ORGANIZATION

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

Organization Personnel Equipment Purchasing & Inventory Process Control (Quality Control & Specimen Management) Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Facilities & Safety

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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 4

Essential:

1. management committed to quality system and, 2. an organizational structure designed to assure quality goals

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1. Leadership, managerial roles

Leadership

 Exercising responsible authority, while providing motivation and vision  Influencing and encouraging staff to good performance 7

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 8

Management Commitment

 Seek support from upper management  Identify appropriate management level  Must involve those making financial decisions  Communicate commitment of laboratory managers to staff 9

2. Organizational structure

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 11

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 13

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 14

3. Planning

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 16

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 17

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 18

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

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What resources are needed



Benchmarks

 Must be available to all staff 20

4. Implementation

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 22

Gantt Chart

ID Task Name 1 5 6 7 2 3 4 8 9 10 Quality System Implementation Quality system planning Training Prepare Quality Manual Approval of Quality Manual Document Procedures Implementation Schedule audits Update Quality Manual 2003 2004

Jun Jul AugSep Oct Jan Feb May Jul Sep Oct 23

Consider Resource Requirements

   Financial requirements / budget Personnel needs   Additional staff Skills, training needed Facilities, equipment, supplies, computers 24

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 25

Implementation Exercise

 Group exercise – development of sample plan for lab X  Include GANTT chart exercise 26

5. Monitoring – maintenance and improvement

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 28

Developing a Quality Manual

  Essential organizational step Management responsibility 29

WHAT IS A QUALITY MANUAL?

A document describing the quality management system of an organization 30

Quality Manual

   Communicates information Serves as a framework or roadmap for meeting quality system requirements Demonstrates managements commitment to quality 31

Maintaining the Quality Manual

• • • Approval process Method of communication to all employees Process for updating    frequency responsibility documentation 32

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 33

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 34

Remember

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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?

EVERYONE!

  Laboratory leaders and management must commit to meeting quality needs Laboratory personnel must follow all quality assurance procedures and adhere to requirements and standards 36

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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