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Quality checklist for opening a second location

#1
Hi everyone,

Was wondering if anyone had any type of quality checklist for opening a second location? A little background - We are ISO 13485 Medical Device company and we are opening a second manufacturing location. Basically just moving all our current Milling equipment to the second location.
Thanks!
 

JoshuaFroud

Involved In Discussions
#3
I unfortunatly dont have a checklist I can share however, the hivemind here may well be able to make some useful suggetions of things to check/do/review to that ends a little more background may help,

Are you looking to open a second site and close the first or continue to run two locations?
Will both locations be doing the same thing?
What will be the physical seperation between the sites?
Do you plan on running the same QMS across both sites or will you be starting again?

Let us know and hopefully someone can help.
 
#4
We'll be running both locations and both locations will be doing the same things. One location in FL and one in CT. I plan on running the same QMS across both sites.
 

indubioush

Involved In Discussions
#5
You should have a quality plan that outlines everything you will need to do to qualify the new facility. You should document the requirements for infrastructure, utilities, location of different manufacturing areas, and plan for process validation if you are duplicating processes that are already validated. Your plan should also state any changes needed to the quality system. As you execute your plan, you will have records that will become part of the facility qualification report. Hope that helps.
 

indubioush

Involved In Discussions
#6
Also know that you will have to notify your customers that their products may be produced at a different location. Many of your customers will want to audit the new facility.
 
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