What are QC, IQC, IPQC, and QA often mentioned in factories? Do you know them?
QC , IQC , IPQC , QA , what are the differences?
I can't tell them apart anymore.
Come, hand over your IQ card first~~~
Now let me help you understand these Q~
1. QC and QA
QC: Quality Control, quality control, product quality inspection, analysis, improvement and defective product control after quality problems are discovered.
Generally include:
IQC (Incoming Quality Control) means the quality control of incoming materials, or simply incoming material control.
IPQC (In Put Process Quality Control) means process control in Chinese, which refers to the quality control of the product from the time the materials are put into production to the final packaging of the product.
FQC (Finish or Final Quality Control) Finished product quality inspection
OQC (Out Quality Control) Finished product inspection
DQC (Design Quality Control) Design Quality Control
MQC (Manufacture Quality Control) process inspection
QA: Quality Assurance, quality assurance, ensure that there are no problems with product quality by establishing and maintaining a quality management system.
Generally include:
IDQA (Design Quality Assurance) Design Quality Assurance, such as DQA Manager (Design Quality Certification Manager)
QE(Quality Engineer)
JQE (Joint Quality Engineer) is a client quality engineer, that is, a quality engineer hired by the supplier to work for the customer. He is the eyes and ears of the customer's SQE.
SQE (Supplier Quality Engineer) Supplier Quality Engineer.
2. The difference between QA and QC
QA not only needs to know where the problems are, but also how to develop solutions to these problems and how to prevent them in the future; QC needs to know that it is only necessary to control them if there are problems, but it does not necessarily need to know why they should be controlled in this way.
[ To make an inappropriate analogy ] QC is the police, QA is the judge. QC only needs to arrest those who violate the law, but cannot prevent others from committing crimes or convict them. Judges, on the other hand, make laws to prevent crimes and pronounce sentences and disposal results based on the law.
To summarize:
QC is mainly a post-event quality inspection activity, which assumes that errors are allowed and hopes to find and select errors. QA is mainly a pre-event quality assurance activity, which focuses on prevention and hopes to reduce the probability of errors.
QC is the operation technology and activities adopted to ensure that products meet quality requirements. It includes inspection, correction and feedback. For example, QC will remove defective products after inspection and then feedback the defective information to the relevant departments to take improvement measures. Therefore, the control scope of QC is mainly within the factory, and its purpose is to prevent defective products from being put into, transferred to other parts, and leaving the factory, to ensure that products meet quality requirements and only qualified products can be delivered to customers.
QA is to provide trust in meeting customer requirements. Even if the customer is convinced that the product you provide can meet his requirements, it is necessary to leave evidence at each stage starting from market research and subsequent review of customer requirements, product development, order taking and material procurement, incoming material inspection, production process control and shipment, after-sales service, etc. to prove 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; ensuring product quality is the task of QC.
QA is mainly to provide assurance, so 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 standardize the activities of each process and leave evidence of the implementation of the activities in order to provide trust.
This trust can be divided into two types : external, that is, customers can rest assured that the factory produces and delivers products according to their requirements; internal, it can reassure the factory owner, because the boss is the first person responsible for product quality, and he must bear full responsibility for product quality accidents. This is also the main requirement for countries to formulate product quality laws to encourage companies to truly 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 staff of the factory are operating according to the document requirements. This requires QA to conduct audits on his behalf to understand whether the document requirements are followed, so as to make the boss believe that the various activities of the factory are carried out in accordance with the document regulations and reassure him.
Therefore, the main difference between QC and QA is that the former ensures that product quality meets regulations, while the latter establishes a system and ensures that the system operates as required to provide internal and external trust.
At the same time, QC and QA have something in common: both QC and QA need to conduct verification. For example, QC tests products according to standards to verify whether the products meet the specified requirements. QA conducts internal audits to verify whether the operation of the system meets the standard requirements. For example, QA conducts shipment audits and reliability tests to verify whether the products have carried out various activities in accordance with regulations and whether they 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 is to monitor finished products (mainly including: Raw material, in-process goods, finish goods, In-process audit), focusing on detecting defects through Sample Inspection.
3. 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 products during production and keep records
2. Fill in the inspection report according to the inspection records
3. Propose improvement measures for problems found during inspection
IQC Responsibilities:
1. Strictly inspect raw materials according to inspection standards
2. Fill in the inspection record form truthfully
3. Maintenance and care of testing equipment
4. Reporting of abnormal raw materials
5. Identification of raw materials
6. Responsible for signing for the warehouse material clerk's inspection report
7. For material quality issues complained by the production line, we are responsible for re-inspecting the materials in the warehouse
QA is quality supervision/monitoring
1. Responsible for the overall work of the department, organize and implement GMP regulations on quality management, and provide opinions and improvement suggestions on product quality to company leaders in a timely manner.
2. Ensure that the company's products are produced in compliance with GMP requirements.
3. Responsible for supervising, implementing, correcting and preventing all people and matters related to quality in the entire enterprise.
4. Instructions that are beneficial to production configuration will be reviewed and approved after being reviewed and signed by designated personnel of this department.
5. Review and approve the inspection results.
6. Review the pilot plans and conclusions for new product development and process improvement.
7. Review and submit relevant technical and quality written materials to the drug supervision and administration department.
8. Review batch records and make a conclusion on whether the finished product is ready to leave the factory.
9. Responsible for organizing the formulation of quality standards and other documents for raw materials, auxiliary materials and packaging materials.
10. Review the procedures for handling non-conforming products.
11. Due to quality management needs, organize the preparation of new technical standards or discuss the revision of technical standards in conjunction with relevant departments.
12. Review the production process procedures, batch production records and batch packaging records of each product, and decide on the release of finished products.
13. To handle product quality issues complained by users, assign personnel or personally visit users. Hold internal meetings, work with relevant departments to study and improve quality issues, and report the complaints and handling results in writing to the person in charge of the company.
14. Regularly (at least once a year) conduct comprehensive GMP inspections of the enterprise together with the General Engineering Office and the Production Department, and report the inspection results to the person in charge of the enterprise in a timely manner.
summary:
Let’s review it again, don’t get it confused!
QC (Quality Control) : Quality control, product quality inspection, the general term for personnel involved in analysis, improvement and control of defective products after quality problems are discovered.
IQC (Incoming Quality Control) : It means the quality control of incoming materials, or simply incoming material control.
IPQC (In Put Process Quality Control) : It means process control in Chinese, which refers to the quality control of the product from the time the materials are put into production to the final packaging of the product.
QA (Quality Assurance) : Quality assurance, ensuring there are no problems with product quality by establishing and maintaining a quality management system.
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