esh&q division quality assurance and continuous improvement bruce lenzer

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  • ESH&QDIVISION Quality Assurance and Continuous Improvement

    Bruce Lenzer

  • WHAT IS QUALITY?Two historic definitions:1) fitness for use - In order to exhibit quality a material, process, product or service must be fit for the use for which it is intended.2) specification of what is wanted - the production of things aimed at satisfying the specification, and the inspection of the things produced (W. A. Shewhart)In todays regulatory environment, it is no longer sufficient to say that we have a quality product, it must be demonstrated through performance and documentation.

  • 10/24/05 Revision 0*QUALITY DEFINITIONSQuality:The condition achieved when an item, service or process meets or exceeds the users requirements or expectations.Quality Assurance (QA):All those actions that provide confidence that quality is achieved.Quality Assurance Program (QAP):A management system established to assign responsibilities and authorities, define policies and requirements, and provide for the performance and assessment of work.

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  • QA/CI OVERVIEWQuality Assurance PlanIncorporating DOE Contract expectations & industry standardsPolices and Procedures nearing completionQuality Improvement PlanBased in findings from DOE-SURA Overlay ReportFew actions remainingContractor Assurance System Program DescriptionAdded to the contract in the Fall 2007Oversight expectations for the overall contractIncludes ESH, Cyber Security, Integrated Safeguards and Security, and Emergency ManagementManagement Controls

  • WHY DO QUALITY?

  • WHY DO QUALITY?QUALITY BENEFITS INCLUDE: Minimize/eliminate reworkMinimize/eliminate poor value processesImprove the effectiveness/efficiency of processesReduce/avoid unnecessary costsApply technology to optimize performanceMeet customer requirements and expectationsDo it right the first timeSupports safety aspects of quality (e.g. counterfeit parts, material traceability)Collaborative team work (facilitated team etc.)Making better quality decision and creative solutions

  • Quality System BenefitsWell defined and documented procedures improve the consistency of outputQuality is constantly measuredProcedures ensure corrective action is taken whenever defects occur Defect rates decrease Defects are caught earlier and are corrected at a lower cost Process Improvement leads to more cost effective performance Value added vs. non Value added functionsEliminate inefficiencies from temporary situations that have become permanent Eliminate low value functions and develop corrective actions to improve poor value performance Defining procedures identifies current practices that are obsolete or inefficient Documented procedures are easier for new employees to follow Breaks down organizational barriers, fosters win-win solutions, and improves collaborative team performance through team building Improves cross organizational communications and performance

  • What is NOT Quality Assurance?

  • QUALITY & SAFETYINTERFACES

  • QA CRITERIA/ISM PRINCIPLES AND FUNCTION CROSSWALK TABLE

  • 2 Faces of QualityRUBBERGLASSQ/A- COST/EFFICIENCYNon-conforming MaterialReduce Re-work/RejectsSupplier PerformanceOptimize Resources/Budget

    Q/A- SAFETYISMSuspect CounterfeitNon-Conforming Material

  • 10/24/05 Revision 0*QUALITY ASSURANCE CRITERIA

    BASICREQUIREMENTS

    PERFORMANCEMANAGEMENTWORK PROCESSESDESIGN PROCUREMENT INSPECTION & ACCEPTANCE TESTINGMANAGEMENT ASSESSMENTINDEPENDENT ASSESSMENTPROGRAMPERSONNEL TRAINING & QUALIFICATIONQUALITY IMPROVEMENTDOCUMENTS & RECORDSASSESSMENTMore detail on each of the 10 criteria to follow.

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  • WHO IS RESPONSIBLE FOR QUALITY AT TJNAF?The achievement of quality requires that everyone be aware of the impact their function has on TJNAFs ability to do science and meet the labs stated goals and objectives. Quality Assurance involves establishing confidence that operations are performed as required. We may know for a fact that we all do our jobs exactly right, however, without documentation, we cannot prove it. Basically, If you didnt document it, you didnt do it.

  • 10/24/05 Revision 0*RESPONSIBLITIES FOR QUALITY ASSURANCE

    MANAGERSIMPLEMENT FEEDBACKRESPONSIBLE AND ACCOUNTABLE FOR ALL ASPECTS OF QUALITY OF PERFORMANCE, INCLUDING PLANNING, ORGANIZATION, DIRECTION, CONTROL, AND SUPPORT

    ASSESSORSPROVIDE FEEDBACK RESPONSIBLE FOR EVALUATING EFFECTIVENESSTO ACHIEVE QUALITY OF PERFORMANCE, IDENTIFY DEFICIENCIES, AND ENSURE CORRECTIONS

    PERFORMERSRESPONSIBLE FOR ACHIEVING QUALITY OF PERFORMANCE SO AS TO ENSURE SAFETY AND RELIABILITY

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  • JLab QA/CI ORGANIZATION

  • COMPLIANCE REPORTINGNotable Event ReportingOccurrence ReportingNon-compliance Tracking SystemQuarterly Trend AnalysisPerformance Evaluation Measurement Plan Reporting for ESH&Q10 CFR 851 CATS ScreeningCausal AnalysisCorporate Operating ExperienceLessons Learned

  • DOCUMENT MANAGEMENT & TECHNICAL WRITINGManage & Coordinate ESH Manual OverhaulTransferring documents from Framemaker to WordRe-formatting documents to new standardStreamline and simplify DocumentsESH Manual revisions and updatesSupports development and maintenance of QA/CI proceduresFacilitate technical reviews of Policies and ProceduresPerforms technical writing and consulting to authorsControls documents and current versions using DocushareUpdate Web based links

  • ASSESSMENT & CORRECTIVE ACTION MANAGEMENTManage Assessment ProgramIndependent and Management Self AssessmentsAnnual Assessment ScheduleMulti-Year Assessment PlanningCorrective Action ManagementAutomated Quality Information Tracking System/Corrective Action Tracking SystemManage and trend Corrective Action PerformanceQA Inspection ProgramWelding program managementWelding inspectionSupplier EvaluationMaterials AnalysisReceipt Inspection and Acceptance Testing Support

  • VALUE ENGINEERING & CONTINUOUS IMPROVEMENTApplied Quality & Value Management Techniques to Improve Products, Services, and Organizational Effectiveness Facilitated High Performance Work TeamsValue Engineering/Value Analysis/Value ManagementSix SigmaLeanOther Quality Improvement and Problem Solving TechniquesAssessments & Corrective/Preventive Actions

  • OTHER SUPPORT12 GeV Quality Assurance Review 12 GeV Specs. Conduct Supplier Evaluations Quality Assurance ConsultationASME Codes & Standards ConsultingWeld Engineering Consulting

  • APPLYING QA TO YOUR WORK

  • 10/24/05 Revision 0*QUALITY ASSURANCE (QA) UNDERLYING PRINCIPLES Define policies and objectives. Ensure understanding and acceptanceSpecify roles, responsibilities, & authorities. Ensure understanding and accepted.Specify and communicate expectations. Identify & allocate resources to achieve them.Establish a culture that is conducive to quality achievement and continuous improvement.Ensure people are competent at the work they do.Training and qualification

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  • 10/24/05 Revision 0*QUALITY ASSURANCE UNDERLYING PRINCIPLES (continued)Ensure the right people have the right tools and information at the right time.Work Control Docs ATLISSeek and use relevant experience.Plan and control the work.Use the right materials, tools, and processes. Control any changes to them Assess work to ensure it meets expectations. Identify and remedy errors and deficiencies. Periodically review management processes to improve effectiveness and efficiency.

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  • QA/CI CORE TEAMBruce Lenzer, Manager, QA/CI X7586 (blenzer@jlab.org)Mary Jo Bailey, Document Control/Technical Writer X7277 (mbailey@jlab.org)Steve Smith, Compliance Reporting Officer X7007 (sjsmith@jlab.org)Bob Doane, Lead Assessment Specialist X6380 (bobdoane@jlab.org)Senior QA/QC Technical Specialist (TBD)

  • THE QA/CI WEB SITELinks available on the quality assurance/continuous improvement this site lead to information about quality functions and operations. Maint Site: http://www.jlab.org/div_dept/dir_off/oa/Examples include: Assessment schedules and reports Quality Assurance PlanQuality Improvement Plan JSA Requirements Management siteCorrective Action Tracking SystemNotable EventsWork Control DocumentsWelding Procedures

  • QUESTIONS & ANSWERS

  • BACK-UP SLIDES

  • QUALITY ASSURANCE CRITERIA

  • QA CRITERIACRITERIA 1 PROGRAM MANAGEMENTCRITERIA 2 PERSONNEL TRAINING & QUALIFICATION CRITERIA 3 QUALITY IMPROVEMENT CRITERIA 4 DOCUMENTS & RECORDS CRITERIA 5 WORK PROCESSES CRITERIA 6 DESIGNCRITERIA 7 PROCUREMENTCRITERIA 8 INSPECTION & ACCEPTANCE TESTINGCRITERIA 9 MANAGEMENT ASSESSMENTCRITERIA 10 INDEPENDENT ASSESSMENT

  • 10/24/05 Revision 0*QA CRITERIA Management/Criterion 1ProgramEstablish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing work.Establish management processes, including planning, scheduling, and providing resources for work.Key ElementsSenior management ownershipPerformance objectives establishedResponsibilities, authorities, and interfaces establishedIndividuals empoweredApplication based on graded approach

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  • 10/24/05 Revision 0*QA CRITERIA (continued)Management/Criterion 2Personnel Training and QualificationTrain and qualify personnel to be capable of performing assigned work.Provide continuing training to personnel to maintain job proficiency.Key ElementsAffects all personnelStimulate professional developmentDesigned to address specific needsMaintain proficiency and promote improvementCondu