Quality is key to any successful business. Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics, medical devices, or other scientific-based organizations should have a Quality Assurance Program or Quality Management Program, especially due to regulatory compliance. Contained in this program are two components that are important to its success- quality control and quality assurance. It is common for individuals to use quality control and quality assurance interchangeably. While both are vital to a quality assurance program, they are both quite different. This article will differentiate between quality assurance and quality control and the significant role both play in the scientific industries.
Quality assurance is a set of systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill requirements for quality. Quality assurance is used as a preventative measure for deviations in processes or products. Any business that has FDA clearance products or processes that need to be FDA compliant should have a robust quality management team. Failure to do so can result in unhappy consumers, FDA 483 notices or FDA warning letters. The quality assurance management team should have an objective of preventing defects and that all processes are followed according to the company’s standard operating procedures. Another significant goal is to improve vital processes and products. A standard operating procedures manual is best and necessary for achieving the goals of a quality assurance program. It should layout the steps of each process that employees must follow. The manual should have maintenance and operation procedures. It is used as a tool to prevent deviations from standardized or validated processes. Quality assurance activities include process documentation, checklists, validations, reviewing cleaning records and certificates of analysis, and many other activities that would contribute to preventing errors.
Quality control identifies when quality standards are not met in processes or products. Identification can be made through testing or inspection. Quality control is important in detecting deviations prior to release of a product. Implementation of excellent quality control measures is critical in any quality assurance program. The standard operating procedures should properly be identified of what is expected in a product or process. An example of a quality control measure is before releasing a final product that utilizes sterilized components, the standard operating procedure may call for a negative rapid readout biological indicator and a negative chemical indicator strip. If negative results are recorded then the instruments can be used, if not they must repeat the sterilization process. This quality control measure prevents contamination of a product or in a process. It is important for a member of the quality assurance consulting team that is not involved in the process to monitor and evaluate the process to verify it conforms to the standard operating procedure. Quality control activities should be ongoing for effective quality products and processes.
A quality assurance program can only be as good as the employees involved in the process. It takes employees to pay attention to the details and follow standard operating procedures precisely, especially if the process is validated. Defects or deviations can occur for many reasons such as expired products, a break in sterility, contaminated products, product specifications not met and so on. It is what the quality assurance team does afterwards that matters. The quality assurance team should investigate why such deviation occurred and make a corrective action. This type of action plan helps with quality improvement.
Quality control is a significant component of a quality assurance program, when both quality assurance and quality control are utilized, errors will be reduced. Quality assurance applied by itself, will result in a set of processes that ensure quality. Alone quality control focuses on testing the product to ensure quality exists. Together, they create a deviation prevention and detection system. A company that has implemented a thorough quality assurance program is demonstrating that quality is a high priority. Regarding quality management as a necessary tool and charging the quality team with the task of regulating processes is important to the success of companies in the scientific field and beyond. Quality team members should be viewed as the police of the organization to make sure regulations are followed and compliance is adhered. It may be necessary to obtain services from a regulatory consulting firm or an expert in quality consulting to ensure FDA compliance is maintained. The company will benefit by having quality products and higher customer satisfaction. Any financial resources used for having a great quality assurance program can easily reduce expenses the company incurs from inefficient processes, return of goods or future litigations.
Author Information: Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. As such, BRG is an integral part of client decision-making processes.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.