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I. QC and QA

QC: Quality Control, the general term for quality control, product quality inspection, analysis, improvement and non-conforming product control related personnel after quality problems are found.

Generally include:

IQC (Incoming Quality Control) means quality control of incoming materials, referred to as incoming material control.

IPQC (In Put Process Quality Control) in Chinese means process control, which refers to the quality control of the final packaging process of products from materials to production.

FQC (Finish or Final Quality Control) finished product quality inspection

OQC (Out Quality control) finished product factory inspection

DQC (Design Quality Control) design quality control

MQC (Manufacture Quality Control) process quality inspection

QA: Quality Assurance, quality assurance, through the establishment and maintenance of a quality management system to ensure that there is no problem with product quality.

Generally include:

IDQA (Design Quality Assurance) design quality assurance, such as DQA manager (design quality certification manager)

QE (Quality Engineer)

JQE (Joint Quality Engineer) client quality engineer, that is, the quality engineer hired by the supplier to work for the customer, is the eyes and ears of the customer's SQE.

SQE (Supplier Quality Engineer) supplier quality engineer.

II.The difference between QA and QC

　　QA not only needs to know where the problems are, but also how to formulate solutions to these problems, and how to prevent them in the future; QC needs to know that if there is a problem, it should be controlled, but it does not necessarily need to know why it should be controlled in this way.

　　[An inappropriate analogy] QC is the police and QA is the judge. QC only needs to catch those who violate the law. It cannot prevent others from committing crimes and convict others. The judge is to make laws to prevent crimes and follow the law. Declare the results of the disposal.

　　To summarize:

　　QC mainly focuses on quality inspection activities after the fact. By default, errors are allowed, and errors are expected to be discovered and selected. QA is mainly an advance quality assurance activity, focusing on prevention, hoping to reduce the probability of errors.

　　QC is the operation technology and activities taken to make the product meet the quality requirements. It includes inspection, correction and feedback. For example, after QC conducts inspection and finds defective products, they will be eliminated, and then the bad information will be fed back to the relevant departments to take improvement measures. Therefore, the scope of QC's control is mainly within the factory. Its purpose is to prevent the input, transfer, and delivery of unqualified products, to ensure that products meet quality requirements and only qualified products can be delivered to 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 from the beginning of market research and later, product development, order and material procurement, incoming inspection, and production process Evidence is left at each stage of control, shipment, after-sales service, etc., confirming that every step of the factory's activities is carried out in accordance with customer requirements.

　　The purpose of QA is not to ensure product quality, it is the task of QC to ensure product quality.

　　QA is mainly to provide 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, formulate corresponding documents to regulate the activities of each process and leave evidence of the implementation of the activities in order to provide trust.

　　This kind of trust can be divided into two types: internal and external: the external, even if the customer is at ease, believe that the factory produces and deliver products according to its requirements; the internal is to reassure the factory owner, because the boss is the first person responsible for product quality, and the product has quality accidents. He has to take full responsibility. This is also the main requirement for countries to formulate product quality laws to encourage companies to really pay attention to quality. Therefore, in order to avoid responsibility for quality, the boss must standardize various activities with documents and leave evidence. However, it is impossible for the boss to know whether the internal personnel of the factory operate according to the document requirements. This requires QA to conduct audits on his behalf to understand whether the document requirements are complied with, so that the boss can believe that the various activities of the factory are carried out in accordance with the document. Reassured him.

　　Therefore, the main difference between QC and QA is: the former is to ensure that product quality meets the requirements, and the latter is to establish a system and ensure that the system operates as required to provide internal and external trust.

　　At the same time, QC and QA have the same points: that is, both QC and QA must be verified. For example, QC testing products according to standards is to verify whether the product meets the specified requirements, and QA's internal audit is to verify whether the system operation meets the standard requirements, just like QA. Shipment audit and reliability testing are to verify whether the product has performed various activities in accordance with the regulations and whether it can meet the specified requirements, so as to ensure that the products delivered by the factory are qualified and comply with relevant regulations.

　　The most important responsibility of QC lies in the monitoring of finished products (mainly including: Raw material, in-process goods, finish goods, and in-process audit), focusing on detecting defects through Sample Inspection.

III. IPQC and IQC

QC is divided into IPQC and IQC,

IPQC: IN PROCESS QUALITY CONTROL process quality control

IQC: IN COME QUALITY CONTROL

Its responsibilities are as follows:

IPQC responsibilities:

1. Inspect the products in the production process and keep records

2. Fill in the inspection report according to the inspection record

3. Suggest improvement measures for the problems found in the inspection

IQC responsibilities:

1. Inspect raw materials in strict accordance with 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 signing and receiving the inspection report of the warehouse material staff

7. For the material quality problems complained by the production line, it is responsible for re-checking the stock materials in the warehouse

QA is quality supervision/monitoring

1. Responsible for the overall work of the department, organize the implementation of GMP-related quality management regulations, and put forward product quality opinions and improvement suggestions to the business leaders in a timely manner.

2. Ensure that the company's products are produced in compliance with GMP requirements.

3. Responsibility for supervision, implementation, correction and prevention of quality-related people and matters in the entire enterprise.

4. The instructions that are beneficial to the production configuration shall be reviewed and approved by the designated personnel of this department after review and signing.

5. Review and approve the inspection results.

6. Review the pilot test plan and conclusions of new product development and process improvement.

7. Review the relevant technical and quality written materials submitted to the drug supervision and administration department.

8. Review the batch record and make a conclusion whether the finished product is out of the factory.

9. Responsible for organizing the formulation of quality standards and other documents for raw materials and packaging materials.

10. Review the procedures for handling non-conforming products.

11. Due to the needs of quality management, organize new technical standards or discuss amendments to technical standards in conjunction with relevant departments.

12. Review the production process regulations, batch production records, and batch packaging records of each product, and decide on the release of finished products.

13. To deal with product quality issues complained by users, assign personnel or visit users in person. Convene internal meetings to study and improve quality issues with relevant departments, and report the complaints and handling results to the person in charge of the company in writing.

14. Regularly (at least once a year) conduct a comprehensive GMP inspection of the enterprise in conjunction with the General Office of Engineering and the Production Department, and report the inspection to the person in charge of the enterprise in a timely manner.

summary:

Review it again, don't get confused!

QC (Quality Control): The general term for quality control, product quality inspection, analysis, improvement and non-conforming product control related personnel after quality problems are found.

IQC (Incoming Quality Control): It means the quality control of incoming materials, referred to as incoming material control.

IPQC (In Put Process Quality Control): Chinese means process control, which refers to the quality control of the final packaging process of products from materials to production.

QA (Quality Assurance): Quality assurance, through the establishment and maintenance of a quality management system to ensure that there is no problem with product quality.