Change control: a poorly described change is a poorly assessed change
A supplier changes production site. A piece of equipment is replaced by an “equivalent” model. A procedure is simplified. On paper, nothing serious. But when the description of the change fits in two lines, nobody can gauge its consequences, and the surprises come at implementation.
It all comes down to the description
What isn’t described will be neither assessed nor anticipated. A vague description lets everyone interpret the change in their own way: production sees a simple update, regulatory a variation to be filed, maintenance a requalification. The assessment is skewed from the outset.
A good description answers a few simple questions: what exactly is changing, and what isn’t? Why? What does it affect? Who needs to be involved?
Describing a change is a skill
Not everyone can do it, and that’s not a criticism: describing a change requires knowledge of the process, the product, regulatory requirements and the quality system. That’s why the description must be owned by identified, trained people, the change owners, rather than by whoever happens to make the request. A well-designed opening form, and a “change or no change” decision-support tool, also avoid opening unnecessary files.
Assess in committee, along three lines
Once the change is well described, its assessment can’t rest on a single person. A multidisciplinary committee (production, quality control, maintenance, regulatory, quality assurance), prepared through pre-reading, answers three questions:
- Impacts: what does the change affect? Products, processes, equipment, documents, regulatory files, customers.
- Risks: what must be anticipated during implementation?
- Effort: what will it require, and from whom?
These three lines make it possible to calibrate the type of change and its priority. Each file then receives the level of treatment it deserves, no more, no less, and the most important goes first, instead of the one that makes the most noise.
Manage before and after approval
A change control doesn’t stop at approval. It is managed in two stages. Up to approval, with a view of open items and each person’s workload, to decide quickly and well. Then during implementation: blocking actions must be closed before implementation is authorised, batch release must be synchronised, customers informed, and an effectiveness review closes the file.
What you can expect
On a pharmaceutical chemistry site, rethinking the description, the committee assessment and the management reduced the number of open change controls by 22% in four months. Change control then stops being an obstacle and becomes what it should be again: a tool that lets you change safely.
