What the inspector wrote
Records of management review consisted of the presentation used at the meeting and a signed attendance list. There was no record of discussion, of conclusions reached on any input, of the review's assessment of the suitability and effectiveness of the quality system, or of decisions on resources. The head of quality described several decisions taken at the meeting that did not appear in any record.
Why it was cited
A presentation is an input. It records what senior management was shown, not what they concluded. EU GMP Chapter 4 makes every part of the quality system a documented one; ICH Q10 4.3(d) expects documentation and communication of the results. Verbal recollection of decisions is not a record and cannot be assessed.
This is often cited as 'Other' or minor when the review itself was sound and only the record failed. It escalates to major when, as here, the missing record means the inspector cannot tell whether a significant issue was decided.
What would have prevented it
- Use a minutes template with a mandatory outcome field for every input: decision, action, or explicit no-action with reasons.
- Record the review's conclusion on the suitability, adequacy and effectiveness of the system, in those words, with its basis.
- Have a minute-taker who is not presenting, and approve the minutes within a defined time of the meeting.