4.11.4 MSA is R&R Enough? Linearity, bias, stability necessary as well?

S

saleh.E

#1
During our last surveillance audit, we were told by the auditor that just doing gage R&R is not enugh to satisfy this requirment. He said that to pass this part of the audit next time, we would have to do more. The requirement says "Appropriate statistical studies...." In my applications, I feel R&R alone is appropriate.
two questions:
1)Has anyone else heard of this requirement?
2)Who defines what is "appropriate" or not?
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
Admin
#2
They want you to address MSA, not just the R&R part. Linearity, bias, stability, etc.

Nope - R&R used to be 'enough'. That 'changed' several years ago.
 
D

Dan Larsen

#3
A question here...can the linearity, bias, stability issue for existing systems be answered with manufacturer statements for the existing gauging systems? Procedures would be required to evaluate these characteristics for any new systems put in place.
 

Marc

Fully vaccinated are you?
Leader
Admin
#4
I'm going to start out by referring you to Elsmar.com/level2/cal_q1.html It's a bit of a read but all in all gives you some idea of the history and debate involved here.

As far as I understand it (I haven't been through a QS implementation in over a year and things do change) NO - You can take that as a 'starting point' and you can use their uncertainty statement for use in your uncertainty calculations, but that's not what is going on here. They want you to explain your system and show what you're tracking 'statistically'. I used to argue that about all that was necessary was R&R but that changed.

The latest is:

->QS 9000 if implemented as per requirement does in fact
->require a MSA on all of your measurement devices denoted
->on the Control plan. The definition of MSA is Gauge
->Repeatability & Reproducibility, Stability, Linearity and
->Bias. All five studies are required on each type of
->measurement device.
 
Thread starter Similar threads Forum Replies Date
Miner Advanced MSA of Continuous Data Part 3: Are 3 Operators or 2 Replicates Enough? Imported Legacy Blogs 0
Miner Advanced MSA of Continuous Data Part 2: Are 10 Parts Enough? Imported Legacy Blogs 0
S MSA annual plan Capability, Accuracy and Stability - Processes, Machines, etc. 4
S If 4 operate to measure, what is the value of k2?(MSA gage R&R) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
8 MSA--Should I Use Parts or Gage Pins? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
W Conducting an MSA Test on scales Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A MSA samples Preparation. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N MSA Frequency related literature Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A %AV=0 in the MSA GRR Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M MSA - Dealing with inherent within-part variation in assemblies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
T Ford Q1 MSA - Virtual Site Visit Hardware Manufacturing and Related Processes 14
R MSA on set of parts with low variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
E MSA Reference Manual 2nd Edition Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
W Medical Device - fixture qualification and MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
V MSA - Using a R&R study for a Tape Measure Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
F MSA for non-contact CMM - ISO10360 Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
T Thermometers and Thermocouple or Transducer's require MSA? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R MSA Studies for chemical analytical instruments in QC Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A IATF MSA study Type 1 General Measurement Device and Calibration Topics 7
Nihls MSA after the device move Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
Ashland78 MSA clause or wording needed. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
S MSA clause 7.1.5.1.1 - Statistical studies on counting weight scale Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Nihls MSA Study Type 2 (special conditions ) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
Nihls When the MSA results show no operator influence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
S MSA for attribute relation gage Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Nihls MSA Study Type 1 (CMM) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
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
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 11
H Need MSA 4th ed. compliant attribute MSA template General Measurement Device and Calibration Topics 4
P MSA for titration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D MSA strategy Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
K Updated MSA with the Annual PPAP validations APQP and PPAP 8
E MSA for Push and Pull test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
6 MSA for Calculated Clearance Dimension Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
G MSA check list to audit IATF 16949 - Automotive Quality Systems Standard 10
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Bev D MSA Tools Misc. Quality Assurance and Business Systems Related Topics 3
R MSA studies for Heat Treatment Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 2
A MSA results differences - Supplier results vs. My results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R Preliminary MSA and Sockets' correlation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
T Correct MSA study for an automated camera system which makes attribute inspection Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1

Similar threads

Top Bottom