12 replies to this topic

[BigLou21972]

Could anyone tell me why some U.S. Government regulatory agency Officers / Auditors / Investigators / employees will not sign a visitor policy? We have a company visitor policy with GMP's, Food Safety and Food Defense criteria that we show to ALL of our visitors that would enter our warehouse storage and production areas. We ask them ALL to review the policy and sign it to acknowledge that they will abide by the criteria. We have had two government regulatory employees in the past 18 months refuse to sign the policy. The first agent said his "Superior" would not allow him to do so but did not divulge the reason why. The second agent from a different governing agency just flat out refused to sign it but with no explanation as to why not. Both agreed to read the policy but would NOT sign...What gives? Any thoughts? 

[FurFarmandFork]

If they were FDA or otherwise, no idea unless there was something in your policy they couldn't comply with (e.g. if you make them sign something that says they won't take pictures or samples, they can't sign that). If it's FSIS, they have to comply with your biosecurity and hygeine measures that you require of everyone else: https://www.fsis.usd...pdf?MOD=AJPERES

[OPizza]

We have the same problem.  Not only will they not sign it, but say they do not have to follow our GMPs because invite them in the building.  (USDA)  For instance, will not remove his wedding ring, with stones, or his watch.  Our GMPs say you cannot wear a hood or have strings.  He has outright said he doesn't have to follow.  Not sure what to do.

[sqflady]

I have attached a letter we were given in Wisconsin from the Department of Agriculture, Trade and Consumer Protection.  Their policy sure does not seem to support food safety.

Attached Files

•  Regulatory Inspection Access Letter.pdf   111.94KB   144 downloads

[BigLou21972]

I have attached a letter we were given in Wisconsin from the Department of Agriculture, Trade and Consumer Protection.  Their policy sure does not seem to support food safety.

Thank You for that letter. I completely agree, these agents show up to make sure we are complying with Food Safety criteria per their standards but then they will not follow our standards. VERY FRUSTRATING!

[FurFarmandFork]

I have attached a letter we were given in Wisconsin from the Department of Agriculture, Trade and Consumer Protection.  Their policy sure does not seem to support food safety.

I don't see anything wrong with that letter. It clearly states that they need to sign a visitor log if asked, and says nothing about you not requiring them to adhere to your GMP's. You cannot obstruct them from entering or inspecting (which you aren't by requiring no jewelry to comply with federal law, which preempts state law), or from taking photos or samples. Requiring a hairnet as a barrier to entry would in no way be considered obstructive unless you were deliberately using it to bar their entry indefinitely.

[FurFarmandFork]

Aha, for future finders of this topic, the 2017 FDA Inspection Operations Manual has the specific requirement for inspectors moving forward, stating they cannot sign policies:

 

5.1.2.3 - Signing Non-FDA Documents

 

Occasionally a firm will request you sign various documents including:

1. A waiver which will exempt the firm from any responsibility or liability should an accident occur and you are injured on the firm's premises,

2. Form letters concerning access to confidential information the firm does not want released,

3. A training form acknowledging that you were briefed on the firm personnel gowning procedures,

4. Information/data you request during the inspection be put into writing, etc.

 

If you receive such a request, inform the firm you are not authorized to sign such documents, letters, requests, waivers, etc., but will report the firm's request in your EIR. All FDA employees are authorized to sign-in and sign-out at a firm and to comply with security measures employed by the firm, including documenting the removal/replacement of seals to inspect vehicles and containers. See IOM 4.3.4.3 and 4.5.4.6. Obviously, the key issue is you are not authorized to waive, without supervisory approval, any of FDA's rights to inspect, sample, photograph, copy, etc. or to sign any interstate shipping record document which could infer the firm could not be prosecuted under the Act.

 

[TimGoss]

Interesting. Our sign in sheet focuses primarily on Ammonia Awareness (we are over the EPA threshold and are a regulated facility). We had a visit from the USDA last month, and she read it and signed it with no problem. I bet it's the "inspect, sample, photograph, copy, etc" part that is tripping some people up.

Heck I'm hard headed, I might refuse entry until proper protocol was followed. Print a sign sheet off where they can cross out and initial any part they don't agree with, but still sign the rest.

[FurFarmandFork]

Another option is to include a clause under your sign-in paper that specifically states: "Note for inspection personnel: this visitor policy does not waive or forfeit any of FDA's rights to inspect, sample, photograph, copy, or otherwise carry out their duties as defined in the Food, Drug, and Cosmetic Act now or hereafter amended".

 

That implies the inspector will actually read it or care however. 

[Alex V.]

If they were FDA or otherwise, no idea unless there was something in your policy they couldn't comply with (e.g. if you make them sign something that says they won't take pictures or samples, they can't sign that). If it's FSIS, they have to comply with your biosecurity and hygeine measures that you require of everyone else: https://www.fsis.usd...pdf?MOD=AJPERES

 

I just want to point out that this directive seems to state that their inspectors must only follow the rules that the company makes their own employees follow.  This would in most cases preclude a visitor sign in sheet.  Thoughts?

[ELarson]

The USDA and other auditors all sign our Visitor GMP policy.

The GDA and FDA don't want to sign it  because of the "photography is prohibited" line, but I just ask them to cross it out and initial it and they seem fine with that. 

However, I explain we will take the photos they want and print them out for them.

We still do not allow auditors to take the actual photos in our facility.

Most have been okay with that and never asked to have a photograph taken. 

[FurFarmandFork]

The USDA and other auditors all sign our Visitor GMP policy.

The GDA and FDA don't want to sign it  because of the "photography is prohibited" line, but I just ask them to cross it out and initial it and they seem fine with that. 

However, I explain we will take the photos they want and print them out for them.

We still do not allow auditors to take the actual photos in our facility.

Most have been okay with that and never asked to have a photograph taken. 

Careful with that...if there ever was an issue that could be considered obstruction.

 

Per a conference I just attended, FDA at the "top levels" is instructing inspectors to only take photos in "for cause" situations, either to record an actual violation or take a picture of a sampling activity/location.

 

If they're just wandering through snapping pictures of everything that is not being encouraged at the top levels. however the IOM still seems to encourage inspectors to go for the "sneak attacK" for photos.

[SQFconsultant]

They sure do think they are above the "law" or in this case your Visitor policy.    

 

I am sure there are some items that they might not be able to comply with such as pens, cameras, recording devices, etc. however the agents I've been exposed to have signed these things as well as Contractor GMPs etc.

 

You could of course have a separate sign in like some of our clients do that is just for regulators and on it says that by signing they agree to abide by all of the items on the Visitor policy and make sure they read it... but then again what are you going to do if they don't abibe by it, would you take some type of action against a regulator.  Could be interesting.