"Release" of TR16949

R

Roger Eastin

#1
I was talking to a colleague last week about the release date of TR16949. I told him that the last date I saw was 1/1/05 and he said that didn't suprise him. He said that not only TR16949, but IS09000:2000 were being delayed (at least in part) by legal questions - liability, mostly. Apparently, legal questions are being raised about using language such as continuous improvement. The issue is whether a company is tied legally to continuous improvement if they bring it up in procedures. Can a customer sue a company for saying they do continuous improvement, but an audit (for instance) indicates a noncompliance in this area? They said they are doing continuous improvement, but don't show adequate evidence of it. My colleague said that's one hang-up with ISO standards - what are the ramifications legally for documenting something like continuous improvement? (Since ISO900:1994) does not mention continuous improvement, apparently it is safe!) As if the standards business wasn't tough enough without the legal stuff...
 
Elsmar Forum Sponsor
R

Roger Eastin

#3
I must admit that when it comes our sue-happy culture, I don't know what happens next. It would seem that QS9000 would also be a "tool" for law suits. Anyone heard anything else?
 
R

Roger Eastin

#4
I think the issue of continuous improvement litigation belong more to ISO9000:2000 than to TR16949. However, because TR16949 is an ISO document, it is getting caught in the whirpool of ISO9000:2000 - at least that is what I hear from my sources. Anyway, the point is that TR16949 has been held up for some time. According to the BSI webpage, it is held up until 1/1/2005. That is the only place where I've seen a date associated with TR16949. Now getting back to your argument about what people sue over - this is the country where someone sued a lawnmower company for an injury they sustained while trying to use the lawnmower as a hedge trimmer and WON! (They won because they said that nowhere on the lawnmower did it state that it could not be used as a hedge trimmer!!) That kind of litigation is pretty scary! And at least for the time being, ALM, you should not wait to get registered to TR16949, so go ahead for QS9000 (I saw your message in the QS9000 forum!)
 
#5
In spite of our sue-happy culture, I cannot imagine the "legal ramifications" of such.

We are talking CQI, here and exactly who is going to sue whom and over what measures?

Forgive my sarcasm but, the quality of my product may be in the toilet (for now) but if I have demonstrated improved preventative maintenance and machine uptime, have I not provided evidence of CQI? In the same situation, haven't I identified an area (toilet-quality) that is an opportunity for future improvement?

Who exactly is going to sue because I claim CQI, but their product stinks? I would think that I would be sued first of my crappy product not meeting required specs than for claiming that I perform CQI and cannot substantiate it is some, even many instances.

ALM
 
R

Roger Eastin

#6
Apparently, all that had to be done to get TR16949 going again was for me to post a topic here about how it is going to be delayed!! I just received a copy of ActionLine from AIAG yesterday where they list on page 14 (albeit, in sketchy form)some details of the launch of TR16949. If I understand the 2nd bullit correctly (from the top of the page), the launch should take place 7/1/99. (I still wonder, though, how this will be affected by the arguing going on with ISO9000:2000.) You can order TR16949 documents (including the standard itself) from AIAG at (248)-358-3003. It is interesting to note that none of the Japanese automotive makers are listed among those accepting registration to TR16949. I expect, though, the Nissan will follow soon because they are a part of Renault now and Renault is listed as one of those ones accepting TR16949 registration. The saga continues....(where's Obi-Won-Kenobi when you need him).
 
Thread starter Similar threads Forum Replies Date
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Informational Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued Medical Device and FDA Regulations and Standards News 0
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S C of C release with accompanying EASA Form 1 for EASA Part 145 EASA and JAA Aviation Standards and Requirements 0
M Informational Health Canada begins release of clinical data Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Manufacturing date does not match release date? Other US Medical Device Regulations 2
P What is expected in a Medical Device Commercial Release Procedure Design and Development of Products and Processes 3
R Medical Device License - CMDCAS certificate release - Health Canada Canada Medical Device Regulations 0
A Certificate of release/certificate of conformity/certificate of compliance Other Medical Device and Orthopedic Related Topics 3
P Is ISO 9001 Model tested for its effectiveness by ISO before its release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
JoCam User Manual Release before CE Mark EU Medical Device Regulations 5
Marc Release of New or Revised Procedures Document Control Systems, Procedures, Forms and Templates 5
E ISO 22000 new release in 2016? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
I How to sample in a real time release process? AQL - Acceptable Quality Level 4
M Release authorization before or after packaging per 21 CFR 820.80(d)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H POA procedure and EASA Form 1 Release EASA and JAA Aviation Standards and Requirements 2
shimonv Using sterilization data obtained from batch release for CE submission EU Medical Device Regulations 11
M A Question on EASA's "Release and Acceptance of Components" EASA and JAA Aviation Standards and Requirements 2
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Engineering Release Process Owner Manufacturing and Related Processes 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4
Colin ISO 9001:2015 Delayed Release? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Annex II List A - Notified Body Fees - Design dossier review and batch release EU Medical Device Regulations 2
L Release of Audit Results Report to 3rd Party ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H Extra checks to do when reviewing the batch records for release of products Records and Data - Quality, Legal and Other Evidence 2
T Expected release date for ISO 50003? Sustainability, Green Initiatives and Ecology 3
Sam Lazzara Lot Release Testing versus Process Validation Studies Qualification and Validation (including 21 CFR Part 11) 9
P MDD position on Final Inspection/Release Employee Experience/Training EU Medical Device Regulations 1
E Procedure for Control of the Release of Laboratory Notebooks Other ISO and International Standards and European Regulations 3
P Records authorizing release of product at Contract Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C DCN or ECN for Initial Release of FMEA & CP and subsequent changes? FMEA and Control Plans 3
C Approval and Release of a new Powder Coating - Which tests should be done? Manufacturing and Related Processes 2
R What does P-release mean in APQP documents regarding drawings and approvals? Design and Development of Products and Processes 1
G Product Release and Component Classification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
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
C Receiving Raw Materials, Inspection, Release Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Similar threads


















































Top Bottom