What the inspector wrote
The site procedure required management review at least every twelve months. The interval between the two most recent reviews was nineteen months. During that interval the site received a critical finding from a customer audit and initiated a product recall. Neither event triggered a review and no mechanism for an unscheduled review was defined.
Why it was cited
The procedure is the site's own commitment, and a nineteen-month interval against a twelve-month requirement is a straightforward departure. The inspector adds the second sentence because a review system that cannot respond to a critical finding or a recall within the interval has failed the purpose of EU GMP 1.6, which is to keep the system effective, not merely to meet on schedule.
EU GMP 1.6 and PIC/S PE 009 say periodic; neither gives a number, so the site's own procedure is the standard the inspector applies. Periodic means often enough to catch what happened.
What would have prevented it
- Set the interval in the procedure, schedule the next review at the close of each one, and treat a missed date as a deviation.
- Define a trigger list for unscheduled reviews: recall, critical or repeated major finding, regulatory warning, serious supplier failure, data integrity event, change in site ownership or strategy.
- Hold a quarterly interim review of metrics, escalations and open actions between annual reviews.