Organization

Purpose and Learning Objectives

Purpose:To describe the organizational structure, management roles and

responsibilities, and other factors needed for a successful laboratory
quality management system.
OBJECTIVES
At the end of this session, you will be able to

 Describe organizational elements needed for a quality

management system.
 Discuss management roles and responsibilities in a quality
system.
 Explain the process for designing, implementing, maintaining,
and improving the laboratory quality management system.

 Explain the purpose of a quality manual.

Organization-Module 18 2
 The Quality Management System
Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Organization-Module 18 3
Essential
1. Management committed to a
quality management system.

2. An organizational structure
designed to assure quality goals.

Organization-Module 18 4
 Leadership, Managerial Roles

Organizational
Structure
Planning
Process

Implementation
Monitoring:
Maintenance
and Improvement

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 Leadership
 exercising responsible
authority, while
providing motivation
and vision

 influencing and
encouraging staff
to good performance

Organization-Module 18 6
Management Responsibilities

 implement and continuously improve the

quality management system

 document and
communicate
to all personnel

 provide a
quality manual

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Management Commitment
Finance Manager
Ministry of Health

Staff
Staff
Meetings
Meetings

Organization-Module 18 8
Organizational Structure

establish a working structure that

ensures sufficiency at all parts in the
laboratory work flow
designate responsibilities and roles;
develop an organization chart
designate a Quality Manager
allocate sufficient resources

Organization-Module 18 9
 Path of Workflow
THE PATIENT Test selection Sample Collection

Preexamination Phase

Sample Transport

Laboratory Analysis
Examination Phase

Report Transport Report Creation

Result Interpretation Postexamination Phase

Organization-Module 18 10
 HOSPITAL DIRECTOR

LABORATORY
DIRECTOR NURSING
DIRECTOR

CHARGE QUALITY
TECHNOLOGIST MANAGER

ASSISTANT CHARGE
NURSING

TECHNOLOGIST TECHNOLOGIST

Organization-Module 18 11
Quality Manager
 ISO 15189 requirement
 has responsibility and authority to
oversee compliance
 reports directly to the decision-
making level of laboratory
management

Organization-Module 18 12
Quality Manager Responsibilities
 monitor quality management system
 assure compliance
 review all records
 conduct, coordinate audits
 investigate deficiencies
 inform decision makers

Organization-Module 18 13
Planning for Quality Management
System
 approaches vary
with local situation
 many factors influence
starting point
 include all quality
elements in plan
 may implement in stepwise process
Organization-Module 18 14
Keep in mind
 communicate, be transparent
 set feasible timelines

 develop realistic,
measurable objectives
 set priorities,
proceed stepwise

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Conduct Gap Analysis
 determine the gaps, using quality management
systems checklist
 develop a task list
— GAP ANALYSIS —
 prioritize by:
 quick fixes first
 determine what
would have the
greatest positive impact

Organization-Module 18 16
Gap Analysis
Common problems identified
 test ordering
 sample management
 training level (competence)
of technical staff
 quality control
 analytical process
 recording and reporting results
 reagent and equipment management

Organization-Module 18 17
Written Quality Management
System Plan should include
 what should be done
 who will be responsible
 when (timeline)
 how many resources are needed
 benchmarks
Must be available to all staff

Organization-Module 18 18
Implementation

 commit to completion
 prepare for implementation in stages
 assure resources are available
 use a Gantt chart
 be sure everyone knows their responsibility

then BEGIN

Organization-Module 18 19
 Gantt Chart

Organization-Module 18 20
Provide Resources
 financial requirements/budget
 personnel needs
 additional staff

 skills, training needed

 facilities, equipment,
supplies, computers

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 Monitoring Compliance
 assign responsibility
 develop indicators
 establish monitoring
system
 conduct audits
 management review

Organization-Module 18 22
Internal Audit

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 What is a Quality Manual?
A document describing the quality
management system of an
organization.

 essential organizational step

 management responsibility

Organization-Module 18 24
Quality Manual
 communicates information
 serves as a framework for meeting
quality system requirements
 demonstrates management’s
commitment to quality
QUALITY

Organization-Module 18 25
Maintaining the Quality Manual

 communicates quality policy

 needs management approval
 requires updating

Organization-Module 18 26
Successful implementation requires
 having management commitment
 understanding the benefits of a quality
management system
 engaging staff at all levels
 striving to
continually improve
 having realistic
expectations

Organization-Module 18 27
Intent to Action
Q
M ual
an ity
ua
l

Organization-Module 18 28
Intent to Action
 assign responsibility for implementation
 allocate resources
 develop and distribute a quality manual
 implement quality system
 monitor compliance with quality
management system requirements

Organization-Module 18 29
Remember
 Quality is not a science,
it’s a way of thinking.
 Spend time today to
gain rewards tomorrow:
quality results
efficiency
professional, personal satisfaction
peer recognition

Organization-Module 18 30
 Who is Responsible for Quality?

EVERYONE!

Organization-Module 18 31
 Organization Personnel Equipment

Purchasing Process Information

Questions?
& Control Management
Inventory

Comments?
Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Organization-Module 18 32
Questions 1
 1. The role of the quality manager usually
includes:
A.running quality control samples as a part of the
testing process
B.monitoring all aspects of the quality system
C.assuring that adequate resources are available
for quality system processes and procedures
D.hiring highly competent staff for the laboratory

Organization-Module 18 33
QUESTION2
 A. When planning for the establishment of a quality
system in the laboratory, it is important to:
 B.inform laboratory staff after completion of the initial
plan, so as to avoid confusion
 C.use a computer-based tracking system
 D.be prepared to implement all steps of the plan
immediately
 E.include all twelve quality elements in the plan

Organization-Module 18 34
QUESTION 3
 A.A quality manual:
 B.establishes the quality policies for the
laboratory
 C.should be printed and widely distributed
 D.should never be changed, as it provides
the framework for the quality system
 E.must include all test procedures

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