Non-Conformances Found After 3rd Party Sorting

#1
Hello! Long time lurker, first time poster. I’ve recently started working for a new company as a Quality Engineer. We recently had a quality issue at a customer facility. There was poor fill visible in a mounting hole of a bracket. We contracted an outside company to go into the customer to certify all of their product. We recently got called into the customers facility as they have found multiple castings with the same condition in their certified material. We are currently performing an additional sort for this. To date we have found twenty castings in the certified material. The company I work for has no process in place for an issue like this. I was hoping to get some advice on how to handle this situation with the sort company.
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
1) Open a corrective action, if there isn't one already.

2) If your system is 9001, I would look at 8.4.2 & 8.4.3 (Control of externally provided processes, products and services - Type and extent of control and Information for external providers). Did your company implement the necessary controls on the service provider or not? Did your company specify the processes and sorting criteria properly, etc.? Did the service provider fail or did your company set them up to fail?

3) If the controls and processes, criteria, etc. were appropriate, I would issue a SCAR to the service provider.

4) In your containment ("We are currently performing an additional sort for this. "), are you doing the same inspection/sorting process as you directed the service provider to perform? If so, what makes you expect that your sort will be better than the service provider's sort?

You say 20 castings were NC. Was that 20 out of 50? 20 out of 1,000? 20 out of 1,000,000? Just trying to get some perspective.
 
#3
We found 20 out of 1,000.

As far as the sort, we are performing the same sort. Unfortunately for this issue, it is a visual sort. As a general rule, I hate visual sorts and feel they only set you up for potential failure. However, the sort method was not up to me. Although if I am being honest, I don’t know if I would have a better solution. I do of course understand that a visual inspection will not be 100% effective but is 2% acceptable fallout post sort?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
I don’t understand why you said “a problem at a customer facility”. Wasn’t the defective castings poured in your plant, the foundry? The fact that your system allowed defective products to be shipped is a serious breakdown.

3rd party sorters don’t certify anything. They “sort” bad from good and apparently your outsourced sorter is not very good at sorting, either.

What is the application of these brackets? Structural? How critical are they?
 

Tagin

Trusted Information Resource
#5
I do of course understand that a visual inspection will not be 100% effective but is 2% acceptable fallout post sort?
The percentage would be part of the criteria your company should have considered, and should consider now with regard to the second sort. The question should be considered with respect to the customer's requirements: what percentage NC does the customer expect, or allow?

Is the visual inspection criteria conveyed clearly to the inspectors? E.g., are they given instructions with multiple photos of example good, bad, and 'review further' conditions?
 
#6
So naturally the customer expects 0% quality defects. The problem I am having is, my employer currently has no policy in place with regards to third party sorting. It is a fairly new company and obviously have some Quality System problems to clean up.

As far as work instructions, the were provided with detailed work instructions that displayed the areas the porosity was found as well as 5 pictures of the differing degrees of porosity found at our location.
 
#7
I don’t understand why you said “a problem at a customer facility”. Wasn’t the defective castings poured in your plant, the foundry? The fact that your system allowed defective products to be shipped is a serious breakdown.

3rd party sorters don’t certify anything. They “sort” bad from good and apparently your outsourced sorter is not very good at sorting, either.

What is the application of these brackets? Structural? How critical are they?
I fully understand there were many serious failures in our internal systems to allow the escape of this material and they will be addressed. I am not trying to place the blame for this issue on the sort company. I do apologize if it came across that way.
 

John Broomfield

Staff member
Super Moderator
#8
For this blemish to be a nonconformity you need evidence that it does not conform to the acceptance criteria.

But you have not mentioned any acceptance criteria. Without acceptance criteria you may be chasing perfection.

Be careful about calling this blemish a defect. A true defect would adversely affect the performance of the casting.
 

Tagin

Trusted Information Resource
#9
The problem I am having is, my employer currently has no policy in place with regards to third party sorting. It is a fairly new company and obviously have some Quality System problems to clean up.
Establishing a policy would be one of the actions you implement on your corrective action to prevent this in the future, assuming that third-party sorting will be an ongoing service you use. More generally, you would want to look at implementing better controls on selection, planning, controls, etc. on any outsourced services.

As for the third-party sorting company, have you asked them to investigate why they failed (or, did they think 2% was acceptable)? Are they responsive or stonewalling, looking to improve or denying all responsibility, etc? Does your company even want to use them again in the future? Or was this really caused by poorly communicated criteria and controls from your company? These kinds of questions factor into how you want address the issue with them from a quality perspective.

Even though the problems caused for the customer are negative, I always feel that it is the role of Quality to promote internally how such events can be used positively for teaching/mentoring your company on planning, risks and controls; as well as on how corrective actions should lead to beneficial results.
 
#10
Establishing a policy would be one of the actions you implement on your corrective action to prevent this in the future, assuming that third-party sorting will be an ongoing service you use. More generally, you would want to look at implementing better controls on selection, planning, controls, etc. on any outsourced services.

As for the third-party sorting company, have you asked them to investigate why they failed (or, did they think 2% was acceptable)? Are they responsive or stonewalling, looking to improve or denying all responsibility, etc? Does your company even want to use them again in the future? Or was this really caused by poorly communicated criteria and controls from your company? These kinds of questions factor into how you want address the issue with them from a quality perspective.

Even though the problems caused for the customer are negative, I always feel that it is the role of Quality to promote internally how such events can be used positively for teaching/mentoring your company on planning, risks and controls; as well as on how corrective actions should lead to beneficial results.
I have already started looking into creating a contract that clearly spells out our expectations with regards to defects, retained traceability information, reporting/communication etc. Essentially establishing our expectations.

When I notified the sort company of the issue the response was “Oh, okay”. There was not even an attempt to defend or apologize, it was simply not a big deal. Unfortunately this is a customer directed sort company, the only one they allow on-site. While I do not like the company we will have no choice but to use them in the future if there is an issue. As mentioned elsewhere, the criteria was clearly laid out and there were multiple pictures. We are allowed a level 2 porosity in the mounting holes, I however instructed them to scrap anything that had visible porosity. I wanted to remove any and all subjectivity from the sort.
 
Thread starter Similar threads Forum Replies Date
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
Q Internal Audits - Categories of non conformances Internal Auditing 12
Ed Panek Are audit non conformances also risk based? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Example of 9001:2015 audit report with non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
N Non-conformances whilst in the Design and Development stage of a project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Corrective action on Non-conformances from a long time ago ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Non-conformances due to Human Error Nonconformance and Corrective Action 64
D Consequences of Major Non-Conformances during a Registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
E Non-Conformances and the Relevant ISO 9001 Paragraph Nonconformance and Corrective Action 4
P Losing Accreditation - JAS-ANZ has changed the conditions of non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T How many complaints, defects and non-conformances are typical? Customer Complaints 5
P Complaints vs. Non Conformances - When is a Complaint a Nonconformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Objecting to Registrar Audit Non-conformances General Auditing Discussions 43
K Cost of Supplier Non-conformances Nonconformance and Corrective Action 5
S Root Cause Analysis Taxonomy - Categorising the reasons for non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Supplier Non Conformances - Format for a Supplier Rejection Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Do ALL non conformances have to be documented? Nonconformance and Corrective Action 1
V Management Review Meeting - Statistics for Customer Complaints and Non Conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Internal Audit Concerns including Escalation of Non-Conformances General Auditing Discussions 6
D Non-Conformances in a Service based industry with no product Service Industry Specific Topics 9
P Interpreting the Process Gap - Open Non-Conformances & ISO Clause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Pharmaceutical Non conformances SOP - Solid oral dose start up company Nonconformance and Corrective Action 2
B Internal Audits save you from Non-Conformances on external audits? General Auditing Discussions 16
B 19011 - Reporting Non-conformances: Grading of findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Examples of Non-conformances during ISO/TS 16949 pre/final audits IATF 16949 - Automotive Quality Systems Standard 2
S Priorizing Non-conformances - What is the best way? Nonconformance and Corrective Action 6
J QS-9000 System redesign - Several Major non-conformances - Where to start? QS-9000 - American Automotive Manufacturers Standard 8
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
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 4
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 8
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
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
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