AS9100 Electronic Backup Statement within SOP's

[NoSleep]

At our most recent audit our auditor mentioned that he felt our Document Control SOP should have a statement dealing with how our electronic backup is handled and if our server were to crash how we would get our information back. I am wondering how you all have dealt with that issue within your SOP's as well as within your quality manuals. Thank you!

 

[Darrell B]

I actually have a work instruction on electronic backup.

 

[NoSleep]

Does your work instruction also talk about how to handle a server crash? Is your IT person internal or external? Would you be willing to share that work instruction or whatever part of it is not proprietary or confidential?

 

[Mikishots]

At our most recent audit our auditor mentioned that he felt our Document Control SOP should have a statement dealing with how our electronic backup is handled and if our server were to crash how we would get our information back. I am wondering how you all have dealt with that issue within your SOP's as well as within your quality manuals. Thank you!

This is part of Clause 4.2.4, which is to include IT if you are using electronic records. We simply state the use of redundant drives, frequency of backups and use of antivirus in our process, and audit these activities.

 

[Darrell B]

Our system is fairly antiquated (we are still using portable drives for backup.) Our IT dept is an outside contractor. The WI just describes the back up process (frequency and responsibility) and the antivirus program use.

 

[NoSleep]

Thank you!!

 

[SmallBizDave]

My systems have always been non-specific. Especially when you're small and growing (hopefully!) it's likely you'll be changing the backup method as you grow.

I recommend that your IT folks create a written instruction outside of the QA documents. As your backup method changes they won't need to bother the QA manager with updates. If the auditor wants to know how they do their backups out comes their written instructions. Some may say that the document must be in the QA system (which makes it subject to audit) but I've never done that in the systems I've written. Nothing in the standard says it must be controlled by the QMS.

 

[NoSleep]

Thank you for your input I will take that into consideration as that may be the best way to go while we are still growing rapidly.

 

[Mike S.]

Do not overlook the importance of data backup -- if you think you get "nosleep" now, if you lose your data, you'll get even less! This is usually low cost but highly valuable "insurance".

 

[NoSleep]

Oh we definitely have backups in place and unfortunately have had the opportunity to be sure they were working as our server crashed. With that said the system is in place it just hasn't been outlined in out QMS or SOP's as to how the backups happen, are maintained and how we can get to the information in the event that we do have a system crash.