1, the most basic document to guide the process quality and provide guidance for the development of pure technical quality activities.

2. Supporting documents of quality system program documents.

Work instruction refers to the procedure established to ensure the quality of working procedure. "Technology" can be understood as a set of related specific operation activities (such as plastering, bricklaying, plug-in, debugging, assembly, and completing a certain training).

Work instruction is also a program, but its object is specific work activities, while the object described in the program file is systematic quality activities. Work instructions are sometimes called work instructions or operating specifications, operating procedures, work instructions, etc.

Extended data:

Operation guidance management:

After the production of 1.SOP is completed, it must be confirmed by the quality assurance department and then by the biotechnology supervisor. (except the producer, the signature part cannot be printed by computer).

2. Each model of SOP should have a version list, indicating the latest SOP version of each workstation at that time.

3. There must be a change record of the SOP of this model, including all change lists of all SOPs of this model.

4. The SOP issued by the manufacturing unit needs to use "A3" paper, and the quality assurance unit needs to use "A4" paper, both of which must be signed.

5. All SOPs must be printed and saved, and electronic documents must be backed up.

Baidu Encyclopedia-Work Instruction