Approval for tool suppliers

Ninja

Looking for Reality
Trusted Information Resource
#21
Best validation I've ever seen is using it and seeing if it works...which is what you're doing...
"The organization doesn't have defined criteria for tool verification."
Sounds like the definition was not communicated to the auditor...
 
Elsmar Forum Sponsor

kuyakut

Involved In Discussions
#22
In approving tools we always start with First Of Tool (FOT) Testing. Samples will be measured corresponding to the 2D drawing.
During FOT , tester need to check the mechanical, electrical and hydraulic ( if applicable) aspect of the mold.
If the acceptance criteria pass, a tool buy off checklist / report will be generated, this signifies the tool is approved and ready to transfer to the production floor.
 
#23
I think that auditor finding was that you don't have written procedure how to release tool supplier and you don't have any evidences that existing supplier was validated.
At my company we have same situation but with machining tool supplier which can also be some trading company.
IATF point 8.4.1.2. and 8.4.2.5.
My question is - do we need to perform an audit at tool maker or at trading company?
 

Evelyn7E

Starting to get Involved
#24
Hello,

I need support regarding approval for tool suppliers for injection molding process.
During last audit, auditors requested to create a procedure how to verify and approve tool/ part (for injection molding) and to specify criteria for tool suppliers.
In most cases we provide only 3D model to tool supplier and they take over the job.

Thank you in advance.

Gefufna,

The most effective way is to request Production Part Approval Package from supplier to show that the process output comply to requirement in drawing and all process input are being evaluated.
 
Thread starter Similar threads Forum Replies Date
A One of APQP Process Steps - OTS (Off Tool Sample) Approval APQP and PPAP 1
D Tool Approval Process - Should we be using Cmk for tool validation Statistical Analysis Tools, Techniques and SPC 6
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Aftermarket product PPAP approval IATF 16949 - Automotive Quality Systems Standard 1
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
S Customer audit report review and approval ISO 13485:2016 - Medical Device Quality Management Systems 3
Z PSW approval process for production IATF 16949 - Automotive Quality Systems Standard 2
S Can the Registrar add an Observer without client approval? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Record approval- Signatures required ISO 13485:2016 - Medical Device Quality Management Systems 4
D State-by-State Approval Medical Device and FDA Regulations and Standards News 1
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
M Approval of Calibration Certificates General Measurement Device and Calibration Topics 1
Crusader AS9100 7.5.2 NOTE Approval methods identified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
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 Can a document (form) 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 3
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 18
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

Similar threads

Top Bottom