Warning as to MSA 3rd edition worksheets

Howard Atkins

Howard Atkins

Forum Administrator
Leader
Admin
Some of the worksheets that have been posted here which are based on the 3rd edition of the MSA book are not correct.
Some, including those posted by me, have had the constants changed but not properly converted.
Please see this thread MSA using tolerances - Page 116 of the AIAG MSA manual
Please treat all worksheets that are downloaded as suspicious.
A good example of the application of 7.6

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
Click to expand...
 
Marc

Marc

Fully vaccinated are you?
Leader
If anyone finds a 'defective' MSA 3rd edition worksheet file, let me or a moderator know the thread and post it is in so we can delete it.

Howard - What will happen if someone inadvertantly uses a defective worksheet?
 
Howard Atkins

Howard Atkins

Forum Administrator
Leader
Admin
As far as I know the result will be slightly different, this could be good or bad depending on your point of view.
Please read the referenced thread to get an explanation
 
D

dougvk

This is an interesting note for me. I have been using the examples, notably pages 114-123 and appendix A to work through the examples. I am trying to develop a spreadsheet to take the ANOVA calculations from Minitab and turn the result into a GRR study. I have not been able to duplicate the results from the MSA. Table 8, p120 gives a MS value of .04598 for Equipment. The square root of that is .2144 Which according to the variance estimate formula on p187 (appendix A) should be the standard deviation. However, the tabulated value of standard dev in Table 19b on p 190 shows the sd as 0.199933, which is not .2144 ???

There is also not a clear description of the discussion comparing the result in the 5.15 sigma column of Table 19b which identifies the EV as 1.029656, and the result in table 9 which identifies the EV as .199933

I am sure that I am probaly missing a key point of the discussion... Can someone help me wiht what it is I am missing?

Thanks!
 
Miner

Miner

Forum Moderator
Leader
Admin
Sorry, I don't have time to run through the math right now, but I am bumping this post after the weekend, so others may see it and respond.
 
Miner

Miner

Forum Moderator
Leader
Admin
Any takers? Work has been too hectic lately to allow me time to investigate.
 
P

prototyper

dougvk said:
This is an interesting note for me. I have been using the examples, notably pages 114-123 and appendix A to work through the examples. I am trying to develop a spreadsheet to take the ANOVA calculations from Minitab and turn the result into a GRR study. I have not been able to duplicate the results from the MSA. Table 8, p120 gives a MS value of .04598 for Equipment. The square root of that is .2144 Which according to the variance estimate formula on p187 (appendix A) should be the standard deviation. However, the tabulated value of standard dev in Table 19b on p 190 shows the sd as 0.199933, which is not .2144 ???

There is also not a clear description of the discussion comparing the result in the 5.15 sigma column of Table 19b which identifies the EV as 1.029656, and the result in table 9 which identifies the EV as .199933

I am sure that I am probaly missing a key point of the discussion... Can someone help me wiht what it is I am missing?

Thanks!
Click to expand...

The 5.15 sigma calculation was factored out of the third edition by the AIAG, see the attached link from the AIAG website http://www.aiag.org/StaticContent/files/MSA_Changes.pdf

As a general rule, I would recommend using data from the MSA third edition manual to validate calculations and formulae where appropriate.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
AnaMariaVR2 Warning Letter #627211 DuPont Nutrition USA Inc. (EXCIPIENT MANUFACTURER) US Food and Drug Administration (FDA) 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 5
G Warning about Deltronic Gage Pins - The "Certification of Accuracy" document General Measurement Device and Calibration Topics 13
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
W IMDS - Help (Common Warning and Error Fixes) RoHS, REACH, ELV, IMDS and Restricted Substances 9
N IMDS Warning Polymer Material Two Substances RoHS, REACH, ELV, IMDS and Restricted Substances 8
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
9 EU Medical Device Manufacturer Warning Letters EU Medical Device Regulations 2
H Most Poorly Written FDA Warning Letter Ever? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J FDA 483 Warning Letter for use of Calipers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
W Medical Device Warning Lights Colors IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T FDA Form 483 Warning Letter - What next? US Food and Drug Administration (FDA) 7
S FDA Warning Letter Remediation - Enforcement Resolution & Remediation Process US Food and Drug Administration (FDA) 3
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
AnaMariaVR2 Agila Specialties Private Limited Warning Letter US Food and Drug Administration (FDA) 0
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
AnaMariaVR2 Gilead plant joins the FDA's "warning club" US Food and Drug Administration (FDA) 0
K Where you can read other companys' 483 FDA Warning Letters 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 Jubilant HollisterStier General Partnership [warning letter] US Food and Drug Administration (FDA) 1
M FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead? US Food and Drug Administration (FDA) 10
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
I IMDS Warning - Chromate Filming of Zinc Plating RoHS, REACH, ELV, IMDS and Restricted Substances 4
A FDA 483 Warning Letter Response Time Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
AnaMariaVR2 FDA writes up Warning Letter to British Homeopathic Drugmaker US Food and Drug Administration (FDA) 0
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
M MDR Rules Change Revealed in Warning Letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
AnaMariaVR2 FDA issued Warning Letters to Beckman Coulter - 2011 US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
T FMEA Severity 9 &10 - Example of "with warning?" FMEA and Control Plans 6
A FDA Audit Documentation - Recently released FDA Warning Letter Qualification and Validation (including 21 CFR Part 11) 12
AnaMariaVR2 The Top 12 FDA 2011 Warning Letters Report US Food and Drug Administration (FDA) 7
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
C Cleanroom Class 8 (100,000) Particulate Control and Warning Limits Statistical Analysis Tools, Techniques and SPC 1
AnaMariaVR2 Anulex sees layoffs after FDA warning letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
AnaMariaVR2 Cordis CAPA Warning Letter US Food and Drug Administration (FDA) 0
AnaMariaVR2 Shocking Warning Letter - Baxter Healthcare Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
AnaMariaVR2 4 API Warning Letters focusing on Laboratory Practices US Food and Drug Administration (FDA) 0
E How to Respond to a US FDA untitled letter - Form 483 or Warning Letter Other US Medical Device Regulations 2
AnaMariaVR2 Warning letter addresses lack of training/education 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 22
F Breakdown and Analysis of FDA Warning Letters US Food and Drug Administration (FDA) 11
Jim Wynne Glass-top Patio Tables Shatter Without Warning Coffee Break and Water Cooler Discussions 14
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
C The warning letter of ONBO - Why FDA require identification of 510(k) ownership? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Risk of Bodily Harm - Warning vs. Caution Statements on Medical Device Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom