QM0012- STATISTICAL PROCESS CONTROL AND PROCESS CAPABILITY

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ASSIGNMENT

DRIVE FALL	2013
PROGRAM	MBADS – (SEM 3/SEM 5) / MBAN2 / MBAFLEX – (SEM 3) PGDTQMN – (SEM 1)
SUBJECT CODE & NAME	QM0012- STATISTICAL PROCESS CONTROL AND PROCESS CAPABILITY
SEMESTER	3
CREDITS	4
MARKS	60

Note: Answer all questions. Kindly note that answers for 10 marks questions should be approximately of 400 words. Each question is followed by evaluation scheme.

1 a. Explain the concept of Statistical Process Control.

Answer : The concepts of Statistical Process Control (SPC) were initially developed by Dr. Walter Shewhart of Bell Laboratories in the 1920's, and were expanded upon by Dr. W. Edwards Deming, who introduced SPC to Japanese industry after WWII. After early successful adoption by Japanese firms, Statistical Process Control has now been incorporated by organizations around the world as a primary tool to improve product quality by reducing process variation.

Dr. Shewhart identified two sources of

b. Describe the procedure to construct Fish bone diagram with an example.

Answer : Dr. Kaoru Ishikawa, a Japanese quality control statistician, invented the fishbone diagram. Therefore, it may be referred to as the Ishikawa diagram. The fishbone diagram is an analysis tool that provides a systematic way of looking at effects and the causes that create or contribute to those effects. Because of the function of the fishbone diagram, it may be referred to as a cause-and-effect diagram. The design of the diagram looks much like the skeleton of a fish. Therefore, it is often referred to as the fishbone diagram.

Basic Steps:

2 Describe Deming’s Funnel experiment and Deming’s Red Bead experiment.

Answer : Deming’s Funnel experiment

The Funnel Experiment was devised by Dr. Deming to describe the adverse effects of tampering with a process by making changes to it without first making a careful study of the possible causes of the variation in that process.

In the experiment, a marble is dropped through a funnel onto a sheet of paper, which contains a target. The objective of the process is to get the marble to come to a stop as close to the target as possible. The experiment uses several methods to attempt to manipulate the funnel’s location to achieve the objective.

3 Differentiate between variable control charts and attribute control charts. Explain with an example how to calculate p Chart and np Chart.

Differences

Answer : Control Charts

Statistical process control was developed as a feedback system that aids in preventing defects rather than allowing defects to occur. One element of a process control system is control charts. Dr. Walter Shewhart defined the concept of common and special cause variation during the 1920s at Bell Laboratories. He developed a tool that he called the control chart, which could graphically depict variation. This control chart, could also distinguish the two types of variation from each other, thus allowing for the elimination of special causes and

4 Explain Multivariate Control Charts and multivariate normal distribution.

Answer : Multivariate control charts and Hotel ling’s T 2 statistic

It is a fact of life that most data are naturally multivariate. Hostelling in 1947 introduced a statistic which uniquely lends itself to plotting multivariate observations. This statistic, appropriately named Hotel ling’s T 2, is a scalar that combines information from the dispersion and mean of several variables. Due to the fact that computations are laborious and fairly complex and require some knowledge of matrix algebra, acceptance of multivariate control charts by industry was slow and hesitant.

5 a. Explain the concept of Process Capability. Give the Significance of Process Capability. Mention the major uses of Process capability

Answer : The capability of a process is some measure of the proportion of in-specification items the process produces when it is in a state of statistical control.

Process capability is different than batch performance. With batch performance, you are interested in what actually was produced. With process capability, you are interested in what the process is capable of producing when in statistical control. This may not sound like a big difference, but it can be very important.

b. Explain the guidelines for using Acceptance Sampling.

Answer : Acceptance sampling is "the middle of the road" approach between no inspection and 100% inspection. There are two major classifications of acceptance plans: by attributes ("go, no-go") and by variables. The attribute case is the most common for acceptance sampling, and will be assumed for the rest of this section.

6 Explain the methodology for Statistical Process Control (SPC) implementation. What are the benefits derived from SPC implementation?

Answer : One way to improve a process is to implement a statistical process control program. Typically used in mass production, an SPC program enables a company to continually release a product through the use of control charts rather than inspecting individual lots of a product. As long as a device company maintains meticulously reviewed and signed documentation of its process, and the process is within specification, FDA will allow product release using SPC. This will reduce time to market by eliminating interruptions in production. SPC enables a company to detect trends and defects earlier in production, thereby reducing

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