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Scott replied to the topic Does your company use ECOs? in the forum Device Documentation 7 years, 11 months ago
The company I currently work for generates ECOs to make specific changes to products or manufacturing processes. Our ECOs are generated in a Product Management System, we currently use Agile but there are others such as OTIS or ADAPTIV. Basically, our ECOs are generated and highlight essentially the description of the change, the justification of the change, and sometimes the risk. If we are changing anything that is a document such as an SOP, Work Instruction, or Batch Record we open a DCO which contains similar fields that an ECO needs. ECO and DCO are separated to ensure there is an easy and organized way to separate changes between the product/manufacturing process vs documentation. To your point, after attaching whatever documents are needed, the ECO is routed for approval and taken to CCB and the changes move from there.
There really isn’t a great way to streamline this from my experience, the biggest issue I’ve seen is people in other departments that are approvers either taking a long period of time to review and approve or after it passes along the Change Order process it gets rejected or demoted by someone and moves back a step.