8.2.4 ... person(s) authorizing release of product - Who could this person be?

D

Don Palmer

#11
Mark_QM said:
Our President frequently disregards our quality policies. In his own words, "It's all BS." to him. His motivation for implementing AS9100 is the $$$ he sees in the additional aerospace work he can pick up.
Soooooooooooo then, BS = $$$ (?), Is this president also OWNER of the company?
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#13
Mark_QM said:
The statement by Wes Bucey, "The issue is that President is overriding the policy he is responsible for." doesn't seem like it fits the situation at our company. Our President frequently disregards our quality policies. In his own words, "It's all BS." to him. His motivation for implementing AS9100 is the $$$ he sees in the additional aerospace work he can pick up.
It fits - when the subpoenas come flying, his name will be on them - he's responsible!

If we are talking AS9100, we are probably also talking FAA PMA for your company or your customer.

I want to alarm you!
We have written about consequences when the feds get involved.
What's the funniest thing you've ever seen during an audit?
especially post #15 (http://elsmar.com/Forums/showpost.php?p=112609&postcount=15http://elsmar.com/Forums/showthread.php?p=121916&highlight=titanium#post121916)
and
C of C Liability - Person who signs a certificate of conformance
especially post #9 (http://elsmar.com/Forums/showpost.php?p=121773&postcount=9)

For your personal safety, :ca: and get president to sign the suggested paper. Elsewhere throughout the Cove, we have threads discussing ethics and liability and protecting yourself and your family from fallout when stuff ultimately hits the fan. The upshot is that often hubris and ignorance are combined in the boss's personality. He may believe he is invulnerable and he sure doesn't care about you or his customer or the people who ultimately fly on the aircraft which may depend on your component for proper functioning. Oddly, it may not even be your component which brings down the aircraft, but when the accident and safety guys finish an investigation, the odds are good they'll discover examples where your company supplied material not meeting the certificate of conformance which accompanied the material. You may end up swimming in the same sort of soup as the guys from the titanium tube company discussed in the links shown. As a result of the investigation, the company closed and EVERYBODY got put out of work, guilty or complicit or not.
 

al40

Quite Involved in Discussions
#14
Speaking from my days in aerospace;

When I went to FAA DMIR school in Oaklahoma the first thing that was told to us was to "Put everything you own in your wife's name" what they meant by this was if you're the one signing off on 8130's/inspection reports then you're the person that will have to answer to the FAA if your part is found to be the cause of an aircraft accident.

Remember your signature are attached to these parts for the life of the aircraft.

I would talk to your internal DMIR (FAA Designated Manufacturing Inspection Representative) to see what they can do to help or if you don't have one then I would explain to your president section 4.13.1 and then ask him to sign off the parts.

As Wes stated earlier, always remember to "cover your backside" when you work for these types of companies.

Best of luck.

Al
 
Last edited:
#15
In response to Al Rosen,
No safety of flight issues have come about that I'm aware of. Parts do get returned from customer's. I've tracked the returns since I've been here (almost 3 years) and found that 4% of our shipments get returned. How does that compare with everyone else?

As far as what equipment our parts go into, for most of the parts we don't know what the intended application is. I don't really want to disclose all of the details, but the most critical parts we make are in military helicopters, aircraft fuel delivery assemblies, various space telescopes and unmanned space vehicles. We also make some parts that are used in submarines and various explosives in the military. In other industries, we make parts for the optical, medical (i.e. various blades, analyzers, and titanium parts for reconstruction of bones after an accident), automotive (i.e. fuel cells), and commercial industries (i.e. fruit juice manufacturer's, the stamping industry and various shims and washers for almost any industry).

We have over 300 different customers annually that give us repeat business. Our largest customer is only 3% of our annual sales revenue.

Our President is the sole owner. He is an emphatic guy, if a customer is unhappy with us he will sometimes tell them where to go. Since I've been here we've lost a couple of customers due to this. He's not very friendly with auditors either and has been known to ask them to leave.

Regarding Certificate of Conformances, I sign most of them and delegate to the Inspection Supervisor when I'm unavailable.

Thanks for everyone's input.

Mark
 
D

Don Palmer

#16
Mark_QM said:
In response to Al Rosen,
No safety of flight issues have come about that I'm aware of. Parts do get returned from customer's. I've tracked the returns since I've been here (almost 3 years) and found that 4% of our shipments get returned. How does that compare with everyone else?

As far as what equipment our parts go into, for most of the parts we don't know what the intended application is. I don't really want to disclose all of the details, but the most critical parts we make are in military helicopters, aircraft fuel delivery assemblies, various space telescopes and unmanned space vehicles. We also make some parts that are used in submarines and various explosives in the military. In other industries, we make parts for the optical, medical (i.e. various blades, analyzers, and titanium parts for reconstruction of bones after an accident), automotive (i.e. fuel cells), and commercial industries (i.e. fruit juice manufacturer's, the stamping industry and various shims and washers for almost any industry).

We have over 300 different customers annually that give us repeat business. Our largest customer is only 3% of our annual sales revenue.

Our President is the sole owner. He is an emphatic guy, if a customer is unhappy with us he will sometimes tell them where to go. Since I've been here we've lost a couple of customers due to this. He's not very friendly with auditors either and has been known to ask them to leave.

Regarding Certificate of Conformances, I sign most of them and delegate to the Inspection Supervisor when I'm unavailable.

Thanks for everyone's input.

Mark
Sounds to me like this president/sole owner would not think twice about giving a noogie to a dutch uncle.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#17
Mark_QM said:
In response to Al Rosen,
No safety of flight issues have come about that I'm aware of. Parts do get returned from customer's. I've tracked the returns since I've been here (almost 3 years) and found that 4% of our shipments get returned. How does that compare with everyone else?

As far as what equipment our parts go into, for most of the parts we don't know what the intended application is. I don't really want to disclose all of the details, but the most critical parts we make are in military helicopters, aircraft fuel delivery assemblies, various space telescopes and unmanned space vehicles. We also make some parts that are used in submarines and various explosives in the military. In other industries, we make parts for the optical, medical (i.e. various blades, analyzers, and titanium parts for reconstruction of bones after an accident), automotive (i.e. fuel cells), and commercial industries (i.e. fruit juice manufacturer's, the stamping industry and various shims and washers for almost any industry).

We have over 300 different customers annually that give us repeat business. Our largest customer is only 3% of our annual sales revenue.

Our President is the sole owner. He is an emphatic guy, if a customer is unhappy with us he will sometimes tell them where to go. Since I've been here we've lost a couple of customers due to this. He's not very friendly with auditors either and has been known to ask them to leave.

Regarding Certificate of Conformances, I sign most of them and delegate to the Inspection Supervisor when I'm unavailable.

Thanks for everyone's input.

Mark
Based on your response, I think some of the boss's hubris has rubbed off and you don't care who might be affected when one of your titanium screws fail.
 
F

fletch

#20
I had a situation where the pres did sign off on some seals we made...and they were wrong...and the customer was BS!!! so when they called and I spoke with them about it I asked who's name was on the cert and shipping docs...and they told me...and I about lost my lunch! how could this person be so stupid as to release non conforming material when he wasn't even an inspector? needless to say the $5K worth of product he shipped at the end of the month....AFTER HOURS...AT THE CUSTOMERS REQUEST:mad: ...was not worth it!!! The HOURS of documents I had to fill out...the explanations:mad: ....how do you ream out the pres for being so dumb? His reply was the old form fit and function story...but it was wrong...and the customer wasn't going to stand for it....and they lost the account....and I left the company because I was sick of instances like that....and moved to much greener lands....:applause:
 
Thread starter Similar threads Forum Replies Date
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 4
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
dgrainger MHRA - Creation of new UK Responsible Person section with added content. Medical Device and FDA Regulations and Standards News 0
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 6
J Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens Other Medical Device and Orthopedic Related Topics 1
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4
T Head of DOA / External Person EASA and JAA Aviation Standards and Requirements 0
Jane's You may or may not have the same person managing Operations and QA ISO 13485:2016 - Medical Device Quality Management Systems 18
Ronen E New Service Offer - MDR's Person Responsible for Regulatory Compliance Paid Consulting, Training and Services 6
J QMS and ISO 9001 for a Single Person Machine Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
J Change of contact person Other US Medical Device Regulations 3
T Document Review And Sign Off Second Person Review - FDA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
somashekar Internal Audit without a person as auditee Internal Auditing 6
G ISO 13485 Certification for one-person startup ISO 13485:2016 - Medical Device Quality Management Systems 7
E Consultant Person who implemented ALSO the Registrar Auditor? Consultants and Consulting 17
E Can corrective actions be written by and resolved by the same person? Nonconformance and Corrective Action 5
E QP (Qualified Person) for Combined Pharma-Medical Devices Quality Manager and Management Related Issues 1
J Testing data for Special 510k and contact person Other US Medical Device Regulations 4
R Document Control Person - Setting KPIs, Development Plan, and Career Path Quality Manager and Management Related Issues 6
M Corrective Action not being done by the responsible person Misc. Quality Assurance and Business Systems Related Topics 5
F What are the requirements for authorized person to release FAA repair shop product AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
V Annual Performance Appraisal - Person vs. Function/Business Career and Occupation Discussions 5
Y Can we obtain ISO 9001 if there is only 1 person that understands the requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Person in charge's role or responsibility in ISMS? ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 3
J Small Company with an established Secretary/Admin person with "Personal" procedures Quality Manager and Management Related Issues 8
K Equivalent role of QP (Qualified Person) in FDA Regulations Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
J Aerospace Parts not Evaluated Properly by Trained Person AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C What to expect in a GE Aerospace Audit of a 100 Person Machine Shop Customer and Company Specific Requirements 5
R Role of Qualified Person (QP) in Contract Manufacturing Pharma Business Quality Manager and Management Related Issues 2
J Reputation of a contact person with FDA while corresponding for 510k ISO 13485:2016 - Medical Device Quality Management Systems 6
J Can a consultant outside of the USA be a contact person on 510k? Other US Medical Device Regulations 13
T Does person responsible for standard have to be the Managment Representative? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
P Can a 2 Person Microbiology Laboratory get ISO 17025 Accreditation ISO 17025 related Discussions 10
A What do you call the person who is assigned a Corrective Action Request? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
J One Person Business and ISO 9001:2008 Quality Manager and Management Related Issues 8
G Sending person(s) to Mars, and not bring them back. Coffee Break and Water Cooler Discussions 4
L Management Representative - 2 Person Device Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Y What is the first step in implementing AS 9100 for a 4 person shop? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
O Understanding PPAP - Could some clever person give me some guidance? APQP and PPAP 5
Anerol C Where should I start as the person responsible for the calibration laboratory? General Measurement Device and Calibration Topics 7
RoxaneB My train ride with the world's most interesting person... Coffee Break and Water Cooler Discussions 29
B Most records are not signed by the person who used it ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Small company where the Quality Manager and HR manager is the same person ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Ajit Basrur Should the Protocol and Report be signed by the same person(s)? Qualification and Validation (including 21 CFR Part 11) 7
D Who should be the person to release product to customer ISO 13485:2016 - Medical Device Quality Management Systems 34
J Initial Supplier Audits In Person or Not? Federal Aviation Administration (FAA) Standards and Requirements 4
J Re-approving documents when the responsible person leaves or changes responsibilities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S FDA approval (Med Device) - Should we use Accredited Person or proceed on Our Own? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Document Approval when the responsible person leaves the company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Similar threads


















































Top Bottom