Last Updated on November 18, 2024 by Owen McGab Enaohwo
Image Credit: Linkedin
Quality assurance (QA) refers to the process of ensuring your products or services meet predefined industry standards and customer expectations.
Why Is Quality Assurance Important?
One of the main drivers behind amazing products – physical or digital – is quality assurance. QA teams and processes ensure that any visible or potential defects are fixed before they become a problem. In other words, QA helps maintain your company’s credibility and win customer confidence, making sales easy.
While QA can be a good-to-have for many fields, it’s compulsory in a few industries. In this post, we’ll explore the following industries and the distinct reasons why they take QA so seriously:
- Pharmaceutical industry
- Food industry
- Medical devices industry
- Cosmetics industry
- Software industry
Let’s get started!
1. Pharmaceutical Industry
The pharmaceutical industry deals with the discovery, processing, and manufacturing of medicines. Quality assurance concerns in this industry include:
- Quality of raw materials
- Adherence to pharma QA standards
- Accuracy and completeness of documents at each stage
- Traceability of data
- Minimization of variability
- Risk of errors
This means that a major part of QA execution in pharmaceuticals involves rigorous testing, validation, and documentation at every stage. From raw material procurement to final product release, every single process and step is monitored for quality standards.
Some essential QA standards in the pharmaceutical industry include:
- Good Manufacturing Practices (GMP) — These are enforced by the Food and Drug Administration (FDA) in the United States. They ensure companies produce safe and pure drugs by controlling all aspects of production, from starting materials to staff training to equipment maintenance.
- Good Laboratory Practices (GLP) — This is a set of rules that help ensure studies related to non-clinical health and environmental safety are done correctly and reliably. It upholds the consistency, reliability, reproducibility, quality, and integrity of data generated in the course of such studies.
- Good Distribution Practices (GDP) — These are enforced by regulatory bodies such as the European Medicines Agency (EMA) and the FDA. They are guiding principles for the storage, handling, transportation, and distribution of pharmaceutical products. They are also a basic requirement for wholesale distributors looking to obtain distribution authorization.
If a pharmaceutical company neglects these QA standards, severe consequences may arise.
For example, the product quality may be compromised and lead to the release of unsafe drugs. Once the regulatory bodies find out about this, they may impose penalties in the form of fines or product recalls, damaging the manufacturer’s reputation. This is why pharmaceutical companies pay a ton to implement QA — the pharmaceutical quality control market will be worth $9.69 billion by 2027 and is projected to grow at a rate of 12.1%
2. Food Industry
The food industry also pays lots of attention to QA. Even the slightest negligence can prove to be the biggest blow for any food company.
Quality assurance in the food industry is mainly about:
- Safe ingredient sourcing and traceability
- Hygiene and sanitation practices
- Allergen control
- Packaging integrity
- Adherence to good manufacturing practices
- Compliance with local and international food safety standards
Some of the most common food safety practices and certifications are:
- Hazard Analysis and Critical Control Points: HACCP is an internationally accepted systematic preventive approach that identifies, evaluates, and controls potential hazards in the food production process.
- International Organization for Standardization 22000: This standard outlines the requirements for a food safety management system, emphasizing a risk-based approach. It covers the entire food supply chain and promotes consistency and traceability.
- British Retail Consortium Global Standards: Primarily used by suppliers to the UK retail industry, BRCGS certification focuses on product safety, legality, and quality. It provides a framework for manufacturers to meet specific safety and quality criteria.
- Safe Quality Food: SQF is a comprehensive food safety and quality management system that incorporates both international and domestic regulatory requirements. It is recognized by the Global Food Safety Initiative (GFSI) and covers all aspects of food production.
- International Featured Standards: IFS focuses on food safety and quality. It emphasizes the importance of management commitment, continuous improvement, and effective communication within an organization.
- USDA Organic Certification: For organic food products in the United States, this certification ensures compliance with strict organic farming and production standards set by the United States Department of Agriculture (USDA).
- Kosher Certification: While not strictly a food safety certification, kosher certification verifies that food products meet the dietary requirements of Jewish law. It also usually means that food products are produced by the highest quality manufacturing processes.
3. Medical Devices Industry
The primary aspects of quality assurance in this industry are risk management and hazard analysis throughout the product life cycle. This is because a malfunctioning or defective device can risk the life of the user.
This means that medical devices undergo rigorous testing protocols and validation processes to reduce any potential risks. Traceability systems are also implemented, ensuring the highest possible safety standards for these devices.
The most important standard governing QA in this field is the ISO 13485 certification. This globally recognized standard outlines specific requirements for quality management systems in the design, development, and manufacturing of medical devices.
It places a sharp focus on risk management, process validation, and the establishment of a robust quality management system tailored to the unique intricacies of the medical device industry.
Manufacturers of medical devices should also comply with Good Manufacturing Practices (GMP), which encompass cleanliness, equipment calibration, and personnel training to prevent contamination and ensure the consistency of device quality.
Plus, the implementation of Good Laboratory Practices (GLP) in the research and development phases guarantees the reliability of the data generated during the production of a device.
If a medical device manufacturer ignores QA, it can lead to:
- Compromised patient safety due
- Fines due to regulatory non-compliance
- Production suspension
- Product withdrawals
- Financial strains due to legal consequences
The reputational damage resulting from safety issues can also be severe. It can impact market share and brand trust and companies might face increased operational costs and barriers to market access, which can limit global expansion.
4. Cosmetics Industry
Without QA, substandard or contaminated cosmetics may cause allergic reactions, skin irritation, or more severe health issues like cancer. This risks consumer safety, brand reputation, and ultimately company survival.
This is why the cosmetics industry has various quality assurance standards to ensure product safety and excellence. Some of these standards include:
- Adhering to proper testing protocols
- Selecting reliable and high-quality ingredients
- Establishing clear protocols for sourcing and inspecting ingredients
- Meticulously documenting the entire process for traceability
The CTFA Quality Assurance Guidelines provide voluntary guidelines for the development of cosmetic products, while ISO Standard 22716 gives guidelines for the production, control, storage, and shipment of cosmetic products.
ISO 9001 certification is also important for the cosmetics industry because it helps ensure consistent quality and customer satisfaction
Quality control and quality assurance practices for cosmetic manufacturers include using instruments like thin-layer chromatography, gas-liquid chromatography, high-pressure liquid chromatography, and infrared and ultraviolet spectrophotometers, as well as conducting microbiological quality control.
5. Software Industry
Lastly, we have the software industry, where quality assurance is necessary for end-user security, operational efficiency, and overall system safety. If the software is not up to par or developed properly, it may result in:
- Data breach
- Loss of confidential data
- System failures
- Software glitches
The ruling QA certification in the software industry is ISO/IEC 25010. It focuses on software product quality, covering attributes such as functionality, reliability, and security.
If there’s a lack of robust quality assurance in this industry, it can lead to customer dissatisfaction, increased support costs, and legal consequences (if privacy or regulatory standards are violated). For example, the Chinese ride-hailing firm Didi Global faced a $1.19 billion fine when it violated data and network security laws.
Final Words
As you saw, QA is key in many industries, from making medicines to creating software. It’s all about making sure everything is done right and keeping customers safe and happy.
The main part of QA? Good documentation and following the rules.
This is where SweetProcess comes in. To learn how it can help you implement effective QA, check out our post on Gluu vs SweetProcess: Which Is Better for Process Documentation?
About the author
My name is Audrey Gagnon and I am a Digital Food Safety Specialist working at FoodDocs.