Auditing Process

STEPS REQUIRED TO IMPLEMENT A REMOTE AUDIT

BRIEFING

A briefing with the client is welcome in order to retrieve essential information about the company, gather as many indications as possible about the topics to be explored during the audit, frame and assess exactly what the potential deviations might be, and any critical issues on which to focus.

If present, the following information/documents can undoubtedly be useful:

Audit report of a previous audit
Follow-up on the CAPA plan of a previous inspection.

Pre-audit

This stage represents the first step to the auditee; essentially is a preliminary phase in which the requested documents are made available through the formal delivery of the agenda (audit plan), shared and previously approved by the client. At this stage, actual simultaneous interaction with the audited entity is not required; an exchange of information with respect to the requested documents may be sufficient.

Interview

This is the main phase of interaction with the interviewee(s). There is a strong need to share documents, presentations, procedures, log-books that need to be mostly reviewed on the spot as a result of pointed questions. Where possible, the availability of a “virtual tour” to production sites, storage warehouses, or analysis laboratories is appreciated.

Conclusions

This is the second moment of interaction, in which the wrap-up meeting is held, in which people from company management can participate in addition to the interviewees. Here, there is usually a space dedicated to questions and answers on the topics discussed in the previous session, followed by the release of a provisional list of the observations made.

From the point of view of documentation, there may be a need for some documents or excerpts of them to be left available for a period of time to be defined with the company.

Delivery of the draft report

Normally, a draft of the report is sent to the auditee in order to avoid mistakes or misunderstandings; if necessary, it may be possible to comment face to face some corrections/comments received from the auditee, before the official delivery of the final report to the client.