Approved Vendors List - Excluding office supplies, housekeeping services, consulting

J
#1
Humble and other opinions requested.

It is my plan to create a Approved Vendors List for:
"all vendors supplying materials effecting the quality of products manufactured for sale."

This list would not include office supplies, housekeeping services, consulting services, etc.

Will this fly with the auditors?

Regards

James
 
Elsmar Forum Sponsor
#2
Depends on your auditor and how your list indicates approval. I use an approved vendors list, but not once has an auditor asked for it. An approved vendor list, in itself, is not a requirement.
Subcontractor development and subcontractor evaluation is a requirement. Your vendors should be approved based on development of there quality system and a rating system.
 

barb butrym

Quite Involved in Discussions
#3
Are consultants critical commodities? Some are, some not...LOL.

Most MRP systems have a module that allows a field for Approval codes, which works nicely...and doesn't add a new thing/list to control. Sam is correct........the approval plan and records are much more important than the format of a "list'...although sometimes a list is the auditor friendly way to go.........but tends to be a useless activity....who actually pulls out a list every time they buy something???
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Re: Approved Vendors List

JRKH said:

Humble and other opinions requested.
It is my plan to create a Approved Vendors List for:
"all vendors supplying materials effecting the quality of products manufactured for sale."
This list would not include office supplies, housekeeping services, consulting services, etc.
Will this fly with the auditors?
Regards

James
James,

This is exactly what I've done. So far, no customer auditors have complained. Registrars? From what I see they can be a tough bunch to predict. Common sense would say it should be okay, but some Cove members seem to have run into some auditors who seem to have no common sense. I'd go with it and make them explain why it isn't okay if they ding you.

Mike S.
 

E Wall

Just Me!
Super Moderator
#5
That is what we do too

Additionally we categorize the suppliers based on classification:

Following are six classifications utilized for categorizing suppliers:

5.1 Class I
Parts or subassemblies made to Company X drawings and/or specifications, which if defective, may cause equipment failure or malfunction when used in Company X end item products.

5.2 Class II
Services used which, if incorrectly applied or performed, may contribute to failure or malfunction of affected Company X end item products.

5.3 Class III
Raw materials, which are used as basic materials in the fabrication of Company X battery cells.

5.4 Class IV
Materials, parts and services that are considered non-critical to end product performance or are certified as conforming to established industry standards.

5.5 Class V
Chargers and peripheral equipment which can directly affect the performance or life of Company X cells and/or batteries.

5.6 Class VI
Resin/material suppliers for resin/material specific to Company X Products.
 
#6
Approved vendor list

Everything I've heard (read) so far sounds good, but I would like to remind you that there is no requirement for an approved vendor list.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
Re: Approved vendor list

db said:

Everything I've heard (read) so far sounds good, but I would like to remind you that there is no requirement for an approved vendor list.
_____________________
db,

You're right of course, 9001-2000 doesn't say "make an approved vendor's list". However, I think James looks at an AVL as a way of meeting 7.4.1 which is certainly one way to skin that cat.

9001-1994 says in 4.6.2c "establish and maintain quality records of acceptable subcontractors" and I think the majority of companies decided an AVL was the best way to satisfy this requirement. Therefore, anyone transitioning from 1994 to 2000 would probably at least consider keeping the AVL or using it because it is familiar.

I think the statements in both standards about the "extent of control...dependent on the effect of the purchased product" etc. on your products gives you the option to exclude things like office supplies, cleaning services, or a consulting service. However, if the auditor balks at complete exclusion or one is nervous about doing that, perhaps you could put a "weasel statement" in your document something like "vendor control for the following goods/services, which have little or no impact on XYZ's products, shall be limited solely to the real-time decision of the Purchasing Department for each purchase order based on their knowledge and experience and requires no formal record-keeping".

Anyone see any holes?

Mike S.
 
#8
AVL

Mike I agree that an AVL is one way (perhaps the best way) to achieve control over suppliers. Notwithstanding that, I would never argue with James. Afterall he is within easy B-17 distance to Detroit. :biglaugh:
 
J
#9
Thanks everyone for your input.
At this point I beleive I'll look at dropping the AVL altogether. We have our approved vendors in a comuter database, and as others have pointed out I just need some verbiage to clear up the extent question. Something like Mike's idea.

db: I'd never bomb Detroit.....It's the home of Motown......
YYYAAAAYYYY 60's music...... Peace Bro'. :bigwave:


James:vfunny:
 
Thread starter Similar threads Forum Replies Date
S How to get calibration vendors (manufacturers in particular) approved without 17025 ISO 17025 related Discussions 8
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
Ajit Basrur Why is ISO 14644-3:2019 not approved by US? Other Medical Device Related Standards 1
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
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
Kuldeep Singh Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
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
D Document review on already approved registrations requested by China's NMPA? China Medical Device 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
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
J Change management with CFDA approved devices China Medical Device Regulations 1
J Dr Training Records - Training doctors to use a PMA approved medical device Other US Medical Device Regulations 2
L CQI & IRCA not accepting new applications for ATPs (Approved Training Partner) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
I Adverse Event Reported during Non-Approved Indication Use EU Medical Device Regulations 4
F Scientific and Research Papers for Foreign Approved Devices Other US Medical Device Regulations 1
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J FDA approved Medical Devices for PVD and DLC Coatings US Food and Drug Administration (FDA) 2
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
J Why Control Plan Review needs to be Approved by the Customer IATF 16949 - Automotive Quality Systems Standard 1
F China Medical Device Labeling - Not approved for use, is for an exhibition EU Medical Device Regulations 4
S API Q1 Approved Training & Professional Certification Sources Oil and Gas Industry Standards and Regulations 5
gunnyshore Benchmarking: Approved Supplier List for Multiple Sites Supplier Quality Assurance and other Supplier Issues 2
S Why Drugs and generics are Approved while Biologics are Licensed ? US Food and Drug Administration (FDA) 1
L Do HR consultants need to be on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 5
M Making a change to an approved Medical Device Other US Medical Device Regulations 9
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Investigational Device Exemption approved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Do Machine Service Contractors Need to be an Approved Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Can I ship Demo Units to the UAE if we are not Approved? Other Medical Device and Orthopedic Related Topics 2
J PT/ILC - No Approved Programs within our Scope of Accreditation General Measurement Device and Calibration Topics 2
Q Is there an Approved Pigment List to be used in Medical Devices ? US Food and Drug Administration (FDA) 8
S Mexico: Paths to approval for product that is CE-marked, but not FDA approved? Other Medical Device Regulations World-Wide 2
S AS9100 Approved Supplier List (ASL) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
V Variations - Changes to Approved Dossiers - Drug Product US Food and Drug Administration (FDA) 0
P PSU Transformer Tests Approved to IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
N Which Suppliers Belong on my AVL (Approved Vendor List)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
N TGA CA Certificate approved suppliers ISO 13485:2016 - Medical Device Quality Management Systems 3
B API approved Auditors in India Oil and Gas Industry Standards and Regulations 3
R Terminology for referring to a product that has an approved Technical File EU Medical Device Regulations 3
S Can the Management Manual have only Issued and Approved By? Quality Manager and Management Related Issues 12
K Method to qualify COTS Suppliers into AVL (Approved Vendor List) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P Documents Approved via Email Records and Data - Quality, Legal and Other Evidence 7
I Advice Needed For EASA Approved Aircraft Mod EASA and JAA Aviation Standards and Requirements 1

Similar threads

Top Bottom