Guidance Needed for QA During New Facility Startup and Move

Hello all, 

To start, I'd like to state that I have no experience in the events following the move to a new facility. I have some knowledge of the things that need to be done but I don't want to be caught by surprise with things I'm not aware of. For instance, I know that our relevant regulatory agencies (FDA, USDA, BRC) have to be made aware of our change in address, our PPP paperwork needs to revised to reflect the changes as well and pre-production environmental testing needs to be done. Aside from that, I'm a bit lost. 

That said, I have 8-12 months of lead time before our actual move in date. I'd like to spend as much time as possible preparing for this so any information on what to expect or helpful suggestions would be greatly appreciated as I'm currently, and for the foreseeable future, the only person in the QA department for this company.  

FYI: 

•  We are an FDA/BRCGS governed facility making RTE sandwiches, uncooked pie shells and uncooked biscuits.  
• We'll be employing the use of multiple reefer trucks and cold storage companies in leu of industrial freezer space on site. 

Thanks in advance for any help! 

If you are leaving a site and moving to a new location/site  its not just a change of address that BRC will need - just like SQF you will need a new certification.

QA absolutely 100% needs to be involved in the building design, equipment choices, layout, flow, everything.  DO NOT rush the floor installations and the coming down to the less than 50F temperatures.  The floor or coating or whatever will separate from the concrete and create on-going repairs.  Make sure the lab is large enough and has a functional sink.  I worked for a company that had to change locations due to building damage and the engineer was nothing but excuses and brush offs.  Nothing was his fault and lots of Quality critical items were overlooked.  

It's not a lot of fun during Audits trying to explain how a Food safety and Quality culture company managed to completely forget about certain things when we had a clean slate to start with.    

Every equipment change and process change should have a risk assessment completed for it or a Management of Change form or even a manufacturing deviation to document that the risks were assessed and the changes will be better or minimally equivalent to current situations. 

I have been involved in a couple of new build projects and with multiple new equipment ones.  

My watch out is at this stage, it feels a long way off, it's not.  The team running the project needs to be resourced.  My preference having done this a few times is to staff the team with the people who will be in role long term and back fill them with temporary staff if you can.

Considerations apart from the regulatory and 3rd party scheme side are you need to have food safety involvement in everything.  Design of area.  RTE sandwiches means high care so you need everything to be built to that standard and ideally above it.  Air flows, drains, falls to drain on the floor.  Wall, floor and ceiling finishes...  At design stage if you can, I'd map out on CAD diagrams your people, product and waste flows, you'll thank me later.

Then there's all the work on equipment choice and design.  Some will have 12 months leadtime so are probably already on order.  Is there a design specification?  Can you or others get sight of how they are intending to make the equipment food safe and cleanable?  Trust me, PDI is too late.

Then processes.  Are any going to be new?  That will need consideration and input into design.

When you get your new equipment in, make sure there is PLENTY of time for validation for cleaning (micro and allergen).  You will probably need it.

Lastly, staff.  Are existing staff coming over or are you bringing in new?  How will you select, train, upskill?

Hopefully the above is clear why I think you really need a project team on this and it cannot just fit into the day job.  You need ops, engineering, food safety, health and safety and others to be in the utmost detail.  But even with all that, accept that you WILL get some things wrong.

It's been a long time since I've done a complete green field site but from memory BRCGS need 3 months of record for full certification so it's worth talking to them and your customers early on if that's still true and about how you can trade on days 1-90.

Get your program and new documents written NOW so you can focus on other things

ANY new facility (but particularly one with RTE AND raw under the same roof) is more work than you think it is

I agree with a project lead--a MUST

DO NOT let engineers steam roll you (cause they will)