Dealing with non conformity caused by Supplier Components detected in the production line

Graciel

Involved In Discussions
#1
Hello! I would like to know what's the best approach for dealing with a batch of bad Components that was detected in the production line. Considering a situation that the cause is not known yet, the only thing is that this component is affecting the line efficiency.
For example:
- reject the batch
- change batch
- start investigation (measuring or other)
- call supplier to visit the company
- start selection if you can ,if not return the batch and advise logistic team
Is that good? Or you guys practice different approach?
Thank you.
 
Elsmar Forum Sponsor

silentmonkey

Starting to get Involved
#2
How did you detect the issue in the production line? If practical, I would apply the same detection mechanism on all products on the line to contain the issue. The screening will ensure all products going through the line henceforth will be good product. This will allow your line to keep going and protect the customer while buying you more time to actually investigate the root cause.

You will need to assess the impact of this issue on all products including WIP, released product and product in storage. All of this should be managed in a NC report.
 

Johnny Quality

Involved In Discussions
#3
Graciel,

Your ideas sound like a sensible way to start. I'd swap batches to see if there is any change and if you have the capability to investigate the component in-house then that's also a good thing to do. I would also get in touch with the supplier and ask for their support but not pin any blame, only ask for their support. As you mentioned you don't know the cause and it could very well be out of the suppliers scope of control.

Best of luck!
 

John C. Abnet

Teacher, sensei, kennari
#4
Hello! I would like to know what's the best approach for dealing with a batch of bad Components
Good day @Graciel ;
Below is something I coined years ago titled "the 5C,s of containment". This example was created for supply chain management but can be applied internally in order to ensure no aspect is overlooked. Consider this and/or similar...

When the supplier becomes aware of actual and/or potential nonconforming product, the supplier is required to immediately…
Undertake inspection, segregation, and/or repair of suspect parts using the following “5C” guideline for problem containment and response…

CUSTOMER (Acme) All affected Acme product should be prioritized and immediately contained and verified according to the following considerations….
Does Acme have product at Acme’s customers that is suspect and requires action?
Does Acme have product en-route to Acme’s customer that is suspect and requires action?
Does Acme have finished product at Acme that is suspect and requires action prior to further shipments to Acme’s customer?
Does Acme have WIP that is suspect and requires action?
Does Acme have product in inventories that is suspect and requires action?
Does Acme require immediate replacement of product?

CONTAIN All included affected product that has not been received at Acme…
Does the supplier have product in transit to Acme that is suspect and requires action?
Does the supplier have product on the shipping dock (prepared for transit to Acme) that is suspect and requires action?
Does the supplier have finished product in inventories that is suspect and requires action?

CONTROL Supplier must immediately confirm and initiate control at all stages that are at risk of producing additional suspect product.
Does the supplier have product being produced that is suspect and requires action?
Doe the supplier have scheduled production that could produce additional suspect product and requires action??
Does the supplier have items (i.e. tools, inventory, raw materials, orders, drawings, designs, etc…) that could allow additional n/g product to be produced??

CORRECT (countermeasure), the root cause...
Utilize a problem solving method such as fishbone, 8D, 5p etc,, for identification-correction-confirmation to identify the root cause and provide countermeasure to Acme on or before the due date.

CONFIRM that all concerns have been addressed….
Has problem ceased, with no re-occurrence??
Has all n/g product been returned-reprocessed-scrapped-etc??
Does Acme have adequate supplies of good product?

Hope this helps.
Be well
 

optomist1

A Sea of Statistics
Trusted Information Resource
#5
Hi Graciel,

...."bad Components that was detected in the production line..." a more fundamental problem question is why your firms RI did not detect these defects...catching during the manufacturing process is expensive and wasteful, etc, etc
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Wow @optomist1 . With all due respect, Deming is rolling in his grave at the idea of requiring/relying on receiving inspection vs supplier relationship/management and well established processes of control at the supplier location.
The point # 3 by Deming stated: Cease dependence on inspection to achieve quality.

But, if the corporate culture is one of selecting bad suppliers because they are CHEAP, there are no resources available to perform meaningful supplier oversight and development, then, if you abolish incoming inspection, you are, undoubtedly, failing to mitigate risks, and you will end up with bad parts being uncovered in production, or, even worse, by the end customer/user.

One must understand that the goal is to run processes so robust can you can eliminate non value added inspection, but, quality by faith is massively misguided.
 

Tagin

Trusted Information Resource
#8
Hello! I would like to know what's the best approach for dealing with a batch of bad Components that was detected in the production line. Considering a situation that the cause is not known yet, the only thing is that this component is affecting the line efficiency.
For example:
- reject the batch
- change batch
- start investigation (measuring or other)
- call supplier to visit the company
- start selection if you can ,if not return the batch and advise logistic team
Is that good? Or you guys practice different approach?
Thank you.
We really don't have enough information to make some of those decisions...but roughly:
  1. Containment (as previously mentioned)
    • Is any of what has been produced now suspect? Contain it.
    • Did any of it reach the customer, or is in transit? Contact shipper or customer and discuss options.
    • Account for the entire unused or in-process bad component batch and segregate it so it doesn't get used.
  2. Correct the problem
    • How detectable is the defect in the component prior to production? Can you reliably sort good from bad? In this case, it doesn't sound like it since you say "the cause is not known yet".
    • So, changing batches may also not be a viable or reliable correction, unless you can create some cost-effective and reliable test that use can used for an AQL of the other batch. But this also involves costs (testing costs vs. linedown costs vs. rejected product cost vs. customer commitments, etc.)
    • Determine root cause
      • Work with supplier to isolate the root cause.
      • Issue a SCAR to supplier as needed or per your policies.
  3. Permanent corrections
    • Have supplier implement permanent corrections
    • Implement any additional corrections on your side (e.g., additional receiving inspection)
  4. Effectiveness
    • Monitor some number of batches from the supplier with the permanent correction for defects or issues to track if the problem is truly permanently resolved.
 

optomist1

A Sea of Statistics
Trusted Information Resource
#9
although not ideal, if RI doesn't catch it...better to catch it during manufacturing process?? The real/ correct solution is to push to responsibility back to the supplier...if this is a supplier they use and on their approved list, have they been qualified, periodically audited, etc. The point is manufacturing is not the place to detect, etc defects from suppliers, the SQA group needs to address this type of issue. If this auto or aero issue supplier NCs etc...perform root cause, CA or in many cases send in a Third Party Containment/Problem Resolution team and the supplier gets charged. And more to the point the further down the supply chain "defects travel" the cost, risk etc., increase exponentially (in general terms). Trust but always verify what suppliers produce and state...if they persist in shipping junk to the customer, replace them...in todays market the risks are too great to tolerate sub spec parts or services. Lastly, the greater the Tier #s i.e. 1-2-3 etc, the murkier things get...generally speaking
 
Last edited:
Thread starter Similar threads Forum Replies Date
R Transforming or not Transforming - Dealing with Non-Normal Data Statistical Analysis Tools, Techniques and SPC 10
samer Oracle computer records - Special procedure for dealing with non-paper Records? Records and Data - Quality, Legal and Other Evidence 2
A Capability Analysis - Dealing with non-normal data in Minitab Using Minitab Software 8
K Tips for dealing with third party auditors General Auditing Discussions 11
Q Dealing with a forgetful Special Processor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
C Specification + MU - Dealing with reported MU Values Measurement Uncertainty (MU) 6
F Dealing with, and Analysis of, Data Statistical Analysis Tools, Techniques and SPC 6
R Dealing with Device/Design changes by a "Letter to File" vs. 60601 Retesting IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
Sidney Vianna Cleaning up the Global Compact: Dealing with Corporate Free Riders Sustainability, Green Initiatives and Ecology 2
J Integrated Management System - Anyone with experience dealing with ISOQAR? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Dealing with Excessive Within-Part Variation when doing MSA and Cpk studies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S Auditing Career: Dealing with Mentally Unstable Managers Career and Occupation Discussions 7
K Has anyone had experience dealing with SEDEX (Supplier Ethical Data Exchange)? Customer and Company Specific Requirements 4
P Hard Milling Process - Dealing with Within Part Variation for SPC Statistical Analysis Tools, Techniques and SPC 18
optomist1 Real World SPC Dealing with Outliers Statistical Analysis Tools, Techniques and SPC 22
P Advice on dealing with difficult Colleagues Career and Occupation Discussions 24
R Effects of Dealing with Out of Tolerance Monitoring Equipment General Measurement Device and Calibration Topics 4
Z Dealing with a defiant Operations Manager Quality Manager and Management Related Issues 41
ScottK Are any other USA manufacturers dealing a lot with ARRA requests? Various Other Specifications, Standards, and related Requirements 6
N Nissim Shaked is dealing with these topics at his desk Imported Legacy Blogs 14
D Dealing With a Chinese Supplier to follow up on quality problems Quality Manager and Management Related Issues 26
D Dealing with pesky telemarketers Coffee Break and Water Cooler Discussions 4
B Dealing with Outsourced Processes in a DMR ISO 13485:2016 - Medical Device Quality Management Systems 7
Marc Government of Mozambique - Dealing with Lions Funny Stuff - Jokes and Humour 14
P Dealing with Second Party Audits Quality Manager and Management Related Issues 6
R Service Company dealing with FAI requirements - Small stocklist broker AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Is zero defects possible? We are dealing with 25 to 30 parameters Quality Tools, Improvement and Analysis 21
Marc Advisory Notices - Who is responsible for dealing with Advisory Notices? ISO 13485:2016 - Medical Device Quality Management Systems 7
S Process of dealing with the Customer - PRRs, GQTS Nonconformance and Corrective Action 5
Douglas E. Purdy Dealing with Procurement Documentation and an Industry Conglomerate General Auditing Discussions 4
P Dealing with recruiters: What if a job is listed after.... Career and Occupation Discussions 17
P Recently Certified!! One minor finding dealing with Dock Audits IATF 16949 - Automotive Quality Systems Standard 11
T Industrial Belt Sander Systems - Dealing with chatter marks Manufacturing and Related Processes 5
B Dealing with dishonest customers - One customer who is a supplier - Bad Material Supplier Quality Assurance and other Supplier Issues 16
A Dealing with Possible Alcohol Use by Employees in the Work Place Misc. Quality Assurance and Business Systems Related Topics 23
B Published standards dealing with calibration of pressure and vacuum gauges? General Measurement Device and Calibration Topics 5
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 6
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 5
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

Similar threads

Top Bottom