ࡱ> i J"bjbj .{b{bJ"J"J"J"J"^"^"^"8"\",^"r$$^|$|$|$%.%% wryryryryryryr$twrJ"(%%((rJ"J"|$|$4r,,,(J"|$J"|$wr,(wr,,hm|$Ptn^)vj8crr0rjx)xpmxJ"m%vt&T,&D '%%%rrp+N%%%r((((x%%%%%%%%%B !:  Occurrence Management PolicyPolicy NumberDoc10-14AppHEffective Date30-Jul-08Approval Signature: Laboratory DirectorSupersedesNewLast Review10-Feb-20Review byHeidi HanesSMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your labs specific processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol policies when considering the application of this document. If you have any questions contact SMILE.QSE 8: Occurrence Management - Policy PolicyThe laboratory identifies, documents, and investigates occurrences (nonconformances); classifies, analyzes, and trends the information they represent; performs remedial/corrective actions; and identifies the need for root cause analysis and process improvement.PurposeThis policy provides direction for the processes and procedures to effectively detect and resolve problems and to classify problems so that corrective actions aimed at removing root causes and improving processes can be planned and implemented. ResponsibilityThe Laboratory Supervisor is responsible for problem resolution and investigations. The Quality Manager and Quality Management Team are responsible for collecting and analyzing occurrence data. The Lead Technologists are responsible for documentation of complaints and problem resolution.Identifying OccurrencesThe laboratory has a means to identify, document, investigate, and respond to complaints from internal/external customers; recalls of materials, equipment, or software; and other nonconforming events.Investigation and Response to OccurrencesThe laboratory has a procedure for identifying, documenting, and investigating occurrences and performing remedial and corrective actions in response to those nonconforming events.Classifying and Analyzing Occurrence InformationThe laboratory has a procedure for classifying and analyzing occurrences, including trending information, so that the portions of the path of workflow with the most important patient-related and costly problems can be identified, corrected, and referred for root cause analysis and process improvement.Supporting DocumentsThe following processes support this policy: Identifying and Documenting Occurrences Remedial Actions and Investigation of Occurrences Analyzing Occurrence Information and Referring for Root Cause Analysis and Process Improvement Identifying and Documenting Occurrences - Process Process for Identifying and Documenting Occurrences What HappensWhos ResponsibleProceduresThe laboratory identifies or receives complaints from internal and external customersLaboratory Supervisor Quality Manager Technicians/Technologists External CustomersCommunication of Safety and Quality ConcernsThe laboratory receives recalls or notification of nonconformances as related to materials, equipment, or softwareLaboratory Supervisor Laboratory Supply ManagerInventory Management Communication of Safety and Quality ConcernsA nonconforming event is identified from internal/external audits, QC/Calibration/EQA failures, or management reviewsLaboratory Director Laboratory Supervisor Quality Manager Technicians/TechnologistsAudit-Related SOPs EQA SOPs Quality Management Communication of Safety and Quality ConcernsThe occurrence is documented on appropriate electronic or paper-based occurrence report formLaboratory Supervisor Quality Manager Technicians/TechnologistsCommunication of Safety and Quality ConcernsThe form is submitted to the designated individual for further action, including remedial/corrective actions, root cause analysis, and process improvementLaboratory Supervisor Quality Manager Technicians/TechnologistsCommunication of Safety and Quality Concerns Quality Management Process Improvement Remedial and Corrective Actions Remedial Actions and Investigation of Occurrences - Process Process for Remedial Actions and Investigation of Occurrences What HappensWhos ResponsibleProceduresImmediate remedial actions are initiated to resolve any immediate concerns related to patient careLaboratory Supervisor Quality Manager Technicians/TechnologistsCommunication of Safety and Quality Concerns Investigations of Occurrences Remedial and Corrective ActionsRemedial actions are documented on the occurrence report formLaboratory Supervisor Quality Manager Technicians/TechnologistsInvestigations of Occurrences Quality Management Remedial and Corrective ActionsThe occurrence is investigated and documentation is completedLaboratory Supervisor Quality Manager Quality Management TeamInvestigations of Occurrences Quality ManagementAdditional corrective or preventive actions are completed and documentedLaboratory Supervisor Quality Manager Quality Management Team Technicians/TechnologistsInvestigations of Occurrences Quality Management Technical SOPs Remedial and Corrective ActionsOccurrence report form is submitted to designated individual for additional occurrence analysisLaboratory Supervisor Quality Manager Quality Management TeamQuality Management Process Improvement Analyzing Occurrence Information and Process Improvement Referral - Process Process for Analyzing Occurrence Information and Process Improvement Referral What HappensWhos ResponsibleProceduresInformation regarding individual occurrences is entered into an electronic or paper-based databaseQuality Manager Quality Management TeamCommunication of Safety and Quality Concerns Occurrence Report Forms Quality Management Occurrence Data Analysis Process ImprovementOccurrences are categorized, tracked, and organized in a manner to facilitate analysis of collective dataQuality Manager Quality Management TeamOccurrence Data Analysis Quality Management Process ImprovementDatabase and occurrence report information are reviewed at regular intervals to identify trends in occurrence informationQuality Manager Quality Management Team Occurrence Data Analysis Quality Management Process ImprovementManagement reviews data and allocates resources for root cause analysis and process improvementQuality Manager Quality Management Team Laboratory ManagementQuality Management Occurrence Data Analysis Process Improvement Allocation of Resources     SMILE Johns Hopkins University 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