Once a CA has been identified it is the responsibility of the staff member in charge of that area (or their delegate) to investigate the root cause of the problem. How did the QMS allow the problem to occur ?

Potential causes of CA may be:

The original specimen was not adequate; this may indicate that the specimen acceptance procedure was not effective or was not followed.

The methods or procedures which produced the problem were not effective or were not followed exactly as intended.

Staff were not adequately trained to carry out the activity correctly, suggesting a problem with the training procedure or its implementation.

That equipment was not calibrated or was not performing appropriately.

Depending on the size and complexity of the problem more than one person may need to investigate the problem. A problem solving team may be established.

As with each step of the CA process the outcome of the investigation into the the CA must be recorded on the CAR form.