Writing audit observations that support effective action
An audit observation should provide a clear account of what was found, the expectation against which it was assessed and why the finding matters. The recipient needs sufficient information to investigate the issue and determine an appropriate response.
A statement such as 'maintenance records were inadequate' leaves considerable room for interpretation. It does not identify the records reviewed, the information missing or the potential consequence for the equipment and its use.
A more useful observation would describe the equipment, the records sampled and the specific gap. If maintenance had been recorded as complete but the required functional check was unavailable, the observation should make that distinction clear. The associated concern can then be explained without assuming that the equipment had failed.
This separation between evidence and inference is important. An auditor may identify insufficient assurance of control without having evidence of an actual product defect. The report should preserve that distinction.
The extent of the review also needs to be visible. A finding based on one sampled record should not imply that every record has been examined. Where similar issues appear across departments or activities, the report can describe the evidence supporting a broader concern.
In my view, the significance of an observation should follow from the activity, the control that is absent or ineffective, the potential consequences and the available mitigating measures. The number of procedural discrepancies alone provides limited insight into risk.
Discussion during the audit helps confirm factual accuracy and allows relevant evidence to be considered. It also helps ensure that the recipient understands the concern before preparing a response.
The resulting action should address the established cause and extent of the problem. Revising a procedure may be necessary, but further work may be needed to address equipment, workload, supervision or the way effectiveness is assessed.
A useful audit report gives the organisation a sound basis for corrective action and provides the commissioning party with a clear understanding of the issues affecting confidence in the audited operation.
Background and scope
EU GMP Part I, Chapter 9, section 9.3. The approach to separating evidence, inference and significance is practical reporting advice.