Page 206 - DMGT524_TOTAL_QUALITY_MANAGEMENT

Unit 14: Statistical Process Control

could indicate a problem with the process. Several different descriptive statistics can be used in Notes
control charts and there are several different types of control charts that can test for different
causes, such as how quickly major vs. minor shifts in process means are detected.

Note Control charts are also used with product measurements to analyze process
capability and for continuous process improvement efforts.

14.1.1 Benefits of SPC

Provides surveillance and feedback for keeping processes in control

Signals when a problem with the process has occurred
Detects assignable causes of variation
Accomplishes process characterization
Reduces need for inspection
Monitors process quality
Provides mechanism to make process changes and track effects of those changes
Once a process is stable (assignable causes of variation have been eliminated), provides process
capability analysis with comparison to the product tolerance.

Self Assessment

Fill in the blanks:
1. …………………… is a graphical representation of certain descriptive statistics for specific
quantitative measurements of the manufacturing process.
2. …………………… is used to monitor the consistency of processes used to manufacture a
product as designed.
3. Statistical Process Control (SPC) involves using …………………… techniques to measure
and analyze the variation in processes.

Caselet Statistical Process Control Tool

tatistical process control is the application of statistical methods to the measurement
and analysis of variation process. Various regulatory authorities such as Validation
SGuidance for Industry (2011), International Conference on Harmonisation ICH Q10
(2009), the Health Canada guidelines (2009), Health Science Authority, Singapore: Guidance
for Product Quality Review (2008), and International Organization for Standardization
ISO-9000:2005 provide regulatory support for the application of statistical process control
for better process control and understanding. In this study risk assessments, normal
probability distributions, control charts, and capability charts are employed for selection
of critical quality attributes, determination of normal probability distribution, statistical
stability, and capability of production processes, respectively. The objective of this study
is to determine tablet production process quality in the form of sigma process capability.
Contd...

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