SBS - The Best Value in QMS software

Does IATF 16949:2016 Clause 7.3 (now 8.3) Apply to "Grandfathered" Products

D

Dan M

Involved In Discussions
#1
#1
We have a number of products that were designed 10-20+ years ago before ISO/TS was in place. The products are going to be transferred to a new modernized production facility that will soon be audited for IATF 16949. The products were originally designed for industrial applications then at some point in time marketed for automotive application but continued to be manufactured at the original plant. In most instances, the automotive customers, at the time, were not prescriptive about ISO/TS or APQP. In transitioning these products, we are reviewing the customer requirements manuals and learning that many of the customers will require formal notification before we make this change to the manufacturing facility. We will have to go through a PPAP process with many of the customers.


These are automotive fluids so the designs consist of raw materials, formulations, manufacturing instructions, and equipment. Because this is a new facility with new/modernized equipment I can see where R&D will need to work with manufacturing to tweak the process based on the new equipment. Will our R&D group be required to go through an exercise to repeat the design work to demonstrate the designs were done according to IATF 16949 and APQP or can we state that the products were grandfathered from earlier design projects?
 
Last edited:
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Stijloor

Stijloor

Staff member
Super Moderator
#2
#2
Dan M said:
We have a number of products that were designed 10-20+ years ago before ISO/TS was in place. The products are going to be transferred to a new modernized production facility that will soon be audited for IATF 16949. The products were originally designed for industrial applications then at some point in time marketed for automotive application but continued to be manufactured at the original plant. In most instances, the automotive customers, at the time, were not prescriptive about ISO/TS or APQP. In transitioning these products, we are reviewing the customer requirements manuals and learning that many of the customers will require formal notification before we make this change to the manufacturing facility. We will have to go through a PPAP process with many of the customers.


These are automotive fluids so the designs consist of raw materials, formulations, manufacturing instructions, and equipment. Because this is a new facility with new/modernized equipment I can see where R&D will need to work with manufacturing to tweak the process based on the new equipment. Will our R&D group be required to go through an exercise to repeat the design work to demonstrate the designs were done according to IATF 16949 and APQP or can we state that the products were grandfathered from earlier design projects?
Click to expand...
These products look like "Bulk Materials" to me. Have you talked to your automotive Customers about these? (The AIAG PPAP Manual has particular requirements for Bulk Materials).
 
G

Golfman25

Trusted Information Resource
#3
#3
Get ready for a world of hurt. But the best thing is to work with your current customers to limit as much pain as possible. You want to try to negotiate a "low level" PPAP and revise the design documentation as applicable. Good luck.
 
D

Dan M

Involved In Discussions
#4
#4
Stijloor said:
These products look like "Bulk Materials" to me. Have you talked to your automotive Customers about these? (The AIAG PPAP Manual has particular requirements for Bulk Materials).
Click to expand...
It seems to me that the customers' requirements will determine the level of design documentation that will be needed?
 
Stijloor

Stijloor

Staff member
Super Moderator
#5
#5
Dan M said:
It seems to me that the customers' requirements will determine the level of design documentation that will be needed?
Click to expand...
True, but if you don't ask, you will not know. I've been in the automotive (consulting-training) business ~30 years, and it always amazes me what open and honest communication can do. :agree1:
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
M IATF 16949 - 8.5.6.1.1 Providing a list of process controls: Does this requirement add value to QMS? IATF 16949 - Automotive Quality Systems Standard 4
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
B Does Toyota utilize IATF 16949? IATF 16949 - Automotive Quality Systems Standard 4
M TS 16949 subscribing customers - Does the IATF issue such a list? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
M IATF Clause 8.4.2.2 - What procedures does this apply to? IATF 16949 - Automotive Quality Systems Standard 1
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D Does anyone have a list of the IATF "Shalls" they would be willing to share? IATF 16949 - Automotive Quality Systems Standard 4
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 1
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom