SECOND LONG EXAM Flashcards
degree of spread of results ( degree of differences in individual test results, expressed as standard deviation, relative standard deviation or RSD).
Precision
degree of agreement of measurements with an acceptable reference value or degree of acceptable method bias. Bias ( sometimes called recovery) is the systematic error of the measuring system
Accuracy
Standard which addresses the technical competence of laboratories to carry out specific tests and calibrations and is used by lab accreditation bodies worldwide
International standard that contains all the requirements that testing and calibration laboratories have to meet if they wish to operate a quality system
ISO/ IEC 17025: 2005
The standards which relates primarily to quality management, for facilities carrying out production, or providing services, including chemical analysis
ISO 9001: 2000
Guidelines concerned with the organizational processes and conditions under which laboratory studies related to certain regulatory work are carried out.
OECD Principles of GLP
ISO/ IEC 17025 : 2005 Management Requirements:
- Organization
- Management system
- Document control
- review of requests, tenders and contracts
- Sub-contracting of tests and calibrations
- Purchasing services and supplies
- Service to the customer
- Complaints
- Control of non-conforming tests
- Improvement
- Corrective action
- Preventive Action
- Control of Records
- Internal audits
- Managements reviews
ISO/IEC 17025:2005 Technical Requirements
- General
- Personnel
- Accommodation and environmental condition
- Test and calibration method validation
- Equipment
- Measurement traceability
- Sampling
- Handling of test and calibration items
- Assuring the quality of test and calibration results
- Reporting of results
( expanded sense)- set of requirements covering the organization of test facilities and conditions to ensure the generation of high quality and reliable test data for specific objectives
( limited sense)- set of practice in the chemical laboratory that controls the laboratory activities and conditions that affect the accuracy of analytical data
GLP Principles
Component of GLP and its objective
QA program - ensure consistent quality of data
Laboratory Conditions - ensure that laboratory conditions are optimized to obtain the desired performance of the test method
Test samples - preserve the identity and integrity of the samples
Test measurements - ensure that an acceptable test method will produce the expected performance
Record management - enable retrieval of undistorted information whenever required
Inclusion of GLP
implementing standard operating procedures
Proper maintenance and calibration of equipment
Correct practices of laboratory personnel in performing analytical work
Efficient management of laboratory records
the measured concentration at which there is a stated probability ( 95% or 99%) that an analyte is present. is defined as 3x standard deviation (of method blank runs).
Method detection limit
the lowest concentration level that can be determined to be statistically different from the blank; the lowest analyte concentration required to be present to ensure an analytical response that will exceed the MDL.
variability is 2 x MDL x t(0.05) where t(0.05) is t statistic used to compensate for the tendency of small sample sizes to underestimate variability.
Reliable detection limit
the level above which quantitative results maybe obtained with a specified degree of confidence. Confidence in the apparent analyte concentration increases as the analyte signal increases above the MDL.
Limit of quantitation (LOQ)
susceptibility of the method to interferences. This maybe determined by recovery of spiked samples.
Selectivity
Method of QA program covers:
Method Selection
Method Validation
Sampling
Equipment
Quality Control
Traceability
Measurement Uncertainty
Proficiency Testing
