Electronic Gauge Measuring Various Heights and Lengths - Your Opinion On our problem

D

D Moore

#1
Hello.

We are currently undergoing a launch programme for Flywheels for Ford Motor company.

We have taken receipt of some gauges, one in particular is causing us some headache.

It is an electronic gauge measuring various heights and lengths.

We have issues with a number of measurements. We measure a height on the flywheel from the dayum bore and face using one transducer. During study this transducer has shown to have 9.8%GRR. Our issue is that three other measurements are measured off this transducer/face. This means then that the other measurements start with a 9.8% possible variation. The actual GRR for these dimensions are 18.67%.

I have two questions.....

Do you think this is an exceptable figure to sign off the gauge bearing in mind they are non-critical features?

Will this possible variation increase or decrease our machine capability? i.e. we have run 32 parts off a newly installed machine and performed capability using this gauge. Will the possible gauge error mean that the machine capability is better or worse? Interestingly, the dimension i stated before where we had 9.8% GRR is showing incapable on machine study.

Cheers
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Your Opinion On our problem

Hello.

We are currently undergoing a launch programme for Flywheels for Ford Motor company.

We have taken receipt of some gauges, one in particular is causing us some headache.

It is an electronic gauge measuring various heights and lengths.

We have issues with a number of measurements. We measure a height on the flywheel from the dayum bore and face using one transducer. During study this transducer has shown to have 9.8%GRR. Our issue is that three other measurements are measured off this transducer/face. This means then that the other measurements start with a 9.8% possible variation. The actual GRR for these dimensions are 18.67%.

I have two questions.....

Do you think this is an exceptable figure to sign off the gauge bearing in mind they are non-critical features?

Will this possible variation increase or decrease our machine capability? i.e. we have run 32 parts off a newly installed machine and performed capability using this gauge. Will the possible gauge error mean that the machine capability is better or worse? Interestingly, the dimension i stated before where we had 9.8% GRR is showing incapable on machine study.

Cheers
It would be helpful if you could post your actual GR&R output; it's hard to see what's actually going on without it. In the meantime, a few questions and observations:

  • What do you mean by "We have taken receipt of some gauges"? Was this a device made to your specifications, or something supplied by a customer?
  • Whether or not the MSA results are acceptable is a function of the level of risk you're willing to assume, and how much tolerance (and tolerance stackup) you have. You need to know how much of the tolerance might be consumed by measurement error, and how much you have left.
  • Measurement error is not directly related to machine capability, but might make it more difficult to appraise. In other words, the machine's capability is independent of your ability to measure it.
  • 32 parts is probably not enough to understand process capability. Before doing capability analysis (Cpk, e.g.) you need to understand the underlying statistical distribution and verify statistical stability. If you're dealing with a machining operation you're probably not dealing with a normal distribution.
  • Two of our regular contributors, bobdoering and Miner, have posted a lot of very good and relevant information related to MSA and SPC for machining in their Cove blogs. Miner's blog is here and bobdoering's is here.
 
Thread starter Similar threads Forum Replies Date
S How to Locate Parts during Measuring with an Electronic Height Gauge General Measurement Device and Calibration Topics 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 7
S Reporting REACH - Electronic components distributor REACH and RoHS Conversations 5
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
D Advice on capturing electronic signatures ISO 13485:2016 - Medical Device Quality Management Systems 8
C Shelf life electronic components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Cleaning of electronic transmitter Other Medical Device Related Standards 2
D Preservation of Electronic Data / Information Technology ISO 13485:2016 - Medical Device Quality Management Systems 5
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
R Electronic and hand-written footnotes for GDP Document Control Systems, Procedures, Forms and Templates 1
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S FDA's E submitter - For clinical electronic thermometer Medical Device and FDA Regulations and Standards News 6
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
T Electronic ECO/ECR Process - Software recommendations Document Control Systems, Procedures, Forms and Templates 3
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
D Benefits of electronic QMS software Software Quality Assurance 5
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
R Electronic handwritten signatures for approvals - Signed with a Stylus or a Finger Document Control Systems, Procedures, Forms and Templates 2
WEAVER Electronic Weighing Scale Calibration Tolerance Manufacturing and Related Processes 1
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P FDA inspections and electronic signatures Other US Medical Device Regulations 2
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Looking to move to an electronic QMS software Software Quality Assurance 11
QIE Electronic IFU - new project, need input Other Medical Device and Orthopedic Related Topics 0
U Electronic templates for making paper control charts Reliability Analysis - Predictions, Testing and Standards 2
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
P Electronic component failure analysis turnaround time Reliability Analysis - Predictions, Testing and Standards 0
W Part Change Request - Standard (OTS) electronic parts (resistors, capacitors etc.) IATF 16949 - Automotive Quality Systems Standard 3
C In cases where users of an electronic system change their names Qualification and Validation (including 21 CFR Part 11) 6
A How a test flow can be build for a car electronic sunroof control Reliability Analysis - Predictions, Testing and Standards 6
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
N Electronic Instructions for use (eIFU) EU Medical Device Regulations 2
M Electronic Signature - Certificate Qualification and Validation (including 21 CFR Part 11) 8
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
M Medical Device News FDA News - 12-09-18 - MD Submissions to Electronic Format to Improve Efficiency Other US Medical Device Regulations 0
Q Real Time Electronic SPC/Control Charting Statistical Analysis Tools, Techniques and SPC 4
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
L Inspection Process for Electronic Parts from Brokers Supplier Quality Assurance and other Supplier Issues 1
N How is documentation affected moving to an electronic system? ISO 13485:2016 - Medical Device Quality Management Systems 13
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
W ISO 14155 - Electronic clinical data systems - Definition Other Medical Device Related Standards 0
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
G Auto electronic signature on Calibration Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S FDA electronic submission gateway (ESG): FAILED eMDR Submission Other US Medical Device Regulations 3
G What's your favourite method of Electronic Folder Filing? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M How to get an electronic version of IATF 16949:2016 which is Searchable IATF 16949 - Automotive Quality Systems Standard 8
J Quality Testing for Tea, Electronic Noses and Such Manufacturing and Related Processes 5

Similar threads

Top Bottom