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Our Expert Tips on Managing Unwilling Auditees

Updated: Nov 20, 2023

One of the most valuable aspects of working with the team of seasoned Quality Professionals here at Zigzag is our unmatched access to deep industry experience. Challenges that auditors, industry wide, face on a daily basis can be combatted by leveraging years upon years of knowledge gained from direct interface with auditees.

So what happens when your auditor shows up at an auditee, and feels tension, lack of respect, or even worse, one or more combative individuals?

We asked our approachable experts on what tools they use to help in a scenario like this:

Cleopatra Dimopoulos Project Manager (20+ Years Direct Auditing Experience)

"This will naturally depend on the type of audit.

In general terms:

If it is an GCP investigator site audit, then the best practice that works is to remind them of their responsibility to accommodate an audit as required by the regulations - ICH-GCP 4.1.4- The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).

If it is a vendor audit, then what usually works is a reminder that new business will be awarded based on the results of the qualification/re-qualification audit. "

Kishan Nandha Associate Director, Pharmacovigilance (15 Years Direct Auditing Experience)

"During the audit, one way to realign with a difficult auditee that is not cooperating to the best of its ability is to explain and establish the basics behind the audit.

The following is often effective:

·1) Take some time to explain to the auditee why the audit is required in the first place. Depending upon the audit being external (business partners or service providers) or internal (process or affiliate), elaborate on which regulatory requirements mandate for such audits to occur and how failure in auditing can invite regulatory complications affecting all concerned stakeholders.

2) If the auditing party has “audit clause” (a contractual provision allowing a party to audit another) in contracts/agreements with the auditee, refer to the same in your explanation to establish that the auditee should cooperate in the audit not only out of good faith but also due to binding contractual requirements, which they agreed to in the contracts/agreements.

3) Explain to the auditee that both the auditors and the auditee have a common goal of fulfilling audit-related regulatory obligations and identifying any non-compliances so that they can be resolved before any issues result in difficulties from regulatory authorities or especially harm to public health.

4) It can be recommended for auditors to be mindful in their verbal communication to NOT minimize or undermine the audit-related workload on the auditee’s end (even unintentionally), but rather, justify the need for it i.e., why it is worth it. "

Vishnu Shyamal Purushothaman Associate Director, Pharmacovigilance

" 1) As an auditor, its always important to emphasize at the beginning of each day, each session that we are here to help improve your systems. The audit is not to determine who is at fault, it is to ensure that the auditee takes accountability, recognises the shortcomings, and works to address any issues identified.

2) As an auditor, having an easy personality always helps. Auditors who show themselves as compassionate and understanding of the local situations will show auditees that we are not authoritarian figures looking to dismantle all of their hard work, instead we are friends (or at best, best practice acquaintances)

3) Always use words like “I understand” or “I can comprehend your difficulty” so that we come across as personnel who gets what’s going on the ground and then always tie it up with regulations and requirements.

4) Always keep your calm, be professional, take a breather, if needed, don’t be afraid to state that you (as auditors) will reconsider and re-review the situation. Auditors can be wrong as well and we must be able to temper the tone of the meetings/ interview sessions."

Jasmine John QA Manager (10 Years Direct Auditing Experience)

"One thing I do is during the closing meeting before going into the findings I’ll reiterate that the findings noted reflect process gaps and deficiencies and not a personal attack on any one individual. For example, I’ll say something like

“Please keep in mind that these process gaps or deficiencies identified are gaps in the various processes we reviewed and are not a personal representation or personal attack on anyone. I greatly appreciate the work that is done by the site staff to conduct the various trials and hope these observations will help with process improvement in the future.” "

Mujib Rohman QA Manager, Pharmacovigilance (10 Years Auditing Experience)

"I tend to try to mention that the Sponsor requires us to complete the audit. This sponsor is therefore going to require their cooperation with the requests and timelines that we are working to."

Amy Wotawa Senior QA Manager (15 Years Direct Auditing Experience)

"I think the approach should be twofold: conflict management and stakeholder management. I see auditees as stakeholders in the process as well.

From a conflict management standpoint, my preference would be not to engage in the heat of the moment, if possible, but to take a few moments to reflect and regroup with a more well thought out re-engagement strategy. This is more conducive to not escalating the situation. I do not argue. If they are not forthcoming with information or documents, I’ll simply state that in the report. If they disagree with my findings, I will discuss that with the client and the auditee can state their point of view in their audit response. I strive to lead with empathy to reduce defensiveness in the other party and communicate that I’m open to productive discussion.

From a stakeholder management standpoint, the relationship with the auditee begins with the first contact, which for us is typically an email introduction before we ever go onsite. Being proactive and timely with communications can help build that early trust and credibility. Setting expectations early on and even being an educator in the process can make for a much smoother audit process for the auditee. When auditees know what to expect, stress can be reduced. Being able to “read” auditee behaviors and communication styles while onsite can also help us to tailor our approach to interviews/requests for additional documents and information in a way that is more productive and less likely to be met with resistance.

A little bit of emotional intelligence goes a long way."

Renee Molina Senior Quality Assurance Manager (20+ Years Auditing Experience)

"One phrase can help result in a better auditing experience: Collaboration with the Auditee is Key."

Marcia Sherry-Newby Senior Quality Assurance Manager (20 Years Auditing Experience)

"The best way to deal with difficult auditees is take the position of being the messenger, not the decider. When auditees disagree with my observations, I do not get defensive, and just politely explain that I appreciate and/or respect their position and that I will relay to the sponsor/client their (the auditee’s) position and the sponsor/client will decide what to do."

Khaled Ibrahim Project Manager (15 Years Quality Experience)

"In a recent example, detailed communication from the sponsor on behalf of the auditor was required explaining why the audit was necessary. This included a very detailed email prior, then a subsequent discussion over the phone with the auditor and auditee, for the auditee to be happy for the audit to go ahead.

The crux of it then, make it clear why they need to be audited from the outset, and it always helps to speak to them to allay any objections."

This blog leverages 140 years of Direct Quality Experience. Do you need help managing your auditees? Reach out today:


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