Integration Of Quality Assurance And Environmental Management System For A Chemical Plant That Produced Pharmaceutical Bulk Materials

Tez (Yüksek Lisans) -- İstanbul Teknik Üniversitesi, Fen Bilimleri Enstitüsü, 1998Thesis (M.Sc.) -- İstanbul Technical University, Institute of Science and Technology, 1998Bir firmanın neden "Toplam Kalite Yönetimi" ni uygulaması gerektiği çok açık ve hemen herkes tarafından bilinen verimlilik, rekabet gücü, karlılık gibi sebeplerken, çevre ile ilgili nedenler; tüketici talebi, pazarlama aracı, yasal zorunluluklar, ekonomik zorunluluklar ve/veya çevresel sorumluluklar olabilir. Bu nedenler içinde sadece " çevresel sorumluluk" uzun vadeli bir amaca yöneliktir ve bu konudaki faaliyetlere sistematik yaklaşımı ISO 14000 Çevre Yönetim Sistemi getirir. ISO 9000 Kalite Güvence Sistemi'ni takiben gündeme gelen ve mevcut sistemlerle entegre edilebilen Çevre Yönetim Sistemi 'nin getirdiği en önemli yenilik, çevreye ilk defa gerçekçi, çevresel sorumluluk getirici, katılımcı, dürüst ve umut verici bir gelişme olmasıdır. ISO 9000 Kalite Güvence Sistemi ve ISO 14000 Çevre Yönetim Sistemi'nin entegrasyonu çerçevesinde hazırlanan çalışmanın birinci bölümünde kalite ve çevre kavramlarının bugünkü önemi, ikinci bölümünde ise; kalite ve çevre kavramlarının ne olduğu, günümüze kadarki gelişim süreçleri ve bu iki olgunun bütünleştirilmesine yer verilmiştir. Üçüncü bölümde ise; ISO 14000 Çevre Yönetim Sistemi, Çevre Yönetim Sistemi'ne sahip olmanın yararları, ISO 14001 Çevre Yönetim Sistemi belgelendirme gereklilikleri, ISO 9000 Kalite Güvence Sistemi ile ISO 14000 Çevre Yönetim Sistemini'nin felsefi ve standardın maddeleri bakımından karşılaştırılması ele alınmıştır. Dördüncü bölümde ise; Kalite Güvence Sistemi ile Çevre Yönetim Sistemi'nin entegrasyonu, ilaç hammaddesi üreten bir kimya sanayi işletmesine yönelik hazırlanmıştır. Çalışmanın uygulama kısmını oluşturan bu bölümde öncelikle, ISO 14000 Çevre Yönetim Sistemi gereklilikleri irdelenerek yorumlanmış ve model şeklinde tanımlanmıştır. Daha sonra mevcut Kalite Güvence Sistemi faaliyetleri ve İSO 14000 Çevre Yönetim Sistemi gereklilikleri karşılaştırılarak, her iki sistemin entegre edilmesi yönünde yapılması gerekenler tespit edilmiştir. Beşinci bölüm ise, çalışmanın sonuç ve öneriler kısmı olup, çalışmanın genel değerlendirmesini kapsamaktadır. Çalışma sonunda gerek yeni bir sistem olan ISO 14000 Çevre Yönetim Sistemi'ne yönelik, gerekse de her iki sistemin entegrasyonu çerçevesinde yapılması gerekenlerin tesbiti ile birlikte ISO 9000 Kalite Güvence Sistemi ile ISO 14000 Çevre Yönetim Sistemi'nin "Toplam Kalite Yönetimi" felsefesinde odaklaştırılarak entegre edilmesinin her iki sistemin etkin ve sürekli kılınması için kaçınılmaz olduğu kanaatine varılmıştır.In the first and second sections of this work, the information is given about importance of quality and environment, in our world the result of the fast going globalization day by day. The companies to be endure and to compete with each and change is that the world is come to an one market, and the clearest result of globalization is the competition getting hardly other they have to appropriate the integration of quality and environment. The industrialist needs to be able to operate effectively and efficiently produce their product at a competitive price. Equally, this must be done without an unacceptable level of pollution to the environment. Because, pollution control is becoming increasingly internationalised. In the third section, it is explained ISO 14000 Environmental Management System (EMS) and relationship between ISO 14000 and ISO 9000. Environmental management system has become a very important issue for business organizations recently. There is no return to a simpler world where environmental impacts are limited to few considerations that are mostly economic in nature. Thus, business and industrial organizations must cope with an environment that is being polluted and adopt new ways for its protections. For example; when manufacturing a new product or buying land for expansion, business organizations must investigate the potential impact on environment. They must also consider new forms of organizational structures and processes that will enable them to respond to a changing environment in the long term. The traditional model of industrial activity is one in which raw materials are used by processes to produce products for people and then the waste material generated is disposed in some way. This present system of manufacturing should be changed radically. Such changes, however, call for new kinds of thinking and new strategies regarding the environment. For example, a new kind of manufacturing system must be totally integrated where consumption of energy and raw materials are optimized and waste generation is minimized. In addition to this, there must be more incentives for recycling, conservation, and alternative materials in comparison to present system which will cause problems for future generations. An environmental management system (EMS) is that aspect of organization's overall management structure that address the immediate and long-term impact of its products, services, and processes on the environment. It provides order and consistency in organizational methodologies through the allocation of resources, assignment of responsibilities, and ongoing evaluation of practices, procedures, and processes. An EMS is essential to an organization's ability to anticipate and meet growing environmental performance expectations and to ensure ongoing compliance with national and international requirements. EMS's succeed best when corporations make environmental management among their highest priorities. In general EMS should achieve the following principles:. Establish an appropriate environmental policy, including a commitment to prevention of pollution,. Determine the legislative requirements and environmental aspects associated with the organization's activities, products, and services,. Develop management and employee commitment to the protection of the environment, with clear assigment of accountability and responsibility,. Encourage environmental planning throughout the full range of the organization's activities, from raw material acquisition through product distribution,. Establish a disciplined management process for achieving targeted performance levels,. Provide appropriate and sufficient resources, including training, to achieve targeted performance levels on an ongoing basis,. Establish and maintain an emergency preparedness and responce program,. Establish a system of operational control and maintenance of the program to ensure continuing high levels of system performance,. Evaluate environmental performance against the policy and appropriate objectives and targets and seek improvement where appropriate,. Establish a management process to rewiev and audit the EMS and to identify opportunities for improvement of the system and resulting environmental performance,. Establish and maintain appropriate communications with internal and external interested parties,. Encourage contractors and suppliers to establish an EMS. The ISO 14000 series comprises a number of unique standards. The product- oriented standards include environmental labelling, life-cycle assesment, and environmental aspects in product standards; the organization and process xi standards include environmental management systems, environmental auditing, and enviromental performance evaluation. Organization or Process Standards ISO 14001 : EMS- Spesification with Guidance for Use ISO 14004 : EMS- General Guidelines on Principles, Systems and Supporting Techniques. ISO 14010 : Guidelines for Environmental Auditing-General Principles of Environmental Auditing. ISO 1401 1/1 : Guidelines for Environmental Auditing- Audit Procedures- Auditing of EMS. ISO 14012 : Guidelines for Environmental Auditing- Qualification criteria for Environmental Auditors. ISO 14013 : Management of Environmental Audit Programs. ISO 14014 : Initial Reviews. ISO 14015 : Environmental Site Assesment ISO 14031 : Evaluation of Environmental Performance. Product-Oriented Standards ISO 14020 : Environmental Labelling ISO 14021 : Terms and Definitions for Self-Declaration Environmental Claims. ISO 14022 : Environmental Labelling-Symbols. ISO 14023 : Environmental Label ling-Testing and Verifications Methodologies. ISO 14024 : Environmental Labelling-Guide for Certification Procedure ISO 14040 : Environmental Management- Life Cycle Assestment- Principles and Guidlines. ISO 14041 : Environmental Management- Life Cycle Assestment- Goals and Definitions/Scope and Inventory Analysis. ISO 14042 : Environmental Management- Life Cycle Assestment- Life Cycle Impact Assestment. The elements of an ISO 14001 is as follows:. Environmental Policy : Develop statement of your organization's commitment to the environment. Use This policy as a framework for planning and action. XII Environmental Aspects : Identify environmental attributes of your products, activities and services. Determine those that could have significant impact on the environment. Legal and Other Requirements : identify and ensure access to relevant laws and regulations. Objectives and Targets : Establish environmental goals for your organization, in line with your policy, environmental impact, views of interested parties and other factors. Environmental Management Program : Plan actions to achieve objectives and targets. Structure and Responsibility : Establish roles and responsibilities and provide resources. Training, Awareness and Competence : Ensure that your employee are trained and capable of carrying out their environmental responsibilities. Communication : Establish process for internal and external communications on environmental management issues. EMS Documentation : Maintain information on your EMS and related documents. Document Control : Ensure effective management of procedure and other system documents. Operational Control : Identify, plan and manage your operations and activities in line with your policy, objectives and targets. Emergency Preparedness and Response : Identify potential emergencies and develop procedure for preventing and responding to them. Monitoring and Measurement : Monitor key activities and track performance. Nonconformance and Corrective and Preventive Action : Identify and correct problems and prevent recurrences. Records : Keep adequate records of EMS performance. EMS Audit : Periodically verify that your EMS is operating as intended. Management Review : Periodically review your EMS with an eye to continual improvement. Also similarities and differences between ISO 14000 and ISO 9000 are as follows: XIII Similarities ISO 14001 share the same concept as ISO 9000, in providing generic requirements for a management systems approach to a specific function of an organization. Whereas ISO 9000 deals with an organization's Quality System, ISO 14001 deals with an organization's Environmental Systems. Common or similar elements to both programs include :. Policy,. Management Review,. Corrective/ Preventative Actions,. Document Control,. Records,. Internal Audits,. Training,. Organizational Structure. Differences Whereas ISO 9000 is designed to focus on customer requirements, ISO 14001 addresses the needs of a broad range of interested parties-shareholders, the public at large, employees, environmentalist, govermental and regulatory agencies etc. Concepts and issues unique to ISO 14001 are as follows :. System for compliance with existing Environmental Legislation and Regulations,. Conformance to Industry Codes of Practices,. Continual Improvement and Pollution Prevention,. Identification of Relevent/Significant Environmental Aspects,. Identification of Objectives and Targets,. Emergency Preparedness and Response,. Communications Regarding Environmental Aspects. In the fourth section, it is explained the integration Quality Assurance System(QAS) and Environmental Management System (EMS) from a chemical industry plant. This plant consist a current QAS and has started EMS studies. In this section it is necessary to integrate EMS into QAS. Benefits of EMS implementation and integration of ISO 9000 QAS and ISO 14000 EMS are follows :. Operational,. Marketing,. Financial,. Regulatory.Yüksek LisansM.Sc