SBS - The best value in QMS software

Line accums as a non-conformance?

#1
We are in the middle of consolidating three business units into one corporate non-conformance tracking system. It is my job to set "guidelines" for this process flow. One of the gray areas I am in is in regards to the subject of line accums - the onesy-twosy quality rejects we receive from suppliers. I have two schools of thought being discussed:
1) it should be written up in an official non-conformance to the supplier that would then hit their report card (but would not require a corrective action), or
2) this is inherent in any customer/supplier relationship and simply recouping the cost of the defect parts is adequate.

Please let me know what school you are in and why...?? Thank you so much!
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
I think it's all about risk and expense. There are costs beyond the price paid for parts that will be incurred, not the least of which is the cost of all of the tracking and report cards. If expense is negligible and occurrences are infrequent, throw them out and move on. If a nonconformity doesn't merit corrective action (if the risk of further events is negligible) throw them out and move on. Why make a "hit" on a report card if nothing appreciable has been lost?
 

Tagin

Trusted Information Resource
#3
(Keep in mind we are a small company) We track defect qtys and have acceptable max limits which trigger us to escalate to the supplier and internally. We also look for trends, and also look for defects that might indicate a safety problem or a potential for repeat defects.

So, in short, we take a risk-based approach, to allow us to spend effort only proportional to the extent of the risk presented, whether it is a single defect occurrence or multiple months of trending increases in defects.
 
Thread starter Similar threads Forum Replies Date
L Concerning "allowable" supplier line accums before starting a corrective action Supplier Quality Assurance and other Supplier Issues 4
B 3-phase supply, overvoltage catogory, line-to-neutral and working voltage (IEC 61010-1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Risk of stopping your customer's line IATF 16949 - Automotive Quality Systems Standard 4
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
G Bad Parts cause Customer line stop IATF 16949 - Automotive Quality Systems Standard 13
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
F Internal transfer of work from one line to another? Qualification and Validation (including 21 CFR Part 11) 3
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
H Line Balancing in Backpack Manufacturing Manufacturing and Related Processes 2
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
Q Clean Line Validation ISO 13485:2016 - Medical Device Quality Management Systems 6
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
Edward Reesor Design owner: The line between inventor and manufacturing facility Manufacturing and Related Processes 3
G Uncertainty of staging a short line scale standard on longer measuring machine? Measurement Uncertainty (MU) 4
E What is the general time line to prepare for IATF Letter of Conformance? IATF 16949 - Automotive Quality Systems Standard 1
M Establishing a FTQ (First Time Quality) process for an engine assembly line Quality Tools, Improvement and Analysis 1
P Production Line Pump Cleaning Validation Method Question Qualification and Validation (including 21 CFR Part 11) 0
I SMD line PQ Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Controlled Setup Sheets for a production line Document Control Systems, Procedures, Forms and Templates 2
T Production line requirements for IATF 16949 - Need to have dedicated lines? IATF 16949 - Automotive Quality Systems Standard 3
K IATF 16949 Line and Dock Auditor Competency Requirements Internal Auditing 4
N Gantt Chart / Time Tracker in Excel - Combining Tasks on the Same Line Excel .xls Spreadsheet Templates and Tools 2
gard2372 Line or Process Stoppage - Andon Authorities and Process Manufacturing and Related Processes 1
M Lean Time Line (History and Theory) Lean in Manufacturing and Service Industries 5
R The on-line re-certification option on ASQ's website Professional Certifications and Degrees 5
M Anyone know of an on-Line Bachelor's degree that work with Quality Career and Occupation Discussions 3
J Medical Device Failure Effects - Where to draw the line? FMEA and Control Plans 8
K 21 CFR Part 11 (and EU) compliant Digital Signatures on a Production Line Other US Medical Device Regulations 5
R IEC 60601-1 4th Edition - Is a "Red-line" version available? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Mandatory Electrical Safety Tests - Regular Production Line IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
T A question on Calibration on In-line Laser Micrometer General Measurement Device and Calibration Topics 1
J Excel spreadsheet to use Basic and Mini MOST for Line Balancing Document Control Systems, Procedures, Forms and Templates 1
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
K TS16949 registration for Kitting and Line Sequencing Service company IATF 16949 - Automotive Quality Systems Standard 1
G Service Parts Assembly Line and Scope of TS16949 Registration IATF 16949 - Automotive Quality Systems Standard 3
U TS16949 Internal Auditor Training - Is On-line training OK? Training - Internal, External, Online and Distance Learning 1
D Inquiry about QC Testing (In Line Sampling) Reliability Analysis - Predictions, Testing and Standards 13
LRE67 What do you do when your Auditor crosses the line to Consulting? General Auditing Discussions 9
P MSA on an in-line automatic X-ray thickness measuring gage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Are ISO 9001 certificates delivering confidence in line with the expected outcomes? Registrars and Notified Bodies 2
M Wire Harness Line Process and Inspection Criteria Manufacturing and Related Processes 9
M Packaging Material Requirement Calculation Sheet for a Bottle Packaging Line Manufacturing and Related Processes 3
D Hot Line (Safety) Rescue Hook Testing - 29 CFR Part 1910 Manufacturing and Related Processes 1
V Handling decomissioned line/equipment during 1st time product-based inspection US Food and Drug Administration (FDA) 1
B Outsource Production Line need ISO13485 Certificate ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom