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Developing a Quality Developing a Quality Management SystemManagement System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
Today’s PresentationToday’s Presentation
LLSG profileImplementation PlanOutline Quality System EssentialsReview: Where are we? Outline the next steps
London Laboratory Services GroupLondon Laboratory Services Group
Joint venture between LHSC and SJHCPathology and Laboratory Medicine
Program9 disciplines55 laboratories4 campuses500 employees
What is a Quality What is a Quality Management SystemManagement System
ISO 9000 defines a QMS as:
“ Management system to direct and control an organization with regard to quality”
Why Quality Management Why Quality Management System?System?
QMP-LS: Quality Management Program – Laboratory Services; Ontario Laboratory Accreditation (OLA)
Consistent with international trends and laboratory science
We are committed to providing the highest level of care to the patient
LLSG Implementation PlanLLSG Implementation Plan Quality Coordinator Discipline Task Teams Quality Team Develop Policies GAP analysis Map Processes Write procedures Quality Manual Communicate/Educate/Train Audit Accreditation
Structure for a Quality system
Quality System EssentialsOrganization
Personnel
Equipment
Purchasing/Inventory
Process Control
Documents/Records
Occurrence Mgmt
Internal Assessment
Process Improvement
Service and Satisfaction
Facilities and Safety
Information Management
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Quality system essentials apply to all operations in
the path of workflow
QSE: Documents and RecordsQSE: Documents and Records
Document Management System- create - identify- change- approve- file - distribute - archive
Hierarchy of DocumentsHierarchy of Documents
Policy
Process
Procedures
Forms
What to do
How to do it
How it happens
Records
Policy DevelopmentPolicy Development
Quality Policies- QSE’s- Map OLA requirements- Policy statement- Responsibility- Supporting statements- Supporting processes
Operational Policies
- included in procedures
POLICY STATEMENT:
PURPOSE:
This policy provides the direction for the processes and procedures to….
RESPONSIBILITY(use those that apply)
Program Leader/Discipline Leader/Section Head is responsible for Lab Manager is responsible for Technical Specialist/Coordinator is responsible for Staff members are responsible for Other:
The following sections are derived from the OLA requirements. They determine the supporting statements for the policy. There should be one section and related statement for the major categories defined in the requirements. Make a broad statement about the Laboratory's intentions for the sections below.
References:
NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline QMP-LS- Ontario Laboratory Accreditation Requirements Others:
SupportingDocuments
List the processes that support this policy:
SECTION SUPPORTING STATEMENTS
Process MappingProcess Mapping
Address the path of workflowDescribe how things happen hereFlow Charts or Tables
Procedure DevelopmentProcedure Development
Identified from process mappingTemplates developed based on NCCLS
guidelinesUsed for analytical and non analytical
procedures
PURPOSE This procedure gives instructions……
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS
APPENDICES
QSE: Process ControlQSE: Process Control
Laboratory processes and procedures Validation Establishing Reference Intervals Quality Control Internal and External QA Method Comparability Accreditation
QSE: Occurrence ManagementQSE: Occurrence ManagementQuality Control: Corrective Action External and Internal Quality AssuranceTurn Around Time (TAT) delayDiscrepant ResultsCorrected ResultsSpecimen Rejection Criteria
QSE: Information ManagementQSE: Information Management
Results ReportingRelease of Results Computer ProceduresChange ApprovalComputer QAComputer SecurityComputer Validation
QSE: Purchasing and InventoryQSE: Purchasing and Inventory
Inventory Control SystemExternal ServicesPurchasing DocumentsMaterial Resources
QSE: SafetyQSE: Safety
Safety Officer, Safety CommitteeSafety ManualAudit and InspectionsReporting Incidents, Accidents, IllnessTraining Personnel Responsibilities
QSE: FacilitiesQSE: Facilities
Location and designEnvironmental ConditionsAccessCommunication SystemsStorageComputer Environment
QSE: EquipmentQSE: EquipmentEquipment selection, calibration,
verification, validation InventoryEquipment operation maintenance and
recordsDefective Equipment
QSE: PersonnelQSE: PersonnelJob Description and
QualificationsTrainingCompetenceContinuing EducationPersonnel RecordsPerformance Appraisal
QSE: OrganizationQSE: OrganizationLicenseMission StatementAccreditationOrganizational StructureResource AllocationReferral Laboratories
QSE: Process ImprovementQSE: Process Improvement
Quality Improvement ActivitiesOccurrence managementProblem Solving
QSE: Service and SatisfactionQSE: Service and Satisfaction
Customer Satisfaction (Complaints)Internal and external
Where are We?Where are We?
Quality TeamQuality policies developedProcesses identified/mappedProcedures writtenDocument Management System Quality ManualWeb site for referral labs
Where are We?Where are We?
Discipline Task TeamsGAP analysisProcesses mappedProcedures writtenRevisit requirements and close GAP
What’s Next?What’s Next?
Quality Team to continue to address QSE
Discipline Task Teams to complete sections of OLA requirements
Educate and train staffPerform self assessment