How do you define "Quality"?

"Quality" is one of those words that is used all the time, but rarely defined. We are
supposed to produce "quality" products or high-quality" products. For example, a product
or service is "high-quality" if it

Conforms to Specification
Satisfies Users' Needs
Implements "Best Practices"
Is produced using defined processes
Is acceptable to the customer
Fits cleanly into the operational environment
Does not fail in any serious way
or

"Quality is the extent to which products, services, processes, and relationships are free
from defects, constraints, and items which are valuable for customers."

or

Quality is the ability of a product or service to meet a customer's expectations for that
product or service.

or

Quality is meeting customer requirements at lower cost with built in preventive actions in
the processes and employee involvement ensuring the best product to the customer/end
user with it delivery.
 What do you mean by Quality of Pharmaceuticals?
Quality means if the pharmaceutical product has maintained /established identity,
strength, purity, and other quality parameters to ensure the required levels of safety and
effectiveness.

What is the difference between quality assurance and quality control?

Answer:
Quality Assurance is process oriented Activity and focuses on defect prevention; while quality
control is product oriented Activity and focuses on defect identification.
Quality Assurance Quality Control

1 QA aims to prevent defects with a focus QC aims to identify defects in the finished
on the process used to make the product. Quality control, therefore, is a reactive
product. It is a proactive quality process. process.

2 The goal of QA is to improve The goal of QC is to identify defects after a

development and test processes so that product is developed and before it's released.
defects do not arise when the product is
being developed.

3 QA is set of activities whose purpose is QC is set of activities whose purpose is to ensure

ensuring that an entity/product meets that all quality requirements are being met. This
is defect detection, and done by testing.
all quality requirements. This is done by
adopting/following a
standard/procedure and policies and
usual QA techniques like review,
training, facilitation etc. it can be
termed as defect prevention

4 Quality assurance is an audit function. Quality Control is mainly an inspection function.

5 A QA engineer may be involved in The QC engineer would only be focused on

developing packaging & shipping making sure product meets the requirements of
requirement or be involved in providing quality plan as set by QA.
quality specifications to purchasing.
Quality Assurance Quality Control

QA is critical than QC as QA has QC is a part of QA, it's mean QA is wider that

responsibility to control the defects in QC. QC only check and make sure for today
future. QA has a role of defining the purpose only.
quality policy and how to follow the
policies in better way do that there
wont be any issues/defects to customer