Quality control measures Flashcards
Quality is fitness for purpose
or use. It refers to features
and characteristics that
satisfy consumer needs.
Juran’s Definition
Systematic control of
variables in manufacturing
that affect end product
excellence.
Broom’s Definition
Techniques to manufacture products of uniform acceptable
quality.
Alford and Beatty’s Definition
____focused on preventing defects by
improving development processes. Aims to improve
processes so defects don’t arise during product development. (QA)
proactive process
Proactive process focused on preventing defects by
improving development processes. Aims to improve
processes so defects don’t arise during product development.
quality assurance
____focused on identifying defects in finished
products before release. Aims to find and correct defects
after development but before release. (QC)
reactive process
Reactive process focused on identifying defects in finished
products before release. Aims to find and correct defects
after development but before release.
quality control
role of QC in pharmaceuticals
Ensure Safety and
Efficacy, Keep Pace with
Advances, Key Responsibilities
Drugs must be safe and
therapeutically active with
consistent, predictable
performance.
Ensure Safety and
Efficacy
Evaluate new medicinal
agents using sophisticated
analytical methods.
keep pace with advances
Efficacy, safety, quality, and compliance.
key responsibilities
Quality Control Areas in
Pharmaceuticals
Raw Materials and API, Packaging Components, Finished Products
Techniques: Raman/IR spectroscopy, HPLC
assay, physical tests
raw materials and API
Tests: Appearance, spectroscopy, loss on
drying
Packaging components
Techniques: HPLC, assay, dissolution,
content uniformity
finished products
Errors can occur at any stage from raw material reception to
final packaging. Risk increases with more materials and
complex methods.
quality variation
control measures?
Material control
Manufacturing practice control
Packaging control
Distribution control
Establish systems for
receiving, testing, and
storing all supplies including
drug substances, excipients,
and packaging materials.
reception and testing (MC)
Maintain complete records
of all procedures and tests.
Documentation (MC)
Properly store and label materials, conduct laboratory testing, and
mark as “Passed” or “Rejected”.
Storage and labeling (MC)
Properly educated and trained
staff in all departments. Regular
training and supervision.
personnel (MPC)
Suitable design, size, construction,
and location. Non-reactive, easy to
clean and operate.
Equipment and building (MPC)
Maintain master formula records
and batch production records for
each product and batch.
Record control (MPC)
Use recommended containers, ensure correct labeling and
batch numbers. Select packaging material based on product
nature and distribution.
packaging control
Keep samples of each batch in record for years. Examine or
test material for any necessary demand or purpose.
distribution control
Objectives of Quality
Control
Establish Quality
Standards, Locate Quality
Deviations, Evaluate Production Methods
Economical production of
high-quality products at
customer-desired levels.
Establish Quality
Standards
Implement corrective measures to maintain quality.
Evaluate Production Methods
Analyze trends and extent of
quality deviations using
statistical techniques.
Locate Quality
Deviations
More Objectives of Quality Control
Quick Sale of Quality
Goods, Produce Standard
Quality Goods, Improve Quality
Accelerate sales by supplying only
quality goods.
Quick Sale of Quality
Goods
Manufacture standard quality
products and avoid inferior
quality.
Produce Standard
Quality Goods
Create quality consciousness at all
organizational levels.
Improve Quality
Steps in Quality Control
control raw materials, Set Standards and Specifications, Control Production Operations
Ensure quality of raw materials as they largely
determine finished product quality.
Control Raw Materials
Predetermine standards and specifications for
successful quality control.
Set Standards and Specifications
Investigate operating methods to execute efficient
practices.
Control Production Operations
More Steps in Quality Control
Locate Inspection Points, Maintain Equipment Quality, Maintain Records
Properly locate points where defects occur to avoid hindering quality control.
Locate Inspection Points
Ensure quality of equipment and devices used as they affect final product quality.
Maintain Equipment Quality
Keep records related to quality inspection, control, and rejections.
maintain records
Advantages of Quality Control
Improved Quality and
Cost Reduction, Uniformity and Customer
Satisfaction, Reduced Rejections and
Increased Exports
cost of quality
Prevention Costs - Quality planning, training, process control
Appraisal Costs - inspection, testing, quality audits
Internal Failure Costs - Scrap, rework, re-inspection
External Failure Costs - complaints, returns, warranty claims
Total Quality management (TQM)
A process designed to focus
on customer expectations,
prevent problems, build
commitment to quality, and
promote open decision-
making.
Not restricted to goods and
services, but applies to all
aspects of management.
Requires cooperation and involvement from all employees for
maintaining efficiency.
why TQM is needed?
Customer
Satisfaction-Focus on meeting and
exceeding consumer
expectations.
Competitive Edge-Face market competition
effectively and create
goodwill.
Employee Motivation-provide better facilities,
training, and participation in
decision-making.
Industrial Growth-Facilitate economic progress
and prosperity for the
nation.
principles of TQM
Customer Focus-Recognize that customer needs and business goals are
inseparable.
Continuous Improvement-Never-ending quest for achieving new levels of
performance.
Employee Involvement-Encourage participation and cooperation at all levels.
Management Commitment-Requires total commitment from top management for
viable leadership.
Quality circle
A small group of volunteers
doing similar work, meeting
regularly to identify
problems, set priorities,
discover causes, and propose
solutions.
Quality, productivity, safety,
job structure, and process
flow.
A form of participative management, human resource
development, and problem-solving technique.
Advantages of Quality
Circle
Productivity and
Quality-Promotes productivity and
quality mindedness, reduces
waste and costs.
Employee
Development-Increases motivation, job
satisfaction, and sense of
belongingness. Develops
leadership skills.
Organizational Benefits-improves communication, creates team spirit, and increases
human resource potential.
