QC Quality Control, quality control, product quality inspection, analysis and improvement after quality problems are discovered, and the general term for the personnel involved in the control of non-conforming products. Generally include:
IQC (Incoming Quality Control, incoming material inspection)
IPQC (In-Process Quality Control, process inspection)
FQC (Final Quality Control, finished product inspection)
OQC (Out-Going Quality Control, shipping inspection)
QC focuses on products, not systems (systems). This is the main difference between it and QA. The purpose is the same as that of QA, both of which are "to meet or exceed customer requirements."
QA Quality Assurance, quality assurance, ensures that there are no problems with product quality by establishing and maintaining a quality management system.
Generally include system engineers, SQE (Supplier Quality Engineer: supplier quality engineer), CTS (customer technical service personnel), 6sigma engineers, calibration and management of measuring instruments, etc.
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 how to control just when there are problems, but does not necessarily know why they need to be controlled in this way.
To use an inappropriate analogy, QC is a policeman and QA is a judge. QC only needs to arrest those who violate the law, but it cannot prevent others from committing crimes and convict others. Judges make laws to prevent crimes and pronounce sentences according to the law. Disposal results.
To summarize, QC: Mainly focuses on post-event quality inspection activities. By default, errors are allowed, and errors are expected to be discovered and selected. QA is mainly a prior quality assurance activity that focuses on prevention and hopes to reduce the probability of errors.
02
QC is the operating technology and activities taken to make products meet quality requirements. It includes inspection, correction and feedback. For example, QC will remove defective products after inspecting them, and then feed back the bad information to relevant departments to take improvement measures.
Therefore, the control scope of QC is mainly within the factory. Its purpose is to prevent unqualified products from being input, transferred, and shipped out of the factory, ensuring that products meet quality requirements and that 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 needs to start from market research and review customer requirements, product development, order taking and material procurement, incoming material inspection, and production process. Evidence is left at each stage of control, shipment, and after-sales service to prove that every step of the factory's activities is carried out according to customer requirements.
The purpose of QA is not to ensure product quality. Ensuring product quality is the task of QC.
QA mainly provides assurance, so it needs to manage the entire process from understanding customer requirements to after-sales service. This requires the company 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 kind of trust can be divided into two types: internal and external: the external one is to reassure customers that the factory will produce and deliver products according to their requirements; the internal one is to reassure the factory owner.
Because the boss is the first person responsible for product quality, 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 taking quality responsibility, the boss must Documents regulate activities and leave evidence.
However, it is impossible for the boss to know one by one whether the internal personnel of the factory are operating in accordance with the document requirements. This requires QA to conduct audits on his behalf to understand whether the document requirements are complied with, so as to convince the boss that all activities in the factory are carried out in accordance with the document provisions. Reassure him.
Therefore, the main difference between QC and QA is: the former is to ensure that product quality meets 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 thing: both QC and QA need to be verified. For example, QC testing products according to standards is to verify whether the products meet the specified requirements. QA's internal audit is to verify whether the system operation meets the standard requirements. Another example is QA's production Cargo audit and reliability testing are to verify whether the products have carried out various activities according to regulations and whether they can meet the prescribed requirements to ensure that the products delivered by the factory are qualified and comply with relevant regulations.
03
The most important responsibility of QC is the monitoring of finished products (mainly including Raw Material, In-Process Goods, Finish Goods, In-Process Audit), focusing on Detecting Defect through Sample Inspection.
QC is divided into IPQC and IQC.
IPQC: IN PROCESS QUALITY CONTROL process quality control
IQC: IN COME QUALITY CONTROL Incoming material quality control
Its responsibilities are as follows:
IPQC Responsibilities:
1 . Inspect products during production and keep records
2 . Fill out the inspection report based on the inspection records
3. Propose improvement measures for problems discovered during inspections
IQC Responsibilities:
1 . Inspect raw materials strictly according to inspection standards
2 . Fill in the inspection record form truthfully
3. Maintenance and maintenance of testing equipment
4． Reporting of abnormal raw materials
5． Identification of raw materials
6. Responsible for signing and receiving inspection reports from warehouse material clerks
7． For material quality issues complained about on the production line, be responsible for re-inspecting the materials stored in the warehouse.
QA is quality supervision/monitoring
1. Responsible for the overall work of this department, organize the implementation of GMP-related quality management regulations, 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 supervision, implementation, correction and prevention of quality-related people and things throughout the enterprise.
4. Instructions that are beneficial to production configuration will be reviewed and approved after being reviewed and signed by the designated personnel of this department.
5. Review and approve the inspection results.
6. Review pilot plans and conclusions for new product development and process improvement.
7. Review relevant technical and quality written materials submitted to the drug regulatory department.
8. Review and approve approval records and make a conclusion whether the finished product leaves the factory.
9. Responsible for organizing the formulation of quality standards and other documents for raw materials, auxiliary materials, packaging materials.
10. Review the procedures for handling nonconforming 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. Handle product quality issues complained by users, and assign personnel or personally visit users. Convene internal meetings to study and improve quality issues with relevant departments, and report complaints and handling results to the person in charge in writing.
14. Regularly (at least once a year) conduct comprehensive GMP inspections of the enterprise with the General Engineering Office and Production Department, and report the inspection results to the person in charge of the enterprise in a timely manner.