Podcast
Questions and Answers
Which organization was the predecessor of the ISO and was disbanded during the Second World War?
Which organization was the predecessor of the ISO and was disbanded during the Second World War?
- AvP92
- International Federation of the National Standardizing Associations (correct)
- North Atlantic Treaty Organization
- International Organization for Standardization
Which policy, adopted by the US military in 1942, resulted in significantly less reports of malfunctions and uncontrolled explosions of ammunition and equipment?
Which policy, adopted by the US military in 1942, resulted in significantly less reports of malfunctions and uncontrolled explosions of ammunition and equipment?
- MIL-Q-9858 (correct)
- BS 5750
- ISO 9000
- ISO 15189
Which system, adopted in 1968 by NATO, was based on the more stringent European system for military contractors?
Which system, adopted in 1968 by NATO, was based on the more stringent European system for military contractors?
- ISO 17025
- ISO 9001
- ISO 15189
- AQAP-1 (correct)
Which policy, adopted in 1979, expanded the scope of quality management systems to include general quality requirements for industrial, commercial, and governmental products and services?
Which policy, adopted in 1979, expanded the scope of quality management systems to include general quality requirements for industrial, commercial, and governmental products and services?
Which ISO guideline forms the basis for quality operations in a variety of industries, including the services offered by analytical laboratories?
Which ISO guideline forms the basis for quality operations in a variety of industries, including the services offered by analytical laboratories?
Which of the following is a requirement for equipment maintenance records?
Which of the following is a requirement for equipment maintenance records?
What is the purpose of a chain of custody form?
What is the purpose of a chain of custody form?
What is the purpose of a standard operating procedure (SOP)?
What is the purpose of a standard operating procedure (SOP)?
What must be done if there are deviations from a standard operating procedure?
What must be done if there are deviations from a standard operating procedure?
What parameters are included in the validation of analytical methods?
What parameters are included in the validation of analytical methods?
What is the purpose of having a logbook or record keeping method for equipment maintenance?
What is the purpose of having a logbook or record keeping method for equipment maintenance?
What is a chain of custody form used for in a laboratory?
What is a chain of custody form used for in a laboratory?
Why is it important to validate computer tracking systems used for sample tracking?
Why is it important to validate computer tracking systems used for sample tracking?
Which organization sets guidelines for the management of laboratories, including training policies and procedures for personnel?
Which organization sets guidelines for the management of laboratories, including training policies and procedures for personnel?
Who is responsible for the health and safety of employees in a forensic laboratory?
Who is responsible for the health and safety of employees in a forensic laboratory?
What is the purpose of providing training about the dangers inherent in a forensic laboratory?
What is the purpose of providing training about the dangers inherent in a forensic laboratory?
Which of the following is NOT a piece of information typically provided in a Safety Data Sheet (SDS)?
Which of the following is NOT a piece of information typically provided in a Safety Data Sheet (SDS)?
What does the NFPA Hazard Code symbol use to depict dangers?
What does the NFPA Hazard Code symbol use to depict dangers?
Under what circumstances can a single Safety Data Sheet (SDS) be saved for multiple bottles of the same chemical from different manufacturers?
Under what circumstances can a single Safety Data Sheet (SDS) be saved for multiple bottles of the same chemical from different manufacturers?
Which position in a forensic laboratory is responsible for the technical operations of the laboratory?
Which position in a forensic laboratory is responsible for the technical operations of the laboratory?
Which OSHA standard mandates that employers and employees must be informed of the hazards of all chemicals used within the laboratory?
Which OSHA standard mandates that employers and employees must be informed of the hazards of all chemicals used within the laboratory?
What information should be included in a chemical inventory according to the Hazard Communication Standard?
What information should be included in a chemical inventory according to the Hazard Communication Standard?
Which of the following substances is considered a bloodborne pathogen?
Which of the following substances is considered a bloodborne pathogen?
What is the purpose of Universal Precautions in a laboratory setting?
What is the purpose of Universal Precautions in a laboratory setting?
Which of the following is NOT considered ionizing radiation?
Which of the following is NOT considered ionizing radiation?
Which organization is responsible for reviewing and approving studies involving animals?
Which organization is responsible for reviewing and approving studies involving animals?
Which organization provides accreditation for facilities that use animals?
Which organization provides accreditation for facilities that use animals?
Which studies are more stringently regulated?
Which studies are more stringently regulated?
What is the purpose of an Institutional Review Board (IRB)?
What is the purpose of an Institutional Review Board (IRB)?
What are some of the training programs that may be provided by the organization?
What are some of the training programs that may be provided by the organization?
Which of the following is a requirement for the technical leader of a horseracing and canine racing laboratory in the State of Florida?
Which of the following is a requirement for the technical leader of a horseracing and canine racing laboratory in the State of Florida?
What are the degree/educational requirements for the technical manager or leader of a forensic testing laboratory or convicted offender DNA databasing laboratory?
What are the degree/educational requirements for the technical manager or leader of a forensic testing laboratory or convicted offender DNA databasing laboratory?
What are the degree/educational requirements for a DNA analyst?
What are the degree/educational requirements for a DNA analyst?
Which of the following is NOT a requirement for a laboratory conducting forensic DNA testing and convicted offender databasing?
Which of the following is NOT a requirement for a laboratory conducting forensic DNA testing and convicted offender databasing?
What is the purpose of having separate areas for pre- and post-amplified DNA in a laboratory?
What is the purpose of having separate areas for pre- and post-amplified DNA in a laboratory?
What is the recommended frequency for reevaluating the ventilation system in a laboratory?
What is the recommended frequency for reevaluating the ventilation system in a laboratory?
Which reference provides details needed for a chemical hygiene program?
Which reference provides details needed for a chemical hygiene program?
What is the purpose of having a logbook or record keeping method for equipment maintenance?
What is the purpose of having a logbook or record keeping method for equipment maintenance?
What is the purpose of Universal Precautions in a laboratory setting?
What is the purpose of Universal Precautions in a laboratory setting?
Which of the following is a requirement for a fume hood when perchloric acid is used?
Which of the following is a requirement for a fume hood when perchloric acid is used?
What is the purpose of a PCR set up cabinet in a DNA laboratory?
What is the purpose of a PCR set up cabinet in a DNA laboratory?
What is the purpose of an eyewash device in a laboratory?
What is the purpose of an eyewash device in a laboratory?
Which type of laboratory requires sinks, bench tops, electrical outlets, and hoods?
Which type of laboratory requires sinks, bench tops, electrical outlets, and hoods?
What is the purpose of separate cabinets in a wet chemistry laboratory?
What is the purpose of separate cabinets in a wet chemistry laboratory?
What is a requirement for stockrooms and storerooms?
What is a requirement for stockrooms and storerooms?
What type of refrigerator must be used to store flammable liquids?
What type of refrigerator must be used to store flammable liquids?
Where should gas cylinders be stored when not in use?
Where should gas cylinders be stored when not in use?
What must be done to ensure the safety of gas cylinders when stored?
What must be done to ensure the safety of gas cylinders when stored?
Which of the following is NOT a requirement for maintaining a sanitary animal care facility?
Which of the following is NOT a requirement for maintaining a sanitary animal care facility?
What is the purpose of limiting access to an animal care facility?
What is the purpose of limiting access to an animal care facility?
Who is responsible for providing veterinary care for the animals in an animal care facility?
Who is responsible for providing veterinary care for the animals in an animal care facility?
What is a requirement for the storage of animal waste in an animal care facility?
What is a requirement for the storage of animal waste in an animal care facility?
What must be done to prevent the spread of disease in an animal care facility?
What must be done to prevent the spread of disease in an animal care facility?
Which of the following is NOT a reason for restricting radioactive experiments to a small area?
Which of the following is NOT a reason for restricting radioactive experiments to a small area?
Why is it important to maintain a tracking system for the location of remaining specimens in a laboratory?
Why is it important to maintain a tracking system for the location of remaining specimens in a laboratory?
What must a laboratory have in order to dispose of chemical, biological, and radioactive waste?
What must a laboratory have in order to dispose of chemical, biological, and radioactive waste?
What are some of the other facilities that must be allocated space in a laboratory?
What are some of the other facilities that must be allocated space in a laboratory?
Why must corridors in a laboratory be unobstructed?
Why must corridors in a laboratory be unobstructed?
What studies are required to show the reliability of a forensic DNA testing laboratory?
What studies are required to show the reliability of a forensic DNA testing laboratory?
What is the purpose of internal validation studies in a laboratory?
What is the purpose of internal validation studies in a laboratory?
What do the FBI Quality Assurance Standards require in terms of studies completed by a forensic DNA testing laboratory?
What do the FBI Quality Assurance Standards require in terms of studies completed by a forensic DNA testing laboratory?
Which of the following components are key parameters that should be considered when validating an analytical procedure?
Which of the following components are key parameters that should be considered when validating an analytical procedure?
What must be included in the developmental validation of procedures for DNA laboratories?
What must be included in the developmental validation of procedures for DNA laboratories?
When must internal validation be conducted in a laboratory?
When must internal validation be conducted in a laboratory?
What studies are required by the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Databasing Laboratories?
What studies are required by the FBI Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Databasing Laboratories?
Which of the following components are important to consider when determining the uncertainty of a measurement?
Which of the following components are important to consider when determining the uncertainty of a measurement?
What is the purpose of including an uncertainty budget in the measurement process?
What is the purpose of including an uncertainty budget in the measurement process?
What is the role of uncertainty in reporting quantitative measurement results?
What is the role of uncertainty in reporting quantitative measurement results?
How can Type A uncertainty be determined in the absence of historical laboratory data?
How can Type A uncertainty be determined in the absence of historical laboratory data?
Which analytical technique is typically used to determine the chromatographic purity of a compound?
Which analytical technique is typically used to determine the chromatographic purity of a compound?
What is the purpose of checking the homogeneity of a compound preparation before quantitative analysis?
What is the purpose of checking the homogeneity of a compound preparation before quantitative analysis?
How is the extraction recovery of a drug or metabolite determined?
How is the extraction recovery of a drug or metabolite determined?
How is the range of the standard curve and control samples established in an analytical procedure?
How is the range of the standard curve and control samples established in an analytical procedure?
Which equation represents the standard curve used in the validation of analytical procedures?
Which equation represents the standard curve used in the validation of analytical procedures?
What is the typical acceptable value for the y-intercept in the standard curve equation?
What is the typical acceptable value for the y-intercept in the standard curve equation?
How is sensitivity generally reported in analytical procedures?
How is sensitivity generally reported in analytical procedures?
What is the typical signal-to-noise ratio considered acceptable for estimating the detection limit?
What is the typical signal-to-noise ratio considered acceptable for estimating the detection limit?
Which of the following is a recommended approach to establish accuracy in an analytical procedure?
Which of the following is a recommended approach to establish accuracy in an analytical procedure?
How is precision expressed in the context of assay and quantitative determination of impurities?
How is precision expressed in the context of assay and quantitative determination of impurities?
What is the recommended number of determinations to assess accuracy?
What is the recommended number of determinations to assess accuracy?
What parameter should be less than 5% to demonstrate the stability of extracted biological samples?
What parameter should be less than 5% to demonstrate the stability of extracted biological samples?
Which type of maintenance is intended to protect the equipment and/or personnel?
Which type of maintenance is intended to protect the equipment and/or personnel?
What is the purpose of equipment qualification?
What is the purpose of equipment qualification?
What is the purpose of equipment inspection?
What is the purpose of equipment inspection?
What is the purpose of a laboratory maintaining an equipment file?
What is the purpose of a laboratory maintaining an equipment file?
Which step of instrument qualification involves testing the instrument to ensure it meets previously set specifications?
Which step of instrument qualification involves testing the instrument to ensure it meets previously set specifications?
Who usually performs the operational qualification (OQ) for more sophisticated instruments?
Who usually performs the operational qualification (OQ) for more sophisticated instruments?
What is the purpose of performance qualification (PQ) in instrument qualification?
What is the purpose of performance qualification (PQ) in instrument qualification?
What is the role of ISO 9001 in instrument qualification?
What is the role of ISO 9001 in instrument qualification?
Which term refers primarily to items such as freezers, thermometers, and automatic pipettes?
Which term refers primarily to items such as freezers, thermometers, and automatic pipettes?
What factors should be considered before purchasing equipment for a laboratory?
What factors should be considered before purchasing equipment for a laboratory?
What must be done to ensure the quality of analytical data?
What must be done to ensure the quality of analytical data?
What are instrument specifications used for?
What are instrument specifications used for?
Which of the following is a requirement for calibration documentation?
Which of the following is a requirement for calibration documentation?
What is the recommended number of points to be used for calibration?
What is the recommended number of points to be used for calibration?
What units should numerical data be expressed in?
What units should numerical data be expressed in?
What can instruments be calibrated against?
What can instruments be calibrated against?
Which of the following is NOT an example of routine maintenance?
Which of the following is NOT an example of routine maintenance?
How often should routine and/or preventative maintenance be scheduled?
How often should routine and/or preventative maintenance be scheduled?
What is the purpose of calibration in a laboratory?
What is the purpose of calibration in a laboratory?
What must be done before equipment can be returned to service after malfunctioning?
What must be done before equipment can be returned to service after malfunctioning?
What should the documentation on a calibration be able to do?
What should the documentation on a calibration be able to do?
What can instruments be calibrated against?
What can instruments be calibrated against?
What should standards used for calibration be traceable back to?
What should standards used for calibration be traceable back to?
How many points should be used to cover the entire operating range of an instrument during calibration?
How many points should be used to cover the entire operating range of an instrument during calibration?
In what units should all numerical data be expressed?
In what units should all numerical data be expressed?
Which of the following is a requirement for maintaining the chain of custody in a forensic laboratory?
Which of the following is a requirement for maintaining the chain of custody in a forensic laboratory?
What is the typical retention time for test articles in forensic laboratories?
What is the typical retention time for test articles in forensic laboratories?
What must be done to ensure the quality of reagents and materials used in the analysis of test articles?
What must be done to ensure the quality of reagents and materials used in the analysis of test articles?
Which of the following is NOT a requirement for field sample collection according to the text?
Which of the following is NOT a requirement for field sample collection according to the text?
What is the purpose of a complete chain of custody according to the text?
What is the purpose of a complete chain of custody according to the text?
What is the purpose of adding a colored cleaning agent to the water in the toilet during urine sample collection according to the text?
What is the purpose of adding a colored cleaning agent to the water in the toilet during urine sample collection according to the text?
What is the purpose of a laboratory information management system (LIMS)?
What is the purpose of a laboratory information management system (LIMS)?
What is the purpose of a chemical information management system (CIMS)?
What is the purpose of a chemical information management system (CIMS)?
What is the purpose of an analytical information management system (AIMS)?
What is the purpose of an analytical information management system (AIMS)?
Which of the following is NOT a requirement for the storage of samples in a laboratory facility?
Which of the following is NOT a requirement for the storage of samples in a laboratory facility?
Which of the following documents is NOT part of the chain of custody for a sample?
Which of the following documents is NOT part of the chain of custody for a sample?
What must be included in the documentation for instrument calibration?
What must be included in the documentation for instrument calibration?
Which of the following is NOT a requirement for maintaining the chain of custody (COC) for forensic samples during transport?
Which of the following is NOT a requirement for maintaining the chain of custody (COC) for forensic samples during transport?
What information should be included in the sample log in a laboratory?
What information should be included in the sample log in a laboratory?
Which of the following procedures must be documented during sample analysis?
Which of the following procedures must be documented during sample analysis?
Which of the following best describes a closed system in the context of a LIMS (Laboratory Information Management System)?
Which of the following best describes a closed system in the context of a LIMS (Laboratory Information Management System)?
What is the role of personnel in a LIMS?
What is the role of personnel in a LIMS?
When are electronic signatures considered acceptable in a LIMS?
When are electronic signatures considered acceptable in a LIMS?
What must be documented in a LIMS regarding system problems?
What must be documented in a LIMS regarding system problems?
In a LIMS, what is the purpose of limiting access to authorized users?
In a LIMS, what is the purpose of limiting access to authorized users?
What is a LIMS?
What is a LIMS?
What are the responsibilities of personnel using a LIMS?
What are the responsibilities of personnel using a LIMS?
In what situations are electronic signatures considered acceptable in a LIMS?
In what situations are electronic signatures considered acceptable in a LIMS?
What does it mean for a LIMS to be a closed system?
What does it mean for a LIMS to be a closed system?
Why is it important to limit access to a LIMS?
Why is it important to limit access to a LIMS?
Which of the following is NOT a suitable method for indicating an error in a laboratory notebook?
Which of the following is NOT a suitable method for indicating an error in a laboratory notebook?
What type of ink should be used when recording information in a laboratory notebook?
What type of ink should be used when recording information in a laboratory notebook?
Which of the following is a requirement for a laboratory notebook?
Which of the following is a requirement for a laboratory notebook?
When should each procedural step be recorded in a laboratory notebook?
When should each procedural step be recorded in a laboratory notebook?
What should be done upon completion of a procedural step in a laboratory notebook?
What should be done upon completion of a procedural step in a laboratory notebook?
Which of the following is a key component of a standard operating procedure (SOP)?
Which of the following is a key component of a standard operating procedure (SOP)?
Why are official SOPs required by some governmental agencies and granting organizations?
Why are official SOPs required by some governmental agencies and granting organizations?
What is the purpose of preparing a standard operating procedure (SOP)?
What is the purpose of preparing a standard operating procedure (SOP)?
Why do funding agencies and accreditation bodies prefer the use of official SOPs?
Why do funding agencies and accreditation bodies prefer the use of official SOPs?
What is the purpose of a standard operating procedure (SOP) in terms of obtaining comparable data?
What is the purpose of a standard operating procedure (SOP) in terms of obtaining comparable data?
Which section of a Standard Operating Procedure (SOP) lists the apparatus and materials used in the analysis?
Which section of a Standard Operating Procedure (SOP) lists the apparatus and materials used in the analysis?
What is the purpose of the Quality Control section in an SOP?
What is the purpose of the Quality Control section in an SOP?
What section of an SOP may contain specific methods for collecting, preserving, and handling a sample?
What section of an SOP may contain specific methods for collecting, preserving, and handling a sample?
What is the purpose of the Method Performance section in an SOP?
What is the purpose of the Method Performance section in an SOP?
Which section of an SOP briefly describes the equipment and general procedures followed in order to obtain data?
Which section of an SOP briefly describes the equipment and general procedures followed in order to obtain data?
Which of the following is a required element for an 'in-house' Standard Operating Procedure (SOP)?
Which of the following is a required element for an 'in-house' Standard Operating Procedure (SOP)?
What is the purpose of a Standard Operating Procedure (SOP)?
What is the purpose of a Standard Operating Procedure (SOP)?
When should a laboratory prepare an SOP for a specific analyte in a specific matrix?
When should a laboratory prepare an SOP for a specific analyte in a specific matrix?
What is the purpose of the scope section in an SOP?
What is the purpose of the scope section in an SOP?
What must a laboratory do before using a method outlined in an SOP?
What must a laboratory do before using a method outlined in an SOP?
Which of the following is NOT a requirement for a standard operating procedure (SOP) according to the text?
Which of the following is NOT a requirement for a standard operating procedure (SOP) according to the text?
What must be done before a revised SOP can be approved according to the text?
What must be done before a revised SOP can be approved according to the text?
What happens to the original SOP and its attached OCR after a revision is made according to the text?
What happens to the original SOP and its attached OCR after a revision is made according to the text?
What must be done when a document (or record) is altered or corrected according to the text?
What must be done when a document (or record) is altered or corrected according to the text?
What should be done before a new or revised SOP can be useful according to the text?
What should be done before a new or revised SOP can be useful according to the text?
What is the purpose of using hard bound laboratory notebooks?
What is the purpose of using hard bound laboratory notebooks?
When should each procedural step be written in a laboratory notebook?
When should each procedural step be written in a laboratory notebook?
What information should be included in each procedural step in a laboratory notebook?
What information should be included in each procedural step in a laboratory notebook?
What is the purpose of signing and dating each page in a laboratory notebook?
What is the purpose of signing and dating each page in a laboratory notebook?
What is the purpose of using hard bound laboratory notebooks?
What is the purpose of using hard bound laboratory notebooks?
Which of the following is a common use of study protocols?
Which of the following is a common use of study protocols?
What is the primary purpose of a study protocol?
What is the primary purpose of a study protocol?
When are protocols usually required for laboratories?
When are protocols usually required for laboratories?
What are the components of a well-written protocol?
What are the components of a well-written protocol?
In which type of studies are protocols primarily found?
In which type of studies are protocols primarily found?
Which regulatory body mandates that studies funded by the FDA or EPA be conducted using protocols?
Which regulatory body mandates that studies funded by the FDA or EPA be conducted using protocols?
What is the role of an Institutional Review Board (IRB) in clinical studies?
What is the role of an Institutional Review Board (IRB) in clinical studies?
Which agency requires that an IRB approve studies involving human subjects before any experimentation can begin?
Which agency requires that an IRB approve studies involving human subjects before any experimentation can begin?
What is the purpose of a study protocol in the context of laboratory research?
What is the purpose of a study protocol in the context of laboratory research?
What is the role of the Code of Federal Regulations (CFR) in laboratory research?
What is the role of the Code of Federal Regulations (CFR) in laboratory research?
Which of the following is a component of a study protocol?
Which of the following is a component of a study protocol?
What is the purpose of a study protocol?
What is the purpose of a study protocol?
What information should be provided about the sponsor in a study protocol?
What information should be provided about the sponsor in a study protocol?
Which of the following is the role of the sponsor in a study?
Which of the following is the role of the sponsor in a study?
What is the purpose of the Institutional Review Board (IRB) in a study?
What is the purpose of the Institutional Review Board (IRB) in a study?
What must be included in the Informed Consent (IC) form for human participants in a study?
What must be included in the Informed Consent (IC) form for human participants in a study?
Which of the following is a key consideration in experimental design when selecting test subjects?
Which of the following is a key consideration in experimental design when selecting test subjects?
Which of the following is a key consideration in experimental design when measuring a parameter?
Which of the following is a key consideration in experimental design when measuring a parameter?
Which of the following is a key consideration in experimental design when selecting test subjects for a crossover experiment?
Which of the following is a key consideration in experimental design when selecting test subjects for a crossover experiment?
Which of the following is a requirement for amending a study protocol according to the text?
Which of the following is a requirement for amending a study protocol according to the text?
What must be done if deviations from the study protocol occur according to the text?
What must be done if deviations from the study protocol occur according to the text?
What is the purpose of an Informed Consent Form according to the text?
What is the purpose of an Informed Consent Form according to the text?
What is the purpose of SOPs (Standard Operating Procedures) according to the text?
What is the purpose of SOPs (Standard Operating Procedures) according to the text?
What is the purpose of an (animal) Owner Consent Form according to the text?
What is the purpose of an (animal) Owner Consent Form according to the text?
What must be included in a description of collection sites according to the text?
What must be included in a description of collection sites according to the text?
What are some examples of documents that should be included in a study protocol?
What are some examples of documents that should be included in a study protocol?
When can a study protocol be amended?
When can a study protocol be amended?
What must be done if deviations from the study protocol occur?
What must be done if deviations from the study protocol occur?
Who must sign and date a study protocol amendment?
Who must sign and date a study protocol amendment?
What should be done with a study protocol amendment?
What should be done with a study protocol amendment?
Which of the following is NOT a factor that determines the emphasis placed on quality, price, and turnaround in a laboratory?
Which of the following is NOT a factor that determines the emphasis placed on quality, price, and turnaround in a laboratory?
What is the purpose of conducting tests for analytes that are not specified by the customer?
What is the purpose of conducting tests for analytes that are not specified by the customer?
What are matrix-matched standards used for in laboratory analyses?
What are matrix-matched standards used for in laboratory analyses?
Which term is frequently used to refer to laboratory inspections?
Which term is frequently used to refer to laboratory inspections?
What is the goal of a laboratory audit?
What is the goal of a laboratory audit?
According to ISO, what is an audit?
According to ISO, what is an audit?
What is the term used to describe a methodical examination and review of a laboratory program?
What is the term used to describe a methodical examination and review of a laboratory program?
What are the benefits of a laboratory inspection?
What are the benefits of a laboratory inspection?
What is the definition of a laboratory audit?
What is the definition of a laboratory audit?
What is the goal of a laboratory audit?
What is the goal of a laboratory audit?
Why are laboratory inspections sometimes referred to as laboratory audits?
Why are laboratory inspections sometimes referred to as laboratory audits?
Which of the following records may the auditor inspect in addition to the ones listed in the text?
Which of the following records may the auditor inspect in addition to the ones listed in the text?
What should be done if a sample is spilled while in storage or being transferred to another area, according to the text?
What should be done if a sample is spilled while in storage or being transferred to another area, according to the text?
What information should be provided to the auditor prior to their visit, according to the text?
What information should be provided to the auditor prior to their visit, according to the text?
What is the purpose of an accreditation audit?
What is the purpose of an accreditation audit?
What is the major difference between an internal audit and an accreditation audit?
What is the major difference between an internal audit and an accreditation audit?
What does an inspection team primarily look for during a laboratory audit for accreditation?
What does an inspection team primarily look for during a laboratory audit for accreditation?
Which organization or agency can provide accreditation for a laboratory that wishes to establish an accredited program at a new or non-accredited laboratory?
Which organization or agency can provide accreditation for a laboratory that wishes to establish an accredited program at a new or non-accredited laboratory?
What must a laboratory demonstrate during a laboratory audit to become accredited?
What must a laboratory demonstrate during a laboratory audit to become accredited?
What is the criteria for a laboratory to be deemed proficient in analyzing analytes during proficiency testing?
What is the criteria for a laboratory to be deemed proficient in analyzing analytes during proficiency testing?
Which of the following is NOT a possible outcome after a regulatory agency inspection?
Which of the following is NOT a possible outcome after a regulatory agency inspection?
What does the audit report from the regulatory agency inspector typically contain?
What does the audit report from the regulatory agency inspector typically contain?
What must the laboratory do in response to the audit report?
What must the laboratory do in response to the audit report?
What type of evidence may the regulatory agency require from the laboratory to demonstrate that deficiencies were corrected?
What type of evidence may the regulatory agency require from the laboratory to demonstrate that deficiencies were corrected?
Under what circumstances may the laboratory argue that a specific observation does not indicate a deficiency?
Under what circumstances may the laboratory argue that a specific observation does not indicate a deficiency?
What is the purpose of an audit based on the Case Study in the module?
What is the purpose of an audit based on the Case Study in the module?
What happens after the regulatory agency inspector has departed?
What happens after the regulatory agency inspector has departed?
Can the laboratory continue operations while correcting deficiencies?
Can the laboratory continue operations while correcting deficiencies?
What must the laboratory provide to demonstrate how the deficiencies were corrected?
What must the laboratory provide to demonstrate how the deficiencies were corrected?
What can the laboratory argue if a specific observation does not provide evidence of a deficiency?
What can the laboratory argue if a specific observation does not provide evidence of a deficiency?
What is the purpose of an audit based on the Case Study in the module?
What is the purpose of an audit based on the Case Study in the module?
Which statistical technique is used to determine whether two groups of data are different?
Which statistical technique is used to determine whether two groups of data are different?
What is the purpose of Duncan's Separation of Means Procedure?
What is the purpose of Duncan's Separation of Means Procedure?
Which statistical technique is used to interpret laboratory data?
Which statistical technique is used to interpret laboratory data?
What type of programs can perform statistical manipulations on tabulated data?
What type of programs can perform statistical manipulations on tabulated data?
Which of the following is NOT mentioned as a source for finding equations required for statistical calculations?
Which of the following is NOT mentioned as a source for finding equations required for statistical calculations?
What is the purpose of a calibration curve?
What is the purpose of a calibration curve?
Which of the following can be used to obtain averages, standard deviations, and other statistics from tabulated data?
Which of the following can be used to obtain averages, standard deviations, and other statistics from tabulated data?
What is the purpose of a t-test?
What is the purpose of a t-test?
What is the purpose of the theoretical calculated value in statistical analysis?
What is the purpose of the theoretical calculated value in statistical analysis?
Which of the following is NOT mentioned as a program that can perform statistical manipulations on tabulated data?
Which of the following is NOT mentioned as a program that can perform statistical manipulations on tabulated data?
Which organization provides information for federal agencies concerning record management?
Which organization provides information for federal agencies concerning record management?
What is one area of interest addressed by the FDA?
What is one area of interest addressed by the FDA?
What is the subject of interest in relation to electronic records and signatures?
What is the subject of interest in relation to electronic records and signatures?
What other organization addresses the subject of electronic records and signatures?
What other organization addresses the subject of electronic records and signatures?
What information does the NARA website provide for federal agencies?
What information does the NARA website provide for federal agencies?
What is one consideration when formulating laboratory record management policies?
What is one consideration when formulating laboratory record management policies?
What does the NARA website provide that may be useful for formulating laboratory record management policies?
What does the NARA website provide that may be useful for formulating laboratory record management policies?
What is one area of interest in record management policies?
What is one area of interest in record management policies?
What does the FDA address in relation to record management?
What does the FDA address in relation to record management?
What is one area of interest in relation to electronic records and signatures?
What is one area of interest in relation to electronic records and signatures?
Study Notes
Quality Management Systems
- The International Organization for Standardization (ISO) was preceded by the International Federation of the National Standardizing Associations (IFNSA), which was disbanded during World War II.
- The US military adopted a policy in 1942, resulting in fewer reports of malfunctions and uncontrolled explosions of ammunition and equipment.
Quality Control and Quality Assurance
- In 1968, NATO adopted a system based on the stricter European system for military contractors.
- In 1979, a policy expanded the scope of quality management systems to include general quality requirements for industrial, commercial, and governmental products and services.
Laboratory Management
- The ISO 15189 guideline forms the basis for quality operations in various industries, including analytical laboratories.
- Equipment maintenance records must include information on maintenance activities, repairs, and calibration.
Chain of Custody
- A chain of custody form is used to track the possession and handling of evidence throughout the entire analytical process.
- The purpose of a chain of custody form is to maintain the integrity of evidence and ensure accountability.
Standard Operating Procedures (SOPs)
- A SOP is a written procedure that outlines the steps to be taken in a specific situation.
- If there are deviations from a SOP, they must be documented and justified.
Validation of Analytical Methods
- Parameters included in the validation of analytical methods include accuracy, precision, linearity, range, detection limit, and robustness.
- Validation of computer tracking systems is essential to ensure the reliability and accuracy of data.
Laboratory Safety and Health
- The International Laboratory Accreditation Cooperation (ILAC) sets guidelines for the management of laboratories, including training policies and procedures for personnel.
- The laboratory supervisor is responsible for the health and safety of employees in a forensic laboratory.
Safety Data Sheets (SDS)
- An SDS is not typically provided for multiple bottles of the same chemical from different manufacturers.
- The NFPA Hazard Code symbol uses numbers to depict dangers.
Forensic Laboratory Operations
- The technical leader of a forensic laboratory is responsible for the technical operations of the laboratory.
- The OSHA standard mandates that employers and employees must be informed of the hazards of all chemicals used within the laboratory.
Chemical Inventory and Handling
- A chemical inventory should include information on the chemical, its properties, and its handling procedures according to the Hazard Communication Standard.
Bloodborne Pathogens
- Hepatitis B and HIV are considered bloodborne pathogens.
- The purpose of Universal Precautions is to prevent exposure to bloodborne pathogens in a laboratory setting.
Institutional Review Board (IRB)
- The IRB is responsible for reviewing and approving studies involving animals.
- The IRB provides accreditation for facilities that use animals.
Laboratory Accreditation and Certification
- The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) provides accreditation for facilities that use animals.
- Studies involving animals are more stringently regulated.
Training and Education
- Training programs provided by the organization may include hazardous materials handling, laboratory safety, and emergency procedures.
Quality Assurance and Control
- The purpose of internal validation studies is to demonstrate the reliability of a forensic DNA testing laboratory.
- The FBI Quality Assurance Standards require studies to be completed by a forensic DNA testing laboratory.
Analytical Procedures
- Key parameters to consider when validating an analytical procedure include accuracy, precision, linearity, range, detection limit, and robustness.
- The developmental validation of procedures for DNA laboratories includes the evaluation of critical factors affecting the procedure.
Uncertainty and Error
- Uncertainty is a key component in reporting quantitative measurement results.
- The purpose of including an uncertainty budget in the measurement process is to account for all sources of uncertainty.
Analytical Techniques
- Chromatography is typically used to determine the chromatographic purity of a compound.
- The extraction recovery of a drug or metabolite is determined through the use of analytical techniques.
Instrumentation and Equipment
- Equipment maintenance is intended to protect the equipment and/or personnel.
- Instrument qualification involves testing the instrument to ensure it meets previously set specifications.
Calibration and Maintenance
- Calibration is essential to ensure the quality of analytical data.
- Instrument specifications are used to establish the performance requirements of an instrument.
- Calibration documentation should include information on the instrument, calibration procedure, and calibration results.
Laboratory Operations
- Routine maintenance should be scheduled regularly to ensure the quality of analytical data.
- The purpose of calibration in a laboratory is to ensure the reliability and accuracy of data.
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Description
Test your knowledge on quality assurance (QA) and quality control (QC) with this quiz! Learn about the definitions and procedures involved in ensuring high-quality standards in various industries. Challenge yourself and see how well you understand the concepts of QA/QC.
