When does containment event not require 100% sort?

gtr01

Registered
#1
Greetings,

I am a QE that has transitioned from a IATF Tier 1 to a Tier 2 and we make a single components to send to a tier 1 assembly facility. Our process produces an incomplete part every 10000 cycles, and have issues with them escaping to customer. Our process shows satisfactory capability and excellent PPM, however customer still demands 100% sort all parts made when they receive defect. Sorting 50000 parts (typical batch size) for an unfinished part seems unnecessary granted extremely low possibility that defect can occur.

Is it reasonable to push back on these demands for 100% sorts and put more pressure on the customer to provide statistically relevant data to justify such a sort?

Any feedback is appreciated.

Greg
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Leader
Admin
#2
Is it reasonable to push back on these demands for 100% sorts and put more pressure on the customer to provide statistically relevant data to justify such a sort?

Any feedback is appreciated.
Customers are not always right, but they are always the customer. Can you dialogue with the customer? Can you explain that the sorting process costs are eventually (most likely indirectly, obviously) passed on to them? Can you assess from both organizations' perspectives that it is more cost efficient (for the business relationship) to live with a 100 DPPM rate? Until both organizations agree that the current performance is acceptable from both a quality and cost perspectives, any unilateral attempt for you to use statistics to convince the customer is wrong will likely backfire.

Good luck.
 
#3
possibility to check with customer on their quality acceptance limit. There must be a reason they are rejecting the lot( batch).
 

optomist1

A Sea of Statistics
Super Moderator
#4
Hi gtr01,

"however customer still demands 100% sort all parts ...", how is or are these demands documented, a performance spec, what does your PO state and what was originally specified (source package or RFQ)...and your firm quoted?

Cheers,
Optomist1
 

PaulJSmith

Quality Jerk
#5
I have seen acceptance of as much as 15% incorrect parts in the aerospace industry, and have also seen automotive customers who see one NC part and want someone to fly to their location for a 100% sort on their dock. Every customer will have different expectations of their suppliers, and it usually depends on the criticality of the part.

It's best to talk with your customer and work out a solution that's reasonable for both parties. If their documented requirements state 100% sort on this particular part, then you're probably stuck with that, and should do it before it leaves your facility.

It's also possible that such a requirement was simply a copy/paste from a previous spec, and may not actually be necessary for that part. An open dialog with them may get that changed to something more reasonable and cost-effective for both.

Talk with your customer.

Also, if you know you're having an escape issue, you need to deal with that internally.
 

Matt's Quality Handle

Involved In Discussions
#6
Customers are not always right, but they are always the customer. Can you dialogue with the customer? Can you explain that the sorting process costs are eventually (most likely indirectly, obviously) passed on to them? Can you assess from both organizations' perspectives that it is more cost efficient (for the business relationship) to live with a 100 DPPM rate? Until both organizations agree that the current performance is acceptable from both a quality and cost perspectives, any unilateral attempt for you to use statistics to convince the customer is wrong will likely backfire.

Good luck.

What is the impact of an incomplete part at your customer's facility? Does it create downtime for them? Is it a pass through that they have no opportunity to detect, but could cause functional problems with THEIR customer?

In short, this is the default mode for the customer. Likely to move them off this position will require cooperation, not a statistical proof.

If I were your SQE, some questions that I would ask of you are:
  • What causes this? How do you know?
  • How do you know the defect rate won't get worse?
  • What are you doing to improve the process? When will it take effect?
 
Thread starter Similar threads Forum Replies Date
Raffy Preventive Action - Does generating an FMEA help future containment? Preventive Action and Continuous Improvement 2
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 0
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 0
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
M How does FDA determine OAI and VAI after inspection? ISO 13485:2016 - Medical Device Quality Management Systems 0
G Does TPI agencies comes under outsourced process as per Q1 Oil and Gas Industry Standards and Regulations 11
N FPY requested for an industry that does not have rework IATF 16949 - Automotive Quality Systems Standard 4
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
Ajit Basrur Does "Refurbishment" fall under "Service"? ISO 13485:2016 - Medical Device Quality Management Systems 13
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
T What does VW mean by annual requalification? Customer and Company Specific Requirements 4
I Does BSI require suppliers to be ISO 9001 Certified? EU Medical Device Regulations 12
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
M Does 4.5 - Alternative RISK CONTROL apply to the Particular Standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
D What does a level 1 (PSW) PPAP actually promise? APQP and PPAP 19
R GS1 DataMatrix code does not meet GS1 Specification EU Medical Device Regulations 0
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Why does load cell supplier requires force verification General Measurement Device and Calibration Topics 3
M Does C=0 strictly mean 1 bad, all bad, all the time? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 6
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
M What does "constantly" mean ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
G Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely? Document Control Systems, Procedures, Forms and Templates 1
B Does FDA Registration QSR need to cover non-medical devices for contract repackager? US Food and Drug Administration (FDA) 1
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
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom