GR&R for a test fixture that outputs variable data per measurement

#1
I am challenged to perform a GR&R on an air gage that returns hundreds of data points for each measurement cycle for one part.

I am familiar with the typical GR&R for variable data, but in this scenario, when an operator takes a measurement of a single part, the result is over 100 data points.

Is there a GR&R process to address this type of gage output?
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
You use the data from the gage (100's of points) to verify something:
- proper function
- in-spec operation
- adequate air pressure
- ....something...

If you were to record the measurement from this gage to ensure proper operation, what would you record? On what data is your decision of "it is ok" made?

My guess is that you use either the minimum, or the mean...or someone glancing at the gage and calling out a number...not hundreds of numbers.

If my supposition above is at all correct, I would run GRR on the number you conclude from the gage, not the hundreds of points per measurement.

Can you tell us more about how you USE the gage in normal operation?
 
Thread starter Similar threads Forum Replies Date
L GR&R for a Test Fixture Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Adjustable Shaft for a Test Fixture to Test Perpendicularity Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
T Simulated Use Cardiac Catheter Test Fixture Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
F Gage R&R Destructive Test With Breakaway Fixture To Simulate A Part Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
L ASQ's Biomedical Auditor Course Test ASQ - American Society for Quality 1
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 0
R SAT (System Accuracy Test) temperature according to AMS2750E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Earth leakage current test for Permanently installed Large scale MEE IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Bench test report translation to English for 510(k) submission Other US Medical Device Regulations 2
J Production Line Test Brasil - High Voltage Dielectric Strenght Test Other Medical Device Regulations World-Wide 5
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Cord anchorage pull test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Minitab assistant: 1-Sample % Defective Test Using Minitab Software 1
N Is capability applicable for a destructive test? Capability, Accuracy and Stability - Processes, Machines, etc. 9
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Medical Device Airworthiness, DO-160 Test Planner IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Audit Finding For Not Retaining Test Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W ASTM F1929 dye penetration test - Validation for in-house testing ISO 13485:2016 - Medical Device Quality Management Systems 13
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
N Heavy tare to simulate high load in a routine sensitivity test of a floor scale? General Measurement Device and Calibration Topics 3
bryan willemot Looking for a certified test report for aerospace parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
A Information about Medical Device Test Laboratories Other Medical Device and Orthopedic Related Topics 4
B Standard for Dielectric Strength Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
J EN61010 Electrical Withstand Test IEC 62304 - Medical Device Software Life Cycle Processes 0
Z MDD ER 7.5, "phthalate test"? Aspiration tips EU Medical Device Regulations 3
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
M Proper method to test flow of a regulator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
C CQA Test Questions Bank General Auditing Discussions 1
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Watchcat Identification of Test Sample in Test Reports? Design and Development of Products and Processes 22
S Safety Class A with no test? IEC 62304 - Medical Device Software Life Cycle Processes 1
A IEC 60601-2-2 - Defib-proof test amendment to base standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K The correct way of doing a 2 Sample T test Reliability Analysis - Predictions, Testing and Standards 7
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
B EU: Alcohol test kits for breast milk IVDD EU Medical Device Regulations 2

Similar threads

Top Bottom