DAY_1 L4 Concepts for implementing a quality management system RevPV.pdf
- 1. IAEA International Atomic Energy Agency L4 Concepts for implementing a quality management system
- 2. IAEA Objectives •This lecture will present a step by step introduction into the task of implementing a quality management system. 2
- 3. IAEA WHY ? ➢ to demonstrate ability to deliver a product that consistently meets customer and applicable regulatory requirements and ➢ to address customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of non-conformity. 3
- 4. IAEA Customer •The concept of „CUSTOMER“ is mainly applied to EXTERNAL customers: they position orders and bring in money. •Never forget the INTERNAL customers in your organization. They keep the workflow going and support the quality of your product. 4
- 5. IAEA Understanding the Process Approach 5
- 6. IAEA The advantage of the process approach 6
- 7. IAEA A process PROCESS (with interactions) RESOURCES Input Output KPI’s 7
- 8. IAEA Implementation basics ➢ identify the processes needed for the QMS; ➢ determine interaction of these processes; ➢ determine evaluation criteria for these processes; ➢ ensure the availability of information for these processes and ➢ measure, monitor and analyze the processes, and implement action necessary to achieve planned results and continual improvement. 8
- 9. IAEA Implementation process 1. Decision taking 2. Management commitment 3. Implementation team 4. Plan the implementation 5. Identify existing processes 6. Define document structure 7. Write procedures 8. Initial Training of personnel 9. Implementation 10. Internal Audit 11. Management Review 12. Improve system 9
- 10. IAEA Flowchart Quality Management System needed Management commits to QMS Collect Input Customer needs, Regulations, Laws & Standards Day-to-day workplace experience Implementation Team for QMS installed Design Quality Plan Timetable Responsibilities Objectives Process Identification Managerial Processes Workforce Product Realization Resource Management Measurement and Improvement Designing the Quality Management System Quality Manual (Handbook) Managerial Procedures Administrative Procedures Technical Procedures Document Control Develop System for Documentation Prepare Drafts Training & Evaluation Implement Quality Management System Feedback to Management Measurement, Analysis and Improvement PLAN DO CHECK ACT Improve installed system 10
- 11. IAEA Gap analysis There are various types of analysis that will be needed to help you define the scale, scope and potential impact of the transition to the 17025 requirements. GAP analysis is particularly helpful here: 1. What is point B: Where are you trying to take the organisation; what does the new system look like? 2. What is the point A: Where are you now by comparison with point B? 3. What are the changes needed to close this gap? CHANGES NEEDED TO CLOSE THE GAP 3 2 1 B A 11
- 12. IAEA Make a link between the standards of your choice e.g. ISO 9001, GSR part 2, ISO/IEC 17025 and your own documents Documentary check or an integrated MS (IMS) ISO 9001 ISO 17025 IAEA GSR part 2 Document# in Quality System To Do § 4.2 § 5.5.1 § 5.2.5 Ref. Doc # PO.606 Add § on PPC and on occupational limits 12
- 13. IAEA Management commitment Top management shall: ➢ Take decision to implement a quality management system. ➢ Take the lead and manage the implementation as a TOP DOWN process. ➢ Show interest in completing the process in time and within the planned budget. 13
- 14. IAEA Decision Two different type of factors may govern the decision to implement a quality management system. External factors: ➢ demand by customers ➢ requirement by State or Regulatory authorities or Internal factors: ➢ cost-effectiveness analysis ➢ need to restructure the organization due to mayor changes in work focus or workforce 14
- 15. IAEA Implementation team Team members need good knowledge and experience or need to receive training in: ➢ Structure and workload of the organization; ➢ Applicable standards, laws and regulations; ➢ Internal processes of the organization; ➢ Communication methods within the company; ➢ Team organization and teamwork. 15
- 16. IAEA Implementation planning ➢ Evaluate the workload ➢ Devise quality plan ➢ Identify existing processes ➢ Group processes, according to the action they are describing: – (Strategic) management processes; – Product realization (core) processes; – Supporting processes; – Management system processes. 16
- 17. IAEA Management processes examples ➢ Strategic management (quality policy) ➢ Finance management ➢ Risk & Opportunities Management ➢ Management of Change ➢ Knowledge Management ➢ Nuclear Safety ➢ Occupational Health & Safety ➢ Quality Management review 17
- 18. IAEA Product realization processes examples ➢ Individual monitoring ➢ e.g. TLD-dosimetry, OSL-dosimetry, Fingerdosimetry ➢ Calibration/Irradiation ➢ Workplace monitoring ➢ Container verification ➢ Contamination control ➢ Nuclear transport 18
- 19. IAEA Supporting processes examples ➢ Customer relation ➢ Marketing ➢ Legal support ➢ Procurement ➢ IT support ➢ Human Resources – Training, Competence Management ➢ Technical infrastructure ➢ Transport ➢ House keeping ➢ Maintenance ➢ Waste Management 19
- 20. IAEA Quality system processes ➢ Control of documents and records ➢ Customer complaint management ➢ Corrective and preventive actions ➢ Internal audits ➢ Control of nonconformities 20
- 21. IAEA A quality system has a pyramidal structure Why? (including Quality policy) What (when, where, who)? How to do it? How was it done? The proof 21
- 23. IAEA Management system procedures may further be supplemented with detailed work instructions, forms, reports etc. termed as Level C documents. The quantity of documented procedures, work instructions, forms, reports etc. and the nature of their format and presentation are to be determined by the individual functional units. It is preferred that each of these set of documents are arranged in the same structure and format so that the users become familiar with the consistent approach applied to each requirement. 23
- 24. IAEA Procedure template providing a procedure template early during the implementation process helps to capture all relevant information for the operated processes. 24
- 25. IAEA Procedures Of great importance: ➢ For later acceptance of quality management system by all members of the staff ➢ As many staff members as possible should be included in the authoring process using the approved document template. ➢ Due to better training in the contents of standards and regulations, the members of the implementation team, should provide assistance in editing the procedures. 25
- 26. IAEA Procedures All drafted procedures will have to be reviewed by the implementation team: ➢ consistency with other procedures ➢ compliance with the management directives and ➢ compliance with the applicable standards to ensure conformity and integrity of the quality documentation. 26
- 27. IAEA Training ➢ on applying the documented procedures ➢ on applying quality management principles Training period may show need to correct the documentation. 27
- 28. IAEA Implementation • After the training period: ➢ quality management system may be piloted for an initial testing period, typically three to six months 28
- 29. IAEA Internal audit The first assessment of the newly implemented quality management system will certainly be carried through by an or with the help of an external auditor. This may be the same person that acts as ex/in-ternal advisor during the creation phase. 29
- 30. IAEA Management review Assess the status of the quality management system from : ➢ implementation process ➢ staff quality training sessions and ➢ internal audit Identify still necessary improvements. 30
- 31. IAEA Top-down: Top Management decides that a system is needed. TOP-DOWN support is absolutely necessary 31
- 32. IAEA Bottom-up approach is needed to start 32
- 33. IAEA Pitfalls 33