Checklist Organization

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

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.

Is the position of Quality Officer visible, at the right place, in the Organizational Chart?

Is the position of Quality Officer included in the Authorization Matrix?

If a staff member was appointed as Quality Officer, has his former position been filled by a new/another staff member if necessary?

Is the Vision of the laboratory documented and stored?

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

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?

Does the laboratory have a clear Mission?

Are staff meetings held regularly (weekly)?

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

Does the laboratory have an up-to-date routine work schedule?

Do all staff members know where to find the Daily Routine Work Schedule?

Take a sample by asking this question to several staff members.

Are the long-term goals of the laboratory covering all the core-activities?

Are the long-term goals of the laboratory documented and stored?

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

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

Is the laboratory and its status recognized by the appropriate authorities?

Does the Quality Policy describe clearly the scope of the laboratory services?

Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?

Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these?

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Has an Equipment Officer been appointed?

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

Are the Organizational Charts signed and dated by the appropriate management?

Is purchasing of new equipment taken into account in making the laboratory budget for the next year?

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

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

Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?

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

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

Does the laboratory plan its activities through a Quality Year Plan?

Has the Quality Year Plan been formulated with input from the Quality Officer?

Take a sample by asking the Quality Officer and some members of the Quality Project Team.

Is the Quality Year Plan signed and dated by management?

Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?

Are staff members aware of action points assigned to them?

Take a sample by asking staff members about action points assigned to them.

Is the quality manual part of the document control system?

Is the performance of the quality management system recorded in Quarterly Reports?

Are reports drafted of management reviews?

Are the result of the management review presented to all staff?

See meeting minutes.

Does the Quality Year Plan include action points from the management review?

Is an action plan drafted based on the action points yielding from the Quality Year Plan?