Quality Assurance Quality Control Procedures
lsManua2010FORENSIC BIOLOGYQUALITY ASSURANCE / QUALITY CONTROLMANUALforApproving Authority: Eugene Y. Lien, Quality Assurance ManagerArchivedEffective DateRevision HistoryProceduresAudits and Assessments2/9/2010Initial Version of ProcedureControl of Data2/9/2010Initial Version of ProcedureControl of Non-Conforming Work2/9/2010Initial Version of ProcedureControl of Reference Collections2/9/2010Initial Version of ProcedureCourt Testimony Monitoring2/9/2010Initial Version of ProcedureEquipment Calibration and2/9/2010Initial Version of ProcedureMaintenanceExogenous DNA Prevention2/9/2010Initial Version of ProcedureLab Types Database2/9/2010Initial Version of ProcedurePreventive Action2/9/2010Initial Version of ProcedureProficiency Testing Program2/9/2010Initial Version of ProcedureQuality Incident Review2/9/2010Initial Version of ProcedureReagents2/9/2010Initial Version of ProcedureValidation2/9/2010Initial Version of ProcedureQUALITY CONTROL REAGENT SHEETSQUALITY CONTROL PROCEDURESControlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN1 OF 6GUIDING PRINCIPLES AND SCOPEAudits and assessments are conducted to improve the quality of the laboratory, as well as tomaintain compliance with accreditation standards such as ISO 17025, the ASCLD/LABInternational Supplemental Requirements, and the FBI Quality Assurance Standards forForensic DNA Testing.ManualsAn Internal Audit is an audit conducted by qualified and trained auditors employed by theDepartment of Forensic Biology. An External Audit or Assessment is an audit conducted byqualified and trained auditors/assessors employed by agency external to the Department ofForensic Biology.2010This document describes the external audits/assessments to which the Department of ForensicBiology is subject and the internal audit program of the Department.PROCEDUREforThe management system of the Department of Forensic Biology is designed to conform to thefollowing sets of standards:ivedASCLD/LAB-International Standards: The ASCLD/LAB-International Standardsencompasses the ISO/IEC 17025 requirements and the ASCLD/LAB-International SupplementalRequirements.ArchFBI Quality Assurance Standards for Forensic DNA Testing: The FBI Quality AssuranceStandards for Forensic DNA Testing is issued by the FBI Director and is a set of standardsspecific to Forensic DNA Testing (mitochondrial and autosomal). ASCLD/LAB-Internationalalso requires compliance with these standards as a condition of accreditation.I.External Audits/AssessmentsA.The Department is subject to external accreditation assessments/surveillancevisits as required by ASCLD/LAB.1.Assessment scheduling and the assessment process are the responsibilityof ASCLD/LAB.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN2 OF 62.An external DNA audit to ensure the Department’s conformance with the FBIDNA Quality Assurance Standards for Forensic DNA Testing is conducted atleast once every two (2) calendar years.1.An external DNA audit could occur as part of an ASCLD/LABaccreditation assessment or could be a stand-alone DNA audit such asthose provided through the DNA laboratory audit program of the NationalForensic Science Technology Center (NFSTC).2.For an external DNA audit to “count,” it must occur at least 6 months, butno more than 18 months, after an internal or external DNA auditconducted during the prior calendar year.3.The audit must be conducted with the version of the FBI DNA QAS auditdocument in effect at the time of the audit.4.The audit document and any Quality Incident Reviews stemming fromnon-conformities identified during the audit are submitted to the DNATechnical Leader(s) for review and for approval of proposed follow-upactions.5.A copy of the DNA audit documentation and laboratory responses to nonconformities is provided to the NDIS Custodian at the FBI within 30 daysof the laboratory’s receipt of the audit report.6.The laboratory maintains the following records from external DNA audits:a.Audit reportsb.Self-verification forms completed by the members of the auditteam to certify their qualifications as auditors and experience withthe DNA technologies and platform(s) used by the Department.Archivedfor2010ManuaB.ls3.Level 1 non-conformities (as defined by ASCLD/LAB) must be correctedto the satisfaction of ASCLD/LAB before a recommendation foraccreditation is made.Corrections for Level 2 non-conformities may commence immediatelyupon discovery. Otherwise, the Department shall obtain approval fromASCLD/LAB to correct the non-conformity prior to the next, annual onsite Surveillance Visit.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSAPPROVED BYPAGE02-09-2010EUGENE LIEN3 OF 6C.External audits outside of normal accreditation assessment or external DNA auditschedules may be required by ASCLD/LAB or the New York State Commissionon Forensic Science as a response to very serious quality incidents.D.The Quality Assurance Manager (QAM) is the point of contact for any externalaudit of the laboratory that concerns the technical operations of the laboratory.lsInternal AuditsManuaThe internal audit program is a critical component of the Department’s managementsystem. It is designed to ensure that the Department’s management system is functioningcorrectly and that the Department is operating is in compliance with its own proceduresas well as regulatory and accreditation requirements.General Internal Audit InformationThe Quality Assurance Manager (QAM) is responsible for scheduling andplanning the internal audits of the laboratory. Scheduling is done inconsultation with the Technical Leaders, Deputy Director(s), and theDirector.a.Should an audit require personnel from external organizations, theQAM will take into consideration the schedule and availability ofthese external auditors prior to agreeing to a date.chiv1.edA.for2010The internal audit program consists of two parts: (1) audits to evaluate the laboratory’sconformance with respect to the management system, including the testing activities, andwith the ISO 17025 and ASCLD/LAB-International Supplemental requirements and (2)DNA audits to evaluate the laboratory’s conformance with respect to the FBI’s QualityAssurance Standards for Forensic DNA Testing Laboratories.ArII.DATE EFFECTIVE2.“ISO” audits are generally scheduled for the first half of the calendar yearand DNA audits are generally scheduled for the second half of thecalendar year.3.The QAM selects auditors to ensure that an audit team is “qualified” asper the requirements for each type of audit.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN4 OF 64.The QAM develops an audit plan that, at a minimum, contains the auditschedule, the activities to be audited, and the audit team(s) assigned toaudit the specified activities. Each audit team has a lead auditor/teamleader.5.The general process for any internal audit is as follows:The QAM notifies the laboratory that an internal audit will beconducted, the general scope of the audit, and provides anapproximate timeframe.The QAM schedules an opening conference with the auditors todiscuss the audit objectives, assignments, timing, and report formatand distribution.The auditors perform their audit activities to assess the soundnessof the quality system, management system, and technicaloperations.The audit teams provide the QAM with their audit findings,including potential non-conformities and observations.The QAM discusses preliminary observations (if any) withmanagement.1) Non-conformities that are non-systemic, are easily corrected,and do not indicate serious deficiencies in the managementsystem can be corrected prior to the completion of the audit.2) The correction is documented in the audit records, but is notincluded in the final audit report.The QAM, Technical Leaders, and other manager(s) as requestedby the QAM review the audit results submitted by the audit teamsand verify the findings that are true non-conformities supported byobjective evidence.The QAM writes the audit report; laboratory managers areinformed.The QUALITY INCIDENT REVIEW procedure is used forfollow-up on audit non-conformities identified in the audit report.If audit non-conformities show that laboratory results may havebeen affected, the laboratory must notify its customers andaccreditation agency of the results, in writing, within thirty (30)days of Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN5 OF 6k.ManuaInformation Specific to Internal “ISO” AuditsThe scope of the internal audit must ensure that all elements of themanagement system are addressed. The QAM or designees may developchecklists to be used by the audit teams.2.Auditors are “qualified” in any of the following ways:a.Documented completion of an ASCLD/LAB-International assessortraining course.b.Documented completion of an external ISO 17025 training courseand auditor training conducted in-house by a qualified auditor suchas the QAM.c.Documented completion of ISO 17025 and auditor trainingconducted in-house by a qualified auditor such as the QAM.3.Only qualified auditors will be selected to lead an internal audit team.Staff that has not completed the required training may be used as teamauditors, but they must report directly to a qualified auditor.20101.C.ArchivedforB.Audit reports may need to be submitted to the NYS Commissionon Forensic Science, ASCLD/LAB, or the board members of theNational DNA Indexing System (NDIS). The Quality AssuranceManager shall ensure timely submission of audit reports whennecessary.Audit reports are a form of records and shall be retained accordingto the guiding principles of the laboratory. See CONTROL OFRECORDS for further information.lsj.Information Specific to Internal DNA Audits1.DNA internal audits are conducted using “The FBI Quality AssuranceStandards Audit for Forensic DNA Testing Laboratories.”2.Auditors are “qualified” to conduct DNA audits if they have successfullycompleted an FBI-sponsored DNA Auditing Workshop/Course.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN6 OF 6The DNA audit team must contain at least one qualified auditor and atleast one person that is, or has previously been, a qualified analyst for eachspecific DNA technology (technology is used to describe the type offorensic DNA analysis performed in the laboratory, such as STR, YSTR, ormitochondrial DNA) performed in the laboratory. This may beaccomplished by having a single auditor who meets all of the specifiedqualifications or through a combination of various members of a multiperson audit team.4.Internal DNA audits are optional in calendar years when external DNAaudits have been conducted.Archivedfor2010Manuals3.Revision History:February 9, 2010 – Initial version of procedure.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF DATADATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN1 OF 2GUIDING PRINCIPLES AND SCOPEWhen computers or automated equipment are used for the acquisition, processing, recording,reporting, storage or retrieval of test data, the laboratory shall ensure that:Calculations and data transfers are subject to appropriate checks in a systematic manner.2.Computer software developed by the laboratory is documented in sufficient detail and issuitably validated as being adequate for use.3.Procedures are established and implemented for protecting the data; such proceduresshall include, but not be limited to, integrity and confidentiality of data entry orcollection, data storage, data transmission and data processing.4.Computer and automated equipment are maintained to ensure proper functioning and areprovided with the environmental and operating conditions necessary to maintain theintegrity of test data.2010Manuals1.forThis section describes the procedures to achieve these guiding principles.edPROCEDUREArchivOnly Department of Forensic Biology staff members have unlimited access to the ForensicBiology network drive. Exceptions may only be granted by the Director or designee. Access iscontrolled by the OCME Management Information Systems (MIS) Department. Unlessotherwise authorized by an existing standard operating procedure, only the Quality AssuranceManager may authorize the release of data to any party (via any means) external to theDepartment of Forensic Biology.Computer software may be used during the processing of case work; however, a copy of theprint-out of the results will be incorporated in case files. The original print-out will bemaintained as a record within the Department of Forensic Biology.Any calculations and data transfers made using computer software are reviewed for its accuracyby a supervisor prior to its incorporation into a case file and/or are reviewed for its accuracyduring the final technical review process of the case file.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF DATADATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN2 OF 2Computer software or software modifications developed by the laboratory (such as simplespreadsheets to calculate data and macros to streamline/transfer data) are suitably validateddepending on the purpose of the modification.The appropriate Technical Leader must be consulted prior to validation to ensure thatsuitable validation tests are carried out.2.If the software is used to streamline/transfer data, sufficient proof must be furnished todocument that the intended purpose of the software is achieved. This may beaccomplished by entering a simple set of data to ensure that the streamline/transfer ofdata is accurate.3.If the software is used to calculate data, sufficient proof must be furnished to documentthat the intended purpose of the software is achieved. This may be accomplished byinputting a simple set of data and comparing it to hand-calculated results to ensure thatthe calculations made are correct.4.Computer software developed by the laboratory must be approved by the appropriateTechnical Leader prior to its use in casework.5.Validation records are stored by the Quality Assurance Unit.edfor2010Manuals1.ArchivOnce calculations and data transfers have been reviewed by a supervisor, they may be deletedfrom the Forensic Biology network drive. For some data, such as DNA electropherograms, boththe print-out and the electronic data will be maintained indefinitely.Revision History:February 9, 2010 – Initial version of procedure.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF NONCONFORMING WORKDATE EFFECTIVEAPPROVED BYPAGE09-24-2010EUGENE LIEN1 OF 2GUIDING PRINCIPLES AND SCOPEAll non-conforming work related to testing must be dealt with upon discovery or at the earliestopportunity so that the work can be appropriately evaluated and corrected, and the QualityIncident Review procedure initiated where necessary.ManualsThis procedure describes the Department’s process for evaluating nonconforming testing workand taking appropriate follow-up action. Technical problems or difficulties can arise in allphases of Department operations. Listing each potential problem is impractical, and this topic isconsidered in general terms.PROCEDUREb.The supervisor evaluates the potential seriousness of the non-conforming work, whetherthe non-conforming work is acceptable, and what must be done to correct the issue.a.The Quality Manager and appropriate DNA Technical Leader are consulted if thenature of the issue indicates that testing work should be halted or test reportswithheld.Ar2.chivc.Rotation supervisors are responsible for the management of technical problemsrelated to the testing of a batch of samples during their assignment.Technical problems related to individual case samples, e.g., a possible samplemix-up, are reported to the affected rotation supervisor, the analyst responsible forthe case, and/or the supervisor of the analyst responsible for the affected case.Management of technical problems identified during routine quality controlactivities such as instrument performance checks is the responsibility of a QualityAssurance supervisor.fora.2010Any member of staff who discovers a technical error or realizes that there is a technicalproblem that may compromise evidence integrity or the accuracy of casework analysismust address the issue immediately or as soon as practicable.ed1.i.ii.iii.The DNA Technical Leader(s) have the authority to suspend DNAanalytical operations for the Department or an individual.The Quality Manager has the authority to suspend serology analyticaloperations for the Department or an individual.The Director, Deputy Director(s) and Assistant Directors are notified assoon as practicable when actions to suspend testing are proposed or taken.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF NONCONFORMING WORKDATE EFFECTIVEAPPROVED BYPAGE09-24-2010EUGENE LIEN2 OF 2b.Non-conforming work must be dealt with as a QUALITY INCIDENT REVIEWwhen the evaluation indicates that:i.ii.Action is taken to correct the issue. Incidents that do not require a formal QualityIncident Review can often be corrected easily, such as by reanalysis.ls3.The nonconforming work could recur, orThere is doubt about the compliance of the Department’s operations withits own management system.The action taken is documented on the batch worksheets, in case notes, or onperformance check worksheets, as appropriate to the situation.Incidents that do not require a formal Quality Incident Review must also bedocumented on the Non-Conformity Reporting Form and forwarded to theQuality Assurance Manager.If the initial action taken fails to correct the problem, the issue should be referredto the Quality Manager and/or appropriate DNA Technical Leader for furtherinvestigation.Manuaa.b.2010c.A manager is consulted if the situation seems to require notification of customer(s) otherthan through normal reporting processes. Special verbal or written notification ofcustomers may be necessary when, for example, non-conforming work affects theusability of a previously issued report.5.Testing that had been suspended is resumed after the technical issues have been resolved.ivedfor4.The DNA Technical Leader(s) have the authority to resume DNA analyticaloperations for the Department or an individual.The Quality Manager has the authority to resume serology analytical operationsfor the Department or an individual.cha.Arb.Revision History:February 9, 2010 – Initial version of procedure.September 24, 2010 – Added step in procedure to document non-conformities on the Non-conformity Reporting Form.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF NONCONFORMING WORKDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN1 OF 2GUIDING PRINCIPLES AND SCOPEAll non-conforming work related to testing must be dealt with upon discovery or at the earliestopportunity so that the work can be appropriately evaluated and corrected, and the QualityIncident Review procedure initiated where necessary.ManualsThis procedure describes the Department’s process for evaluating nonconforming testing workand taking appropriate follow-up action. Technical problems or difficulties can arise in allphases of Department operations. Listing each potential problem is impractical, and this topic isconsidered in general terms.PROCEDUREb.The supervisor evaluates the potential seriousness of the non-conforming work, whetherthe non-conforming work is acceptable, and what must be done to correct the issue.a.The Quality Manager and appropriate DNA Technical Leader are consulted if thenature of the issue indicates that testing work should be halted or test reportswithheld.Ar2.chivc.Rotation supervisors are responsible for the management of technical problemsrelated to the testing of a batch of samples during their assignment.Technical problems related to individual case samples, e.g., a possible samplemix-up, are reported to the affected rotation supervisor, the analyst responsible forthe case, and/or the supervisor of the analyst responsible for the affected case.Management of technical problems identified during routine quality controlactivities such as instrument performance checks is the responsibility of a QualityAssurance supervisor.fora.2010Any member of staff who discovers a technical error or realizes that there is a technicalproblem that may compromise evidence integrity or the accuracy of casework analysismust address the issue immediately or as soon as practicable.ed1.i.ii.iii.The DNA Technical Leader(s) have the authority to suspend DNAanalytical operations for the Department or an individual.The Quality Manager has the authority to suspend serology analyticaloperations for the Department or an individual.The Director, Deputy Director(s) and Assistant Directors are notified assoon as practicable when actions to suspend testing are proposed or taken.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF NONCONFORMING WORKDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN2 OF 2b.Non-conforming work must be dealt with as a QUALITY INCIDENT REVIEWwhen the evaluation indicates that:i.ii.Action is taken to correct the issue. Incidents that do not require a formal QualityIncident Review can often be corrected easily, such as by reanalysis.ls3.The nonconforming work could recur, orThere is doubt about the compliance of the Department’s operations withits own management system.The action taken is documented on the batch worksheets, in case notes, or onperformance check worksheets, as appropriate to the situation.If the initial action taken fails to correct the problem, the issue should be referredto the Quality Manager and/or appropriate DNA Technical Leader for furtherinvestigation.Manuaa.b.A manager is consulted if the situation seems to require notification of customer(s) otherthan through normal reporting processes. Special verbal or written notification ofcustomers may be necessary when, for example, non-conforming work affects theusability of a previously issued report.5.Testing that had been suspended is resumed after the technical issues have been resolved.for20104.The DNA Technical Leader(s) have the authority to resume DNA analyticaloperations for the Department or an individual.The Quality Manager has the authority to resume serology analytical operationsfor the Department or an individual.eda.Archivb.Revision History:February 9, 2010 – Initial version of procedure.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF REFERENCE COLLECTIONSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN1 OF 3GUIDING PRINCIPLES AND SCOPEReference standards and reference materials shall be stored in a manner that ensures theprevention of contamination or deterioration in order to protect their integrity. Procedures forsafe handling, transport, and use of reference standards are outlined below.Reference StandardsManuaA.lsPROCEDUREReference MaterialsivedforReference materials used to conduct intermediate performance checks of instruments andequipment are, where possible, traceable to certified reference materials such as thosefrom the National Institute of Standards and Technology (NIST). Reference materialsthat cannot be traceable to certified reference materials must be certified according tooriginal manufacturer’s specification. Internal reference materials are checked as far as istechnically and economically possible.chWhere possible, reference materials are obtained from sources that can supplyappropriate traceability information such as a Certificate of Analysis.ArB.2010Reference standards of measurement are to be used for calibrations only and for no otherpurpose. Since the laboratory does not conduct any calibrations, reference standards donot exist within the laboratory.Reference materials are stored according to manufacturer’s specifications. If themanufacturer’s specification does not indicate storage conditions, the laboratorydetermines how similar materials are stored within the laboratory and applies thosestorage conditions to the reference materials.Storage conditions must ensure the safe handling and safe transport of referencematerials. Furthermore, storage conditions must minimize contamination ordeterioration, where possible.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF REFERENCE COLLECTIONSDATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN2 OF 3Checks needed to maintain confidence in the calibration status of the reference materialsshall be carried out periodically. Where practical, reference materials must be re-certifiedon or before the expiration date or they must be removed from use. Any referencematerial that does not have an expiration date must be re-certified or removed from useafter one (1) year of its first use.2010Manuals1. Standard Reference Materials (SRMs)The use of standard reference materials is essential to reliable methodology. Thelaboratory will check its DNA typing procedures against an appropriate andavailable SRM annually or whenever substantial changes are made to the typingprocedure. SRMs will be purchased from the National Institute of Standards andTechnology (NIST) and shall have an associated Certificate of Analysis available.The laboratory may choose to use other SRMs to check any of its procedures, butit is not required to do so. SRMs must not be used beyond its expiration dateunless a Certificate of Analysis is issued from NIST to document itsrecertification.chivedforSecondary standards that are traceable to SRMs may be created by the laboratoryfor use in lieu of purchasing them directly from NIST. To create a secondarystandard, a “lot” of DNA samples (such as a blood stain) must be run andanalyzed in parallel with an appropriate NIST SRM. Documentation must bemaintained to demonstrate that the results for the SRM are correct (as comparedto the certificate of analysis) and the results of the secondary standard areconsistent (as compared to a prior result).Ar2. WeightsThe laboratory will conduct intermediate performance checks of balances usingClass 1 weights that are traceable to NIST Standards. Weights must be calibratedprior to the expiration date of the Certificate of Analysis, or must be removedfrom use. Various companies exist that can calibrate weights traceable to NISTStandards. However, the Department of Forensic Biology will endeavor to selecta company that is accredited in accordance with ISO 17025 standards forcalibration laboratories.Prior to each use, analysts should visually inspect the weights to ensure that thereare no physical defects that would affect their performance.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies.
FORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROL MANUALCONTROL OF REFERENCE COLLECTIONSC.DATE EFFECTIVEAPPROVED BYPAGE02-09-2010EUGENE LIEN3 OF 3Reference CollectionsArchivedfor2010ManualsThe laboratory uses a DNA “Lab Types” reference collection for comparison to caseworkDNA profiles to ensure that no exogenous DNA is present in samples and a “suspectdatabase” to determine if there is an association between a named suspect and DNAprofiles from previously tested cases. The use of these reference collections are outlined
QUALITY ASSURANCE / QUALITY CONTROL MANUAL Approving Authority: Eugene Y. Lien, Quality Assurance Manager Procedures Effective Date Revision History Audits and Assessments 2/9/2010 Initial Version of Procedure Control of Data 2/9/2010 Initial Version of Procedure Control of Non-Conforming Work 2/9/2010 Initial Version of Procedure
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This quality assurance manual specifies the methods to prepare and submit Quality Assurance Process Design Diagram for products and parts to be supplied to NSK by suppliers. 2. Purpose Each supplier should prepare quality assurance process design diagram clearly showing the quality assurance methods used in each products and parts production .
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