Sustainability Report 2010 Lek d.d.

27 Lek Health, Safety and Environment Systems • Reducing emissions of volatile organic compounds (VOC), • Reducing waste volumes, • Reducing the number of work-related injuries. 2.8 HSE aspects and system of achievement monitoring When identifying and assessing environmental aspects as- sociated with the company’s activity, pharmaceutical produc- ts and services, Lek takes into account the following: • Direct impacts which are within the company’s direct control, and • Indirect impacts resulting from the company’s coop- eration with third parties, i.e. suppliers, buyers, serv- ice providers (see Item 3.9. Indirect environmental impacts) At Lek, environmental aspects have been upgraded into so- called HSE aspects. For a specific area of expertise, they are created at the proposal of the qualified person for each site separately. In addition to environmental aspects, we thus also have HSE, chemical 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 qualified HSE person evaluates them in con- sideration of the following: • GAP analysis, • Audit (internal, by Novartis), • Inspections, • Complaints / internally identified deviations, • Risk analyses, • Accidents / hazardous occurrences (near-misses). According to the risk methodology, aspects are evaluated in the following manner: Corrective measures needed Special caution needed Risks managed appropriately In the evaluation process, compliance in the following areas is taken into account: • legislation, • business efficiency, and • company reputation. Based on the findings in the Registry of HSE Aspects, cor- rective measures as well as business objectives and pro- grams are defined. Within the environmental aspects identified in 2010, the fol- lowing areas were evaluated: raw materials and ancillary materials (water, energy, raw materials entering the produc- tion process‚.....), air and water emissions, waste (genera- tion, management, treatment), noise, transport, lighting, and some other specific areas (ionizing radiation, electromag- netic radiation.....). Based on the evaluation of environmental aspects, the fol- lowing aspects were attributed major significance at the company level: use of water and energy, emissions of vola- tile organic compounds, and the level of environmental pol- lution with waste. Objectives for 2010 were set in considera- tion of the major environmental aspects defined. Revisions of the Registry of HSE Aspects are carried out at least once a year or in case of major change to the internal or external environment. The Register of HSE Aspects is managed by the HSE site teams. 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 qualified persons. In our operations, our compliance with legal and other re- quirements is reflected in successfully completed internal and external audits, inspections, water and noise monitoring, and with the environmental permits in effect. Internal audits of the HSE service are planned on an annual basis and per- formed according to individual HSE areas. Internal Novartis and Sandoz audits are more extensive, covering all areas of HSE on the part of the site being audited: environmental protection, occupational safety and health, chemical safety, fire safety, biological safety, explosion safety, and BCM and NEM. The frequency of audits depends on the nature of pro- duction: at API production sites, they take place every two years, whereas at pharmaceuticals production locations they are performed every three to four years. Environmental performance assessment with regard to Lek’s general and individual objectives is an integral part of the Management Review procedure. All Lek sites meet all the basic EMAS requirements, includ- ing environmental performance improvement. In line with Novartis and Sandoz policy, Lek is committed to continuous improvement of environmental performance in compliance with local and national programs. Internal audits according to EN ISO 14001:2004 standard are carried out periodically. The planning, launching, implementation and maintenance of the auditing program are carried out in accordance with the requirements of EN ISO 14001:2004 standard and the EMAS system. 2.9 Reporting methodology The reporting methodology used at Lek enables monitoring of absolute indicators and trends for individual critical HSE aspects. HSE data is collected, recorded, verified and confirmed within a uniform Novartis reporting system in the Data Man- agement System (DMS), whereby their transparency and comparability is ensured. Reporting frequency depends on the relevance of the reported data (monthly, quarterly or annually). Collected data serves as a basis for manda- tory regulatory reporting to ministries and other interested stakeholders, whereas once a year it is subject to review within the environmental management review performed by