Is it possible to get Natural Tolerance (Tn) with Non Normal Distribution?

M

Mark_Navigator

Hi all,

this is a question so long in doubt for me and that I need......
If I get a non normal distribution, Am I able to calculate and communicate to the designer the actual process natural tolerance, if the distribution found is non normal?
Specially with new processes and no Tp (project tolerance) given, the natural tolerance is the crucial information..........
Thank you whoever explain me and to all this "heavy" question............
 

Bev D

Heretical Statistician
Leader
Super Moderator
if this is for design and you aren't doing statistical tolerancing (which you shouldn't do if the distibution isn't known) AND you have representative data (several lots, set-ups, different operators, raw materials etc.) you can probably safely use the min and max values of the observed data
 
M

Mark_Navigator

Sorry, but your answer doesn't seem to fully match my question........
The question is to get the natural tolerance of the process with non normal distribution, specially in the case I tried, with a not previous designed dimension in a new product zero series production........
 
B

Barbara B

The so called natural tolerance is the area which covers hte middle 99.73% of a distribution. (0.27% of the distribution values will be outside of this area). The limits of this range are defined by the 0.27%/2 = 0.135% quantile (lower limit) and the 100% - 0.27%/2 = 99.865% quantile (upper limit), independent of the distribution itself.

In case you have normally distributed data, the lower limit is equal to
mean - 3*stddev
and the upper limit is equal to
mean +n 3*stddev

For other distributions the quantiles could be calculated using a statistical software package (e.g. Minitab, JMP, R) if thes provide quantile calculations for the specific distribution you're interested in.
 
M

Mark_Navigator

Thank you so much Barbara, I know, but how can MINITAB (that we use in our company for statistical analisys) calculate the 99,73% area for non normal distributions?
I'm a Clements' method sympathizer, but it's not mentioned in MINITAB and I tried by myself to use it but I got some doubts about the usage....(like the "teta" table selection for specified skewness and kurtosis data).......
Thank you for your support.....
 
B

Barbara B

Thank you so much Barbara, I know, but how can MINITAB (that we use in our company for statistical analisys) calculate the 99,73% area for non normal distributions?
  1. Choose a distribution for your data (it should suit the measurement situation, e.g. Weibull for reliability data)
  2. Estimate the parameters of the distribution, e.g. using
    Graph > Probability Plot > Single
    Graph variables: [name of the data column]
    > Distribution: [select the distribution from the drop down list on tab "Distributions"]
    > OK > OK
  3. Check if there are any relevant/significant deviations visible on the probability plot (points should lie within the 95% confidence limits, points should follow the blue line in a linear manner) and if the distribution test reveals any significance (p-value should be above 5%). If the distribution could be used to model the data, proceed with the next step. If not, ask yourself what systematic effects are present in your process and/or if your process is stable at all. Afterwards eliminate all systematic effects and/or stabilize your process and go back to step 1.
  4. Calculate the 0.135% and 99.865% quantile:
    1. Fill in the percentage values (e.g. 0.00135 for the lower quantile and 0,99865 for the upper quantile) in an empty colum of your worksheet (e.g. c2)
    2. Calc > Probability Distribution > [select appropriate distribution, see step 3]
      select "inverse cumulative probability" (=quantile function)
      fill in the estimated distribution parameters (e.g. shape and scale for Weibull)
      select the input column (e.g. c2) and an empty column for the calculated quantiles (e.g. c3)
      > OK

I'm a Clements' method sympathizer, but it's not mentioned in MINITAB and I tried by myself to use it but I got some doubts about the usage....(like the "teta" table selection for specified skewness and kurtosis data).......
I appreciate this apparent "lack" of feature in Minitab, because the Clements/Pearson method is not useful to obtain reliable capability indices.

In ISO/TR 22514-4:2007: "Statistical methods in process management -- Capability and performance -- Part 4: Process capability estimates and performance measures" it is stated that a Johnson transformation or the usage of the Pearson/Clement's method shouldn't be used as a standard calculation (see p.20):
5.5.3 Pearson curves method
[...]
This method is not preferred but is presented here for completenesss due to its occasional use.

This approach, and a similar one based on Johnson curve, should be regarded with considerable caution, especially when it is a procedure within a "black box" computer program used to analyse large sets of data.[...]

But you can use this approach and say that your method is in compliance with a standard (or technical report TR). In the end you'll get non-informative numbers which can be called "process capability indices". (Sorry for being that blunt. I know it is hard to find a useful and reliable statitistical method for capabilities.) Just take a look at the attached paper to get an impression for yourself how "reliable" the Pearson/Clement's-method and the Johnson as well as the Box-Cox transformation are.

Thank you for your support.....
Your're welcome :bigwave:
 

Attachments

  • How reliable are different methods for capability indices.pdf
    579.3 KB · Views: 191

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
Just take a look at the attached paper to get an impression for yourself how "reliable" the Pearson/Clement's-method and the Johnson as well as the Box-Cox transformation are.

Awesome paper - it is the approach I have been supporting for a long time! If you don't use the right model the results realy have a hard time being correct!
 
M

Mark_Navigator

Hi Barbara,

I'm trying your instructions but I'm not able to go on with point 4:

It's not clear for me at subpoint No.1 -> "Fill in the percentage values (e.g. 0.00135 for the lower quantile and 0,99865 for the upper quantile) in an empty colum of your worksheet (e.g. c2)".
Which percentage values do I have to fill in there? How can I find that values?
 
B

Barbara B

Which percentage values do I have to fill in there? How can I find that values?
The limits of the natural process spread (or natural tolerance) are given by the 0.135%- and 99.865%-quantiles of a distribution. You don't have to choose other values, but simply use those two numbers for the calculation.

Attached you'll find 3 screenshots with an example for simulated Weibull data (first column / c1 / "data").
  • Fig 1: Fill in the percentage values for process spread quantiles (0.00135 and 0.99865)
  • Fig 2: Use Calc > Probability Distribution > [select distribution, here: Weibull],
    1. Choose "Inverse cumulative probability"
    2. Fill in the distribution parameters provided in the probability plot (e.g. shape 1.294 and scale 183.1) and
    3. select "Input column:" c2 (second column, the one which contains the percentages for quantiles).
    4. To store the quantile values within the worksheet, fill in a number of an empty column in the worksheet (e.g. c3 for column 3).
  • Fig 3: Result of the settings: quantile values are stored in the worksheet column 3 (c3): 1.110 for the 0.135% quantile, 787.805 for the 99.865% quantile
  • Finally you can calculate the 99.73% process spread or natural tolerance (nt) by subtracting the lower 0.135%-quantile from the upper 99.865%-quantile
    nt = Q(99.865%) - Q(0.135%) = 787.805 - 1.110 = 786.695

Hope this helps :bigwave:

Barbara
 

Attachments

  • Quantiles in Minitab 1.png
    Quantiles in Minitab 1.png
    4 KB · Views: 176
  • Quantiles in Minitab 2.png
    Quantiles in Minitab 2.png
    22.1 KB · Views: 186
  • Quantiles in Minitab 3 - result.png
    Quantiles in Minitab 3 - result.png
    11.2 KB · Views: 177
M

Mark_Navigator

Thank you so much, Barbara!!!

Now I finished to test the procedure and it's so.....wonderful!!!!
I got the "nt" of one my non normal distribution found!!!!!
You open me and probably in my factory a very, very important way!!! No I'm able to get all indicators for also non normal distributions!!! GREAT!!!!
Another time, thank you so much, you've been so useful!!!!! You're my Guru!!!!!
:applause::applause::applause::applause::applause::applause::thanx::thanx::thanx::thanx:
 
Thread starter Similar threads Forum Replies Date
S Possible termination of MDD Certificate CE Marking (Conformité Européene) / CB Scheme 4
M It is Possible to apply a wall plug power adapter to provide power from the actuators of a dialysis chair or hospital bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
MaHoDie Is it possible to assign medical software to security class A (according to IEC 62304)? EU Medical Device Regulations 8
B SAE J 524 Pressure Test/Possible conflicting requirements? Manufacturing and Related Processes 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 5
S Operation of possible rework in control plan FMEA and Control Plans 8
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
C Narrow definition of IMTE or calibration possible? ISO 13485:2016 - Medical Device Quality Management Systems 8
L Reduce risks as far as possible - Quartz Crystal ISO 14971 - Medical Device Risk Management 11
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0
K Silver Plating corroding possible during SMT Manufacturing and Related Processes 10
K Is it possible to avoid the OQ? ISO 13485:2016 - Medical Device Quality Management Systems 20
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
M Informational EU – Possible EUDAMED delay Medical Device and FDA Regulations and Standards News 3
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
dhuot1990 USP 41 Hanging Scale - Is it possible to make a hang scale adhere to USP41 Standards? ISO 17025 related Discussions 3
F Apple Watch is not a medical device. How can this be possible? CE Marking (Conformité Européene) / CB Scheme 1
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Ashok sunder Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints? FMEA and Control Plans 6
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G ISO 9001:2015 - Is control possible with Excel adaptable measurement sheets? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S Indications for Use - Is it possible to have a different indication for use EU Medical Device Regulations 3
C %GRR <10% not possible. How to get approval by auditor? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
M Is Automated Internal Auditing Possible? Internal Auditing 13
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Is it possible to receive EASA STC within 48 hours after modification? EASA and JAA Aviation Standards and Requirements 1
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Marc Yahoo probes possible huge data breach - BBC News - 2016 World News 1
Marc Yahoo probes possible huge data breach World News 0
S Preparing a Root Cause Report - Possible Root Causes Document Control Systems, Procedures, Forms and Templates 11
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Is it possible to have more than one authorized representative in Saudi Arabia? Other Medical Device Regulations World-Wide 6
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
T Reduced Audit days when UPGRADING from AS9100 to TS16949 - Is it possible? IATF 16949 - Automotive Quality Systems Standard 2
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom