Checklist Phase 1 - Organization

Is the implementation of the quality management system coordinated through a Quality Project Team?

Activity

Does the laboratory have a Quality Focal Point to which staff can turn to for information about the quality management system?

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Are Quality Project Team meetings held on a regular basis?

The presence of minutes serve as prove for this.

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Is the Quality Project Team functioning correctly?

Look into the minutes to find indications of the quality of functioning of the team; look at the action points, if these are often not completed on/before their deadline this is a sign that the team has trouble implementing activities. In this case, try to find out via signs in the minutes and interviewing team members what the cause of the problem is.

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Does the laboratory make use of action plans with SMART formulated action points?

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Are action plans all stored together in one folder, with a logical structure (e.g. completed action plans in the back, open action plans in the front, sorted on date, etc.)?

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Is the completion of action points and action plans checked on a monthly basis and, if necessary, followed-up?

I.e. do you see action points that have not been completed while their deadline has passed?

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p>Are staff meetings held regularly (weekly)?

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Are minutes made of weekly staff meetings?

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Do the minutes of weekly staff meetings include a summary of discussions, SMART action points and the agenda for next week?

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Are the minutes of weekly staff meetings stored in a well-organized way?

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Has a Biosafety Officer been appointed?

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Is there a description of the tasks and responsibilities of the Biosafety Officer?

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Do all the staff members know who the Biosafety Officer is?

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Do all the staff members know the function of the Biosafety Officer?

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Has an Equipment Officer been appointed?

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Is the Equipment Officer trained in calibration and technical maintenance of equipment (if necessary)?

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Is the Equipment Officer protected against overburdening of work by allocating tasks of his/her former work to other staff members (if necessary)?

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Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officer”)?

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Are all laboratory staff members aware of the existence of the position of Stock Officer?

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Do all laboratory staff members know who the Stock Officer is?

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Do all laboratory staff members know what the tasks of the Stock Officer are?

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If the laboratory is part of a bigger organization: does the laboratory have an Organizational Chart that clearly shows the position of the laboratory within the total organization?

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Is the Organizational Chart that shows the position of the laboratory in the total organization signed and dated by the management of the total organization?

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Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory?

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Is the chart showing the organization of positions within the laboratory signed and dated by the Laboratory Manager?

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Are the Organizational Charts stored in a folder that is accessible to all the staff members of the laboratory?

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