FIS 480 EXAM 2 QUESTIONS ANSWERED CORRECTLY LATEST UPDATE 2026

FIS 480 EXAM 2 QUESTIONS ANSWERED CORRECTLY LATEST UPDATE 2026 What is the main purpouse of an audit? - Answers Verify compliance True/False:An Audit is a fact finding mission - Answers True An Audit is a search for ________ - Answers Opportunities for Improvement *not an excercise for blame Who performs an internal audit? - Answers The laboratry itself Who performs Assesments or external audits? - Answers ASCLAD-LAB/ANAB or FQS-ISO Purposes of Audit - Answers *make sure management system is impemented *Investigate causes of quality problems *Identify oppertunites for improvement Basic Audit Process - Answers *Plan: Schedule audit, audit checklist, auditors *Do: Audit as scheduled, ask questions, examine records *Check: Check degree of conformity *Act: make CARs when dont you have a nonconformity (#1 rule of auditing) - Answers If you cannot express the nonconformance in the words of the standard or the company's own policies and procedures then you DO NOT have a confonformity Questions to avoid when doing an Audit - Answers *Self answering *"You do this, dont you?" *No trick, ambiguous or compound questions Keys to communication during an audit - Answers Keep it simple: clear, breif, direct, focused *3 ways of receiving information: seeing, hearing, experiencing *Spend most of your time listening Pre-audit Prep - Answers *Review Management system documentation *Review standards used for audit *Prepare Gap Analysis *Prepare any questions or checklists *Familiarize yourself with lab procedures and processes What is an appropriate method? - Answers A method that would be judged suitable by the scientific community or by qualified scientific peers what does it mean that test methods should be readily avaliable? - Answers SOP should be a the bench or beside the instument What is Validation? - Answers make sure certain method/equipment actiually does what it should True/False: Every method needs to be validated before use in the lab - Answers True What is uncertainty of measurment? - Answers A parameter associated with the result of a measurement, that characterizes the dispirsion of the values that could reasonably be attributed to the measurand What measurments does MU (measurement uncertainty) apply to? - Answers Quantitative Measurments 5.4.7.1- Checking Data - Answers A second person must check calculations and data transfers and initial/Date the transfer 4.3.1- Controlling lab enviromental conditions - Answers Lab must control: * Tempature *Humidity *Vibration *Noise *Dust *Power Supplies *High purity water What are the aspects of controlling access to the lab? - Answers *List who has access to what areas *Records of Key/Keycards *Visitors *After hours security *Emergency calls *Evidence storage areas 5.3.5- Housekeeping - Answers SOPs for cleaning. Such as: frequency, who cleans, health/safety concerns Authorization of equipment/ work? - Answers work authorization- Must be stated that lab emplyee perform certain tasks/ use equipment labeling of equipment that is good or out of service - Answers Eqipemnt should be labeled with "GOOD TO GO" or "OUT OF SERVICE" on the actual peice of equipment What is traceability? - Answers Properties of the result of a measurment or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having states uncertainties *traceability is t he ability to verify the history, location, or application of an item by means of documented recorded identification Difference between reference standard and reference material - Answers *reference standards- used to check calibration (Weights/ rulers) *Reference material- Knows for tests (ie- blood, paint, glass ect) Sampling vs sample selection - Answers *Sampling- take some and make inference about the whole *SS- trying to pick best sample Critical Reagent - Answers reagents that requires testing on established samples before use on casework casework reference sample - Answers Biological material obtained from a known individual methodology - Answers describes the analytical process and procedures used to support DNA typing technology Outsourcing - Answers using a vendor lab to provide DNA services *Original lab retains ownership of DNA data for entry into CODIS Reagent Blank - Answers Control sample that contains no template DNA technical leader - Answers an employee who is accountable for technical operations of the lab and authorized to stop/suspend lab operations Work product - Answers The material that is generated b the analysis What documents are addressed by document retention in QAS? - Answers Proficiency tests, Corrective Actions, Audits, training records, continuing Education, case files, court testimony monitoring minimum number of employees that a DNA lab must have - Answers At least 2 analysts that are qualified in DNA analysis What is a contingency plan? - Answers A plan for when the technical leader is absent What is required of an employee with previous experience? - Answers Pass a proficiency test How many hours of continuing education do DNA analysts need? - Answers 8 per year Educational requirements for a DNA technical leader? - Answers Masters in Bio/Chem/ Forensics, 12 hours classes in Biochem, Molecular Bio, Stats or population genetics Who oversees the CODIS portion of the DNA lab? - Answers Casework CODIS Administrator What coursework is required of a DNA analyst? - Answers BioChem, Genetics, Molecular Bio In a DNA lab, What techniques must be performed at separate times or in a separate space? - Answers Anything performed before prior to PCR What studies must be completed for an internal validation? - Answers *Known and non-probative samples *Reproducibility and precision *Sensitivity and Stochastic studies *Contamination Assessment What has to be completed if a procedure is modified? - Answers *Compare old to new *Performance Check What must reagents be labeled with? - Answers Identification, Expiration Date *If made in house, has more requirements What does QAS specify as critical reagents? - Answers PCR Kits and any genetic typing kits in QAS, Do all samples need quantitated? - Answers No. Have to for reagent blanks and controls When must a lab check their procedures with a NIST control? - Answers Annually in QAS, What must mixture interpretation procedures contain? - Answers Inclusions and exclusions What does the QAS list as critical equipment? - Answers Electrophoresis detection systems Robotic systems Genetic analyzers Thermal Cycler in QAS, what are the requirements for a DNA report? - Answers *Case ID *Description of evidence examined *Description of technology *Locus or amplification system *Results and/or conclusion *Date issued *Quantitative or qualitative *Disposition of evidence *Signature and title in QAS, what is a Admin Review? - Answers an evaluation of the report for consistency with lab policies and editorial correctness What is a technical review? - Answers Evaluation of a report to ensure there is an appropriate and sufficent basic for the scientific conclusion