Developing a Quality Management System
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Transcript Developing a Quality Management System
Developing a Quality
Management System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
Today’s Presentation
LLSG profile
Implementation Plan
Outline Quality System Essentials
Review: Where are we?
Outline the next steps
London Laboratory Services Group
Joint venture between LHSC and SJHC
Pathology and Laboratory Medicine
Program
9 disciplines
55 laboratories
4 campuses
500 employees
What is a Quality
Management System
ISO 9000 defines a QMS as:
“ Management system to direct and
control an organization with regard
to quality”
Why Quality Management
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
Management System?
LLSG 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 Essentials
Organization
Personnel
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Equipment
Purchasing/Inventory
Process Control
Documents/Records
Occurrence Mgmt
Internal Assessment
Process Improvement
Service and Satisfaction
Facilities and Safety
Information Management
Quality system essentials apply
to all operations in the path of
workflow
QSE: Documents and Records
Document
-
-
-
create
identify
change
approve
file
distribute
archive
Management System
Hierarchy of Documents
Policy
Process
Procedures
Forms
What to do
How it happens
How to do it
Records
Policy Development
Quality Policies
-
QSE’s
Map OLA requirements
Policy statement
Responsibility
Supporting statements
Supporting processes
- included in procedures
-
-
Operational Policies
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.
SECTION
SUPPORTING STATEMENTS
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:
Supporting
Documents
List the processes that support this policy:
Process Mapping
Address the path of workflow
Describe how things happen here
Flow Charts or Tables
What Happens
(List the steps)
1)
2)
3)
Who’s
responsible
Procedure (or
another Process)
Results
Procedure Development
Identified from process mapping
Templates developed based on NCCLS
guidelines
Used for analytical and non analytical
procedures
PURPOSE
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS
APPENDICES
This procedure gives instructions……
Procedures
Accessible
Up
to date
User friendly- accurate, easy to
follow
QSE: Process Control
Laboratory processes and procedures
Validation
Establishing Reference Intervals
Quality Control
Internal and External QA
Method Comparability
Accreditation
QSE: Occurrence Management
Quality Control: Corrective Action
External and Internal Quality Assurance
Turn Around Time (TAT) delay
Discrepant Results
Corrected Results
Specimen Rejection Criteria
QSE: Information Management
Results Reporting
Release of Results
Computer Procedures
Change Approval
Computer QA
Computer Security
Computer Validation
QSE: Purchasing and Inventory
Inventory Control System
External Services
Purchasing Documents
Material Resources
QSE: Safety
Safety Officer, Safety Committee
Safety Manual
Audit and Inspections
Reporting Incidents, Accidents, Illness
Training
Personnel Responsibilities
QSE: Facilities
Location and design
Environmental Conditions
Access
Communication Systems
Storage
Computer Environment
QSE: Equipment
Equipment selection, calibration,
verification, validation
Inventory
Equipment operation maintenance and
records
Defective Equipment
QSE: Personnel
Job Description and
Qualifications
Training
Competence
Continuing Education
Personnel Records
Performance Appraisal
QSE: Organization
License
Mission Statement
Accreditation
Organizational Structure
Resource Allocation
Referral Laboratories
QSE: Assessment
Quality
Indicators
Internal Audits
Management Review
QSE: Process Improvement
Quality
Improvement Activities
Occurrence management
Problem Solving
QSE: Service and Satisfaction
Customer
Satisfaction (Complaints)
Internal and external
Where are We?
Quality Team
Quality policies developed
Processes identified/mapped
Procedures written
Document Management System
Quality Manual
Web site for referral labs
Where are We?
Discipline Task Teams
GAP analysis
Processes mapped
Procedures written
Revisit requirements and close GAP
What’s Next?
Quality Team to continue to address
QSE
Discipline Task Teams to complete
sections of OLA requirements
Educate and train staff
Perform self assessment
Celebrate Success!
Resource Material
•
•
•
•
•
ISO documents:
9001:2000
15189
NCCLS documents:
GP26-A
GP22-A
HS1- A
QMP-LS- OLA Consensus Requirements