Management Review - NIST

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Management ReviewLaboratory Name:Date:Completed By:Participants (Name, Title):Outline1Executive Summary: Changes in Relevant Issues (Internal and External) Fulfillment of Objectives Short-term/Long-term Goals HighlightsSuitability of Policies and Procedures:Quality Management System Documentation Quality Manualo Quality Policy and Objectives (e.g., Competence, impartiality, consistentoperations)Documentation, Process Systems, Procedures, Supporting Documents2, andRecordso Administrative Procedures (SAPs)o Good Measurement Practices (GMPs)o Operating Procedures (SOPs)o Documentary Standards, Technical Procedures, Specifications (ExternalSources)o Softwareo OtherImprovement Opportunities1This report template describes the essential elements required by NIST Handbook 143 (2018) forlaboratory recognition. A management review must be conducted at least once every 12 months, but canoccur more frequently.2See the Laboratory Master List for approved processes, procedures, and supporting documents.NIST Weights and MeasuresPage 1 of 6November 2018

Management ReviewReports:Previous Management Review(s) OutcomeStatus of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsInternal Audits(Quality, Technical, Safety) OutcomeStatus of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsOther Corrective Actions OutcomeStatus of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsExternal Assessments(Recognition, Accreditation, Customers) OutcomeStatus of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsWorkload:Summary of Work Volume, Type, and Changes Customers (New, Returning)Areas of Measurement Scope, Number of ArtifactsTrends (Increases, Decreases)o How has your workload changed (increase/decrease)?o Are you seeing trends in the workload (measurement area, artifact type)?o Are you observing changes in customer requests (frequency, turnaroundtime needed)?o Workload survey. Describe workload comparison with other labs (e.g.,with similar scopes, region)?o Changes in customers (quantity, industry sector)?o Increase/decrease in out of state customers?Opportunities for Improvemento Expand, improve, or discontinue measurement service(s) offered?NIST Weights and MeasuresPage 2 of 6November 2018

Management ReviewCustomer and Personnel Feedback: Sources may include: surveys, direct elicitation, benchmarking, focus groups,social media analysis, customer service notes, correspondence, suggestion box,website analytics, feedback/complaint forms, and cancelled services.Quantity, Trends (increase/decrease)PositiveNegative (Complaints)Status of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsOpportunities for Improvemento Identified customer needs?o Process improvements?Other Relevant Factors:Resource Adequacy(6.1) Describe the level of available resources that enable the laboratory to manage andperform its activities. Personnel (6.2 - Impartiality, competence requirements, selection, training,supervision, authorized signatories, monitoring of competence, demonstratedproficiency)Facilities and Environmental Conditions (6.3 - Suitability, monitoring, control,stability, upgrades, repairs, access, contamination, interference, incompatibleactivities)Equipment (6.4 - Access, handling, transport, storage, maintenance, purchase,repair, suitability)Metrological Traceability (6.5, Annex A)o Standards (e.g., Calibrations needed, purchasing new standards for gaps)o Measurement Assurance (e.g., Control charts, range charts)o Procedures (e.g., Validation of new and laboratory developed)Externally Provided Products and Services (6.6 - Suitability, defining andreviewing requirements, evaluation, selection, acceptance criteria, competence,monitoring performance, re-evaluation)Risk Identification Results Impartiality (4.1 - Activities, organization and personnel relationships, elimination,minimization)Actions to Address Risks (8.5 - Enhance opportunities, avoid threats, prevent orreduce undesirable impacts and potential failures, achieve improvements)o Identified RisksNIST Weights and MeasuresPage 3 of 6November 2018

Management Reviewo Evaluation of the Probability and Impact of Risks (e.g., Risk, probability,impact)o Prioritization and Planned Actionso Define Actions, Treatment of Riskso Describe Integration and Implementationo Evaluation of Effectiveness of ActionsAssurance of the Validity of Results Outcomes[7.7 - Review of results, detectable trends, monitor performance, proficiency testing(PT), and interlaboratory comparison (ILC)] Evaluation and Outcomeso Highlightso Internally Obtained Measurement Assurance Data (GLP 1)o Externally Obtained Measurement Assurance Data (GLP 1) PT Participation Plan (e.g., 5-year plan)Status of Actions (Corrective & Improvement)Evaluation of Effectiveness of ActionsOther Relevant Factors Monitoring Activities Training (e.g., Planned and accomplished training, training application andeffectiveness, personnel competency, authorized signatories, successionplanning)Management Review Outputs:Record all Decisions and Actions Related to: Quality Management System EffectivenessLaboratory Processes EffectivenessImprovement of Laboratory Activities Related to Fulfillment of ISO/IEC 17025,NIST HB 143 (Recognition), and NIST HB 150 (Accreditation)Provision of Required ResourcesAny Need for ChangeNIST Weights and MeasuresPage 4 of 6November 2018

Management ReviewAction Plan3SUMMARY: Corrective Actions (CA) and Improvement Actions (IA) IdentifiedAction TypeaPrioritycCriteriaFindingTypeb andDescriptionRiskAssessmentRoot CauseProposedActionDue DateCompletionDateTaskAssigned ToTaskVerified ByFinal d ByAction Typesa: Corrective Actions (CA) and Improvement Actions (IA)Finding Typesb: Complaint (C), Internal Audit (A), LAP Problems (LAP), Employee Observations (EO).Priorityc:: High 1, Intermediate 2, and Low 33Copy and paste the table as needed for each action item that results from the Management Review.NIST Weights and MeasuresPage 5 of 6November 2018

Management Review Action Plan Log4ActionTypeAction#4TitleDescriptionProposed ActionAssignedToGoalCompletionDateAction Plan Log may be maintained electronically in a spreadsheet or database format.NIST Weights and MeasuresPage 6 of 6November 2018ActualCompletionDate

Improvement of Laboratory Activities Related to Fulfillment of ISO/IEC 17025, NIST HB 143 (Recognition), and NIST HB 150 (Accreditation) Provision of Required Resources Any Need for Change . NIST Weights and Measures Page 4 of 6 November 2018. Management Review

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