Subject - QUALITY CONTROL & STANDARDIZATION

CONCEPTS OF QUALITY

Definition of Quality
a. A degree of excellence
b. Conformance to requirements
c. Totality of characteristics which act to satisfy a need
d. Fitness for use
e. Fitness for purpose
f. Freedom from defects
g. Delighting customers

BASIC QUALITY CONCEPTS

Quality Management
Quality management ensures that an organization, product or service is consistent. It
has four main components: quality planning, quality assurance, quality control and quality
improvement.

Quality Management - Components

Quality planning Quality assurance Quality control Quality improvement.

 Quality Planning
Quality planning (QP) means planning how to fulfill process and product (deliverable)
quality requirements

 Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved
in production.

 Quality Assurance
Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products
and avoiding problems when delivering products to customers.

Two principles included in quality assurance are: "Fit for purpose" (the product should be
suitable for the intended purpose); and "right first time" (mistakes should be eliminated).

 Quality Improvement
Quality Improvement (QI) is a formal approach to the analysis of performance and systematic
efforts to improve it

Total Quality Management

Total Quality Management (TQM) refers to management methods used to enhance quality and
productivity in business organizations.

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Difference between Quality assurance(QA) & Quality control (QC)

QUALITY – BENEFITS TO EMPLOYEES, ORGANIZATIONS, CUSTOMERS,

SUPPLIERS, SOCIETY

Benefits to  Improves job satisfaction

Employees  Increases confidence level.
 Improves team spirit & reduces ego
 Improved Performance
Benefits to  Improves Production/Productivity
Organization  Improvement in - quality of product
 Improve goodwill
 Reduction in costs due to reduction of defects
 Assured Customer/Market Share
 Increased Customer Satisfaction
Benefits to  Quality Service
Customer  Increased Confidence in Service
 Improved Supply/Consistent Quality
 Competitive Pricing
Benefits to  Stability
Suppliers  Growth
 Partnership and mutual understanding
Benefits to  Improved health and society
Society  Increased security

FUNDAMENTAL FACTORS AFFECTING QUALITY

The nine fundamental factors (9 M’s), which are affecting the quality of products and services,
are:
1. Market 4. Men 7. Machines and mechanization
2. Money 5. Motivation 8. Modern information methods
3. Management 6. Materials 9. Mounting product requirements

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DIMENSIONS OF QUALITY

In 1987 David Garvin suggested that there are eight dimensions to quality.

Eight dimensions to quality :

1. Performance - characteristics & purpose of product
2. Features - additional characteristics of product
3. Reliability - trustworthy/perform as expected over time
4. Durability - lifetime of product
5. Conformance - Following standards
6. Serviceability - warranty or repairing of fault
7. Aesthetics - appearance/beauty of product
8. Perceived Quality - quality according to customer's perception or opinion

ZERO DEFECTS
Zero Defects - a term coined by Mr. Philip Crosby in his book "Absolutes of Quality
Management" has emerged as a trending concept in quality management.

Definition:
Zero Defects is a management tool aimed at the reduction of defects through prevention.
The “right first time “phrase connects with Zero Defect theory

Waste refers in Zero defects includes:

 Unproductive process
 Unproductive tools
 Unproductive Employee

The Principles of Zero Defects are:

 Quality is defined as conformance to the requirements
 Defects prevention is better than quality inspection and correction
 Quality standard means zero defects
 Quality is measured in terms of money (i.e. the price of non-conformance: PONC)

Advantages of Zero Defects are:

 The advantage of achieving a zero defect level is waste reduction.
 By conforming to requirements, customer satisfaction is achieved.
 Increased customer retention and increased profitability.

Disadvantages of Zero Defects are:

 Increased allotment of time and expense on building the perfect process.
 Increase in the costs on these activities.
 There is also a probability of losing a good product due to overly strict criteria.

COST OF QUALITY

 Cost of Quality = Cost of Poor Quality + Cost of Good Quality

 Cost of Poor Quality = Failure Costs

Example: Rework, Delays, Re-designing, Failure analysis, Re-testing, Complaints,
Repairing goods and redoing services, Warranties, Customers' bad will
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 a) Internal Failure Costs:
Costs associated with discovering poor product quality before the product reaches the
customer.

Examples: Rework, Scrap, Material, labor, and Machine cost spent in producing the
defective product, Cost of machine downtime due to failures in the process.

b) External Failure Costs:

Costs are associated with quality problems that occur at the customer site. These costs
can be particularly damaging because customer faith and loyalty can be difficult to
regain.

Examples: Costs of failure at customer site, including returns, repairs, and recalls. A
final component of this cost is lost sales and lost customers.

 Cost of Good Quality = Prevention Cost + Appraisal Cost

a) Prevention Costs:
Prevention costs are costs of all activities that are designed to prevent poor quality from
arising in products or services

Examples : Quality planning, Supplier evaluation, New product review, Capability

evaluations, Quality improvement team meetings, Quality improvement projects, Quality
education and training

b) Appraisal Costs:
Appraisal costs are costs that occur because of the conformance to quality standards and
performance requirements.

Examples: Checking and testing purchased goods and services, In-process and final
inspection/test, Field testing

DEFECT

What is a Defect?
 A flaw or weakness in a system that causes the system to fail
 Non-conformance to a standard
 A disorder in the system or process which can cause a failure or discrepancy in the
delivery of product or services.
 Expectations are not meet.
 A defect can be seen as an opportunity for improvement.

Causes of Defect
 Incorrect information
 Lack of skill/knowledge
 Lack of training
 Proper monitory
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  Poor planning
 Poor Execution

PDCA – Plan Do Check Act

Originally developed by American physicist Walter A. Shewhart during the 1920s. It formed the
basis of Dr William Edwards Deming's approach to organizational development and leadership.

PDCA act as an Improvement Tool

 Plan: What an organization wants to change.
 Do: Implement the desired changes.
 Check: Test the changes whether they meet the required standards or not.
 Act: Make necessary changes if there is any diversity.

Partnership Sourcing
 The idea of exclusive long time purchasing partnership is referred as Partnership
Sourcing
Benefits of strategic partnership sourcing
o Customer benefits
o Mutual benefits
o Supplier benefits

Benefits of customer point of  Fair and long term partnership agreement

views  No multiple tooling costs

Benefits of mutual point of  Equitable pricing

views  better Quality and closer Customization

Benefits of supplier point of  Fair and predictable margin

views  Clear awareness of customer requirements

Different methods of vendor rating

 Vendor (suppliers) – Person selling goods or service
 Methods:
1. The Categorical plan (prepare list and evaluate then shortlist)
2. The weighted point method (weightage for each factors. Eg: quality – 30 points, timely
delivery – 20 points, etc )
3. The cost –ratio plan (compares total cost {quotation, quality, service, delivery cost} for
specific purchase

Operational program
 The effort required for locating and fixing an error in an operational program -
Maintainability
 The effort required for modifying an operational program - Flexibility

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 INSPECTION

 Inspection is an important tool to achieve quality concept.

 It is necessary to assure confidence to manufacturer and aims satisfaction to customer.
 It helps to control quality, reduces manufacturing costs, eliminate scrap losses and
assignable causes of defective work.
 It checks the components at various stages with reference to certain predetermined factors
and detecting and sorting out the faulty or defective items.

Objectives of Inspection
 To detect and remove the faulty raw materials before it undergoes production.
 To detect the faulty products in production whenever it is detected.
 To bring facts to the notice of managers before they become serous to enable them
discover weaknesses and over the problem.
 To prevent the substandard reaching the customer and reducing complaints.
 To promote reputation for quality and reliability of product.

Purpose of Inspection
 To distinguish good lots from bad lots.
 To distinguish good pieces from bad pieces.
 To determine if the process is changing.
 To determine if the process is approaching the specification limits.
 To rate quality of product.
 To rate accuracy of inspectors.
 To measure the precision of the measuring instrument.
 To secure products-design information.
 To measure process capability.

Types of Inspection
 Floor inspection - performed at the place of production (material & machine
checking)
 Centralized inspection – inspection at central place with all testing equipment in air-
conditioned area
 Combined inspection - Combination of two floor & central
 Tool Inspection - inspecting tools like clicking dies
 Periodic Inspection - carried out in definite intervals
 Functional inspection - only checks for the main function
 First piece inspection - First piece of the shift or lot is inspected
 Pilot piece inspection - done immediately after new design or product is developed
 Final inspection - done only after completion of work (checklist)

Methods of Inspection
 There are two methods of inspection
o 100% INSPECTION - every piece is separately inspected at various stages,
requires more number of inspectors and hence it is a costly method eg: footwear,
jet, engines, medical, aircrafts, etc
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 o SAMPLING INSPECTION - randomly selected samples are inspected, If the
sample proves defective, the entire concerned is to be rejected or recovered.
cheaper and quicker eg: leather sample testing

Drawbacks of Inspection
 Adds cost
 It is partially subjective; inspector has to judge whether a products passes or not
 Fatigue and Monotony may affect any inspection judgment
 Inspection merely separates good and bad items. It is no way to prevent the production of
bad items.

QUALITY CONTROL

Quality Control (QC) may be defined as a system that is used to maintain a desired level
of quality in a product or service.

It is a systematic control of various factors that affect the quality of the product. It
depends on materials, tools, machines, type of labour, working conditions etc.

TYPES OF QUALITY CONTROL

QC is not a function of any single department or a person. It is the primary responsibility
of any supervisor to turn out work of acceptable quality. Quality control can be divided into three
main sub-areas, those are:
1. Off-line quality control,
2. Statistical process control, and
3. Acceptance sampling plans.

OBJECTIVES OF QUALITY CONTROL

Following are the objectives of quality control:
 Improvement of quality
 Reduction of scrap and rework
 Efficient use of men and machines
 Economy in use of materials
 Removing production bottlenecks
 Decreased inspection costs
 Reduction in cost per unit
 Quality caution at all levels
 Reduction in customer complaints
 To prevent the poor quality product reaching to customer

BENEFITS OF QUALITY CONTROL

 Encourages quality consciousness
 Satisfaction of consumers
 Reduction in production cost
 Most effective utilisation of resources
 Reduction in inspection costs
 Increased goodwill
 Higher morale of employees
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  Improved employer-employee relations
 Improved techniques and methods of production
 Effective advertisement
 Facilitates price fixation
 Increased sales

SEVEN TOOLS FOR QUALITY CONTROL

 The Seven Basic Tools of Quality (also known as 7 QC Tools) originated in Japan when
the country was undergoing major quality revolution and had become a mandatory topic
as part of Japanese’s industrial training program.
 These tools were often referred as Seven Basics Tools of Quality because these tools
could be implemented by any person with very basic training in statistics and were simple
to apply to solve quality-related complex issues.
 These tools are effect on quality improvement. The seven quality control tools are:
1. Pareto charts
2. Check sheets
3. Cause and effect diagram
4. Scatter diagrams
5. Histogram
6. Graphs or flow charts
7. Control charts

1. PARETO CHARTS
The Pareto analysis can be used to identify the problem in a number of forms.

Example: The Fig. shows a Pareto chart of defects in finished shoe. Leather defects, Stitching
fault, Over Roughing & Poor bond strength will be the major reason, as indicated by 75%. Thus,
this is the problem that the manufacturing unit should address first.

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2. CHECK SHEETS
Check sheets are used to collect data on the frequency of problems or defects during production.

3. CAUSE AND EFFECT DIAGRAM

 The very purpose of this diagram is to identify all root causes behind a problem.
 Once all of the possible causes are identified, they can be used to develop an
improvement plan to help resolve the identified problem
 In manufacturing industry, to identify the source of variation the causes are usually
grouped into below major categories:
 People
 Methods
 Machines
 Material
 Measurements
 Environment

4. SCATTER DIAGRAM (SCATTER PLOTS)

Very purpose of scatter Diagram is to establish a relationship between problem (overall effect)
and causes that are affecting.

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5. HISTOGRAM (OR) BAR CHARTS
 A Histogram is a bar graph used to present frequency data.
 The bar height indicates the number of times a particular quality characteristic was
observed.

6. FLOW CHARTS (OR) GRAPHS

 It shows the sequence of events in a process. They are used for manufacturing operations.
 Flow charts are often used to diagram operational procedures to simplify the system.
 They can identify bottlenecks, unneeded steps and non-value added activities.

7. CONTROL CHARTS
 Control chart is the best tool for monitoring the performance of a process.
 These types of charts can be used for monitoring any processes related to function of the
organization.

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 ISO - International Organization for Standardization

DEFINITION
Total Quality Management (TQM) describes a management approach to long-term success
through customer satisfaction.

In a TQM effort, all members of an organization participate in improving processes, products,

services, and the culture in which they work.

QMS DEFINITION:
Quality management system can be define as a set of interrelated or interacting elements that the
organizations use to direct and control how quality policies are implemented and quality
objectives are achieved.

OBJECTIVES OF QMS
 Customer focus: Actively reviewing customer needs through dialogue; making customer
aware of new products and services; ensuring the organization is aware of customer
needs; corrective action when the service fails to meet expectation.
 Continual improvement- of products, services, working environment, staff
development, and management and production processes.
 Reduce waste - a reduction in wasted products, repeated or corrective work and
unnecessary processes.

ISO
 ISO stands for International Organization for Standardization.
 ISO Head Quarters located at Geneva, capital of Switzerland
 Total number of countries registered with ISO is 162
 ISO standards are developed in the year 1987
 Bureau of Indian Standards (BIS) are the Indian representative to ISO, ISO and
International Electro Technical Commission (IEC)) operate jointly as a single system.
 BIS is a national standard body of India established under the BIS Act in the year 1986
 These are non-governmental organizations, which exist to provide common standards on
international trade of goods and services.

ISO 9000
 ISO 9000 is a Quality management system
 ISO9001:2015 Stands for - Set out the requirements of a QMS
 ISO 19011:2011 Set out the guidance for - Internal & External Audits

ISO 9000 series has five international standards on quality managements. They are:

1. ISO 9000 — Quality management and Quality assurance standards

2. ISO 9001 — Quality systems: Model for quality assurance in - Design /Development,
Production, Installation and servicing
 ISO 9001 is a peak standard of ISO 9000 series

3. ISO 9002 — Quality systems: Production and Installation Quality in design

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 4. ISO 9003 — Quality systems: Model for quality assurance in Final inspection and testing

5. ISO 9004 — Quality management and systems for internal use

ELEMENTS OF QMS
 Responsibilities
 Procedures
 Processes
 Resources
 Customer Satisfaction
 Continuous Improvement

IMPLEMENATATION OF ISO QUALITY SYSTEM

Step 1: Commitment from Top Management
Step 2: Establishing an Implementation Team
Step 3: Conducting ISO 9000 Awareness Programs
Step 4: Providing Training
Step 5: Conducting an Initial Status Survey
Step 6: Creating a Documented Implementation Plan
Step 7: Developing a Quality Management System Documentation
Step 8: Control of Documents
Step 9: Implementation
Step 10: Internal Quality Audit
Step 11: Reviewing By Management
Step 12: Pre-Assessment Audit
Step 13: Certification and Registration
Step 14: Continual Improvement

BENEFITS OF ISO 9000 SERIES

Benefits of ISO 9000

 Universal acceptance
 More Focus
 Better Market sales
 To operate efficiently
 To achieve customer satisfaction
 To improve financial results
 Satisfy all the stakeholders
 To secure sustainability

Internal benefits include:-

 Increased productivity
 Less scrap and rework
 Increased employee satisfaction
 Continual improvement
 Increased profits

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External/Marketing Benefits Include:-
 An internationally recognised QMS
 Increased opportunities in specific markets
 Increased customer satisfaction

Advantages of ISO 9000

 Product interchangeability
 Reduce quality costs
 Opportunity to evaluate supplier goods
Disadvantages/Short comes of ISO 9000
 No details about how to document
 Not specify about adequate quality policy

QUALITY AUDITS

Quality audit is the process of systematic examination of a quality system carried out by an
internal or external quality auditor or an audit team.

It is an important part of organization's quality management system and is a key element in the
ISO quality system standard, ISO 9001.

Quality Audit Objectives

Quality audits are intended to achieve the following kinds of objectives:

 Determine the effectiveness of the quality system

 Helps problem-solving
 Facilitate decision making
 Helps employee involvement
 Helps communication and facilitate training

Purpose of Internal Audit

The purpose of internal audit could be:

 Provides objective insight

 Ensure QP are met as per standard
 provides opportunities to improve
 Assesses Controls
 Improves Efficiency of Operations
 Evaluates Risks and Protects Assets
 Ensure Compliance with Laws and Regulations

Purpose of External Audit

 Confidence in the partnership arrangement

 Ensuring that requirements are understood

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  Reducing the risk of failure
 No legal requirement to conduct the audit

Classification of Audit
1. Product Audit
2. Process Audit
3. System Audit

Types of Audit
1. First Party Audit
2. Second Party Audit
3. Third Party Audit

First Party Audit:

 First party audits are also known as internal audits.
 These are performing within an organization to measure it strength & weakness against
its own procedures or methods.
 These are conducted by an auditor employed by the organization being audited.

Second Party Audit:

Second party audits are carried out by one company on another, originally came from the idea of
an organization auditing its suppliers , subcontractors etc.

Third Party Audit:

Third party audits are typically certification audits where an independent body that would certify
companies as conforming with the Standard (or not, as the case may be).

Certification bodies (such as BV, DNV, TUV, Lloyds) are approved as competent to carry out
certification in specified business sectors by national accreditation bodies such as UKAS.

Non Conformance Report

 Usually, the nonconformance observed during the course of audit will be written in the
audit report. One major weakness of audit report is poorly written nonconformance.
 Raise NCR against system and not person.
 Nonconformance report is observed during - Audit.

 Care to be taken while writing the Problem statement (Non Conformance). It should be
clear, else it becomes too easy to misinterpret the problem and lead the investigation in
the wrong direction
While writing a nonconformance report not to forget 3 things:
a. Requirements
b. Failure/Problem
c. Evidence/Location

Quality auditor
 Personal attributes of Quality auditor – Communication
 Professional attributes of Quality auditor – Independence & Appearance
 Technical ability of Quality auditor – 1. Knowledge in Tech & Standards , 2. Quality &
cost analysis 3. Statistical & Diagnostic Techniques
 Professional status of Quality auditor - Professional Expertise
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ISO registration steps
1. Set the registration objective
2. Select the appropriate standards
3. Develop and implement the quality system

Abbreviations
1. CEO - Chief Executive Officer
2. COO - Chief Operating Officer
3. TQM - Total Quality management
4. ISO - International organization for standardization
5. QMS - Quality management system
6. EMS - Environmental Management System
7. IMS - Integrated management system
8. OHS - Occupational Health & safety
9. NCR - Non Conformance report
10. ASQ - American society for Quality
11. ANSI - American National Standard Institute
12. BIS - Bureau of Indian Standards
13. BV - Bureau Veritas
14. PDCA - Plan, Do, Check, Act

Theory Developed by

[Link]. Theory Developed by

1. PDCA cycle Dr. Shewhart/ Walter Schewhart
2. Zero defects Mr. Philip Crosby in book “Absolutes of Quality
management”
3. Fish bone diagram/ Dr. Kaoru Ishikawa
Ishikawa Diagram/
Herring Bone Diagram/ Statements by Dr. Ishikawa
Fishikawa Diagram “Accomplishing quality requires a thought revolution by
management” was said by Dr. Ishikawa

ISO
[Link]. ISO Stands for
1. ISO 9000 QMS - Quality management system
2. ISO 14000 EMS - Environmental Management System
3. ISO 27001 Information security Management systems
4. TS 16949 used in international automobile companies to set automotive
quality system standards

Quality Control Points :

Quality control points in clicking section

 Checking of dies with patterns
 Clicked components to be inspected
 Check mark, size, lot no etc
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Quality points in lining components
 Lining leather damaged
 Poor trimming
 Wrinkles in lining leather

Quality points in pre closing depts.

 Numbering not clear
 Wrong foil used
 Wrong size stamping

Quality points in folding operations

 Folding not proper allowance
 Wrinkles in folding
 Folding in binding unequal

Quality points in attaching operations

 Improper attaching
 Tongue height mismatch
 saddle/component crooked

Quality control points in closing section

 Samples near the operation table
 Follow buyer spec
 Stage inspection in each level

Quality points in bottom section

 Sole attaching
 Back height
 Adhesive cleaning

Quality points in final inspection of finished shoes

 Stamping & sizing
 Cleaning & Finishing
 Lacing as per customer spec

Major defects in shoe making

 Difference in design /material
 Damaged upper/lining
 Incorrect size /size marking

Minor defects in shoe making

 Improper clicking
 Presence of stain/cement
 Improper skiving

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