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Procedure for Development and Maintenance of the Management System

Procedure
MSP 4-2-3.1
Page 2 of 5
Issue Date: 4/8/07
Revision Date:N/A
Title: Development and Change Control of the Management System Documentation

4.0 Procedure

4.2 Management System Structure
The Policies of Foqus, Inc. are established by the management team and documented in the top level document Management System Manual. The next level of the MS are the MS Procedures (and related Work Instructions, etc.), which define how the policies are implemented. Third level consists of Departmental Procedures and related documentation.

Level 1: Management System Manual
Level 2: Management System Procedures
Level 2a: Management System Work Instructions, Forms and Templates
Level 2b: Management System Records

Level 3: Departmental Procedures

Level 3a: Departmental Work Instructions, Forms and Templates
Level 3b: Departmental Records

The documentation at Level 2 must meet the policies defined in Level 1. Documents in Level 3 must meet the policies defined in Levels 1 and 2. All documents must refer to position titles, no names, since titles are linked to names in our organization manual. This will reduce the need for change in documentation when personnel changes take place.

4.3 Management System Access

All system documents Level 1 and 2 are accessible electronically to all employees. The departmental procedures are accessible to all management personnel and employees as needed. Employees within each department have access to all documentation that is needed by them to perform their responsibilities.

The Management System is continually changing. MSP-DB-001 Document Matrix defines the responsibility and authority for approval, changes and implementation of each document. Changes to the documented system are communicated to all employees that may be affected by these changes. Training may be required in some cases and it will be completed prior to the issuance of a new or modified document. Printed copies can be used, as long as the user verifies that they are current prior to use. Our goal is to establish a paperless system, therefore an attempt needs to be made by all employees to limit printed copies.

4.4 Components of the Management System

Management System Manual (MSM)

A Policy Manual that directs corporate policy throughout the Management System. The manual is built around our mission and goals and objectives and drives the continual improvement efforts at Foqus, Inc.

Management System Procedures (MSP)

Procedures that define the process for implementation of the policies, goals and objectives. All employees are required to be familiar with these procedures and implement as applicable to their position.

Management System Work Instructions (MWI)

Work instructions that support MS Procedures. They define how individual tasks are to be completed.

Departmental Documentation

Procedures and work instructions that describe processes within each department.

Forms Forms are unique type of documents since they fall under two control systems. A blank for is purely governed by a document control procedure. Once a form is filled out it becomes a record and follows record control requirements. Printed forms are used only for the purpose of testing a new process. Once test is completed all forms are converted to electronic format. This will help us achieve paperless system and drive our effort to collect data not just information.
Templates Templates are another form of work instructions. Templates are used to assist in creation of new documents.
Databases These can be a combination of instructions and procedures as well as data collection and process control devices. They are controlled as documents, records and as software. Any changes are communicated to the users and any training that is needed, is performed prior to new version release.
Flow Sheets These documents are used to assist in process and improvement analysis as well as a training tool. Process Flow sheets are updated when changes affect the flow sheet or new documents are implemented.


Controlled Document. Refer to electronic copy. Printed copy is valid 4/8/7 unless revision verified by user.

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