Remote “Quality” Auditing-Considerations
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Hello there. Welcome back to the weld N. D. T. Quality guru podcast and I'm your host Stephen Snyder. We've discussed several topics here related to welding and N. D. T. Inspection and careers. However this topic today is directly related to quality and remote auditing. I wanted to bring this subject up some time ago. However today we're gonna just kind of dive into that and give you an overview of some considerations, standards and guidelines when it comes to remote auditing so sit back, relax and hope you enjoy. The purpose of auditing is actually to verify conformance to an organization's processes and their management system to some type of defined requirement where requirements it really depends on the type of audit though and the objective and the stated criteria which can really vary the and also the standards which an audit may be conducted could be really based upon the organization's own internal procedures. It could be based upon a management system standards such as ISO 9001 or for aerospace a. S. 91 100 or it could be underneath the international automotive task force I 80 F. 16 949 and I sold 22,000 which is food safety management systems. There's another brother several others out there and government regulations it conclude FAA Federal Aviation Administration, the Nad Cap National Aerospace defense contractors program and the Nuclear regulatory commission and on and on. Actually we won't dare to go into that deep dive on all the various standards and criteria you know one of the topics that's been really hot over the last year given the circumstances you know surrounding the pandemic and covid 19 is remote auditing now remote auditing will give some overviews and hopefully some resources there for you and some links but it's really been around for over a decade but I think it's popularity now is really being put in the limelight and spurred by the advances in technology and globalization. There's really been a considerable increase that I've seen in organizations and registrars as well as companies offering these services. But also it's due to increase industry. We're looking at multi site companies with operations literally scattered around the globe. And of course more in small medium sized enterprises are are looking to engage or already have international supply change supply chains rather that require auditing and review of their quality management systems. It really doesn't matter the scenario or the organization or the situ regardless proper planning is really the key for this remote auditing option and to actually prepare for contingencies and understand the kind of risk that may be associated as well as to establish the objective the scope of the audit criteria and what is the most suitable available technology out there as well as the auditor And the oddity complete understanding of the I. C. T. Which is the information and communications technology platform that that's to be used and really finding that the information and communication technology is basically just defined as the unified communication and integration of telecommunication. So there's there's a number of those out there. We'll touch briefly on those, some of you are already using that technology. But I think when we, we start looking at the overall impact industry, whether it's a company or a registrar or accreditation organization, they really need to where they must continue to reinvent and adapt to this quote unquote new normal term that's being floated around regarding remote auditing. They've really got to figure out ways to achieve a balance in assuring the quality management system conformance versus, you know, not auditing them at all and maintaining the rigor in the respect of the quality management system and or an accreditation program as we move forward, we'll talk about a little bit about that. You know, I mentioned that remote auditing has been around for over a decade. There's a document so 19011 And the document in its annex a 0.1 and the option in a 0.16 is for remote and virtual auditing. And it's also been recognized since 2011 and the eye. So slash i E C 17 0 21 has also recognized it. It's been around for a while. I think more people are now looking at it closer than they ever have because of the current situation as mentioned. You know, there's obviously limitations to what you can do with the remote audience. I do want to clarify that up front, you've got to consider things like the initial audit of a company or factory or facility and for critical processes that may or may not lend themselves as well as well as highly classified facilities and those with proprietary processes and also facilities that have been previously audit and proven to be problematic. Numerous nonconforming systems previously audited. There are exceptions. Is our for anything I do want to just touch based on this 19011 this 90 you know, 11 is really its guidelines for auditing management systems. So it does provide guidance and management for an audit program for conducting audits of the management system as well as on the competence and evaluation of the auditor and or the audit team. It is intended to apply to auditors and the organizations implementing the management system, it's something that every auditor really should already be familiar with, but I think it's important and when you're understanding this standard in this particular topic, that, that standard, so 19011 is a guidance standard. It does not contain requirements that organizations must meet, nor is it a standard that organizations can secure third party certification again, and it does primarily focus on first party audits, internal audits and second party audits conducted by organizations or external providers and other external interested party. That's an important statement for those that are considering implementing this as well. So, you know, while the required for third party management system certification are contained in the ISO 17 021 X. Series of standards. The ISO 19011 is recognized as providing useful third party conformity assessment or certification. It could be used by organizations that are providing accreditations as well. So that's an important consideration. And I just want to bring that up kind of review that there's discussions in there about remote auditing. It's one of the audit methods actually described the value. The audit method really resides I think more with the potential to provide the flexibility in achieving the audit results or the audit objective as mentioned before the I. C. T. Or the information and communication technologies out there. Now they help increase the size of the quality or the sampling of the audit process when it's properly prepared and can support that. Take a look at that document. I'll put a link in there for where you can source that as well. Now in addition to that I think there's a a pretty important paper that was published I think it was may I'm sorry it's the april of last year so not quite a year ago and it was published by the 9001 auditing practices group and I can also put a link in the show notes for that as well for you. The S. 0. 9000 auditing practices group issued this document or its I guess it's a white paper actually and it's remote auditing including recommendations for remote auditing. It does included in annex an example of identification of the risk and opportunities for using remote auditing techniques. You can take a look at that and it's it kind of outlines the feasibility and the risk analysis for remote audits which giving general recommendations for remote audit. Talking about the risk assessing the audit planning and audit realization and audit conclusions. And again just to give you an annex example the risk and opportunities are included in that you can take a look at that according to the S. 019011 document. The feasibility of a remote audit using the I. C. T. Should be considered when you're established in the audit program. There's several information communication technologies out there. I mean there's Skype there's slack there's facetime there's live streaming instagram facebook screenshots, snag it. There's just so many from you know I mean we've used what's happened several situations for for recording. Weld startups, so to speak and an overview of capability of organization to be able to conduct N. D. T. In accordance with procedures you know there's google hangout google duo Microsoft teams. Cisco, there's just there's numerous out there so I am no expert in any of these. I struggle to keep up with all of the ones that are being used myself. But it does take a little bit of effort to understand which which method or what are you going to use to conduct the audit and also for the audit. D to minimize any impact. Anyway it is important to verify. Also the adequacy of the resources to ensure that the audit is effective in the outcome of kind of flipping back to that annex a 0.1 in the eye. So 19011. It does give several examples of the application for remote audit methods in combination with on site audit methods. So it may just be part of the audits conducted remotely and then maybe there's a follow up an on site visit depending on the situation. The remote audits do refer to the use of I C. T. As I've mentioned two together that information you know, interview of an oddity when face to face methods really aren't aren't possible or aren't feasible. The I. S. 019011 and both Eye af published a document I. F did. That is known as the M. D. Four. Now the I. F. M. D four is a mandatory dot document for the use of I. C. T. For audit assessment purposes. It actually does define the rules that certification bodies Keyword there. It defines for certification bodies and their auditors shall follow to ensure the I. C. T. R. Used to optimize the efficiency and the audit process. So again both both of those documents really should be known by auditors but it's very important to be familiar with them Now an important clarification I want to make about this I. So 19011 document and this a 190110.16 as I mentioned previously is there is a difference between remote audits and auditing. Virtual locations, auditing of a virtual location is sometimes referred to as virtual auditing. Virtual site definition as defined in the I. F. M. D four is the virtual location where a client organization performs work or provides a service using an online environment allowing purses irrespective physical locations to execute processes. So understanding the auditing relative to virtual underneath the mandatory document or M. D. 4 2018. You know the rules allow depending on industry sector which may vary, you know, remember that all requirements including the observation of activities can be remotely audited and that the infrastructure that needs to be in place for the technology needs to be considered as well as really important. The secure and confidentiality needs. So when you're sharing documents and so forth, shared screen or what have you there need there may need to be India or nondisclosure agreements in place to protect both parties in regards to that. And the risk and opportunities they need to identify. You need to identify and document the risk and risk and the opportunities of technology that may impact the audited effectiveness or ineffectiveness. And it can't be emphasized enough that the training and competency needs to sure that the auditors are actually trained and knowledgeable of the technology and assure that the audit clients are also knowledgeable because there's is speaking from experience. It's quite inconvenient and stressful when you're in the middle of an audit and you're not familiar with how to share screen or they're not familiar. That is the audit e or the internet connection is not strong or if for example you're going to the shop to do some auditing of processes, there's not an ad wifi connection in there to be able to stream and monitor the just use for an example of well startup or witnessing ultrasonic testing for example or a number of other things as well. But just remember that additional planning may be necessary when it comes to this which really could impact the audit duration. Think then trying to round this up here, The remote auditing is here I think you know, it's here to stay. The remote audit is still a systematic and independent documented process for for actually obtaining objective evidence and comparing it to audit criteria. You know, using as I've mentioned several times the information communication technology, whether it's cameras, software, hardware and internet would have you phones, headsets. So you know, the remote auditing of a virtual site is conducted. You know when an organization performs work as I mentioned or provides a service using an online environment. Remote audits refer to using technology to gather information whether it be to interview the audit or to review documentation or in some cases actually visit the work area. So I think remote auditing is with us to stay at least for the near future. They can be done just as effectively as face to face audits in many circumstances. Um not sure to what extent will become the new normal, but I think it's going to be here with us for a while. As I mentioned, you know, organizations really need to adopt web based, cloud based document management systems and auditing software and being prepared for this because it's not going to go away. So when I'm thinking about, you know, some conclusive thoughts here and kind of pass those on to you. You know, it's it's important that the to establish the remote auditing process and that it's effective for quality management systems in the future will will actually see a considerable increase in remote virtual approach and the auditor training and probably will start seeing someone rollout qualification and trying to market that. That you need to be qualified to be a remote auditor. So I'm sure that's just a matter of time away. However, you know, follow up and physical site audits may still be required. As I mentioned early in the podcast for certain situations, nonconformity ease and or critical processes. But there's no doubt about it that there's an astronomical amount of cost savings that's going to be realized here and there will likely be in better interviews in some cases when it comes to the quality management side of audits and of course probably extensively reduce costs. I should emphasize due to travel in the time, but either way you slice it, I think it's, it needs to be rolled out by companies maybe in a pilot type approach and at least during the initial phase to make sure they get comfortable with it and they're able to work the kinks or the bugs out in it. But I really think that it's here to stay and even though it's been around for a decade, you know, covid nineteen's really reshape the global business interface and you know, organizations are really really being forced to look at alternatives and how they manage their business and as well as implementing effective cost saving. The opportunities exist to capitalize on the cost savings as well as the auditing processes that have been out there and available. Thanks for listening. I hope this was a benefit to you and we'll put some links in the show notes that you can hopefully put in your toolbox and check out at a later time. Take care, see you next time