# Streamline QC controls through risk analysis.

When volumes rise, the quality control lab's workload explodes — and hiring isn't enough. **Skip testing** based on risk analysis lets you streamline the controls on raw materials (RM) and packaging components (PC) **without weakening compliance**. Here's the method, proven at a French pharmaceutical contract manufacturer (CDMO).

+56%

more control hours in one year, for only +34% more batches: QC workload grows faster than volumes. Impossible to keep up with a flat headcount.

Observed at a French pharmaceutical contract manufacturer (CDMO), 2023 → 2024.

**Skip testing** means spacing out or delegating certain incoming controls, based on a track record and a risk assessment. Done well, it doesn't loosen control: it concentrates the lab's effort where risk genuinely warrants it, and frees up capacity to absorb growth.

We control everything, all the time — even what doesn't call for it.

Out of caution, many labs systematically re-test every batch of every material, regardless of supplier, track record or criticality. The result: a workload that swells with volumes, saturated technicians, batch-release times that stretch out — with no real gain in safety. The question isn't "should we control?" but "where does control actually add value?".

## Three risk indices, one decision.

Delegating or streamlining a control rests on the combined assessment of three levels of risk.

1

### Supplier risk

Approval status, audit history and results, product conformity, administrative reliability, criticality of the material supplied.

2

### Item risk

Severity (active ingredient, excipient, packaging), OOS history, batch volume, method complexity and overlap with the supplier's testing.

3

### Test risk

OOS history on the test, required equipment, method validation status and potential impact on the patient or on regulations.

Each component is scored on objective criteria and compared against an acceptability threshold. Combining the three yields an overall risk level — and a decision.

## From overall risk to action.

Combining the three risks points to a clear decision — traceable and defensible under inspection.

| Supplier | Item | Test | Decision |
| --- | --- | --- | --- |
| Low | Low | Low | Delegate the test and/or reduce frequencies |
| Low | Low | High | Delegate if the supplier masters the method (targeted audit) |
| Low | High | Low | Delegate the tests already performed by the supplier |
| High | Low | Low | First improve the supplier's status |
| High | High | High | Do not delegate: control kept in-house |

Simplified excerpt from the decision grid. Each case is documented and justified, item by item.

## 43 items, three pools.

Analyzing the critical items reveals where to act first — and where control must stay in-house.

8%

of the workload: low risk → immediate delegation (_quick wins_).

56%

moderate risk → improve the supplier's status: the real pool.

36%

high risk → control kept in-house, no compromise.

Key takeaway: the quick wins (direct delegation) represent only a small share of the workload. **Most of the potential lies in moderate risk** — where an effort on supplier qualification progressively unlocks the majority of the possible reductions.

## Free up capacity, for good.

[Suppliers

### Delegate to the supplier (COA)

How to rely on the supplier's certificate of analysis without losing control.

Read the article →](/en/blog/delegate-controls-supplier-coa/) [Consulting

### Operational performance

Assess and free up capacity on your critical processes.

See the approach →](/en/consulting/operational-performance/) [Sinfony × AQE

### Pharma quality assurance

Deviations, batch release and quality flows made reliable in the field.

Discover →](/en/consulting/deviations-aqe/)

## Skip testing & risk analysis.

What is skip testing? +

Skip testing means reducing the frequency of certain incoming controls (or even delegating them to the supplier), based on a favorable track record and a documented risk analysis. It isn't about giving up control, but about proportioning it to the real risk.

Is reducing controls compatible with GMP? +

Yes, provided the decision rests on a traced, justified risk analysis, item by item, and that high-stakes controls stay in place. This is exactly the logic the regulations expect: concentrate control where the risk warrants it.

What criteria does the risk analysis rest on? +

On three combined levels: supplier risk (approval, audits, conformity), item risk (severity, OOS history, volume, method complexity) and test risk (OOS, equipment, validation, patient impact). Each component is scored, then compared against a threshold.

How much workload can you really free up? +

It depends on the portfolio. In our field story, immediate delegation accounted for only 8% of the workload, but a further 56% was reachable through an effort on supplier qualification. Risk analysis exists precisely to quantify that potential before acting.

## Absorb growth without saturating your lab.

Let's quantify together the control workload you could streamline through risk analysis.