Unit II: Quality Control and Quality Assurance

Contents of Unit 2
 The evolution of quality concepts,
 quality control and quality assurance during a product's life cycle,
 benefits and costs of quality assurance,
 Costs of quality failure,
 quality systems,
 quality manual,
 quality organizational structure,
 statistical quality control tools,
 quality-control charts,
 sampling methods,
 investigating the causes of nonconformity,
 six-sigma approach to quality management,
 comparison between ISO 9000, and six-sigma

The Evolution of Quality Concepts

The concept of quality has evolved over time from basic inspection methods to
modern quality management systems. Here’s how it developed:
Stages of Quality Evolution:
1. Craftsmanship Era (Before 1900s) – Individual artisans ensured quality
by handcrafting products.
o Example: Blacksmiths making swords in ancient times ensured
durability through their expertise.
2. Industrial Revolution (1900s-1920s) – Mass production began, leading
to quality issues. Basic inspection-based quality control was introduced.
o Example: Ford’s assembly line in the 1920s relied on visual
inspections to ensure cars met specifications.
3. Statistical Quality Control (1920s-1950s) – Introduced by Walter
Shewhart, using statistical methods for process control.
o Example: The U.S. used Shewhart’s Statistical Process Control
(SPC) in World War II to ensure consistent weapon manufacturing.
 4. Total Quality Management (TQM) (1950s-1980s) – Focus shifted from
detection to prevention. Japanese companies (Toyota, Sony) embraced
Deming’s principles, emphasizing continuous improvement (Kaizen).
o Example: Toyota’s lean manufacturing system reduced defects and
improved efficiency.
5. Modern Quality Standards (1990s-Present) – ISO 9001, Six Sigma,
and AI-driven quality assurance became industry standards.
o Example: Companies like Samsung and Apple use Six Sigma to
minimize defects in their products.

Quality Control and Quality Assurance During a Product's Life Cycle

Difference Between Quality Control (QC) & Quality Assurance (QA):
 QC focuses on detecting and correcting defects after production.
 QA focuses on preventing defects through better design and processes.
Quality Control & Assurance in Product Life Cycle:
1. Design Phase (QA Focus)
o Ensure the product design meets performance and safety standards.
o Example: Boeing uses simulation and stress testing during aircraft
design to prevent in-flight failures.
2. Production Phase (QA & QC Focus)
o Implement quality standards, perform inspections, and test
prototypes.
o Example: Tesla performs rigorous battery testing before installing
them in vehicles.
3. Post-Production & Customer Feedback (QA Focus)
o Monitor product performance, gather customer feedback, and
improve future designs.
o Example: Apple releases software updates to fix bugs and improve
iPhone performance based on user reports.
Benefits and Costs of Quality Assurance
Benefits of Quality Assurance:
✔️ Higher customer satisfaction – Leads to repeat business and brand loyalty.
 Example: Amazon’s commitment to quality ensures fast, reliable
deliveries, boosting customer trust.
✔️ Lower production costs – Reducing defects early prevents expensive
recalls.
 Example: Intel uses defect detection in chip manufacturing to avoid
costly replacements.
✔️ Compliance with regulations – Avoids legal penalties and bans.
 Example: Pharmaceutical companies must follow Good Manufacturing
Practices (GMP) to sell medicines globally.
✔️ Competitive advantage – High-quality products attract more customers.
 Example: Toyota’s quality assurance led to its global success over
American car brands.
Costs of Quality Assurance:
💰 Investment in testing and inspections – Hiring QA teams, buying testing
equipment.
💰 Training employees – Educating workers on quality standards.
💰 Longer production time – Additional checks can delay production.

Costs of Quality Failure

If quality is not ensured, companies face direct and indirect costs, known as the
cost of poor quality (COPQ).
Types of Quality Failure Costs:
1. Internal Failure Costs (Before the product reaches customers)
o Rework, scrap, production delays.
o Example: Samsung recalled the Galaxy Note 7 before mass sales
due to battery explosions, costing $5.3 billion.
2. External Failure Costs (After the product reaches customers)
 o Product recalls, warranty claims, reputational damage, lawsuits.
o Example: Toyota’s unintended acceleration issue led to a $1.2
billion fine and a recall of millions of cars.
3. Loss of Market Share & Reputation Damage
o Customers lose trust, leading to long-term revenue loss.
o Example: Boeing’s 737 MAX crashes (due to software failure) led
to $20 billion in losses and major trust issues.

Quality Systems
What is a Quality System?
A Quality System is a set of procedures, processes, and policies that ensure
products or services meet customer expectations and regulatory requirements. It
helps organizations maintain consistency, efficiency, and compliance with
industry standards.
Real-Time Examples:
🔹 ISO 9001 – Quality Management System (QMS)
 Ensures standardized processes for better efficiency and customer
satisfaction.
 Example: Companies like Toyota, Samsung, and IBM follow ISO 9001
to maintain product consistency and global competitiveness.
🔹 Six Sigma – Process Improvement Methodology
 Focuses on reducing defects and improving quality.
 Example: General Electric (GE) saved $12 billion using Six Sigma to
reduce defects in manufacturing.
🔹 GMP (Good Manufacturing Practices) – Pharmaceutical Industry
 Ensures safe production of medicines and medical devices.
 Example: Pfizer and Johnson & Johnson follow GMP to meet FDA
regulations.
Quality Manual
What is a Quality Manual?
A Quality Manual is a document that outlines an organization’s quality
policies, procedures, and responsibilities. It serves as a guide for employees to
maintain consistency in quality practices.
Real-Time Examples:
🔹 Airbus Quality Manual
 Defines manufacturing, inspection, and safety procedures to ensure
high aircraft safety standards.
🔹 McDonald's Quality Manual
 Standardizes food preparation processes globally (e.g., every Big Mac
must follow the same recipe, temperature, and serving method).
🔹 Tesla Quality Manual
 Includes testing standards for battery safety, vehicle durability, and
software updates to maintain quality across electric cars.

Quality Organizational Structure

What is a Quality Organizational Structure?
A Quality Organizational Structure defines roles and responsibilities within a
company to ensure quality is integrated across all departments.
Common Roles in a Quality Structure:
1. Quality Manager – Oversees the entire quality system.
2. Quality Engineers – Implement quality control tools and methods.
3. Quality Auditors – Inspect and verify compliance with standards.
4. Production Team – Ensures quality during manufacturing.
Real-Time Example:
🔹 Apple’s Quality Control Team
 Apple has a dedicated quality control structure for hardware (e.g.,
iPhones, MacBooks) and software (iOS updates).
🔹 Ford’s Quality Division
 After past defects, Ford implemented a Quality Leadership Structure to
enhance reliability in its vehicles.

Statistical Quality Control (SQC) Tools

What are SQC Tools?
SQC tools use statistics and data analysis to monitor and control production
quality.
Key SQC Tools with Examples:
🔹 Pareto Chart – Identifies the most common defects.
 Example: A mobile phone manufacturer finds that 80% of defects
come from 5 common issues (e.g., faulty screens, battery problems).
🔹 Histogram – Shows variation in product quality.
 Example: A cement factory tracks strength variations in its cement
batches.
🔹 Fishbone Diagram (Ishikawa Diagram) – Identifies root causes of defects.
 Example: Toyota uses it to analyze causes of engine failure in specific
models.
🔹 Scatter Diagram – Shows the relationship between two quality factors.
 Example: Intel uses scatter plots to find a correlation between chip
overheating and failure rate.

Quality-Control Charts
What are Quality-Control Charts?
Quality-Control Charts (also called Control Charts) track production
performance over time to detect process variations and defects early.
Types of Control Charts & Examples:
🔹 X̄ (Mean) Chart – Monitors the average value of a process.
  Example: A bottling plant uses an X̄ chart to ensure each bottle contains
exactly 500ml of water.
🔹 R (Range) Chart – Tracks variability in product measurements.
 Example: A pharmaceutical company ensures tablet weight
consistency using an R chart.
🔹 p-Chart (Proportion Defective) – Tracks the % of defective items in a
batch.
 Example: A car tire factory monitors defects in randomly selected
batches of tires.
🔹 c-Chart (Number of Defects per Unit) – Monitors the total number of
defects per item.
 Example: A laptop manufacturer counts the number of defective
screens in 100 laptops per batch.

Sampling Methods
What are Sampling Methods?
Sampling methods are techniques used to inspect a subset of products from a
production batch rather than checking every item. This saves time and costs
while ensuring quality.
Types of Sampling Methods with Real-Time Examples:
🔹 Random Sampling – Selecting items randomly from a batch to check
quality.
 Example: A chocolate factory randomly picks 50 chocolate bars from a
batch of 10,000 to check for defects.
🔹 Stratified Sampling – Dividing a batch into groups (strata) and sampling
from each.
 Example: A car manufacturer checks engines separately from tires to
ensure quality in different sections.
🔹 Systematic Sampling – Selecting every nth item in a sequence.
  Example: A juice bottling company inspects every 100th bottle for
proper sealing.
🔹 Acceptance Sampling – A batch is accepted or rejected based on a sample’s
quality.
 Example: A pharmaceutical company tests a few pills from each batch
before approving them for distribution.

Investigating the Causes of Nonconformity

What is Nonconformity?
Nonconformity occurs when a product or service fails to meet quality
standards or customer expectations.
Methods to Investigate Nonconformity:
🔹 Root Cause Analysis (RCA) – Identifying the fundamental reason behind
defects.
 Example: If a smartphone screen keeps breaking, RCA may reveal that
the glass supplier changed its material composition.
🔹 5 Whys Technique – Asking “Why?” multiple times to find the root cause.
 Example: A car paint defect is investigated:
1. Why? The paint is peeling.
2. Why? The adhesion is weak.
3. Why? The primer wasn’t applied correctly.
4. Why? The machine temperature was too low.
5. Why? A sensor malfunctioned. → Root Cause Identified!
🔹 Fishbone Diagram (Ishikawa Diagram) – Categorizing possible causes
into groups (e.g., Materials, Methods, Machines).
 Example: A restaurant’s food quality drops → A fishbone diagram
helps find if it’s due to ingredient sourcing, chef training, or kitchen
equipment issues.
🔹 Pareto Analysis (80/20 Rule) – Finding the most significant factors causing
defects.
  Example: A clothing brand finds that 80% of customer complaints
come from just 20% of production issues (e.g., stitching defects).

Six-Sigma Approach to Quality Management

What is Six-Sigma?
Six-Sigma is a data-driven approach to reduce defects and improve efficiency
by following a structured DMAIC process (Define, Measure, Analyze,
Improve, Control).
Real-Time Examples of Six-Sigma in Action:
🔹 Motorola – The Founder of Six-Sigma
 Reduced defects per million opportunities (DPMO) from 20,000 to less
than 3.4.
🔹 General Electric (GE) – Saved $12 billion using Six-Sigma to optimize
manufacturing and services.
🔹 Amazon – Enhancing Delivery Efficiency
 Uses Six-Sigma to reduce errors in order fulfillment and packaging.
🔹 Airbus – Aircraft Manufacturing
 Implements Six-Sigma to reduce component failure rates in jet engines.

Comparison Between ISO 9000 and Six-Sigma

Feature ISO 9000 Six-Sigma

International standard for Data-driven methodology for

Definition quality management systems reducing defects and improving
(QMS). processes.

Process standardization & Process improvement & defect

Focus
documentation. reduction.

Uses DMAIC (Define, Measure,

Establishes what needs to be
Approach Analyze, Improve, Control) to
done but not how.
systematically improve processes.
Feature ISO 9000 Six-Sigma

Individuals can earn Six-Sigma

Organizations can get ISO
Certification belts (Yellow, Green, Black,
9001 certification.
Master Black).

Primarily used in manufacturing,

Industry Used in various industries
healthcare, and IT for defect
Use for general quality assurance.
reduction.

A hotel chain (e.g., Marriott) Ford uses Six-Sigma to reduce

Example follows ISO 9001 to ensure defects in car engine
consistent service quality. manufacturing.