EQMS - When the internet or system might not be available

[duff999]

I have a question regarding eQMS. We are in the process of establishing our QMS electronically and would like some feedback regarding what to do in a backup situation, where the internet or system might not be available. Do folks handle this offline somehow via a backup, etc. Any help would be appreciated.

 

[Tagin]

To me this is a business continuity planning topic. I would look at it from a risk perspective based on outage time. E.g. what are the risks if connectivity is lost for:

• 10 minutes?
• 1 hour?
• 1 day?
• 1 week?
• Permanent loss of data (i.e., the eQMS hosts really messed up badly or suddenly went out of business)?

And then, subdivide into:

• Local ISP / street wiring issue
• Major internet backbone outage
• eQMS hosting outage
• eQMS business failure

So, if its intolerable to be disconnected from eQMS for a day or more due to local phone pole being down, maybe you plan for installing cellular backup connectivity to the internet onto your office router.

You mentioned having backups of the eQMS. Even if you have the backups, will they be in a format that is accessible? Updateable? That's unlikely. Maybe instead you plan for paper forms until the system is up again and then enter all the paper data into the eQMS?

 

[yodon]

There are usually 2 options with such systems: locally hosted or cloud hosted. If hosted in the cloud, it's virtually impossible to lose access (if it's a reasonable provider with mirror sites geographically distributed) other that what @Tagin mentions about going out of business. Locally hosted is where such issues may be more likely realized and @Tagin gave good advice. Take preventive actions commensurate with the risk.

 

[duff999]

Good information, thank you. What to do if your in an audit and there is an outage? Any advice for planning?

 

[Tagin]

Good information, thank you. What to do if your in an audit and there is an outage? Any advice for planning?

Again, from a risk perspective - what is at risk if there is an outage during an audit? Major NC? loss of certification? Or will the auditor allow for exceptional circumstances and reschedule the unfinished portion? What is the likelihood of an outage during that audit day (or days)?

Based on your responses, you might want to make sure to always have local copies of all current QMS docs, and maybe copies of records that might be audited. It's going to depend on your unique circumstances.

 

[duff999]

Good points again. I think I was driving towards having some sort of retrievable storage location for the documents, records, etc. I appreciate the feedback. I wasn't sure if that was a requirement.

 

[Tagin]

Good points again. I think I was driving towards having some sort of retrievable storage location for the documents, records, etc. I appreciate the feedback. I wasn't sure if that was a requirement.

I don't know of such a requirement. However, if your plan calls for maintaining local copies of docs, records, etc., then I expect that your document control process has to be extended to cover those as well.

 

[Ninja]

We kept a single printed copy of the QMS as well as SDS's to cover us for power outages...
Cloud host is wonderful...but is useless if you don't have power to the computer, or the internet connection...
A single copy got the job done...and was only ever used once in 10yrs...for an OSHA audit to prove we still had access to SDS's for workers.