Documented procedure

Documented procedure
See also

Documented procedure - a documented established way of carrying out an activity or performing a specific work (process). An ordered set of interrelated certain relations of actions aimed at solving the problem, the procedure established by the method of implementation of the activity or process.

Role of the documented procedure

The documentary procedure is responsible for:

  • scope of application;
  • purpose, objectives and results (outputs) of the process, activity or work described;
  • in what sequence should be done the procedure;
  • powers that bear responsibility participating in the process, activities or work;
  • documents, resources, materials and equipment are used in the process;
  • indicators and characteristics, which assess the quality and effectiveness of the work at all its stages, how and by whom they are measured and monitored;
  • image of documentation and registration of work performed;
  • the results of the work (process).

The format of the documented procedures (paper copy or electronic media) can be determined on the basis of the recommendations given in the document. As a means of describing the process can be used text, flowcharts, tables, a combination of them, or any other suitable means according to the needs of the enterprise. Documented procedures should contain the necessary information and be identified,they can contain links to Instructions that determine the order of work, regulations and records that are used or created in the implementation of the documented procedure. Documented procedures generally describe actions that cover a variety of functions.

Structure of the documented procedure

Based on the General requirements for a documented procedure, its contents should include the following sections: Title page - contains the approver's signature and a matching signature with the indication of the officials, their names and initials and dates the approval. The list of matching signatures, which is usually a table in the footer, depends on the specific purpose of the documented procedure. The content of the documented procedure describes:

1) Purpose and scope of the procedure. The purpose of documented procedure and its scope is defined. The processes and officials involved in the procedure are indicated.

2) Description of procedure. General provisions on the procedure of documented procedure and other provisions characterizing features of the process described in documented procedure. The description of the documented procedure may vary depending on the complexity of the activities, the methods used and the level of experience and training required for the production. In the section «Description of procedure» should be defined:

  • requirements necessary for the implementation of documented procedure;
  • indicators and characteristics of the quality of the documented process and its results, methods of measurement and monitoring, decision-making mechanisms based on the results of the analysis;
  • recordings made in the framework of the documented procedure.

The forms that you want to use for these records must be identified. The methods required completing, registering, and store records must be established.

3) Responsibility. It describes the distribution of work, responsibility and authority of employees and their organizational functions, as well as their relationship with the processes and actions described in the procedure should be identified.

4) Normative document. References to all normative documents of both external and internal origin which concern or are used at implementation of this documented procedure are given.

5) Addition. Additions can include tables, charts, and forms that contain information that supports a documented procedure.

6) Registration of changes. Contains information on the changes made in the document with indication of their numbers, dates of introduction and administrative documents, sections or sheets of the documented procedure to which changes belong.

The procedure of development and approval of documented procedure

The procedure for the development and approval of standards of the organization provides for the creation of conditions for participation in the discussion of draft standards of employees of interested structural units of the organization. In the development of standards for products supplied to the domestic and (or) foreign market, the work performed by the organization on the side, or on the services provided by it on the side-representatives of other organizations, customers and (or) purchasers of the supplied products, works and services. The standard should indicate the objects of standardization within the organization.

Development of a documented procedure

The development of normative documents begins with the definition of the requirements for the document, exhibited by the customer (consumer), the study and analysis. The documented procedure must include the scope, normative references, terms and definitions, description of the documented procedure, responsibility of personnel, the application sheet for registration of changes. Development of the design of the documented procedure is aimed at establishing the order of work with nonconforming products, ensuring its detection, identification, isolation, elimination and prevention, and is developed in accordance with the requirements. The purpose of this documented procedure is to analyze and prevent unintentional receipt by the consumer of products that do not meet the requirements established by regulatory documents and exclude subsequent costs associated with the completion of defective products.


Author: Anna Korovytska