ORGANIZATION

1. ORGANIZATION

2. The Quality System

3. Key Components Leadership Organizational structure Planning Implementation Monitoring Key Requirements as part of the Organzation Leadership (must have these qualities Commitment of laboratory leaders Vision Team building Resources - How to use what you have well Organizational Structure Functional Organizational Chart Assignment of Responsibility Process of Planning Short Term Time management Who�s going to do what Use of human resources Management of workflow Financial resources Set Benchmarks or standards Long Term Resource needs (Human and Financial) Quality Program Planning Implementation Making your plans happen Directing resources to accomplish plans Monitoring Checking to see if plans have been accomplished as outlined Benchmarks and standards met Key Requirements as part of the Organzation Leadership (must have these qualities Commitment of laboratory leaders Vision Team building Resources - How to use what you have well Organizational Structure Functional Organizational Chart Assignment of Responsibility Process of Planning Short Term Time management Who�s going to do what Use of human resources Management of workflow Financial resources Set Benchmarks or standards Long Term Resource needs (Human and Financial) Quality Program Planning Implementation Making your plans happen Directing resources to accomplish plans Monitoring Checking to see if plans have been accomplished as outlined Benchmarks and standards met

4. 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

5. Who is responsible for Quality? EVERYONE IN THE LABORATORY! Laboratory management must commit to meeting quality needs Laboratory personnel must carry out quality assurance procedures Develop collage of laboratory scenes (people) to emphasize pointL Laboratory personnel must make it happen!Develop collage of laboratory scenes (people) to emphasize pointL Laboratory personnel must make it happen!

6. Management Commitment Seek support from upper management Identify appropriate management level Must involve those making financial decisions Communicate commitment of laboratory managers to staff Implementing a Quality Management System (QMS) Management Management is not just about organising and controlling, but leads to challenge processes, show the way and encourage the �spirit� of the organisation. Encourage enthusiasm Instill confidence Serve as agent of change The title of Quality Manager is irrelevant. This person may have other duties, however, most important the �Quality Manager� has direct access to top management Implementing a Quality Management System (QMS) Management Management is not just about organising and controlling, but leads to challenge processes, show the way and encourage the �spirit� of the organisation. Encourage enthusiasm Instill confidence Serve as agent of change The title of Quality Manager is irrelevant. This person may have other duties, however, most important the �Quality Manager� has direct access to top management

7. Approaches to developing a quality system vary with local situation Many factors influence starting point Plan should include all quality elements May implement in stepwise process Quality System Planning Address all elements of a quality system Plan broadly Implementation may need to progress in a stepwise process Learn from other organizations Train of appropriate personnel Quality System Requirements What needs to be done Who will need to b involved The QMS needs to be tailored to the needs of the organisation. However, there is benefit in learning from the experience of other comparable organisations.Address all elements of a quality system Plan broadly Implementation may need to progress in a stepwise process Learn from other organizations Train of appropriate personnel Quality System Requirements What needs to be done Who will need to b involved The QMS needs to be tailored to the needs of the organisation. However, there is benefit in learning from the experience of other comparable organisations.

8. Conduct Gap Analysis Determine the gaps in your QA program Use Quality Systems Checklist Develop a task list using identified gaps Prioritize filling these gaps by � Considering the quick fixes first Determining what would have the greatest positive impact A useful first step might be to conduct a Gap analysis of your existing system. What elements are not currently addressed, and how are you doing with the programs that are already being conducted?A useful first step might be to conduct a Gap analysis of your existing system. What elements are not currently addressed, and how are you doing with the programs that are already being conducted?

9. Quality System Plan Plan should be written, available to all staff include training needed, assignment of responsibility Develop timeline Sources of information and assistance

10. Assign Responsibility Prepare laboratory organizational chart Appoint Quality Manager Designate Quality Committee Define responsibility for all staff Prepare an organizational chart describing the laboratory as part of the health organization In smaller labs, the committee could include everyone in the lab Define responsibility for all staff Staff outside the laboratory may influence the implementationIn smaller labs, the committee could include everyone in the lab Define responsibility for all staff Staff outside the laboratory may influence the implementation

11. Quality Manager / Committee Responsibilities Monitor and maintain records of data in support of QA program Conduct audits to assess compliance with QA policies and procedures Investigate deficiencies Coordinate on-site inspections of monitoring or accrediting agencies

12. Implementing a Quality System �Resource Requirements Financial requirements / budget Personnel needs Additional staff Skills, training needed Facilities, equipment, supplies, computers Financial resources � (Exercises: What part of plan would require financial resources? Establish a budget for implementing your Quality System Adequate Personnel Number of staff dependent on personnel budget, timeline Equipment, Supplies, Computer Funds It is in the area of fiscal activity where it becomes evident that management support and commitment is essential. Those who have the authority to make financial decisions must be involved in order to achieve this step. Financial resources � (Exercises: What part of plan would require financial resources? Establish a budget for implementing your Quality System Adequate Personnel Number of staff dependent on personnel budget, timeline Equipment, Supplies, Computer Funds It is in the area of fiscal activity where it becomes evident that management support and commitment is essential. Those who have the authority to make financial decisions must be involved in order to achieve this step.

13. Documenting the Quality System WHAT IS A QUALITY MANUAL? A document stating the quality policy, quality system and quality practices of an organization (ISO/IEC Guide 25) The quality manual is a documentation of the quality policy, the Quality strategy and the description of how all elements of the relevant standard(s) are carried out within the organisation. Communicate information Provide guidance to staff and others on quality policies and other elements of the quality system Serve as roadmap for quality system requirements Provide evidence of management �s commitment to quality Provide evidence of compliance with quality system requirements The quality manual is a documentation of the quality policy, the Quality strategy and the description of how all elements of the relevant standard(s) are carried out within the organisation. Communicate information Provide guidance to staff and others on quality policies and other elements of the quality system Serve as roadmap for quality system requirements Provide evidence of management �s commitment to quality Provide evidence of compliance with quality system requirements

14. Quality Manual WHAT IS IT�S PURPOSE ? Communicates information Serves as a framework for meeting quality system requirements Demonstrates management �s commitment to quality

15. Quality Manual (Add work instructions) Different approaches for developing the quality manual Different approaches for developing the quality manual

16. Quality Manual Basics Table of contents, introduction Description of the organization, including scope of activities Quality policy Reference to supporting documents Structure of documentation Glossary of terms Quality Policy � Mission Statement The Quality policy should be: Concise State Overall objectives Authorized by chief executive Commitment to good practice Commitment to Standard(s) Quality Policy � Mission Statement The Quality policy should be: Concise State Overall objectives Authorized by chief executive Commitment to good practice Commitment to Standard(s)

17. Structure of Documentation Quality Manual Processes Procedures Work instructions Forms Records

18. Quality Manual � Implementing and Maintaining Approval process Method of communication to all employees Process for updating frequency responsibility documentation

19. Estimate time needed based upon available resources Prepare for implementation in stages Stagger start dates Determine resource requirements Developing a Gantt chart may be useful Implementing a Quality System

20. Implementing a Quality System

21. Monitoring Compliance Assign responsibility; usually Quality Manager Develop indicators using quality policy Systems for monitoring Conduct audits or periodic reviews Internal and external

22. planning, management commitment belief in system understanding the �spirit� of the standard understanding organization�s aims having staff involved at all levels looking for ways to continually improve setting realistic time frames Successful implementation requires: Exercises: planning for the quality system: brainstorm how to best solicit support from the top level of the organization Exercise: Specify the responsibility, authority, and interrelationships of all personnel within your laboratory or organization Exercise using quality systems checklist: Ask participants to determine gaps in their organization For each identified gap, determine what resources you will need to implement the quality requirements Prioritize tasks\ Establish timeline Exercises: planning for the quality system: brainstorm how to best solicit support from the top level of the organization Exercise: Specify the responsibility, authority, and interrelationships of all personnel within your laboratory or organization Exercise using quality systems checklist: Ask participants to determine gaps in their organization For each identified gap, determine what resources you will need to implement the quality requirements Prioritize tasks\ Establish timeline