Ref. No.

RPK-WI-QA-05
Work Instruction Rev. No. &
01/13.01.2019
Statistical Process Control Date
Issue Date 20.09.2011

Format No. for SPC: - RPK/FR/QA-09C Rev. 01 , dtd. 26.11.2018

Conduct SPC:
1. For initial submission (PPAP Samples)
2. Once per month for 3 month or initial 3 lots whichever later during safe launch period as
identified in Control Plan.
3. As per SPC yearly plan.

Purpose: To establish a method for improving statistical control and verify the capability.

Scope : For the special characteristics identified (variable), and decided by MDT

A. For Preliminary Process Control (Process Capability) :

1. This Preliminary process study is to be carried out during the new Product / Process
Development or change in the existing process )
2. “X bar – R” chart / “X bar – S” chart can be used to study the preliminary
process performance.
3. Ensure that the measurement system is acceptable before conducting preliminary Statistical
Process Capability study.
4. The study should be based on at least a total of 50 individual readings (short term).
5. Interpret the control chart for stability (control), If stability is not achieved determine appropriate
action.
6. Interpret for capability (process performance). The 6 range of a process total variation, where 
is usually estimated by the standard deviation (S), calculated using all of the individual values .
N
 Sq.Root ( Xi – X BAR)2
STANDARD DEVIATION ( S ) = 1--------------------------------- , Where N = Total No. Of Readings
N –1

USL – LSL
Pp = --------------- &
6s
USL - X double bar X double bar -LSL
Ppk = Min {( --------------------------------- ),(------------------------------)}
3 sigma(s) 3 sigma (s)

Note : It should be used only to compare to or with Cp and Cpk and to measure and prioritised
improvement over time. Calculate the Ppk index and take the following actions.
RESULTS INTERPRETAION
Processes that The process probably meets requirements.
appear stable
Pp & Ppk > 2.0
1.67 < Ppk < 2.0 The process may not meet requirements. Give additional attention to the
characteristic until ongoing Cpk > 1.67 is achieved.
Process that appear Unstable Depending on the nature of the instability, the process may not
Unstable meet requirements. Special Causes should be identified, evaluated and
whenever possible, eliminate. Use 100% inspection & increase SPC
sampling until ongoing stability with a Cpk of 1.67 is demonstrated or
until the customer is satisfied. Process improvement must be given a
high priority and documented in a corrective action plan.
 Ref. No. RPK-WI-QA-05
Work Instruction Rev. No. &
01/13.01.2019
Statistical Process Control Date
Issue Date 20.09.2011

B. On Going Process Capability Study :

1. Ensure the measurement is appropriate i.e. (least count of instrument is at least 1/5 th of the
expected process variation (or) 1/10th of tolerance whichever is less).
2. Before collecting data, ensure that there are no obvious deficiencies like faulty gauge, loose
clamp, improper tool etc.,
3. Ensure R&R (MSA study) is carried out for the measurement system and it is acceptable.

Data Collection :
4. Plan the data collection like how many samples, what frequencies, who will measure, the format
etc. also decide which process parameters needs to be monitored during study. Generally up to
10 or more subgroups containing about 50 or more individual readings give a good test of
stability (for control chart method).
5. The frequency of subgroup should be based on the prior knowledge on repetitiveness of the
process & the rate of production. It gives a good estimation.
6. While collecting data, note down all the process events with respect to time.
7. Select suitable scale for the control chart. (Generally for X bar chart, the scale should be
such that the UCL / LCL should occupy approx.50 % the middle of the chart. For R chart, the
scale should be double that of X bar chart.)
8. Calculate the average (X bar and range R of each sub-group).
9. Plot the average and ranges on the control chart, connect the points with lines.
9.1 : Significant process events, such as tool change or machine repair, must be recorded on the
control Chart.
10. Ensure that the calculation and plots are correct.
11. For the charts UCL and LCL value not calculated shall be mentioned as ‘INITIAL STUDY’ on the
date column.

Calculate Control Limits :

R-chart
R1 + R2 + …. + Rn
R bar = ------------------------------------ , N = No. of subgroups
N
Xbar.1 + Xbar.2 + … + Xbar.n
Xbar = -------------------------------------------
N
Then,
UCLr = D4R bar , LCLr = D3R bar , D4, D3 are constants varying by sample size.

12. Draw lines for the averages and the control limits on the charts.

Interpretations For Control :

13. Analyse the data for control in prediction. Check the existence of Special causes as per
conditions given under action on Special Causes on Control Chart. If the process is not under
control (i.e. approximately more than 20% of points fall outside limits) study the process using
cause and effect diagram prepared for that process.
14. Establish control by taking action on the process and repeat the study

Homogenisation :
15. Re-calculate the control limits with the excluded readings of out of control point affected by
special causes in the R chart. Calculate new average range (R bar) & confirm that all range
points show control when compared to new limits.

Calculate Process Capability :-

16. Once control is established, evaluate process capability Cp & Cpk.
 Ref. No. RPK-WI-QA-05
Work Instruction Rev. No. &
01/13.01.2019
Statistical Process Control Date
Issue Date 20.09.2011

R bar
SIGMA ( ) = ---------
d2

USL - LSL Tolerance

Cp = ------------------ = ----------------
6 6

If Cp is > 1.33 carry out the following steps, else follow step 16.8.

Xbar chart :
Calculate UCL X bar = X double bar + A2 Rbar
LCL X bar = X double bar – A2 R bar

16.1 Follow the steps described 13 to 15 for X bar charts

USL -Xdouble bar Xdouble bar - LSL

16.2 Calculate Cpk = Min (------------------------) or (-------------------------)
3 SIGMA 3 SIGMA

16.3 X bar chart signals the variation in the process averages w.r.t. time, the recorded process
events like dressing, adjusting, tool change etc. should be correlated to the variation in the
control chart.
Xbar charts generally describe the stability of the process, i.e. maintaining the process
average w.r.t. time.

16. 4 If all conditions are satisfied, establish UCL, LCL for both Xbar & R chart & use it for on going
control, mention the date on which control limits calculated in the ongoing control chart.

16.5 Based on the knowledge obtained from the interpretation and process knowledge establish
corrective action instructions to prevent the defects due to probable special causes which
occurs during on going process. Establish disposition action instructions when out of control
situation occurs, depends upon the Cp and Cpk values as per the following table.
 Ref. No. RPK-WI-QA-05
Work Instruction Rev. No. &
01/13.01.2019
Statistical Process Control Date
Issue Date 20.09.2011

The MOST RECENT ACTIONS ON THE PROCESS OUTPUT

POINT indicates that Based on the Ongoing process capability (Cpk)
the process
Less than 1.33 ** 1.33 - 1.67 Greater than
1.67
Is in Control 100% inspect Accept product Continue to reduce product
variation.
Has gone out of control IDENTIFY & CORRECT SPECIAL CAUSE
in an adverse direction.
All
individuals in the sample Inspect 100% since the last Accept product
are within specification. 100% Inspect in-control point. Continue to
reduce product
variation.

Has gone out of control IDENTIFY & CORRECT SPECIAL CAUSE

in an
and one more 100% inspect product produced since the last in-
individuals in the sample 100% Inspect control sample..
are outside
specification
16.6 The process shall be focused at the mean to achieve Cpk to the value of Cp, depends upon
the process.

16.7 Periodically review the control charts for

a) Repetitive out of control conditions and its causes
b) Effectiveness of SPC implementation w.r.t actual Vs estimated rejections.
c) Continuous improvement plan can be initiated for the special characteristics identified once
if the stability & required capability is achieved (Cpk>1.67) to reduce the variation.
d) Review and revision of control limits on evidence of improvement.

16.8 If Cp & Cpk is less than 1.67 , QA I/C shall initiate a corrective action with resp. & target to
achieve the desired process capability index. Till that time, 100% inspection shall be carried
out at that station / at final inspection as appropriate.

COMPILED BY CHECKED BY APPROVED BY

NAME
SIGNATURE AND

DATE