Difference between Test Method Validation and Gage R&R

Elsmar Forum Sponsor

Ninja

Looking for Reality
Staff member
Moderator
#4
Test Method Validation is a broader term.
Some ways of performing a Test Method Validation include (but is not limited to):
- GR&R
- Customer approval
- ASTM directed test with quantified, verified output

In short, GR&R is one method of TMV...but not the only one available.
FWIW, GR&R is by far the most commonly and easily accepted one in my experience.
 

William55401

Quite Involved in Discussions
#5
Another example. Attribute TMV involves challenging a test method with known bad units. Does it detect them? I don't consider this a pure GRR approach. One more. Don't get so wrapped up in labeling something (GRR vs TMV for example). Spend more time thinking about how to demonstrate a particular method is effective.
 

Frypot

Starting to get Involved
#6
I have been asked by a customer to validate our test method for seal strength (as in ASTM F88) I have no 'known value' standards, the customer also wants me to compare the method at two different sites (i.e. two different tensile machines) I can produce plenty of samples for testing though they have quite a lot of variability due to the materials (grid lacquer paper as a 4SS pouch).
Any suggestions?
 

Ninja

Looking for Reality
Staff member
Moderator
#7
Howdy,
Typically a tensile tester "known value" is just calibrating the load cell.
I know of no "known value" destructive standards for this type of test...

If it helps, you can send out some samples to an outsource lab, then compare sample means to show that your equipment is giving nominally similar values. If your customer also does this test...you may have more overall benefit sending to them, and thus correlating your sites with the customer as well (and it would be free).
HTH
 

Frypot

Starting to get Involved
#9
Well so far what I've done is to use a t-test on ~ 50samples to get a measure of repeatability the had another 50 samples tested on our other site, done a t-test to tick the reproducable box. Hopefull the customer will be happy with it, the machines are, calibrated externally and within calibration period.
Thanks for the responses!
 
Thread starter Similar threads Forum Replies Date
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Difference between a "check" and a "test" Manufacturing and Related Processes 7
L Difference between a Quality Plan and Inspection & Test Plan (ITP) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C Difference between "Pass/Fail Testing" "Test To Failure" "Degradation Test" FMEA and Control Plans 1
C What is difference between a t-test and Correlation Coefficient Statistical Analysis Tools, Techniques and SPC 2
S What is the difference between a Test Protocol and a Test Report? Records and Data - Quality, Legal and Other Evidence 9
C Difference between proficiency test and interlaboratory test? General Measurement Device and Calibration Topics 3
G What's the difference between 1.32 and 1.33 Cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 18
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 3
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
K Difference between Medical Electrical Equipment and Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom