Processes

A Quality Management System serves as a repository. The quality of the repository is only as good as the people that populate it. The old phrase "GIMGO - Garbage In, More Garbage Out" applies aptly.

A QMS should possess the following characteristics, in a traceable and evidentiary manner:

• It expresses the objectives, values and mission of the organisation
• It reflects the character of the organisation
• It encapsulates the best practices of the organisation
• It identifies the standards expected by customers of the organisation
• It provides a framework for managing change and evolution over time
• It reflects the actual work flow and scope of the organisation
• It defines the roles and responsibilities of all those that work in the organisation
• It shows customers how serious the organisation is about doing business
• It shows staff how serious the organisation is about quality and its achievement
• It provides a framework for training new members to the organisation

When designing a QMS, the process framework needs to be mapped out. The map is usually made up from primary processes, secondary processes and supporting processes. The top level process should be the commercial entity or company. This is important as a company possesses all of the characteristics of a process, so each characteristic can map to one or more internal processes. Taking a Systems Engineering approach to QMS Design, for instance, can lead to a more complete QMS framework that closely supports the business, and facilitates better change management across the business when it embarks into new product lines and market territories.

Many standards focus on specific areas, but all processes should possess a common set of characteristics that demonstrate compliance to their respective standards.

The characteristics encapsulate the range of common themes that need to be identified in each process no matter its level or scope in the business. The most common characteristics are:

• Process inputs

• Process outputs

• Transformation rules

• Customers (consumers of process outputs)

• Suppliers (producers of process inputs)

• Overseers (monitors of process quality and compliance)

• Managers (directors of process tasks and activities, schedulers)

• Infrastructure

  • Tools

  • Facilities (physical spaces, utility services)

  • People

  • Training

  • Standards

• Resources (performers of tasks and activities, enabling the transformation of input into output)

• Process Measures (metrics showing process performance)

• Process Controls (methods for controlling process performance)

• Process Map