A Concept of Quality Management System for Krsko 2 Project

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1 A Concept of Quality Management System for Krsko 2 Project dr. Robert Bergant, dr. Tomaž Žagar, Jože Špiler, Gregor Androjna, Tomaž Ploj GEN energija, d.o.o. Cesta 4. julija 42, 8270 Krško, Slovenia robert.bergant@gen-energija.si, tomaz.zagar@gen-energija.si, joze.spiler@gen-energija.si, gregor.androjna@gen-energija.si, tomaz.ploj@gen-energija.si ABSTRACT Markku Pitko QualiFinn Engineering Oy Teknologiakeskus Pripoli, Building K Tiedepuisto 4 FI Pori FINLAND markku.pitko@qualifinn.com In order to perform activities for new NPP construction preparation a Quality Management System (QMS) should be developed. Developed QMS should comply with specific regulatory and industry quality requirements imposed by nuclear safety requirements for safety related activities and adequately expanded to other activities to assure overall quality of the whole process. The basic structure of the QMS will be established according to ISO 9001 structure. Slovenian Nuclear Safety Administration (SNSA), International Atomic Energy Agency (IAEA), Western European Nuclear Regulators Association (WENRA), Nuclear Regulatory Commission (NRC) and American Society of Mechanical Engineers (ASME) safety related requirements will be appropriately integrated in the developed QMS. QMS developed according to this concept will cover preparation, bidding, construction and commissioning phases of the project. Activities related to the QMS conceptual design and QMS development preparations have started in March 2008 and will be finished by the end of Since the project is in progress, the paper will be focused on the QMS concept presentation. 1 INTRODUCTION Quality Management System (QMS) can be defined as a set of policies, processes and procedures required for planning and execution (production / development / service) in their core business area of an organization. QMS integrates various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved performance. In other words QMS is a network of processes, and a process is made up of people, work, activities, tasks, records,

2 documents, forms, resources, rules, regulations, reports, materials, supplies, tools, equipment and so on all things that are needed to transform inputs into outputs. The QMS of Krsko 2 project will apply to activities that will affect the quality of items and services supplied by GEN. It will define the basic requirements applicable to customer contracts and will be a commitment to our customer. It will serve as a directive for all functions in establishing necessary policies and procedures that will comply with the requirements of ISO 9001:2000 [1] and in addition, as applicable for safety-related activities, national and international nuclear laws, guidelines and standards. Safety-related items, services and activities are those that may impact those nuclear power plant structures, system and components that are relied upon to remain functional during and following design basis events. Moreover, they have to assure the integrity of the reactor coolant pressure boundary, the capability to shutdown the reactor and maintain it in a safe shutdown condition or the capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to the applicable guideline exposures set by the governing regulatory agency, if applicable. In addition, safety-related items, services and activities may be those defined by a governing regulatory agency or contract. If there is any relevance concerning the differences on the philosophy or otherwise between the national and international requirements, rules and regulations, the following order of application is prescribed: a) SNSA (ZVISJV [2], draft JV5 [3]), b) IAEA GS-R-3 [4] c) WENRA Issue C: Quality Management [5] d) 10 CFR 50 App. B [6] e) ASME NQA-1 [7], and f) NRC NUREG 0800 [8]. ASME standard will be considered as the main code for the project s mechanical systems and components design and manufacturing. Others will be also considered as an acceptable alternative based on proven presentation to meet the same level of safety and quality. Otherwise, first focus will be on a process based management system for the construction phase trying to achieve an effectively implemented management system based on Slovenian, IAEA, ISO 9001 and WENRA guidelines. Second, in addition to that it will be carefully considered, which features of the U.S. regulation will be adopted. Features of the U.S. regulation will be adopted only up to the level necessarily needed. The development of the management system for the operation phase will be commenced at a later stage. 2 QUALITY MANAGEMENT SYSTEM IMPLEMENTATION The Finish company QualiFinn was chosen to develop the quality management system for the purpose of JEK 2 project. The consultants of Qualifinn have already gained experience in the construction phase of Olkiluoto 3 project by developing and implementing the project quality management system. Qualifinn also works for the oil and gas production industry constructing those facilities. Their experiences in new nuclear power plant project were one of the main reasons for their selection. Figure 1 shows QMS development schedule. The first phase is the clarification and input development phase. The second is the actual development phase followed by the GEN

3 review and comment period. After that the management system will be finalized as far as it is practically possible. Cooperation between the supplier and the investor is very important and thus very strong. In the initial phase all requirements were clarified, processes were identified together and also the meeting with SNSA was organized where QMS project was presented. One of the assumptions at the beginning of the QMS project was that the contract will be a turnkey contract. It means that there will be only one contract between GEN and supplier, while supplier will have subcontractors for all work and disciplines including the very first site preparation activities with needed excavations, refilling, basement work, etc. Direct subcontracts by GEN include only studies, investigation, design and engineering work in the pre-preparation phase, like geotechnical investigations, design and other related activities. Figure 1: JEK2 Project QMS Development Flow Chart. The management system documentation forms the following structure as presented below. This is the structure in case that the documents are in a traditional paper format and in server directory to be used by everybody. Later, the documentation will be formatted in a different way using links when some software application will be used. The management system documentation structure is as follows: 1. Quality policy 2. Quality manual + related attachments 2.1. Organization Organization chart Job descriptions

4 Documented QMS procedures Procedure for control of documents Procedure for control of records Procedure for internal audit Procedure for controlling nonconforming product Procedure for corrective action Procedure for preventive action 3. Process map 4. Process descriptions (listed below) + procedures + instructions 4.1. Project management and control processes Project management process Safety and quality culture measurement process Overall project planning and control process Human resources planning and management process Quality management process Risk identification and mitigation process 4.2. Project execution and control processes (project realization) Technical task contracting process Internal tasks allocation, execution and follow-up process Purchasing process Bid document preparation process Bid clarification process Design control process Equipment manufacturing control process Civil works control process Installation control process Commissioning control process 4.3. Supporting processes Quality planning process Licensing and permitting process National legislation follow-up process Public relations and interested parties supporting process Documentation control process Nuclear safety, quality, environment policies etc. can be included into one single document or in separate documents. Such document is called quality policy and expresses

5 overall intentions and direction of an organization related to quality as formally expressed by top management. At the first stage of our QMS the nuclear and quality policies will be combined into one document. At later stages environmental, occupational health and safety, security polices etc. will be written and compiled in a suitable manner. The safety and quality policy, together with GEN energija s environmental, occupational health and safety and security policies, includes the principles by which the management of GEN energija directs and controls the organization and improves its performance so that the requirements of the construction contract for the new Krško 2 nuclear power plant unit will be met as well as the expectations of the operation organization and the society. Section of ISO 9001: 2000 requires developing of a quality manual [1]. According to Praxiom Research Group Limited [9], the quality manual should: describe how quality system processes interact, define the scope of quality management system, explain any reductions in the scope of the system, justify all exclusions (reductions in scope) and document procedures or refer to them. It should be emphasized that quality manual is not a quality system. A quality manual is just a document, while the quality system is a network of real processes. The quality manual is supposed to document the quality system; it is not supposed to be the system. A process map shown in Fig. 2 is a single page, upper level presentation on the processes hierarchy. It is similar to the process map of any QMS with customer requirements on the left side and satisfactions on the right side. Satisfaction of customer needs can be implemented by different processes as stream of activities that transforms a well defined input or set of inputs into a pre-defined set of outputs. Red colored processes are recognized as key processes in Krsko 2 project execution. A process is a set of interrelated or interacting activities which transform inputs into outputs [10]. In the early phase of QMS project 21 processes were identified by both QualiFinn and GEN energija. They are divided in three main groups: Management and control processes, Project execution and control processes, and Supporting processes. Each process consists of three typical documents: - Process flow chart where all activities and interrelations between them are seen, - Process data sheet (PDS) where purpose, owner, customer, inputs/outputs, resources, objectives and keys to success, indicators, improvement methods and - Process activity description (PAD) where responsibilities, essential and critical factors, methods, guidelines, models, generated and traceable data and records are identified for each activity within the process. Many of the above mentioned processes are already implemented in the draft version at the moment. If some compulsory processes or procedures are not listed here as per the requirements, they will be included into the quality manual or into the processes as separate sub-processes and procedures.

6 Figure 2: Process map with currently identified processes. The permanent improvement of QMS is one of the most important activities which actually increase the probability of enhancing the satisfaction of customers and other related parties. It will be also case in our QMS and here are some possible actions for improvement [10]: a) Analyzing and evaluating the existing situation to identify areas for improvement, b) Establishing the objectives for improvement, c) Searching for possible solutions to achieve the objectives, d) Evaluating these solutions and making a selection, e) Implementing the selected solution, f) Measuring, verifying, analyzing, and evaluating results of the implementation to determine that the objectives have been met, g) Formalizing changes. 3 CONCLUSION To lead and operate a project successfully, it is necessary to direct and control it in a systematic and transparent manner. Basic structure of JEK2 QMS will rely on ISO 9001: 2000 structure, i.e. it will use a process approach which is mandatory by ISO, but since we are

7 dealing with nuclear facility, it will be supplemented with QA requirements for safety-related activities. The management system documentation includes Quality policy as the top level document, quality manual with organization description and documented QMS procedures, the overall process map and process description. QualiFinn and GEN have identified 21 processes so far and they are divided in three main groups: management and control processes, Project execution and control processes, and Supporting processes. It will be important that GEN will start to use QMS in practice as soon as possible in order to get familiar and to recognize the weakest points which should be either supplemented with additional procedures or revised in the way which is more convenient for the system. The management of GEN energija is committed to create such an internal environment that fully encourages the personnel to involve themselves and to use their abilities for the project s benefit. The activities and the related resources of the project organization will be managed as processes. By understanding and managing the system, which is compiled of interrelated processes, the management will strive for systematic improvement of the effectiveness and efficiency of the organization in achieving the project targets. Decision making at all levels of the organization will be based on the analysis of data and information. The overall NPP Krsko 2 Quality Management System will include all the planned and systematic actions taken by GEN, its contractors, and consultants which provide adequate confidence that the safety related and major structures, systems, and components perform as required in operation. REFERENCES [1] ISO 9001:2000 Quality Management System Requirements. [2] Zakon o varstvu pred ionizirajočim sevanjem (ZVISJV). [3] JV5, Vodenje varnosti in kakovosti, draft. [4] IAEA Safety Series No. GS-R-3. [5] WENRA Issue C: Quality Management. [6] 10 CFR 50, Appendix B [7] ASME NQA [8] NUREG 0800 Standard review Plan [9] Praxiom Research Group Limited. [10] ISO 9000: 2005 Quality management systems Fundamentals and vocabulary.