Engineering Change Process

In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedure. I am going to describe this change control procedure in this post.   A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:   Identification   The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data. Read more

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.   The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.   Change control is used in a wide variety of products and systems. For Information Technology (IT), it is a major aspect of the broader discipline of change management. Typical examples from the computer and network environments are patches to software products, installation of new operating systems, upgrades to network routing tables, or changes to the electrical power systems supporting such infrastructure. Read more

Let's look at the engineering change process and how Engineering Change Order (ECO) is used in this process.   The stages of the engineering change process are:   1. Issue identification & scoping:   Someone identifies a problem or issue and determines that it may require a change. The scope of the issue and its possible impact are estimated.   2. ECR creation:   An engineering change request (ECR) is created to examine the necessity and feasibility of the change, to identify parts, components and documentation that might be affected, to estimate costs and to list the resources required to implement the change.   3. ECR review:   The ECR is circulated for review and discussion among key stakeholders and is modified as needed. Read more