Remote Audit Experiences - June 2020

[jmech]

I've already got a couple dozen days delivering remote MS audits since March (9001, 14001, 45001, 18001, RC), most common platforms are email, phone & Skype. I've done a couple Webx and Teams as well.

Randy, do you think these audits were more or less effective than on-site audits? Did you notice any difference in the type or number of findings?

 

[Randy]

Randy, do you think these audits were more or less effective than on-site audits? Did you notice any difference in the type or number of findings?

I prefer the hands on touch. For Environmental and Safety it's probably a 75-25 especially Safety (the places I've done have had really curtailed activities). What we're doing is performing a percentage Remote and planning a reduced proportion later in the year that includes extensions to expiry dates when necessary...I've a 14001 Recert next week, I'll be doing 3 days remote and 2.5 days sometime between Aug-November. Low/medium Risk, no adverse regulatory history, minor permits and so on. Higher risk could have dictated less remote time. A recent 14001 recert was done completely remote, but their risk was so low it was almost off the scale, no permits, no HW, nothing. Risk is a major factor when planning/performing these things.

Quality can be pretty much the same as Env & Safety but I've felt more comfortable with the remotes, however it's still based on risk.

Touchy remote work involves Extension to Scope & Stage 2's....Gotta be onsite. There may be other exceptions as well. The rules have fluctuated since March/April.

 

[somashekar]

Hi.
We just completed a two week remote audit of multiple location sites for the ISO 13485. I was on one path of a two path remote audit.
I can say that the effectiveness is about 75% based on my experience. This depends upon the site and the persons involved in the audit process and their ICT facilities and documentation management system. Some of the areas are not permitted for the remote audit, and this certainly puts the visit to site on the plan at a later date to suppliment the remote audit outputs.
Some of my learnings are:
Be sure to test the ICT compatibility with the site with the actual auditee as a part of the planning.
Familiarity of the client and his processes by way of a previous audit visit adds value for the remote audit.
Make the audit agenda much more in detail so that the correct responsible persons are available for the audit in time.
The role of the guide is now felt more then ever to facilitate the ICT connectivity as well as the linking to the correct personnel for the audit activity. You may not have such a guide at the client side, more so if its a two path.
Audit notes taking is a challenge. If you are good at two Laptop operations, it could help.
We used MS teams. Screen shareing works well, but has a lag. You need to show a lot of patience with the auditee.
After the start, you could choose to off the video to have better bandwidth in the connectivity.
Processes having paper records, its not practical to see the records on cam as a part of evidence collection. You need to trust the auditee and his inputs after viewing the records. Planning and client support is of utmost importance.
I can say that the remote audit process is largely successful. I am looking for more audit mandays to happen remotely.

 

[Randy]

We have to provide assurance that information shared through email is deleted, I also let my clients know that I might take a screenshot that will also be deleted as part of our policy for confidentiality (included as part of the report record). I don't have a problem getting rid of stuff as I've a habit of not keeping a bunch of anything as my desktop can show (my files are pretty much the same, only what I absolutely have to keep for business). As you can tell, I keep it simple and I follow through with remote audit material, just what's necessary and that's all.

 

[Tagin]

Does anybody have experiences undergoing remote audits for ISO 9001 (or similar) that they can share? Specifically:

We just had our 9001 surveillance audit by remote audit, using WebEx. Overall, it was smooth. However, our system is entirely electronic, so using screen-sharing made display of all records, procedures, etc. exceedingly easy. A paper-based system is going to have a more difficult time of it, and I would imagine preparing some kind of setup for a camera (e.g.,cellphone, IPad) as a separate attendee to view/share documents.

- How was the remote audit experience different from an on-site audit?​

​

There was minimal difference. A slight issue was high local screen resolution causing difficulty for the remote auditor, often requiring zooming in on the documents. If the auditor had a larger, higher res screen this would likely have been avoided.​

​

- Was there any increase in audit duration due to it being a remote audit?​

​

None.​

​

- Do you think the remote audit was more or less effective than an in-person audit?​

​

About the same.​

​

- Did you notice any difference in the findings?​

​

No.​

 

[R2DWiW]

We just had our 9001 surveillance audit by remote audit, using WebEx.

Tagin,

Was there any on site follow up required for later in the year or was the full 100% surveillance done remotely?

 

[Tagin]

Tagin,

Was there any on site follow up required for later in the year or was the full 100% surveillance done remotely?

No other followup required - it was considered a complete surveillance audit.

 

[Randy]

Tagin,

Was there any on site follow up required for later in the year or was the full 100% surveillance done remotely?

It would mostly depend on Risk as identified in IAF MD5, for me a High risk client requires onsite followup later in the year, I've got a couple in August, Sep & Oct already

 

[Cari Spears]

We just completed our AS9100 recert audit last week. We had two auditors. We used GoTo in the conference room, and found that Zoom worked best out on the floor. We used a laptop on the floor - it was too loud in a lot of our manufacturing areas, so some people had to pop into an office or go to a quieter place to talk to the auditor.

We provided lots of documents and records to the auditors about a week prior to the audit - uploaded to the registrar's MoveIt. We had a few minor technical difficulties on our end and the auditors', but our auditors were great and we all thanked each other for having patience, lol.

I think that going through the documented information was just as thorough as if they were on-site, and I think that the employee interviews were just as effective; however, I think that the remote audits almost eliminate an auditor observing some things on the floor. There isn't an opportunity for them to trip over an unidentified part, for example.

 

[Mark Meer]

No other followup required - it was considered a complete surveillance audit.

@Tagin Curious: is manufacturing in the scope of your certification? Our CB says they cannot do a completely remote audit, due to the need to physically inspect manufacturing premises. ...that said, they can still conduct most of the audit remotely (which cuts down on auditor expenses).

We opted for this, and our experience with the remote audit was the same as Tagin: no problems. Had a shared folder (Google Drive, OneDrive, Dropbox, etc.) available for sharing files the auditor requests to inspect, and otherwise live video conference + screenshare, was almost the same experience as with onsite audits.

That said, this assumes a pretty integrated (single point of access) electronic documentation system. For companies with mostly paper records, and/or many independent systems, it'd probably be a much more difficult experience.