organization. 2 problem scenario develop an organizational chart for your laboratory showing lines...
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ORGANIZATION
2
Problem scenario
Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to all laboratory staff.
Design each line’s responsibility for quality.
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The Quality System
Process Control
(Quality Control & Specimen
Management)
Purchasing & Inventory
AssessmentOccurrence
Management
Information Management
Process Improvement
Customer Service
Facilities & Safety
Organization Personnel Equipment
Documents & Records
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Learning Objectives
At the end of this session, you will be able to: Describe organizational elements needed for
quality system management Discuss management roles and responsibilities
in a quality system Understand the process for designing,
implementing, maintaining, and improving the laboratory quality system
Explain the purpose of a quality manual
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Essential:
1. management committed to quality system and,
2. an organizational structure designed to assure quality goals
1. Leadership, managerial roles
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Leadership
Exercising responsible authority, while providing motivation and vision
Influencing and encouraging staff to good performance
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Management Responsibilities
Design, implement, maintain and continuously improve the quality management system
Document and communicate policies, processes, programs, procedures, and instructions to all relevant personnel
Provide a quality manual describing the quality management system
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Management Commitment
Seek support from upper management
Identify appropriate management level
Must involve those making financial
decisions
Communicate commitment of laboratory
managers to staff
2. Organizational structure
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Organizational Structure
Establish a working structure that ensures efficiency and high quality at all points in the laboratory workflow
Designate responsibilities, define roles of all staff, develop organizational chart
Designate a quality manager Allocate sufficient resources to assure that
personnel and infrastructure needs are met
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Example – organizational chart
Director
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Quality Manager
Quality manager vital to quality system implementation, required under ISO 15189
Delegated responsibility and authority to oversee compliance
Reports directly to the decision-making level of laboratory management
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Quality Manager Responsibilities
• Monitor all aspects of the quality system• Regularly review records, quality control
and other data, EQA performance• Conduct audits to assess compliance with
quality policies and procedures• Investigate deficiencies• Assure that decision makers are informed• Coordinate on-site inspections of
monitoring or accrediting agencies
3. Planning
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Planning for Quality System
• Approaches to developing a quality
system vary with local situation
• Many factors influence starting point
• Plan includes all quality elements
• May implement in stepwise process
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Planning: General rules
Don’t go too fast, don’t demoralize staff Do not neglect communication Analyze the situation, present the conclusions Be transparent Manage priorities, deal with biggest problems Work on realistic, measurable objectives Move forward step by step Do not work on factors over which you have little
influence
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Conduct Gap Analysis
• Determine the gaps in your current quality practices, using quality systems checklist
• Develop a task list using identified gaps• Prioritize filling these gaps by –
Considering quick fixes first Determining what would have the greatest
positive impact
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Reminder and general direction:Factors influencing quality
Areas usually needing corrective action: Test ordering Specimen management Training level of technical staff Reagent and equipment management Insufficiency of control procedures Analytical process Interpretation of raw results Transcription and transmission of the results Interpretation and use of the results
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Quality System Plan
Written quality system plan should include: What should be done
Who will be responsible
Timeline
What resources are needed
Benchmarks
Must be available to all staff
4. Implementation
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Implementation
• Commit to completion• Estimate time needed based upon
available resources• Prepare for implementation in stages• Stagger start dates• Determine resource requirements• Developing a Gantt chart can be useful
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IDTask Name
1 Quality System Implementation
2 Quality system planning
3 Training
4 5 6
Prepare Quality Manual
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Schedule audits 8 910
Implementation
Update Quality Manual
Jun Jul AugSep Oct Jan Feb May Jul Sep Oct2003 2004
Gantt Chart
Document Procedures
Approval of Quality Manual
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Consider Resource Requirements
Financial requirements / budget Personnel needs
Additional staff Skills, training needed
Facilities, equipment, supplies, computers
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Implementation Exercise
Post-it exercise Purpose – How to organize what needs to
be done and determine sequence that will lead to successful implementation
List the 5 major steps, one post-it at a time, n°1, n°2, etc
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Implementation Exercise
Group exercise – development of sample plan for lab X
Include GANTT chart exercise
5. Monitoring – maintenance and improvement
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Monitoring Compliance
Assign responsibility, usually quality manager
Develop indicators using quality policy Systems for monitoring Conduct audits or periodic reviews
Internal and external Management review
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Developing a Quality Manual
Essential organizational step Management responsibility
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WHAT IS A QUALITY MANUAL?
A document describing the quality management system of an organization
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Quality Manual
Communicates information Serves as a framework or roadmap for
meeting quality system requirements Demonstrates managements commitment
to quality
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Maintaining the Quality Manual
• Approval process• Method of communication to all employees• Process for updating
frequency responsibility documentation
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From Intent to Action
Assure commitment from top management Develop quality system plan Assign responsibility for implementation Allocate resources Develop and distribute a quality manual Implement quality system Monitor compliance with quality system
requirements
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Successful implementation requires:
• planning, management commitment• understanding the purpose of seeking quality• understanding organization’s aims• having staff involved at all levels• looking for ways to continually improve• setting realistic time frames
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Remember Quality is not a science, it’s a way of
thinking Do what you wrote, write what you did If you are willing to spend some time
today, you will gain: Quality results Time Professional, personal satisfaction Peer recognition
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Who Is Responsible for Quality?
Laboratory leaders and management must commit to meeting quality needs
Laboratory personnel must follow all quality assurance procedures and adhere to requirements and standards
EVERYONE!EVERYONE!
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Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to all laboratory staff. Design each line’s responsibility for quality.
Problem scenario