Ethics: Failure to File Regulatory Reports




I am the quality manager of small company that manufactures a laser/class 1 [uses class IIIb diode] we have 2 major models and several sub-models. History: we are in the process of filing for ISO 9001 last may I conducted our first internal audit, during the audit I found that we have never filed a product report with cdrh cer 1040.10 for 4 sub models associated with an approved model and one new product line not associated with any approved model. And last year we failed to file our annual report.My problem is this my employeer does not see this as a major problem, His attitude is no one ever looks at the reports anyway. When I told him it was against the law to sell/ offer to sell or advertise for sale any product containing a laser before the product report has been filed he accused me of being over dramatic and reading more into the regulations. He stated that we are a small company no one pays attention to what we do. I am new to FDA requirements, is there something I am missing, are there exemptions for very small companies? HELP! I do not feel right about this. Thank Nancy
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In the courtroom, "I thought the laser was eyesafe, but then my left eye started to burn real bad"


Please let me know which ones you make...I need to pay for a house and towards my retirement.

You can show this to whoever is in charge..

Oh by the way, do you have a Non-ionizing (Laser) Radiation Safety plan as required by OSHA (another bothersome regulatory agency)? I guarentee if an employee calls 1-800-I'm-mad-at-the-boss, that organization will inspect the output and a lot of other stuff.

Someone needs to discuss liability with the boss real fast.

I'm sorry to get off the quality track, but sometimes the quality of a product is directly tied to product safety too.

Jim Evans


I went through a similar experience a number of years ago. The company I worked for made RV lighting products. We had recently been bought out and the new management was very aggressive in acquistions and expansion. One of our competitors went out of business and my company bought up their assests to eliminate some competitive product lines. However we did sell replacement parts as we didn't want to leave customers high and dry (in some cases we didn't we have a replacement from our product line).

It was my job to test the external lighting products to make sure they met all of the DOT's photometric requirements for brake lights, tail lights, reflectors etc. One particular model failed every test in my lab and was confrimed in an independent lab. The new company president and his vp for sales wanted to continue to sell this product. I was adamant about not selling as it is unethical and immoral (not to mention highly illegal) to knowingly sell defective product that is related to safety. In the end I was able to win the day by showing them the portion of the law that spelled out the fines and jail time for company officers that knowingly sell safety related product that is defective.

Interestingly enough, two years later the DOT via their random testing of product purchased in the field, issued a recall on these lights. In the test records we received from the company we bought, the last successful testing of this model light was ten years previous. Thefore the recall went back that far. Since we were able to produce records that we had never sold even one light from this product line we were not directly involved with the recall. Because the original company was out of business the vehicle manufacturers got stuck with the bill for the recall (tens of thousands of these lights). One company had 40,000 trailers (80,000 lights) to replace.

My advice: Keep in mind your boss is the company president and will probably do what he wants to anyway. Keep him informed as to the consequences of his actions. Put your concerns in writing i.e. memos to your boss and keep accurate personal records (off site?). Good Luck with your problem, I know it is not easy when you feel like the lone voice in the wilderness.

Best Regards,


[This message has been edited by Jim Evans (edited 28 August 2000).]


Don't do it!!!!!

Sometimes we just have to stand up and be counted (Regardless of the outcome).
if there are "ANY" requirements or constraints that restrict your organization from releasing an unsafe or certified product, "Just don't release it".
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