Double-Retest of Nonconforming Material to Accept the Material

J Allen

Involved In Discussions
When meeting the requirement for raw material validation, by sending out a sample of raw material to an independent lab for test, I encountered a rejection for tensile strength.
The results were low. The original material test report showed compliance.
I asked the independent lab if they could have made a mistake that led to a incorrect finding they said no but would be willing to test another sample.
Question: If a test report indicates noncompliance, can a double retest be sufficient to accept that material if retesting shows acceptable results. Do primes (Lockheed, Boeing, Northrop) accept double re-test to validate a failed test.
 

Bev D

Heretical Statistician
Leader
Super Moderator
It really depends. Ultimately your SQE will have to weigh on this one...

tensile testing can be affected by several measurement system variables. I suggest looking at the data from a continuous data perspective rather than a categorical (pass/fail) perspective.

Plot the two sample results on a chart with the specification line. Are the two results close to each other and the specification or are they very different form each other and far from the specification? Is there a lot of variation within the first and the second sample set? If the first and second sample are far from each other it is more plausible that the difference is due to some error (in sample prep or measurement) and a 'tie breaker' might provide convincing evidence - either way. If the two results are close to each other and the specification you will have difficulty as this is probably simple measurement error and/or part variation. It might be helpful if you provided your data...

Also consider the science of the test and the material...
How many samples are tested? what are the samples? Are they actual material or coupons? do they require some prep? (are they whole or 'cut'.) can you get multiple tests from one sample. Where did the samples come from within the batch? were they 'close to each other' in manufacturing sequence or randomly selected from across the lot? was the same measurement system and test party used for the two samples or are they different?
 

Sidney Vianna

Post Responsibly
Leader
Admin
Question: If a test report indicates noncompliance, can a double retest be sufficient to accept that material if retesting shows acceptable results. Do primes (Lockheed, Boeing, Northrop) accept double re-test to validate a failed test.
As Bev mentioned, you should involve the customer(s) about the acceptability of retesting before proceeding with the processing of this material. As it stands right now, the material should be deemed rejected as the (periodic? AS9100 mandated?) independent validation test rejected the material.

From a risk based thinking perspective, I would take action with the supplier and assess how much confidence you can have in their CoC's. I would assess if their material properties testing processes are adequate or not. If you can't assess that for yourself, and they have some kind of QMS certification (ISO 9001, AS9100, NADCAP, etc...) I would engage with them as well.

Assuming your customers are ok with the retesting, your supplier should bear the costs, in my opinion. Or, alternatively, sometimes your customer might have the test lab they could use for this test.

All of that (above) assumes the independent test lab you sent the sample to is reliable. Are they 17025 accredited?
 
K

krayworth

Were tests performed in accordance with a testing standard? If so, standards usually specify how many samples must be tested to gather the accurate data. I would also ask the test lab about the calibration of their equipment if the product failing the test was a surprise.
 

Marc

Fully vaccinated are you?
Leader
... Assuming your customers are ok with the retesting, your supplier should bear the costs, in my opinion. ...

Just a quick thought - Until it is known why the test failed it wouldn't be proper to assign a responsibility. It may be that the outside test lab is at fault (I'd take their offer for a re-test if free), and if so I would want to know what happened. If the customer tested wrong... Problem.

Food for thought with regard to lab tests. Unless I witness the test I'm a skeptic (must be my DoD work history...).
 

J Allen

Involved In Discussions
It turns out the failure was due to incorrect calculations for the wall thickness. The lab confirmed the error and on re-test of the original and an addition (2nd sample) both were acceptable.
Thanks for your input.
 
Thread starter Similar threads Forum Replies Date
H Regarding Double Insulation & Caution Symbol on Product according to IEC 61010-1 CE Marking (Conformité Européene) / CB Scheme 6
CaliperJim Double Ended Thread Plug Gauge Calibration General Measurement Device and Calibration Topics 9
L Class II (Double Insulated) Power Supply with Output Tied to Earth: FE or PE? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Scanton Double Major for the same infraction? IATF 16949 - Automotive Quality Systems Standard 11
U Cpk Calculation - I analyse a double seam cans Manufacturing and Related Processes 21
R IMDS for double sourced component RoHS, REACH, ELV, IMDS and Restricted Substances 3
S Double Thermocouple - Two types, same sheath (AMS2750/Nadcap) Manufacturing and Related Processes 9
S Is double packaging obligatory for surgical single-use scalpels? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Difference between a "Double D" slot and a "True Slot" Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
P Lot Acceptance Plan that specifies BS 6001 Double Sampling Plans, general inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
P IEC 60601-1-11 - Conversion to Double Insulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M FDA Submission Printing Format - Is double sided printing allowed? Other US Medical Device Regulations 5
M OC Curves for Double Sampling Plan - How are they Derived? Statistical Analysis Tools, Techniques and SPC 2
R Double Spec'ing in Control Plans FMEA and Control Plans 11
P Understanding IEC 60601-1:2005, Clause 8.1 b) - Short Circuiting Double Insulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
I ERP acronym has double meaning in our company Internal Auditing 6
G Double Blister Pack for an Implantable Device Other ISO and International Standards and European Regulations 1
S Do insulation layers in double insulation have sequence requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Calculation Mean for Control Chart -X Double Bar Statistical Analysis Tools, Techniques and SPC 13
M Effect of double ETO (Ethylene Oxide) Sterilization ISO 13485:2016 - Medical Device Quality Management Systems 13
S Double certification 93/42/EEC and 89/689/EEC for gloves possible? EU Medical Device Regulations 4
kedarg6500 Writing the symbol for R bar bar (double bar) in Excel Excel .xls Spreadsheet Templates and Tools 3
B Define Fault, Double Fault and Normal Conditions - Preparing a Risk Management File FMEA and Control Plans 1
T Double Sampling Plan Explanation for * Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
T Double-sided (USL, LSL) Variables sampling plan Z1.9 - Use in Excel spreadsheet? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
T From ECR (Engineering Change Request) to ECN (Engineering Change Note) - double work! Document Control Systems, Procedures, Forms and Templates 2
W Advice on the best way to approach a double moving average using Minitab 15 Using Minitab Software 3
J Screw Thread Inspection Standards? Double Ended Stud Inspection Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V Draw OC curve - Double sampling plan Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
C Company has double identity - How do I state this in our QM (quality manual)? Quality Management System (QMS) Manuals 4
Marc Toyota vehicle recalls double in 2005 World News 1
D Unilateral / Bilateral Tolerances for dimensions with Double Plus or Minus Tolerance Statistical Analysis Tools, Techniques and SPC 12
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Engineering retest in line - Machine stability issues IATF 16949 - Automotive Quality Systems Standard 8
marmotte Adding a Funct. Earth. to a class II / BF device...retest needed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Retest for Reconfiguration IEC 60601 - Robot that processes samples onto glass plates IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Scratched tubing to be treated as nonconforming product? Manufacturing and Related Processes 10
R 8.7 Control of Nonconforming Outputs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
W Nonconforming-Material Process Nonconformance and Corrective Action 1
T Control of Nonconforming Material AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Z AS9100 Control of Nonconforming Outputs - Rework Dispositions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
F Recording Nonconforming Purchased Parts Nonconformance and Corrective Action 5
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
M Nonconforming parts accepted by operator with intention Human Factors and Ergonomics in Engineering 33
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
S How do you record your Nonconforming product? Batch production of staged processes Nonconformance and Corrective Action 2
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
T Nonconforming product at customer detected by a routine inspection by field service Nonconformance and Corrective Action 9
Juby Tan Action on Customer Replacement (Nonconforming Product - ISO 9001) Customer Complaints 2

Similar threads

Top Bottom