“If it isn’t documented, it didn’t happen” is an often-repeated and heavily loaded phrase. One that I want to unpack in a lot of ways on this blog.
Here I want to focus on the interaction between change management and document control, as I think the two are closely intertwined, and that close relationship can confuse you.
Change Management is all about how we assess, control and release our changes. Document control is how we create, review, modify, issue, distribute & access documents. Document control is part of knowledge management (an enabler of the enabler), it is a tool for change control, and is often a deliverable, but it is important to understand that change management is broader than document control, and the principles of change management should enwrap and permeate a document control system.
Let’s start with a SIPOC.
Change Management here is all about the how of the change:
- Assess – What is the impact of our changes
- Handle – Implementing our changes
- Release- Using the change
All three of these are a risk-based approach, the amount of effort and rigor depends on how risky the change is. There are a few principles to keep in mind when developing that risk-based approach:
- Changes come in different sizes
- Keep your type of change control mechanisms to a manageable minimum.
- Have a consistent way of performing that assessment and moving between your change control mechanisms.
When I review 483s and other inspection trends one of the consistent areas is changes not going through a rigorous enough change management. They faltered on assessment, handling and/or release. It is pretty easy to put everything in the document control system and then miss a lot. (For example, those specification changes that don’t end up being filed in all appropriate markets).
So what do I recommend?
Ensure change management sits around and through document control. Build a set of standardized decision-making principles that allow a document revision to end up in the right size change control process (which can just be a document change) and then ensure there is a way to document and review those decisions. This allows us to drive continuous process improvements in this decision making.
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