General Principles of Quality Assurance and Quality Control

Bea Jacob
Flashcards by Bea Jacob, updated more than 1 year ago
Bea Jacob
Created by Bea Jacob over 6 years ago
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For Advanced Analytical Chemistry :)

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Question Answer
Quality totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs
Quality Control (ISO 9000) set of activities intended to ensure that quality requirements are actually being met
Quality Assurance (ISO 9000) set of activities intended to establish confidence that quality requirements will be met
Calibration set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding values of a known measurand (a quantity subjected to a measurement)
Traceability – the property of a measurement whereby it can be related to appropriate national/international standards thru an unbroken chain of comparisons
Quality System – the organizational structure, responsibilities, procedures, processes and resources for implementing quality management
o Method blank - contains all components except analyte, and it is taken thru all steps of the analytical procedure
o Reagent blank – similar to a method blank, but it has not been subjected to all sample prep procedures
o Field blank – similar to a method blank but it has been exposed to the site of sampling
• Spike (Fortification) – a known quantity of analyte added to sample is the same as that expected from a calib curve
• Performance test samples – stable homogeneous, typical in composition to the types of sample normally examined, and available in large quantities; used to study the variation within and between batches of a particular analysis
o Repeat sample – repeated later on in the batch of samples or in a different batch; analyst is aware when repeat samples are used
o Blind sample – type of repeat sample inserted into the batch w/o knowledge of analyst
• Standard Operating Procedures – states what steps will be taken and how they will be carried out; describe how your lab will handle a hazardous chemical safely, including the amount and concentration you will use, how you obtain or create the working solution, and special handling procedures, engg controls, and PPE
• Quality Manual – details in the lab’s quality system need to be written down so that everyone in the laboratory can see what the system is and what is expected of them
• Quality Audit – a continuing process of testing the quality systems in use in the lab to check if the systems are effective, documented, and being adhered to by the working staff
• Quality System Review – periodic re-examination of the lab’s quality systems to check if the systems are still appropriate
o ISO/IEC 17025:2005 (International Organization Standardization/International Electrotechnical Commission) – standard which addresses the technical competence of labs to carry out specific tests and calibrations and is used by lab accreditation bodies worldwide as the core reqs for the accreditation of labs
o ISO 9000 series – std which relates primarily to quality management, for facilities carrying out production, or providing services, including chemical analysis
o ISO 15189:2003 – prepared specifically to cover medical labs
o OECD (Organization for Economic Cooperation and Development) Principles of GLP (Good Lab Practice) – guidelines concerned w/ the organizational processes and conditions under w/c lab studies related to certain regulatory work are carried out
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