Is 'Supplier Part Batch' a Root Cause - No Receiving Inspection

Bev D

Heretical Statistician
Staff member
Super Moderator
#11
Ah - but this happens with frightening regularity...the feature that is at the root of a defect or functional failure is often NOT specified on a drawing OR is not toleranced correctly. (After all there are thousands of features - geometries, properties, etc. - that go into any system and not all of them are identified and characterized resulting in engineered tolerances)

In these cases you will find defects/failures cased by a feature that a supplier creates and yet all specified tolerances on the drawing are met. The supplier is NOT responsible, you are. You must do the work to determine what the correct tolerances are for the feature in question and change the drawing. This can mean a price increase but such is life.
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Staff member
Super Moderator
#12
Ah - but this happens with frightening regularity...the feature that is at the root of a defect or functional failure is often NOT specified on a drawing OR is not toleranced correctly. (After all there are thousands of features - geometries, properties, etc. - that go into any system and not all of them are identified and characterized resulting in engineered tolerances)
Totally agree. There is a distinct economical drive to launch a product, be first to market, whatever. This is totally necessary, of course, since the perfectly designed and toleranced product that has been through every concievable test for failure modes would hit the market about 10-50 years after the market has dried up.

All the same, when production takes a serious hit like "this batch doesn't work and we don't know why" the root cause has to be found so that it doesn't keep happening.

You roll the dice on launch (everybody does to some degree or other). When you lose the bet, prtect yourself from losing the same bet twice (or 50x)
 
Thread starter Similar threads Forum Replies Date
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
R Utilizing supplier 510(k) as part of medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
G AS9102 Design Supplier Part Number vs. Customer Part Number AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Supplier Part Qualification for a Medical Device Company Supplier Quality Assurance and other Supplier Issues 4
S Supplier Quality with Prototyping Parts with no Part Number or Drawings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Who in the supplier organization has to sign the PSW (Part Submission Warranty)? APQP and PPAP 6
C SCAR (Supplier Corrective Action Request) as part of NC/CAPA? Nonconformance and Corrective Action 3
I Supplier Using Reference Part for PASS/FAIL Inspection Supplier Quality Assurance and other Supplier Issues 8
T Can an Automotive Supplier require an IMDS # for a Non-Automotive part? RoHS, REACH, ELV, IMDS and Restricted Substances 7
S Material Supplier Part Submission Warrant (PSW) APQP and PPAP 2
F Who should Sign Supplier PPAP (Production Part Approval Process) documents? APQP and PPAP 13
I Must Quality Incoming fill the checksheet for checking the Supplier part, In ISO TS? IATF 16949 - Automotive Quality Systems Standard 5
M Toyota Supplier "Pulse Rate" Evaluation - Is this document part of the Toyota SQAM? Customer and Company Specific Requirements 4
P Definition Dock-to-Stock Process based on Historical Quality Performance of a Part and Supplier Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
P Part Identification question - Supplier's identification on the box ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Calibration required? We buy part of our machined parts - Supplier gage calibration? General Measurement Device and Calibration Topics 6
S Dock Audits as part of Supplier Containment Action Nonconformance and Corrective Action 3
G Part Numbers and Qualified Suppliers - Put supplier name in the actual drawing sheet? Document Control Systems, Procedures, Forms and Templates 4
A Customer not willing to reveal the usage or function of the part to the supplier Philosophy, Gurus, Innovation and Evolution 18
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

Similar threads

Top Bottom