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Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.
We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
Q. During a recent audit of our company, the auditor found some non-conformance issues that we disagreed with. Do we have to make the changes the auditor suggested?
A. Those of you who have been audited will likely have come across the following situation: the auditor has identified a non-conformance with the applicable regulations. Purely for illustrative purposes, let us say that the auditor identified missing documents that should have been prepared as part of a laboratory information management system (LIMS) validation. Now the auditor informs the auditee about this finding.
The auditee shows surprise and retorts that this site/company/laboratory has a long history of successful inspections by regulatory authorities from three continents and that they never had an observation like this. In fact, during the last inspection by an agency, the LIMS validation package had been reviewed and found perfectly acceptable. Therefore, the auditee refutes the validity of the auditor’s observation.
So, how do we resolve this? Shouting match? Exchange of heated arguments? Certainly not! After all, we are professionals. And as such, we need to understand both sides.
No matter what conclusions the auditor comes to, the auditee should review the validity of the results. Obviously, the auditees will accept a positive inspection outcome with no or few or only minor observations as confirmation of the validity and acceptability of their quality systems, modes of operation, facilities and equipment, and organizational structures. However, any such result should be carefully analyzed, and the following questions (not all-inclusive) should be asked by the auditee:
Auditors should always challenge their decisions and statements, as their audit findings can have as much impact on the audited company as a regulatory inspection. Questions an auditor should ask themself include, but are not limited to:
We should bear in mind that inspectors and auditors alike are humans. As such, auditors make mistakes, have preferences, and to some extent, may be biased. Furthermore, an audit or inspection can only ever be looking at a snapshot in time. For example, unlike the people working in the company under scrutiny, auditors will not see all the behaviors, all the operations, etc. As a result, all statements made are based on a limited amount of information and observations.
And we must not forget that the focus of an inspection (or audit) can change over time, be it for developments in the regulatory field (e.g., the increase in data integrity-related inspections in recent years) or changes to the circumstances in the inspected site (e.g., new ownership, the introduction of new dosage forms, etc.), to name a few possible reasons. Consequently, a site may have been in compliance over many years, but may not have kept up with the changes, which may suddenly find the site in a state of diminished compliance.
It is better to have a non-conformance picked up during an audit than have it recorded during an inspection. So, the next time your auditor tells you about an issue you didn’t know about, it may be sensible to accept and investigate it before deciding to reject it.
Volume 32, Number 5
When referring to this article, please cite it as S. Schmitt, "The Auditor Vs. Inspector Issue," BioPharm International 32 (5) 2019.