How are the common titles of quality inspection QC, IQC, IPQC and QA different?

[wy zw]

1. What are QC and QA
QC: quality control, quality control, product quality inspection, analysis and improvement after quality problems are found, and the general name of relevant personnel for nonconforming product control. Generally include:
IQC (incoming quality control) refers to the quality control of incoming materials, which is referred to as incoming material control for short.
IPQC (in put process quality control) in Chinese means process control, which refers to the quality control of the final packaging process of the product from the input of materials into the production channel.
FQC (finish or final quality control) finished product quality inspection
OQC (out quality control) finished product delivery inspection
DQC (design quality control)
MQC (manufacturing quality control) process quality inspection
QA: quality assurance, through the establishment and maintenance of 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 SQE.
SQE (Supplier Quality Engineer) supplier quality engineer.

2. Main differences between QC and QA
QA should not only know where the problems are, but also know how to formulate solutions to these problems and how to prevent them in the future. QC should know that if there is only a problem, it should be controlled, but it is not necessary to know why it should be controlled in this way.
– QC mainly focuses on the quality inspection activities after the event. The default error is allowed. It is expected to find and select the error. QA is mainly a quality assurance activity in advance, focusing on prevention, hoping to reduce the probability 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 eliminate the defective products after inspection, and then feed back the defective information to relevant departments for improvement measures. Therefore, the control scope of QC is mainly within the factory. Its purpose is to prevent the input, sequence transfer and delivery of unqualified products, and ensure that the products meet the quality requirements and only qualified products can be delivered to customers.
– QA is to provide trust to meet the customer’s requirements, even if the customer is sure that the products you provide can meet his requirements, so it is necessary to leave evidence from the review of customer requirements, product development, order receiving and material procurement, incoming inspection, production process control and delivery, after-sales service and other stages from the beginning of market research to prove that each step of the factory activities are carried out according to the customer’s requirements.
– The purpose of QA is not to ensure product quality, which is the task of QC. QA is mainly to provide assurance, so it is necessary to manage the whole process from understanding customer requirements to after-sales service, which requires enterprises to establish a quality control system, formulate corresponding documents, standardize the activities of each process, and leave evidence of activity implementation, so as to provide trust. This kind of trust can be divided into internal and external: external, even if customers are assured that the factory produces and delivers products according to their requirements; The internal is to reassure the factory boss, because the boss is the first person responsible for product quality, and he should be fully responsible for product quality accidents. This is also the main requirement for countries to formulate product quality laws, so as to urge enterprises to really pay attention to quality. Therefore, in order to avoid assuming quality responsibility, 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 one by one. Therefore, QA is required to audit instead of him to understand whether the document requirements are complied with, so as to make the boss believe that all activities of the factory are carried out according to the document requirements and reassure him.

Therefore, the main difference between QC and QA is that the former is to ensure that the product quality meets the regulations, while 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 point: that is, QC and QA should verify. For example, QC testing products according to standards is to verify whether the products meet the specified requirements, QA internal audit is to verify whether the system operation meets the standard requirements, and QA shipping audit and reliability testing is to verify whether the products have carried out various activities according to the regulations and whether they can meet the specified requirements, To ensure that the products delivered by the factory are qualified and comply with relevant regulations.

The most important responsibility of QC is to monitor the finished products (mainly including raw material, in-process goods, finish goods, in-process audit), focusing on detecting defect through sample inspection.

3. Differences between IPQC and IQC
QC can be divided into IPQC and IQC,
IPQC: in process quality control
IQC: in come quality control

Its responsibilities are as follows:
IPQC responsibilities:
1. Inspect the products in the production process and make records
2. Fill in the inspection report according to the inspection records
3. Put forward improvement countermeasures 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 of testing equipment
4. Report of abnormal raw materials
5. Identification of raw materials
6. Be responsible for signing and receiving the inspection report of the warehouse material clerk
7. For the material quality problems complained by the production line, be responsible for rechecking the materials stored in the warehouse

QA is quality supervision/monitoring
1. Be responsible for the overall work of the Department, organize the implementation of GMP related quality management regulations, and timely put forward opinions and improvement suggestions on product quality to enterprise leaders.
2. Ensure that the products of the enterprise are produced under the requirements of GMP.
3. Be responsible for supervising the implementation, correction and prevention of quality related people and things in the whole enterprise.
4. The instructions conducive to production configuration shall be reviewed and approved after being reviewed and signed by the designated personnel of the Department.
5. Review and approve the inspection results.
6. Review the pilot plan and conclusion of new product development and process improvement.
7. Review the relevant technical and quality written materials submitted to the drug regulatory department.
8. Review the batch records and make a conclusion whether the finished products leave the factory.
9. Be responsible for organizing the formulation of quality standards and other documents for raw and auxiliary materials and packaging materials.
10. Review the handling procedures of nonconforming products.
11. Due to the needs of quality management, organize the preparation of new technical standards or discuss and revise technical standards with relevant departments.
12. Review the production process procedures, batch production records and batch packaging records of each product, and determine the distribution of finished products.
13. Handle the product quality problems complained by users, assign personnel or visit users in person. Hold internal meetings, work with relevant departments to study and improve quality problems, and report the complaints and handling results to the person in charge of the enterprise in writing.
14. Regularly (at least once a year) conduct a comprehensive GMP inspection on the enterprise together with the chief engineer’s office and the production department, and timely report the inspection to the person in charge of the enterprise.

Surveying library is the first professional third party quality service platform of Internet plus testing, providing third party inspection, inspection and clearance. The cost performance of warehouse inspection is high, the order arrangement is fast, and the report is issued on the same day. It also has lbs real-time positioning system to realize accurate service matching; One click online video function to view the inspection site.

[Author]

Posts