Help with SCAR - Not all sub-assemblies had properly received a First Article

M

msr0143

#1
My company provides third party inspection services, including first article approval. We have received a Supplier Corrective Action Request from a customer due to misses in a first article an inspector approved 14 months ago. In short the customer found a problem with a part. During their review they looked at the first article and found that not all sub-assemblies had properly received a first article.
I'm at a loss on what other than more training can be done. I understand that short-comings to training as a corrective action, but in this instance it seems to be the best course of action. 5-Whys will also be a challenge. The customer insists on 5-Why and, there must be at least 5....

Any feedback would be appreciated.:thanx:
 
Elsmar Forum Sponsor

Project Man

Involved In Discussions
#2
You need to focus on the quality system. What does your quality system require? Did all the requirements get met? How do you document that the requirements are met? Do you verify the requirements were met?
Now, this doesn't necessarily mean the answer is to follow the system (as written). You need to find out why the requirements weren't met. Is the system too cumbersome/time consuming? Does the system need to be simplified/clarified/modified?
Maybe just start with this question: Was the quality system effective?
This should take you down at least one good 5Why path.
 
M

msr0143

#3
The inspector reviews the FAI to the customer requirements, in this case AS9102. They also complete a customer provided checklist/approval report. Unfortunately on this one, there were ~45-50 parts/sub-assemblies listed on Form 1. Most of them are COTS or SCH, however 4 of them were not. He verified 3 sub-assembly FAIs, but missed one. The one that was missed turned out to only be a partial and subsequently failed.
I'm at a loss to find 5-whys on why this was missed. Unfortunately, it was 15 months ago and has just come to light....
 
Thread starter Similar threads Forum Replies Date
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
marmotte Help with Surgical Class I + 510(k) exemption US Food and Drug Administration (FDA) 0
T Help with updating procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
P Looking for help with an Ansys Workbench problem Manufacturing and Related Processes 0
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
O New metal detector, ccp -help! Food Safety - ISO 22000, HACCP (21 CFR 120) 0
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
J Help needed on clauses identification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
S Help in SMART goals AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Vader22 IATF 16949 extended manufacturing site help IATF 16949 - Automotive Quality Systems Standard 4
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
A Please Help With EOQ Calculation Manufacturing and Related Processes 2
S Help needed in choosing the method of calculating the minimum sample size Internal Auditing 12
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
S I need help in corrective action plan Nonconformance and Corrective Action 15
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 8
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
Edward Reesor ISO 19223 Discussion (Help) Other Medical Device Related Standards 1
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
S NC and Deviation approach - please help Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 12
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
J HELP NEEDED ! Risk Management Exercise ISO 14971 - Medical Device Risk Management 12
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 8
A Nonconformity help IATF 16949 - Automotive Quality Systems Standard 5
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Azaarus Help with CAPA for an IATF finding regarding inspection documentation IATF 16949 - Automotive Quality Systems Standard 10
A Help needed with locating conector Design and Development of Products and Processes 0
Y CER: can "state of the art" help to make up for literature search on equivalant devices? EU Medical Device Regulations 1
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
B Can someone help me explain P-Value with a simple word please? Capability, Accuracy and Stability - Processes, Machines, etc. 11
M Help on formulating a LP minimization problem Manufacturing and Related Processes 2
N Help with understanding Process Controls Manufacturing and Related Processes 7
K Screen printing ink and machine selection_ Need help Manufacturing and Related Processes 6
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2

Similar threads

Top Bottom