Picto La Vague

January  2022

La Vague n°72

Remote Audit

Download the original issue

Summary

✻

Remote Audit. The role of the Covid crisis in its generalization, principles, technologies and auditor profiles.

The audit is a necessary component of the customer-supplier relationship, used particularly to evaluate the supply chain and distribution of health products. The COVID-19 pandemic has triggered new behaviours and has led numerous sites that are audited regularly to restrict the number of visitors, even to prohibit access to auditors.

To alleviate this new situation which has affected all countries to various degrees, the use of remote audits has grown,  as they are presented as an alternative. This form of audit existed before the pandemic, but the health industries, as well as the other industrial sectors, have had to face the generalization of this practice.

The GXP assessment of subcontractors, suppliers, and other partners that was usually conducted on site has migrated to remote audits.

In this article, we will present an overview of practices, as well as of the advantages and limits of this new mode of operation in the context of the assessment of suppliers and other external partners.

1. The context of the framework

In 2020 and 2021, States adopted measures to restrict movement, even closing borders. In addition to these national decisions, companies also decided to close access to their site(s) to visitors to ensure the safety of their employees and allow activity to continue.

The practical consequences of these decisions quickly made themselves felt, particularly in audit schedules which were disrupted. The schedules defined at the end of 2019 and beginning of 2020 were initially postponed and then had to be adapted, first for audits of subcontractors (manufacturing and analysis) and active principle manufacturers which could not be postponed too long, at the risk of no longer having an up-to-date report.

The option of purchasing a report from an audit service provider is an option in some cases, but it is not always appropriate. The use of local auditors is another solution, but in the case of sites that are no longer accepting visitors, the last-resort solution is the remote audit.

 

National restrictions also caused health authorities to adapt their practices and publish texts to this effect. For example, at the end of 2020, the EMA (European Medicines Agency) published a  “Guidance related to GMP/GDP and PMF distant assessments” intended for the inspectors of European authorities. On the basis of these recommendations, we were able to “validate” the provisions that we had put in place to regulate remote audits conducted on behalf of our customers.

Similarly, in April 2021, the FDA also published a text on “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency“.

 

Finally, several certification bodies also put in place procedures on this subject.

To make this article easier to read, we have chosen to limit its scope to external audits conducted in the context of the COVID-19 pandemic. The vast majority of points are also applicable to other contexts, but this article does not aim to be provide exhaustive coverage of these. The framework is therefore established, we must now ensure that the applicable cases are selected.

2. How to select the applicable cases?

The audit schedule of a pharmaceutical site is composed of audits of subcontractors, manufacturers API, excipients, packaging items and various service providers and suppliers.

Not all types of audit and their context lend themselves to the same remote audit method. There are obvious reasons, such as difficulty in visualizing the environment of a production solely on the basis of photos or films prepared by the site, as well as the reason for the audit; for example, during a for cause audit, or when we wish to ensure that there is no risk of cross contamination on a multi-product site.

 

Carrying out a remote audit on a site that we have already visited physically, rather than a qualification audit of a new supplier or subcontractor, is also more easily conceivable.

For these different reasons, audits addressing documentary activities lend themselves more naturally to this exercise. For example, audits of pharmacovigilance service providers in very distant or unsafe countries have been carried out in the form of remote audits for several years.

In any event, a remote audit is always better than no audit at all, or than the use of an evaluation questionnaire sent by email. The audits of subcontractors, those of active principle manufacturers, and in particular audits of sterile product manufacturers, must be tackled with particular attention. In these cases, it appears clearly that the remote audit cannot fully replace the on-site audit. It is a derogating measure pending the time when we will be able to return on site, to complete the assessment made remotely. It is the same for the qualification audits of new suppliers and subcontractors. The performance of a risk analysis allows definition of needs relative to a complementary on-site audit and their prioritization.

Planning

Practice tells us that for an equal duration, the remote audit is not as efficient as the on-site audit, even on documentary matters; the estimated loss is 25 to 30%. As we will see later, communication via screens is less dynamic, without counting possible outages or reduction of network quality, which are always possible.

This reduced efficiency may be offset by consulting part of the documentation in advance, during the audit preparation phase.

Another lesson from these last two years is that it is better to replace a full audit day with two consecutive half-days (an afternoon and a morning), when possible. This requires schedules to be flexible but the experience feedback is positive. This structure allows an intermediate assessment to be made at the end of the first half-day, and thus the adjustment of priorities for the following day. It also allows auditees the opportunity to add to their responses on themes already covered. Finally, this structure allows the auditor to limit the loss of efficiency commonly experienced after 7 to 8 hours of remote audit.

 

3. Auditor Sélection 

The choice of auditor is also very important, for several reasons:

– Competence in the subject matter

The auditor will only be able to draw on documents and the viewing angles of photos or videos offered by the auditee to understand the process and to identify associated risks, such as those of cross contamination for example. This is why their knowledge and prior experience with the types of processes concerned will make a difference and increase audit efficiency.

It is on this point that the remote audit introduces a valuable advantage relative to the on-site audit. An additional auditor can be brought in, on one or more themes, for a field requiring specific expertise.

– Qualification of the remote audits

Our experience shows us, that, with regard to form also, conducting a remote audit requires a specific level of qualification. In fact, because of the form of the remote audit, the auditee is more inclined to control the running of some sequences. During the virtual visit, the auditor does not have the possibility of capturing peripheral information out of the field of view of the camera, as they can do during a site visit.

This is why for new auditors we ask that they have taken training in the specific features of the remote audit or whether they have previously accompanied experienced auditors.

– The location of the auditor and the difference in time zones

Finally, the choice of auditor must also be made taking into account the time difference between the place of the audit and the place of residence of the auditor(s). Conducting an audit remotely in fact allows the use of an auditor based in a country different from the site audited. This allows greater flexibility and/or the mobilization of one or more auditor(s) with greater expertise than a local auditor. Nevertheless, the use of an auditor from another country requires several limiting factors to be taken into account:

  • Proficiency in the local language remains an essential attribute, as for on-site audits. And the presence of a translator leads to a loss of audit fluidity that is more of a handicap than during an on-site audit.
  • The difference in culture is also to be taken into account. The impact of an error in the discussion is increased by the impossibility of taking account of a large part of the non-verbal communication. An experienced auditor will be able, in the field, to detect a change in rhythm, in intonation or a different physical position in their interlocutor during a discussion. This capacity to detect non-verbal elements is made more difficult if specific cultural characteristics are not mastered.
  • To these first two factors, we have to add the time difference. When travelling for an on-site audit on the other side of the planet, the factoring in of the time difference has entered into practice. A recovery time is arranged to incorporate a 10 to 12 h time difference.

A time difference of this size is not recommended for a remote audit. Conducting an audit during the night during a working week is complicated for an auditor, even when this is anticipated with a day of rest before and after the audit. Experience has taught us not to exceed a 6 hour time difference when we mobilize auditors of another country.

4. Preparation

If we save time on the logistical aspects associated with travel, experience shows us that the  preparation of a remote audit takes more time than that of an on-site audit. It is particularly necessary to organize a preparatory meeting with the site to be audited. This allows consideration of the most commonly encountered difficulties, such as those touching upon means of communication, confidentiality aspects, the presence of different participants.

 

Means of communication

Particular attention must be paid to the means of communication that will be available to exchange documents before and during the audit and for video exchanges. Several tools are possible for the interview phases, the most widely used are Teams and Zoom. For the sharing of  documents, we have witnessed a professionalization of practices during the last eighteen months. Sending of a document by email or showing its content to the camera, occurs only exceptionally.  In some cases, the exchange of documents may also take place via a secure cloud.

For these reasons, we have incorporated a testing phase for the communication tools that will be used in audit preparation. This is essential to be sure of being able to start the audit at the specified time. The installation of a new tool requires time and sometimes the agreement of the IT Department, as well as a check of connection speed which must be sufficient to ensure conversation quality, the visualization of images or of videos and the exchange of information. This test must be performed at least one week before the audit and in audit configuration (with the same IT stations and in the time slot selected for the audit). This time frame allows for switching to another solution ifnecessary.

 

The equipment available to the auditor

It is preferable that the auditor has 2 screens, one for exchange of information, the other for note-taking.

 

The screen for information exchange must also be sufficiently large to be able to capture interesting details during the viewing of images or videos and to limit visual fatigue. Also, as with any remote meeting, good quality audio equipment is vital to facilitate exchanges and limit auditory fatigue.

 

The confidentiality agreement

For preparation of the audit, and while it is being conducted, the auditor will ask the auditees for access to information, part of which may be identified as confidential. The remote audit necessitates the setting up of a confidentiality agreement. In fact, the site audited has greater control over deciding which documents they wish to show to the auditor, but their communication before and during the audit requires that their conditions of use are defined, especially as regards their retention or destruction after the creation of the report.

 

The audit agenda

The audit agenda must show clearly how it will be conducted “remotely”. Experience shows that interlocutors for each of the themes on the agenda may be located in different rooms or on different sites. This is particularly true in the context of COVID-19. This is why it is important to check with the main contact, that the other participants will indeed be available at the times specified in the agenda. This point should be recalled during the preparatory meeting with the audited site. The information that will be available and their form.

All those who have already conducted or participated in an audit of a third party know that when we wish to consult a  document, such as an old batch record or a log-book, the auditor must anticipate their request to allow the auditees to go and look for the document which is sometimes archived in paper form only. During a remote audit, in addition to this constraint, the time required for digitization of the document by the auditees so that it can be shared should also be included.

 

This is why it is important during audit preparation to:

– Validate the types of document that the audited site already has in digital format,

– Share the list of specific documents that the auditor wishes to consult during the audit, in order to allow the auditees to be able to digitize them, if need be.

 

5. Conduct of the audit

Adherence to the agenda

As with an on-site audit, adherence to the audit agenda is an important point. All the more as the persons audited may be located on several sites. A delay of half an hour may prevent the following theme being covered correctly.

The sequence of interview phases during the same day is another difficulty to be managed for the auditors. They must remain focused on each of the themes up to the end of the day without being able to alternate with site visit phases.

 

On the other hand, the option of distributing this audit day over two consecutive days, as seen in the paragraph ” Planning“, is not always possible. This is why it is important to take breaks during a remote audit day. A lunch break, as well as a break of five to fifteen minutes during each half day. We recommend to our newly qualified auditors that they should take advantage of these breaks to get up and move around.

 

Last point, if the auditors mobilized on the same audit wish to separate to cover different  points on the agenda individually at the same time, this needs to be anticipated when the agenda is constructed. The auditee must be able to give their consent, as they will have to mobilize different  interlocutors at the same time and make the necessary technical resources available.

 

The kick-off meeting

During a remote audit, the kick-off meeting provides the opportunity to make the auditees aware of the limits of this type of audit and to recall what has been defined for the communication of documents in order to avoid any inactivity during the audit.

It is also imperative to properly validate each planned time slot, including the breaks during which the participants can log off. It is necessary to be sure that the persons concerned will indeed be present at the restart in order not to waste time.

 

Taking notes

Note-taking can be facilitated by conducting audits remotely. The auditor, if comfortably installed in their office, can in fact take their notes directly on their digital tool: computer or tablet.

 

The document review

The document review is one of the points to be prepared before the audit as we have seen previously, especially via the sharing of the list of specific documents that the auditor wishes to consult. It is the auditor’s role to decide between the need to anticipate in order not to be obstructed by excessive time spent on digitization and their desire to keep the flexibility necessary to select documents at the last minute.

 

The document sharing method is also a point to be considered. If it is the auditee who maintains control of document scrolling, the screen-based document review can take more time than a paper-based review.

 

The conduct of interviews

In addition to the usual skills associated with the conduct of an on-site audit, the remote audit demands increased listening capacity. The use of a screen results in the auditor losing a significant portion of the information that is usually provided by non-verbal communication. There remains, of course, the intonation of the voice but the majority of the information provided by the analysis of the auditee’s behaviour during the interview is lost. This listening often allows the identification of an incomprehension, a lack of clarity in the auditor’s question even the onset of irritation in the auditee. In this last case, this skill allows the auditor to better manage any tension.

 

The other important point is the fact of notifying deviations in real time or as a minimum, at the end of each interview phase. The auditor by stating the deviation that they have just noted, allows the auditee to add to their argument or to inform the auditor of any incomprehension. It is all the more important as the interlocutor will perhaps not be present at the closing meeting.

 

The virtual visit

Uncommon at the beginning of the pandemic, the practice of virtual inspections has grown markedly. They allow for familiarization with a site, its organization and its flows. They may take the form of the projection of photos associated with a plan, a pre-recorded video, or a video produced live with an auditee who moves around the premises. The last format is the most valuable, if there is a high quality image and if the auditor can control their interlocutor’s camera remotely. In this case, the conditions approximate those of a physical visit.

 

Nevertheless, the auditor does not have the peripheral vision they usually have on site and sounds rapidly become noises that are partly unusable. Moreover, this type of exercise is not always possible, particularly if part of the audit takes place in ATEX areas, which in this case necessitate specific equipment that is not always available on site to produce a video. The pre-recorded video, prepared internally, has the benefit of having better quality images and often enables a good understanding of the process and flows. The main limitation of this medium is the lack of spontaneity, which is one of the benefits of on-site audits.

 

The closing meeting

For this feedback phase, as during the opening meeting, auditors rarely have the possibility of seeing all their interlocutors. Before following the classic closing meeting format, the remote audit context and its limitations should be recalled.

The usual thanks addressed to the participants are an opportunity to acknowledge their availability. Each observation that is made must be associated with a document, an area or a department so that the persons concerned can act if necessary. Finally, remind participants, if this was defined beforehand, that an on-site audit will complete the remote audit, as soon as conditions allow.

 

6. The report 

The audit report must clearly include, as a minimum on the first page and in the conclusion, the fact that the audit was conducted remotely. This avoids any misinterpretation.

 

7. The follow-up

The follow-up to a remote audit remains identical to that of the on-site audit. It is nevertheless necessary to exercise vigilance with regard to 2 points:

  • The effective conduct of the action plan. Experience has shown that, on several sites audited, one of the consequences of the COVID-19 crisis has been a significant delay in the setting up of action plans following the audit. Among the reasons identified:
  • the reduction in the workforce present on the site audited, either because of the portion of staff who are teleworking, or absences of individuals who are sick,
  • the difficulty in mobilizing teams on improvement projects when the routine is more difficult to maintain,
  • the reduced number of interactions with customers, which influences the definition of priorities internally.

– The rescheduling of the on-site audit if the type of audit or the deviations noted demand it. The conditions of this rescheduling must be discussed before the audit, to avoid any drifting. Especially if the remote audit was a derogation measure while waiting for an on-site audit.

 

8. The advantages

Among the advantages associated with the remote audit, we have identified the following:

  • Improved audit flexibility
  • facilitating the planning of audits, during busy periods, by the elimination of travel time,
  • getting round the last minute unavailability of an auditor, by a facilitated replacement.
  • Improved expertise
  • being able to request specific expertise complementary to the principal auditor or to the audit team, to be able to deal in depth with a part of the audit field while avoiding travel costs.
  • Improved the monitoring of the site audited:
  • allowing a follow-up audit to be conducted within a shorter time frame after an initial audit,
  • for audits subcontracted to a service provider, to allow, after the agreement of the audited site and the audit team, the participation as observer of the person ordering the audit. They can be present at the opening and closing meetings, as well during the running of the audit.
  • Improved the carbon footprint of the audit, through the reduction in travel,
  • In the context of COVID-19, reduced risk of contagion and improved audit comfort through the absence of mask wearing for persons alone at their screen.
  • Optimized budget through the elimination of travel.

 

9. The limitations of the tool

The limitations of this form of audit are less numerous but they may be prohibitive:

  • The remote audit does not provide the same wealth of information as the on-site audit, in particular for audits of complex and hazardous manufacturing processes.
  • This partial evaluation must be supplemented by an on-site audit in certain cases.
  • The quality of exchanges is impacted by the interview conducted through an interposed screen.
  • Audit preparation requires greater anticipation, particularly regarding the checking of technical aspects and definition of the documentation that the auditor wishes to consult to allow the auditee to digitize this, if need be.

 

Conclusion

The remote audit existed before the COVID-19 crisis. Through its generalization, it has allowed our sector of activity to get round the impossibility of companies visiting the sites of their suppliers and subcontractors during this period and to maintain assessment frequencies.

 

The remote audit cannot replace an on-site audit. Nevertheless, as with teleworking, it will take its place in our operational methods after the crisis. It will be an additional tool in the monitoring and assessment of suppliers and subcontractors. Rather than being imposed by necessity, it will become an option that is chosen, as it allows for improved monitoring of on-site audits and the optimization of their frequency. For some laboratories, the alternation of a remote audit with an on-site audit is already an area for reflection for some categories of supplier. This new parameter should now be included in risk analyses in order to find the right balance.

Share the issue

Laurent MOREAU – EUROFINS

laurentmoreau@eurofins.com

Références

[1] : International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 Working Group: Remote GCP and GMP Regulatory oversight inspections “Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 Pandemic”, 2021.

[2] : FDA : “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency”, 2021.

[3] : EMA – “Guidance related to GMP/GDP and PMF distant assessments”, 2020