Quality assurance, or QA for short, is how companies prevent mistakes and defects in the manufacturing process. These are the processes companies use to ensure that products are not only of the highest quality when they are finished but also consistent, safe, and at their most effective. Most manufacturers have a QA department or at least a person in this role, but true QA should include everyone involved in the process. This is the best way to ensure that the best practices and appropriate steps are being followed at all times. To help anyone involved in manufacturing understand more about quality assurance, here are five QA terms all manufacturers should know.
In this acronym, the G and the P stand for “Good Practices” and the x means “insert your industry here.” For manufacturers, you may also see this written or spoken about as “GMP” (Good Manufacturing Practices). Good practices are important in any industry and are a hallmark of the best-managed companies, but in industries like manufacturing where there are health and safety issues, compliance issues, and where producing a quality product is of the utmost importance, these good practices take on added importance.
GxP means something different for every industry and even for different companies within the same industry. While the specifics may vary, the general foundation of these concepts remains the same across the board. GxP is driven by accurate, comprehensive data that is collected that allows companies to establish, test, and analyze the practices. This data creates a record of the who, what, where, when, and how of the company’s processes and allows for careful analysis of this information with the goal being continuous improvement and increasingly meeting higher standards. For more detail on GxP, this guide from Dickson has some useful information.
2. IQ OQ PQ
In many niches within the manufacturing industry, an incredible level of precision is necessary. For companies manufacturing things like medical devices, pharmaceuticals, or aerospace technology, having manufacturing equipment that is in top condition and producing the exact results you need is critical. That is why equipment validation is so important in the QA process. To validate that the equipment is functioning as it should, there are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
These three qualifications are done during different times of a machine’s lifecycle to ensure it is capable of or is currently delivering the exact quality specifications it needs to. IQ is done when a machine is first installed in a manufacturing site to ensure that it is capable of delivering the quality results that are required. Once the IQ is met, OQ is performed once the machine starts manufacturing products. OQ is done to confirm that the machine is delivering consistent, repeatable results every time it completes its function. Finally, the machine is tested throughout its life for PQ, which makes sure that the results stay consistent over time under real-world conditions.
This is the acronym for hazard analysis and critical control points. This is a QA process that was created to help keep food safe in space and is still most often seen in relation to the food supply chain. It can be used in other industries where contamination is a concern as well, such as pharmaceuticals or cosmetics. The idea behind HACCP is to implement quality assurance measures that limit the product’s exposure to possible contaminants instead of having to test all finished products for contaminants. This process is meant to keep the products safe for use, not necessarily to ensure overall quality.
According to the FDA, “Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation.” These seven principles create a plan where exposure to contaminants is minimized, the process is monitored for exposure along the way, and data is recorded throughout the process to validate the plan at each step (or “critical point”).
4. Cold Chain Monitoring
A cold chain is a temperature-controlled supply chain for products that have to be manufactured, stored, and transported in a specific low-temperature range for the safety and integrity of the product. Cold chain is most often associated with food, pharmaceuticals, and other biological products. Monitoring the environmental conditions (specifically temperature but also things like humidity and pressure as well) is vital. While this used to be done with thermometers and thermostats on walls, it is now done with internet-connected data loggers and remote monitoring systems.
Data loggers are sensors placed throughout the areas of the cold chain that are monitoring and reporting environmental conditions to a central location. This location will have a remote monitoring system that receives all this data, analyzes it, and allows for the cold chain to be controlled by one person or at least controlled in one room. This allows for more consistency, quicker reaction times, and a more efficient cold chain monitoring system, which is what QA is all about.
ASQ is the American Society for Quality. This is the top organization for QA professionals in American and around the globe. The professional association provides its QA-related membership with everything from certifications to training to conferences and more. They also produce several publications about quality assurance. If you have anything to do with manufacturing QA, you should be a member of ASQ.
Between 1968 and 2016, ASQ created 18 different certifications that test and certify that a person is knowledgeable and competent in the world of quality assurance. These certifications cover general QA positions such as Engineer, Technician, Inspector, Auditor, and Manager as well as specialized areas of expertise like CQA-HACCP, CQA-biomedical, and Pharmaceutical good manufacturing practices professional certification There are also four martial arts-style belts you can earn in the process improvement methodology of Six Sigma.
Knowing these five terms will help anyone in the manufacturing field become more of a quality assurance expert. Understanding them and helping a company implement them will create safer and higher-quality end products that are beneficial for a company’s bottom line. And that is the best reason why all manufacturers should know these terms.