) or the Process Risk Assessment (PRORA) • Introduction of new products and production proc- esses: Process Risk Assessment – PRORA, • Assessment of product quality risks: priority use of the FMEA method. The Risk Portfolio provides the management team with an overview of major HSE risks and levels of risk manage- ment by individual site, country, business group, and in the corporation as a whole. The Risk Portfolio development and compilation are carried out in three steps: • Risk assessment and preparation of a Risk Portfolio for individual sites, • Preparation of a Risk Portfolio for Lek d.d. (Slovenia) and Sandoz, • Annual review of the Risk Portfolio for business groups at the corporate level. In 2013, we performed all the risk management activities required in accordance with the Novartis HSE guidelines. Special care was given to identifying HSE risks in our ope- rations and processes. On this basis, we implemented the measures to minimize risks, such as avoiding potential risks, limiting the risk of exposure to hazards, and taking action to mitigate the negative impacts of any hazardous occurrence that actually took place. In 2013, we had one HSE emergency event in Prevalje as reported under Item 2.9.1. HSE aspects and system of achievement monitoring Pursuant to the Novartis guidelines, environmental aspects at Lek d.d. were upgraded into so-called HSE aspects. For a specific area of expertise, they are created at the proposal of the authorized person for each site separately. In addition to environmental aspects, we thus also have HSE, chemi- cal safety, fire safety, explosion safety and biological safety aspects. A standard selection of aspects for individual areas of exper- tise is determined by the head of the respective area at Lek d.d. The site's HSE responsible person makes an assess- ment based on the results of the Gap Analysis, audits (inter- nal, Novartis'), inspections, complaints, and in consideration of hazardous occurrences (near-misses). The aspects are evaluated in consideration of the criteria of legal compli- ance, profitability and the company's reputation, using the risk assessment methodology. Based on the findings in the Registry of HSE Aspects, correc- tive measures as well as business objectives and programs are defined. Revisions of the Registry of HSE Aspects are carried out at least once a year or the case of major change to the internal or external environment. It serves as a basis for the preparation of the Risk Portfolio, business and activity plans and programs, and for the setting of personal goals for responsible persons. In our operations, our compliance with legal and other re- quirements reflects in successfully completed internal and external audits, inspections, water, air and noise monitoring, and with applicable environmental permits. In 2013, audits of an external customer were carried out as well as an internal energy audit and external auditing of the company's compliance with ISO 14001:2004 and BS OHSAS 18001:2007 and and an audit according to the EMAS Directive.