Table of Contents

1. Quality Definition by ISO 9000 .........................................................................................................2

2. Definition of Control Charts and Types of Control Charts ..........................................................3
3. Reliability Evaluation Methods and Calculations for System in Series and Parallel ..............4
4. Single Sampling Plan, Double Sampling Plan and Sequential Sampling Plan .........................5
5. ISHIKAWA’s Model ............................................................................................................................7
CONCLUSION .............................................................................................................................................8
REFERENCES .............................................................................................................................................9

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 1. Quality Definition by ISO 9000
ISO 9000 Overview
ISO 9000 is a family of standards related to quality management systems (QMS). It provides guidelines
and tools for companies and organizations to ensure their products and services consistently meet
customer requirements, and that quality is continually improved.

Definition of Quality
In the context of ISO 9000, quality is defined as the degree to which a set of inherent characteristics of
an object fulfills requirements. Here, "object" can refer to products, services, processes, or systems, and
"requirements" are the needs or expectations that are stated, generally implied, or obligatory.

Key Concepts
i. Customer Focus
Quality is heavily centred around meeting customer needs and enhancing customer satisfaction.
Organizations must understand and meet customer requirements to achieve high quality.

ii. Process Approach

Effective quality management involves systematic processes that transform inputs into valuable
outputs, emphasizing efficiency and effectiveness.

iii. Continuous Improvement

ISO 9000 promotes ongoing improvement of all organizational processes to enhance quality
consistently.

iv. Involvement of People

The involvement of employees at all levels is crucial for achieving quality objectives. Engaged
and competent people contribute to the enhancement of quality.

v. Evidence-based Decision Making

Decisions related to quality should be based on the analysis and evaluation of data and
information, ensuring they are reliable and effective.

vi. Relationship Management

Managing relationships with stakeholders, including suppliers and partners, to improve
performance and achieve sustained success.

ISO 9000 Family

The ISO 9000 family includes standards such as:

i. ISO 9001: Specifies requirements for a QMS and is the only standard in the family that
can be certified.
ii. ISO 9004: Provides guidance for sustaining success through quality management.
iii. ISO 19011: Offers guidelines for auditing management systems.

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Benefits of ISO 9000

i. Enhanced customer satisfaction.

ii. Improved operational efficiency and effectiveness.
iii. Greater market competitiveness.
iv. Compliance with regulatory requirements.
v. Facilitation of continuous improvement.

2. Definition of Control Charts and Types of Control Charts

Definition of Control Charts
Control charts, also known as Shewhart charts or process-behavior charts, are a statistical tool used in
quality control to monitor and analyze the stability and variability of processes over time. They help in
identifying whether a process is in control (stable and consistent) or out of control (showing signs of
special cause variation).

A control chart typically consists of

i. Central Line (CL): Represents the average or mean value of the process.
ii. Upper Control Limit (UCL): The upper boundary within which the process should operate.
iii. Lower Control Limit (LCL): The lower boundary within which the process should operate.

Types of Control Charts

1. Variable Control Charts

i. X-bar Chart: Monitors the mean values of a sample. It is used to track changes in the central
tendency of the process.
ii. R Chart (Range Chart): Monitors the range within a sample, which indicates the dispersion
or spread of the process.
iii. S Chart (Standard Deviation Chart): Similar to the R chart, but uses standard deviation to
measure dispersion.
iv. Individual (I) and Moving Range (MR) Charts: Used when data are collected individually
rather than in subgroups. The I chart monitors individual data points, while the MR chart tracks
the variation between consecutive measurements.

2. Attribute Control Charts

i. P Chart (Proportion Chart): Used for monitoring the proportion of defective items in a
sample. Suitable for pass/fail or yes/no type data.
ii. NP Chart (Number of Defectives Chart): Similar to the P chart but monitors the number of
defective items rather than the proportion.
iii. C Chart (Count of Defects Chart): Tracks the count of defects per unit when the sample size
is constant.
iv. U Chart (Defects per Unit Chart): Similar to the C chart but used when the sample size varies.
It monitors the average number of defects per unit.

Applications and Benefits

i. Early Detection of Issues: Control charts help in identifying trends, shifts, or any unusual
patterns that indicate potential problems.
ii. Process Improvement: By distinguishing between common cause variation (natural
variability) and special cause variation (due to specific circumstances), control charts enable
targeted improvements.
iii. Decision Making: Provide a visual and statistical basis for making informed decisions about
process control and quality improvements.

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 3. Reliability Evaluation Methods and Calculations for System in Series and Parallel

Reliability Evaluation Methods

Reliability evaluation methods are techniques used to assess and predict the reliability of
systems, components, or processes. These methods help in determining the likelihood that a
system will perform its intended function without failure over a specified period under stated
conditions. Key methods include:

i. Failure Mode and Effects Analysis (FMEA)

Identifies potential failure modes of a system or component and their causes and effects. It
helps prioritize risks based on severity, occurrence, and detectability.

ii. Fault Tree Analysis (FTA)

A top-down approach that uses a tree diagram to model the pathways through which a system
can fail. It identifies root causes of system failures and evaluates their probability.

iii. Reliability Block Diagrams (RBD)

Represents the configuration of a system in terms of blocks that symbolize components or
subsystems. It helps analyze the overall system reliability based on the reliability of individual
blocks.

iv. Weibull Analysis

Uses the Weibull distribution to model life data and predict failure rates. It helps estimate
parameters such as the shape parameter (β), scale parameter (η), and location parameter (γ).

v. Monte Carlo Simulation

Uses random sampling and statistical modelling to estimate the reliability of complex systems.
It helps simulate various failure scenarios and predict overall system reliability.

Reliability Calculations for Systems in Series and Parallel

Series Systems
In a series system, all components must function for the system to succeed. If any component
fails, the entire system fails. The reliability of a series system is the product of the reliabilities
of its individual components.

Reliability of a Series System (Rseries)

Rseries = R1× R2 × ⋯ × Rn

where Rn is the reliability of the nth component

Example:
For a system with three components in series, with reliabilities: R1 = 0.9, R2 = 0.95 and
R3 = 0.99

Rseries = 0.9 × 0.95 × 0.99 = 0.84645

So, the series system reliability is 0.84645 (or 84.645%).

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Parallel Systems
In a parallel system, the system succeeds if at least one component functions. The system only
fails if all components fail. The reliability of a parallel system is given by the complement of
the probability that all components fail.

Reliability of a Parallel System (Rparallel)

Rparallel = 1 − (1 − R1) × (1 − R2) × ⋯ × (1 − Rn)

Where (Rn) is the reliability of the nth component.

Example:
For a system with three components in parallel, with reliabilities R 1 = 0.9, R2 = 0.95 and
R3 = 0.99

Rparallel = 1− (1 − 0.9) × (1− 0.95) × (1−0.99)

Rparallel = (1 − 0.1) × 0.05 × 0.01
Rparallel = 1− 0.00005
Rparallel = 0.99995

So, the parallel system reliability is 0.99995 (or 99.995%).

4. Single Sampling Plan, Double Sampling Plan and Sequential Sampling Plan

I. Single Sampling Plan

Definition: A single sampling plan is a statistical method used in quality control to determine
acceptance or rejection of a batch of products based on the inspection of a single sample from
the batch.

Advantages:
• Simplicity: Single sampling plans are straightforward and easy to implement.
• Reduced Inspection Costs: Requires fewer resources and less time compared to other
sampling methods.
• Immediate Decision: Provides a quick decision regarding the acceptance or rejection
of a batch.

Disadvantages:
• Limited Information: The decision is based on a single sample, which may not
accurately represent the entire batch's quality.
• Risk of Error: There is a risk of making incorrect decisions due to sampling variability.
• Lack of Flexibility: Does not adapt well to situations where the quality of the batch
may vary.

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 II. Double Sampling Plan:

Definition: A double sampling plan involves two stages of inspection. If the first sample
inspection result is inconclusive, a second, larger sample is inspected to make the acceptance
or rejection decision.

Advantages:
• Increased Accuracy: Provides more information than a single sampling plan, leading
to more accurate decisions.
• Reduced Risk of Error: The second sample helps in reducing the risk of making
incorrect decisions based on sampling variability.
• Improved Flexibility: Allows for adjustments based on the results of the first sample
inspection.

Disadvantages:
• Increased Inspection Costs: Requires more resources and time compared to single
sampling plans.
• Complexity: Double sampling plans are more complex to design and implement than
single sampling plans.
• Potential Delay: The need for a second inspection may delay the decision-making
process.

III. Sequential Sampling Plan

Definition: Sequential sampling plans involve inspecting samples from a batch one at a time
until a decision to accept or reject the batch can be made. The decision is based on
predetermined acceptance and rejection criteria.

Advantages:
• Efficiency: Typically requires fewer samples than fixed-size sampling plans, leading
to faster decision-making.
• Adaptability: Can adapt to varying batch qualities by adjusting the sampling process
accordingly.
• Improved Accuracy: Allows for more precise estimation of the batch quality
compared to fixed-size sampling plans.

Disadvantages:
• Complexity: Designing and implementing sequential sampling plans can be complex,
requiring statistical expertise.
• Potential for Bias: If not properly designed, sequential sampling plans may introduce
bias into the decision-making process.
• Resource Intensive: Depending on the sampling scheme, sequential sampling plans
may require more resources than fixed-size sampling plans.

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 5. ISHIKAWA’s Model
Purpose: To identify root causes of problems affecting product quality.

Structure:
• Central Spine: Main problem (e.g., loss of weld quality).
• Fishbones: Major categories affecting the problem (e.g., Manpower, Machine,
Material, Method, Measurement, Environment).
• Twigs: Further details for each category (e.g., welder fatigue, machine calibration).

Benefits:
• Structured problem-solving approach.
• Identifies various potential causes.
• Helps prevent future quality issues.

Applications: Widely used in manufacturing and quality control.

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 CONCLUSION

This session covered a range of quality management concepts essential for understanding and
achieving product and process excellence. We started with the foundation, exploring the
definition of quality according to the ISO 9000 standards. Then, we delved into tools for
monitoring and controlling quality, specifically focusing on control charts.
Moving on to reliability, we discussed various methods for evaluating how consistently a
product or process performs over time. To ensure efficient resource allocation during
inspections, we explored different types of sampling plans. Finally, we wrapped up by
examining the Ishikawa diagram, also known as the fishbone diagram, a valuable tool for
identifying and analyzing the root causes of quality problems.

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 REFERENCES

https://www.iso.org/home.html
https://www.wiley.com/en-
ie/Statistical+Quality+Control:+A+Modern+Introduction,+7th+Edition+International+Studen
t+Version-p-9781118531372
https://www.amazon.com/Introduction-Reliability-Maintainability-
Engineering/dp/0070188521
https://www.routledge.com/Acceptance-Sampling-in-Quality-Control/Schilling-
Neubauer/p/book/9781498733571
https://asq.org/quality-resources/fishbone
www.wikipedia.org
www.google.com