Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi there,

Has anyone experienced a situation where an auditor (in this case, internal to the organization but I'm interested in ones that are external as well) requests a personal favor?  This person is in a position of authority, and I'm not sure how best to respond without jeopardizing the outcome of the audit.  Are there guidelines on auditor conflicts of interest? There is a monetary value associated with this favor that is not nominal.

Thank you,
Anonymous

Dear Anon.

First question, no. Next question, yes, guidelines exist. Almost any kind of "favor" being requested by a qualified auditor of an auditee, especially associated with any "not nominal" monetary value, would be in clear violation of the American Society for Quality (ASQ) Code of Ethics. Even if the auditor in question was not a member pledged to adhere to specific policies like the ASQ Code of Ethics, I believe what you describe appears to present a serious ethical breach. Your organization may already have policies in place (e.g., workplace harassment, etc.) that could govern this kind of incident as well.

The element from the ASQ Code of Ethics on this probably fits in statement number C.3., under "Expectations of a Quality Professional," about avoiding any real or perceived conflicts of interest that could reasonably impair objectivity or independence. To quote an excerpt from that part in context:

C. Safeguard Proprietary Information and Avoid Conflicts of Interest

1. Ensure the protection and integrity of confidential information.
2. Do not use confidential information for personal gain.
3. Fully disclose and avoid any real or perceived conflicts of interest that could reasonably impair objectivity or independence in the service of clients, customers, employers, or the Society.

As your organization may already have a policy and procedure about reporting ethical issues, harassment, or related problems, be sure you follow that reporting procedure, if possible. If you don't have such a policy to follow, I'd recommend you report this request for a "favor" to your quality team leadership, your direct supervisor, or a company official (e.g., in HR). I would not wait to see if the situation, whether you decide provide the favor or not, had a negative impact on the audit report.

Personally, I can imagine defending specific limits for what is considered of "not nominal" monetary value relative to an audit. For example, it could be a request for anything of more value than a cup of coffee or a soft drink. (Expected or not, such nominal items like water or coffee and light snacks are usually provided by auditees for the auditors without a second thought. But free lunch and a free ride back to the airport for the auditor may stretch the issue too far for some organizations, but not so for others. I've experienced it both ways. What is a courtesy being extended for some could be [the appearance of] an undue influence to others. But coming as a request from the auditor to you seems to be painfully awkward and probably wrong.) I'm sure people have varying opinions on this, and it may even depend on who the auditor represents, i.e., an FDA Inspector or your internal QA team member. The way you described your situation seems to indicate this is pretty far down the slippery slope. Good luck and best regards.
​

------------------------------
Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
Consultant and
VP of Regulatory Affairs and Quality
Global Regulatory Partners, Inc.
United States
------------------------------

Original Message:
Sent: 16-Apr-2020 18:32
From: Anonymous Member
Subject: Conflict of interest

This message was posted by a user wishing to remain anonymous

Hi there,

Has anyone experienced a situation where an auditor (in this case, internal to the organization but I'm interested in ones that are external as well) requests a personal favor?  This person is in a position of authority, and I'm not sure how best to respond without jeopardizing the outcome of the audit.  Are there guidelines on auditor conflicts of interest? There is a monetary value associated with this favor that is not nominal.

Thank you,
Anonymous

It does not matter if a favour, a request, being paid for it, exchange of services, etc., there are codes of ethics for auditors defined by various groups including as Jan pointed out ASQ.  More precisely, the ISO 19011 standard has plenty of information about audits being independent, objective, and withholding ethical standards as an auditor.  If doing this favour is going to put you in a compromising situation because they want a "blessed" audit, then politely decline due to conflict of interest.  And personally if someone asks for a personal favour compromising your ethics, maybe not so personal after all.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 18-Apr-2020 04:02
From: Jan Peterson
Subject: Conflict of interest

Dear Anon.

First question, no. Next question, yes, guidelines exist. Almost any kind of "favor" being requested by a qualified auditor of an auditee, especially associated with any "not nominal" monetary value, would be in clear violation of the American Society for Quality (ASQ) Code of Ethics. Even if the auditor in question was not a member pledged to adhere to specific policies like the ASQ Code of Ethics, I believe what you describe appears to present a serious ethical breach. Your organization may already have policies in place (e.g., workplace harassment, etc.) that could govern this kind of incident as well.

The element from the ASQ Code of Ethics on this probably fits in statement number C.3., under "Expectations of a Quality Professional," about avoiding any real or perceived conflicts of interest that could reasonably impair objectivity or independence. To quote an excerpt from that part in context:

C. Safeguard Proprietary Information and Avoid Conflicts of Interest

1. Ensure the protection and integrity of confidential information.
2. Do not use confidential information for personal gain.
3. Fully disclose and avoid any real or perceived conflicts of interest that could reasonably impair objectivity or independence in the service of clients, customers, employers, or the Society.

As your organization may already have a policy and procedure about reporting ethical issues, harassment, or related problems, be sure you follow that reporting procedure, if possible. If you don't have such a policy to follow, I'd recommend you report this request for a "favor" to your quality team leadership, your direct supervisor, or a company official (e.g., in HR). I would not wait to see if the situation, whether you decide provide the favor or not, had a negative impact on the audit report.

Personally, I can imagine defending specific limits for what is considered of "not nominal" monetary value relative to an audit. For example, it could be a request for anything of more value than a cup of coffee or a soft drink. (Expected or not, such nominal items like water or coffee and light snacks are usually provided by auditees for the auditors without a second thought. But free lunch and a free ride back to the airport for the auditor may stretch the issue too far for some organizations, but not so for others. I've experienced it both ways. What is a courtesy being extended for some could be [the appearance of] an undue influence to others. But coming as a request from the auditor to you seems to be painfully awkward and probably wrong.) I'm sure people have varying opinions on this, and it may even depend on who the auditor represents, i.e., an FDA Inspector or your internal QA team member. The way you described your situation seems to indicate this is pretty far down the slippery slope. Good luck and best regards.
​

------------------------------
Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
Consultant and
VP of Regulatory Affairs and Quality
Global Regulatory Partners, Inc.
United States

Original Message:
Sent: 16-Apr-2020 18:32
From: Anonymous Member
Subject: Conflict of interest

This message was posted by a user wishing to remain anonymous

Hi there,

Has anyone experienced a situation where an auditor (in this case, internal to the organization but I'm interested in ones that are external as well) requests a personal favor?  This person is in a position of authority, and I'm not sure how best to respond without jeopardizing the outcome of the audit.  Are there guidelines on auditor conflicts of interest? There is a monetary value associated with this favor that is not nominal.

Thank you,
Anonymous

This message was posted by a user wishing to remain anonymous

You said this was internal to the organization. If this happens with an FDA employee, please report it to the chain of command immediately. While the Agency can't tell you what personnel action is taken, if that person returns to the audit, tell the next person in the chain of command. You should also report it to the Agency Ombudsman.

I have experienced this and the organization decided to provide the favor.  I guess they evaluated the cost. I wonder if another organization with less money to lose could have afforded this.

On another trip, an investigator asked to be admitted tot he clean room with a piece of sentimental jewelry on. When it was declined, she was caught sneaking it under her gown. Sigh. It wasn't a favor of value but it triggered an expense of re-cleaning the area pursuant to a protocol.

Original Message:
Sent: 16-Apr-2020 18:32
From: Anonymous Member
Subject: Conflict of interest

This message was posted by a user wishing to remain anonymous

Hi there,

Has anyone experienced a situation where an auditor (in this case, internal to the organization but I'm interested in ones that are external as well) requests a personal favor?  This person is in a position of authority, and I'm not sure how best to respond without jeopardizing the outcome of the audit.  Are there guidelines on auditor conflicts of interest? There is a monetary value associated with this favor that is not nominal.

Thank you,
Anonymous

Any time I have been asked to remove my jewelry during an audit the site contact has always offered a secure location for it, such as a locked office. Had the offer not been made I would have requested a secure location.

As far as an auditor asking favors goes, that is not acceptable. NO auditor should ask for a favor, nor accept one. Favor - in this context - can too easily be construed as bribe. Years ago the host of an audit I was conducting asked me to play a practical joke on the site head at the wrap-up (it was his birthday), and ask him for a bribe. I declined to do so, citing the potential for damage to my professional reputation (but during the final questions regarding missing bits of information, I did ask him his mother's maiden name; it had the desired effect).

------------------------------
Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
------------------------------

Original Message:
Sent: 19-Apr-2020 09:47
From: Anonymous Member
Subject: Conflict of interest

This message was posted by a user wishing to remain anonymous

You said this was internal to the organization. If this happens with an FDA employee, please report it to the chain of command immediately. While the Agency can't tell you what personnel action is taken, if that person returns to the audit, tell the next person in the chain of command. You should also report it to the Agency Ombudsman.

I have experienced this and the organization decided to provide the favor.  I guess they evaluated the cost. I wonder if another organization with less money to lose could have afforded this.

On another trip, an investigator asked to be admitted tot he clean room with a piece of sentimental jewelry on. When it was declined, she was caught sneaking it under her gown. Sigh. It wasn't a favor of value but it triggered an expense of re-cleaning the area pursuant to a protocol.

Original Message:
Sent: 16-Apr-2020 18:32
From: Anonymous Member
Subject: Conflict of interest

This message was posted by a user wishing to remain anonymous

Hi there,

Has anyone experienced a situation where an auditor (in this case, internal to the organization but I'm interested in ones that are external as well) requests a personal favor?  This person is in a position of authority, and I'm not sure how best to respond without jeopardizing the outcome of the audit.  Are there guidelines on auditor conflicts of interest? There is a monetary value associated with this favor that is not nominal.

Thank you,
Anonymous