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

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Quality Assurance and Quality Control – Unit Objectives

The 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.

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Quality Assurance and Quality Control – Unit Outline

• Quality Assurance

• Quality Control

• Quality methods

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Quality Assurance

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• 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?

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What is Quality?

• A high standard or level.• Degree of excellence.• Distinguishing feature.• Faculty, skill, accomplishment.• Satisfaction of a customer’s needs or requirements.

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

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Quality assurance requirements

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• 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 monitored• Magnitude and likelihood of exposures• Number of individuals monitored• Type of monitoring provided

• Direct measurements• Indirect measurements

• Choice of monitoring periods

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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.

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A Quality Assurance programme should provide for:

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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.

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• 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.

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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.

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Quality Control procedures

• Should be carried out at appropriate intervals

• 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

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Quality Control procedures

• Quality 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,

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Quality Control procedures

• Finally, Q.C. procedures should cover:• Evaluation of compliance with the

performance criteria of appropriate standards

• Evaluation of quality control data to ensure the long term consistency of analytical ‑results

• Verification of determinations of minimum detectable activities

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Documentation of methods, procedures and test results

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• 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

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• 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

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• 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

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• Training is essential for direct and indirect measurement staff

• Personnel responsible for:

• operation• calibration• interpretation of data, and• equipment maintenance

Staff training should include:

• Basic philosophy and strategy of internal dose assessment

• Principles and details of the methods used

• Technical details and potential problems of the processes in which they are involved

• Recognition and reporting of problems that arise

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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

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Various sources of training are available

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• Training can be provided through• On-the-job training• Formal classroom sessions• Technologist certification programs• Participation in intercomparison programmes• International fellowship programmes

QUALITY TECHNIQUES

• Joint problem solving• Brainstorming• Methods of analysis• Planning for just-in-time (JIT) managementAims of JITThe operation of JIT

Joint Problem Solving

• The 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 solving

• Depersonalizing 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.

BRAINSTORMING

• Brainstorming 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:

•     don’t discuss just concentrate on writing up ideas ‑

as quickly as possible without criticising anything

that is said

METHODS OF ANALYSIS

• Once 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 analysis

Paired comparison

Cause and effect diagrams

Matrix

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

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