Statement of Work. Quality Management System (including data management and record keeping) development and implementation in Moldova

Transcription

1 Statement of Work Quality Management System (including data management and record keeping) development in Moldova 1. Scope: The Statement of Work (SoW) describes the requirements for development and implementation of quality management system for the National Radioactive Waste Management Company of Moldova. The aim of the SoW is to support the development of a Quality Management System, (QMS) including data management and record keeping concerning radioactive waste management, to ensure the safe operation and decommissioning of Special Facilities 5101 and 5102 radioactive waste management facilities located in Moldova. The SoW assumes that the quality management shall cover all the activities that are or will be carried out by the National Radioactive Waste Management Company concerning operational issues of Special Facilities 5101 and 5102 and it takes in consideration the Moldavian National Strategy on Radioactive Waste Management. The SoW includes the data management and record keeping aspects concerning merely radioactive waste management and is limited to the specification of Quality Management System, which may be in a later stage part of an Integrated Management System. The SoW contains the requirements for the documentation and mechanism of the QMS, the deliverables of the Service Procurement Contract, the implementation schedule as well as project management requirements for implementation. 2. Background: The IAEA provides technical cooperation support to Moldova in frame of project titled Building Operational and Institutional Capacity in Decommissioning, Remediation and Radioactive Waste Management Processes (TCP MOL9008). The object of the project is Moldova s only radioactive waste disposal facility, named Special Facilities 5101 and 5102 (hereinafter referred to as Special Facilities ). The Special Facilities started its operation in 1961, the last waste shipment was made in The facility has a Chisinau street address and has a village nearby. Radioactive waste inventory at the Special Facilities in Moldova includes Disused Sealed Radioactive Sources (DSRS) safely stored in an above ground storage facility, legacy DSRS and solid waste (Radium contaminated soils and solid waste of unknown origin) disposed of in an old Radontype facility and contaminated soil from a construction site, which is placed in a temporary building. The legacy radioactive waste inadequately stored in a RADON type facility is of concern with a view to long term behaviour. Radiological investigations show increased Sr-90 and Ra-226 contamination of soil near the facility. A feasibility study for the retrieval of radioactive waste from the storage facility has been completed in 2015 aiming to prevent further contamination of soil and ground water and to store/dispose of the waste retrieved. The next step is implementation of the feasibility study, although there is a lack of expertise in the country on decommissioning, management of radioactive waste retrieved and remediation of the site. Thus, the retrieval of legacy waste from Page 1 of 9

2 the near surface concrete trenches of the old repository followed by characterisation and conditioning of this waste, decommissioning of the trenches, cleaning of local contamination is a challenging task which shall be well prepared, considering burdens arising from retrieval and processing operations. To achieve a safer status of radioactive waste in the Republic of Moldova, this Project is intended to achieve three main objectives: 1) developing radioactive waste processing/ management structure; 2) strengthen institutional capacity to effectively condition radioactive waste; and 3) confirming legacy waste retrieval as the preferred option. According to the objectives mentioned above and in line with the working plan of the Project, a mandatory step is development, implementation and certification of a Quality Management System including data management and record keeping. 3. Assumptions and applicable documents The scope of SoW is based on the following assumptions: a) The National Radioactive Waste Management Company will nominate a designated Representative for Quality Management for coordination of QMS at organizational level. b) The Operator will contribute free of charge by providing its premises and other facilities for the organization of training required to be performed by the Contractor. c) There would not be significant changes in the requirements of ISO 9001 and ISO standards. d) The relevant IAEA standards and guides would not be superseded. e) The Moldovan National Strategy on the Radioactive Waste Management would not be changed. f) The Moldovan decision maker s commitment to implement the QMS will remain. g) The requirements of Moldovan legislation system concerning radioactive waste management and radiation safety would not be changed significantly. h) There would be appropriate accredited certification body available in Moldova, with the experience in radiation safety, management of radioactive waste or management of hazardous materials. i) The operator will have enough trained and competent human resources to successfully implement and continuously improve QMS. j) The operator will have appropriate IT system to comply with record keeping requirements for radioactive waste management. The SoW is based on documents listed below: a) ISO 9001:2015 Quality management systems. Requirements. international standard. b) ISO 19443:2018 Quality management systems - Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS) c) Leadership and Management for Safety IAEA General Safety Requirements No. GSR Part 2, IAEA, Vienna, Page 2 of 9

3 d) The Management System for the Processing, Handling and Storage of Radioactive Waste, Safety Guide No. GS-G-3.3, IAEA, Vienna, e) Predisposal Management of Radioactive Waste, IAEA General Safety Requirements Part 5, No. GSR Part 5, IAEA, Vienna, 2009 f) Methods for Maintaining a Record of Waste Packages during Waste Processing and Storage IAEA Technical Reports Series No.434, IAEA, Vienna, 2005 g) Handling and processing of Radioactive Waste from Nuclear Applications IAEA Technical Reports Series No. 402, IAEA, Vienna, 2001 h) Retrieval and Conditioning of Solid Radioactive Waste from Old Facilities, IAEA Technical Reports Series No. 456, IAEA, Vienna, 2007 i) Terminology used in nuclear safety and radiation protection, IAEA Safety Glossary, 2007 Edition, IAEA, Vienna, 2007 j) Moldovan Law no. 132 from 8 June 2012 on Safe deployment of nuclear and radiological activities : k) Moldovan Government Decision No. 727 of about Regulation on Authorization of nuclear and radiological activities l) Moldovan Government Decision No. 388 of about Regulation on Radioactive waste management. The regulation contains many requirements shall be considered by QMS. m) Moldovan Government Decision No from about Regulation on National Register of the account of ionizing radiations sources and of legal authorized persons or entities. n) Moldovan National Strategy on Radioactive Waste Management o) Development of Feasibility Study including Remediation Plan for the retrieval of legacy radioactive waste from near surface Disposal Facility RADON type, located in Chisinau, Republic of Moldova (IAEA, July 2015, based on contract with TS Enercon Kft. according to Request for Quotation No LB,) p) End-of-Mission Report: IAEA Technical Cooperation Expert Mission to collect information and elaborate the Statement of Work (SOW) for development of a detailed decommissioning and remediation plan for Near Surface storage facility "RADON" (EVT , Project Number: MOL9008, Project Title: Building Operational and Institutional Capacity in Decommissioning, Remediation and Radioactive Waste Management Processes, July 2018) q) End-of-Mission Report: IAEA Technical Cooperation Expert Mission to collect information on quality management system (EVT , Project Number: MOL9008, Project Title: Building Operational and Institutional Capacity in Decommissioning, Remediation and Radioactive Waste Management Processes, Sep 2018). 4. Tasks 4.1. General task description In accordance with the best international practices of ISO auditors and quality manager trainers, the implementation of the QMS could include the following steps in general: a) Commitment of Management and training the Operator s staff b) Planning the QMS Implementation Page 3 of 9

4 c) Development of documentation according to implementation plan d) Deployment of QMS e) Internal Audits and Management reviews f) Selection the certification body and certification According to the scope of SoW, the Contractor shall focus to the QMS document development, while the Operator ensures the training of its staff, the execution of internal audits and management reviews, and finally the organization of its certification. In this context, the Contractor s tasks and responsibility are the followings: Phase I: Planning the QMS Implementation; Phase II: Development of documentation according to implementation plan; Phase III: Providing technical support during the certification process Specific task description Work breakdown by each phase is described below Phase I: Planning the QMS Implementation Identification of the needs and requirements All processes that may affect the quality of the final product in some way shall be identified, and shall include the quality management process itself, as well as resource management, training, awareness, procurement, design and development, production, product service, product management, customer relationship management, internal auditing, and management review. The Contractor task is to determine, evaluate and to document: a) the context of the organization; b) the scope, objectives and policies of the organization; c) the processes in the organization; d) the sequence of the processes; e) the interfaces, risks and activities within the process; f) people or remits who take process ownership and accountability; g) the monitoring and measurement requirements; h) the need for documented information; i) the resources needed Performing gap analyses It is needed to compare the existing quality relevant procedures with the requirements of the ISO 9001 standard. Contractor shall conduct a gap analysis to determine what existing company processes and procedures already meet, need to be modified to meet or need to be created to meet ISO 9001 requirements. The gaps shall be documented. In the gap analyses it is necessary to make a list of all documented information, including procedures, work instructions, forms, lists and type of records, including their current status (missing, incomplete, lacking specific detail, be out of date, or not to integrate within the scope of the QMS the latter shall be listed in the exclusions documented in the Quality Manual). Page 4 of 9

5 Developing the QMS Implementation plan A detailed implementation plan shall be developed that identifies and describes task required to make the QMS fully compliant with the ISO 9001 / ISO standards and relevant IAEA requirements. The Contractor shall develop the detailed implementation plan considering the inputs from the Operator. This implementation plan shall be thorough and specific, detailing: a) List of requirements: The relevant ISO 9001 / ISO standard sections, IAEA requirements, and national legal prescriptions b) Quality documentation (maintained documented information in ISO terminology) to be developed c) Consideration for other items generally included in the implementation plan: d) Person or team responsible: the contractor responsible for the development of documentation, however the position of person responsible to review it in the future shall be addressed. e) Approvals required: The detailed implementation plan shall be reviewed and approved by Quality Management Representative and the Operator s top management. The review and approval of quality management documents are contained in section on deliverables. f) The initial training to implement the QMS shall be provided by the Contractor and followup trainings required to implement the QMS will be ensured by Operator. g) Resources required to implement the QMS will be ensured by Operator, except for the initial trainings. h) The PDA cycle planning phase shall apply by the following: i) Planning starts with understanding the context of the organization and the needs of parties interested in the QMS (ISO 9001: 4.1 & 4.2), which is then used to define the scope of the QMS and the QMS processes (ISO 9001: 4.3 & 4.4). This is followed by defining the organizational roles and responsibilities and by establishing a quality policy to give the overall QMS a focus (ISO 9001: 5.1, 5.2 & 5.3). The next level of planning is to identify and address risks and opportunities of the QMS, including setting and planning for quality objectives and changes to support continual improvement (ISO 9001: 6.1, 6.2 & 6.3). The final level of planning is to identify and implement the support structure to allow you to carry out your plans. This includes resources (ISO 9001: 7.1), identifying competence (ISO 9001: 7.2), awareness (ISO 9001: 7.3), communication (ISO 9001: 7.4) and to set the processes for creation and control of documented information (ISO 9001: 7.5) Phase II: Development of documentation according to implementation plan The contractor shall develop all documentation necessary according to implementation plan. In the development the Contractor could rely on the support of the Operator s implementation team and the Quality Management Representative. There is documented information to be maintained such as scope, and objectives of QMS, quality policy, information on control of processes, information necessary to enable traceability, internal audit programme, etc. 1. The Quality Manual shall include: a) A statement explaining the scope of the QMS, including exclusions and their justification b) A description of the Quality System processes and their interactions c) An overview of the system level procedures Page 5 of 9

6 2. The quality policy shall address the QMS principles and the key objectives of the QMS. 3. For system level procedures shall consider: a) design and control of processes b) document control, c) nonconformity, corrective action and preventive action d) quality assurance programs 4. Information necessary to enable traceability shall include control of records (retained documented information) As far as necessary for the completeness of the QMS implementation, detailed quality management work instructions, lists and forms shall be prepared. A Documentation Control System must be created to manage the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. The document control systems shall be as simple and as easy to operate as possible but enough to meet ISO 9001 requirements. It shall include: a) A unique identification of the document; b) Tracking number according to the revision control; c) A change history summarizing changes made to a document; d) Signatures of the person preparing and the person approving the document. A verification signature is also usually required to confirm that the contents of the document are accurate; e) The date of the version or revision. Formal requirements for documented information: a) The primary audience for the each of the documents shall be considered to use language and vocabulary that is appropriate for the users; b) Templates shall be developed for all the controlled document types intended to use. Templates shall have consistent styles and formats so that documents are easy to read and navigate. Each template must meet controlled document requirements; c) Procedures and Work Instructions shall have Purpose, Scope and Responsibilities sections. A company logo can also be included with the document headers; d) Clearly define and document authorities Phase III: Providing technical support during the certification process The contractor shall provide any support to the beneficiary (Radioactive Waste Management Co.) to obtain the Quality Management System certification. Also, the contractor shall provide training required to ensure quality awareness training for the Operator s staff for the successful implementation of QMS. Before the deployment of QMS documents, the Contractor ensures the training on preparation of procedures, work instructions and forms for the middle management and line management of the Operator, as well as provide training for the internal auditor(s) 5. Requirements This section describes the approach and methodology of implementation of QMS, the suggested minimal phases and tasks to be done, and the specifications and performance requirements to be applied. Page 6 of 9

7 5.1. Methodology The QMS to be implemented shall be based on the ISO 9001:2015 international standard. Although the Special Facilities are not nuclear installations but nuclear facilities [9], the notes and supplementary requirements of ISO 19443:2018 international standard shall be considered and according to the principle of graded approach adopted. During the implementation of QMS the requirements of relevant national legal documents and certification processes shall be taken into account. The QMS to be developed shall reflect the QMS principles (customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, relationship management) as defined by ISO The implementation shall be directed by process approach together with the concepts of riskbased thinking and PDCA cycle. Risk-based thinking shall be used throughout the process approach to: a) Decide how risk (positive or negative) is addressed in establishing the processes to improve process outputs and prevent undesirable results; b) Define the extent of process planning and controls needed based on risk; c) Develop a system that inherently addresses risk and meets objectives Waste management specific requirements Due to the specific professional area of the National Radioactive Waste Management Company, the QMS shall comply with the most relevant requirements laid down in IAEA GSR Part 2, IAEA GSR Part 5 standards and IAEA GS-G-3.3 guide. The relevant IAEA requirements and guidance detailed shall be considered by graded approach. In the planning phase of processes, where necessary specific quality assurance and quality control programs shall be developed for the key processes and shall be integrated for the procedures and work instructions. According to the recommendations of studies [15, 16, 17] made in the framework of IAEA Technical Cooperation Program and due to the requirements of relevant Moldovan statutory documents [10, 11, 12], specific quality assurance and quality control programs shall be implemented for the following processes: a) operating the integrated record keeping system of waste packages b) transportation of waste c) storage of RW d) treatment of RW e) security (its development it is out of scope of SOW) For these processes the findings of IAEA TRS No. 402, 434 and 456 reports shall be considered. The requirements of IAEA documents mentioned above are associated to the relevant ISO requirements in Annex I Legal requirements affecting the QMS Page 7 of 9

8 Concerning the quality management system, it is a crucial point to define how the licensee of Special Facilities can meet the requirements of the regulatory body. During the quality planning stage, the legal requirements shall be taken into account in such manner that the procedures shall be developed to meet the operational criteria derived from the legislative requirements, and quality control shall be placed into the operational procedures and work instructions. The action plan for the Implementation of the provisions of the National Strategy on the Radioactive Waste Management contains in Section 1. on Implement the RWA management standards and procedures used internationally the action No. 1.5, which is Develop or change the related legislation (target period is January December 2026, responsible organizations: LM, NARNRA, Ministry of Health). It means that the QMS implementation team may face the changing legislative system during implementation. Concerning the waste management activities planned at Special Facilities, the relevant regulations having affect to the QMS and the Operator s actual documented information reflecting the legal requirements are outlined in the Annex II Requirements for Contractors To ensure the successful implementation of the QMS which complies with the requirements mentioned above, the Contractor itself shall have expertise in: a) implementation or external audit of quality management system, or b) design or operation of radioactive waste related management systems Contractor and the subcontractors or consultants involved together shall have the expertise in: a) project management; b) implementation or external audit of quality management system, and c) design or operation of radioactive waste related management systems. The Contractor shall have the capability to read and write all the documented information necessary for executing the project in the official national language of the Operator. The Contractor shall have the capability to conduct the project meetings in English or in the official national language of the Operator. The Contractor may involve subcontractors or consultants as certified QMS auditors, radiation safety experts, proficient radioactive waste management experts, translators, etc. 6. Deliverables This section states the timeline (table 1), the milestones and deliverables. Regarding the outcomes of implementation of QMS documented deliverables expected from the Contractor according to the implementation phases: a) QMS implementation plan at the end of phase I. b) Documented information on QMS at the end of phase II Required documented information: a) Quality manual, b) QMS procedures, c) Quality policy d) Quality management system procedures e) Quality assurance programs Page 8 of 9

9 f) Quality management related work instructions, list, forms necessary for the implementation of QMS Table 1 Proposed schedule of implementation of QMS Phase Steps Timeline in months* Phase I. Planning the QMS Implementation Phase II. Development of documentation Phase III. Providing technical support during the certification process *T o contract start date Development of the detailed implementation plan Submit detailed implementation plan for approval Development of documentation Submit draft QMS documentation for reconciliation Submit final QMS documentation for certification Assuring the technical support to the beneficiary during the certification process T o+1 T o+1.5 T o+ 5 T o+ 5 T o+6 T o+9 Proposed payment schedule 30% 50% 20% The deliverables shall be provided in both English and the official national language of the beneficiary. 7. Termination of contract The documents shall be submitted both to the end-user Special Facilities and IAEA for approval. The approval shall be in written, or in the case of comments, additional requirements provided, they must be concluded and implemented within 15 working days. After the final approval, the documents will be submitted to the certification authority and to regulatory body for certification/approval/licensing. During all these processes, the Contractor shall assure technical support for the beneficiary, until the regulatory body license is granted and the QMS is certified. The final documents shall be delivered in electronic format (3 copies in CD-ROM) and hard format (3 copies in print), both in English and Romanian languages. 8. Annexes Annex I to Statement of Work ISO and IAEA requirements on QMS Annex II to Statement of Work Situation overview Page 9 of 9