Approved Supplier Control Requirements for Outsourced Special Processes

D

Daizes4me

#1
How much control do I need to have if I send my product out for special processes to an aoproved vendor.
 
Elsmar Forum Sponsor
C

Chance

#2
Re: special processes

I don't know what you mean by "special processes". Why are you sending your product? For additional assembly? I guess there is no enough detail to assist you. Please explain further. Thanks.
 
D

Daizes4me

#3
Re: special processes

Sorry about that I am talking about heat treat and plating special processes.
 
C

Chance

#4
Re: special processes

Sorry about that I am talking about heat treat and plating special processes.
Thanks for the clarification. I would hope that other Covers can provide the very detail of what you need.
IMHO, you would need to know the standard operating procedures from that vendor. Evaluate and see if they fit your needs. If not, you might want to give them your specific requirements, have them understand what you expect from them and see if they can meet your needs or not. Proper documentation of this is necessary to cover each other's side in case there is an issue that may arise. I hope this helps.
 

somashekar

Staff member
Super Moderator
#5
How much control do I need to have if I send my product out for special processes to an aoproved vendor.
Since you say approved vendor, I gather that he knows your heat treatment and plating requirements and has the capability and ability to do them consistently meeting your requirement (he or you or both have validated this heat treatment and plating process does meet the requirement)
You have done a base control already:
Now:
How much control ~~~
1) Get your vendor to certify that the process validated and established has been followed for every batch processed and supplied.
2) Audit his process periodically, if need be, based on an agreement set earlier for this
3) Use a 3rd party lab to sample test a random sample periodically
4) Agree that the source informs of any changes that are out of his control to identify what and how a re-validation must be planned and performed.
5) Use a source who has a QMS implemented and maintained so that he understands and responds to validation and change requirements.
All or a combination of the above can be your controls (The extent of control depends upon the requirement of the outsourced process)
 
Thread starter Similar threads Forum Replies Date
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
Q Approved Supplier List - Control in the same way forms and procedures are? Supplier Quality Assurance and other Supplier Issues 5
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
gunnyshore Benchmarking: Approved Supplier List for Multiple Sites Supplier Quality Assurance and other Supplier Issues 2
L Do HR consultants need to be on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 5
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Do Machine Service Contractors Need to be an Approved Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S AS9100 Approved Supplier List (ASL) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Do I need to approve my Registrar and include them in the Approved Supplier List? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Corrective Action - AS9100 Approved Supplier List Audit Nonconformance Nonconformance and Corrective Action 14
S Trading Company - Evaluating Supplier Performance and Approved Supplier List ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Approved Vendor (Supplier) List and Supplier Evaluation Supplier Quality Assurance and other Supplier Issues 16
P Requirements for an Approved Supplier List? No new suppliers in years ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q AS9100 Clause 7.4.1 Purchasing Process and Approved Supplier List Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
P Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
D Do Freight Carriers or Transportation Companies need to be an Approved Supplier? Supplier Quality Assurance and other Supplier Issues 14
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
N Acceptance of Supplier to AVL (Approved Vendor List) - How long? Supplier Quality Assurance and other Supplier Issues 9
D Approved Condom-Benzocaine Supplier name - Need Help ISO 13485:2016 - Medical Device Quality Management Systems 6
D What document do you give to your supplier after approved parts? Supplier Quality Assurance and other Supplier Issues 12
L Approved Supplier List - Customer Approved Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
GStough Approved Supplier List (ASL): Document or Record? Supplier Quality Assurance and other Supplier Issues 29
R Approved Vendor (Supplier) List contain Vendor Evaluation? Supplier Quality Assurance and other Supplier Issues 6
C Approved Supplier? When supplier is no longer in business. Supplier Quality Assurance and other Supplier Issues 7
B What happens if we evaluate supplier as not approved and there are no anothers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
J Approved Supplier List - Required to evaluate every supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Required to put original manufacturers on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 6
M Approved Supplier List ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 43
V How to become approved supplier by Sikorsky Helicopter? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Approved Vendor (Supplier) if Customer Pays Sub-tier Shipping Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I Approved Supplier List - R & D, Capital Equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
I Which Fringe Suppliers to Include in the Approved Supplier List? ISO 13485:2016 - Medical Device Quality Management Systems 11
D How can a vendor (supplier) with no third party certification be approved? Supplier Quality Assurance and other Supplier Issues 1
Z Supplier of Automatic Gaging Systems need to be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 6
B Approved Supplier List for Transportation (Trucking) and other Services IATF 16949 - Automotive Quality Systems Standard 5
Q Do I have to qualify my approved vendor (supplier) status? Supplier Quality Assurance and other Supplier Issues 2
H Approved Supplier Listing - One time purchase? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
ScottK ISO9001 Approved Supplier List format question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Approved Supplier List vs. Auctions - One-Time Equipment Buys ISO 13485:2016 - Medical Device Quality Management Systems 8
M Grandfathering suppliers to approved supplier list - Have to send out surveys? Supplier Quality Assurance and other Supplier Issues 11
C Approved supplier/vendor - How do I approve my Registrar? Supplier Quality Assurance and other Supplier Issues 17
P Seeking: Approved Supplier (Vendor) Log Example Supplier Quality Assurance and other Supplier Issues 35
D Approved Vendor (Supplier) List Issues - Class II medical device maker Supplier Quality Assurance and other Supplier Issues 2

Similar threads

Top Bottom