There are a lot of English abbreviations in the quality management, how to distinguish their meanings, I hope this article can help you!
QC: QualityControl, quality control, product quality inspection, general analysis of the analysis, improvement and non-conforming product control personnel after the quality problem. Generally include: IQC (IncomingQualityControl, incoming inspection); IPQC (In-ProcessQualityControl, process inspection); FQC (FinalQualityControl, finished inspection); OQC (Out-goingQualityControl, shipment inspection) QC is concerned with products, not systems (System) This is the main difference between it and QA. The purpose is the same as QA, which is “to meet or exceed customer requirements.â€
QA: QualityAssurance, Quality Assurance, ensures quality without problems by establishing and maintaining a quality management system. Generally include system engineers, SQE (SupplierQualityEngineer: Supplier Quality Engineer), CTS (Customer Service Service Staff), 6sigma Engineer, and calibration and management of measuring instruments. QA not only needs to know where the problem lies, but also how to solve these problem solutions. How to prevent it in the future, QC needs to know that it is just a matter of control, but it does not have to know why it should be controlled. Inappropriate analogy, QC is the police, QA is the judge, QC can only take the violation of the law, it can not prevent others from committing crimes and finally convicting others, and the judge is to enact laws to prevent crime, according to the law Disposal results.
To sum up, QC: Mainly after-the-fact quality inspection activities, the default error is allowed, and it is expected to find and select errors. QA is mainly a prior quality assurance activity, mainly based on prevention, and it is expected to reduce the probability of occurrence of errors. QC is the operation technology and activities adopted to make the products meet the quality requirements. It includes inspection, correction and feedback. For example, QC will detect the defective products and remove them, and then feedback the bad information to relevant departments for improvement measures. Therefore, the control scope of QC is mainly in the factory, the purpose is to prevent the non-conforming products from being invested, transferred, and shipped out, to ensure that the products meet the quality requirements and only qualified products can be delivered to the customers. QA is to provide trust to meet customer requirements. Even if the customer is convinced that the product you provide can meet his requirements, it is necessary to review customer requirements, product development, order and material procurement, feed inspection, and production process from the beginning of market research and later. Control and shipment, after-sales service and other stages leave evidence to confirm that every step of the factory's activities are carried out according to customer requirements. The purpose of QA is not to ensure product quality, but to ensure product quality is the task of QC. QA is mainly to provide conviction, so it is necessary to manage the whole process of understanding customer requirements from start to after-sales service. This requires enterprises to establish a quality control system, formulate corresponding documents to regulate the activities of each process and leave evidence of activity implementation to provide trust.
This kind of trust can be divided into two kinds: internal and external: even if the customer is assured, the factory is to produce and deliver the product according to its requirements; the internal is to let the factory owner rest assured, because the boss is the first responsible person of product quality, the product has a quality accident. He has to bear full responsibility. This is also the main requirement for countries to formulate product quality laws, so that enterprises can really pay attention to quality. Therefore, in order to avoid bearing the quality responsibility, the boss must document the activities and leave evidence. However, the internal staff of the factory is not required to operate according to the documents. The boss cannot understand them one by one. This requires QA to replace him for auditing to understand whether the documents are complied with, so that the boss can believe that the activities of the factory are carried out according to the documents. Reassure him.
Therefore, the main difference between QC and QA is that the former guarantees product quality and the latter, and the latter establishes the system and ensures that the system operates as required to provide internal and external trust. At the same time, QC and QA have the same point: QC and QA should be verified. For example, QC tests the product according to the standard to verify whether the product meets the requirements. QA conducts internal audit to verify whether the system meets the standard requirements, and QA The goods audit and reliability test is to verify whether the products have been carried out according to the regulations, and whether the requirements can be met to ensure that the products delivered by the factory are qualified and comply with relevant regulations. QC's important responsibility is to monitor the finished products (mainly including Rawmaterial, in-processgoods, finishgoods, In-processaudit), focusing on Detectdefect through SampleInspection.
QC has IPQC and IQC points, IPQC: INPROCESSQUALITYCONTROL process quality control; IQC: INCOMEQUALITYCONTROL feed quality control. Its responsibilities are as follows:
IPQC responsibilities:
1. Inspect the products in the production process and make a record
2. Fill in the inspection report according to the inspection record
3. Suggest improvements to the problems found in the inspection
IQC responsibilities:
1. Strictly inspect raw materials according to inspection standards
2. Fill in the inspection record form truthfully
3. Maintenance and maintenance of testing equipment
4. Report of abnormal raw materials
5. Identification of raw materials
6. Responsible for the receipt of the inspection report of the warehouse material
7. Responsible for re-inspecting the inventory materials of the warehouse for material quality problems in the production line complaints
QA is quality supervision / monitoring
1. Responsible for the overall work of the department, organize the implementation of GMP quality management regulations, and timely submit product quality opinions and suggestions for improvement to business leaders.
2. Ensure that the products of the company are produced in compliance with GMP requirements.
3. Responsible for the implementation, correction and prevention of people and things related to quality throughout the enterprise.
4. The instructions for the production configuration are reviewed and approved after the designated personnel of the department have signed the audit.
5. Review and approve the test results.
6. Review the pilot program and conclusions of new product development and process improvement.
7. Review the relevant technical and quality written materials submitted to the drug regulatory authority.
8. Review the batch records and conclude whether the finished product is shipped.
9. Responsible for organizing the development of quality standards and other documents for raw materials and packaging materials.
10. Review the non-conforming product handling procedures.
11. Due to the needs of quality management, we will organize the preparation of new technical standards or discuss the revision of technical standards with relevant departments.
12. Review the production process rules, batch production records, batch packaging records of each product, and determine the release of finished products.
13. Deal with product quality issues with user complaints, assign personnel or return to the user in person. The meeting will be held internally, and relevant departments will study and improve the quality issues, and report the complaints and the results of the complaints to the person in charge of the company.
14. Regularly (at least once a year) will conduct comprehensive GMP inspections with the General Works Office and the Production Department, and report the inspections to the person in charge of the enterprise in a timely manner. 
Editor in charge: Hu Na
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