For many companies operating in a regulated environment effectively managing their change control process poses a significant challenge. Engineering Change Orders (ECO), Document Change Orders (DCO) and the whole Validation and Qualification (V&Q) effort causes managers to comment:
“The Change Control process takes too long, particularly the approvals part of the process with multiple sign-offs required even for the smallest of changes”.
“There’s a perception (or a reality) that the change control process is owned by support departments (QA, Validation, Document Control) and not by the individual project managers or system owners”.
“Metrics to measure the performance of the change control process in terms of quality, speed, and cost don’t exist”.
“We’re spending a lot of time and money on our change control process and asking ourselves where is it adding value.”
BSM’s approach to Lean Change Control addresses these concerns in a structured way. We use our expertise in optimising end to end value streams and apply it to the change control process.
Tom Reynolds will respond to your query.