How do I do a GR&R study if there is no specified tolerance?

K

kristin

#1
How do I do a GR&R study if there is no specified tolerance?

I am writing a proposal for a supplier to include GR&R and Cpk data with shipments. One very important specification for this material invloves only a lower limit (example, >50 MPa). All of the formulas I have seen for EV and AV involve using the specified tolerance. Since I don't have a tolerance specified for this parameter, is it possible to calculate the %R&R?? Is it possible to do a GR&R study without changing this spec?


I would appreciate any suggestions. I will be performing a process capability analysis (Cpk) for this particular parameter and I know this is possible when only one limit is specified.

Thanks!!
 
Elsmar Forum Sponsor
A

Al Dyer

#2
Kristin,

I'm not sure about formulas for your situation, but I pose this:

As the customer, could you set an upper limit for your supplier?

i.e. >50 ----- < 300

I guess I would have to ask why there is no upper limit? I don't know your process.

Only you or your company has the knowledge to know what that upper limit would be.

ASD...
 
A

aysan

#3
Hi
there are three types to calculate EV%, AV% and R&R%:

EV%=EV/RF
AV%=AV/RF
R&R%=R&R/RF

where, Reference Figure is one of these parameters:
- Tolerence(USL_LSL)
- Process Variation (6 sigma)
- Total Variation(TV=PV+R&R)

If you don't have Tolerence, you can use two types else to calculate those parameters.

Aysan
 
D

Dave Stauffer

#4
Contact AIAG and request an MSA Manual.
Look for the forms that utilize process variation rather than tolerance for finding the percentage R&R. ANOVA does this.

------------------
Dave Stauffer
 
Thread starter Similar threads Forum Replies Date
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 2
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
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
K IATF & Attribute Study requirements IATF 16949 - Automotive Quality Systems Standard 9
T Correct MSA study for an automated camera system which makes attribute inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1
L ASQ CBA biomedical auditor - CBA primer material is enough to study? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Machine Setup for a CNC Machine Capability Study Capability, Accuracy and Stability - Processes, Machines, etc. 1
M Brazil forced degradation study requirements Reliability Analysis - Predictions, Testing and Standards 0
P RAC-US Spring 2020 Study group_Discussions Professional Certifications and Degrees 15
M Custom Medical Device For Clinical Study Other Medical Device Regulations World-Wide 1
G Capability Study for Tapped Hole Reliability Analysis - Predictions, Testing and Standards 3
R PMCF plan to justify that our product not require PMCF study EU Medical Device Regulations 2
E How much a bioequivalence study will cost in the UK Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Gage type 1 study on CMM Capability, Accuracy and Stability - Processes, Machines, etc. 2
N MSA Study for a Leak Testing Device Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Do I need part variation while doing Destructive Variable Gage R&R MSA study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
Prashant G MSA Study - AS 9100 and and our customer want us to do MSA study for their parts dimension Reliability Analysis - Predictions, Testing and Standards 4
Ajit Basrur How do I label this commercial product ready for clinical study? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Safety and efficacy study for CE marking CE Marking (Conformité Européene) / CB Scheme 1
J AIAG PPAP: 2.2.11.3 Acceptance Criteria for Initial Study (page 9, 4th edition) APQP and PPAP 1
A Audit purpose - case study - What is the role of SQE in such case? General Auditing Discussions 3
E MSA Study on MTS dynamic rate measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K Student wanting Case Study about Internal Audit Report Internal Auditing 1
T RAC US Spring 2019 certification - Study group Professional Certifications and Degrees 5
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
G Plotting capability study data - I have a bimodular data distribution Capability, Accuracy and Stability - Processes, Machines, etc. 4
A Accelerated aging and real time study EU Medical Device Regulations 2
F Extension of a stability study for an API Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A Expanded GR&R Study questions Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Users won't return devices from pre-CE performance evaluation study EU Medical Device Regulations 3
S ITA (Investigational Testing Authorization) for Clinical Feasibility Study Canada Medical Device Regulations 4
J GLP requirements in preclinical study CE Marking (Conformité Européene) / CB Scheme 3
O MSA Study for a steel ruler Manufacturing and Related Processes 6

Similar threads

Top Bottom