Checklist Personnel

Does this SOP contain one or more standardized form(s) that must be used to record the findings of the assessment?

Is a report made of each competency assessment?

Are the reports of the competency assessments stored in the personnel files?

Is the competency of the Laboratory Manager annually assessed?

If potential conflicts of interest among laboratory staff were identified, were they appropriately solved and documented?

Have all staff members participated in an introductory course in quality management for medical laboratories?

Does the laboratory have an induction program for new staff?

Does the SOP for Induction of New Personnel include a checklist for verifying correct completion of the program?

Is a personnel replacement matrix present in the laboratory?

Is the competency of the backup staff members checked for the tasks they need to take over from absent staff members?

Does the laboratory have a standardized procedure for hiring new permanent and temporary staff, and having guests?

Does the procedure for hiring new permanent and temporary staff cover all the following elements:

• Regarding permanent and temporary staff:
  • Criteria to which all applicants must comply
  • Procedure for defining specific criteria for the vacancy
  • Procedure of drafting and publishing the vacancy
  • Procedure of selecting suitable applicants based on application letters
  • Procedure of inviting applicants and organizing the application interview
  • Procedure of selecting applicants based on the application interview
  • Procedure of hiring suitable applicant, including:
    • Determining salary
    • Writing Personal Job Description
    • Adapting Authorization Matrix
    • Creating a personnel file
    • Ensuring that staff member is properly induced according to the SOP for Induction of New Personnel
    • Providing training to new staff (e.g. training into quality management to ensure that the staff member understands and works via the quality management system).
• Regarding guests:
  • Procedure of identification and recording of guest details
  • Procedure of recording details of the visit
  • Procedure of allowing access of the staff member to the laboratory (including a health check to determine if the guest’s health allows for accessing the testing areas).

Is the certificate of the laboratory biosafety training of the Biosafety Officer stored in a folder called "Personnel Files"?

Are findings of performance appraisals discussed with staff members that were assessed to find the root cause and come to a good approach on eliminating this root cause and improving performance?

Are all staff members appropriately trained for the tasks performed?

Are training needs consistently fulfilled?

Is the Authorization Matrix signed and dated by the Laboratory Manager?

Do staff members know what the Authorization Matrix is?

Are staff members able to explain how the Authorization Matrix works?

Are all the records described in ISO 15189:2012 article 5.1.9 (ISO 15189:2007 5.1.2) present in the personnel file of each staff member?

Is the Personnel Files folder stored in a locked cabinet that is only accessible to the Laboratory Manager and the secretary?

Is budget available for the Continuous Education Program?

Does the laboratory have a job description for each position in the laboratory?

Is the ability of all technical staff members to correctly perform examinations observed by letting them analyze external quality assessment samples and evaluating the results?

Are all job descriptions (both Position Job Descriptions and Personal Job Descriptions) up to date?

Has a laboratory staff member appropriately been trained in performing failure-mode-effect-analyses?

Have all staff members adequately been trained in the procedures they are performing?

Ask several staff members this question for the procedure they are doing at that moment and cross-check with their Personnel File.