What does "moving QA to the floor" mean?

It means bringing quality assurance closer to the product, in time and in space: a presence aligned with production shifts, able to decide in real time and handle deviations at the source, rather than a late review on paper.

What is a risk-based batch record review?

It means focusing the review effort on critical parameters and points of real risk, by grouping controls and sign-offs by activity, rather than re-verifying every instruction with the same intensity. You gain in speed and in relevance.

Is streamlining the review GMP-compliant?

Yes: you don't remove the review, you make it proportionate to risk and you clarify the meaning of each sign-off. This is consistent with the spirit of the standards, which expect targeted, documented control, not indiscriminate exhaustiveness.

Do you need to increase quality headcount?

Not necessarily. In our experience, the reorganization was done at constant overall headcount: it was about repositioning QA in the right place at the right time, and reinforcing the release team, not adding roles.

Quality assurance · Batch record

Move quality assurance to the floor.

QA far from the product and a batch record review that re-checks everything, line by line: that's the recipe for queues and correction loops. By bringing quality assurance closer to the floor and moving to a risk-based review, you decide faster — without giving up anything on compliance.

Rethink my quality organization See pharma quality assurance

corrections per batch, on average — the symptom of a review that comes too late, is too exhaustive, and sits too far from the action that produced the data.

Assessment, international pharmaceutical CDMO (sterile fill-finish).

When quality assurance discovers deviations weeks after production, all it can do is correct on paper — not at the source. Every correction triggers a back-and-forth, lengthens the queue and delays release. Bringing QA closer to the product, in time and in space, breaks that cycle.

The real problem

Re-checking everything means prioritizing nothing.

A review that verifies every instruction with the same intensity treats a critical parameter like a trivial checkbox. The result: an enormous review time, diluted attention, and paradoxically poorly controlled risk. Compliance doesn't come from an exhaustive review, but from a relevant one.

What we did

Bring QA closer, streamline the review.

1 · QA as close as possible to the product

A quality assurance presence on the floor, aligned with production shifts, to decide in real time.
Deviations are handled at the source, while the context is still fresh — not weeks later on paper.
A reinforced release team to consolidate the batch record, at constant overall headcount.

2 · Risk-based review rules

Group controls and sign-offs by activity, instead of a sign-off for every instruction.
Make the meaning of each sign-off explicit (operator, verifier, supervisor, pharmacist): who commits to what.
Focus the quality review on critical parameters and points of real risk.

The Gemba walk: QA that goes and sees on the floor →

The effect

Decide fast, fix at the source.

By bringing QA closer to the product and targeting the review, corrections dry up, the queue melts away and quality decisions are made in hours, no longer weeks. Quality stops being an end-of-line control gate and becomes a partner on the floor — and compliance comes out stronger, because attention goes where the risk demands it.

Go further

A quality function that accelerates, not slows down.

Flow

Frequently asked questions

Field QA & risk-based review.

Make quality an accelerator.

Let's rethink where your QA sits and how you review — with no compromise on compliance.

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