Activities related to Phase 3 - Process Control

  • Write an SOP on validation of examinations and equipment.

    In this phase and in phase 4 validation of all examinations and equipment is necessary. Therefore, an SOP should be written for this activity.

    Validation is the evaluation of whether a procedure or a piece of equipment actually delivers the values you are expecting to receive. For example, an incorrectly manufactured spectrophotometer could have been delivered to the laboratory, i.e. instead of a 600 nanometer filter a 400 nanometer filter was installed. When this spectrophotometer is set at measuring samples at a wavelength of 600 nanometers, it gives a value as you measure samples. But only when you compare the value from the new spectrophotometer with that from an old spectrophotometer you see that this value is different. This will lead you to finding that the filter for the 600 nanometer setting is wrong. The process of comparing the values from the new spectrophotometer with those from the old one is called validation.

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

    * SOP on Validation
  • Validate all examination procedures performed in the laboratory.

    Do this according to the procedure described in the SOP on Validation. The results of these validations are recorded and archived in a file called “Validations”.
  • Describe the procedure for rejecting a sample, make a sample rejection form and send this to the requester when a sample and/or sample request form proves to be unsuitable for examination.

    When the primary sample quality is of such level that reliable diagnosis is impossible, the sample must be rejected. Or when the request form is filled out in such a way that the request is unclear and may endanger the correctness the reported results, a sample rejection form must be send to the requester.

    Both forms were developed and included in the service manual developed in phase 2.

    Copies of both forms should be made and archived.

    * Service Manual
  • Monitor adherence to the turnaround times as determined for each examination.

    In the quality manual (developed in this phase) turnaround times were set for each examination. Make sure that all personnel are familiar and adhering to these time-frames by presenting these in a regular staff meeting.

    In phase 2 the SOP on Reporting of Results was developed. This SOP should be amended with a description of a procedure that needs to be followed for notifying the requester when the examination is delayed and exceeds the turnaround time set for that examination.

    * SOP on Reporting of Results
  • Monitor transportation of samples.

    This will be done passively, meaning that the personnel in the sample reception unit will report when samples continuously don’t comply to the transportation time and packaging instructions described in the Service Manual that was sent to the laboratory clients in phase 2. If this is the case, the clients from which these samples originate must be contacted to verify comprehension of the instructions contained in the Service Manual. Monitor if improvement is seen. Document this occurrence with following corrective action on a Notification Form (also developed in this phase).