By Susan Gould, MBA, MS
With the improvement in secure documentation sharing, many auditors are utilizing remote auditing practices to conduct audits. This saves travel time and costs and can be an efficient auditing method.
However, this does not mean that all audits should be completed entirely remotely. For example, Good Manufacturing Practices (GMP) and Good Clinical Laboratory Practices (GCLP) audits require facility and process inspection. Video and webcam technology today is not sufficient for assessing such things as facility design and layout, environmental and equipment controls, or observing work in progress.
A hybrid method of both remote and on-site auditing may provide the best of both worlds. Remote auditing of the documentation can be done prior to the on-site visit. An upfront assessment of documentation before an on-site visit frees the auditor to focus fully on how the manufacturing plant or laboratory actually works on a day-to-day basis. This minimizes time needed on-site for the auditor as well as the resources needed to host the audit.
Prior to initiating a hybrid approach it is crucial to define roles and responsibilities. Will one auditor do both the remote and on-site? Or will one auditor work remotely while another goes on-site? Ensuring smooth transitions between remote and on-site activities is essential to prevent gaps or duplication. Contingency plans should also be put in place to address technology issues, such as loss of connectivity, during the remote phase of the audit.
Using a hybrid approach may cut down the total number of days needed on-site and therefore save travel costs, but more importantly it offers auditors a way of maximizing their resources and therefore conducting the audit with greater overall efficiency.
To learn more about using audits to gain efficiency, click here.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.