Background

An operations manual describes policies, processes, workflows, engineering data etc that in turn define an organization’s best practices and ensure compliance with laws, regulations and standards as applicable for the particular organization. An organization developing medical devices for the US market for instance needs to have an operations manual that complies with FDA’s medical device Quality System Regulation. Other companies are required to keep their operations manuals compliant with the ISO 9001 quality management system standard.

I use “operations manual” as a synonym for “quality management system manual”. I prefer the former term even though e.g. FDA uses the latter. The reason is that the word “quality” is sometimes a too narrow delimiter for what the manual shall cover. An operations manual shall not only ensure quality but also parameters such as time to market and productivity. An other way out of this terminology problem would be to give the word “quality” a very wide definition but that is not immediately accepted by everybody either. So “operations manual” it is for now! (Whatever the goals for the operations are.)

In addition to policies, processes and workflows an operation manual (OM) typically describes aspects of the organization and the roles defined in the organization. It may describe how work products such as helpdesk tickets and project specifications are supposed to look like and when they are created and updated. It may also describe how various events, such as new customer complaints, are to be handled.

A process support application (PSA) does everything that an operations manual does but it also holds actual data for the process instance (such as a project) and uses this data to actively guide the user through the process providing IT support along the way. Examples of data a PSA may hold is the status and contents of documents, the status of tasks, various metrics used to monitor and control the project and so on. Examples of IT support would be functions for handling help desk tickets, change requests, bug reports and time reporting.

Leave a Reply

Your email address will not be published. Required fields are marked *