Is R&R Study applicable? Ten Production lines & Automated Measurements

R
#1
Problem with Gage R&R

Hi,

I have problem that how to perform a Gage R&R-test. We have almost ten production lines and in every line there is a same kind of automated measurement system. Measurements is saved automatically to test files. So in this case we don´t have an appraiser variation, right? I think that I can´t take another production lines to appraiser two and three, because gages can´t be exactly identical.

The question is how do I perform Gage R&R-test "right" in this kind of situation?
 
Elsmar Forum Sponsor
T

Tom W

#2
It sounds like your variation could be in the test software. If you don't have an actual human variation you can do other types of MSA. You could do a stability test to satisfy the requirement for Measurement System Anylisis in QS9000. You might be able to do some type of variation study base on your test data.
 
Thread starter Similar threads Forum Replies Date
M ASQ certification study material Professional Certifications and Degrees 1
I Clinical study suppliers (service providers) -- extent of control ISO 13485:2016 - Medical Device Quality Management Systems 4
P Type of MSA study according to measurement equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Using real time shelf life study as accelerated ISO 13485:2016 - Medical Device Quality Management Systems 1
T Gage R&R study - Ordinal data Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
E Which regulatory framework for an app-based study for research purposes? EU Medical Device Regulations 1
M Registry study in Europe CE Marking (Conformité Européene) / CB Scheme 1
P 21 CFR 58 GLP Periodic Study Phase Inspection Report Other US Medical Device Regulations 0
Aymaneh Clinical study CE Marking (Conformité Européene) / CB Scheme 1
S Equivalency study - Comparing 2 similar equipments Reliability Analysis - Predictions, Testing and Standards 1
M Early feasibility study V&V requirements Design and Development of Products and Processes 2
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
M RAPS RAC Device - Looking for resources / prep materials & study group Professional Certifications and Degrees 7
V MSA - Using a R&R study for a Tape Measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
Miner Reported content: Post in thread 'Form of real time study for establish shelf time' Document Control Systems, Procedures, Forms and Templates 1
A Form of real time study for establish shelf time Reliability Analysis - Predictions, Testing and Standards 4
S Capability Study for Leak Tester Capability, Accuracy and Stability - Processes, Machines, etc. 9
A % STUDY VARIATION VS. % TOLERANCE Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 31
A IATF MSA study Type 1 General Measurement Device and Calibration Topics 7
M Type 1 Gage r study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Mistakes in the CQE Study Guide Misc. Quality Assurance and Business Systems Related Topics 11
Nihls MSA Study Type 2 (special conditions ) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
S 95% UCL - Attaching an excel for recovery study Statistical Analysis Tools, Techniques and SPC 0
Nihls MSA Study Type 1 (CMM) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
M MSA Study Type 1 not capable. We are at the limit. And manufacturing wants to continue producing. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Lean: Conducting Capacity Study, calculating Cycle times on laser cutting machines Lean in Manufacturing and Service Industries 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
Q Capability study with a minimum spec Statistical Analysis Tools, Techniques and SPC 8
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Case study resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Attributes SPC study - Attributive control (Go gage) Statistical Analysis Tools, Techniques and SPC 5
S Capability or Gage R&R Study for Leak Tester? Reliability Analysis - Predictions, Testing and Standards 15
N % Tolerance - Type 1 study on the gages, then a gage R&R (ANOVA) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Definitive answer on Type 1 vs Type 2 vs Type 3 Gage Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D Gage R&R Study on Load Cells - Large chemical blending tanks IATF 16949 - Automotive Quality Systems Standard 1
A CE Mark and PMCF study EU Medical Device Regulations 3
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Gauge Study for Small Lots Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5

Similar threads

Top Bottom