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dipanpatel replied to the topic Discussion Topic: ECO's in the forum Device Documentation 7 years, 1 month ago
A particular change order that occurred was that my companies supplier for a certain plastic was changed. The difference was very slight but however, proper protocol is very important. Therefore an ECO was issued due to the change in the product. This lead to every department being notified about the change. Due to the modifications the regulatory depart became heavily involved and were more modifications with SOP changes, additional work in verification, risk analysis and especially testing. Due to the minor change, it was not as extensive, but there was still an overhaul of things needing to be done to accommodate the change.