ANNAMALAI UNIVERSITY

FACULTY OF ENGINEERING AND TECHNOLOGY

DEPARTMENT OF PHARMACY

QUALITY MANAGEMENT SYSTEM MQA 102T

STATISTICAL PROCESS CONTROL (SPC)

PRESENTED BY SUBMITTED TO
[Link], Dr. K. DEVI, [Link]., PH.D,
[Link] (PQA) - Ⅰ Year, Assistant Professor,
Department of pharmacy, Department of Pharmacy,
Annamalai University. Annamalai University.
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 CONTENT
1. HISTORY OF SPC
2. DEFINITION
3. IMPORTANCE OF SPC
4. QUALITY MEASUREMENT IN MANUFACTURING
5. STATISTICAL CONTROL CHART
6. ADVANTAGES
7. PROCESS CAPABILITY
8. MEASURING PROCESS CONTROL AND QUALITY IMPROVEMENT
9. PURSUIT OF DECREASED PROCESS VARIABILITY
10. REFERENCE
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 HISTORY OF SPC

• Statistical process control was pioneered by Walter A.

Shewhart at Bell Laboratories in the early 1920s.
• Shewhart developed the control chart in 1924 and the
concept of a state of statistical control.
• Walter Andrew Shewhart (1891-1967) was an American
physicist, engineer and statistician.

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 HISTORY OF SPC

• He is sometimes also
known as the grandfather
of statistical quality
control and also related to
the Shewhart cycle.

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 HISTORY OF SPC
• Nokia Bell Labs, • Its headquarters
commonly referred to as located in Murray
Bell Labs, is an American hill, New Jersey.
industry research and
development company
owned by Finnish
technology company
Nokia
Bell Labs

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 DEFINITION

• Statistical process control (SPC) is a methodology used

in the pharmaceutical industry to monitor and control
manufacturing processes.
• It involves the use of statistical techniques to measure,
analyse, and control process variation to ensure
consistent product quality.

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 DEFINITION

The benefits of implementing SPC in the pharmaceutical

industry include:
• Enhance the product quality and uniformity
• Decreased production expenses by reducing waste and rework.
• Quicker resolution of issues and identification of root causes.
• Improve adherence to regulations by showcasing process control.
• Ongoing process enhancement through decisions based on data
analysis.

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 IMPORTANCE OF SPC
• Reduces waste.
• Reduction in the time which is required to produce the product.
• Detecting errors at inspection.
• Reduce inspection cost.
• Save cost of material by reducing number of rejects.
• More uniform quality of production.
• Customer satisfaction.
• It provides direction for long term reduction in process
variability.
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 QUALITY MEASUREMENT IN MANUFACTURING

• Quality measurement in pharmaceutical manufacturing

means using objective metrics and systematic processes
to ensure drugs are consistently safe, effective and
compliant.

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 QUALITY MEASUREMENT IN MANUFACTURING

➢Essential QA Processes
• GMP Compliance: Following Good Manufacturing
Practices, aligning with international regulatory
standards (FDA, WHO, EMA).
• Document Control: Keeping accurate records such as
SOPs, batch records, and audit trails for traceability.

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 QUALITY MEASUREMENT IN MANUFACTURING

• Process Validation: Making sure machines, procedures,

and processes always give consistent results.
• Change Control: Evaluating any process changes to
ensure they won’t harm product quality.
• Internal Audits: Regularly reviewing systems to find and
fix problems before external inspections.

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 QUALITY MEASUREMENT IN MANUFACTURING

• Deviation and CAPA Management: Investigating

deviations (unexpected issues) and fixing root causes
with CAPA.
• Training: Ensuring everyone understands and follows
quality processes.

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 STATISTICAL CONTROL CHART

➢Statistical control chart are essential tools in

pharmaceutical industries for quallity assurance, used to
monitor and control the manufacturing process to ensure
consistent product quality and regulatory compliance.
➢They helps distinguish between common (inherent) and
special (assignable) causes of variation, trends, and out-
of-specification conditions before they lead to failures.

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• The center line (labeled [bar{x} ]) shows the average
value of the data.
• The lines at the top (Upper Control Limit) and bottom
(Lower Control Limit) are the limits set for the
process.
• The dots and connected lines show how the
values move over time. 14
 TYPES OF CONTROL CHARTS

TYPES OF CONTROL CHARTS

VARIABLES CHART ATTRIBUTE CHART

X-bar and R chart X-bar and S chart np-chart p-chart c-chart u-chart

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 TYPES OF CONTROL CHARTS
• Control chart can be divided broadly into two categories:
Variable chart (for quantitative data) and attribute chart
(for qualitative/count data).
1) VARIABLES CONTROL CHART
• Used to measure the weight, thickness or concentration.
2) ATTRIBUTE CONTROL CHART
• Used to track data that can be counted, such as the
number of defects or defectives, rather then measurable
quantities. 16
 X-bar and R Chart

• It is a pair of control charts used in statistical process

control to monitor a process mean (average) and range
(variability) based on subgroup sample collected over
time.
• It also called as “Average and range” chart.
• Subgroups size 2-10.
• It can be applied to any continuous variable like weight,
size, cycle time and error rate.
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R chart
• Calculate control limits
UCL for R= D4 R
LCL for R= D3 R
X-bar chart
• Calculate control limits
UCL for X = X + A2 R
LCL for X = X - A2 R
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Chart part X-bar R chart
chart

Center line 155.561 2.252

UCL 156.860 4.761

LCL 154.262 0

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 X-bar and S Chart

• It also a statistical process control tool used to monitor

the mean (average) and standard deviation (variability)
of a process based on samples(subgroups) taken over
time.
• Subgroups size is more then 9.

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S chart
Calculate the control limits
UCL for S = B4 S
LCL for S = B3 S
X-bar chart
Calculate the control limits
UCL for X= X + A2 S
LCL for X= X - A2 S
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Chart X-bar S chart
part chart
Center 19.99971 0.01009
line
UCL 20.00956 0.01732

LCL 19.98987 0.00286

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 p Chart

• A p chart or proportion chart, is a type of control chart

used in SPC to monitor the proportion of nonconforming
or defective in process over time.
Calculate control limit

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p Chart

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 np Chart

• np chart is a SPC chart used to monitor the number of

nonconforming or defective unit in fixed size sample
over time.
• It’s similar to p chart.
Calculate control limit

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np Chart

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 c Chart

• A c chart is a type of control chart used in SPC to

monitor the total number of defects or nonconformities.
• c charts is also known as the control chart for defects.
Calculate control limit

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c Chart

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 u Chart

• It is also a control chart used in SPC to monitor the

average number of defects per unit when the sample size
varies.
Calculate control limits

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u Chart

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 ADVANTAGES

1) Early detection of process variation.

2) Improved process consistency.
3) Cost reduction.
4) Enhanced process efficiency.
5) Increased product reliability and safety.
6) Better understanding of process behavior.

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 PROCESS CAPABILITY

• Process capability is the measurement, inherent

variation of the product turned out by a process.
e.g. in case of capsule filling operation, there are 3
types of machines, namely:
1. Hand filling
2. Semi-automatic and
3. Fully automatic filling
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 MEASURING PROCESS CONTROL AND QUALITY
IMPROVEMENT

• Measuring process control and quality improvement

primarily involves statistical and systematic methods to
monitor, analyze, and enhance manufacturing or
operational processes.
MEASURING PROCESS CONTROL
• Process Control is often measured using SPC which
involves statistical techniques to monitor and control
processes to ensure consistent quality.
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 MEASURING PROCESS CONTROL AND QUALITY
IMPROVEMENT

QUALITY IMPROVEMENT METHOD

• It is a systematic approach to enhance process
performance and product quality.

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PURSUIT OF DECREASED PROCESS VARIABILITY

• The pursuit of decreased process variability focuses on

reducing inconsistencies in manufacturing or operational
processes to improve product quality, reduce costs, and
enhance customer satisfaction.
I. Implementing SOP
II. Using SPC
III. Enhancing Employee Training and Engagement
IV. Regular Process Review
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 REFERENCE
1) Stastistical Process control by John S. Oakland.
2) [Link]
3) [Link]
4) Samip shah., et al. (2010). Control chart: A statistical process control
tool in pharmacy. Asian Journal of Pharmaceutics.
5) Statistical Control by Monitoring and Adjustment, 3rd Edition, John
Wiley and Sons, New York, By Box GE and A. Luceno.
6) Measuring the Process Capability, by bother D.R., Me Graw Hill, New
York.

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THANK YOU

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