This presentation discusses statistical control charts which are tools used in pharmaceutical manufacturing to determine if a process is in statistical control. It defines control charts and explains that they provide a visual representation to monitor a process and identify instances where the process may be going out of control. The presentation covers the objectives, principles, types of control charts including variable and attribute charts, their characteristics and benefits such as improving quality, productivity and reducing defects. It also discusses using control charts to evaluate process capabilities.

1. Presented by-
Ashish Rajendra Chaudhari
M. Pharm 1st Sem.
Statistical Control Chart 17-10-2019
1

2. CONTENT
Introduction
Objective
Principal
Control Chart
Characteristics
Importance
Reference
17-10-20192

3. Statistical process control are tools used to determine
whether a manufacturing of dosage form in pharmaceutical
industry is in a state of statistical control or not
The charts are used to provide a visual graphic representation
of instances when a process is beginning to go out of control.
Monitors, controls, and improves processes through statistical
techniques.
INTRODUCTION
17-10-20193

4. Pareto
Diagram
m
Control
Charts
Process
Flow
Diagram
Histogram
Scatter
Diagram
Check
Sheets
Cause &
Effect
Diagram
17-10-20194

5. What is Control Chart
Statistical chart controlling mfg. processes
Every process exhibits some normal levels of variation, but a control chart is designed
to separate this common cause variation from special cause variations.
When the control chart indicates the process is out of control, an operator should take
action to make adjustments to bring the process back under control .
17-10-20195

6. CONTROL CHARTS
Statistical quality control can be implemented through control charts
that are used to monitor the output of the process and indicate the
presence of problems requiring further action. Control charts can be used
to monitor processes where output is measured as either variables or
attributes.
17-10-20196

7. OBJECTIVE
To secure information to be used in changing specifications or in determining whether
the process can meet specifications or not.
 To secure information to be used on establishing or changing production procedures.
To secure information to be used on changing inspection procedures or acceptance
procedures or both.
To provide a basis for current decision during production.
To provide a basis for current decisions on acceptance for rejection of manufacturing or
purchased product.
To familiarize personnel with the use of control chart.
17-10-20197

8. PRINCIPLE
A process that is operating with only chance causes of variation present is said
to be in statistical control.
A process that is operating in the presence of assignable causes is said to be out
of control.
The 0goal of spc is the elimination of variability in the process
17-10-20198

9. TYPES
CONTROL
CHARTS
Variable
charts
X-Bar R-Bar
Attribute
charts
P-Chart C-Chart nP-Chart
17-10-20199

10. VARIABLE CHARTS
•Charts for variable data requires measurements on continuous scale such as
lengths, weight, PH or resistance
• Variable data include more information than attribute data , thus are preferred
for SPC and essential for diagnosis
•Types of variable charts :
1) x-bar
2) r-bar
17-10-201910

11. ATTRIBUTE CHARTS
•Attribute data requires only a count of discrete measurements such as
good or bad.
•The charts for attributes will be useful provided the defective rate is
high enough to show on the chart with a reasonable subgroup size .
•Current competitive quality requirement in many industries are so high
that attribute charts are not useful .
17-10-201911

12. CHARACTERISTICS
•A control chart is a time-ordered diagram to monitor a quality characteristic,
consisting of:
• 1. A nominal value, or center line, the average of several past samples.
•2. Two control limits used to judge whether action is required, an upper
control limit (UCL) and a lower control limit (LCL).
•3. Data points, each consisting of the average measurement calculated from a
sample taken from the process, ordered overtime. By the central limit
theorem, regardless of the distribution of the underlying individual
measurements, the distribution of the sample means will follow a normal
distribution. The control limits are set based on the sampling distribution of
the quality measurement.
17-10-201912

13. 17-10-201913

14. BENEFITS
•A control chart indicates when something may be wrong, so that corrective action
can be taken.
• The patterns of the plot on a control chart diagnosis possible cause and hence
indicate possible remedial actions.
• It can estimate the process capability of process.
• It provides useful information regarding actions to take for quality improvement
17-10-201914

15. Importance
Improving product quality
Improving productivity
Reducing waste
Reducing defects and improving
customer value
17-10-201915

16. Comparing the control chart information with the tolerance
specification tells you about the process capability.
Process capability is the long-term performance level of the process
after it has been brought under statistical control
Process capability is also the ability of the combination of people,
machine, methods, material, and measurements to produce a product
that will consistently meet the predefined specifications.
PROCESS CAPABILITIES
17-10-201916

17. 17-10-201917
THE CAPABILITY INDEX IS DEFINED AS:
Cp = (allowable range)/6s = (USL - LSL)/6s
USL (Upper Specification Limit)LSL
LCL UCL (Upper Control Limit)

18. CONCLUSION
•Several drawbacks in the conventional approach of drug formulation
development can be solved by using control charts as tools in statistical process
control to determine whether a manufacturing of dosage form in pharmaceutical
industry is in a state of statistical control or not.
•The control charts serve to illustrate the current operational condition of a process
by providing a visual display that clearly indicates whether a process is within
limits, out of control, or headed for an out of control condition, offering
management time to take corrective action and avoid waste.
17-10-201918

19. REFERENCES
1. Joseph M. Juran , A.Blanton Godfrey . Jurann’s Handbook 5th edition,
McGraw-Hill , New York Washington, D.C. pp. 45.1.
2. Shah, S., Shridhar, P. And Gohil, D., 2014. Control chart: A statistical process
control tool in pharmacy. Asian journal of pharmaceutics (AJP): free full text
articles from Asian J pharm, 4 (3).
3. Rami Hikmat Found, Adman Mukattash , Statistical Process Control Tools: A
Practical for Jordanian Industrial Organization ,JJMIE, Volume 4 , No 6,
December 2010, pp- 693-700
4. www.Slideshare.Com /control charts/Dr.Vijendar Palsingh
17-10-201919

20. 17-10-201920