Ethics: Failure to File Regulatory Reports

N

nancyi

#1
Ethics

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
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
In the courtroom, "I thought the laser was eyesafe, but then my left eye started to burn real bad"

Ka-ching$$$$$$$$$$$$$$$$$

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.
 
J

Jim Evans

#3
Nancy,

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,

Jim

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

WALLACE

Quite Involved in Discussions
#5
Don't do it!!!!!

Nancy,
Sometimes we just have to stand up and be counted (Regardless of the outcome).
Nancy,
if there are "ANY" requirements or constraints that restrict your organization from releasing an unsafe or certified product, "Just don't release it".
Wallace.
 
Thread starter Similar threads Forum Replies Date
M Ethics and Legality AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
sutie What is Ethics Escalation (“Whistle-Blowing”) Policy - Corporate Responsibility IATF 16949 - Automotive Quality Systems Standard 7
L Audit Ethics and Practices regarding Evidence Internal Auditing 18
L Ethics Question in regard to a Regulatory Authority CAR Misc. Quality Assurance and Business Systems Related Topics 2
Wes Bucey The Ethics of Risk Assessment Philosophy, Gurus, Innovation and Evolution 13
I Code of Ethics and Conduct wanted Document Control Systems, Procedures, Forms and Templates 3
E Test Data Accuracy Usage - Ethics Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Tool Capability vs. Customers Requirements and Specifications (Ethics) Quality Assurance and Compliance Software Tools and Solutions 6
J Ethics Training and Policy appropriate for an ISO 17025 Testing Laboratory ISO 17025 related Discussions 4
C Your position and ethics on your job - Unqualified Personnel Career and Occupation Discussions 19
C REDACTED Harassment Module: Ethics - Training Materials Career and Occupation Discussions 2
C Workplace Ethics PowerPoint .ppt presentation or other format wanted Training - Internal, External, Online and Distance Learning 9
G Ethics and Quality Management Coffee Break and Water Cooler Discussions 36
K Clinical Trials of Medical Devices in China - Ethics Commision ISO 13485:2016 - Medical Device Quality Management Systems 9
Tim Folkerts Change in ASQ Code of Ethics ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
K Ethics - Tooling drawings and controls passed on to another supplier by the Customer Supplier Quality Assurance and other Supplier Issues 12
D Auditing Ethics - Lead Auditor solicited client for training General Auditing Discussions 6
Wes Bucey Ethics - Moral law vs. Criminal law Philosophy, Gurus, Innovation and Evolution 123
Wes Bucey Corporate ethics revisited - Comments about the concept of corporate ethics Coffee Break and Water Cooler Discussions 22
R Ethics: A Discussion of Company Ethics Philosophy, Gurus, Innovation and Evolution 18
R Ethics: Ethical Question - Knowingly Violating a Regulatory Requirement Philosophy, Gurus, Innovation and Evolution 20
R Ethics: Audit Question points auditor to a possible nonconformance General Auditing Discussions 73
A Ethics: Ethical Decisions Philosophy, Gurus, Innovation and Evolution 4
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 9
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Kaizen Events - Factors Affecting Failure Lean in Manufacturing and Service Industries 13
C Failure nets - Same level effects FMEA and Control Plans 0
C Failure mode at 0h, vs. 1 year vs. 5 year... FMEA and Control Plans 8
R How to properly use Survival Analysis to predict time to machine failure Reliability Analysis - Predictions, Testing and Standards 0
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
M Informational US FDA – Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples Medical Device and FDA Regulations and Standards News 0
C Detection Action for Failure Effects - AIAG 4th Edition Layout FMEA and Control Plans 5
Marc NASA Says Oregon Company Metals Fraud Caused $700 Million Satellite Failure - 2019 World News 16
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
N PFMEA repetitive failure modes in subsecuent stations. FMEA and Control Plans 1
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
J How to look up Failure Modes on FDA website FMEA and Control Plans 4
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
C Design for Assembly in DFMEA - Failure Effect of Sub-System(s) FMEA and Control Plans 5
Marc Server RAM Failure - 7 Dec 2018 Forum News and General Information 3
K Spot weld - Peel test failure Manufacturing and Related Processes 3
C Electrical Power Plant Supply failure in PFMEAs FMEA and Control Plans 10
kisxena Memo to File - Failure to Validate Supply Chain Security Management Systems 1
Y IEC 62304 Section 4.3(a) - 100% probability of failure IEC 62304 - Medical Device Software Life Cycle Processes 3
S FMEA column column ''therblig motion'' for a given potential failure FMEA and Control Plans 12
J What does "factional and failure dependencies“ mean? FMEA and Control Plans 1
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5

Similar threads

Top Bottom