There are some aspects that should NOT be included in the report:

• Inspector’s subjective opinion
• Information that is not relevant to the inspection
• Ambiguous statement that cannot be supported
• And antagonistic statements that do not contribute to the inspection

Here are some general tips to help you write a better final report:

• Be specific about any observations that were observed
• Write for your audience, not for yourself
• Avoid being too technical
• Quantify findings where possible
• Put in context – time, operations, frequency of occurrence
• Support every finding with at least one example drawn from the facts determined in the audit
• Don’t stray too far from the original findings presented in the exit meeting

Here is an example of the difference between a vague observation and one with better wording:

Vague Observation

“Poor bearded operator observed in the aseptic processing area wearing nothing but a head covering”

Better Wording

“A bearded operator observed in the aseptic processing area was not wearing a facial hair restraint as required by SOP XXX”