Checklist Phase 4

Is the SOP on performing a management review up-to-date?

Compare elements in the Management Review Report with required elements defined in the SOP.

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Is staff safeguarded from overburdening?

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

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Is the procedure for hiring new permanent and temporary staff and having guests correctly documented?

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

  • Regarding permanent and temporary staff:
    • Criteria with 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/CVs
    • 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).

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Are all staff members appropriately trained for the tasks performed?

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

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Are training needs consistently fulfilled?

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Does the laboratory have a Continuous Education Program?

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Is budget available for the Continuous Education Program?

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Is the Continuous Education Program included as element in the Quality Year Plan?

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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?

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

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

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Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

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Are all findings of validations (both validation of examination methods and validation of equipment) documented in validation reports?

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Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing after a piece of equipment has been discovered to be defective?

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Is the procedure for determining and correcting the negative influence of defective equipment documented in an SOP?

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Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

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Is there an SOP that covers all the more simple procedures for which it is too laborious/inefficient to make separate SOPs but that are critical for proper functioning of the laboratory?

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Is correct transportation of samples monitored on a continuous basis by the laboratory by checking whether the transportation requirements in the SOP for Sample Collection are met?

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If problems arise in transportation of samples, does the laboratory investigate these problems to find the cause?

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If problems arise in transportation of samples, is a nonconformity form always completed?

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Are corrective and preventive actions undertaken to solve problems in sample transportation?

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Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked?

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Does the laboratory monitor correct performance of all its processes using quality indicators?

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Is action undertaken upon detection of a sudden change in the value of a quality indictors to identify and solve the problem and prevent it from reoccurring?

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Have limits of acceptability been set for each quality indicator?

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Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer?

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Have specific staff members been authorized to communicate with clients so that proper communication and information provision to clients is ensured?

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Are specific laboratory staff members authorized to participate in clinical rounds?

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Do laboratory staff members participate in clinical rounds at least 4 times per year?

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Are meetings between laboratory staff and clinical staff held at least 4 times per year?

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Are minutes made of meetings between laboratory staff and clinical staff?

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If action points arise from a meeting between clinical staff and laboratory staff, is feedback given in the following meeting?

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Has an external audit been performed to verify complete and correct implementation of the quality management system in compliance with ISO 15189 before the laboratory applies for accreditation?

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Are action plans made to solve/correct the nonconformities identified in the external mock audit with corrective actions and control steps and preventive actions when necessary and applicable?

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Is timely implementation of the action plans following the external mock audit monitored?

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Is the audit report of the external mock audit with the action plan archived when all action points have been completed?

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Does the laboratory have an SOP for Nonconformity Management that ensures that nonconformities are always solved/corrected in a standardized way with corrective and preventive actions and, if necessary and applicable, control steps?

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Does the laboratory have an SOP on Handling of Complaints?

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Are complaints handled in a standardized way?

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Are complainers informed about how the laboratory has solved the issue of their complaint?

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Has the laboratory procedures in place on how to act in specific emergency situations?

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Is firefighting equipment in place?

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Is an evacuation plan in place?

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Are evacuation routes indicated?

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Are there organizational emergency arrangements in place including a division of roles and responsibilities for specific emergency situations?

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Are procedures in place on how to handle in different emergency situations?

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Have failure mode and effect analyses been performed on all the procedures routinely performed in the laboratory to identify potential sources of nonconformity?

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Have preventive actions, control steps and corrective actions appropriately been implement to prevent and control nonconformities?

Look into the reports of failure mode effect analyses and see if failure modes have reasonably been prevented and controlled by preventive actions, control steps and corrective actions in practice. With reasonable is meant that the implementation of preventive actions, control steps and corrective actions weighs up against the probability of failure modes in combination with the severity of the consequences.

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Has the effectiveness of control steps and preventive/corrective actions implemented in the laboratory routine procedures following the Failure-Mode-Effect-Analysis been evaluated?

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When control steps and preventive/corrective actions of the Failure-Mode-Effect-Analysis appeared to be ineffective, have they been improved?

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