Remote Audit Experiences - June 2020

[Tagin]

@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.

Technically, it might be called 'light assembly'; but yes,we assemble computer components into systems, test them, burn-in, etc. and package for delivery. That is in our scope.

 

[Mark Meer]

Technically, it might be called 'light assembly'; but yes,we assemble computer components into systems, test them, burn-in, etc. and package for delivery. That is in our scope.

Interesting... either you're lucky with your CB's accommodations, or we're unlucky . ....or maybe it's because it was a surveillance audit?

Does anyone know if there's an authoritative position here? Is there any mandate that CBs must always do onsite audits for manufacturing facilities (but can otherwise audit everything else remotely), or are the COVID accommodations entirely at the discretion of individual CBs?

 

[Randy]

Interesting... either you're lucky with your CB's accommodations, or we're unlucky . ....or maybe it's because it was a surveillance audit?

Does anyone know if there's an authoritative position here? Is there any mandate that CBs must always do onsite audits for manufacturing facilities (but can otherwise audit everything else remotely), or are the COVID accommodations entirely at the discretion of individual CBs?

Guidance and requirements for CB's are in multiple ISO, IAF and Accreditation (ANAB) documents that form a jigsaw puzzle for each CB to finish with its own procedures. There are some things that are absolutes and some things with variability for audits. I've done 100% remote audits for a variety of manufacturing organizations (this week and next I'm doing a 9001 & 14001 integrated multisite all remote). There may be something very specific that hasn't been stated like an extension to scope, high risk or very specific non-conformity close-out the CB has to physically be present to take care of.

Crazy times create crazy problems and their solutions.

 

[jmech]

Does anyone know if there's an authoritative position here? Is there any mandate that CBs must always do onsite audits for manufacturing facilities (but can otherwise audit everything else remotely), or are the COVID accommodations entirely at the discretion of individual CBs?

Randy has described it well. The IAF will tend to have the most open and general requirements, and it can get more restrictive at the AB level and again at the CB level. Further points:

1. The IAF FAQ allows full remote audits for both surveillance and certification, without any restrictions specific to manufacturing, although it also warns that "that regulatory bodies, scheme owners and purchasers may have specific requirements that may need to be adhered to, and which may take precedence."
Q2: Is it permissible to use remote assessments and audits to maintain the validity of accredited certifications during the COVID-19 crisis?
Q5: Is it possible to perform a full certification audit remotely?

2. ANAB Heads Up 450 supports the use of remote audits and does not list any restrictions specific to manufacturing. It also cautions that CBs must still meet the applicable requirements and will be evaluated at their future assessments. It recommends caution in accepting transfers and scope exceptions (without prohibiting them).
https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=17620

3. It took time for CBs that did not previously have remote auditing practices in place to establish these practices and ensure competence, especially if they were diligent in meeting requirements so that they'd avoid findings when evaluated by their AB. For example, APIQR (ANAB-accredited for ISO 9001 and ISO 14001) only started offering ISO 9001 remote audits in June. APIQR audits many manufacturing companies and does not have requirements for onsite auditing of manufacturing activities. APIQR is not allowing remote audits for new certifications or for location changes.
https://www.api.org/~/media/Files/C...emote Audits_Client Notification 06012020.pdf
https://www.api.org/~/media/Files/C...te audits due to location change 20200721.pdf
API Monogram & APIQR: Advisories & Updates

 

[Geoff Cotton]

Hi Folks,

We are finally having to go the remote audit route with our suppliers. QMS audits could be fairly straight forward, but we do few of those, >90% are detailed process audits (medical device).

What I’m trying to find is a headset consisting of a microphone, speaker and HD video/webcam which can remotely livestream to my laptop and allow me to communicate with the wearer.

Does such a device exist? If so, are there any recommendation?

Thanks in advance

 

[Johnny Quality]

Hi Folks,

We are finally having to go the remote audit route with our suppliers. QMS audits could be fairly straight forward, but we do few of those, >90% are detailed process audits (medical device).

What I’m trying to find is a headset consisting of a microphone, speaker and HD video/webcam which can remotely livestream to my laptop and allow me to communicate with the wearer.

Does such a device exist? If so, are there any recommendation?

Thanks in advance

I'd use a smartphone and livestream the video to your laptop - Easily Show Any Phone Screen on a Windows Computer

For audio communication I'd use the same smartphone with a bluetooth headset and have a phone call while you livestream. If that somehow has a problem with the livestreaming, use a second mobile phone for that.

Edit: Sod all that, just have a Skype call between phone and laptop with a bluetooth headset for the phone.

 

[JJ_FDA]

We have a couple of remote audits upcoming.

For those of you with paper-based systems, how did you address providing raw data for the auditor to review? For example, we have equipment record binders that contain qualification / validation / use / maintenance / repair documentation. Did you scan these records in for the inspector, or were they reviewed live by teleconference? I imagine that the former will allow the auditee to editorialize, and can limit the chance observation of non-conformities by the auditor.

For electronic documents, did you allow the inspector to download these, or did you provide them on a controlled platform where the auditor had access to, but could not download them? I am concerned with preserving the confidentiality of certain records.

 

[mattador78]

We have a couple of remote audits upcoming.

For those of you with paper-based systems, how did you address providing raw data for the auditor to review? For example, we have equipment record binders that contain qualification / validation / use / maintenance / repair documentation. Did you scan these records in for the inspector, or were they reviewed live by teleconference? I imagine that the former will allow the auditee to editorialize, and can limit the chance observation of non-conformities by the auditor.

For electronic documents, did you allow the inspector to download these, or did you provide them on a controlled platform where the auditor had access to, but could not download them? I am concerned with preserving the confidentiality of certain records.

We used teams and allowed access to the screen showing the documents live. We also showed and emailed over scanned on documents where required. Due to the fact we also process MOD work our meeting room PC is not connected to the main server for security reasons so we took what was required onto the pc on a memory stick having prepped before hand. Also used teams on my mobile to show around for the site tour, have used this technique twice now once for 14001 and once for AS9100 both times satisfactory for the CB and auditor for recerts.

 

[JJ_FDA]

We used teams and allowed access to the screen showing the documents live. We also showed and emailed over scanned on documents where required. Due to the fact we also process MOD work our meeting room PC is not connected to the main server for security reasons so we took what was required onto the pc on a memory stick having prepped before hand. Also used teams on my mobile to show around for the site tour, have used this technique twice now once for 14001 and once for AS9100 both times satisfactory for the CB and auditor for recerts.

Good to know that we're on the right track as we are doing a similar setup, except using Teamviewer + Zoom instead of Microsoft Teams. Thank you! I'm not sure we will enjoy scanning all that paper in though

 

[Randy]

We have a couple of remote audits upcoming.

For those of you with paper-based systems, how did you address providing raw data for the auditor to review? (It can be done live as a camera shot or thru a screenshare. The auditor should say let me see whatever from dates XX/XX/XXXX )

For example, we have equipment record binders that contain qualification / validation / use / maintenance / repair documentation. Did you scan these records in for the inspector, or were they reviewed live by teleconference? (Yes and No, either way)

I imagine that the former will allow the auditee to editorialize, and can limit the chance observation of non-conformities by the auditor. (Don't be editing no records!!!)

For electronic documents, did you allow the inspector to download these, or did you provide them on a controlled platform where the auditor had access to, but could not download them? (OK here's the thing that we follow....We don't access or download anything.....NADA! You set up the meeeting and invite the auditor as a guest and maintain control of all acces and everything. By our procedure if you email me something, I have to trash the email and delete the document when I'm done. You should never give access to your auditor)

I am concerned with preserving the confidentiality of certain records.

(As you should be)

I've done about 100 or so days of 3rd party "Remote" already this year and have 11 more until Christmas (still have an onsite in a couple weeks as well). Remote audits are a challenge for both sides and good effective communication beforehand and during is an absolute must, and take this to the bank...If you're told that remote access to your documents and your internal system is a must, call a screeching halt, cry BS and say prove it, because it ain't so for ANAB accredited CB's.