Quality Assurance Quality Control Procedures Manual
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGYQUALITY ASSURANCE / QUALITY CONTROLMANUALApproving Authority: Meredith Rosenberg, Quality Assurance ManagerWorking version as of 04/15/2016Table of ContentsAudits and Assessments . 3I.II.External Audits/Assessments . 3Internal Audits . 5Control of Data . 9Control of Non-Conforming Work . 11Identifying Non-Conforming Work . 11Non-Conformity Reporting Form . 12Response to Non-Conformities (Corrective Actions) . 15Control of Reference Collections . 19Court Testimony Monitoring . 22Equipment Calibration and Maintenance . 25A.B.C.D.E.Critical Equipment . 25Non-Critical Equipment . 26General Preventative Maintenance. 26Equipment Decontamination . 26Instrument Irregularities . 27Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERExogenous DNA Prevention . 28A.B.C.D.E.F.G.Facility. 28Laboratory Clean-up . 28Sample Processing. 29Personal Protective Equipment (PPE) . 29Contamination Prevention Equipment (CPE) . 29Identification . 29Interpretation and reporting . 30Lab Types Database . 31A.Sample Collection . 31B.Sample Processing. 32C.Sample Disposition . 32D.Database Maintenance. 33E.Lab Types Reference Databases . 33F. Searching the Lab Types Database . 34Preventive Action . 35Proficiency Testing Program. 37A.B.C.DNA Open-External Proficiecy Testing Program . 37Serology Open-External Proficiency Testing Program . 40Blind Re-analysis Proficiency Testing Program . 40Quality Incident Review . 42A.B.C.Quality Incident Reporting . 43Quality Incident Review. 44Close-out of Quality Incident Reviews . 45Reagents . 46A.B.C.D.E.Reagents Prepared In-House . 46Commercial Reagents . 47Reagent Quality Control Testing. 48Reagent Records . 49REAGENTS USED BY THE DEPARTMENT . 50Validation . 54A.B.C.D.E.Developmental Validation. 55Internal Validation. 55Review and Approval of Validation. 56Training . 57Storage of Validation Records . 57Quality 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. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager3 OF 57Audits and AssessmentsGUIDING 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.An 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.This document describes the external audits/assessments to which the Department of ForensicBiology is subject and the internal audit program of the Department.PROCEDUREThe management system of the Department of Forensic Biology is designed to conform to thefollowing sets of standards:ASCLD/LAB-International Standards: The ASCLD/LAB-International Standardsencompasses the ISO/IEC 17025 requirements and the ASCLD/LAB-International SupplementalRequirements.FBI 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. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager4 OF 572.3.B.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.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 QualityAssurance Manager and the DNA Technical Leader(s) for review and forapproval of proposed follow-up actions.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.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSII.DATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager5 OF 57C.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.Internal AuditsThe 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.The 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.A.General Internal Audit Information1.The 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.2.“ISO” audits and DNA audits are scheduled to occur each calendar 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. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager6 OF 574.Each audit team has a lead auditor/team leader. The QAM and the leadauditor/ team leader develop an audit plan that, at a minimum, contains theaudit schedule, the activities to be audited, and the audit team(s) assignedto audit the specified activities.5.The general process for any internal audit is as follows:a.b.c.d.e.f.g.h.i.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 lead auditor/ team leader writes the audit report. The QAMreviews the audit report. The laboratory managers are informed.The CONTROL OF NON-CONFORMING WORK procedureand/or 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 discovery.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager7 OF 57j.k.B.C.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.Information Specific to Internal “ISO” Audits1.The 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.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. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALAUDITS AND ASSESSMENTSDATE EFFECTIVEAPPROVED BYPAGE12-24-2015Quality Assurance Manager8 OF 573.The 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.Revision History:February 9, 2010 – Initial version of procedure.May 1, 2015 – Updated section to reflect current practices.December 24, 2015 – Removed phrase “as needed” from Section II. A. 2.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALCONTROL OF DATADATE EFFECTIVEAPPROVED BYPAGE07-16-2012Quality Assurance Manager9 OF 57Control of DataGUIDING 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:1.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.This section describes the procedures to achieve these guiding principles.PROCEDUREOnly 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, the results will beincorporated into the case record.Any calculations and data transfers made using computer software are reviewed for its accuracyby a supervisor prior to its incorporation into a case record and/or are reviewed for its accuracyduring the final technical review process of the case.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALCONTROL OF DATADATE EFFECTIVEAPPROVED BYPAGE07-16-2012Quality Assurance Manager10 OF 57Computer software or software modifications developed by the laboratory are suitably validateddepending on the purpose of the modification.1.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.Once 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, theelectronic data will be maintained indefinitely.Revision History:February 9, 2010 – Initial version of procedure.July 16, 2012 – Specific terminology was removed and replaced with generic terminology to accommodate LIMS.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALCONTROL OF NON-CONFORMING WORKDATE EFFECTIVEAPPROVING AUTHORITYPAGE04-15-2016QUALITY ASSURANCE MANAGER11 OF 57Control of Non-Conforming WorkGUIDING PRINCIPLES AND SCOPENon-conforming work is any testing work which does not meet the Department of ForensicBiology’s stated standards, either with respect to mode of execution or outcome. All nonconforming work must be addressed upon discovery so that the work can be appropriatelyevaluated, corrected as needed and prevented in the future.This procedure describes the Department’s process for evaluating non-conforming work,performing root cause analyses and taking appropriate follow-up action. Technical problems ordifficulties can arise in all phases of Department operations. Listing each potential problem isimpractical, therefore this topic is considered in general terms.Apparently similar situations may result in different follow-up actions. This is because notwo circumstances are exactly the same and the consequences of the particular nonconformity may be very different.Identifying Non-Conforming Work1.Any member of staff who discovers a technical, analytical or clerical error or realizes thatthere is a technical, analytical or clerical problem that may compromise evidence integrity, theaccuracy of casework analysis or results reported, must address the issue immediately. Theanalyst who discovers the non-conformity or the supervisor to whom the incident is reportedbecomes the principal investigator of the non-conformity. Situations may arise where an analystthem self may discover their own error. When this occurs, the analyst may become the principalinvestigator and write up the non-conformity for review by their direct supervisor AND theQuality Assurance Manager. The principal investigator is tasked with investigating andevaluating the significance of the non-conforming work.a.Technical problems related to the testing of a batch of samples are reported toa supervisor. As multiple analysts and/or cases may be affected, corrective actionsmay be documented on the batch worksheets, via LIMS deviations or via emailsto analysts’ whose cases are affected. Detection of exogenous DNA in negative controls is reported to a QualityAssurance Supervisor. Note: Determination of the source of exogenousControlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALCONTROL OF NON-CONFORMING WORKDATE EFFECTIVEAPPROVING AUTHORITYPAGE04-15-2016QUALITY ASSURANCE MANAGER12 OF 57DNA where less than 8 alleles are seen in at least 4 loci is difficult and maynot be feasible.b.Technical problems related to individual case samples (e.g., possible samplemix-up) are reported to a supervisor, the analyst(s) assigned to the affectedcase(s), the supervisor(s) of the affected case(s) AND the Quality AssuranceManager.c.Analytical or Clerical errors affecting reported results (e.g., errors inconclusions drawn from analytical results or incorrect recording or transcribing ofobservational or analytical results) are to be reported to the case analysts’ directsupervisor and/or Assistant Director as well as the Quality Assurance Manager.d.Technical problems identified during routine quality control activities, suchas instrument performance checks, are reported to a Quality Assurance supervisorand are reported on the performance check worksheets.Non-Conformity Reporting Form Some non-conforming work can be easily corrected, such as by reanalysis. Anexample of this would be a sample that fails to give interpretable peaks in anelectrophoresis run, but when re-injected an acceptable result is obtained. In suchcases the action is documented on the batch worksheets, in case notes, or onperformance check worksheets, as appropriate to the situation, but no furtherinvestigation is likely to be needed unless the incident was part of a pattern. In suchcases, a Non-Conformity Reporting Form does not need to be filled out. Some non-conforming work, such as contamination incidents or analyst errors inreporting case results require more investigation as to the scope and cause of thenon-conformity. The incident and its evaluation are documented on the NonConformity Reporting Form. Should the cause of the non-conformity be attributed to an individual, theNon-Conformity Reporting Form must be completed by both theprincipal investigator and the immediate supervisor of the individual (ifnot already involved as the principal investigator).Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL EXAMINERFORENSIC BIOLOGY QUALITY ASSURANCE/QUALITY CONTROLMANUALCONTROL OF NON-CONFORMING WORKDATE EFFECTIVEAPPROVING AUTHORITYPAGE04-15-2016QUALITY ASSURANCE MANAGER13 OF 57When a non-conformity has been discovered, the investigation shall proceed in one of twoways. It MUST first be determined by the principle investigator in whichmanner the non-conformity investigation shall proceed. The two routes a nonconformity investigation may take are as follows:1. It must be determined whether or not a “Significant Event” has occurred. Such“Significant Events” (as indicated in Section 17-207 of Chapter 2 of Title 17 of theAdministrative Code of the City of New York) include: Intentional fabrication of work product, evidence examination, analysis or testresults. Significant error(s) by an employee, or deficiency in a system or procedure thatmay have affected the accuracy of reported results of evidence examination or theaccuracy of the reported results of analysis in one or more cases. Failure of an employee to follow protocol such that it may have affected theaccuracy of reported results of evidence examination or the accuracy of thereported results of analysis in one or more cases. Statements made in the course of testimony by which an employee significantlymisrepresents or misstates her/his education, experience, training orqualifications, or the reported results of any evidence examination or analysis.IF it has been determined by the principle investigator that a “Significant Event” hasoccurred, the non-conformity investigation must then proceed as follows:1. The principle investigator of the non-conformity MUST IMMEDIATELY informthe Quality Assurance Manager that a non-conformity on a “Significant Event” levelhas occurred. The Quality Assurance manager will assess the non-conformity todetermine if indeed a “Significant Event” has occurred.a. If a “Significant Event” is found to have occurred, the Quality AssuranceManager MUST IMMEDIATELY inform the Office of Chief MedicalExaminers’ Root-Cause Analysis Officer of the “Significant Event” and theprincipal investigator shall begin to document the non-conformity on the NonConformity Reporting Form.Controlled versions of Department of Forensic Biology Manuals only exist electronically on theForensic Biology network. All printed versions are non-controlled copies. NYC OFFICE OF CHIEF MEDICAL EXAMINER
NYC OFFICE OF CHIEF MEDICAL E
FBI Quality Assurance Standards for Forensic DNA Testing: The FBI Quality Assurance Standards for Forensic DNA Testing is issued by the FBI Director and is a set of standards specif
critical issues the University has established a Quality Assurance Directorate, which is mandated to develop a Quality Assurance Framework and a Quality Assurance Policy. The Quality Assurance Framework would clearly spell out the Principles, Guidelines and Procedures for implementing institutional quality assurance processes.
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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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Quality Assurance and Improvement Framework Guidance 2 Contents Section 1: Quality Assurance and Improvement Framework 1.1 Overview 1.1.1 Quality Assurance (QA) 1.1.2 Quality Improvement (QI) 1.1.3 Access 1.2 Funding Section 2: Quality Assurance 2.1 General information on indicators 2.1.1 Disease registers 2.1.2 Verification
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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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