Audits during Covid-19 pandemia: Remote Inspection

Dec 1, 2021

The Covid-19 epidemic, defined by the WHO as a public health emergency of international importance, and the subsequent declaration of a pandemic have brought considerable changes in the management processes of several companies, including that of Lo.Li. Pharma International and its Quality & Regulatory Affairs department.

What is Auditing?

ISO 19011:2018 standard defines an audit as a “systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled”. In other words, an audit is the verification activity of a process or quality system to ensure compliance to requirements and it can apply to an entire organization or might be specific to a function, process, or production step.

Remote Audit

It became necessary to revise the classic models of audits “on-site”, employing remote audits, to adapt them to were the new needs, born due to the Covid-19 emergency. The Italian Accreditation Body, Accredia, with the Technical Circular DC N° 06/2020 of March 7, 2020, supplemented by the Technical Circular DC N° 08/2020 of March 19, 2020, moved promptly to adopt the mode of management of remote audits during the emergency. Furthermore, this audit method was already provided for in the UNI EN ISO 19011: 2018 standard. Remote audit – also known as virtual audit or re-audit – is an audit in which electronic means are used to collect audit evidence when “face-to-face” methods are not possible or desired. This type of audit involves interactive communication between the audit team and the audited structure, such as email, telephone, file and screen sharing, video conferencing (Skype, Zoom, Microsoft Teams are common platforms), and live data analysis. The audits can be planned in fully remote mode, or they can include a remote part and an “on-site” part, limited to some activities. Furthermore, it is not necessary that the connection remains for the entire duration of the audit but moments of control, in which the auditors can examine the documentation made available to them, can be alternated with moments of confrontation between the auditors and the audited structure.

Advantages of remote auditing

It allows for meetings, verification of documents and recordings, the possibility of visual access to remote locations, and more. The application of remote audits, although required by the current pandemic, has made it possible to seize an opportunity for improvement, which is expressed in significant advantages in the management of audits. The main one is the respect of the planning of the audit programs and the monitoring of the structures and processes subjected to verification, which otherwise, in a historical period such as that due to the global emergency, would be carried out.

Other obvious advantages of the remote audit are the optimization of timing of performance, as well as an economic saving for any trips and transfers.

Conclusions

The application of remote audit is a method that makes it possible to overcome the inconveniences that would have arisen if this instrument had not been used. Therefore, the remote audit is certainly to be considered an opportunity to be pursued with a view to continuous improvement and efficiency of the company.

References

  1. UNI EN ISO 19011: 2018 standard – Guidelines for Auditing Management Systems
  2. Circolare tecnica DC N° 04/2020 del 12/03/2020  https://www.accredia.it/app/uploads/2020/03/Circolare_tecnica_DC_06- 2020.pdf
  3. Circolare tecnica DC N° 06/2020 del 17/03/2020 – https://www.accredia.it/app/uploads/2020/03/Circolare_tecnica_DC_08- 2020-ITA.pdf
  4. “Remote Control, Is e-auditing the next logical step?” J.P. Russell. Published by the American Society for Quality (ASQ).

About Lo.Li. Pharma International

Many high-potential, small to medium-sized pharma companies find it difficult to stay competitive in crowded markets, especially when competing against global giants. They may not have any innovative, ready-for-market products in their pipeline, or have the funds to support internal product development. Lo.Li. Pharma International is a branch of Lo.Li. Pharma Srl, a growing pharmaceutical company, based in Rome, is dedicated to the research, development, and distribution of Medical Devices and Functional Dietary Supplements. As world-renowned experts in basic science and research in inositol, Lo.Li. Pharma International is committed to supporting its partners with the scientific know-how, innovative products, and marketing support needed to be successful. To learn more, go to: www.lolipharmainternational.com