Bulk Materials (Lead {Pb} Alloys) PPAP Requirements

B

Bill Kirsch

#1
Hello.
We are a TS16949 company. I am working with a supplier of lead (Pb) alloys. For new product development the supplier made a single kettle of the custom alloy. So the process for making this alloy has only been done once, with process controls in place and a single content test at the end. This kettle supplied enough lead to make a large number of finished products that all passed testing. We are now working on a production PPAP, but we can't complete it until we have all our supplier PPAPs.

1. How do I complete a PPAP when the bulk material was only tested once? Can I count all the testing of the finished products that the alloy went into?

2. What is the point of the Bulk Material Checklist (section F.3) anyway? As far a I can tell it lists all the same things as the normal PPAP checklist in Table 4.2.

3. Since this is a custom alloy, there is an element of design work in it. Basically, Engineering has told the supplier they want x% of Element A and y% of Element B, etc. Since the supplier is just "building to spec" should I ask them for design documentation? I would guess no, but I welcome any thoughts.

4. So far the supplier's PPAP consists of test results, flow diagram, control plan and PFMEA. Am I missing anything?

5. Alloy testing is done with an Optical Emission Spectrometer. I believe this counts as a "standardized test" as discussed in section F.9. So gage R&R is not required. Your thoughts?

Thanks for the feedback.
 
Elsmar Forum Sponsor

Kales Veggie

People: The Vital Few
#3
Hello.
We are a TS16949 company. I am working with a supplier of lead (Pb) alloys. For new product development the supplier made a single kettle of the custom alloy. So the process for making this alloy has only been done once, with process controls in place and a single content test at the end. This kettle supplied enough lead to make a large number of finished products that all passed testing. We are now working on a production PPAP, but we can't complete it until we have all our supplier PPAPs.

1. How do I complete a PPAP when the bulk material was only tested once? Can I count all the testing of the finished products that the alloy went into?

2. What is the point of the Bulk Material Checklist (section F.3) anyway? As far a I can tell it lists all the same things as the normal PPAP checklist in Table 4.2.

3. Since this is a custom alloy, there is an element of design work in it. Basically, Engineering has told the supplier they want x% of Element A and y% of Element B, etc. Since the supplier is just "building to spec" should I ask them for design documentation? I would guess no, but I welcome any thoughts.

4. So far the supplier's PPAP consists of test results, flow diagram, control plan and PFMEA. Am I missing anything?

5. Alloy testing is done with an Optical Emission Spectrometer. I believe this counts as a "standardized test" as discussed in section F.9. So gage R&R is not required. Your thoughts?

Thanks for the feedback.
So, your supplier must put the PPAP together, right?

You work with that supplier and decide what is required per F.3.

(assuming you are the customer and the supplier is the organization)

(also be aware that lead alloys fall under ELV regulation, if your customer is an automotive customer).
 
B

Bill Kirsch

#4
Kales Veggie,
Since you are the only one to reply, I don't want to sound ungrateful, but you didn't answer any of my questions.
 

Kales Veggie

People: The Vital Few
#5
Kales Veggie,
Since you are the only one to reply, I don't want to sound ungrateful, but you didn't answer any of my questions.
i guess I am confused by your questions. I will try again.

First I would also ask the question: if this is product / material in development, why is a PPAP necessary?

You are the customer. You set the requirements and make sure the requirements of the OEM are flowed down to the lower Tier supplier.

Based on what you have written, I would suggest this:

1) Your supplier completes the PPAP, their responsibility. Your supplier includes a statement why they only have one test results. If you agree, then you accept it.
2) I do not know. (Why use the bulb material approach, I would ask in return?)
3) If all there is an email from Design, than that is the design record for the moment. Engineering must develop an official specification after development / validation have been completed. Engineering better document it.
4) Supplier must have all PPAP elements. If some are not applicable (AAR for example), then include a page in the PPAP stating this.
5) Per TS requirements, every testing device on the control plan must have a MSA done. An MSA is more than a GR&R.
 
Last edited:
B

Bill Kirsch

#6
First I would also ask the question: if this is product / material in development, why is a PPAP necessary?

Isn't a PPAP needed for all parts? We are in development now, but we want to move to production. Are you saying we can release the finished product to production without a PPAP for one of the materials?

I understand that I tell the supplier what I require. I want to be able to justify my requirements. I don't think this case is unusual where a single shipment of bulk material is used for all product development and testing. Statistically, you can't verify the quality of a product if one of the sub-processes was only done once. Yet I am sure new products are released all the time after only using a few barrels of chemical or a few bags of powder or one kettle of alloy. I can't ask the supplier to make 30+ kettles that will take years to consume just so I can complete a capability study before product release. So how have other people handled this quandary?

2) I do not know. (Why use the bulb material approach, I would ask in return?)

This question totally confuses me, even assuming you meant 'bulk' instead of 'bulb'. I would use the bulk material approach because it is a bulk material. It's a couple tons of lead alloy made in a single batch. If this doesn't qualify as a bulk material than nothing does. Page 35 of the AIAG PPAP book says bulk materials shall comply with Appendix F and it specifically mentions metals. The book thinks bulk materials should be handled differently or they wouldn't have created App F to discuss it. When I first read App F it appeared quite different from a regular PPAP, but as I applied it I came to believe there is no real difference. DFMEA, PFMEA, Control Plan, et al. - Appendix F is just using different words to say the same thing as the rest of the book.

5) Per TS requirements, every testing device on the control plan must have a MSA done. An MSA is more than a GR&R.[/QUOTE]

Page 46 - "MSA studies are not required where standardized tests are used,..." My question is - is an OES a "standardized test"? It mentions ASTM, AMS and ISO. Surfing through the ASTM website, I didn't find an exact match to OES, but there were a lot of similar topics. So I am going to say yes to this one.
 
Thread starter Similar threads Forum Replies Date
U Run & rate for bulk materials IATF 16949 - Automotive Quality Systems Standard 6
D Sample Sizes for 'Bulk' Fluids/ Materials (Polymer Synthesis Process) Design and Development of Products and Processes 1
S Batch Traceability for Bulk Materials which are mixed in the Storage Tank IATF 16949 - Automotive Quality Systems Standard 6
J Acceptance Sampling for Bulk Materials - Anyone knowledgeable about ISO 10725? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Bulk Materials PPAP - Is resubmission needed at line change APQP and PPAP 10
P Raw materials as bulk materials (polymer, adhesive, etc) for PPAP IATF 16949 - Automotive Quality Systems Standard 1
K PPAP Requirements for Raw / Bulk Materials? APQP and PPAP 6
N "Bulk Materials Requirements Checklist" example request APQP and PPAP 1
P Bulk Materials PPAP / FMEA - Appendix F of the PPAP manual APQP and PPAP 1
Jim Wynne 4th Edition PPAP manual - Bulk Materials - Can you guess what this means? APQP and PPAP 12
S Is ppm calculation valid or invalid for bulk materials? IATF 16949 - Automotive Quality Systems Standard 4
V Customer Notification - Bulk Materials APQP and PPAP 2
T PPAP Appendix F.3 "Customer Plant Connection" - Bulk Materials - Steel Coil Supplier APQP and PPAP 4
J Bulk Materials Checklist form - 3rd Edition PPAP Manual APQP and PPAP 3
N What are bulk materials? APQP and PPAP 1
S The perils of Bulk Packaging Customer Complaints 5
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Environmental Monitoring for Biopharmaceutical Manufacturing of Bulk Drug Substances Other ISO and International Standards and European Regulations 1
S Electronic (.xls or other) Bulk Material Checklist wanted APQP and PPAP 1
C PPAP Submissions for Thermoplastic Resins (Bulk Material) APQP and PPAP 3
G TS 16949 applicability for Bulk Material Product IATF 16949 - Automotive Quality Systems Standard 25
J Canada Bulk Packaging and IFU requirements for Class IIa and IIb Medical Devices Canada Medical Device Regulations 2
P Bulk Material Requirements Checklist to send along with my PPAP APQP and PPAP 2
D How is transport of Dangerous Goods (limited quantity) regulated for Bulk Transport? RoHS, REACH, ELV, IMDS and Restricted Substances 9
D Bulk Material Supplier Control Plans APQP and PPAP 2
0 Sample divider for PET flake bulk samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
R Is AQL sampling plans applicable for Bulk Pharmaceutical Manufacturing (API)? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M For Bulk Material (eg. paint), are there any guidelines for Ford PPAP Requirements? APQP and PPAP 1
N Can I get a PPAP sample of Bulk Material (Plastic Resin)? APQP and PPAP 2
J We anneal aluminum tube (tier 2, bulk material) - Does CQI-9 apply to us? IATF 16949 - Automotive Quality Systems Standard 4
Q Level of PPAP - Bulk Chemicals Supplier Requirements APQP and PPAP 2
C ISO 27001 and Bulk Email Policy - Your Thoughts, Please IEC 27001 - Information Security Management Systems (ISMS) 3
A Are Steel & Resin Suppliers Bulk Material Suppliers - TS 16949 PPAP APQP and PPAP 6
N Re-Packaging and Re-Labeling Bulk Lots of Class II Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Incoming Inspection AQL Sampling of Bulk Textiles AQL - Acceptable Quality Level 3
S Gamma Sterilization: Change in Bulk Density vs. Revalidation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Gage R&R procedure for Bulk Chemicals Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
O Bulk Material PPAP - Design Matrix instead of a normal Design, Production FMEA APQP and PPAP 3
G Setting up realistic Quality Objectives - Bulk Material Handling Quality Manager and Management Related Issues 4
B Unregistered Bulk Scrap Metal Suppliers - Do they need to be ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 10
A Calculating PPM for bulk-type product Statistical Analysis Tools, Techniques and SPC 1
Casana Detection level in PFMEA (Process FMEA) - Bulk Fluids FMEA and Control Plans 10
P Small parts trouble Kanban - Problems with the common small/bulk parts Lean in Manufacturing and Service Industries 8
M Bulk Class II product sale to kit packers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Bulk Material PPAP (Resin Suppliers) APQP and PPAP 3
G Bulk Material Sample Standard Retention APQP and PPAP 2
D Bulk Suppliers - Design FMEA Required? Aluminium ingots FMEA and Control Plans 10
R Bulk Material PPAP for PCB shop? What would be considered as bulk material? APQP and PPAP 5
M Calibration of Bulk Tank with Scale - Operating capacity is 3400lbs General Measurement Device and Calibration Topics 20
D cGMP and Batch Integrity of Bulk Storage Tanks US Food and Drug Administration (FDA) 8

Similar threads

Top Bottom