Non-conforms or prescribed issue

A
#1
:) Welcome all!
As I can see on the formum there are a lot of experiences so hope that sombody help me in this way.
I'm QE in Automotive and have a problem with the claim: some parts was produced 2 years ago last time and will not produce any more. My customer found the defect on a few samples and charge us of costs and ... ppm! Some action plan? - I don' think so! And is there any explanation in quality specification to cancel this item or maybe we should agree with this matter????

:read: WHat is the best solution? Please help!
 
Elsmar Forum Sponsor
D

D.Scott

#2
First: Welcome to the Cove.

I feel this will depend on the agreement you have with this customer. If you did make the parts and they are really bad, then does the customer have the right to charge back on them? I would have thought 2 years is a little too long to hold the parts with no action but if they are a good customer then you may have to eat the cost. After all, you did make the bad parts in the first place. I don't know of an expiration for good quality. It either meets the requirements or it doesn't. Some products have a specific shelf or use life and therefore are time sensitive. Without a specific "statute of limitations", I would expect to have to stand behind the quality of my product as delivered to the customer no matter what the period of discovery as long as there has been no agreed time or product life limitation. Just my opinion.

Dave
 

SteelMaiden

Super Moderator
Super Moderator
#3
aleksandra said:
:) Welcome all!
some parts was produced 2 years ago last time and will not produce any more. My customer found the defect on a few samples and charge us of costs and ... ppm! Some action plan? - I don' think so! And is there any explanation in quality specification to cancel this item or maybe we should agree with this matter????

:read: WHat is the best solution? Please help!
What is the risk involved? will the defects ultimately cause loss of life or limb? Can this defect occur on parts produced now? I realize the particular parts are no longer produced, but can similar defects be produced on current parts because of the process itself? What is the cost of the claim? If it is small, is it better to write it off as customer relations? If it is large, is it realistic since they cannot get replacements from you? How many parts were bad percentage wise? You have left more questions than you have asked us here. You need to assess the risk that this claim will have on your company if not resolved to the customer's satisfaction, or if indeed the fault even lies with your company. Do a root cause analysis, do a risk analysis, check to make sure this problem cannot affect current processes and then after you have put it all together, your answers should be clear.
 
A
#4
Thank You all for replies. Of course there are a lot of unclears: the customer is important to us but the parts he claimed I think he stopped the production at that time that he stop the order ( 2 years ago) - he may have big stock...?. The problem is not in costs so much but in ppm level. We are going to improvement our process and system and in case of audits I don't know exactly how can I deal with that. I will try to do all analysis (cause and risk) and will send to him - I'm curious about his opinion.
:magic: Thanks
 

Wes Bucey

Quite Involved in Discussions
#5
aleksandra said:
Thank You all for replies. Of course there are a lot of unclears: the customer is important to us but the parts he claimed I think he stopped the production at that time that he stop the order ( 2 years ago) - he may have big stock...?. The problem is not in costs so much but in ppm level. We are going to improvement our process and system and in case of audits I don't know exactly how can I deal with that. I will try to do all analysis (cause and risk) and will send to him - I'm curious about his opinion.
:magic: Thanks
I'm not completely clear what your customer expects you to do.
  • If he expects you to repair or replace the defective pieces - that's not possible.
  • If you can't repair or replace, he expects you to reimburse him for defective pieces - that's possible, but you have to agree the pieces are defective. Have you seen and inspected sample defective parts?
    If you agree they are defective, you have three options:
    (1) accept the customer's tally without confirmation and pay up;
    (2) send an employee to the customer to confirm the count of defective parts and oversee their destruction and pay up;
    (3) pay to have defective parts shipped back to you for scrapping and pay the customer for the confirmed count.
  • If the customer is continuing to use parts from inventory, it might be reasonable for him to expect you to reimburse for sorting good from bad and scrapping the bad parts in addition to reimbursing for defective parts he paid for.
I'm definitely not sure what he expects in the way of "ppm." I understand ppm to mean "parts per million" which is usually applied to an entire lot or production run based on an inspection or sampling plan performed when the entire lot is available to draw samples from.

Almost any sampling plan you perform this late in the game is fatally flawed because you may never know how many parts were scrapped because workers thought THEY were responsible for damage.

Do you have an idea of how many parts are still in inventory? Does the customer intend to continue using the part or is he discontinuing use? If he is discontinuing for other reasons, it is not quite fair for him to expect you to defray part of his cost of discontinuing by asking you to do anything other than pay for defective parts on a piece by piece basis, especially after a two year delay.

Something just occurred to me: You haven't manufactured the parts for two years. We've assumed the customer had them for two years. Did you sell him old inventory just recently? or has the customer, in fact, had the parts for two years?

Give us the answer to these last two questions - they are important factors here.
 
A
#6
Thank You very much for this explanation. It help me a lot to cocider for plus and minus sides. And the next information: The last production in our company was 2 years ago and the last sale and shippment of these parts was also. I suppose that he want to get rid of this reserves that he ordered that time (may be he stop the delivery of this parts to following customer; the part is assembling with any other semi-products) - I have no informations wat is the application of this parts so I have to get know this one as soon as possible.
To complete my data the parts was only in customer inventory in quantity about 65 000 (the kind of this part is component not fastener) since 2002.
I will send the message to our customer - THANKS TO YOUR THIN OVER :thanx: VERY MUCH :)
Bye
 
Thread starter Similar threads Forum Replies Date
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 0
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B Procedure packs with non-medical devices EU Medical Device Regulations 1
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
G Team to analyze a non conformance Customer Complaints 26
J Promoting and marketing of a non approved device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G 0 non conformities in registrar audits over 4 years Management Review Meetings and related Processes 12
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
P Ppk results shown as asterisk after the transformation of Non-normal data Using Minitab Software 4
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Johnnymo62 Non Aerospace topics - Anything for military trucks, trailers, Humvee type vehicles? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
M Who are the go to companies for non-destructive hardness testing? General Measurement Device and Calibration Topics 3
R Non conformance (NC) or Corrective & Preventive action (CAPA) CE Marking (Conformité Européene) / CB Scheme 7
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 7
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
R MDD x PPE Directive - Statement of Non-Applicability EU Medical Device Regulations 3
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Non-Conformances Found After 3rd Party Sorting Supplier Quality Assurance and other Supplier Issues 12
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
N Competent Authority notification for non-EU manufacturer EU Medical Device Regulations 4
M CE marking for NON-EU EU Medical Device Regulations 0
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
S Non-Conformance and Deviations ISO 13485:2016 - Medical Device Quality Management Systems 4
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
T Ideas for developing a Supplier Quality Management System, non automotive ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
C If it doesn't prevent a non-conformance, is it a preventive action? IATF 16949 - Automotive Quality Systems Standard 13
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
I Non-Conformance vs OFI -- your best descriptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 61
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9

Similar threads

Top Bottom