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21CFR117.80 Violation - Whistle blower Advice

Whistleblower 21CFR117.80 FDA FSMA Adulterated Food

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#1 RandomName

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Posted 16 November 2017 - 05:19 PM

I need some advice/resources on how to, and when to become a whistle blower.

 

 

I recently found a possible microorganism (pink slime) in a pipe used to receive/transfer corn syrup into a bulk storage tank. The QA Manager told me to clean the pipe but not to swab the substance for analysis. The manager said that if we test it and it is confirmed to be a microorganism then we will have to take action.

 

The pipe was disassembled for cleaning, this granted us our first look into the bulk tank in years and its bad..real bad. The inside of the tank has not been cleaned in the 6+ years that I have been with the company. There is no kill step in our process (RTE confectionery products), I am told that the corn syrup is filtered before being pumped into the mixer but to my knowledge it is not monitored or cleaned in any way, no one could even  show me were it is (not that this would reduce the hazard to an acceptable level anyways).

 

Multiple members of senior management are aware of the issue and no action is being taken to clean the inside of the tank or to assess the safety of the product that used contaminated corn syrup. As far as they are concerned, the issue has been resolved.

 

 

I tried to find a Lawyer (in New York State) that I could talk to but I didn't have any luck, does anyone know of any? I have no idea how to proceed in a way that doesn't put me in legal jeopardy.

 



#2 FurFarmandFork

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Posted 16 November 2017 - 10:20 PM

Hi Randomname,

 

If you reached out to MarlerClark they might give you some advice and given the mission of that firm it might be pro-bono as well.

 

Definitely a tough issue, I'm not surprised by the decision to clean rather than swab as I don't believe in "curiosity swabbing", correct the issue and move on, but given that they didn't subsequently clean the tank as well that definitely starts to move towards willful negligence (as far as I can tell from your post information).

 

It is entirely possible that the contamination you saw is only spoilage organisms that don't pose a food safety risk, but again, you can either test to try and find evidence that there is no FS risk or correct the problem by cleaning and putting an inspection program in place, your firm doesn't seem to want to do either.

 

Don't know when it's time to blow the whistle or not. I honestly can't tell you what my personal criteria would be for whistleblowing vs. just leaving a firm, so I don't envy your decision.

 

The only other thing I would recommend is to make sure you give it at least a week. No one is more at risk tomorrow than they were yesterday from your products, and sometimes that sort of finding sticks with management and they come back to it a week later with a plan in place (even if it's long-term when it should be now). And assuming you have a relationship with your QA manager, talk to them first one-on-one and ask them to help you understand why they made the decision. I've worked in plenty of places where the "floor" or others were appalled by the decisions we made, but were missing information that hadn't been communicated clearly that helped a lot (e.g. a kill step like you mentioned above which would help justify the decision). In addition, if you do decide to become a whistleblower, that one-on-one conversation will be one more piece of evidence that you will have to bring to the table that you don't have the option to get once you've involved a lawyer or officials.


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Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

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#3 Charles.C

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Posted 17 November 2017 - 06:15 AM

Hi RN,

 

I'm not defending inaction but I recall one comment from a much older/analogous OP that one initial query prior to taking aggressive actions is to maybe ask yourself how much you (and possibly dependents) need yr job to be maintained.

 

Is this in yr experience an isolated incident or just one of a chain of similar questionable occurrences ?

 

How do you know that Senior Management in addition to QA are aware of the situation ?

 

Is the Company FS audited ? If so, it seems rather remarkable that the absence of tank cleaning for 6 years + has not come up previously.


Kind Regards,

 

Charles.C


#4 RandomName

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Posted 17 November 2017 - 10:33 AM

This is not an isolated incident, It just so happens that this one occurred less than a week after everyone received food safety training that made me realize how vulnerable I am in my current position. I am the SQF practiononer, backup PCQI and the sanitation team lead. On paper I have the authority to take action to correct this issue, but i don’t actually have the authority unless it suits managements needs at the time.

This issue was first identified during an internal audit in which the QA manager and another senior manager were in attendance

Hi RN,
 
Is the Company FS audited ? If so, it seems rather remarkable that the absence of tank cleaning for 6 years + has not come up previously.


.....We are SQF level 2. The best explanation I can think of for why we pass our audits is Luck, .low Risk operation, unique/nostalgic products that auditors tend to enjoy seeing how it’s made, more luck, and Planned cleaning the day before scheduled audits (we have our first unannounced SQF audit at some point in the next 60 days).

#5 sqflady

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Posted 28 November 2017 - 01:43 PM

My advice is to get out and find a new job.   I previously worked for a SQF Level 2 dairy company.  Silos were never washed on time (every 72 hours), plant was old and dirty, poorly maintained and sanitation was severely lacking.  Product routinely contaminated with Bacillus cereus.  This plant was inspected by FDA and state inspectors.  None of them ever noticed the lack of sanitation despite silo washing logs indicating they were not washed properly included with all sanitation paperwork.  I left the company and now work for a fabulous company that is serious about food safety.  







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