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M. E. CONSTRUCTION ENGINEERING & MANAGEMENT YEAR – I (SEMESTER – I) SNPIT&RC, UMRAKH GUJARAT TECHNOLOGICAL UNIVERSITY Prepared By : - Patel Dhruv (140490714019) Guided by: Asst. Prof. Hiren Rathod Civil Engineering Department, S.N.Patel Institute of Technology & R.C, Umrakh 1

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  • M. E. CONSTRUCTION ENGINEERING & MANAGEMENTYEAR I (SEMESTER I)SNPIT&RC, UMRAKHGUJARAT TECHNOLOGICAL UNIVERSITYPrepared By : -Patel Dhruv (140490714019)

    Guided by:Asst. Prof. Hiren Rathod Civil Engineering Department,S.N.Patel Institute of Technology & R.C,Umrakh1

  • Quality Assurance and Quality Control Unit ObjectivesThe objectives of this unit is to outline the principles of quality assurance and quality control as they relate to the internal dose assessment programme, and to stress the importance of effective quality assurance to internal dosimetry.By completion of this unit, we should understand the basic concepts of quality assurance, and how to apply them in the workplace.*2

  • Quality Assurance and Quality Control Unit OutlineQuality AssuranceQuality ControlQuality methods*

  • Quality Assurance*Quality Assurance - planned and systematic actions necessary to provide adequate confidence that a dosimetry product or service will satisfy given requirements for quality. Examples of QA:type testing, performance testing, and quality audits required by a regulatory body.blind testing and quality audits of the dosimetry service provider performed by the user of the service.

  • Technical specifications may not in themselves guarantee that a customer's requirements will be consistently met, if there happen to be any deficiencies in the specifications or in the organizational system to design and produce the service.

    Why Quality Assurance?*

  • What is Quality?A high standard or level.Degree of excellence.Distinguishing feature.Faculty, skill, accomplishment.Satisfaction of a customers needs or requirements.

    Quality is totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.*

  • Quality assurance requirements*Registrants and licensees should be responsible for establishing the quality assurance programme required by the principal requirements of the applicable standards. The quality assurance programme should be designed in relation to the magnitude and the likelihood of potential workplace exposures.

  • QA programme should be consistent with;Number of workers monitoredMagnitude and likelihood of exposuresNumber of individuals monitoredType of monitoring providedDirect measurementsIndirect measurementsChoice of monitoring periods*

  • A complete QA program needs:Compliance with operational requirements stated in accepted written criteria,Clear and complete documentation of the in-house QA program,Periodic performance evaluations,Documented procedures and Q.A. program for services provided to customers, Adequate training program for the staff.*

  • A Quality Assurance programme should provide for:*Planned and systematic actions to provide adequate confidence that requirements for monitoring occupational exposure are satisfied, including provisions for feedback of operational experience;

  • A Quality Assurance programme should provide for:A framework for the structuring and analysis of tasks, development of methods, establishment of norms and identification of necessary skills for the execution of the monitoring program and Validation of designs, manufacturing and supply of equipment and materials, as well as operating, maintenance, inspection and testing procedures.

    *

  • Quality Control - The operational techniques and activities that are used to fulfil requirements for quality.

    Examples of QC:routine (i.e. daily) use of irradiated control dosimeters,various statistical analyses used to verify continued system performance.*Quality Control

  • Quality Control demands,Procedures and protocols for proper management of the dosimetry program.Dosimetry system calibration.Routine verification of proper instrument performance.Detailed documentation of all measurement, evaluation and reporting procedures.Data recording and archiving.

    *

  • Quality Control proceduresShould be carried out at appropriate intervalsShould cover the following:Documentation of the required performance criteriaIdentification of the person responsible for operation and maintenance of equipmentUse of traceable radionuclide reference standardsPerformance checks of measurement systems*

  • Quality Control proceduresQuality Control procedures should also cover:Instrument calibration,Participation in interlaboratory-comparison programs,Computational checks,Periodic review of procedures, specifications and operating records,Observation of operations and evaluation of quality control data,*

  • Quality Control proceduresFinally, Q.C. procedures should cover:Evaluation of compliance with the performance criteria of appropriate standardsEvaluation of quality control data to ensure the longterm consistency of analytical resultsVerification of determinations of minimum detectable activities*

  • Documentation of methods, procedures and test results*Methods used and procedures set up to control the various processes within the service, should be well documented.This is important for inspection of the service by official authorities as part of an approval system.

  • Documentation of methods, procedures and test results*Quality Handbook covers all aspects of the quality system in a concise and practical way.uses other documents as references as needed.

    Appropriate parts of the documentation should be made available to staff members It may even be useful to display operational instructions "on the spot".

  • Dosimetry staff needs to be properly trained*Basic philosophy and strategy of individual monitoring.Principles and methods used.Detailed procedures.Technicalities and potential problems of the processes.

  • Training is a basic QA requirement*Training is essential for direct and indirect measurement staffPersonnel responsible for:operationcalibrationinterpretation of data, andequipment maintenance

  • Staff training should include:Basic philosophy and strategy of internal dose assessmentPrinciples and details of the methods usedTechnical details and potential problems of the processes in which they are involvedRecognition and reporting of problems that arise*

  • Staff training should include:Relationship of their work with other parts of the processTrouble shootingKnowledge of the overall quality system and its objectivesTheir particular responsibility within the quality system*

  • Various sources of training are available*Training can be provided throughOn-the-job trainingFormal classroom sessionsTechnologist certification programsParticipation in intercomparison programmesInternational fellowship programmes

  • QUALITY TECHNIQUESJoint problem solvingBrainstormingMethods of analysisPlanning for just-in-time (JIT) managementAims of JITThe operation of JIT

  • Joint Problem SolvingThe key to success in introducing total quality within an organisation, involving task groups and quality circles in seeking ways of continuous improvement to quality, is based on a systematic approach to joint problem solving. While details often vary, the principles are based on:

  • Joint problem solvingDepersonalizing conflicts by diluting emotions and do systematic approach providing a logical framework which encourages the facts come to the surface so that the facts rather than the individuals determine the solution integrating the objectives of the organization and the people working in it.

  • BRAINSTORMINGBrainstorming is a way of getting as many ideas as possible on a problem or a solution in the shortest possible time. Brainstorming works most effectively when there is a group of people responding within the following framework: dont discuss just concentrate on writing up ideas as quickly as possible without criticising anything that is said

  • METHODS OF ANALYSISOnce all the data has been collected, it needs to be analysed so that it is possible to identify the most important causes of a problem or the key features of a particular situation. There is mainly 3 types of method of anaysis: Pareto analysisPaired comparisonCause and effect diagramsMatrix

  • JUST-IN-TIME A strategy for inventory management in which raw materials and components are delivered from the vendor or supplier immediately before they are needed in the manufacturing process

  • *

    ****Quality Assurance can be defined as planned and systematic actions necessary to provide adequate confidence that a dosimetry product or service will satisfy given requirements for quality. Quality Assurance (QA) encompasses those steps necessary to provide for and confirm the accuracy of direct measurements and the validity of the dosimetric interpretation. QA is based on demonstration of proper performance.

    Examples of QA include:type testing, performance testing, and quality audits required by a regulatory body.blind testing and quality audits of the dosimetry service provider performed by the user of the service.

    *QA is mainly a matter of common sense; the development of strategy for it, as well as setting the rules for the QA programme and implementing them systematically in the service, require considerable thought and effort. How to approach the details, depends on the local situation, sometimes on national regulations and often on personal capabilities and views. **The BSS establishes the requirement for a Quality Assurance programme in paragraph IV.24.Registrants and licensees should be responsible for establishing the quality assurance programme required by the principal requirements of the applicable standards. The quality assurance programme should be designed in relation to the magnitude and the likelihood of potential workplace exposures.The need for a Q.A. programme is also identified in the companion Safety Guides on Occupational Radiation Protection, RS-G-1.1, and Assessment of Occupational Exposure Due to External Sources of Radiation, RS-G-1.3.

    *The nature and extent of the QA programme should be consistent with the number of workers monitored, and the magnitude and likelihood of exposures expected in the workplaces covered by the monitoring programme. Of particular importance is the ISO/IEC Guide 25, which is used by many regulatory bodies to accredit testing and calibration programmes.

    *The fundamental requirements for a complete QA program include:compliance with general operational requirements stated in accepted written criteria,a clear and complete documentation of the in-house QA program,periodic performance evaluations, including proficiency-measurement tests,documented procedures and quality assurance program for services provided to customers, an adequate training program for the dosimetry staff responsible measurements.

    *A QA programme should provide for planned and systematic actions to provide adequate confidence that requirements for monitoring occupational exposure are satisfied, including provisions for feedback of operational experience; *A QA programme should also provide for a framework for the structuring and analysis of tasks, development of methods, establishment of norms and identification of necessary skills for the execution of the monitoring program; and*Quality Control - operational techniques and activities aimed both at monitoring a process and at eliminating causes of unsatisfactory performance at relevant stages of the dosimetry process in order to result in economic effectiveness.Examples of QC:routine (i.e. daily) use of irradiated control dosimetersvarious statistical analyses, used to verify continued system performance.*Quality Control demands,Procedures and protocols for proper management of the dosimetry program.Dosimetry system calibration.Routine verification of proper instrument performance.Detailed documentation of all measurement, evaluation and reporting procedures.Data recording and archiving.

    *The quality control procedures should be carried out at appropriate intervals and should cover the following:

    documentation of the required performance criteria,identification of the person responsible for operation and maintenance of equipment,use of traceable radionuclide reference standards,performance checks of measurement systems,*The quality control procedures also should cover:

    instrument calibrationparticipation in interlaboratory-comparison programscomputational checksperiodic review of procedures, specifications and operating recordsobservation of operations and evaluation of quality control data*The quality control procedures should cover:

    evaluation of compliance with the performance criteria of appropriate standards,evaluation of quality control data to ensure the longterm consistency of analytical results,verification of determinations of minimum detectable activities.*Documentation of methods, procedures and test results is an integral part of a QA programme. The methods used and procedures set up to control the various processes within the service, should be well documented.This is important for inspection of the service by official authorities as part of an approval system.

    *The Quality Handbook is an important part of the documentation process. It should cover all aspects of the quality system in a concise and practical way, and uses other documents as references as needed.

    Appropriate parts of the documentation should be made available to staff members It may even be useful to display operational instructions "on the spot, particularly if there has been an event or occurrence that warrants attention or points to an issue to be addressed.

    *Dosimetry staff must be properly trained in those aspects of the dosimetry service activities that impact the successful conduct of their work. This includes, but is not limited to: Basic philosophy and strategy of individual monitoring; Principles and methods used; Detailed procedures; and the Technicalities and potential problems of the processes. It is important that they understand how the dosimetry systems work so that they can recognize when there is a problem. The equipment should not be treated as a black box.

    *Adequate staff training is a key requirement for effective quality assurance in a facility that performs direct measurements. It is essential that personnel responsible for operation, calibration, interpretation of data and equipment maintenance have a complete understanding of the aspects of the direct-measurement process that are relevant to their responsibilities. Each new staff member should be trained for the measurement systems and the specific analyses to be performed. On-the-job training and safety training should be conducted and documented on a regular basis, preferably annually. In addition, staff members should be retrained when measurement equipment or procedures are changed or when they are given new or increased responsibilities. The training needed is likely to include topics that are similar to the topics covered in this report. In addition, training might need to cover issues such as assessment of internal dose from direct-measurement results or medical aspects of data interpretation.*Such training should include:(a) Their particular responsibility within the quality system,(b) The basic philosophy and strategy of internal dose assessment, (c) The principles and details of the methods used,(d) The technical details and potential problems of the processes in which they areinvolved,(e) The relation their work has with other parts of the programme,(f) Recognition and reporting of problems that arise,(g) Knowledge of the overall quality system and its objectives.*Dosimetry staff training should include: Relationship of their work with other parts of the process; Trouble shooting; Knowledge of the overall quality system and its objectives; Their particular responsibility within the quality system.

    *Training can be provided through on-the-job training, formal classroom sessions, or by technologist certification programs. Because of the unique nature of several aspects associated with operation of a direct-measurement facility it is often necessary to use training resources outside of the facility. Such training might be available commercially or through governmental programs. National professional organizations can have established training activities or resources that can direct measurement facility training needs.