Hi All,

In my previous job I had to issue ECOs for many purposes including:
– SOP Changes/updates
– New SOP Release
– Process Changes
– Product Specification Changes
– Documentation Updates

The reason why we used ECOs in everything even in documentation updates is that we needed to make sure that there is no impact on the product safety, performance, or efficacy when that change is executed. ECOs are usually accompanied by Change impact statement which highlights the impact of the change on the design. It also triggers a systematic review of other documents to ensure everything matches your proposed changes. ECOs were sometimes created as part of Corrective and Preventive Actions (CAPAs).