Roadmap Phase 3

Optimize facility and safety Ensure proper data management practices Implement the management cycle Optimize staff performance Establish the audit system Optimize the purchasing and inventory system Optimize the document control system Optimize service to customers Monitor the adherence to the quality year plan Perform a management review & make a quality year plan Complete the validation process Write the quality manul, ensure that all staff reads the manual

Write an SOP on validation of examinations and equipment.

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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