When to draw the line on first articles submissions?

R

RosieA

#11
Pammesue, Are the different locations near each other, and under the same management, or are they far apart or in different countries?

In your situation, I would want to know that information. If one location is in the US, and one in Mexico and one in China, then I'd want to see samples from all three facilities.

If they are twelve miles apart and share the same ISO cert, I wouldn't be as concerned, especially if they have been shipping to you from all three sites for some time and you haven't seen problems.

My 2 cents.
Rosie
 
Elsmar Forum Sponsor
D

DrM2u

#15
The plants are in 3 different states and all share the same ISO cert.
This does not mean that all plants employ exactly the same processes, regardless if they are next door or continents appart. If they are ISO 9001 registered then they should comply (at least) with the requirements of 7.2, just like your organization should comply with the requirements of 4.1 & 7.4.
 
D

dknox4

#16
Then if they are a fairly reliable supplier, I wouldn't worry about qualifying all three.
I gather that this is not an automotive supplier, but unless all three had PPAP'd, or otherwise qualified their parts in my system, I would not accept the movement between locations without proveout.
 
A

alspread

#17
If you are no longer certified or operating to the AS9100 standard, then you don't need any first article unless your customer imposes it on you and requires you to flow it down.
If you want it because your system requires it, well then its your system, and you can change it.
You gotta ask yourself...
Depending on how critical the part is and your availability of resources you could supplement their lack of first article with an increase at your receiving inspection for a period of time until you have validated that their process is capable.
Remember, the purpose of the first article is to verify that the process (including documentation, tooling, et al) is capable of producing a part that meets ALL of the requirements. You could do a lot of the first article for them, if you have the resources. Increasing the inspection from that address for a while would validate the process over that period of time and give you some comfort that the parts should be acceptable.
Not the best solution, but you sound like your between a rock and a hard place.

Good Luck
 
Thread starter Similar threads Forum Replies Date
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
J Medical Device Failure Effects - Where to draw the line? FMEA and Control Plans 8
K Where do you draw the line on what fixtures/testing equipment require calibration General Measurement Device and Calibration Topics 36
J Where to draw the line with Red Lining? US Food and Drug Administration (FDA) 7
C Quality Manager and employee issues, where to draw the line? Career and Occupation Discussions 17
E SOP or system Work Instruction? Controlled Document - Where does one draw the line? Document Control Systems, Procedures, Forms and Templates 5
P How to draw an OC Curve (operating characteristic curve) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D How do I draw Graph a Mean & Range Chart & FIND CL UCL UCL for this data on Excel Statistical Analysis Tools, Techniques and SPC 4
H Steps to Draw a CUSUM Chart with an Example Statistical Analysis Tools, Techniques and SPC 5
J How to connect FMEA, Control Plan, G8d, 5Whys and Draw the pareto Nonconformance and Corrective Action 0
V Draw OC curve - Double sampling plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V How do I draw OC curve? How do I plot this curve in Excel? Excel .xls Spreadsheet Templates and Tools 3
H ISO/TS 16949 Audit Schedule - How to draw up an audit schedule General Auditing Discussions 3
K How would one draw a turtle diagram for 'Control of nonconforming products' Process Maps, Process Mapping and Turtle Diagrams 2
S Linearity study - What is required to draw graph and make decison based on the graph Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
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
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
P Line accums as a non-conformance? Supplier Quality Assurance and other Supplier Issues 2
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
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

Similar threads

Top Bottom