QUALITY ASSURANCE (QA) -

QUALITY CONTROL (QC)

IN INDUSTRY

November 2023

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 ABOUT ME
Apt. Muhammad Khairiskam, S.Farm
Experienced professional in bio and pharmaceutical company as
QA and QC with deep knowledge in Quality Control (Finished
Product and Stability) Calibration, Qualification, Validation, Root
Cause Analysis, Deviation, OOS OOT and CAPA handling, and Risk
Management.

EDUCATION

EXPERIENCE

SKILL

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 Agenda

1 Quality Management

2 QA & QC: Introduction and Principle

3 7 QC Tools / 7 Basic Quality Tools

4 Quality Risk Management

5 Process Improvement

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 What is Quality

How do you rate the quality?

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 What is Quality

How do you rate the quality?

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 Quality Management Principle

Customer
Focus
Quality
Degree to which customer requirement has been
Improvement Leadership
met

Management: Coordinated activities to direct and

control organization
Quality
Management
System Principles
Set of interrelated or interacting element Evidence Based Engagement
Decision Making Of People
Quality Management System
A system to direct and control organization in
regard to quality
Relationship Process
Management Approach

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 Why Is It Important?

Customer Satisfaction Organization Efficiency and

Compliance
Sustainablity
Incorporating compliance into Incorporating customer feedback A QMS
Customer
helps establish important
Satisfaction
Improve process control; Increase
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 QA & QC: Definition

Quality Assurance (QA)

"Part of quality management focused on providing
confidence that quality requirements will be fulfilled.”
(ISO 9000:2015)

“A combination of activities related to establishing

and maintaining quality systems to ensure products
are consistently produced and controlled.”
(Good Manufacturing Practice)

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 QA & QC: Definition

Quality Control (QC)

"Part of quality management focused on fulfilling

quality requirements.”
(ISO 9000:2015)

“A combination of procedures and practices used to

monitor and control manufacturing processes,
ensuring that products are of a consistent and reliable
quality.”
(Good Manufacturing Practice)

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 Difference of QA and QC

Quality Assurance
Quality Assurance (QA) coverage
Managing tools Proactive
• Quality By Design
• Supplier qualification
Process Oriented • Data Integrity
• Qualification of equipment / utilities / system
Prevention of defects • Validation (Process, Packaging, Computerized System, Cleaning)
• Process Robustness
Everyone’s responsibility
• Documentation
QA Goal: Improve • Change Management
process so that defect • Deviation and Complaint Management
don’t raise • Personnel Qualification and Training
QC Goal: to improve final product by • Audit and Self Inspection
identifying defect • Product Quality Review
Testing team /sampler
responsibility
Detection of defect
Quality Control(QC) coverage
Product Oriented
• Testing Specification management
• Sampling and testing
Reactive Corrective tools • Environment Monitoring
• Product Stability Study
• Testing failure investigation
Quality Control
• Analytical Method Validation
• Evaluation of complaint sample

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 Principle of QA/QC in Industry

Compliance with Standard

One of the fundamental principles of QA/QC is ensuring

compliance with applicable standards, regulations, and
requirements

These standards may be industry-specific, such as ISO, GMP,

or other regulatory frameworks.
(ISO, FDA, BPOM, SNI, ASTM, HACCP, etc)

By complying with standards and regulations, organizations

strive to consistently meet quality expectations and deliver
safe and reliable products or services

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 Principle of QA/QC in Industry

Product or service quality control

Include monitoring, inspecting, and examining

products or services at various stages to ensure
they meet the specified quality criteria

Quality Control activities include testing,

sampling, and analysis to assess whether
products or services meet predetermined
standards and requirements

Identify any deviations or defects, initiate

corrective actions, and ensure that only products
or services of acceptable quality reach customers

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 Principle of QA/QC in Industry

Measurement and Quality Improvement

Emphasizes the importance of collecting and

analyzing data related to quality performance

Through data-driven insights, organizations can

identify areas for improvement, detect trends, and
make informed decisions to enhance their quality
processes

Common method: statistical process control, Six

Sigma, or Lean principles, organizations can drive
systematic improvements, reduce defects,
enhance efficiency, and enhance customer
satisfaction

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 7 QC Tools / 7 Basic Tools of Quality

Histogram
Check Sheet Control Chart
How does the frequency
What, when, where, and Which variation to control,
distribution / shape vary?
how often is it done? and how?

Scatter Diagram Pareto Diagram Cause-Effect Stratification

What is relationship What are priorities or What factors cause Sort and categorize
between factor the big problem? the problem? the problem

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 7 QC Tools / 7 Basic Tools of Quality
Check Sheet

Purpose When to use?

• Collect and summarize data in a standardized • Data Collection of a specific process, event, or occurrence.
and easy-to-understand format. • Defect or error tracking
• Data collection are based on answering • Monitor process parameters or performance indicators regularly
question of what, when, how,etc • Conducting observational studies to record specific observations
or occurrences
• Quality audits to systematically assess compliance with standards
or procedures
Types of Check Sheet

Frequency Check Sheet Defect Check Attributes Check Location Check

Sheet Sheet Sheet

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 7 QC Tools / 7 Basic Tools of Quality
Control Chart

Purpose Variations
To determine whether a process is under • Common Cause Variation: represents the normal expected variation within a
control or experiencing variations that may process. It is predictable and caused by factors that are inherent to the
require investigation or intervention process.
• Special caused Variations: It represents unusual variation caused by events
that are outside the normal process behavior. (e.g. faulty equipment,
incorrect procedures, or other identifiable factors that need investigation and
improvement)
Nelson Rules

UCL: Upper Control Limit

LCL: Lower Control Limit
CL: Centerline/mean

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 7 QC Tools / 7 Basic Tools of Quality
Histogram

Purpose Interpretation
To showcase the frequency or occurrence of
different values or ranges.
Histograms are particularly useful for analyzing
continuous data or variables, such as time, weight,
temperature, or length

When to use?
• When the data is numerical (continuous)
• When you want to see shapes of data distribution
• When analyzing if process can meet requirement
• When seeing if process change was occurred.

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 7 QC Tools / 7 Basic Tools of Quality
Scatter Diagram

Purpose Interpretation
To visually examine the relationship between two
continuous variables. It helps in understanding
whether changes in one variable correspond to
changes in another variable

When to Use?
• It help in assessing whether changes in one variable
could potentially cause changes in another variable
• Identify and explore relationships between different
process parameters, factors, or variables
• By analyzing the correlation between variables, we
can make predictions or estimations based on the
observed relationship

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 7 QC Tools / 7 Basic Tools of Quality
Pareto Diagram

Purpose
To separate significant aspects of a
problem from the trivial ones

When to Use?
Vilfredo Pareto • When analyzing data about
1848-1923 frequency of problem
• When there are many problems
and you want to focus on the
most significant
• When analyzing broad causes by
looking at their specific
component

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 7 QC Tools / 7 Basic Tools of Quality
Cause-Effect Diagram

Purpose
To identify and analyze the potential
causes contributing to a specific
problem or effect

When to Use?
• Problem solving
• Quality Improvement
Kaoru Ishikawa
1915-1918 • Process analysis
• Risk Assessment
• Root cause analysis
• Brainstorming

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 7 QC Tools / 7 Basic Tools of Quality
Stratification

Definition
The act of sorting data, people, and objects into distinct groups
or layers

Purpose
to identify and understand variations within a data set by
grouping the data into meaningful categories. By dividing the
data into subgroups, it becomes easier to analyze and compare
specific factors or sources of variation

When to Use?
• Before collecting data
• When data come from several sources or conditions, such as
shifts, days of the week, suppliers, or population groups
• When data analysis may require separating different sources
or conditions

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 Quality Risk Management

Risk: "the effect of uncertainty on objectives, whether positive

or negative.” (ISO 31000:2009)

Quality Risk Management Principle (ICH Q9):

• The evaluation of the risk to quality should be based on
scientific knowledge and ultimately link to the protection of
the patient
• The level of effort, formality and documentation of the
quality risk management process should be commensurate
with the level of risk

Identifying Understanding Prioritizing Risks Risk Mitigation Monitoring and

Potential Risks Risk Factors Review

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 Quality Risk Management
FLOW CHART
SWIMLANE
DIAGRAM
Add a step Add a step

First Add
Add the next
Ste decisi
steps
p on

Add a step Add steps

Last
step

SIPOC DIAGRAM

SUPPLIER INPUT PROCESS OUTPUT CUSTOMER

Add Items Add Items Add Items Add Items Add Items

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 Quality Risk Management
Failure Mode and Effect Analysis (FMEA) Fault Tree Analysis (FTA)

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 Improve the Process

Problem: gap between actual and ideal condition

Problem Solving: the act of defining a problem; determining the cause of the
problem; identifying, prioritizing, and selecting alternatives for a solution; and
implementing a solution (ASQ, American Society for Quality)

Level 1: Restore to current standard

Level 2: Create new standard / improve current standard

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 Improve the Process
Plan-Do-Check-Act (PDCA) Cycle
PDCA or the Deming cycle is a management methodology that aims to continually improve processes
Benefit:
• Able to identify and analyze the problem
• Explore problem solving
• Prevent same problem does not reoccur

Problem: a man ha a cough

observed for more than 2 weeks
He take a lab examination:
rontgent thorax & mucus
He will take anti TBC drugs for
sample: diagnosed as TBC
6-9 month
He is planned to get anti TBC
drugs

Check the progress monthly:

Healty lifestyle lab examination, etc
Personal hygiene
Regular sanitation

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 Improve the Process
DMAIC

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THANK
YOU!

Q&A SESSION

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