In my last job, our small, rural manufacturing facility had significant issues finding audit services due to the distance to get to us.  This was before COVID-19.  We ended up using remote auditing registrar and found a lot of benefit.  Pros: We stayed on topic much more and the audit was more concise and to the point.  Also, a way to get to our community. Cons:  We had to do some legwork to get a cart, with computer and web cam, set up and it could be difficult to hear in some areas of the plant that were more noisy.  Surprisingly, the auditor did not seem to struggle with being able to see anything.

We are preparing to perform our first remote Quality Bench Marking Survey of a remote site. Our clients prefer the term survey over audit. The process will entail an office meeting via WebEx to review project documents and then a project walk utilizing a 360 degree camera and aerial drone footage for high building exteriors. I will follow up and let you know how it went.  
 

I'm both a Lead Auditor for our internal audits ans as the QA manager, the main auditee for our external ISO 9001 audits and regulatory audits (e.g. UL CSA). As far as remote audits and the last external audit was done remotely went well. From the auditee standpoint, this works pretty well as you get to choose documents to show the auditor. The auditor doesn't get to see everything that he/she would be able to see in a normal audit. From the auditor stand point this can be a disadvantage. I do remote auditing when I do our Engineering internal audit. I pick 3 projects and go through these files with a fine toothed comb. I like doing this because I can do this without having to take up an engineer's time and I can go through the files at my leisure. A lot of the time this audit is interrupted by other Quality duties or day-to-day issues that come up. 

Bottom line remote audits have their place and can be used in conjunction with face-to-face audits.

Larry, I would love to hear the audit outcome. Yes, please post an update and let us know how it all turns out. Good luck!

Monica, yes, that's a good point, remote audits are not new. With COVID they are getting their "fifteen minutes of fame" for sure.  I am so happy to hear the auditor didn't struggle with being able to see anything, that is great to hear.  I see so many creative audit methods, the cart and webcam is a great idea.   

Larry Cichelli:
I'm both a Lead Auditor for our internal audits ans as the QA manager, the main auditee for our external ISO 9001 audits and regulatory audits (e.g. UL CSA). As far as remote audits and the last external audit was done remotely went well. From the auditee standpoint, this works pretty well as you get to choose documents to show the auditor. The auditor doesn't get to see everything that he/she would be able to see in a normal audit. From the auditor stand point this can be a disadvantage. I do remote auditing when I do our Engineering internal audit. I pick 3 projects and go through these files with a fine toothed comb. I like doing this because I can do this without having to take up an engineer's time and I can go through the files at my leisure. A lot of the time this audit is interrupted by other Quality duties or day-to-day issues that come up. 

Bottom line remote audits have their place and can be used in conjunction with face-to-face audits.

Yes, Larry, remote audits can limit the sampling as an auditor. Good point.  I agree, mixing the remote with Face to Face audits provides a good balance.  Thanks for the input. If you think of more, or have a good story, please post again! 

Hello,

I am the Quality Manager at a manufacturing plant in Bedford Park, Illinois. I have been in quality for seven years and am comfortable with the auditing process. I was the auditee last month for our periodic audit of our Quality Management System. The remote audit, in my opinion, was not as thorough.

The auditor, due to Covid-19, did our audit remotely with Zoom technology.  A week before the audit, we ensured our technology and software were installed and operable. I felt confident our team was ready and the remote audit would run smoothly. The day of the audit, there were technology issues that hindered response time. Some auditees were not technologically familiar and became uncomfortable sharing screens and documents remotely. For some reason the system did not adjust well with everyone being on camera at the same time. The connections froze and some found it better to use audio only.  We got through the audit after experiencing an hour of frustration and downtime because of technological issues. There were no nonconformances found; however, the auditor did not have time to explore our internal audits due to the issues and time constraints. 

 

Hi all,

I am the Head of QA/QC (for GLP/GMP) and GMP auditor for my company and we perform around 30 external audits a year as we are a virtual company.  Our GCP team is currently doing remote audits and that is going well.  However, for any GMP audits, I am sending out a detailed questionnaire to our new CMOs (Contract Manufacturing Organizations) to act as a stop gap until we can do an in person audit.  Many of the findings that we have found is when we go onto tour to see the SOPs in action.  We go back to the board room and review their processes compared to what we see on the floor.  Almost all CMOs that we work with will not give you their SOPs to review in advance and even if they did it will only catch a few gaps as most SOPs are standard (example of a company that did not have a CAPA system but captured everything in their deviation system which misses the true intent of a preventative action).   It is really seeing the people using the SOPs in action when you find the true gaps or compliance with the processes.

When I do lab and manufacturing tours, I will stop and look at logbooks, open drawers and look at reagents and chemicals. In addition, I get the names of people in the labs and on the manufacturing floors (and talk with them if possible) then take notes on what they are doing and review their training manuals to ensure they are trained on those processes.   There are some companies that actually have a portable camera system that can walk you through a tour which is a plus if you did opt for a remote audit.  However, I am still deferring all audits till Q3/Q4 of 2021 (hopefully) to do the in person audits.  Thus, my two cents is that I do not like to do a remote audit for GMP but I think it would be easier for a GLP and GCP audit where the scope is more defined and less paperwork is reviewed during the audits.  

Hey Susan,

That's a great topic for discussion. I have recently conducted a Quality Improvement Audit Remotely, the main thing about conducting any audit to have a set goal, what is the objective of the audit, so be it remote or onsite, creating an audit plan is very important. I agree with some of the challenges related to sampling, not having access to all the documents handy during the course of an audit, however I believe that remote audit could bring your focus back to the objectivity, and request only documents which will help one to evaluate the data quality, protocol compliance, privacy etc. The interview process with the auditee team didn't change due to the communication media by conducting Video conferencing etc. It was a great experience and we achieved the desired outcome for the the purpose of the audit.

Hello Susan,
Good Evening.
I am a Lead Auditor with a leading certifying body.
Based on the client restrictions due to COVID-19, the audit is completed remotely after risk review.
Remote audits performed as per ISO/IEC 17021-1:2015; and the relevant IAF Guidance documents: IAF MD4:2018 and IAF MD 5:2019.
The client agrees to the criteria for Remote auditing (including, but not limited to allowing the use of ICT to cover the Manufacturing processes), and technology is confirmed as being able to support the audit in a sufficient manner as if the auditor were physically walking through the facility.
The remote audits is the new normal during the Pandemic using the ICT (Information and Communication Tools).
Thanks.
 
Best Regards, 
Girish Trehan 
QMS Lead Auditor-independent contractor
Partial-Load Professor, Sheridan College 
ASQ Education Chair Section 0402
 

Yolonda Lathon:
Hello,

I am the Quality Manager at a manufacturing plant in Bedford Park, Illinois. I have been in quality for seven years and am comfortable with the auditing process. I was the auditee last month for our periodic audit of our Quality Management System. The remote audit, in my opinion, was not as thorough.

The auditor, due to Covid-19, did our audit remotely with Zoom technology.  A week before the audit, we ensured our technology and software were installed and operable. I felt confident our team was ready and the remote audit would run smoothly. The day of the audit, there were technology issues that hindered response time. Some auditees were not technologically familiar and became uncomfortable sharing screens and documents remotely. For some reason the system did not adjust well with everyone being on camera at the same time. The connections froze and some found it better to use audio only.  We got through the audit after experiencing an hour of frustration and downtime because of technological issues. There were no nonconformances found; however, the auditor did not have time to explore our internal audits due to the issues and time constraints. 

 

Yolanda, I know Information Communication Technology isn't always the best.  ICT can freeze and its frustrating, even when you have tested it out already, yet it happens. I understand that feeling. It's a skill to be able to communicate effectively over Zoom, and you definitely need a comfort level with the  ICT.  Thanks for your response.  

Kim K Burson:
Hi all,

I am the Head of QA/QC (for GLP/GMP) and GMP auditor for my company and we perform around 30 external audits a year as we are a virtual company.  Our GCP team is currently doing remote audits and that is going well.  However, for any GMP audits, I am sending out a detailed questionnaire to our new CMOs (Contract Manufacturing Organizations) to act as a stop gap until we can do an in person audit.  Many of the findings that we have found is when we go onto tour to see the SOPs in action.  We go back to the board room and review their processes compared to what we see on the floor.  Almost all CMOs that we work with will not give you their SOPs to review in advance and even if they did it will only catch a few gaps as most SOPs are standard (example of a company that did not have a CAPA system but captured everything in their deviation system which misses the true intent of a preventative action).   It is really seeing the people using the SOPs in action when you find the true gaps or compliance with the processes.

When I do lab and manufacturing tours, I will stop and look at logbooks, open drawers and look at reagents and chemicals. In addition, I get the names of people in the labs and on the manufacturing floors (and talk with them if possible) then take notes on what they are doing and review their training manuals to ensure they are trained on those processes.   There are some companies that actually have a portable camera system that can walk you through a tour which is a plus if you did opt for a remote audit.  However, I am still deferring all audits till Q3/Q4 of 2021 (hopefully) to do the in person audits.  Thus, my two cents is that I do not like to do a remote audit for GMP but I think it would be easier for a GLP and GCP audit where the scope is more defined and less paperwork is reviewed during the audits.  

Hi Kim, I do the same thing, look around, check out the surroundings, check out what people are working on, etc, Observation is a huge audit skill and we do loose some of that in remote audits for sure.  Thanks for your answer.

Kaushal Pandya:
Hey Susan,

That's a great topic for discussion. I have recently conducted a Quality Improvement Audit Remotely, the main thing about conducting any audit to have a set goal, what is the objective of the audit, so be it remote or onsite, creating an audit plan is very important. I agree with some of the challenges related to sampling, not having access to all the documents handy during the course of an audit, however I believe that remote audit could bring your focus back to the objectivity, and request only documents which will help one to evaluate the data quality, protocol compliance, privacy etc. The interview process with the auditee team didn't change due to the communication media by conducting Video conferencing etc. It was a great experience and we achieved the desired outcome for the the purpose of the audit.

Kausal, I love your response, proper audit planning includes defining the audit objective, scope and criteria. Well said! Thanks.

Girish Trehan:
Hello Susan,
Good Evening.
I am a Lead Auditor with a leading certifying body.
Based on the client restrictions due to COVID-19, the audit is completed remotely after risk review.
Remote audits performed as per ISO/IEC 17021-1:2015; and the relevant IAF Guidance documents: IAF MD4:2018 and IAF MD 5:2019.
The client agrees to the criteria for Remote auditing (including, but not limited to allowing the use of ICT to cover the Manufacturing processes), and technology is confirmed as being able to support the audit in a sufficient manner as if the auditor were physically walking through the facility.
The remote audits is the new normal during the Pandemic using the ICT (Information and Communication Tools).
Thanks.
 
Best Regards, 
Girish Trehan 
QMS Lead Auditor-independent contractor
Partial-Load Professor, Sheridan College 
ASQ Education Chair Section 0402
 

For sure, remote audits are here to stay, now more than ever.  I like the reference to the client agreeing to the remote audit and risk assessment.  These are good points. Thanks for posting, keep up the conversations!
 

Our company has conducted three remote audits, and have several more scheduled. Each one is managed slightly differently depending on the vendor, but they have been quite successful. From the lead auditor's perspective (mine), it is more work. It takes a lot of planning, and the vendor does need to be willing to be more flexible, and be onboard with the process. The way that we have performed the audits is to provide an extremely detailed agenda and document request list well before the audit. The auditee has provided the requests prior to the audit (at least one business day, and sometimes several days prior). This allows most of the actual auditing to occur prior to the scheduled meeting time. The documents have been shared through a secure software platform that does not allow us (auditor) to download or save the files (e.g. Box). The meeting time is then used to ask any clarifying questions based on our review. 

Typically, we are given a day or two to complete our audit. Because the companies we work with are all over the world, we have scheduled meetings in blocks to adjust for the time zone differences (e.g. two 3-4 hour blocks instead of the normal 8 hour days). We still start the audit with a tour, but it is pre-recorded. Our product is manufactured in a clean room, so this made sense for us. In other scenarios, a live walk-through may be feasible if technology allows. We then ask any questions we have accumulated from our document/record reviews. 

The point is, there is a lot that goes very much like a typical audit. Create an agenda, review documents/records, ask questions, verify compliance or identify issues, write a report. The areas where it differs is that you cannot do a "Gemba walk" to identify what you want to focus on during an audit. We used records provided instead. I don't think this had a negative impact on the results of the audit. 

Overall, the consensus from our team is that remote audits have their place, and onsite audits have their place. Even after we are able to travel freely again, we will likely want to continue with the practice in order to save time/cost related to travel, etc. 

Thank you Kelly for such a comprehensive response.