Bulk Materials PPAP / FMEA - Appendix F of the PPAP manual

P

philstunell

#1
Appendix F of the PPAP manual specifies alternative rating scales for assessing 'non conformance' in bulk materials supplied which may be used to calculate the RPN and develop / review the process control plan.

The table for Occurrence Ratings refers to -

High - repeated failures
Moderate - occasional failures
Low - relatively few failures

These definitions are not quantified or related to the capability of the production process providing the bulk materials - so how would you interpret them?

Should they be referenced to a specified failure rate or level of process capability?

Phil
 
Elsmar Forum Sponsor

Jim Wynne

Leader
Admin
#2
Re: Bulk Materials PPAP / FMEA

Appendix F of the PPAP manual specifies alternative rating scales for assessing 'non conformance' in bulk materials supplied which may be used to calculate the RPN and develop / review the process control plan.

The table for Occurrence Ratings refers to -

High - repeated failures
Moderate - occasional failures
Low - relatively few failures

These definitions are not quantified or related to the capability of the production process providing the bulk materials - so how would you interpret them?

Should they be referenced to a specified failure rate or level of process capability?

Phil
I think that the whole bulk materials section of the PPAP manual was provided as an afterthought, more or less, just to provide some way of documenting bulk material processes. You should first check to see whether your customer has a preferred method, but in the absence of customer mandates you're free to do whatever works for you. The terms given in the manual--repeated, occasional, relatively few--are all relative, and there is no one-size-fits-all scale.
 
Thread starter Similar threads Forum Replies Date
B Bulk Materials (Lead {Pb} Alloys) PPAP Requirements APQP and PPAP 5
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
Jim Wynne 4th Edition PPAP manual - Bulk Materials - Can you guess what this means? APQP and PPAP 12
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
D Bulk Materials (Greases) and IATF 16949 IATF 16949 - Automotive Quality Systems Standard 11
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
N "Bulk Materials Requirements Checklist" example request APQP and PPAP 1
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
N What are bulk materials? APQP and PPAP 1
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
C Bulk Record Retention Review Records and Data - Quality, Legal and Other Evidence 4
S How to upload data in bulk on EUDAMED? EU Medical Device Regulations 13
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

Similar threads

Top Bottom