Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records

Beth Workman

Involved In Discussions
#1
Help! Hurricane Harvey has likely destroyed Quality Systems Records at our medical device facility in Texas and I need to develop a risk mitigation plan to address the issue. Records include: calibration, sterilization, DHR, retention labels, qualifications, validations, inspection records. Where do i get started? Thanks!
 
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Bev D

Heretical Statistician
Staff member
Super Moderator
#2
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

were these paper records or locally stored electronic records that were destroyed?

your approach for WIP and local finished goods will be different than for already shipped and installed products.

Have you contacted your regulatory agency for guidance? surely this isn't the first time this happened in the medical device industry...
 

BradM

Staff member
Admin
#3
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

Beth... honestly I wouldn't worry about it now. There is still rain, there is still flooding.

Once everything is done, the facility will have to perform an entire risk-based plan for the entire facility and the processes.

Do you think you can wait?
 

Marc

Hunkered Down for the Duration
Staff member
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#4
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

A bit :topic: but I saw this not too many years ago in the disk drive industry - Wikipedia reference-link2011_Thailand_floods where companies without disaster recovery plans were SOL, but even those with DRP's took a few years to recover (and many went out of business all together).
 

BradM

Staff member
Admin
#5
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

A bit :topic: but I saw this not too many years ago in the disk drive industry - Wikipedia reference-link2011_Thailand_floods where companies without disaster recovery plans were SOL, but even those with DRP's took a few years to recover (and many went out of business all together).
Actually, that is exactly the point I was trying to make.
I'm not sure how much people outside of Texas are seeing all the pictures/videos...

But the damage is incredible.

Once the floodwaters reside, the recovery plan of this facility will need to be reviewed (if they had one).

If there was no recovery plan and the entire (or even half) of the facility was under water, there will have to be high level assessments (and decisions) made regarding the future of the facility.
 
#7
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

Is there a back up of these records? You may be able to piece some of them together. For instance, calibration records may be accessible if service is preformed by an outside lab, for they should have a copy.
 

Randy

Super Moderator
#8
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

It's happened before to quite a few of my clients along the Gulf coast as most are chemical/petroleum industry the crisis management/business recovery/disaster mitigation plans were in place.

Worst case scenario, start from scratch, try to recover what you can from email histories and trails, and get copies of records from vendors/suppliers (like the calibration stuff)
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#9
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

It's happened before to quite a few of my clients along the Gulf coast as most are chemical/petroleum industry the crisis management/business recovery/disaster mitigation plans were in place.

Worst case scenario, start from scratch, try to recover what you can from email histories and trails, and get copies of records from vendors/suppliers (like the calibration stuff)
This is medical devices, not oil/gas. Totally different.
 
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Beth Workman

Involved In Discussions
#10
Re: Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Rec

were these paper records or locally stored electronic records that were destroyed?

your approach for WIP and local finished goods will be different than for already shipped and installed products.

Have you contacted your regulatory agency for guidance? surely this isn't the first time this happened in the medical device industry...
Thanks everyone! I do need to move forward with drafting the plan of recovery at this time, as the FDA will need to inspect us before we move forward with manufacturing operations and, of course, time is of the essence.

My largest concern is of the data records and manufacturing job travelers with evidence of the manufacturing process and receiving inspection data. These are signed records demonstrating work done which may only be able to be partially recreated. Ultimately, I'm looking for what would be acceptable in the event that a lot traceability record is destroyed, who did the work, to what revision, with what equipment and on what date.
 
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