A QA friend of mine called me this morning with a dilemma that I said I'd post and see what other QA folks think.

His company knowingly violated a regulatory requirement, with the decision made by the company's president. QA was bypassed and found out after the fact, by accident. The violation in no way compromised the product itself.

In the good faith belief that the president did not understand the consequences of what he'd done, my buddy wrote him an email and made him aware of them. The president's reply was that it was his risk to take and it was unlikely to be found in a regulatory inspection.

My friend's question is this: What should/could he do now? Let it sit?

In the good faith belief that the president did not understand the consequences of what he'd done, my buddy wrote him an email and made him aware of them. The president's reply was that it was his risk to take and it was unlikely to be found in a regulatory inspection.


Ouch...tough position to be in. For the president to say it was "his risk" is wrong. He is willingly in this business, and with that come the good, bad and the ugly. This time it did not effect product quality, but what about the next time, will the limits be stretched even further.

This situation is probably symptomatic of a larger issue. Could the company be experiencing some tough times, hence the shortcut. This will probably result in some really serious issues down the road.

My move would be to bail out now, before the excrement starts to fly.

JMHO,

CarolX

A QA friend of mine called me this morning with a dilemma that I said I'd post and see what other QA folks think.

His company knowingly violated a regulatory requirement, with the decision made by the company's president. QA was bypassed and found out after the fact, by accident. The violation in no way compromised the product itself.

In the good faith belief that the president did not understand the consequences of what he'd done, my buddy wrote him an email and made him aware of them. The president's reply was that it was his risk to take and it was unlikely to be found in a regulatory inspection.

My friend's question is this: What should/could he do now? Let it sit?

Beyond Carol's excellent advice, I would recommend your friend save that email and reply (if it were email as well). :ca: :bigwave:

This sure isn't any fun, Rosie. I'd have to agree with Carol. Time to circle the wagons and find a new place to work. This is both from an ethical and practical standpoint. As the stuff hits the air circulator, finding a job will be more difficult. Would you hire an Enron accountant, even if they didn't know?

As far as blowing the whistle, to me that would depend. If lives are at risk, though, its a no-brainer.

Wish them luck for me.

Craig

So far, you're pretty much echoing what I told my friend. It's a lousy economy and, with kids and being the primary breadwinner, he's reluctant to jump ship, but also very concerned about having any association with this kind of company culture.

I've never had this experience. I wonder how pervasive it is, especially in a down economy?

I've never had this experience. I wonder how pervasive it is, especially in a down economy?
Rosie,

I went through something kinda similar. I don't think ii is the norm, even in a down economy. The consequences far outweigh the benefits. I think that desperation is the usual culprit.

I will use this example.....
Jane is a law abbiding citizen and a single mom of 2 kids. She has a job that pays her well. She has a decent car, a nice townhouse for her and the kids. Now, she is laid off through no fault of her own. She begins the job hunt, but things do not go well. After 3 months, she is working at a job that pays 2/3 of what she had, and she is having a tough time making ends meet. What are the chances she might do a little shop lifting at the grocery store????? Probably pretty good....and what are the chances she might continue this??? Who knows?

CarolX

His company knowingly violated a regulatory requirement, with the decision made by the company's president. QA was bypassed and found out after the fact, by accident. The violation in no way compromised the product itself.

My friend's question is this: What should/could he do now? Let it sit?

What type of regulatory requirement was it? Was it a really stringent or technical requirement or just one of those stupid things like not tying your horse in frot of the dry goods store if you're in the saloon? Was there any real potential harm or damage from this deviation?

There is such a thing as situational ethics and risk assumption. I was ethically bound to arrest everybody that I observed violating "the law" when I was a cop. If I had done so I would still be booking people from 1974 alone. I cannot tell you the number of times I kinda looked the other way.

There are laws and then again there are laws.

Have you ever exceeded the speed limit?

A regulated label was altered from what was approved by the regulatory agency. I'd say more, but my buddy prefers I not get too specific. I believe the reason was to obscure from the customer the true manufacturing location of the item.

I'd say there would be more potential here for fraud than regulatory non-compliance, but both come into play here.

If there is some consistency to this type of activity I would become really concerned. As it is, or as you stated, this is a type of anomoly.

As this appears to be documented and known in the company and the boss is assuming the "risk" your friend should continue to march. If future behaviour patterns indicate a continuance of this type of mentality, especially if it starts concerning any type of safety or serious fraud issues, other decision may have to be made on the part of your "friend".

I know of a company that does not even try to meet an air permit situation. They pay a fine every day for not meeting the permit. The feeling is that it is cheaper to pay the fine, than to make the changes. They don't even have the particular aspect listed as a significant aspect in their 14001. They claim, if their not going to do anything with it, why bother? Their registrar is aware of the situation.

This is completely different. I would feel a lot better if they let the responsible agency know about it (at least then it would not be behind everyone's back). I would also wonder what legal trouble your friend could be in if and when it is discovered? Could the email be used to send you friend up the river?

One other thing I've found over time. Any organization that willingly violates the law will be very quick to violate their employees. I agree...its time to monster.com

Rosie,

I would have to look at the circumstances and what violations occurred and if it could come back and bite your friend.

I left a company once because they falsified inspection documents sent to customers. There was more to it than that, but the main reason was that I had to live with myself and the employer and my ethics did not agree. I have never knowingly participated in falsifying documents and never plan to.

On the other hand, I have seen or choose not to have seen some violations. They are small in nature, put no lives at risk, are not malicious, and does not affect product or anything else.

Tough spot to be in.

Cindy

A tough spot indeed. If I found myself in that situation (as I once did) I would start looking for a new employer, staying only as long as it takes me to find a new haven. I wanted to split right away but that would have ruined my personal economy. I left given the first opportunity, though.

I also have to say that db (as usual) scores a heavy point: If a company violates the law, what about the employees?

/Claes

This could be a significant issue. More questions need to be answered before jumping ship, although, I agree with the folks here that an organization willfully disregarding a regulatory requirement on the hunch that it won’t be spotted calls to question as to how far they would go in another instance.

Some questions that come to mind (and needn’t be answered here):

Ж Are any activities (i.e. unpacked finished good is packaged and labeled) by the original manufacturer?
Ж Where were the PV activities carried out? Were they repeated at the alternate facility?
Ж Is the alternate location registered under the same/different notified body? CE markings involved??
Ж Is the alternate facility approved/registered for the manufacturing of medical devices??

The regs are there to protect the public and to relieve some of the ambiguity in their interpretation. Stealing a gum or a car is still an act of stealing, wrong by any standard. While their magnitudes are significantly different, courts find in the same way, fine according to magnitude. Gum: get a fine. Car: get some time in the joint. What is the magnitude of the issue your friend is experiencing? He needs to do more research and act accordingly.

Apparently, the President there has an ego larger than his brain.

Regards,

Kevin

My friend's question is this: What should/could he do now? Let it sit? I would sit but keep a copy of the e-mail reply, or of the original e-mail if the reply was verbal. And I would keep that copy at home.

However - If it's a Mil manufacturer, pharmacutical, etc. your friend may be liable to prosecution if found out for not reporting it.

I'd say there would be more potential here for fraud than regulatory non-compliance, but both come into play here. Sounds like it to me, too.

Trouble is now you know you may be found guilty of collusion if you dont report it.

Is this actually breaking a law, or just an internal procedural requirement ??

Trouble is now you know you may be found guilty of collusion if you dont report it.

Is this actually breaking a law, or just an internal procedural requirement ??


The Regulatory Game

Personally, I had been involved with Health-Safety-Environmental tasks since 1980. While I was assigned the responsibilities, there was always the GM/President approving any regulatory schemes. Sure, you bring everything to their attention and try to instill in them the need to comply with all regulatory requirements. Here’s two cases involving Wastewater Discharge Permits.

1.Fullblown Waste Water Treatment Discharge Permit. This took three months of hard work to put together. Working with DEP representatives, everything was scripted as what to say or not. I told the President, “I hope you don’t expect to see my signature on the Permit Application.” He asked why. Simply said, “The signature required is from an Official of the Company (I was not). Also, see that paragraph just above the signature line? It says falsification of documents can lead to fine and/or imprisonment. I’m not getting fitted for a striped uniform.” We both laughed. He asked, “Why’s that?” My answer was that I wasn’t comfortable with a couple of his interpretations and the plan as submitted. You know what he did? Went back and addressed those issues until we were both comfortable with the decision. I still didn’t sign it. But, I would have if I had to. Incidentally, the city water for making coffee was not clean enough for our process. Had yours today?

2.This one involved a Hydrostatic Discharge Permit. Clean water was brought in from the city water supply, processed through 5 micron filters, pumped into new PVC piping and lined pressure vessels and the pressure increased 150 PSI for an hour to check the integrity of the system. Then the “clean” water was discharged to the sanitary sewer. Because the water is considered the by-product of a manufacturing process, it has to be Permitted. No problem there. Here’s the rub: They want an analysis (grab sample) of this clean water during the first ten percent and the last ten percent of each discharge. We took exception a few years and were allowed to sample once every quarter for 5 elements. That amounted to about $400/yr. Now they have a revised permit that makes no exceptions. Let’s say we have 4 discharges a day. That’s 8 grab samples of perfectly clean water at $90.00 a pop. You do the math for a year. Figure 24 samples a week. Absolute bull. This water, as is under normal conditions, is fed throughout hospitals and other facilities and is very clean. All tests results come back the same. So, what scheme would they use?
Put in a 5000 gal tank to re-cycle the water. Everybody was happy. There has been no discharge sampling because they never discharge to the sewer. Never. Get it? The re-cycle tank always has clean water in it. Get it? Was it legal? No. Was it necessary to stop spending resources foolishly? Yes. I’ve heard stories about samples being taken, before my time, from the Office water Cooler. This water is no threat to the waterways of the state, is cleaner when it leaves the building than when it comes in and is safe for consumption. (That is if you are comfortable in drinking from a drain valve.

Did I turn a not so blind eye toward the re-cycling scheme? Take a guess. If the CEO/President/Owner assumes the risk, let them. Just make sure you play dumb and don't have to sign anything to implicate yourself and go about your business. It is his/her call.
:smokin:

I just thought I'd report back with what I know of the status of this situation from my friend.

He called his family lawyer, and the lawyer told him that by emailing the president and copying his boss, he'd effectively protected himself from being implicated.

He asked if he was required to report this to the regulatory agency or the customer and the lawyer told him no. (M Greenway suggested that he might be required to, but that may be a US vs UK difference too)

So far my friend is hanging in there, but he's thoroughly soured on the job and is actively looking for another....no easy feat in this economy.

Tell your friend that he would be HARD pressed to find any organization that doesn't bend a rule now and then. There is a time for maturity to kick in and to start understanding the realities of life and business, he may have arrived at that time.

Just tell him not to compromise himself.

The one thing which would concern me most about the scenario you mentioned was that QA found out about this by accident :eek:. To me, that would raise the question of what else did QA miss? and has management done this before? or have they allowed even more serious regulatory requirements to be overlooked? If I saw a trend there, then I would be concerned.

Ultimately, it is a company's President who is responsible for ensuring their customers are happy and that all Local, State, Federal and International regulations are adhered to. Your friend's company President has obviously accepted this responsibility, but I don't think their explaination would make me feel any better :rolleyes: either... I do not like getting brushed off without knowing why they felt it necessary to bypass a particular regulation? and to state that it's not likely that the issue would be found in a regulatory inspection? ummmmm... That seems like a poor argument to violate a regulatory requirement. For your friends concience, I would recommend they take the advice I have seen in some of the other posts above and at least keep a copy of their communications.

Good luck, and remember what Rodney Dangerfield said in that movie - Back to School - "You gotta watch out for # 1, but don't step in #2..."

A QA friend of mine called me this morning with a dilemma that I said I'd post and see what other QA folks think.

His company knowingly violated a regulatory requirement, with the decision made by the company's president. QA was bypassed and found out after the fact, by accident. The violation in no way compromised the product itself.

In the good faith belief that the president did not understand the consequences of what he'd done, my buddy wrote him an email and made him aware of them. The president's reply was that it was his risk to take and it was unlikely to be found in a regulatory inspection.

My friend's question is this: What should/could he do now? Let it sit?

Rosie-

I am taking your friend works at a Medical Company? I understand that the product is not compromised and he e-mailed the President, however, if and when it is found out during an inspection does he really think the President is going to take the blame or the fall?? Your friend is in a difficult situation and really needs to talk to the President of the company face to face and explain what could happen and there are steps they can take to rectify the situation.