BNN20303Quality 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 Quality Assurance in Biotechnology

CHAPTER 2.4: Current Good Manufacturing Practice (cGMP)

Chapter 2.3

Quality Control and Quality Assurance in

Biotechnology

Chapter OverviewCHAPTER 2.3: QUALITY CONTROL AND QUALITY

ASSURANCE IN BIOTECHNOLOGY

CHAPTER 2.3.1: Definition of Quality Control

CHAPTER 2.3.2: Four Common Quality Control Misconceptions

CHAPTER 2.3.3: Objectives of Quality Control

CHAPTER 2.3.4: Elements of Quality Control

CHAPTER 2.3.5: Benefits Obtained From Quality Control

Chapter OverviewCHAPTER 2.3: QUALITY CONTROL AND QUALITY

ASSURANCE IN BIOTECHNOLOGYCHAPTER 2.3.6: Benefits Obtained Due to Improved Quality

Control Function

CHAPTER 2.3.7: Tools of Quality Control

CHAPTER 2.3.8: Definition of Quality Assurance

CHAPTER 2.3.9: Objectives of Quality Assurance

CHAPTER 2.3.10: Elements of Quality Assurance

Chapter OverviewCHAPTER 2.3: QUALITY CONTROL AND QUALITY

ASSURANCE IN BIOTECHNOLOGY

CHAPTER 2.3.11: The Importance of Quality Assurance Program

CHAPTER 2.3.12: How to Build a Successful Quality Assurance Program

CHAPTER 2.3.13: Characteristics of a Successful Quality Assurance Program

CHAPTER 2.3.14: Benefits Obtained From Quality Assurance

CHAPTER 2.3.15: Conclusions

Chapter 2.3.8

Definition of QualityAssurance

2.3.8: Definition of Quality Assurance

Quality Assurance (QA) is a management method that is defined as:

“All those planned and systematic actions needed to provide adequate confidence that a

product, service or result will satisfy given requirements for quality and be fit for use”

ISO 9002:1994

2.3.8: Definition of Quality Assurance

A Quality Assurance Programme is defined as:

“The sum total of the activities aimed at achieving that required standard”

ISO 9002:1994

Chapter 2.3.9

Objectives of QualityAssurance

2.3.9: Objectives of Quality Assurance The objectives of implementing quality assurance in

any business are listed under:

1. Promoting Legal Compliance

Quality assurance improves legal compliance in the production process.

For example: “Companies that manufacture or distribute children's products must comply with the Consumer Product Safety Improvement Act of 2008, which requires

kids' products to have permanent tracking information affixed to the product and its packaging. As a quality manager, you must ensure all kids’ products, have information on the manufacturing process and name of the

manufacturer.”

2.3.9: Objectives of Quality Assurance The objectives of implementing quality assurance in

any business are listed under:2. Conducting Consumer Research

Typically, the quality assurance department researches the consumer market to detect what customers consider when purchasing various products and services.

This information can be integrated into the manufacturing process to develop satisfactory and breakthrough products.

For instance:

“A quality assurance engineer working in an electronic firm can investigate the market to gather views from consumers on what they look for in a smart television before buying. If most customers

prefer TVs with parental controls, he will focus on enhancing the functionality of this feature.”

2.3.9: Objectives of Quality Assurance The objectives of implementing quality assurance in

any business are listed under:3. Enhancing Workforce Training

Quality assurance specialist must create a workplace environment that promotes production of safe and healthy goods through regular training of employees.

For example, If you work for a food production company, enrolling staff in educational workshops helps improve their technical abilities and updates their knowledge of production processes, ingredient use and customer demands.

When employees involved in the production cycle are conscious of expected quality outcomes, manufacturing products that meet industry standards and market expectations becomes easy.

2.3.9: Objectives of Quality Assurance The objectives of implementing quality assurance in

any business are listed under:4. Providing Effective Communication

A sound communication strategy helps quality assurance directors to communicate with clients, customers and government agencies.

It minimizes the amount of time spent clearing up misunderstandings or needing to repeat information.

For example, if a local regulatory agency raises concerns over your quality assurance systems, you must be able to produce the documentation proving compliance to requirements in a timely manner.

The quality assurance department also can focus on publishing organizational newsletters to educate the public on its programs, products and services.

Chapter 2.3.10

Elements of QualityAssurance

2.3.10: Elements of Quality Assurance

1. Setting Up The System2. The Quality Manual3. Training4. Standard Operating Procedures (SOPs)5. The Quality Assurance Manager6. Auditing and Checking Compliance7. Maintaining Quality Assurance

1. Setting Up The System

There is no single method for establishing a quality assurance system.

Each organization has its own problems that will require special consideration and planning.

However, once the decision to implement a quality assurance system has been taken and the necessary funds and facilities have been made available, then a plan must be drawn up.

For a new project the quality assurance system can be drawn up before the start but if the project is already established then a quality assurance system can be retrofitted.

2. The Quality Manual The Quality Manual is composed of the management documents

needed to implement the quality assurance programme and includes:

i. A quality policy statement, including objectives and commitments.ii. The relationship between management, technical operations, support

services and the quality system.iii. Procedures for control and maintenance of documentation.iv. Job descriptions for key staff and reference to the job descriptions of other

staff.v. Procedures for ensuring traceability of all paperwork, data and reports.vi. The laboratory's scope for calibrations and tests.vii. Procedures to be followed for feedback and corrective actions whenever

testing discrepancies or departure from documented procedures are detected.

3. Training

The development of the programme must include all staff.

Typically, the management commit resources, establish policy and standards, approve plans, assign responsibilities and maintain accountability.

The supervisory staff take responsibility for the development and implementation of the programme and operating personnel provide technical expertise and advice.

At all stages, the operating personnel must be consulted about thepracticalities of any proposed changes.

In turn, they must notify management of any problems or changes that may affect the programme.

4. Standard Operating Procedure

Standard Operating Procedures (SOPs) are the documents detailing all specific operations and methods, including sampling, transportation, analysis, use of and calibration of equipment, production of reports and interpretation of data.

They are the internal reference manual for the particular procedure and should detail every relevant step.

Anybody of the appropriate training level should be able to follow the SOP.

Method SOPs may originate from organizations such as the International Organization for Standardization (ISO), British Standards Institute (BSI), American Standard Technical Method (ASTM)

5. The Quality Assurance Manager For larger projects, proper management of quality assurance will require

the appointment of a quality assurance manager to liaise with staff, to manage data archives, to conduct regular audits and reviews and to report on any quality assurance issues.

The manager is responsible for inspecting all aspects of the system regularly to ensure compliance, for reporting on such inspections and audits to management and for recommending improvements.

These activities involve inspecting facilities and procedures regularly, tracing samples and documents back through the system and ensuring that all appropriate records have been kept.

Appointment of a full time quality assurance manager is difficult in a small organization and in these cases the responsibility for quality assurance should be assigned on a part-time basis, to a suitable member of staff.

6. Auditing and checking compliance

When all the documentation for the quality assurance system is in place, it should be piloted.

During this time, the quality assurance manager should conduct a series of audits covering all aspects of the system.

Traceability of data is a key component which can be checked by picking data at random and tracing them back through all relevant paperwork to the sampling procedure.

A review of the system with positive and negative areas clearly defined should be written at the end of the pilot phase.

7. Maintaining Quality Assurance

In order to maintain the quality assurance system, it is necessary to check periodically each area of the system for compliance.

This involves auditing the component parts to assess whether they continue to meet the original criteria.

This procedure should be formerly documented.

Reports on all audits should be made available to management and to the persons responsible for the work concerned.

Deviations from required standards must be corrected as soon as possible.

The audit must be independent, and should be thorough and unannounced.

Chapter 2.3.11

The Importance of Quality Assurance Program

2.3.11: The Importance of Quality Assurance Program

1. Quality assurance programs will assure that an organization is adhering to standards.

2. The quality assurance program will continuously and systematically evaluates the adequacy and appropriateness of the company's products and services.

Quality assurance program is an integral element to the success of every company quality assurance policy.

The importance of the quality assurance program are enumerated as under:

3. Through development of standards with measurable goals, documenting policies and procedures, staff training and review of data associated with standards, the quality assurance program acts as a system of checks and balances for your organization.

Chapter 2.3.12

How to Build a Successful Quality Assurance Program

2.3.12: How to Build a Successful Quality Assurance Program

Businesses use quality assurance program to increase efficiency and improve customer satisfaction.

A thorough and successful quality assurance program can be build by following the five steps listed below:

Step 1: Create standards for the business and criteria for the standards.

Step 2: Create policies and procedures in conjunction with the standards.

2.3.12: How to Build a Successful Quality Assurance Program

Step 3: Create a quality program description.

Step 4: Establish a quality committee that include employees from departments other than the quality assurance department.

Step 5:Implement corrective action plans when results are unsatisfactory and performance needs improvement.

2.3.12: How to Build a Successful Quality Assurance Program

Step 1: Create standards for the business and criteria for the standards.

Use federal and state regulations and client contractual obligations as a starting point.

Align the criteria with accreditation standards, even if the organization does not pursue accreditation.

Review best practices in the industry and determine how the organization can strive to achieve them.

These will become the basis of the organization's policies and procedures.

2.3.12: How to Build a Successful Quality Assurance Program

Step 2: Create policies and procedures in conjunction with the standards.

Create policies and procedures in conjunction with the standards.

Work with various departmental leaders to develop workflows and standard operating procedures that support the quality program and meet high principles for running the business.

Train staff to ensure workflows are understood, implemented and meeting the needs of the business.

2.3.12: How to Build a Successful Quality Assurance Program

Step 3: Create a quality program description.

This document should include a mission statement, company reporting structure, annual program evaluation process, goals, business practices and specific policies relevant to the quality program's scope.

Develop reports to measure and validate the progress and success of the company.

Review and update the program document at least once a year to ensure goals and processes are current and match the company's direction and industry standards.

2.3.12: How to Build a Successful Quality Assurance Program

Step 4: Establish a quality committee that include employees from departments other than the quality assurance department.

Include external participants, such as clients, who can provide subjective feedback.

Meet on a quarterly basis to review quality reports, trends and improvement activities.

The data the committee reviews should include quality metrics, such as sales reports, satisfaction survey results and other screening tools relevant to the business.

The committee function is to "checks and balances" to assure adherence to standards.

2.3.12: How to Build a Successful Quality Assurance Program

Step 5: Implement corrective action plans when results are unsatisfactory and performance needs improvement.

Hold management accountable for developing action plans and achieving results.

Continue monitoring to ensure that the company is providing the best possible products and services.

Chapter 2.3.13

Characteristics of a Successful Quality

Assurance Program

2.3.13: Characteristics of a Successful Quality Assurance Program

• Nowadays, business continue to push boundaries to create advanced capabilities and work to stay on the cutting edge of the trends customers care about.

• However, at the end of the day, a successful business begins with the basics, and attention to the details around areas like quality assurance program.

• It’s therefore important to get these baseline programs right, so below are the outlined of ten characteristics of a successful quality assurance program.

2.3.13: Characteristics of a Successful Quality Assurance Program

1. Synergistic:A successful quality assurance program begins with the

culture of an organization, and stems into all areas of the program.

Quality assurance program works best when it is formed by an established message that is derived from an organization cultural values.

Avoid contradictory messaging and strive to put the quality assurance program on the same page for everyone in the organization.

2.3.13: Characteristics of a Successful Quality Assurance Program

2. Relevant:

When choosing elements for the quality assurance program, take a cue once again from the company culture and messages, and work to create a form that’s unique to the organization.

Pull components from past experience, industry examples and instinct, but keep the elements of the quality assurance program relevant to the environment and manageable in terms of business capabilities.

2.3.13: Characteristics of a Successful Quality Assurance Program

3. Correlated to Goal:

As with any quality assurance program, keep the destination in mind and map the content back to the end goal.

Know what need to measure, and keep eyes open for opportunities these objectives may identify, for instances, improving customer satisfaction and increasing sales.

Know where the quality assurance program going, and be aware of opportunities along the way to get there.

2.3.13: Characteristics of a Successful Quality Assurance Program

4. Balanced:

5. Concise:

The quality assurance program must strike a balance between the needs of the business and the needs of the customer by aligning weights and make adjustment appropriately to meet the program goals.

Prioritize which objectives in the quality control program matter the most and need to be measured.

Streamline (integrate) the quality assurance program where possible and keep evaluations focused.

2.3.13: Characteristics of a Successful Quality Assurance Program

6. Actionable:

Data is only useful if it can be used to make improvements.

Think ahead about the data being generated and how it may be used to create actionable results.

Evaluate if the quality assurance program is addressing the right issues, how the responses could be leveraged, and whether there are other approaches that may be helpful in that pursuit.

2.3.13: Characteristics of a Successful Quality Assurance Program

7. Defined:

Empower employees to succeed by ensuring that the criteria from the quality assurance program are well defined

Make sure that the criteria from the quality assurance program are well defined ahead of time to make sure employees are given the clarity they need.

2.3.13: Characteristics of a Successful Quality Assurance Program

8. Calibrated:

Accurate quality data requires ongoing calibration (measurement).

Make calibration a priority and consider it an ongoing part of the quality assurance program.

2.3.13: Characteristics of a Successful Quality Assurance Program

9. Evolving:

Quality assurance program does require a certain level of consistency to allow for ongoing tracking, but that doesn’t mean the program should be complacent (satisfied).

Evaluation may reveal areas where the quality assurance program is not accurately reflecting opportunity for improvement or creates a divide between ideals and what is actually happening.

Take advantage of continuous evaluation to inform how the program should evolve to improve it.

2.3.13: Characteristics of a Successful Quality Assurance Program

10. Celebrated:

Don’t operate quality assurance program in isolation.

Instead, celebrate it as an extension of the organization’s culture and promote corporate pride.

Get everyone on board before rolling the program out, and celebrate it as a way to recognize key players who perpetuate the company’s values and reward based on those observations.

Chapter 2.3.14

Benefits Obtained From Quality Assurance

2.3.14: Benefits Obtained From Quality Assurance

Quality assurance offer internal benefits to the company and workforce and external benefits to the customer and community.

I. Increased sales that result from-

Increased customer satisfaction as a result of better dependability of product and service delivery.

Increased customer satisfaction as a result of fewer problems with products and services.

Increased customer satisfaction as a result of employees ability to respond quickly and reliably to customers' problems.

2.3.14: Benefits Obtained From Quality Assurance

Quality assurance offer internal benefits to the company and workforce and external benefits to the customer and community.

II. Reduced costs that result from-

Fewer problems and defects to deal with and fix after delivery to the customer, by identifying problems at the earliest possible stage.

Reduced waste because of fewer defects, as a result of systematic resolution and analysis of quality-related problems.

Less time spent by employees searching for needed information.

2.3.14: Benefits Obtained From Quality Assurance

Quality assurance offer internal benefits to the company and workforce and external benefits to the customer and community.

III. Improved operating efficiency that results from-

Better control of supplier inputs to production and service processes.

Continual review and refinement of the system and methods resulting from disciplined problem identification and resolution.

Availability of accurate, reliable, and accessible data and information for analysis.

Chapter 2.3.15

Conclusions

2.3.15: Conclusions• It is important for an organization to agree on what

the meanings of Quality Assurance (QA) and Quality Control (QC).

• Both form an integral part of the organization's quality management plan, and the effectiveness of delivery teams relies on the differences being well understood by all stakeholders, including management.

Assignment 1Understanding what quality is can contribute enormously to the success of an organization, but the counterpoint is that, when poorly understood, it can also likely contribute to the failure of the organization. Therefore, using your own words, describe at length what this quote means to you:

"Quality costs us, manage it wisely"Handwritten, > 10, <150 words