6

Statistical Concepts in Quality Management

If you cant measure it, you dont understand it. Vince Lombardi

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Learning Objectives
After studying this chapter, you should be able to:

Understand Variation Explain mean, range, standard deviation and normal distribution Explain Measurement System Analysis (MSA) Describe Process Capability Discuss Sampling Understand quality assurance, quality policy and quality manual

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Variation
Variation is the enemy of quality. The less variation there is in a product or process, the greater the number of items that will work as designed. To

reduce variation, one must measure it .The concept of variation states that
no two items will be perfectly identical even if extreme care is taken to make them identical in some respect. Variation is a fact of nature. All processes are subject to a certain degree of variability. Usually, variations are of two types:

Natural (Common) Assignable (Special)

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Statistical Quality Control (SQC)

SPC is the application of statistical methods to the measurement and analysis of variation of any process. It is used to measure the performance of a process and thereby ensure that the process is meeting specified standards. It is a methodology for monitoring a process to identify special causes of variation and signaling the need to take corrective action when it is appropriate.

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Quality Control Measurements

Quality control measurements and indicators fall into one of two categories:

Attribute Variable

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Probability Distributions

The Binominal distribution The Poisson distribution The Exponential distribution The Normal distribution

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Measurement System Analysis (MSA)

MSA an experimental and mathematical method of determining how much the variation within the measurement process contributes to overall process variability.There are five parameters to investigate in an MSA:

Bias Linearity Stability

repeatability
reproducibility

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Precision and Accuracy

Precision: Precision is the degree which determines how well Accuracy: Accuracy is the degree to which the measured value of the

identically performed
measurements agree with each other. It is measured in terms of:

quality characteristic agrees with

the true value. Accuracy measurement has three components:

Repeatability Reproducibility

Linearity Bias Stability

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Difference Between Precision and Accuracy

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Process Capability

The process capability is defined as the performance of a process over a certain period of time while in the statistically controlled state. Process-capability studies are used to assess the ability of a process to meet specifications. Process capability compares the output of an in-control process to the specification limits by using capability indices. The process capability study facilitates the various business functions Process capability can be expressed with an index. Two widely used process capability indices are Cp and Cpk are process capability estimates.

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Process Capability Indices

Cp index: This is a process capability index that indicates the process potential performance by relating the natural process spread to the specification (tolerance) spread. It is often used during the product design phase and pilot production phase. This measures potential or inherent capability of the production process. It evaluates a processs ability to meet two sided specification limits. Cpk index: These measures realized process capability relative to actual production. It is used to summaries a processs ability to meet two sided specification limits.

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Six Sigma Concept of Process Capability

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Levels of Six-Sigma
Sigma 6-Sigma 5- Sigma 4- Sigma Defects per million 3.4 233 6,210 Cost of poor quality < 10% of sales 10-15% of sales 15-20% of sales Industry average Product status World class

3- Sigma
2- Sigma 1- Sigma

66,807
308,537 690,000

20-30% of sales
30-40% of sales 40-70% of sales Non-competitive

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Inspection

100 percent inspection: In 100 percent inspection all the parts or products are subjected to inspection, whereas in sampling inspection only a sample is drawn from the lot and inspected. Sampling inspection: can be defined as a technique to determine the acceptance or rejection of a lot or population on the basis of number of defective parts found in a random sample drawn from the lot. If the number of defective items doesnt exceed a predefined level, the lot is accepted otherwise it is rejected.

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Sampling Methods

Non Probability Sampling Judgmental Sampling Probability Sampling Simple random sampling, Systematic sampling, Stratified sampling, Cluster sampling, Two stage sampling.

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Quality Indices for Acceptance Sampling Plans

Acceptable Quality Level (AQL) Reject able Quality Level (RQL) Indifference Quality Level (IQL) Average Outgoing Quality (AOQ)

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Operating Characteristic Curve (OC-Curves)

Operating characteristic curves are a graphical means for comparing sampling plans. They enable SQC plans to be compared. They show the relationship between lot size and number of defectives. OC curve shows a plot of proportion of defectives in the lot p and probability of acceptance Pa. In this case the number of non-conforming items in a batch will follow binomial distribution.

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Operating Characteristic Curve (OC-Curves)

B Pa

Evaluate Sampling plans

Lot Fraction Defective

Comparing alternative plans A & B

The Two point method

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Sampling Plans

Single sampling plan

Double sampling plan

Multiple sampling plan

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Comparison Between Sampling Plans

Criteria Single sampling plan Double sampling plan Multiple sampling plan Lowest

Average number of pieces inspected per lot Cost of administration

Largest

In between single and multiple plans

Lowest

In between single and multiple plans In between single and multiple plans

Largest

Information available regarding prevailing quality level

Largest

Least

Acceptability to producers

Less (gives only one chance of passing the lot)

Most acceptable

Indecision is continued for a long term

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Quality Assurance
ISO 8402 defines quality assurance as:
All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality.

Quality assurance is a system of management activities to ensure that a process, item, or service is of the type and quality needed by the user.

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Quality Policy
The quality policy is a guide for everyone in the organization as to how they should provide products and services to the customers. It should be written by the CEO with feedback from the work force and should be approved by the quality council. It is a requirement of Quality Management System. Common characteristics of quality policy are:

Quality is first among equals Meets the needs of internal and external customers Equals or exceeds the competition Continually improves quality Includes business and production procedures Utilizes the entire workforce

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Quality Manual
A quality system which is defined as an assembly of components such as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management must be documented in the form of a quality manual.

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