Reworked components in PPAP production

T

tamster

#1
My company is an automotive supplier and we just completed a PPAP which resulted in a failure resulting in all the units being torn down and the components reworked to original dimensional specs. They want to reuse the components in the next PPAP run. Can we do that? I heard that you aren't suppose to use reworked components for PPAP production but I do not see this in the PPAP 4th edit manual. Thank you for any help.

Tammy
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
My company is an automotive supplier and we just completed a PPAP which resulted in a failure resulting in all the units being torn down and the components reworked to original dimensional specs. They want to reuse the components in the next PPAP run. Can we do that? I heard that you aren't suppose to use reworked components for PPAP production but I do not see this in the PPAP 4th edit manual. Thank you for any help.

Tammy
So long as the components meet the specifications--all of them--it shouldn't be an issue unless your customer has specific requirements regarding rework. You will need to update your PFMEA if there were failure modes not accounted for in the original document, or if a change in RPNs is necessary. You might also need to update your control plan. If you're TS16949-registered, be aware of 8.3.2:
Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
I don't think you can use reworked parts for a PPAP run.
 

Jim Wynne

Staff member
Admin
#4
I don't think you can use reworked parts for a PPAP run.
You're right, and I wasn't paying attention to the original question. :frust:The PPAP parts (the "significant production run") has to represent the production process that will be used to produce the product, and reworked parts don't qualify. This doesn't mean that the reworked parts can't be reserved and used later, after PPAP approval, so long as they meet specifications and the customer doesn't object.
 
T

tamster

#5
Thank you so much for your answers. The problem is that we cannot find this in the PPAP manual and I have to show my colleages where this is defined so they understand. Do you where it is in the maual? Thank you again.
 

Stijloor

Staff member
Super Moderator
#6
Thank you so much for your answers. The problem is that we cannot find this in the PPAP manual and I have to show my colleages where this is defined so they understand. Do you where it is in the maual? Thank you again.
It would help us very much if you can explain this to us.

My company is an automotive supplier and we just completed a PPAP which resulted in a failure resulting in all the units being torn down and the components reworked to original dimensional specs.
Did the manufacturing/assembly process fail to meet the (product) specifications? Or was the initial PPAP submission rejected by the Customer?

Stijloor.
 

Jim Wynne

Staff member
Admin
#7
Thank you so much for your answers. The problem is that we cannot find this in the PPAP manual and I have to show my colleages where this is defined so they understand. Do you where it is in the maual? Thank you again.
From page 1 of the 4th edition PPAP manual:
The purpose of PPAP is to determine...that the manufacturing process has the potential to produce product consistently meeting [the] requirements during an actual production run at the quoted production rate.
(Emphasis in the original)

If your "significant production run" has not demonstrated the potential to produce product that consistently meets the requirements, you're not ready for PPAP.
 
U

Umang Vidyarthi

#8
My company is an automotive supplier and we just completed a PPAP which resulted in a failure resulting in all the units being torn down and the components reworked to original dimensional specs. They want to reuse the components in the next PPAP run. Can we do that? I heard that you aren't suppose to use reworked components for PPAP production but I do not see this in the PPAP 4th edit manual. Thank you for any help.

Tammy
Let us look at the problem from a different angle.

There will be a number of steps for tearing down the components, another number of steps for rework, and more steps for reassembley. So for pushing the reworked material, you will have to include all these steps in your PPAP, and will be rquired to submit revised PPAP. In that case, you will have to go through all these steps in regular production too!?! If you think any customer in his right mind will accept such a product, you have another think coming.

Other alternative is, you submit the reworked parts, without including rework steps in the PPAP. Which perhaps is what your colleagues want to do.( I may be wrong)
That is against ethics, and also fraught with attracting detection at the customer's end, in which case you may get blacklisted. So take your pick

Thank you so much for your answers. The problem is that we cannot find this in the PPAP manual and I have to show my colleages where this is defined so they understand. Do you where it is in the maual? Thank you again.
Jim has given an appropiate reply to this question. Show to your colleagues the requisites for PPAP approval, and ask them wheather the reworked parts qualify or not. Only the correct dimensions(end result) do not satisfy the PPAP, rather the whole manufacturing process is examined under a microscope, before giving the nod of approval.

we cannot find this in the PPAP manual

This IMO is an argument for the sake of argument, which does not hold water. In which manual it is written that you should not supply an inferior part? Do you infer from that to be a permission to supply inferior part? :mg:

Umang
 
T

tamster

#9
Jim,
Thank you very much! Your response is exactly what we were looking at in the manual and what we thought we can base our argument on. Thank you again for taking the time to help me. Hope you have a great weekend.

Tammy
 
T

tamster

#10
Umang,
I did not ask the question inferring that we were trying to do anything unethical and I do not appreciate the suggestion that we are. I was simply trying to get help from others in this forum on how to explain this to some people who may not have the understanding of a Quality System that you do. I was under the impression that this site was to help others in the Quality field. I was not aware that it was a forum to get attacked for asking for help. I can assure you that the primary reason for my question was to make absolutely sure that we provide a fully conforming product to our customer without doing anything to compromise the quality of it. Please excuse my ignorance.
 
Thread starter Similar threads Forum Replies Date
T IATF16949:2016 8.7.1.4 Control of non-applicable reworked product IATF 16949 - Automotive Quality Systems Standard 3
I IATF 16949 Cl. 8.7.1.4 Control of reworked product IATF 16949 - Automotive Quality Systems Standard 2
SATHYABALARAMAN 8.7.1.4 Control of Reworked Product & 8.7.1.5 Control of Repaired Product IATF 16949 - Automotive Quality Systems Standard 2
P IATF Definitions - Reworked product (8.7.1.4) vs Repaired product (8.7.1.5) IATF 16949 - Automotive Quality Systems Standard 40
N Reason for determining no adverse effect on reworked product ISO 13485:2016 - Medical Device Quality Management Systems 8
S When to give a new Batch Number for a reworked batch ? Nonconformance and Corrective Action 3
S Reworked DOA (Dead On Arrival) Return back to Inventory as New? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Q Reworking and identifying these 'Reworked' PCBAs Misc. Quality Assurance and Business Systems Related Topics 8
Q Proof of defect - Customer reworked all the defective parts Supplier Quality Assurance and other Supplier Issues 8
I Difference between Repaired and Reworked QS-9000 - American Automotive Manufacturers Standard 5
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
S Reporting REACH - Electronic components distributor REACH and RoHS Conversations 5
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
U Procedure pack components EU Medical Device Regulations 3
T Sterilized components expiration date ISO 13485:2016 - Medical Device Quality Management Systems 1
T Sterilized components shelf life Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
C Warehousing two separate components to a finished device while meeting regulations Other US Medical Device Regulations 7
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
C Shelf life electronic components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 12
K 510K new manufacturer but same components Other US Medical Device Regulations 6
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
R What is meant by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Medical Device Components US to EU commercialization EU Medical Device Regulations 7
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
A Components of a medical device - Hardware robotic hand EU Medical Device Regulations 3
D IMDS for Like Components (Interior Plastic, Leather/vinyl Armrest, etc.)other than Color APQP and PPAP 1
JoshuaFroud Serial numbers and labelling when sharing device components ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Nicole Desouza Plastic Extrusion of Medical Device Components - No ISO or AS 9100 Certifications Other Medical Device and Orthopedic Related Topics 7
Q Handling Off-the-Shelf Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I PPAP Assembly and Components Manufacturing and Related Processes 3
D CB Certificate - Distributor for a product with electrical components CE Marking (Conformité Européene) / CB Scheme 4
K Selling Medical Device Components to US hospitals and doctors US Food and Drug Administration (FDA) 4
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
F Mig Welded Components - IMDS International Material Data System RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
G Audit finding - Components being transferred inter-plant Internal Auditing 3
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
S How are Medical Device Components and Subassemblies defined? ISO 13485:2016 - Medical Device Quality Management Systems 1
H Classification of a Class IIb Medical Device with 3 Components CE Marking (Conformité Européene) / CB Scheme 1
P REACH - A few of the hundreds components in my product no longer meet requirement REACH and RoHS Conversations 2
C Medical device file for components such as adhesives, gaskets, films, etc. ISO 13485:2016 - Medical Device Quality Management Systems 13
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Is it acceptable to mix components from two different lots into an assembly? ISO 13485:2016 - Medical Device Quality Management Systems 1
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom