SBS - The best value in QMS software

Supplier related drawings and verification of process requirements - Source Inspection

#1
Good morning. I have a key supplier for multiple buy items. The supplier says they cannot provide drawings because some are NRE or they are contractually bound from another customer so that they cannot release them to us. Are they in violation of an AS9100 standard? The items will be source inspected where apparently SQA will be allowed to review the drawings there. However one item is a specific CLIN deliverable for government source inspection at our facility. How can I sell off an item without a drawing for them to review? Any inputs would be greatly appreciated.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Are they in violation of an AS9100 standard?
Nope. They could be in violation of a contractual requirement IF your organization had contractually required them to provide the drawings, but, apparently, you did not. Your organization did not do a very good job at complying with AS9100D 8.4.3a)

However one item is a specific CLIN deliverable for government source inspection at our facility. How can I sell off an item without a drawing for them to review?
Easy: have the government source inspector performing the inspection at the supplier's facility. Apparently they don't object to outside inspectors having access to the drawings, as long as the inspection is done at their premises and they maintain control over the drawings.
 
#3
Thanks but the government said they cannot support that request.

A contract/subcontract SOW is in the process of being generated with drawing requirements. They are taking exception to this.
 
Thread starter Similar threads Forum Replies Date
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
K Which clause would best fit this Nonconformance? (Supplier Related) Internal Auditing 2
B ISO 14001:2015 Aspects and Impacts: Haze occurrence (Supplier related) ISO 14001:2015 Specific Discussions 3
T AS9100 and related AS9102 Supplier First Article Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
H FDA Site generic Supplier Related forms help needed ISO 13485:2016 - Medical Device Quality Management Systems 2
J Supplier not responding to PPAP request APQP and PPAP 5
D Supplier audit Medical Device and FDA Regulations and Standards News 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
John Broomfield Five ways to botch your supplier management program Misc. Quality Assurance and Business Systems Related Topics 7
C Supplier survey - 200 to 250 duppliers Supplier Quality Assurance and other Supplier Issues 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Supplier protocol for the Quality Supplier Quality Assurance and other Supplier Issues 6
A API Spec Q1 Purchasing Process - Supplier Reevaluation based on Supplier Risks 5.6.1.4 Oil and Gas Industry Standards and Regulations 17
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
G Supplier doesn't share drawings IATF 16949 - Automotive Quality Systems Standard 15
S Use of raw materials by two supplier CE Marking (Conformité Européene) / CB Scheme 2
D Are Supplier Quality Agreements Quality Records ? Other Medical Device Regulations World-Wide 9
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
G Supplier doesn't accept the complaints Supplier Quality Assurance and other Supplier Issues 20
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? 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
M SemaTech SSQA Standardized Supplier Quality Assessment - my favorite tool ever Manufacturing and Related Processes 1
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
J Supplier Controlled Shipping (GM CS1) Condition Manufacturing and Related Processes 3
L Supplier within the Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Supplier Quality - How to classify a supplier level Medical Device and FDA Regulations and Standards News 10
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
M How Supplier Capacity check is done by competitors Manufacturing and Related Processes 0
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
M Supplier Audits - Stop Wasting Everyone's Time! General Auditing Discussions 15
G Supplier management when the supplier is your headquarter IATF 16949 - Automotive Quality Systems Standard 3
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
J Minimum Supplier Certifications for Food Supplements Food Safety - ISO 22000, HACCP (21 CFR 120) 4
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom