What does SOP, GMP, ECR/ECN mean?

The so-called SOP is the capital of the first letter in the three words of standard operation procedure, that is, the standard operating procedure, that is, to describe the standard operation steps and requirements of an event in a unified format, used to guide and standardize daily work. the essence of SOP is to quantify the details. In more general terms, SOP is to refine and quantify the key control points in a program.
In more general terms, SOP is to refine and quantify the key control points in a program. From the above basic definitions of SOP, sop has the following internal characteristics:
SOP is a program. SOP is a description of a process rather than a result. at the same time, SOP is neither a system nor a form. It is a process in which the control points in a program under the process are standardized.
SOP is a job program. SOP is a kind of operation-Layer Program, which is real and operable, not at the conceptual level. in combination with the ISO9000 system standards, SOP is a third-level file, that is, a job file.
SOP is a standard operating procedure. the so-called standard has the concept of optimization here, that is, not any written operating program can be called sop, but it must be the most optimized operating program design that can be achieved under the current conditions after continuous practice. the so-called standard is to refine, quantify, optimize, and refine the relevant operation steps as much as possible, the degree of quantification and optimization is that under normal conditions, everyone can understand and will not produce ambiguity.
Sop standardized operating procedures SOP is not a single system. although we can define each SOP separately, from the perspective of enterprise management, the SOP cannot be a single one, but it must be a whole and a system and an indispensable part of the enterprise. in his lecture, Yu Shiwei also mentioned that a company must have two books, one of which is a Redbook, and the other is the company's strategy, that is, the operational guidelines. The other is the blue book, that is, sop, standard operating procedures, and the standard operating procedures must be refined and quantified.

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"GMP" is the abbreviation of "Good Manufacturing Practice", which means "good operation standards" or "excellent manufacturing standards" in Chinese ", it is an autonomous management system that pays special attention to implementing product quality and health and safety in the production process. It is a set of mandatory standards applicable to pharmaceutical, food and other industries, enterprises are required to comply with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, and quality control to meet the hygiene quality requirements, the formation of a set of operational specifications to help enterprises improve the company's health environment, and promptly discover and improve problems existing in the production process. In short, GMP requires food production enterprises to have good production equipment, reasonable production processes, perfect quality management and strict inspection systems, ensure that the final product quality (including food safety and hygiene) complies with regulatory requirements.

ECR: The change request is used to describe in detail the changes and their impact required to solve product problems or improve product quality, and to authorize changes. The change request indicates that the formal change process has started. One change request can solve the problems described in multiple problem reports.

ECN: after the change request is approved, the requester or other designers of the change request will receive a task of "Creating ECN". Based on this task, the designer can create and change ECN.

Engineering change is one of the important control items for enterprise activities. According to the implementation time and purpose, the control details are as follows: generally, engineering changes used in the process of new product development are issued after the Engineering Department confirms the changes and notifies the relevant units. Engineering Change order (engineering change order) Engineering Change command: usually used for engineering changes after the completion of new product development. After the Engineering Department confirms the necessary changes, it issues a document to the relevant organization for signing, in order to ensure that the inventory and In-process items are properly handled, the items are changed immediately and after use. The sales unit, manufacturing unit, and material unit must agree and take necessary actions, generally, ECOs involve a large scope and long import time, which requires rigorous system management. ECR (Engineering Change Request) Engineering Change Application: Usually after the completion of a new product, the non-engineering unit issues a project change application as needed and submits the application to the engineering unit for research, if the engineering unit agrees, an ECO will be issued, and each unit will sign and agree to import the eco-product. ECA (Engineering Change authority) engineering change authorization: in some cases, engineering changes must be authorized by the customer. In this case, the ECA must be issued and the customer needs to sign back as the basis for the ECO.