Posted 30 July 2019 - 09:35 PM
The last total renovation consult that we did on layout included the need to put the maintenance shops in the middle of the facility - not my idea, but that was what a set of plans called for. We did extensive risk analysis on the location - all the potential if's and known items that could and have happened came into analysis and with a containment surround built around the shops (3 separate shops + office - each interconnected) the plant now has a self-contained maintenance system that has a Non-GMP pathway marked off to the nearest point of delivery and removal of items.
It was a lot of work, not for the light-hearted to undertake, but it is doable and no issues at audit time were found or "glaring" to be written up.
With all that said - most of the facilities I have been in either have a fully contained outside structure that houses maintenance/mechanics or the shops/room/office is located adjacent to production but at one of the four walls and NOT in the center of production.
All the Best,
All Rights Reserved,
Without Prejudice,
Glenn Oster.
Glenn Oster Consulting, LLC
-SQF System Development, Implementation & Certification /Internal Auditor Training /eConsultant Retainer
Oak Bluffs, Martha's Vineyard Island, Massachussetts
Republic of these United States (restored)
www.GlennOster.com | 774.563.6161 | glenn@glennoster.com