This should be done by the laboratory supervisor.
The quality project team will be the main coordinating body in setting up the quality management system. This team will support the management in carrying out the activities of this GLI implementation guide leading to establishment of the quality management system, so that the laboratory supervisor will not be burdened with coordinating the establishment of the quality management system all by him/herself. The laboratory supervisor needs to decide for him/herself how many persons will be included in the quality project team, depending on what is appropriate for the local situation.
The chair of the quality project team will be the quality focal person and coordinate the main activities of the team. He/she is responsible for the correct execution of activities of the GLI implementation guide by team members and decides who should focus on which activity and when.
This team will have meetings with the laboratory director and/or manager at least twice per month to discuss progress and find solutions to problems encountered. Minutes of these meetings are made by one member of the quality project team (not the quality focal person since he/she has to lead the meetings) and these minutes are given to all members of the project team, including the laboratory manager/director, and they are archived (i.e. they serve as proof that the meetings were held and they serve as tool to monitor progress).
Activities related to Phase 1 - Organization
Make an organizational chart indicating the position of the laboratory within the organization (i.e. the position of the laboratory within the organizational structure of the national tuberculosis program or the hospital).
Make a detailed chart of the organizational structure of the laboratory. This chart shall comply to the following requirements:
- Every position of the laboratory should be clearly distinguishable, including its relation to other positions in the hierarchy. Include a short description of every type of position below the organizational chart.
- The chart is signed and dated by the management.
- The organizational chart is accompanied by an authorization matrix specifying the authorizations of each position in the organization chart.
Ensure that the person responsible for the laboratory (e.g. laboratory director or laboratory manager), and those responsible for the quality (the quality project team), are independent from each other. This means that the quality focal point functions as a source providing advice to management: the quality project team is not placed in line with management but as a position providing input to the management (see the template organizational chart).
Ensure that the results of tests done are checked by a second person. Example: in a big laboratory this could be a supervisor per section; somebody responsible for correct work in the section sample collection (checking that all samples have been collected and processed correctly each day). In a smaller laboratory the could be a person from another section with knowledge of work done in the section were the results were generated.
In addition to the organizational chart an authorization matrix should be made. This matrix indicates the responsibilities and authorizations of every position in the laboratory. For example: in this matrix one should be able to find who is authorized to review and alter result reports and who is responsible for that activity. Or who may use, and who is responsible for certain equipment, software, changing passwords, analytical systems, reagents, storage, etc. The best way to be as complete as possible in formulating the tasks is to use the CLSI QSE framework: formulate, per QSE, the key tasks.
Of each position in the laboratory a description should be available that contains information on which responsibilities and competencies a person in that position should have. For example: the job description of the position "laboratory technician" contains a description of what responsibilities and competencies a person with the position "laboratory technician" should be able to show.
This document is used later in competency assessments of personnel members; during such an assessment the laboratory manager investigates whether the responsibilities and competencies shown by a specific personnel member comply with the responsibilities and competencies described in the job description of the position of that personnel member.
Note that this document is thus not related to a specific personnel member but to a specific position in the laboratory.