QUALITY ASSURANCE

INTRODUCTION TO
QUALITY ASSURANCE

MT 257
QUALITY means
Increasing Mean Time to Failure

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 QUALITY means
Reducing Percent Defective during first 90 days of Usage

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QUALITY means
Stopping Product Recalls

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QUALITY means
Lowering Rates of Return

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 Importance of Quality:
LONG-TERM SUCCESS

Competitive Edge
“The first job we have is to turn
Satisfied Customers - Reward
out quality merchandise that company via Patronage, Word of Mouth

consumers will buy and keep on

buying. If we produce it
efficiently and economically,
we will earn a profit, in which
you will share.”
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 Importance of Quality:

No quality, no sales.

No sales, no profit.

No profit, no jobs.

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 History of Quality Assurance
Early 20th Century
Fredrick Taylor – Father of Scientific Management
Segmenting Jobs into Specific Work Tasks
Production

Planning Execution

Managers Engineers Supervisors Workers

Inspectors

• Resulted in Greater
• Efficiencies Sole Responsibility: Quality
• Output Quantity Removed Defects
• Less Focus
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 History of Quality Assurance
Post World War II KAIZEN – 20 Year Process
• Focus on Integrated Quality throughout Organization
• Focus on Upper Management, rather than Quality Specialists Alone
• Culture of Continuous Improvement 1987 – 100 Automobile Models
# of Problems in first 60 – 90 days

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162 - 180 159 129 9
 GE PRODUCT LINE STUDY
PRODUCT QUALITY TOTAL QUALITY MANAGEMENT

• Tight Tolerance
• Emphasized Satisfying Customer
• Conformance to Specifications Expectations

• Manufacturing Flow • Customer Needs through Market

Research
• Number of Defects per Unit • Customer Based Quality
Performance Measures
Quality Control Only in
Manufacturing Quality Control Systems for All Business
Functions, not just Manufacturing

POOR REPUTATION
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 Quality Assurance Definition
...is any planned and systematic activity directed toward providing
customers with goods and services of appropriate quality, along with the
confidence that products meet consumers’ requirements.

QA depends on Excellence of..

Design of Goods & Services Control During Execution

aided by..

Measurement Inspection
Can you think11:26
5/19/2020 of other
PM definitions? 11
 Defining Quality
86 Firms in U.S were asked to DEFINE QUALITY
Perfection Fast delivery

Providing a good, usable product

Consistency

Eliminating waste
Doing it right the first time
Delighting or pleasing customers
Total customer service and satisfaction
Compliance with policies and procedures
5/19/2020 11:26 PM Let’s look at the Formal Definitions of Quality.. 12
Formal Definitions of Quality
• Product-Based definition
• Function of Specific, Measurable Variable
• Differences in Quality reflect Differences in Quantity
• Quality often related to Price of Product or Service

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Formal Definitions of Quality
• User-Based definition
• Quality is determined by What Customers Want
• Individuals have different wants & needs and thus different
Quality Standards
• How well it performs its Intended Function

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Formal Definitions of Quality
• Value-Based definition
• Relationship of Usefulness to Price
• Useful as Competing Products & Lower Price
• Balance Product Characteristics with Cost

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Formal Definitions of Quality
• Manufacturing-Based definition
• Conformance to Specifications
• Targets & Tolerances determined by Designers

Enough Definitions..Which is for me?

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Integrating Perspectives on Quality
Your Quality Definition depends on Your Position in the Value Chain

Marketing
Customer

Design

Manufacturing
Distribution
Information flow
Product flow
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 Quality Perspectives
Your Quality Definition depends on your position in the Value Chain
• Customers
• Product-based definition – measurable, variable

Marketing
Customer

Driving Design
Force

Manufacturing
Distribution
Information flow
Product flow
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Quality Perspectives
Your Quality Definition depends on your position in the Value Chain
• Marketing
• User-Based definition – what customers want, intended
function Marketing
Customer

A Quality Product
should meet Design
Consumers
Needs

Manufacturing
Distribution
Information flow
Product flow
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Quality Perspectives
Your Quality Definition depends on your position in the Value Chain

• Design
• Value-Based definition – usefulness to price
Product Specifications:
Marketing Size, Material, Finish,
Customer Safety

Balance
Performance Design Translate to Manufacturing
& Cost
Process Specifications:
Manufacturing Equipment, Tools,
Facilities
Distribution
Information flow
Product flow
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Quality Perspectives
Your Quality Definition depends on your position in the Value Chain

• Manufacturing
• Manufacturing- Based definition - Targets & Tolerances
• Conformance to Product Specs
Marketing
Customer
Machine Setting
Incorrect, Operator
Mistakes, Defective Design • Adhere to Design Specs
Materials

Manufacturing
Distribution
• Performs as Intended
Information flow
Product flow
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Quality Perspectives
Your Quality Definition depends on your position in the Value Chain
• Manufacturing Services (Service Industry)
• Transcendent – Judgmental
Marketing Hospital
Customer
Competency of Medical Staff
Hospital
Service
Image of Excellence Design
Availability of Treatments

Manufacturing Service
Distribution
Advanced Medical Technology
But ANSI & ASQ have their own Definitions
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 Customer-Driven Quality
• “Meeting or exceeding customer expectations”
• Customers can be...
– Consumers: Ultimate Purchaser of P&S

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 Customer-Driven Quality
• “Meeting or exceeding customer expectations”
• Customers can be...
– External Customers: Before reaching Consumer, flows through a Supply Chain of
Firms

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 Customer-Driven Quality
American National Standards Institute (ANSI)
American Society for Quality (ASQ)
Define Quality as..
• “Meeting or Exceeding Customer Expectations”
• Customers can be...
– Internal Customers: a business consists of a chain of customers

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 How to Achieve Quality
1. Determine the Customer’s Requirements – Wants & Needs

2. Set Standards to define all Requirements

3. Prepare Plans to meet those Requirements

4. Communicate Requirements and Plans effectively to all concerned

5. Assess the ability to meet the requirements and Use Capable Processes

6. Control the Processes – Consistency

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How to Achieve Quality
Customer • Clearly
Requirements Defined

• Product
Quality of
Design • Process
• Service
• Process Capability – Ability to
meet Requirements?
• Process Control – Consistently
Quality of Produce within Process
Conformance Capability
to Requirements • Trained & Motivated
Workforce
• Management Commitment &
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Support
 Quality Organization
• Old School Quality
o Quality Organization is a Separate Department of
skilled personnel with Direct Responsibility for Quality

• New School Quality

o All Functions in the company are Responsible

o Quality Department still Exists

o Quality is Not achieved by Monitoring & Policing

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Quality Systems
• All Activities and Responsibilities associated with
Quality have been Clearly Defined

• Policies & Procedures

• Quality Activities Integrated into Company’s policies &
Procedures
• Documented so that Personnel across different
functions know their responsibilities and understand
those of others

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Elements of a Quality System
• Contract Review • Inspection & Testing
• Design Control • Control of Non-
Conforming product
• Process Control
• Corrective Action
• Document Control
• Handling, Storage,
• Purchasing
Packaging & Delivery
• Training
• Quality Records
• Product Identification
• Internal Quality Audits
& Traceability
• Statistical Techniques

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 Quality System Documents
• Quality Policy
o Statement of Position on Quality

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 Quality System Documents
• Procedures
o What Tasks are required to be performed?

o When should these Tasks be performed?

o Who is responsible for performance of the Tasks?

o ISO-9000
o Need to be a procedure that covers each element
o Evidence that procedures are being followed
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 Quality System Documents
• Procedures

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 Quality System Documents
• Work Instructions
o Define How to perform a Task at any given step of a Process
o Need to be Consistent
▪ Everyone does it the same way

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 Quality System Documents
• Records
o Traceable Checks & Balances intended to Provide:
▪ Evidence
▪ Numerical Results for Evaluation
▪ Status of product or process Quality

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Non-Conforming Materials &
Corrective Action Systems
• Material Review Board (MRB) Responsible for:
o Representatives from Engineering, Materials, Quality Purchasing
o Review, Dispositions & Initiating Corrective Action

• Non-Conforming Materials
o Must be Identified and Controlled to:
▪ Prevent Mixing with Conformance Material
▪ Isolate and Correct the Root Cause
o Needs to be a Review for the Cause followed by:
• Dispositioning – complete missed operations, rework, repair,
scrap, use as is. Etc.
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Non-Conforming Materials &
Corrective Action Systems
• Effective Corrective Action
o Eliminate Root Cause of Non-Conformance
o Make Changes in Process to Prevent Recurrence of Cause

• Corrective Action Systems

o Material Review activities
o Quality Reporting & Analysis
o Problem-solving teams
o Bonding and segregating defective materials
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Prevention-Oriented Quality Systems
• Preventive Quality Systems Detection vs. Prevention System
o More Effective than Tradition Detection
Systems

Cost Trends
• Costs of Appraisal
• Inspection, Auditing, Testing

• Internal Failure Costs

• Scrap, Rework, Repair

• Appraisal a& Internal Failure Costs trend

together and increase overall costs of
Quality
Investment in Prevention System
• Prevention & External Failure are small decreases all Quality Costs
in comparison
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 Quality and Communication
Producer Consumer Engineering Manufacturing
Poor Poor
Communication Communication
regarding regarding
Customer Specifications,
Requirements Standards,
Drawings

Marketing Engineering

Need Cross-Functional Communication

between Departments
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 Motivation and Quality
• People play a vital role in the success of any process
• Lack of Motivation comes from:
o Lack of training, skills, tools, standards, ability to measure output
and control process, pay, management style, work environment

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 Motivation and Quality
• To Assure Quality Output provide People with:
o Training and Skill
▪ No Training will lead to more Mistakes & less Improvements
o Proper Tools
o Clearly Defined Standards
▪ Provides a Baseline for people to Measure Results
o Measurement
▪ Ability to accurately & repeatedly measure output of process
o Graphical Analytical Tools
▪ Statistical Process Control Charts, Histograms - Reduce
Variation
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