Engineering Changes (ECR, ECO, ECN) and how they should be Structured

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Engineering Changes (ECR, ECO, ECN) and how they should be Structured

2023-04-14 05:33| 来源: 网络整理| 查看: 265

Because of the potential impacts, medical device really needs the planning and review cycles to lock in a bullet-proof process. Change can be a significant hurdle, so you must be able to justify it. Without electronic distribution, there certainly are some additional difficulties, but it can be managed.

You might find the following article link helpful... :popcorn:

http://www.arenasolutions.com/resources/articles/engineering-change-order

The ABCs of Engineering Change Orders

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.

4. ECO creation: Once the ECR is approved, an engineering change order (ECO) is generated, which lists the items, assemblies and documentation being changed and includes any updated drawings, CAD files, standard operating procedures (SOPs) or manufacturing work instructions (MWIs) required to make a decision about the change.

5. ECO review: The ECO is then circulated to a change review board made up of all stakeholders (including external partners when appropriate) who need to approve the change.

6. ECN circulation: Once the ECO has been approved, an engineering change notification/notice (ECN) is sent to affected individuals to let them know that the ECO has been approved and the change should now be implemented.

7. Change implementation: Those responsible for implementation use the information in the ECO and ECN to make the requested change.

While an engineering change order is used for changes that are executed by engineering, other types of change orders may be used by other departments. These include the:

Manufacturing change order (MCO) ? A change order describing modifications to the manufacturing process or equipment.

Document change order (DCO) ? A change order detailing modifications to documents, specifications or SOPs.

Engineering Change Orders: Paper-based vs. electronic software systems...

The article continues...

Conclusion

Companies need to be able to adapt quickly in today?s constantly changing environment, and often that means making changes to their products. Engineers make modifications during development and production with the intent of adding functionality, improving manufacturing performance or addressing the availability of a particular part.

To make sure proposed changes are appropriately reviewed, a solid process is critical?especially if members of your product team are scattered across multiple locations (for instance, design engineers in Boston, the manufacturing team in St. Louis and component manufacturers all over the world). At the heart of a solid change process is the engineering change order.



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