statistical method in pharma industry

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statistical method in pharma industry

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You are on page 1of 137

Speaker: Heru Purnomo

1

Module Outline

PART 1: Introduction

PART 2: Capability Studies

PART 3: Cp, Cpk and Six Sigma

PART 4: Use of Capability Studies

PART 5: Technical Considerations

PART 6: Control Charts

PART 7: Use of control chart

PART 8: Overview of Statistic Application

PART 1:

Introduction

What is Statistical Process Control?

requirements on a consistent basis. This is achieved by preventing

defects at each stage of the manufacturing process.

By itself will not insure our products, processes and services meet our

customers expectation. Therefore, we assume that all initial work has

been done to meet those requirements such as:

Establishment of specification

Process Characterization

Standards and SOPs

Validation

Training

Where should we use SPC?

Already Been Established:

Customer

Process

Product

So, how do we prevent defects, and build products,

processes and provide services with consistently good

quality?

operation to illustrate various methods of preventing defects.

How Does One Prevent Defects?

?

Two Possible Causes

to Low Cap Never Put

Removal Force Onto Vial

CAP NEVER PLACED ONTO VIAL

cannot occur or cannot go undetected.

Reference

Shingo, Shigeo (1986). Zero Quality Control: Source Inspection and the Poka-yoke System. Productivity

Press, Cambridge, Massachusetts.

Low Removal Forces

Reduction problem.

Low removal forces are prevented by identifying and controlling the key

inputs and establishing proper targets and tolerances.

Reference

Taylor, Wayne A. (1991). Optimization and Variation Reduction I Quality. McGraw-Hill, New York and

ASQC Quality Press, Milwaukee.

Optimization & Variation Reduction

(O.V.R)

Target

Lower Upper

Spec Spec

Limit Limit

Typical O.V.R Problems

Larger the Better

Lower

Spec

Limit

Target

Smaller the Better Upper

Spec

Limit

microbial level

particulate level

contamination level

Target

Lower Upper

Vial fill volume Spec Spec

Potency, Assay Limit Limit

Two Approaches to Preventing

Defects

Mistake Proofing

Reducing Variation

just a few words, Id say it all had to do with

reducing variation.

W. Edward Deming

Tools for SPC

1) Control Charts

2) Capability Study

study.

incorporate many other tools including:

Design Experiments

Variation Decomposition Methods

Taguchis Methods

Statistical Variation

The differences, no matter how small, between ideally identical units

of product.

2.3 ml

DIFFERENCES

0.9 ml 1.4 ml

Displaying Variation

5

Number Measured

0

21.6 22.4 23.2 24.0

Cap Removal Force in PSI

The Bell-Shaped Curve

Normal

Curve

We use the Normal Curve to Model systems having expected outcomes or goals.

The Standard Normal Curve

Contains an Area equal to One

Corresponds to 100% of ALL possible Outcomes in a Stable System.

Has a Mean = 0, and SD = 1

Total Area = 1

-3 -2 -1 1 2 3

Standard Deviations from the Mean

A STABLE PROCESS

Total

Variation

Slide 20

AN UNSTABLE PROCESS

Total

Variation

Slide 21

A CAPABLE PROCESS

CAPABLE

Spec

Limits

NOT

CAPABLE

Slide 22

Objective of SPC

To consistently produce high quality

products by achieving stable and

capable processes.

Slide 23

WHY

REDUCE

VARIATION?

Slide 24

Reducing Variation Reduces Defects

Spec Spec Spec Spec

Limit Limit Limit Limit

GOOD GOOD

PRODUCT PRODUCT

Slide 25

Reducing Variation Widens

Operating Windows

Spec Spec Spec Spec

Limit Limit Limit Limit

Slide 26

Reducing Variation Improves

Customer Value

Target Upper

Lower

$20 Spec

Spec

Limit Limit

L

O GOOD Bad

Bad

S $10 PRODUCT Product

Product

S

$0 Taguc

his

Target

Lower Loss

$20 Upper

Spec

Spec

Limit

Limit

L

O

S $10

$0

Slide 27

Better Management

Provides facts on process performance to allow:

Prioritized improvement projects

Tracking progress

Demonstrating results

Provides data on process capability required in

product design.

Better management of suppliers.

Slide 28

Maximize Process Capability

Replace existing equipment only if necessary.

Improve capability make new product feasible.

Slide 29

Benefits of SPC

Fewer Defects

Wider Operating Windows

Higher Customer Value

Better Management

Maximize Process Capability

Slide 30

PART 2:

Capability Studies

Slide 31

Variation Reduction Tools

stable and capable processes:

Scatter Diagrams

Screening Experiments

Multi-Vari Charts

Analysis of Means (ANOM)

Response Surface Studies

Variation Transmission Analysis

Component Swapping Studies

Taguchi Methods

Control Charts & Capability Studies

Slide 32

Capability Study

Determines if a Process or System is Stable and

Capable i.e., can it consistently make good product.

Can Measures the Progress and Success achieved

after changes or improvement

Pre-Capability

Study

Variation

Reduction Tool

Post Capability

Study

Slide 33

Capability Study

Process capability measures statistically summarize

how much variation there is in a process relative to

costumer specifications.

Too much variation Hard to produce output within Low index value

costumer requirement (e.g. Cpk < 0.5)

(specification) (Process sigma between 0 and 2)

requirement (Cpk between 0.5 and 1.2)

(Process sigma between 3 and 5)

Very little variation Virtually all of output meets High index value

costumer requirements (Cpk > 1.5)

(Process sigma 6 or better)

Slide 34

Short-Term vs Long Term Sigma

Long-Term Sigma

This is the variation is due to both common and special

causes. This variation is calculated based on all of

individual readings (population). Used for Pp and Ppk

calculations

Short-Term Sigma

This variation is due to common causes only. This

variation is estimated from the control chart data. Used for

Cp and Cpk calculations

35

Cp and Cpk vs. Pp and Ppk

These metrics are calculated the same way, but they

use a different way to estimate standard deviation

Cp and Cpk are considered short-term measures

R

The estimated StDev (Within) is average of d 2 for

each subgroup

Pp and Ppk are considered long-term measures

The estimated StDev (Overall) is calculated using

the standard deviation (n-1) for all the data set

points

The conservative approach is to report whichever set of statistics is

smaller. Typical data sets are usually too small to be able say with

certainty that one metric is better than the other.

36

Process Capability Ratio Cp (Cont.)

Allowed variation (spec .) USL - LSL

Cp = or Cp =

Normal variation of the process 6

Where is within

rather than pooled

99.73% of values

-3 +3

Process Width

LSL T USL

37

Subgroup Measured Values Average Std. Dev.

1 52.0 52.1 53.0 52.3 51.7 52.22 1.3

2 51.7 51.5 52.0 51.7 51.3 51.64 0.7

3 51.7 52.2 51.9 52.6 52.5 52.18 0.9

4 51.3 52.2 51.8 52.5 51.4 51.84 1.2

5 50.8 50.9 51.7 51.8 51.4 51.32 1.0

6 52.6 51.4 52.9 52.6 52.4 52.38 1.5

7 53.0 52.9 52.5 52.5 51.8 52.54 1.2

8 52.5 52.7 51.2 53.7 51.3 52.28 2.5

9 51.9 51.6 51.6 52.7 51.7 51.90 1.1

10 52.2 52.7 52.3 51.8 53.2 52.44 1.4

11 52.4 52.6 52.1 51.8 51.9 52.16 0.8

12 51.3 51.2 51.9 53.1 52.9 52.08 1.9

13 51.7 51.6 51.4 51.4 51.1 51.44 0.6

14 51.8 51.0 52.4 51.2 51.6 51.60 1.4

15 52.0 51.7 52.6 51.8 52.7 52.16 1.0

16 52.0 52.3 51.8 52.0 51.5 51.92 0.8

17 51.8 51.8 51.8 51.9 52.0 51.86 0.2

18 52.0 51.9 51.4 51.8 53.3 52.08 1.9

19 51.5 52.6 52.8 52.4 52.0 52.26 1.3

20 51.5 51.8 50.8 51.3 52.5 51.58 1.7

51.99 1.22

38

Is the process Stable?

Control Chart for Average and Range

53.0 UCL=53.043

52.5

Individual Value

_

52.0 X=51.994

51.5

51.0 LCL=50.945

1 3 5 7 9 11 13 15 17 19 21

Observation

UCL=1.289

1.2

0.9

Moving Range

0.6

__

MR=0.394

0.3

0.0 LCL=0

1 3 5 7 9 11 13 15 17 19 21

Observation

Slide 39

Is the process Capable?

Histogram of H1

20

LS US

L L

15

Frequency

10

0

50 51 52 53 54 55

H1

Potential

Capability Cp = 1.55

Actual

Capability Cpk = 1.23

Slide 40

Calculating the Grand Average

If 1,2, ,20 are the subgroup averages, the

grand average is:

X = 1+2+ +20 Grand

Average

20

e

m

Ti

Slide 41

Calculating the Average Range

If R1,R2, ,R20 are the subgroup ranges, the

average range is:

R = R1+R2+ +R20

20

Estimates the average within the subgroup

variation.

Slide 42

Between and Within Subgroup Variation

Total

Variation

Between Subgroup

Variation

Within Subgroup

Variation

Noise

Unexplained

Inherent

Error

Slide 43

Process Capability Ratio Cp

Ratio of total variation allowed by the specification to the total

variation actually measured from the process

Use Cp when the mean can easily be adjusted (i.e., plating,

grinding, polishing, machining operations, and many

transactional processes where resources can easily be added

with no/minor impact on quality) AND the mean is monitored

(so operator will know when adjustment is necessary doing

control charting is one way of monitoring)

Typical goals for Cp are greater than 1.33 (or 1.67 if of

considerable importance)

is greater than the specification limits.

44

Different Levels of Cp

LSL USL

The Cp index reflects the

Cp = 1

potential of the process if

the mean were perfectly

centered between the

specification limits.

USL LSL

Cp =

6

Cp < 1

Cp = 2

45

Process Capability Ratio Cpk

This index accounts for the dynamic mean shift in the

process the amount that the process is off target.

USL x x LSL

C pk = Min or Where is within

3 3 rather than pooled

46

Process Capability Ratio Cpk (Cont.)

Ratio of the distance to the closest spec to of the estimated process variation

Use when the mean cannot be easily adjusted (i.e., stamping, casting,

plastics molding)

Typical goals for Cpk are greater than 1.33 (or 1.67 if of considerable

importance)

For sigma estimates use:

R/d2 [short term] (calculated from X-bar and R chart) use with Cpk

s = (xi -x) 2 [ longer term] (calculated from (n-1) data points) use

with Ppk

n-1

Longer term: When the data has been collected over a sufficient time period

that over 80% of the process variation is likely to be included

47

Actual Process Performance (Cpk)

Unlike the Cp index, the Cpk index takes into account off-centering of the

process. The larger the Cpk index, the better.

6 6

Cp = 1 Cp = 1

Cpk = 1 Cpk < 1

48

Calculating Cp, Cpk and Pp, Ppk

How did Minitab calculate these values?

Process Capability Analysis for Supp1

LSL USL

Process Data

USL 602.000

Within

Target *

LSL 598.000 Overall

Mean 599.548

Sample N 100

StDev (Within) 0.576429

StDev (Overall) 0.620865

Potential (Within) Capability Cp and Cpk values are calculated based on estimated

Cp

CPU

1.16

1.42

StDev(Within).

CPL

Cpk

0.90

0.90

The minimum of CPU (capability with respect to USL) and

Cpm *

CPL

598 (capability 599 with respect

600 to LSL) 601 is the Cpk 602.

Overall Capability

IfObserved

a target is entered,

Performance

then Cpm, Taguchis

Exp. "Within" Performance

capability index,

Exp. "Overall" Performance

Pp 1.07 is <also

PPM LSL calculated.

10000.00 PPM < LSL 3621.06 PPM < LSL 6328.16

PPU 1.32 PPM > USL 0.00 PPM > USL 10.51 PPM > USL 39.19

PPL 0.83 Cp and Cpk values are considered to be short term.

PPM Total 10000.00 PPM Total 3631.57 PPM Total 6367.35

Ppk 0.83

49

Cp, Cpk vs. Pp, Ppk

How did Minitab calculate these values?

If the Cp and Pp values are significantly different this is an

Process Capability Analysis for Supp1

Process Data

indication

LSL of an out of control process. USL

USL 602.000

Within

Target *

LSL 598.000 Overall

Mean 599.548

Sample N 100

StDev (Within) 0.576429

StDev (Overall) 0.620865

Cp 1.16

CPU 1.42

CPL 0.90

Cpk 0.90

Cpm *

StDev(Overall).

598 599 600 601 602

Observedminimum

Performance of Ppu

Exp. (capability

"Within" Performance with Exp. respect to USL) and

"Overall" Performance

Pp

PPU

1.07

1.32

P pl (capability

PPM < LSL

PPM > USL

10000.00

0.00

with respect

PPM < LSL

PPM > USL

to LSL)

3621.06

10.51

is the

PPM < LSL

PPM > USL

P pk . 6328.16

39.19

PPL

Ppk

0.83

0.83

Pp and Ppk values are considered to be longer term.

PPM Total 10000.00 PPM Total 3631.57 PPM Total 6367.35

50

PART 3:

Cp, Cpk and Six Sigma

Slide 51

Process Should be Stable before Checking Capability

UCL

LCL

UCL

LCL

A Stable Process

Slide 52

Stable Process are Predictable!

Distance from Average

Percentage out of Spec.

(d)

d

-4.5 3.4/million

Individuals

Distribution -4.0 31/million

Percent out of

Spec -3.5 233/million

-3.0 0.135%

-2.5 0.6%

-3 -2 -1 0 1 2 3 -2.0 2.3%

-1.5 6.7%

-1.0 15.8%

-0.5 30.9%

0.0 50%

Slide 53

Cp

Compares the Specification Range to

the Width of the Process, (3 each

side of the mean):

Cp = USL-LSL

6S

USL

Cp = 0.5

Cp = 1 Cp = 1.5

Cp = 2

Slide 54

Cp = 1

1.5

LSL USL

6.75%

Defective

-3 3

3 Sigma Process

is 6.7% defective.

Slide 55

Cp = 1.5

1.5

LSL USL

1350

Defects/Million

-4.5 4.5

4.5 Sigma Process

is 1350 defects per million.

Slide 56

Cp = 2.0

1.5

LSL USL

3.4

Defects/Million

-6 6

6 Sigma Process

is 3.4 defects per million.

Slide 57

What has Changed?

1.5

LSL USL

3 Sigma Process

-3 3

1.5

LSL USL

-4.5 4.5

1.5

LSL USL

6 Sigma Process

-6 6

Slide 58

Operating Windows

Dont forget to include them in your

process design.

Stable process can hold a 1.5 operating

window.

Automated processes may be able to hold

a 1.0 operating window.

If a process is not stable, a 1.5 window

may not be enough room for the average.

Why?

UCL, LCL = X 3/n

When, n = 5

then,

3/n = 3/5 = 1.34

Slide 59

Cp Does Not Consider Centering

Cp = 2

LSL USL

-6 6

Slide 60

Determine Cpk

Distance from X to the nearest Spec

Cpk =

3S

X

LSL

3S

Average - LSL

Slide 61

Cpk = 1

USL

Cp = 1

LSL

Slide 62

Cpk = 2

USL

Cp = 2

LSL

Slide 63

Cpk When Cp = 2

USL

Cpk = 1/2

Cpk = 1

Cpk = 1.5

Cpk = 2.0

Cpk = 1.5

Cpk = 1

Cpk = 1/2

LSL

Fix the variability, then move the average

Cpk = Cp.

Slide 64

Interpreting Cpk

Table below gives the corresponding defect level of

various Cpks with Cp = 2.0:

1 1350 dpm

0.83 0.6%

0.5 6.7%

Slide 65

PART 4:

Use of Capability Studies

Slide 66

Uses of Capability Study

Identifying processes needing improvement.

Tracking process performance.

Verifying the effectiveness of fixes.

Determining the ability of suppliers to consistently make

good product.

Qualifying new equipment.

Determining the manufacturability of new product.

Slide 67

Identifying Processes Needing Improvement

Unstable processes of processes with poor Cps and/or

Cpks are target for improvements.

If the process is unstable it is a good candidate for control

chart.

If the process is stable, but not capable, one should first

look for obvious sources of variation.

If no obvious sources exist, then you should perform

designed experiments to uncover them.

Slide 68

Verifying Effectiveness of Fixes

Use a capability study to demonstrate the

effectiveness of fixes.

New estimates of Cp and Cpk should be at least

15% greater than the pre-fix estimates.

True changes are unlikely when pre and post

capability estimates are within 15% of each

other.

Slide 69

Assessing the performance of Suppliers

Materials and components from our suppliers make up one

or more inputs in our manufacturing process.

Our final quality is only as good as our suppliers quality.

All suppliers need to provide good product on a consistent

basis.

Consistency requires a stable process of manufacturing.

If the process is not stable, the products produced will not

be stable in quality.

Stability can only be assessed by looking at time ordered

samples.

Slide 70

Qualifying New Equipment

Want to demonstrate the equipment can

consistently make good products.

Should use a capability study to demonstrate

consistency.

Consider requesting a capability study when

purchasing a new equipment.

Slide 71

Determining the Manufacturability of New

Product

Capability studies measure the match between

product specifications and process variation.

A process may be capable of manufacturing one

product, but not another.

For new products, use capability studies to

determine how well the product design adapts to

the manufacturing process.

Slide 72

PART 5:

Technical Considerations

Slide 73

The Normality Assumption

Common Misconception:

The data has to be normally distributed to be

control charted

Control charts work well even when the data are not

normally distributed.

The normality assumption was originally introduced from the

control chart constants, i.e. d2, A2, D4, etc,

Even the control chart constants do not change appreciably

when the data are non-normal*.

Slide 74

Why 3 Standard Deviation Limits?

Not established solely on the basis of probability theory.

Outcomes in most stable processes generally occur

between 3 S.D.s from the average.

Originally designed to minimize the time looking

unnecessarily for shifts in the process average.

Additionally concerned with missing an actual process shift

as it occurs.

Slide 75

Rational Sub grouping

Organizing the data into rational subgroups allows

us to answer the right questions.

The variation occurring within the subgroups is

used to set the control limits.

The control chart uses the within subgroup

variation to place limits on how much variation

should naturally exist between subgroups.

Slide 76

Rational Sub grouping

Some Guidelines:

Try not to place unlike things together into the same

subgroups.

Organize in a way that produces the lowest variation within

each subgroup.

Maximize the opportunity to observe the variation between

subgroups.

Slide 77

PART 6:

Use of Control Charts

Slide 78

Control Charts

Control charts are one of the most commonly

used tools in our Lean Six Sigma toolbox

Control charts provide a graphical picture of the

process over time

Control charts are both practical and easy-to-use

Control charts help us establish a measurement

baseline from which to measure improvements

79

What Do Control Charts Tell Us?

When the process location has shifted

When process variability has changed

When special causes are present

Process not predictable

A learning opportunity

When no special causes are present

Process is predictable

No clues to improvement available; may need to

introduce a special cause to effect a change

Control charts tell you when, not why

80

Why Use a Control Chart?

Statistical control limits are another way to separate common cause and

special cause variation

Points outside statistical limits signal a special cause

Can be used for almost any type of data collected over time

Provides a common language for discussing process performance

When To Use:

Track performance over time

Evaluate progress after process changes/improvements

Focus attention on process behaviour

Separate signals from noise

81

Control Chart Selection

Control chart selection should be based

upon:

Data type

Number of observations

Sample size

Subgrouping

The primary determinant in control chart

selection is Data Type

82

Data Types

There are many different types of data

Each type of data has its own unique control chart

The basic format and underlying concepts are the same

across the entire family of control charts

A basic understanding of the different data types is

important to increase the successful use of control charts

How many different types of data are there?

83

Two General Kinds of Data

Attribute The data is discrete (counted).

Results from using go/no-go gages, or from the

inspection of visual defects, visual problems,

missing parts, or from pass/fail or yes/no

decisions

Variable The data is continuous (measured).

Results from the actual measuring of a

characteristic such as diameter of a hose,

electrical resistance, weight of a vehicle, etc.

84

Continuous Data

Continuous data is a set of numbers that can potentially take on any

value

Also known as variable data

Examples: 0.1, 1/4, 20, 100.001, 1,000,000, -3.26, -10,000

Common Applications

Dimensions (lengths, widths, weight, etc)

Time (seconds, minutes, hours, etc)

Finance (mills, cents, dollars, etc)

Distribution Types

Normal

Uniform

Exponential

Because continuous data has more discrimination, go for continuous

data whenever possible

85

Control Charts for Individual Values

Time ordered plot of results (just like time plots)

Statistically determined control limits are drawn on the plot.

Centerline calculation uses the mean

53.0 UCL=53.043

LCL= X + 2.66mR

52.5

Centerline = X

52.0 Avg=51.99

UCL= X + 2.66mR

51.5

51.0

LCL=50.945

2 4 6 8 10 12 14 16 18 20

Index

86

Attribute Data

Attribute data has two main subsets, Binary data and Discrete

Data

Binary Data is a characterized by classifying into only two

outcomes

Examples: Pass/Fail, Agree/Disagree, Win/Loss,

defective/conforming

Common uses: Proportions and ratios

Distribution: Binomial

Key assumptions

Events are independent of each other

Mutually exclusive outcomes

Number of trials and outcomes of each trial is known

87

Attribute Data (Cont.)

Discrete Data is a set of finite outcomes, usually

integers, and is measured by counting

Also known as Ordinal data

Common uses and examples:

Number of product defects per item

Number of customer requirements per order

Number of accounting errors per invoice

Distribution: Poisson

Poisson characteristics and assumptions

Unlimited number of defects per item

Constant probability of defect per item

Probability of defect per unit is low

Defects are independent of each other

88

Control Chart Selection Tree

TYPE OF DATA

(Attribute Data) (Variable Data)

Count Classification

Defects or Defectives or

Nonconformance Nonconforming Units

Opportunity Opportunity Opportunity Opportunity Size of 1 Size < 9 Size > 9

PoissonDistribution

Poisson Distribution BinomialDistribution

Binomial Distribution Normal

Normal Distribution

Distribution

89

Individuals and Moving Range

Charts

Display variables data when the sample subgroup size is

one (And in certain situations, attribute data)

Variability shown as the difference between each data

point (i.e., moving range)

Appropriate Usage Situations:

When there are very few units produced relative to the opportunity for process

variables (sources of variation) to change

When there is little choice due to data scarcity

When a process drifts over time and needs to be monitored

continuous data

90

Calculations for Individuals Charts

1. Determine sampling plan

2. Take a sample at each specified interval of time

3. Calculate the moving range for the sample. To calculate each moving

range, subtract each measurement from the previous one. There will be

no moving range for the first observation on the chart

4. Plot the data (both individuals and moving range)

5. After 30' or more sets of measurements, calculate control limits for moving

range chart

6. If the Range chart is not in control, take appropriate action

7. If the Range chart is in control, calculate limits for individuals chart

8. If the Individuals chart is not in control, take appropriate action

91

Why Use Subgroups?

sample variation and between sample

variation

92

X-Bar & R Chart

The X-bar & R chart is the most commonly used control chart due to its use of

subgroups and the fact that it is more sensitive than the ImR to process shift

Consists of two charts displaying Central Tendency and Variability

X-bar Chart

Plots the mean (average value) of each

subgroup

Useful for identifying special cause changes

to the process mean (X)

X-bar control limits based on +/- 3 sigma

from the process mean are calculated

using the Range chart

R Chart

Displays changes in the "within" subgroup dispersion of the process

Checks for constant variation within subgroups

93

Calculations for X-Bar & R Charts

1. Determine an appropriate subgroup size and sampling plan

2. Sample: (Take a set of readings at each specified interval of time)

3. Calculate the average and range for each subgroup

4. Plot the data. (Both the averages and the ranges)

5. After 30' or more sets of measurements, calculate control limits for the

range chart

6. If the range chart is not in control, take appropriate action

7. If the range chart is in control, calculate control limits for the X-bar chart

8. If the X-bar chart is not in control, take appropriate action

94

Rational Subgrouping

An important consideration in using the X-bar & R (and X-bar & S) chart

is the selection of an appropriate subgroup size

Rational Subgrouping is the process of selecting a subgroup based

upon logical grouping criteria or statistical considerations

Subgrouping Examples

Natural Breakpoints:

3 shifts grouped into 1 day;

5 days grouped into 1 week,

10 machines grouped into 1 dept

Wherever possible, both natural breakpoints and homogenous group

considerations should be combined together in selecting a sample size

95

Attribute Control Charts

Attribute control charts are similar to variables

control charts, except they plot proportion or count

data rather than variable measurements

Attribute control charts have only one chart which

tracks proportion or count stability over time

Chart Types

Binomial: P chart, NP chart

Poisson: C chart, U chart

96

Attribute Control Charts

Binomial Distribution Charts

Use one of the following charts when comparing a product to a

standard and classifying it as being defective or not (pass vs. fail):

P Chart Charts the proportion of defectives in each subgroup

NP Chart Charts the number of defectives in each subgroup

Use one of the following chart when counting the number of defects

per sample or per unit

C Chart Charts the defect count per sample (must have the same

sample size each time)

U Chart Charts the number of defects per unit sampled in each

subgroup (using a proportion so sample size may vary)

97

PART 7:

Use of Control Charts

Slide 98

Uses of Control Charts

Evaluation

Improvement

Maintenance

Slide 99

Uses of Control Charts

and capable, as part of a capability study.

Improvement

Maintenance

Slide 100

Uses of Control Charts

Evaluation

that the causes may be investigated and

eliminated.

Maintenance

Slide 101

Improvement

Control Charts search for differences over time.

Observing a change on the control charts means a key

input variable has changed.

The pattern observed on the control chart provides clues

about the key variable that changed:

Timing of the change

Shape or pattern

Trends

Jumps or shifts

Slide 102

Maintenance

Control charts can help us to decide when to make

adjustments to the process.

Using control charts we can make better decisions, and

minimize the chance of making two possible errors:.

20% - Failing to adjust when the process needs adjustments

80% - adjusting when the process does not need adjustment

center the average around the desired target.

Slide 103

Statistical Step to Establish Control Limit

1. Collect the data 30 or more

2. Prepare Individual moving range chart (I-MR) using appropriate

statistical software

3. Review the moving range chart, if any data point beyond are beyond

the UCL, the data the data point must be evaluated and excluded if

there is an assignable cause, then replot the moving range chart.

4. Review the individual chart, if any data point beyond are beyond the

UCL and LCL, the data the data point must be evaluated and excluded

if there is an assignable cause, then replot the individual chart.

Slide 104

Real Time Evaluation

Rule 1 The data outside of control limit: One point of outside the

control limit

56

55

54

53 UCL=53.043

52 Avg=51.99

51 LCL=50.945

2 4 6 8 10 12 14 16 18 20

Index

105

Real Time Evaluation

Rule 2 Trend Shift: 8 consecutive point on same side of center line

UCL=53.043

53.0

52.5

52.0 Avg=51.99

51.5

51.0

LCL=50.945

3 6 9 12 15 18 21 24 27

Index

106

Real Time Evaluation

Rule 3 Trend drift: 6 consecutive points that trend in the same

direction (all increasing or all decreasing)

53.0 UCL=53.043

52.5

52.0 Avg=51.99

51.5

51.0

LCL=50.945

3 6 9 12 15 18 21 24

Index

107

PART 8:

Minitab Exercise

Slide 108

Opening a new project in Minitab

Menu bar

Toolbars

Session

window

Data window

Project

Manager

window

(minimized)

109

Overview of Minitab

Worksheet

Each Minitab worksheet can contain up to 4,000

columns, each column is identified by a number

The letter after the column number indicates the

data type:

D : date / time

T : text (alphanumeric)

110

Example 1

Problem

Supervisor of medical company is preparing a sales report for a

new line of facial cream that the company intends to distribute

nationally. In a pilot launch, the company sold facial cream at

various stores in Jakarta and Bandung for three months.

Data Collection

The supervisor recorded the daily revenue for two locations

during the three months and stored them in minitab project

111

Example 1

Tools

Dotplot

Time Series Plot

Graphical Summary

Display Descriptive Statistics

Layout Tools

112

Open Project

1. Choose File > Open project

2. Choose ISPE_Example 1.MPJ.

3. Click open.

113

Creating Dotplots

Choose Graph > Dotplot

Complete the dialog as shown below, then click OK

by highlighting them and double clicking each variable, then

click OK

114

Interpreting your result

The graph shows the sales data during the three month period

for both location. On average, Bandung sales appear higher

than Jakarta sales.

115

Correcting the Outlier

After checking with the person who entered the data, your

discover that the sales information for data n=20 is missing.

Instead of entering 0, you should enter an asterisk (*) to indicate

that the value is missing.

Click project manager toolbar

In the Bandung column, highlight the cell in column 3 and

row 20 as show below.

Press [DELETE]

116

Updating a graph

To choose the dotplot, click in the project manager toolbar

Click the graph to make it the active window

Choose Editor > Update > Update graph now

117

Time Series Plot

Choose Graph > Time Series Plot

Choose Multiple, then click OK

In series, enter Jakarta Sales Bandung Sales

Click Time / Scale

Complete the dialog as shown below

118

119

Graphical Summary

Choose Stat > Basic Statistic > Graphical Summary

Complete the dialog as shown below

120

121

Display Descriptive Statistic

Choose Stat > Basic Statistic > Display Descriptive

Statistics.

In variable, enter Jakarta Sales Bandung Sales

Click statistics

Complete the dialog box as shown below, then click OK

122

123

Creating a multiple graph

Click graph folder, then click the dotplot in the project

manager. Click the graph to make it the active window.

Choose Editor > Layout tool

Double click all graph have been created to place the graph

in the layout window.

124

125

Example 2

Problem

The validation supervisor want to evaluate the consistency of

the fill weight for hydrocortisone cream. The cream is packed in

tube. The target weight is 1150grams. The specification limit are

1100 and 1200 grams.

Earlier evidence indicate this process is stable with a mean of

1150 grams and a standard deviation of 8.6 grams

Tools

I-MR

126

I-MR

Open ISPE_Example 2.MPJ

Choose Stat > Control Charts > Variable Charts for

Individuals > I-MR

Complete the dialog box as shown below

127

I-MR

Click Scale, under X scale, choose stamp

Under Stamp columns, enter date/time. Click OK

Click I-MR Options.

In Mean, type 1150; in standard deviation type 8.6, then click

OK

128

Individual chart shows that the process is clearly not in

statistical control also process operated consistently above the

mean.

129

Next Step

Remove mean then replot the I-MR Chart

130

Example 3

Problem

With previous data analyse normality and capability process

Tools

Probability

Capability Six Pack

131

Probability Plot

Open ISPE_Example 2.MPJ

Choose Grap > Probability Plot > Single

Complete the dialog box as shown below

Complete dialog as shown below

132

Normality Check

Check normality data (P>0.05)

Normal - 95% CI

99.9

Mean 1164

Normal Data

99

StDev 8.576

N 60 P > 0.05

AD 0.293

95 P-Value 0.591

90

80

70

Percent

60

50

40

30

20

10

5

0.1

1130 1140 1150 1160 1170 1180 1190 1200

Fill Weight

133

Capability Analysis

Open ISPE_Example 2.MPJ

Choose Stat > Quality Tools > Capability Analysis

Complete the dialog box as shown below

Complete dialog as shown below

134

Capability Analysis

Process Capability Report for Fill Weight

LSL USL

Process Data Overall

LSL 1100 Within

Target *

USL 1200 Overall Capability

Sample Mean 1163.58 Pp 1.94

Sample N 60 PPL 2.47

StDev(Overall) 8.57554 PPU 1.42

StDev(Within) 8.34686 Ppk 1.42

Cpm *

Potential (Within) Capability

Cp 2.00

CPL 2.54

CPU 1.45

Cpk 1.45

Performance

Observed Expected Overall Expected Within

PPM < LSL 0.00 0.00 0.00

PPM > USL 0.00 10.81 6.39

PPM Total 0.00 10.81 6.39

135

Summary

Know important parameter

Know variation and trending

Know proper tools for data evaluation

Combine data statistic and product

knowledge

136

137

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