REVISION RECORD SHEET

TITLE : PROCEDURE FOR STATISTICAL TECHNIQUES.

REV.NO 00 DESC. OF AMENDMENT PROCEDURE INTRODUCED. DATE OF AMENDMENT 14.06.1997

PR.NO : QP-09-05 PAGE NO : 1 OF 9 ISSUE NO : 01 REV NO : 00 DATE : 14.06.1997 REASON FOR AMENDMENT QS 9000 : 1995 UPDATION

DISTRIBUTED TO :
SL.NO DESIGNATION NAME & SIGNATURE OF THE RECEIVER

PREPARED BY:

REVIEWED & RELEASE CONTROLLED BY :

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

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Purpose : 1. 2. Scope

To Identify the need for statistical techniques. To establish statistical process control through the implementation of Statistical Techniques.

: Statistical Process Control shall be applied for all special characteristics identified and any others identified during Advanced Product Quality Planning stage by C. F. T. Statistical Process Control - Statistical Process Control - SPC - refers to the rigorous and systematic application of statistical techniques to reduce undesirable variability in our products and processes, thereby, improving overall quality and productivity. 3. Concept of variation CONCEPT EXAMPLE # 1 EXAMPLE # 2

Procedure :

Everthing variesPeople live to Different Ages.All partterns fluctuateIndividual things are unpredictable.No one knows how long he himself will live.The individual points are unpredictable.Groups of things from a constant system of causes tend to be predictable.Insurance companies can tell with a great deal of accuracy what % of people will live to a given age.A group of series of points from a constant process will tend to follow a patterns that obeys a fixed law.

4.

Types of Variation 5. Varitation due to Chance or common causes : 6. 7. 8. 9. Slight variation in raw-material. Slight machine vibration. Lack of human perfection in reading Instruments.

Variation due to Assignable or special causes : 10. 11. 12. Batch of defective raw-material. Faulty machine set-up. Uncalibrated test equipment or untrained operator.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.
13. Conclusion -

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14. 15. 16. 17. 18. 19. 20.

All manufacturing processes have variability. The control of quality is the control of this variability. Causes of variability are either chance or assignable. Assignable causes can be found and eliminated We can predict the future in terms of past behaviour. The only economic way to improve a process in control is to change the system.

S P C System 21. Select the problem Pareto Chart

Pareto Chart is a bar graph in magnitude order used to aid in the selection of the problem to work on. 22. 23. 24. 25. 26. The problem that presents the largest opportunity for gain. The problem that costs the most. The problem that occurs most frequently. State the problem in clear, definite terms. Process Flow Chart

Define the process

A process flow chart is a schematic diagram used to sequentially analyze the steps of any product or system flow. 27. List of possible problem causes Fishbone Diagram

A fishbone diagram is a technique that breaks the problem causes down to their smallest elements. 28. 29. 30. Brainstorm possible causes. Develop cause and effect diagrams. Fishbone Diagram

Select key process variable

Determine from the fishbone the most probable cause(s) to study. Carefully discern the correct product and process combination that requires attention. 31. 32. Prioritize possible causes. Determine ability to resolve.
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QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

If special characteristics are identified during APQP by CFT, the above 4 steps shall be by passed and step 5 and onwards shall be applicable. 33. Collect Data Sample sizeClass Interval51 - 1007101 - 2008201 - 5009501 100010Over 100011 - 15

34. 35. 36. 37.

Gather facts about the most probable cause(s) to study. Study process variables not product variables. Planning for collection is a critical step.

Conduct the initial SPC study as per the following points : 38. 39. 40. 41. Select sample size between 60 to 100 to the same degree of accuracy. Find out maximum and minimum readings. Calculate Range (R) = Maximum - Minimum reading reading Select the class interval as per the following table :

R+W 42. Calculate class width (C) = K Where, W = Least count of the instrument used. K = No. of used class interval. 43. Then, Calculate class boundary. = X min - 0.500

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

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QP-09-05 5 OF 9 01 00 14.06.1997

Prepare the frequency distribution table as mentioned below :

Sl. NoClass BoundaryTally markFrequency

Read the observation in order and for each observation put tally mark against the particular interval containing that value. Count the total number of tally mark in each class to give the frequency of that class. Draw the Histogram by taking class boundary as OX axis and freqency as OY axis. Verify whether the graph follows normal distribution i.e. bell shapre curve. If the graph obtained is of bell shape, then, the current process is said to be statistically stable, then, go for capability study : Cpk for Ongoing Process Capability, and ; Ppk (Preliminary Process Capability) for PPAP.

Ongoing Process Capability. Take minimum 21 sample readings at a sub group size of 3 to 5. Compute X and R for each sub group. Calculate R for the entire set of samples. Calculate UCL and LCL for R Chart by using appropriate D4 and D3 factors using the formulas as given below : UCL R = D4 R LCL R = D3 R n 2 3 4 5 6 7 8 9 10 D4 3.27 2.57 2.28 2.11 2.00 1.92 1.86 1.82 1.78 D3 * * * * * .08 .14 .18 .22 A2 1.88 1.19 .80 .69 .55 .51 .43 .41 .36 * There is no lower control limit for ranges for sample sizes below 7.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

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Check if any value are out side the control limits. If all values are within limits proceed to next step. If there are one or two values out side the control limits; that sub group is suspected to be influenced by assignable causes eliminate that samples giving rise to R values out of limits and recalculate R and control limits as same above, this is called HOMOGENISATION TECHNIQUE. If it necessitates discarding a large number of sub group that is more than 25 % of the sub groups. It may conclude that the data

were under erratic process condition. In such a situation, it is advisable to discard the entire data and carry out fresh study. Calculate X for all samples excluding any sample that may have been eliminated for R chart. Calculate UCL and LCL for the X chart using appropriate value of A2 by using the formulas UCL X = X + A2R LCL X = X - A2R Check all X values are within limits and proceed as given above for R chart and calculate process capability for the same process by using the following formulae. Potential Process Capability : USL - LSL Cp = 6 Ongoing Process Capability index : USL - X Cpk = Min. 3 Where, X is Process mean. & 3 X - LSL = d2 R

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

PR.NO : PAGE NO : ISSUE NO : REV NO : DATE :

QP-09-05 7 OF 9 01 00 14.06.1997

If Cpk(min.) 1.33, then, this process is said to be capable. If it is less than given above, find out the assignable causes affecting the process, after eliminating those, go for fresh data and repeat the same process up to the process as explained above to re-calculate Cp and Cpk values.

Preliminary Process Capability Study (Ppk Study) or Initial Study Minimum 63 sample readings to be taken in a minimum sub group of 3. Compute X & S for each sub group X 13.272.572.272.091.971.881.821.761.72 + X2 + X3 + - - - - - - Xn n2345678910B B ****0.030.120.190.24
0.28A32.661.951.951.431.241.181.101.030.98 C40.7980.8860.8860.9400.9520.9590 .9650.9690.973
4 3

X = n (X1 - X) 2 + (X2 - X)2 + (X3 - X)2 S = n-1 Calculate S for entire set of samples. S S = K Compute the upper and lower control limits. UCL = B4S & LCL = B 3S

Where B3 & B4 are statistical constant which depend on subgroup size n given below :

If any sub group / standard deviation exceeds its upper control limit the sub group is suspected to be influenced by assignable causes. The mean standard deviation S and the corresponding control limits are re-calculated after discarding the suspected sub group. This is called homogenisation of standard deviation.

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

PR.NO : PAGE NO : ISSUE NO : REV NO : DATE :

QP-09-05 8 OF 9 01 00 14.06.1997

If it necessitates discarding a large number of sub groups that is more than 25% of the sub groups one may conclude that the data were under erratic process condition. In such a situation, it is advisable to discard the entire data and carry out fresh study. Calculate UCL and LCL for X chart using appropriate value of A3 given above. Check all individual values are within limits and proceed as given above for S chart and calculate process capability by using following formulae. Potential Capability : USL - LSL Pp = s = S

6s Preliminary Process Capability : USL - X Ppk = Min. 3s Where, X is Process mean. &

c2

X - LSL 3s

If Ppk 1.67 , then, this process is said to be capable. If it is less than given above, find out the assignable causes affecting the process, after eliminating those, go for fresh data and repeat the same process up to the process as explained above to recalculate Pp and Ppk values.

Control Chart. Once process is found capable from the above on going process capability study, these values can be used on Control Charts. Select appropriate scales X and R charts. The X axis for both the charts has to be identical. Space provided for R chart is usually double than that provided for X chart on the Y axis. The scale spacing for the S chart should be the same asper its corresponding X chart. Draw the central lines as continuous lines and control limits as dotted lines in both the charts.
PR.NO : PAGE NO : ISSUE NO : REV NO : DATE : QP-09-05 9 OF 9 01 00 14.06.1997

QUALITY ASSURANCE PROCEDURE

TITLE : Procedure for Statistical Techniques.

Plot all values of X and R on the charts and look for patterns & trends, indications of the process going out of control or changing, making it necessary to take corrective actions. If any, changes have been occured in the process, such as the source of a material has changed, a major repair work has been under taken, a tool changed, some process parameters have been changed, or any adjustments are made, these are recorded on the process log sheet . Continuously monitored the ongoing process through the above mentioned control chart. If S is the final revised mean standard deviation process standard deviation is estimated as S / C2 and process capability as 6S / C2. C2 & d2 are statistical constants which depend on the sub group size n given in same format above .

If any special characteristics found unstable / non-capable, due to any reason, then, 100 % inspection for the above parameter to be continued till further capabilities are established.