Interim Approval

D

Douglas E. Purdy

#1
Have an automotive customer who is requiring a Level 3 PPAP for a tooling rebuild, while at the same time wanting to meet the current delivery requirements. Due to the number of Special Characteristics they want for Capability Studies we are not able to turn in a complete PPAP Submittal in the time needed to get production running.

My questions are:

1) How do you submit a PSW for an Interim Approval when not all of the items are completed?

2) Is there an alternative way to meet both production requirements and PPAP requirements in this situation?

Thanks for any recommendations you may give!

------------------
 
Elsmar Forum Sponsor
L

Laura M

#2
Re question 2 - that's exactly what the interim allows you to do.
When you fill out the interim worksheet you note the exceptions to "full" PPAP and what you are doing to ensure the product you are shipping. In other words, if because you did not do a full capability study, you do not (may not) know if your process is capable of producing with a 1.67 Cpk - to "guarantee" you will meet the spec. So you may add inspections, or 100% sorting for the product you ship.

Have you seen the worksheet? Fairly self explanatory. Submit what you have for PPAP with the interim documenting the exception. The B3 are used to it!
 
#3
Maintain contact with your customer on this one.
Also refer to section II of the PPAP for interim approval requirements.
 
D

Douglas E. Purdy

#4
I only see a GM Interim Recovery Worksheet (GM 1411) in Section 2 of the PPAP. Diamler-Chrysler talks about an Interim Approval Authorization (IAA) document and Ford has other requirements. I do not see a worksheet generic for all three - OR am I missing something?

[This message has been edited by Douglas E. Purdy (edited 24 July 2000).]
 
Thread starter Similar threads Forum Replies Date
M Can I release an "Approved PPAP" if one purchased component has a Interim Approval APQP and PPAP 2
V Repercussions for Interim Approval of Supplier PPAP's APQP and PPAP 3
V Can I get Full PPAP approval when some components are at interim approval? APQP and PPAP 12
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
M FDA News FDA Safety communication – Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings Medical Device and FDA Regulations and Standards News 0
S PPAP Levels compared to Interim Class APQP and PPAP 1
G Interim Control Plans FMEA and Control Plans 6
D FDA Guidance on Interim Use of ISO13485 for Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
M Supplier PPAP for Interim Materials - Oil to test functionality of finished product IATF 16949 - Automotive Quality Systems Standard 4
G Interim PPAP Guideline and what Documents are Needed APQP and PPAP 3
W Gage Block Interim Test Guidance General Measurement Device and Calibration Topics 5
S SFDA Regulation of Medical Device Recall (Interim) - MOH decree No. 82 China Medical Device Regulations 1
R Interim Stages of Medical Device Manufacturing Production ISO 13485:2016 - Medical Device Quality Management Systems 4
M 8D timing questions and Interim Action Response Manufacturing and Related Processes 6
A Receiving a 'Major' (Hold Point) during an Interim Assessment Registrars and Notified Bodies 5
A Interim PPAPs - Is this normal for GM, triplication of paperwork? APQP and PPAP 2
K ISO DIS 9001:2000 - Interim Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
J Standards Australia releases Interim 9000-2000 series ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
B SN95 Respirator Approval Information Other Medical Device Related Standards 0
P Notified Body Approval of Change EU Medical Device Regulations 2
Marcel DS GOST-R (Type approval for Vehicles in Russia) Other ISO and International Standards and European Regulations 0
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
O Radio modular approval in Brazil Other Medical Device Regulations World-Wide 2
O Radio Modular approval in China China Medical Device Regulations 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
F How to fill out an Appearance Approval Report (AAR) APQP and PPAP 0
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Production approval testing - Alternative ideas for Validation Reliability Analysis - Predictions, Testing and Standards 4
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
I Question 1 - Nitpicking on Document Approval - can a document approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
C AS9145 Appendix D PPAP Approval Form APQP and PPAP 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
D ROW Approval Matrix Other Medical Device Regulations World-Wide 2
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Can Brazil approval be used for other countries in Latin America? Other Medical Device Regulations World-Wide 2
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
S NADCAP approval for Conventional Machining and Chemical processes - need assistance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
DuncanGibbons FAA approval of articles (PMA, TSO) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
M Criteria and when to carry out Setup Approval Manufacturing and Related Processes 5
D Engineering Drawing Review and Approval Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K ISO 9001 Requirements for Raw Material Supplier Assessment and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8

Similar threads

Top Bottom