Remote Audit. Hesitant beginnings with a sustainable method. Experience feedback

In 2020, the audit world was turned upside down and called into question by the pandemic.

Travel was postponed, cancelled,… without a real vision of the future that awaited us.

 

Auditors and auditees have had to adapt their practices to this new situation and the use of remote audits is growing fast

A Remote auditCIG (Common Interest Group) was started by A3P at the end of 2020 with the aim of creating a guideline for the conduct of remote audits, both from the point of view of auditors and auditees. In this context, participants contributed their experience and this article was created to share them with you, as well as the changes that have taken place in our methods, the advantages conferred, the disadvantages encountered, and finally how this new challenge fits into our future.

 

1.Beginning the practice of remote audits (point of view of the laboratory)

Like most of our colleagues, we began by postponing our supplier and subcontractor audits. The summer of 2020 offered us a breathing space that allowed us to partly catch up with the backlog accumulated over the first half of the year. Unfortunately, the epidemic resumed in the autumn and with it the postponements or cancellations of audits.

Our schedule was turned completely upside down and even if we could justify this delay, we could not absorb the total postponement of workload that that involved. It was therefore necessary to reflect on what we could put in place: the subcontracting of more audits (we could not travel in some countries, but local auditors could visit the sites to be audited) or the remote audit.

As not all audits could be contracted out, to maintain the link with our suppliers, because of our need to know about their work internally, and for the financial aspect, the second solution had also to be seriously envisaged.

We absolutely had to audit one of our suppliers in 2020 to finalize an initial approval. The audit of this intermediate supplier was to supplement the site audit of a subcontractor for the manufacture of finished products. We therefore only had to audit their quality system, as the product did not pass through their premises.

We therefore took the decision to launch into a remote audit for this specific case where it could be easily applied in our audit field and where not carrying out this audit would prove more critical than doing it remotely.

 

With my co-auditor, Mr A. O., Quality Manager of the Gerland site, we decided to separate the audit into two parts:

  • a first half-day on which we audited the documents sent by the site (corresponding to a list which we had sent to them two weeks previously) and prepared a list of associated questions. We carried out this work together and drafted the associated part of the report directly.
  • a second half-day in Teams with the auditees when they answered the list of questions and when we audited the documentation that they were not authorized to send to us. Given that it was our first experience working remotely and in English, we decided to stay together in the same office in the same Teams window with our auditees. We took our notes on separate computers. This allowed us to better comprehend the audit and to understand everything that was presented to us. The audit was conducted under good conditions for everyone despite this first experience and we concluded it successfully.

 

I found tackling this new experience difficult. We did not know exactly how to organize ourselves, whether we were applying the right method, or how the exchange would take place with our auditees. But we threw ourselves into it, at once anxious and impatient to test this new audit method. Finally, the audit went well apart from a few misunderstandings linked to the language and use of Teams, and we found our balance. The half-day on Teams had been fairly demanding despite a break and signalled that adjustments were to be anticipated for longer days.

I repeated this method on my own for the internal audit of the quality system of a partner company, in French. The audit went well overall, but I was teleworking on that day and the morning was disrupted by some work. The situation was exceptional and I had not been able to do otherwise, but I advise not conducting a remote audit from home. It is better to be at the office, with optimal environmental and connection conditions. I gradually understood that the remote audit was not a temporary solution, but a new challenge which correctly used and supervised, could become a development in our life as auditors.

At this moment, I joined the A3P CIG dedicated to Remote Audits, with the goal of creating a true guide with my experience and that of others. What a pleasure to be able to exchange information with all these professionals who shared the interests and the concerns of my everyday work! This has already helped me to establish a framework, to have some ideas on how to continue with the next stage and to really recognize that we were at the beginning of a real change in our way of auditing.

2.When auditors are also audited

In parallel with these audits that we conducted, we were ourselves inspected and audited remotely:

  • Our subsidiary in Canada experienced its first authorization to operate inspection by Santé Canada remotely. The members of the Corporate Quality team, to which I belonged, attended the opening and closing meetings via Teams. Throughout the inspection days, the Quality Manager of the subsidiary was contacted on the telephone by the inspector for questioning and to supply the documents that he needed. The inspector was not continuously on the telephone, and took the time to study the documents between two calls. The Quality Manager of the subsidiary sent us the list of questions and documents to which she could not respond without our support each evening. We spent the following morning in preparing everything that was requested, then the manager began her new day of inspection at the beginning of the afternoon French time. Finally, we managed this inspection in the Corporate team in the same way as if the Quality Manager of the subsidiary had received Santé Canada on site. It was mainly for her that the situation had had to be adapted and she gave us positive feedback. In addition, we obtained the authorization to operate of the subsidiary.
  • One of our ordering customers also audited us remotely, with a single auditor on their side. Several of us were in the same meeting room, with a single computer serving as contact with the customer and the person audited installed facing them. Searches were carried out on another computer. As our document system is in a DMS system, this assisted us with our preparation as auditee and facilitated the sharing of documents during the audit and the experience went well overall. The auditor did not request documents from us before the audit.
  • The ANSM inspected us remotely one day on one of our medical devices. We sent documents in advance by email and we were questioned with document review on the day.

 

These three audits demanded preparation beforehand, but overall equivalent to an on-site audit thanks to our computerized systems. The auditors just ask for more documents in advance than for an on-site audit.

 

3. Gradual introduction in 2021

Below I share two items of experience feedback.

I begin with Mesdames H. T. and L. P., Supplier Quality Assurance Officers, who audited one of our  temporary employment service providers remotely for a whole day.

“There has really been no change in audit preparation, apart from the creation of a precise agenda, describing how the day will unfold”, L.P. explained to me. Certain persons had to be involved from time to time and were presented at specific times. The auditees appeared very transparent to us and there was a real atmosphere of trust. Everything that we requested was presented to us.

“The work had been well prepared beforehand, the auditees made themselves available and knew at which time they would be involved, it ran very smoothly. There were 4 connections on Teams at the same time, L.P. and I were both teleworking and the auditees on different sites, but that did not pose any problem”, added H.T. “Previously I had followed the remote audit of one of our service providers conducted by one of our audit partners, which allowed me to apply the same principles to my remote audit: specifying the break times, the times when the camera was turned on/off, organizing the agenda, … It was very instructive.” said L.P. “It was a documentary audit, which is very well suited to a remote format. We would not have seen more on the site. The company had entirely electronic documentation which facilitated the conduct of the audit. We just asked them to log off to prepare the closing meeting, but we did not need to confer at another time” said H.T.

Both appreciated the advantages over travel and the fact of having easier access to participants, but did share a few difficulties with me: the signature of the opening and closing minutes when electronic signatures are not possible/validated, the taking of notes when there is only one screen or computer for the interface with the auditees. All the same it remains a positive experience overall.

 

While Mme A. N., Quality Assurance System Manager, shares her feedback on the audits of our subsidiaries.

“I had to design my audit differently from what I would have done if I had been on site and that is what I remember as being most important. In particular, I had to review my use of IT tools (here Microsoft Teams), and my agenda. The preparation work is not the same, therefore I planned for more time to prepare the audit beforehand and to focus on my questions during the audit. I requested more documents before conducting a detailed examination. We really discussed key points during the audit. Thanks to her work with the CIG, Margot had informed me about breaks and that really helped me to discuss with my co-auditor during these breaks and to take a step back from the audit. Because you get caught up in the questions, the technical problems, …This allows the audit to be reoriented after having a breather for a few minutes. The positive points, it is that this highlighted the responsiveness of the auditees (speed with which they supplied the documents), reflected their quality level and installed a climate of trust (they knew what to expect in relation to the initial request and the pre-audit). We were therefore very precise and the discussions were more pleasant. In addition; the remote audit is easier to organize in relation to people’s availability. Conversely, there are disadvantages, such as little moments of inactivity (there were several auditees on different sites and there were times when not everyone was present). The scope was adapted to a remote audit, but we had never thought of applying this type of audit before. However, if we carry out a risk analysis as explained in the guideline, there is no risk associated with such an audit for subsidiaries. But I think that a system of alternating remote audits/on-site audits should be retained, because we lose the aspect of human contact with the auditees, which is all the more important with a subsidiary.”

Subsequently, we finished by accepting remote audits with a site visit, as the health situation remained complicated for some travel. They were conducted by our audit service providers.

 

 

4. The sustainability of remote audits in the quality system

The culture of remote audits has therefore gradually entered our way of auditing. Other remote audits were conducted during the year and bore fruit. Our quality system is in the process of evolving to gradually incorporate these changes. Currently it contains remote audits as a solution to be used for certain types of supplier, in certain specific situations such as a pandemic. But it will develop to incorporate the methods developed during the year, as well as the work carried out in parallel with the A3P CIG. The next steps are therefore the dedicated risk analysis and the incorporation of the A3P guideline which will allow the finalization of a sustainable system.

As I was saying earlier, the Laboratoire Aguettant auditors did not conduct a remote audit involving a site visit, therefore I cannot share that experience with you. But I had the opportunity in the Remote Audit CIG of meeting Mme Marie-Noel Maumus, Pharmacist with Gianelli Maumus Partners consultants, audit specialists, who had had several experiences of a remote audit with a site  visit and who will share them with you.

 

 

5. Beginning the practice of remote audits (point of view of the consultant)

In March 2020, the lockdown hit like a ton of bricks, stopping the ongoing audit programme planned for our customers, audit instructing parties, dead in its tracks. Immediately, auditors in the networks to which I belong conferred to decide how to proceed. Some wished to wait until the pandemic had passed: at that time in fact everyone hoped it would finish rapidly. Others wanted to adapt immediately to the situation without wasting time, and to try to apply another form of audit: the remote audit. Of course we did not all have experience of this, but there were articles and texts on the subject, particularly from AFNOR, and it seemed all the same that for the documentary and quality system parts, the approach would not be fundamentally different. Finally, it appeared interesting to innovate, and to transform this constraint into an opportunity.

 

We therefore held meetings (remotely of course), had many discussions, exchanged documents, sent and commented on proposals. The prior risk analysis, as presented during the Remote Auditslecture of the A3P Congress on 23/11/2021, appeared immediately to all of us as self-evident; nevertheless this topic was the subject of numerous discussions, to determine its methodology and content, and also to determine who should bear responsibility for the conclusion, that is of considering the risk of conducting the audit remotely as acceptable or not: the instructing party since it is they who are responsible for the audit to the authorities? The auditor, since it is they whose competence is at stake? Both? The form that we put in place contains the signature of both. The methodology was proposed to the instructing parties who were satisfied with it.

 

6. Development of the methodology

The methodology introduced at the start has proved effective, and has just increased in precision with experience, and as we discovered the pitfalls to be avoided. The feasibility study questionnaires were enriched with the experience acquired during the audits that were conducted. One of the very first audits that I conducted was stopped rapidly because the conditions were not satisfied, as the auditee had overestimated their capacity to accommodate an audit of this type, and the questionnaire at that time was not sufficiently detailed to reveal this weakness.

With regard to document management, we began with a single form, which brought together the  information collected both from the auditee and the auditor. In practice we realized that it was more practical to split the information into 3 documents: the first containing auditee information, the second instructing party information, and a third form on which only the date of each of the first two forms is carried forward, and the conclusion with any comments.

On the basis of this feasibility study, it has happened that I have refused to conduct the audit remotely, judging that the risk was not controlled. On other occasions, I agreed to conduct the audit, but with documented reservations, taken into account by the instructing party. It is important for me to be able to compare my practices and my interrogations with the other auditors in my network, in accordance with confidentiality rules. My participation in the A3P Remote Audit CIG was for me a good opportunity for meetings and discussions to further extend the comparison of experiences and ideas.

 

7. The assessment after 20 months

I conducted my first remote audits in April 2020, and since that date I have done 23 of them. At the beginning I was the first to be astonished by how powerful a tool a remote audit is; obviously apart from the visit to the premises, which is impossible by definition, the investigations are thorough and the observations relevant. The clients appear satisfied with the reports, which for a consultant is obviously an essential goal.

On the basis of these results and their quality impact, I am defending the incorporation of this mode of audit into the quality practices of the pharmaceutical sector, with an understanding of its limits. Nevertheless, my personal preference, obviously, is without comparison to conduct an audit on the spot, to visit the premises and engage in a real discussion with the auditees! …… When I conduct a remote audit, I at least have the satisfaction of reducing my environmental footprint, and compensating a little for my sometimes disastrous carbon footprint during an on-site audit ….

 

In conclusion, what is the future of remote audits?

Whether in a manufacturing company or in an audit consultancy company, remote audits are a novelty which has revolutionized our way of auditing and which will be a permanent feature in the future. In the pure form of remote audit for documentary system audits or in the hybrid audit form (part on site visit, with the documentary part being done remotely).

Through our various experiences and those of our CIG partners, then our time spent in lectures and workshops during the A3P Congress of November 2021, we have driven our practices forward and will be able to deliver a guideline that is adapted as closely as possible to the situation.

The next publication by the A3P of the Good Practices Guide for Remote Audits will have the aim of  compiling our experience feedback which, we, hope will facilitate the initiatives of new members and perhaps provide other suggestions for those who have already experienced the technique.

The pandemic is in its fifth wave, exceeding the predictions of the most pessimistic among us, and we unfortunately do not know what the future holds for us, but we may think that the remote audit will allow us to keep a number of audit programs up-to-date again. The remote audit is not temporary, however. It is not a quality tool associated solely with the pandemic. In less than two years, we have understood and put in place new methods to adopt this new way of auditing which has demonstrated its efficacy, and which is today almost normal. The role of the remote audit is not to replace the in-person audit, but this method represents a new alternative in the choice of quality management tools.

 

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Gibert

Margot GIBERT

Laboratoire Aguettant

margot.gibert@aguettant.fr

Maumus

Marie-Noël MAUMUS

Gianelli Maumus Partners consultants

marienoel.maumus@gmail.com