chapter 2.1 introduction to quality management, control and assurance

BNN40703Quality Assurance and Quality Control in Biotechnology

By: Dr. Nadirul Hasraf Mat Nayan

CHAPTER 2QUALITY MANAGEMENT,

CONTROL AND ASSURANCE

Chapter OverviewCHAPTER 2: QUALITY MANAGEMENT,

CONTROL AND ASSURANCECHAPTER 2.1: Introduction to Quality Management,

Control and Assurance

CHAPTER 2.2: The difference between Quality Control and Quality Assurance

CHAPTER 2.3: Quality Control and Assurance in Biotechnology

CHAPTER 2.4: Current Good Manufacturing Practice (cGMP)

Chapter 2.1

Introduction to Quality Management, Control and

Assurance

Chapter OverviewCHAPTER 2.1: INTRODUCTION TO QUALITY MANAGEMENT, CONTROL AND ASSURANCE

CHAPTER 2.1.1: Introduction to Quality Management

CHAPTER 2.1.2: What is Quality Management?

CHAPTER 2.1.3: Objectives of Quality Management

CHAPTER 2.1.4: Significance of Quality Management

CHAPTER 2.1.5: Quality Management: Transforming an Organization

Chapter OverviewCHAPTER 2.1: INTRODUCTION TO QUALITY MANAGEMENT, CONTROL AND ASSURANCE

CHAPTER 2.1.6: Elements of Quality Management

CHAPTER 2.1.7: Six Sigma

CHAPTER 2.1.8: Reasons For Failure

CHAPTER 2.1.9: Introduction to Quality Control

CHAPTER 2.1.10: Introduction to Quality Assurance

CHAPTER 2.1.11: Role of Managers in Quality Management, Control and Assurance

2.1.2: Introduction to Quality Management

Competition is getting harder and becoming global.

Companies must now have to be more responsive, offer a better product and keep improving.

Quality management increases customer satisfaction by boosting quality.

Quality management does this by motivating the workforce and improving the way the company operates.


In an increasingly competitive market, firms with a continuous improvement culture and external focus are more likely to survive and prosper.

Therefore, quality management is considered an ultimate catalyst in this context.


There are many definitions of quality management.

One of the most comprehensive is given by Jack Strickland in Army Research, Development and Acquisition Bulletin:

“Quality management is both a philosophy and a set of guiding principles that represent the foundation of a continuously

improving organization. Quality management is the application of quantitative methods and human resources to improve the

materials and services supplied to an organization, all the processes within an organization, and the degree to which

need of the customer are met, now and in the future.”


A simplified definition of quality management is:“Management activities and functions

involved in determination of quality policy and its implementation through means such

as quality control and quality assurance, including quality control.”

2.1.2: What is Quality Management?

Quality management is an approach to improve the effectiveness and flexibility of business as a whole.

It essentially a way of organizing and involving the

whole organization, every department, every activity and every single person at every level.

Quality management ensures that the management adopts a strategic overview of the quality and focuses on prevention rather than inspection.


Quality management is made up of five basic tenets(principle):

i. Quality is customer driven.ii. Quality improvement efforts focus on preventing

problems.iii. Quality management focuses on process

optimization.iv. Management decisions are based on facts.v. Quality management is a never-ending process of

continuous improvement.


Five basic tenets quality management :i. Quality is customer driven.

The first tenet, provides the fundamental building blocks of any quality management effort.

From this, the working definition of “quality is conformance to the customers' valid requirements” evolved.

Customer in this context means both the external (or ultimate) customer and the internal (or intermediate) customer.


a. External CustomerThey are called external customers because they

come from outside of the business. The external customer is the party that pays money

for the final product.They bring in all the revenue that keeps a firm afloat.The ultimate goal of a business is to ensure that the

external customer is so happy that they return to the business again, and tell others just how good it is.

Without an external customer, a company, whether manufacturing or service oriented, cannot survived.


b. Internal Customer Internal customer is the people that work within an

organization. They may also include people in other organizations that

work with an organization to provide the products or services.

Internal customers are easy to overlook, take for granted, and generally not treat as well as external customers.

However, the employees of any organization are a key factor in facilitating its success and should be treated well and with respect.

Therefore, an organization is responsible to create a positive and productive working environment where staff morale is high.


Five basic tenets quality management :ii. Quality improvement efforts focus on

preventing problems. It has been found that it is much easier and less

costly to design quality into a product than it is to change the product after the production has started.

This reduced rework and scrap in addition to reducing wasted labour.

It is also easier to prevent problems than it is to try and handle them as they arise.


Five basic tenets quality management :ii. Quality improvement efforts focus on

preventing problems.Example:

If a particular product has a problem with delivery time, it is more effective in the long run to analyze the problem and implement a solution than it is to deal with each individual late delivery. (Initially, it definitely takes more time, but the time ultimately saved.)


Five basic tenets quality management :iii. Quality management focuses on process

optimization. The third tenet is a direct result of the first two

concepts. If rework, scrap, and downtime are reduced by

designing quality into the product and if all employees have been trained to think of the next process as their customer, then the first step to process optimization has been taken.

As new products or changes are introduced, process procedures are reexamined and updates if necessary.


Five basic tenets quality management :iv. Management decisions are based on facts.

In the past, management by objectives was the accepted way of managing.

Now, due to intense competition in the world market, decision must be driven by facts which are supported by data.

The organization can still have objectives, but these objectives evolve from examining what the organization can realistically achieve and then setting attainable goals.


Five basic tenets quality management :iv. Management decisions are based on facts.

Management by facts also means that not only managers but all employees manage the work they do by collecting objective data and making decisions based on this information.

This creates an organization where everyone is speaking with facts.


Five basic tenets quality management :iv. Quality management is a never-ending process

of continuous improvement. Basically, this means that just making one improvement does

not mean all the issues are resolved forever. It means always striving for and seeking new ways of

improving processes and people. This is best illustrated through the use of the Plan-Do-Check-

Act (PDCA) cycle, which is the work philosophy behind the continuous improvement process.

The PDCA separates the continuous improvement process into four distinct phases, with specific goals and tasks.


Plan-Do-Check-Act (PDCA) cycle :

CONTINUOUS IMPROVEMENT


Plan-Do-Check-Act (PDCA) cycle:i. Plan what to do:

ii. Do it:

Determine goals and prioritiesDetermine processDetermine tracking indicators

Apply the planTrain and educate workersMonitor tracking indicators


Plan-Do-Check-Act (PDCA) cycle:iii. Check it:

iv. Act on results:

Check results of the implemented plan Identify any problems

Take action to eliminate any problems foundStandardize process if plan is successfulPlan future improvements

2.1.3: Objectives of Quality Management

Three objectives of executing quality management:

i. Meeting the customer’s requirements is the primary objective and the key to organizational survival and growth.

ii. The second objective of quality management is continuous improvement of quality. The management should stimulate the employees in becoming increasingly competent and creative.

iii. Third, quality management aims at developing the relationship of openness and trust among the employees at all levels in the organization.

2.1.4: Significance of Quality Management

Significance of implementing quality management in an organization:i. Quality management ensures superior quality products

and services.

Quality of a product can be measured in terms of performance, reliability and durability.

Quality is a crucial parameter which differentiates an organization from its competitors.

Quality management tools ensure changes in the systems and processes which eventually result in superior quality products and services.

Quality management methods such as Total Quality management or Six Sigma have a common goal - to deliver a high quality product.

Quality management is essential to create superior quality products which not only meet but also exceed customer satisfaction.


Significance of implementing quality management in an organization:ii. Quality management is essential for customer

satisfaction which eventually leads to customer loyalty. It is important for every business to have some loyal customers. You need to have some customers who would come back to your

organization no matter what. Customers would return to the organization only if they are satisfied

with the organization products and services. Therefore, it is important that an organization make sure the end-user is

happy with their products and services. Any organization must remember that a customer would be happy and

satisfied only when the products and services meets his/her expectations and fulfills his/her needs.


Significance of implementing quality management in an organization:iii. Quality Management ensures increased revenues and

higher productivity for the organization. An organization must put in mind that what its is earning, employees are also

earning. Employees will be frustrated only when their salaries or other payments are not

released on time. Would you feel like working if your organization does not give you salary on

time? Ask yourself. Salaries are released on time only when there is free cash flow. Implementing quality management ensure high customer loyalty, thus better

business, increased cash flow, satisfied employees, and provide healthy workplace.

Quality management processes make the organization a better place to work.


Significance of implementing quality management in an organization:iv. Quality management helps organizations to reduce

waste and inventory. Quality management help to remove unnecessary processes

which merely waste employee’s time and do not contribute much to the organization’s productivity.

Quality management enables employees to deliver more work in less time.

It enables employees to work closely with suppliers. It ensures close coordination between employees of an

organization and will inculcates a strong feeling of team work in the employees.

2.1.5: Quality Management: Transforming an Organization

2.1.6: Elements of Quality Management

i. Be customer focused

ii. Do it right the first time

iii. Constantly improve

It requires the company to check customers’ attitudes regularly and includes the idea of internal customers as well as external ones.

This means avoiding rework.

Continuous improvement allow the company gradually to get better.


iv. Quality is an attitude

v. Telling staff what is going on

vi. Educate and train people

Everyone has to be committed to quality. That means changing the attitude of the entire

workforce, and altering the way the company operates.

This involves improved communication. Typically, it includes team briefing.

Giving more skills to workers means they can do wider range of jobs, and do them better.


vii. Measure the Work

viii. Top management must be involved

ix. Make it a good place to work

Measurement allows the company to make decisions based on facts, not opinion.

It helps to maintain standards and keep processes within the agreed tolerances.

If a senior management is not involved, the program will fail.

Many companies are full of fear, such as fear of their boss. There is no point in running quality management program

unless the company drives out fear.


x. Introduce teamwork

xi. Organize by process, not by function

Teamwork boosts employees’ morale. It reduces conflict and solves problem by providing them

with a wider range of skills. It pushed authority and responsibility downwards and

provides better, more balanced solutions.

This elements of quality management seeks to reduce the barriers that exist between different departments, and concentrates on getting the product to the customer.

2.1.7: Six Sigma

The concept of Six Sigma was introduced by Bill Smith from Motorola in 1986, but it was Jack Welch who popularized it by incorporating the strategy in his business processes at General Electric.

The concept of Six Sigma came into existence when one of Motorola’s senior executives complained of Motorola’s bad quality.

INTRODUCTION:

2.1.7: Six Sigma

Six Sigma is a quality management strategy which aims at improving the quality of processes by minimizing and eventually removing the errors and variations.

Quality plays an important role in the success and failure of an organization.

Neglecting an important aspect like quality, will not let you survive in the long run.

Six Sigma ensures superior quality of products by removing the defects in the processes and systems.

According to Six Sigma, any sort of challenge which comes across in an organization’s processes is considered to be a defect and needs to be eliminated.

INTRODUCTION:

• The process of Six Sigma originated in manufacturing processes but now it finds its use in other businesses as well.

• There are two Six Sigma Methods:

SIX SIGMA METHODS:

i. DMAIC - focuses on improving existing business practices.

ii. DMADV - focuses on creating new strategies and policies.

i. DMAIC Method

SIX SIGMA METHODS:

DMAIC has Five Phases:

1. D - Define the Problem. In the first phase, various problems which need to be

addressed to are clearly defined.

Feedbacks are taken from customers as to what they feel about a particular product or service.

Feedbacks are carefully monitored to understand problem areas and their root causes.

i. DMAIC Method

SIX SIGMA METHODS:


2. M - Measure and find out the key points of the current process.

Once the problem is identified, employees collect relevant data which would give an insight into current processes.

i. DMAIC Method

SIX SIGMA METHODS:


3. A - Analyze the data.

The information collected in the second stage is thoroughly verified.

The root cause of the defects are carefully studied and investigated as to find out how they are affecting the entire process.

i. DMAIC Method

SIX SIGMA METHODS:


4. I - Improve the current processes.

Based on the research and analysis done in the previous stage.

Efforts are made to create new projects which would ensure superior quality.

i. DMAIC Method

SIX SIGMA METHODS:


5. C - Control the processes.

So that they do not lead to defects.

• DMADV Method

SIX SIGMA METHODS:

DMADV has Five Phases:

1. D - Design.

2. M - Measure

Strategies and processes which ensure hundred percent customer satisfaction.

and identify parameters that are important for quality.

• DMADV Method

SIX SIGMA METHODS:

DMADV has Five Phases:3. A - Analyze.

4. D – Design

5. V - Verify

and develop high level alternatives to ensure superior quality.

details and processes.

various processes and finally implement the same.

2.1.8: Reasons For Failure Quality management fails because:

Top management sees no reason for change.

Top management is not concerned for its staff.

Top management is not committed to the quality management programme.

The workforce and the management do not agree on what needs to happen.

No performance measures or targets are set, so progress cannot be measured.

Processes are not analyzed, systems are weak and procedures are not written down.

2.1.9: Introduction to Quality Control

What is Quality Control? Quality control is a process that is used to ensure a certain level of

quality in a product or service.

It might include whatever actions a business deems necessary to provide for the control and verification of certain characteristics of a product or service.

Most often, it involves thoroughly examining and testing quality of products or the results of services.

The basic goal of this process is to ensure that the products or services that are provided meet specific requirements and characteristics, such as being dependable, satisfactory, safe and fiscally sound.


Basic Examples of Quality Control:Manufacturers of food products often have

employees who test the finished products for taste and other qualities.

Clothing manufacturers have workers inspect garments to ensure that they are properly sewn.

Service-oriented companies often have representatives who observe the services being performed or who do follow-up checks to ensure that everything was done properly.

2.1.10: Introduction to Quality Assurance

What is Quality Assurance? Quality assurance is a process-centered approach to

ensuring that a company or organization is providing the best possible products or services.

It is related to quality control, which focuses on the end result, such as testing a sample of items from a batch after production.

Although these terms are sometimes used

interchangeably, quality assurance focuses on enhancing and improving the process that is used to create the end result, rather than focusing on the result itself.

2.1.10: Introduction to Quality Assurance

Basic Examples of Quality Assurance: A quality assurance technician in a food corporation

implements food-manufacturing processes that support compliance with safety standards and FDA requirements, rather than inspecting finished food items.

For a medical device manufacturer, quality assurance technology puts production measures in place to promote patient safety and accurate performance of the final product.

A quality assurance technician for a software company writes use cases and automated scripts to be used for testing new software.


When Does Quality Assurance Occur?Testing

Documentation

Labeling

Vendor audits

Vendor approval

Raw material receipt

Product release

Product Specifications

Training

Validation

2.1.11: Role of Managers in Quality Management, Control and Assurancei. The role of a manager is to act as a facilitator at the

workplace and to assist employees in implementing quality.

A manager is responsible in selecting and appointing right individuals who can work as line managers and take charge of the entire project.

The employees that the manager select ought to be reliable and diligent and should be capable enough to handle a crucial project like quality management, control and assurance.

The manager’s also responsible in allocating time for various training programs and appreciate employees who come up with various improvement ideas and strategies which would help the organization deliver superior quality products.

2.1.11: Role of Managers in Quality Management, Control and Assurance

ii. A manager must communicate the benefits of quality to all other members of the organization.

Call employees on a common platform and address the benefits and importance of total.

Make them understand how successful implementation of quality programs would yield high quality products which would not only benefit the organization but also the employees associated with the same.

2.1.11: Role of Managers in Quality Management, Control and Assurance

iii. A manager must always be a strong source of inspiration for other employees.

A manager need to practice quality himself before expecting others to believe in the same.

Employees feedbacks should be carefully monitored and taken into consideration while formulating company’s major strategies.

Provide frequent reports to employees highlighting scope of improvement.

chapter 2.1 introduction to quality management, control and assurance

Documents

quality control chapter

quality assurance chapter

quality management competition

bnn40703 quality assurance

chapter overview chapter

management activities

biotechnology chapter

failure chapter