Unit -I

Introduction

Quality is a relative term and it is generally used with reference

to the end use of the product.
Quality begins with the design of a product in accordance with
the customer specification further it involved the established
measurement standards, the use of proper material, selection of
suitable manufacturing process etc.
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Introduction

 Quality is how good something is. If the quality of a

product is high then that means that it is fit for its
purpose. If the quality of an item is low that means that
the product may break easily or not work properly. When
people say something is a quality product that means that
the product is of good quality.
 An example of quality is a well-made product.
Definition of quality

 Crosby defines quality is conformance to a requirement or specification

 Juran defined as “quality is fitness for use”. “The quality of a product or
service is the fitness of that product or service for meeting or exceeding
its intended use as required by the customer.”
 According to Juran, quality means that a product meets customer needs
leading to customer satisfaction
 Quality is the degree to which asset of inherent characteristics fulfils
requirement.(ISO9000-2015)
 Quality can be quantified as follows

Q=p/e
 Where q=quality
 p=performance
 e=expectations
 If Q is greater than 1.0 then the customer has a good feeling about product or services
 IMP - Dimensions of quality

Dimensions Meaning and example

Performance Primary product characteristics ex. the brightness of the picture

Features Secondary characteristics, added features ex. remote control

Conformance Meeting specification/industry standards, workmanship

Reliability Consistency of performance over time ,average time for the unit to fail

Durability Useful , include repair

Service Resolution of problems and complaints, ease of repair

Response Human-to-human interface such as the courtesy of the dearer

Aesthetics Sensory characterstics, such as exterior finish

Reputation Past performance and other intangibles such as being ranked first
Fundamental Factors Affecting Quality

Market: Due to technology advancement, many new products to satisfy customer

wants. At the same time, the customer wants are also changing dynamically. So, it is
the role of companies to identify needs and then meet it with existing technologies or
by developing new technologies.
 Money: the increased global competition necessitates huge outlays for new
equipment's and process. This should be rewarded by improved productivity. This is
possible by minimizing quality costs associated with the maintenance and
improvements of quality level.
Fundamental Factors Affecting Quality

Management: Increased complex structure of business organization, the quality

related responsibilities lie with persons at different levels in the organization.
 Men: the rapid growth in technical knowledge leads to development of human
resource with different specialization. This necessitates some groups like,
system engineering group to integrate the idea of full specialization.
Fundamental Factors Affecting Quality

Motivation: if we fix the responsibility of achieving quality with each

individual in the organization with proper motivation techniques, there
will not be any problem in producing the designed quality products.
 Materials: selection of proper materials to meet the desired tolerance
limit is also an important consideration. Quality attributes like, surface
finish, strength, diameter etc., Can be obtained by proper selection of
material.
 Machines and mechanization: in order to have quality products
which will lead to higher productivity
Fundamental Factors Affecting Quality

Machines and mechanization: in order to have quality products

which will lead to higher productivity of any organization, need to
use advanced machines and mechanize various operations.
 Modern information methods: the modern information methods
help in storing and retrieving needed data for manufacturing,
marketing and servicing.
 Mounting product requirements: product diversification to meet
customers taste leads to intricacy in design, manufacturing and
quality standards. Hence, companies should plan adequate system
 What is quality?
 What is Assurance?
 Quality is extremely hard to
 Assurance is certainty of a product
define, and it is simply stated: "fit
for use or purpose." It is all about or a service, which it will work
meeting the needs and well. It provides a guarantee that
expectations of customers with the product will work without any
respect to functionality, design, problems as per the expectations
reliability, durability, & price of or requirements.
the product.
What is Quality Assurance?

 Quality assurance (QA) is defined as an

activity to ensure that an organization is
providing the best possible product or service to
customers.
 QA focuses on improving the processes to
deliver quality products to the customer. An
organization has to ensure, that processes are
efficient and effective as per the quality
standards defined for software products. Quality
assurance is popularly known as QA testing
 How to do Quality Assurance: Complete Process

Quality assurance has a defined cycle called PDCA cycle or deming cycle. The phases of this cycle
are:
 Plan
 Do
 Check
 Act
 Plan - organization should plan and establish the process related objectives and determine the processes
that are required to deliver a high-quality end product.
 Do - development and testing of processes and also "do" changes in the processes
 Check - monitoring of processes, modify the processes, and check whether it meets the predetermined
objectives
 Act - implement actions that are necessary to achieve improvements in the processes
An organization must use quality assurance to ensure that the product is designed and implemented with
correct procedures. This helps reduce problems and errors, in the final product.
What is Quality Control?(QC)

 Quality control is a software engineering process used to ensure quality in a product or a service. It
does not deal with the processes used to create a product; rather it examines the quality of the "end
products" and the final outcome.
 The main aim of quality control is to check whether the products meet the specifications and
requirements of the customer. If an issue or problem is identified, it needs to be fixed before
delivery to the customer.
 Qc also evaluates people on their quality level skill sets and imparts training and certifications. This
evaluation is required for the service based organization and helps provide "perfect" service to the
customers.
Difference between Quality Control and Quality Assurance activities ?

Quality Control Activities Quality Assurance Activities

Walkthrough Quality Audit

Testing Defining Process

Inspection Tool Identification and selection

Checkpoint review Training of Quality Standards and

Processes
 Best practices for Quality Assurance:

 Create a robust testing environment

 Select release criteria carefully
 Apply automated testing to high-risk areas to save money. It helps to fasten the entire process.
 Allocate time appropriately for each process
 It is important to prioritize bugs fixes based on software usage
 Form dedicated security and performance testing team
 Simulate customer accounts similar to a production environment
 Quality Assurance Functions:
 There are 5 primary Quality Assurance Functions:
 Technology transfer: This function involves getting a product design document as
well as trial and error data and its evaluation. The documents are distributed, checked
and approved
 Validation: Here validation master plan for the entire system is prepared. Approval of
test criteria for validating product and process is set. Resource planning for execution
of a validation plan is done.
 Documentation: This function controls the distribution and archiving of documents.
Any change in a document is made by adopting the proper change control procedure.
Approval of all types of documents.
 Assuring Quality of products
 Quality improvement plans
Quality manual

 A quality manual is a document that states the company’s intentions

for operating the processes within the quality management system. It
can include policies for all areas of the business that affect your
ability to make high-quality products and meet your customers’ and
iso’s requirements. These policies define how your department
managers will implement procedures within the boundaries specified
in the quality manual.
Steps of Quality manuals

 List policies to be written (note any ISO requirements that do not apply).
 Draft policies based on applicable ISO requirements.
 List operating procedures or refer to them as appropriate.
 Determine the format and structure of the manual and make the first draft.
 Circulate the draft manual for input from all departments and address inadequacies
identified.
 Attain a formal approval and release.
Contents of Quality manuals

 The scope of QMS

 Quality policy
 Explanation of the company’s documentation structure
 Organizational chart
 Policy statements for each applicable ISO requirement
 Reference to operating procedures
 1) The scope of the Quality Management System.
This is in place to identify the limit of the system and is based on the scope agreed with the
registrar to be placed on the ISO9001 certificate. This is the explanation of what your company
does, be it
Examples
“Design and Manufacture of the bevel Gear,”
“Machining Services for Customers in the oil and service Industry,” or
“Providing Fast Food for People in Kuwait city.”
 2) The documented procedures
 ‘Documentation’ means anything written down or captured in some form such as written
procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, IT systems.
This is called ‘documented information’ in the current version (2015) of ISO 9001.
 Records’ – those things that showed what had been done, such as registers, logs,
competed for forms, reports, meeting minutes and so on. ‘Documented
information’ in 9001 terms means both the ‘written stuff’ that describe quality
system and say how it should operate (eg, flowcharts, procedures, policies,
checklists) and the ‘written stuff’ that shows what was done.
 3) A description of the interaction of processes. This is most
simply done with a flowchart that identifies all the processes in the
organization with arrows showing how they connect.
The use of Quality Manual are as follows:

 To communicate management’s expectations to employees

 To demonstrate the company’s plan to conform to the requirements of ISO 9001:2015
 To demonstrate the fulfilment of clause 5.3, that organizational roles, responsibilities and authorities are
assigned, communicated and understood
 To provide a starting point for auditors:
 Internal
 Customer
 ISO certification body
WHAT IS PROCESS CONTROL?

 Process control is the ability to monitor and adjust a process to give a desired output. It is
used in industry to maintain quality and improve performance.
 An example of a simple process that is controlled is keeping the temperature of a room at
a certain temperature using a heater and a thermostat. When the temperature of the room
is too low, the thermostat will turn on a heating source until the temperature reaches the
desired level at which point the heater is turned off. As the room cools, this process
repeats itself to keep the room at the desired set point.
Need of Process Control

 Process control is vital for any company that wants to run automated or semi-automated
processes. It almost entirely removes the need for human intervention (apart from
monitoring the process controls) to allow plants to operate autonomously despite minor
variations in input, conditions, etc.

 It’s estimated that process manufacturing businesses could save up to 15% in energy costs
through an effective process control system.
Benefits of Process Control

 Raise the quality of their products and consistently hit quality requirements
 Save energy and water by running equipment more efficiently
 Increase efficiency in the plant, limit rework and scrapped batches, and reduce the risk of
human error
 Improve safety levels by ensuring that all equipment and processes are running correctly
 Lower manufacturing costs by maintaining a more efficient plant
 Same time previously spent on manual checks
Design controls

 Design controls are a set of quality practices and procedures that are
incorporated into the product design and development process to ensure that a
device is appropriate for its intended use
 Design controls designates the application of a formal methodology to the
conduct of product development activities. It is often mandatory (by
regulation) to implement such practice when designing and developing products
within regulated industries (e.g. medical devices).
 The purpose of design control is to make sure that a plan has been made to be
implemented by the company and manufacturer that ensures that all final
requirements of the design are met during the process and development

 Essentially, design control consists of planning, design execution, testing against

specifications (inputs) and requirements (user needs), and uncovering and fixing problems
at an early stage (risk reduction).
Inspection
 Inspection is an important tool to achieve quality concept. It is necessary to
assure confidence to manufacturer and aims satisfaction to customer. Inspection
is an indispensable tool of modern manufacturing process. It helps to control
quality, reduces manufacturing costs, eliminate scrap losses and assignable
causes of defective work.
 The inspection and test unit is responsible for appraising the quality of incoming
raw materials and components as well as the quality of the manufactured product
or service.
 It checks the components at various stages with reference to certain
predetermined factors and detecting and sorting out the faulty or defective items.
It also specified the types of inspection devices to use and the procedures to
follow to measure the quality characteristics.
 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 are:

 Floor inspection
 Centralized inspection
 Combined inspection
 Functional inspection
 First piece inspection
 Pilot piece inspection
 Final inspection
Testing in quality control

 Quality control involves testing units and determining if they are

within the specifications for the final product. The purpose of the
testing is to determine any need for corrective actions in the
manufacturing process. Good quality control helps companies meet
consumer demands for better products
Testing in quality assurance

 Quality assurance (QA) testing is a process organizations use to

ensure their products and services meet specified regulations and
standards. It's a series of techniques that companies employ to
prevent issues from occurring and ensure they satisfy the customer
with their finished product. QA testing also checks a product's
functionality to ensure it meets its intended purposes successfully.
Difference between inspection and testing

 Inspection involves visually examining products for defects, while

testing employs systematic methods to assess functionality or
performance. Inspection is subjective, focusing on appearance,
while testing is objective, assessing specific criteria to ensure
product quality and compliance.
Inspection and Testing of Purchased Materials and Equipment

 All materials and equipment shall be inspected and tested to ensure conformance with the
project requirements before it is released for use. Verification that all items conform to specified
requirements of the quality plan shall be documented and filed in the project QA/QC file. In
determining the amount and nature of inspections, consideration should be given to the control
exercised at the manufacturing source and documented evidence of quality conformance
provided from the supplier
Thank you…..