Can we choose to not allow auditor back on site? Conflict of Interest?

C

Calico

#1
Good Morning,

Question for all you quality folks out there...

I work for a call center (part of a hospital) that does data intake for pharmaceutical companies. We take calls on Adverse Events basically and then process that information and submit Medwatch forms back to the client so that they can send to the FDA.

My question is around one of our clients hiring an auditor to come in and audit our processes. This particular auditor owns his own consulting business. This auditor came in several years ago and there was some conflict of interest involved because he was also the consultant for our competitors. I believe there were some hard feelings involved because my company made him take down a website that was advertising our competition.

Long story short is one of our clients had this same auditor back in a few months ago and we feel that the auditor was NOT impartial in his evaluation. He wrote up findings against many different standards such as the European Union (we do not do anything outside of the US). He also included major findings in his audit report that were not disclosed during the closing meeting.

We feel that this auditor is not in our best interest and would prefer to not allow him back onsite again. Do we have grounds to deny him? What is the best way to document this that would not be specifically aimed at him but that we could use for all client auditors?

Hopefully this makes sense but we really feel that this particular auditor is a detrement to our business.

Thanks much for any help,
Callie
 
Elsmar Forum Sponsor
#2
Re: Can we choose to not allow auditor back on site?

For those reasons? Very definitely you should deny him! They client is also not getting what they need, whether they know it or not...
 
C

Calico

#3
Re: Can we choose to not allow auditor back on site?

Thanks for the quick response,

How is the best way to actually deny an auditor that a client wants to bring in though? Any ideas?

I feel like we need to document something somewhere so that we are covered legally but I'm not sure if this would be part of our supplier evaluation SOP or an actual legal document. He's not really acting in a supplier role so I don't think the SOP is the best fit.

Callie
:thanks:
 
#4
Re: Can we choose to not allow auditor back on site?

I guess it depends upon the relationship you have with your client. I'm sure that they'd want to have a fair audit done, to agreed criteria. So, it might be worth pointing out that to ensure an appropriate result, you'd like to agree the audit 'conditions' such as audit scope, criteria, qualifications, reporting methods etc. which should cover all the bases.

Maybe your client isn't 'mature' when it comes to those things, so point them at the ISO 19011 standard which is the recognized document covering this type of audit. Is your client knowledgeable about ISO 9001 etc? Are you registered?
 
C

Calico

#5
Re: Can we choose to not allow auditor back on site?

No we aren't registered because we don't really fall under ISO. We audit to general ISO standards for the sake of consistency but our clients generally fall under the FDA QSRs. Some departments here are under the Good Clinical standards where others are more general.

I think what you mentioned about coming up with some standard audit conditions perhaps is the way to go. I'm not sure if this needs to be a legal document or just basic quality guidelines.

Your input has been very helpful, thanks!
Callie
 
#6
Re: Can we choose to not allow auditor back on site?

All (good) audits are done with a basic set of 'rules of engagement'. You should at least know the 'scope' and 'criteria'. What you're being audited against and what the focus of the audit is. Also, the objective(s) of the audit are important. You should ask for details about how the audit is to be reported, the 'protocol's if you like - a schedule, timings, logistical arrangements (office space) and so forth.

You're quite within your rights to request details of the auditor - bio, confidentiality arrangements etc.

Unless you request these, the auditor won't bother - especially based on your descriptions - and your client may not know enough to have the auditor do this...

BTW - you are VERY welcome!
 

Jim Wynne

Staff member
Admin
#7
Re: Can we choose to not allow auditor back on site?

No we aren't registered because we don't really fall under ISO. We audit to general ISO standards for the sake of consistency but our clients generally fall under the FDA QSRs. Some departments here are under the Good Clinical standards where others are more general.

I think what you mentioned about coming up with some standard audit conditions perhaps is the way to go. I'm not sure if this needs to be a legal document or just basic quality guidelines.

Your input has been very helpful, thanks!
Callie
In addition to Andy's good advice, what you might want to do is check the purchase orders/service agreements from your clients to see whether or not auditing is covered. Your company might already have agreed unknowingly to what's going on. You would be well within your rights to refuse customer audits if they weren't contractually agreed to in the beginning. Short of outright refusal, you can create conditions and make them a part of the service agreement. It would be best to have all of this reviewed by a competent attorney.

In the meantime, if you choose to ask for this particular auditor to be disqualified, get all your ducks in a row before going to the client. Be specific about the conduct of the audits, the auditor's questionable objectivity, your exceptions to the audit findings, etc. You'll want to avoid creating the impression that you're just ticked off about the results.
 
C

Calico

#8
Re: Can we choose to not allow auditor back on site?

Thanks Andy,

Sometimes the client and auditor have a "relationship" that is hard to deny without injuring the relationship with the client.

I also think that the scope and criteria was set in advance but once onsite the auditor completely deviated from what was arranged. I'm not sure what can be done once you have allowed them onsite if that happens.

What I'm thinking (thanks to your advice) is to come up with a written 3rd party audit criteria agreement that would state the scope, criteria etc.. with a statement that my company has the right to deny the 3rd party auditor based upon their ability to comply with the agreement or some such verbiage. Of course this will have to go through our legal department but it's a start.

Thanks again,
Callie
 
C

Calico

#9
Re: Can we choose to not allow auditor back on site?

Thank you,

You are absolutely correct about the statements of work. Each client SOW is different so we will need to review but think that going forward we need to make sure that a right of refusal is built in to the SOW.

The annoying thing is that you go through the audit, have the closing meeting, argue the auditor down to one major and we all walk away pretty happy. Then the audit reports arrives three months later and there are three majors and a couple minor's that were never even discussed in the closing meeting.

I'm a lead auditor myself and this goes agains everything that auditors stand for such as ethics and integrity!
 
B

Boingo-boingo

#10
Re: Can we choose to not allow auditor back on site?

What is the best way to document this that would not be specifically aimed at him but that we could use for all client auditors
Customers don't necessarily behave logically. They are not necessarily bound to ISO 19011 or any other standard. However, you as a supplier to them should expect their audits to be objective and unbiased. You have to communicate with their supplier audit program manager and explain why you believe this individual is not being objective and fair. Hopefully they would understand your concern and assign someone else to audit you. In the meantime, if the auditor wrote up NC's not supported by requirements and objective evidence, you can appeal to your customer and request them to be voided, but remember that it is possible for the customer to side with the auditor.
 
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