Checklist Personnel

Has the personnel file of the staff member participating in failure mode effect analysis training been updated after completing this training?

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

Have certificates of the introductory course in quality management been stored in the Personnel Files folder?

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?

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?

Does the laboratory have an Authorization Matrix, showing for each position in the laboratory the authorizations, responsibilities and tasks?

Is the Authorization Matrix accessible to all staff members?

Are staff members able to find the Authorization Matrix?

Have Personal Job Descriptions been made for all the staff members?

Are Personal Job Descriptions stored in an orderly fashion in the Personnel Files folder?

Does the job description for each position in the laboratory give a complete and clear impression of the tasks, responsibilities and authorities of each position?

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

Is budget available for the Continuous Education Program?

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?

Is the folder Personnel Files up-to-date; i.e. have all certificates and diplomas been collected for all staff members and been stored in the personnel files?

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 the procedure of the induction program documented in an SOP?

Are completed checklists stored at a logical location (e.g. in the personnel file of the new staff member)?

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 a backup staff member defined for each staff member in the laboratory?

Is the laboratory staff aware of the existence of the personnel replacement matrix and which purpose it serves?

Take a sample by interviewing some staff members.

Are educational needs consistently assessed in competency assessments and performance appraisals?