How to distinguish between the common QC, IQC, IPQC, and QA roles in quality management?

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For newcomers to the field of quality control, it is common to encounter various job titles related to quality that seem similar but are actually different. For example, what is the difference between QC and IQC, and IPQC? And what’s the difference between QC and QA? Today, Certification Guy will help you get to know these titles. 1QC and QA QC: Quality Control, meaning the inspection of product quality; it refers to the personnel responsible for analyzing issues identified during quality checks, implementing improvements, and managing defective products. It generally includes: IQC (Incoming Quality Control), which refers to the quality control of incoming materials, also known simply as material inspection. IPQC (In-Process Quality Control) refers to process control, which involves the quality control of products from the point at which raw materials are used in production until the products are finally packaged. FQC (Finish or Final Quality Control) refers to the quality inspection of finished products; OQC (Out Quality Control) is the inspection of finished products before they leave the factory; DQC (Design Quality Control) deals with the quality control of the design phase; MQC (Manufacture Quality Control) involves the inspection of products during the manufacturing process. QA: Quality Assurance, which entails establishing and maintaining a quality management system to ensure that product quality is satisfactory. It generally includes: IDQA (Design Quality Assurance), which refers to the assurance of design quality; positions such as the DQA Manager (Design Quality Assurance Manager) and QE (Quality Engineer); JQE (Joint Quality Engineer), who is a quality engineer working for the client – one hired by the supplier to work on behalf of the client, and acts as the client’s SQE’s eyes and ears. SQE (Supplier Quality Engineer) is a supplier quality engineer. The difference between 2QA and QC: QA needs to not only know where the problems lie but also understand how to develop solutions for them and how to prevent such problems in the future. QC, on the other hand, only needs to take action to address existing problems, without necessarily knowing why such actions are required. To use an inappropriate analogy, QC is like the police, while QA is like the judge. QC is only responsible for arresting those who break the law; they cannot prevent others from committing crimes or pass final judgments on them. On the other hand, the judge is responsible for creating laws to prevent crime and issuing judgments based on those laws. To summarize, QC mainly involves post-event quality inspection activities; errors are tolerated by default, with the aim of identifying and selecting them out. QA mainly refers to pre-event quality assurance activities that focus on prevention in order to reduce the likelihood of errors occurring. QC refers to the techniques and activities employed to ensure that products meet quality requirements; it includes inspection, correction, and feedback. For example, after conducting inspections and identifying defective items, QC removes them and then provides feedback on these defects to the relevant departments so that corrective actions can be taken. Therefore, the scope of QC control is mainly within the factory, with the aim of preventing defective products from being fed into production, moving to the next stage of processing, or leaving the factory, ensuring that products meet quality requirements and that only qualified products are delivered to customers. QA is aimed at providing confidence by meeting customer requirements; even when customers are certain that the products supplied will fulfill their needs, it is still necessary to keep evidence from various stages (starting with market research, through evaluating customer requirements, product development, order processing and material procurement, incoming material inspection, production process control, and delivery, to after-sales service) to prove that every step taken by the factory is in accordance with the customer’s requirements. The purpose of QA is not to ensure product quality; ensuring product quality is the task of QC. QA is primarily aimed at providing assurance; therefore, it is necessary to manage the entire process from understanding customer requirements to after-sales service. This requires companies to establish a quality control system, develop relevant documents to standardize the activities in each stage, and keep evidence of these activities carried out, in order to build trust. This trust can be divided into two types: external and internal. External trust refers to customers’ confidence that the factory will produce and deliver products in accordance with their requirements ； Internally, this is done to reassure factory owners, as they are the primary responsible parties for product quality; they bear full responsibility in case of any quality issues. This is also a key requirement in the quality control laws enacted by various countries, aimed at ensuring that companies truly prioritize quality. Therefore, to avoid taking on quality-related responsibilities, owners must regulate all activities through documents and keep evidence of them. However, it is impossible for the boss to know whether the people inside the factory are following the requirements outlined in the documents; therefore, QA is needed to carry out audits on their behalf to determine whether those requirements are being met. This allows the boss to be assured that all activities in the factory are conducted in accordance with the established rules. Therefore, the main difference between QC and QA is that the former ensures that product quality meets specified standards, while the latter establishes systems and ensures that these systems operate as required in order to gain trust from both internal and external parties. At the same time, QC and QA share some common aspects: both involve verification. For example, QC tests products according to standards to verify whether they meet the specified requirements, while QA conducts internal audits to ensure that the system’s operations comply with standard requirements. Additionally, QA carries out inspections before product shipment and performs reliability tests to confirm that all necessary procedures have been followed and that the products meet the specified requirements, thereby ensuring that the products delivered by the factory are of good quality and comply with relevant regulations. The most important responsibility of QC is to monitor finished products (mainly including raw materials, goods in process, finished goods, and in-process audits), with an emphasis on detecting defects through sample inspection. 3. IPQC and IQC: There is a difference between IPQC and IQC. IPQC stands for IN PROCESS QUALITY CONTROL, which refers to quality control during the production process, while IQC stands for INCOMING QUALITY CONTROL, which refers to quality control of raw materials before they are used in production. Their responsibilities are as follows: IPQC responsibilities: 1. Inspect products during the production process and keep records of these inspections. 2. Prepare inspection reports based on the inspection records. 3. Propose solutions to address any issues identified during inspections. IQC responsibilities: 1. Inspect raw materials strictly in accordance with established standards. 2. Fill out inspection records accurately. 3. Maintain and service inspection equipment. 4. Report any abnormalities in raw materials. 5. Label raw materials properly. 6. Be responsible for receiving inspection reports from warehouse staff. 7. Address any quality issues related to materials reported by the production line by re-inspecting the materials stored in the warehouse. QA refers to quality assurance/monitoring: 1. Be responsible for overall operations within the department, implement GMP-related quality management regulations, and provide suggestions to company management regarding product quality from time to time. 2. Ensure that the company’s products are manufactured in compliance with GMP requirements. 3. Bear the responsibility for supervising, implementing, correcting, and preventing matters and people related to quality throughout the entire company. 4. Instructions that are conducive to production allocation are reviewed and approved after being examined and signed by the designated personnel in the department. 5. Review and approve the test results. 6. Review the pilot plan and conclusions for the development of new products and process improvements. 7. Review and submit the relevant technical and quality documentation to the drug regulatory authorities. 8. Review the approval records to determine whether the finished product is ready for release. 9. Responsible for organizing the formulation of quality standards and other documents for raw materials, auxiliary materials, and packaging materials. 10. Procedure for handling non-conforming products. 11. To meet quality management requirements, collaborate with relevant departments to develop new technical standards or discuss amendments to existing ones. 12. Review the production process procedures and batch production records as well as batch packaging records for each product, and decide on the release of the finished products. 13. Address product quality issues related to customer complaints by assigning staff or visiting the customers in person. Internal meetings are held to discuss improvements regarding quality issues in collaboration with relevant departments, and the details of complaints along with the outcomes of their handling are reported in writing to the company’s management. 14. Conduct comprehensive GMP inspections of the enterprise on a regular basis (at least once a year) in conjunction with the Chief Engineer’s office and the Production Department, and report the results of these inspections to the enterprise’s management in a timely manner. - End -