The difference between QC, QA, IPQC and IQC

The difference between QC, QA, IPQC and IQC

1 Introduction

Quality management work can usually be divided into two stages: quality control (QC) and quality assurance (QA). In some small and medium-sized manufacturing enterprises, quality control personnel often hold two positions and do QA and QC work at the same time. Therefore, some quality control personnel cannot fully distinguish the respective responsibilities of QA and QC. Today we will talk about their respective difference.

2. Concept classification

QA---Quality assurance, quality assurance, which is defined as "all planned and systematic activities implemented in the quality management system and verified as needed in order to provide sufficient confidence that the entity can meet quality requirements."General include:

DQA: Design Quality Assurance

PQE: Process Quality Engineer

QE: Quality Engineer

SQE: Supplier Quality Engineer.

QEH: Home of Quality Engineers

JQE: 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.

QC---Quality control, quality control, is defined as "the operation technology and activities adopted to meet the quality requirements, product quality inspection, analysis, improvement and non-conforming product control related personnel after the quality problem is found." Generally include:

QC: quality control

IQC: Incoming Quality Control

FQC: Finished product quality inspection

OQC: finished product factory inspection

DQC: Design Quality Control

MQC: process quality inspection

IPQC: process control, refers to the quality control of the product from the material into production to the final packaging process of the product.

By definition, QA focuses on the establishment, maintenance and improvement of the entire quality management system. QC is mainly product quality inspection, and also includes the control of product-related people, environment, and equipment.

3. Responsibilities of QA and QC

Responsibilities of QA:

01

Responsible for the overall work of the department, organize the implementation of GMP related quality management regulations, and timely put forward product quality opinions and improvement suggestions to the enterprise leaders;

02

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

03

Responsible for supervising, implementing, correcting and preventing quality-related personnel and events throughout the enterprise;

04

Review and approve the instructions that are beneficial to production configuration after being reviewed and signed by the designated personnel of the department;

05

?Review and approve the test results;

06

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

07

Review and report relevant technical and quality written materials to the drug supervision and management department;

08

Approval of batch records, giving the conclusion of whether the finished product leaves the factory;

09

Responsible for organizing the formulation of quality standards for raw and auxiliary materials and packaging materials

standards and other documents;

10

Review the procedures for handling non-conforming products;

11

Due to the needs of quality management, organize the preparation of new technical standards or discuss the revision of technical standards 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

Handle product quality issues complained by users, assign personnel or return to users in person. Hold internal meetings, 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 Engineer's Office and the Production Department, and report the inspection situation to the person in charge of the enterprise in a timely manner.

QC Responsibilities:

01

Participate in various inspections of the entire production process (including raw materials, on-site, and finished products);

02

Monitor the specific implementation of the on-site inspection work of the project, including personnel organization, technical implementation, quality, progress, safety, product protection, etc.;

03

Timely report batch quality problems and timely transfer of unqualified information;

04

In order to correct quality problems, the right to stop production on site;

05

?Management of inspection tools, maintenance of lists.

IPQC Responsibilities:

01

First sample inspection;

02

Self-inspection, mutual inspection and patrol inspection;

03

Formulation of limit samples;

04

Handling of non-conforming products;

05

?Deal with the quality problems of the production line in time;

06

Quality control of the rework production process;

07

Applicability and online tracking of work instructions;

?IQC Responsibilities:

01

Strictly inspect raw materials according to inspection standards;

02

Fill in the inspection record form truthfully;

03

Maintenance and maintenance of testing equipment;

04

Reporting of abnormal raw materials;

05

?Identification of raw materials;

06

Responsible for the receipt of the inspection report of the material clerk in the warehouse;

07

For material quality problems complained by the production line, be responsible for re-checking the materials in the warehouse.

4. The difference between QC, QA, IPQC and IQC

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

QC:

QC is mainly a post-event quality inspection activity. Default errors are allowed, and errors are expected to be found and selected. QA is mainly a quality assurance activity in advance, focusing on prevention, and expecting to reduce the probability of errors.

The control scope of QC is mainly within the factory, and its purpose is to prevent unqualified products from being input, transferred, and shipped, to ensure that products meet quality requirements and only qualified products can be delivered to customers.

QA:

QA is to provide trust to meet customer requirements, even if the customer is sure that the products you provide can meet his requirements, so it needs to start from market research and then review customer requirements, product development, order receiving and material procurement, incoming inspection, production process Evidence is left at each stage of control, shipment, and after-sales service to prove that every step of the factory is carried out according to customer requirements.

IPQC:

IPQC is manufacturing process quality control. Process roving inspection, during the product manufacturing process, regularly inspect and confirm process parameters, job changes, and standards used in the process of product manufacturing, and record the inspection status, and carry out necessary control and supervision.

IQC:

IQC is mainly to control raw materials, including quality inspection of incoming materials, handling of bad raw materials, etc. The more advanced concept also includes supplier quality system management, which moves the quality control of important raw materials to suppliers.

Summarize:

Therefore, the main difference between QC and QA is: the former is to ensure that the product quality meets the regulations, and the latter is to establish a system and ensure that the system operates as required to provide internal and external trust. QA must not only 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 the problem, but not necessarily why it should be controlled in this way. The purpose of QA is not to ensure product quality, which is the task of QC. IPQC and IQC belong to the branches of QC, one is the quality control of the manufacturing process, and the other is the inspection of incoming materials.

At the same time, QC and QA have the same point: that is, both QC and QA must be verified. For example, QC tests products according to standards to verify whether the products meet the specified requirements, and QA conducts internal audits to verify whether the operation of the system meets the standard requirements. Cargo 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, so as to ensure that the products delivered by the factory are qualified and comply with relevant regulations.

5. The relationship between QC, QA, IPQC and IQC

QC is the most basic part of quality control, including all inspection work. While QA includes QC, its core is still in quality control. However, it goes beyond detection and includes related tasks like training, document management and auditing. Quality management is a broader scope, which includes not only QA and QC, but also the thinking and management of quality system.

When manufacturers sell products, they often claim how good the quality is, so it is their responsibility to ensure that the quality of the product is really as good as he says. Therefore, QC is needed to test the quality of products in each production link.

However, only QC inspection is far from enough, someone must control all the links related to the production of the product from an overall perspective. These links include the quality of raw and auxiliary materials, the quality of factory operation, the quality of equipment and equipment, the quality of production and inspection, etc. If any link is missing, the quality of the product cannot be guaranteed.

Therefore, the establishment of QA and QC is to satisfy customers and play a "win-win" role for enterprises and consumers.

Both QA and QC are an integral part of the quality management system. Establishing a good quality management system is crucial to an enterprise. The quality of the QA and QC system does not entirely depend on the complexity of the system, nor does it mean that the stricter the system, the better. For different companies, specific problems must be analyzed in detail.