21.5 Quality System, Including Process Management

In this section, quality system refers to the collection of process descriptions used throughout a company. Process descriptions are descriptions of procedures or ways of working, methods, conventions, and templates for what is being done. In this context, what is being made are products with more or less software included. Typically, an independent organization unit, such as a quality management function or methods department, carries the responsibility for managing the company's quality system (processes).

Configuration Management Considerations

The contents of a quality systemall the process descriptionsshould be placed under configuration management. The requirements in ISO 9000 include control of changes to the quality systemconfiguration management of the quality system is required. It may be important to know the history of the quality system, not least the reasons for decisions on the presentation of procedures and templates.

In some cases (e.g., for safety-critical systems), process descriptions used during the production of a product may have to be placed under configuration management with the rest of the items for and in the product. If so, the interface between the general configuration management for the process descriptions and the specific one connected to such a project must be clearly defined. This resembles internal component development.

Responsibility

The entity responsible for configuration management of the quality system must be clearly defined. Typically it will be the unit carrying general responsibility for processes performing this part of process management activities.

Identification

The principles for identification of documents apply to items in the quality system. Since these objects are to be used company-wide and may be included in deliveries for a specific project, their unique identification must be selected to avoid conflicts.

Storage

The quality system should be stored in it own isolated configuration management library. Release for usage may be the quality system in hard copy or accessible via an intranet or some other way. Electronic access should not allow uncontrolled changes to the contents.

Change Control

A quality system requires fast reaction to event registrations by users (employees). Employees should have an easy way to create event registrations for the quality system, and the configuration control board should provide an answer within a few hours. This does not have to be in the form of an implemented change but should at least provide information about the expected life of the event. All involved should receive frequent information during the life cycle of an event registration, and users of the quality system should be informed when changes are implemented. This should be presented in a manner that can not be easily overlooked, such as via an e-mail or verbally at an information meeting.

Status Reporting

The visibility and the accessibility of the quality system are important factors in its success. Status reports for the quality system must be available to all users of the process descriptions. It might be made possible for employees to search directly in metadata.



Configuration Management Principles and Practice
Configuration Management Principles and Practice
ISBN: 0321117662
EAN: 2147483647
Year: 2002
Pages: 181

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