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

How to Implement a Quality How to Implement a Quality Management System?Management System?

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

What Happens (List the steps)

Who’s responsible

Procedure (or another Process)

Results

 1)    

     

 2)     

     

 3)     

     

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  

ProceduresProcedures

AccessibleUp to dateUser friendly- accurate, easy to

follow

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: AssessmentQSE: Assessment

Quality IndicatorsInternal AuditsManagement Review

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

Celebrate Success!Celebrate Success!

Resource MaterialResource Material

ISO documents:• 9001:2000• 15189 NCCLS documents:• GP26-A• GP22-A• HS1- A QMP-LS- OLA Consensus Requirements