Activities related to Phase 4 - Occurrence Management

  • Handle non-conformities in a standardized way.

    Since phase 3 complaints, notifications and improvement suggestions were recorded but underlying causes were not solved in a standardized manner (by discussion in staff meetings without using an SOP).

    Nonconformities can occur in many different areas. ISO 15189 provides a few examples of areas that can detect nonconformities in the system (quality indicators):

    • Complaints and suggestions for improvement received from clients, patients, or personnel (see under Customer Service)
    • Instrument calibrations
    • Environmental and equipment parameter monitoring
    • Stock monitoring
    • Sample reception controls
    • Report review (authorization)
    • Adherence to turnaround time
    • Laboratory management reviews
    • Internal and external audits
    • Occurrences taking place during examinations

    When a nonconformity or complaint is detected/received in any process of the laboratory (e.g. deviations from critical intervals, deviations found during EQA), the SOP on nonconformity management is followed and a notification form is filled out and handed to the management who designates a person responsible for handling the notification/complaint.

    Apart from immediate corrective action, it is crucial to perform a root-cause analysis and decide on preventive actions to prevent future occurrence of the non-conformity.

    It is important that when nonconformity originates from a person complaining, the laboratory provides feedback to this person. This shows that the complaint is taken seriously and is used for improving the service of the laboratory. The advantage to the laboratory of doing this is that more customers may be encouraged to provide improvement suggestions to the laboratory, which will in the end lead to optimal improvement of the laboratory service. Store records of feedback given to the complaining person together with the original complaint in the file “Complaints, Notifications and Improvement Suggestions”.

    When a nonconformity seems to influence, or has influenced an examination performed in the laboratory, additional actions are necessary:

    • The significance of the nonconformity on examinations, or of the nonconforming examination itself, is considered.
    • Where appropriate, the requesting clinician of the influenced examination is informed.
    • The examinations concerned are halted and reports withheld.
    • The results originating from influenced examinations already released are recalled. If this is not possible, make sure the customer is notified of the flawed results and give the corrected results anyway.

    Via quarterly reports the correct and complete handling of nonconformities must be monitored (see activity on making quarterly reports in phase 3).

    NOTE: when a nonconformity has occured in a certain activity in the laboratory, provide extra attention to that activity during the next audit. To keep track of the activities that should receive extra attention, keeping a table with an overview of the nonconformities that have been detected over the last period (e.g. the last year) may be a good tool. Every time an audit is planned the auditor can have a look at this table to see what should receive extra attention.
  • Develop an SOP on handling complaints, deviations and suggestions for improvement.

    This SOP standardizes the procedure of, and gives instructions for the process of handling any nonconformity occurring in the laboratory. This SOP instructs on the following topics:

    • Nonconformities are detected. In case of complaints, the laboratory manager determines if the laboratory is receptive to the complaint.
    • A notification form is filled out; the nonconformity is described. The form is also guiding the process by giving instructions on what has to happen next after filling out each section.
    • A root-cause analysis is performed.
    • The corrective and preventive actions to be taken are decided and described on the form. This activity includes review of technical procedures to identify which preventive actions are possible, to estimate the risk on repetition of the nonconformity, and to investigate whether external quality controls are possible to measure performance of the procedure in which the nonconformity occured.
    • Corrective action is taken immediately; preventive actions are planned and implemented (preventive action steps should also be incorporated in the SOPs of the procedure where the nonconformity occured).
    • The notification form is stored in a file titled: Nonconformities. These records are included in the quarterly report and reviewed annually by the laboratory management in the Management Review. The purpose of this is to monitor and evaluate if the implemented corrective and preventive actions were effective in solving the nonconformity.

    A notification Form should thus be designed by the quality officer and this form will be part of the SOP on Nonconformity management (as an appendix). Personnel should be instructed on how to use this form. For every nonconformity detected in the laboratory this form should be filled out and handed to management.

    It is important that the notification form is directive, i.e. after each step, the user of the form is instructed what should happen next. When the corrective action has been taken the laboratory managers verifies this and signs the form. The quality officer subsequently archives the form.

    Make sure that this SOP is read by all relevant personnel members.

    *  SOP Complaints, Deviations and Suggestions for Improvement