Historical analysis
Review of quality reports over 3 years and use of the OOS/OOT history.
Production · In-process controls
Streamline in-process controls without risk.
Sampling and measuring every 30 minutes "because that's how it's always been done" bloats the batch record and the teams' workload — without reducing risk when the process is capable and stable. The Sinfony method scales in-process control (IPC) frequency to real risk, with evidence to back it, and no compromise on compliance. Lessons learned from a pharmaceutical site in Morocco.
0 OOS/OOT
over 3 years, on the parameters checked in-process: the historical evidence that justifies streamlining the frequency — not a hunch.
An in-process control (IPC) checks a parameter during production. Multiplying these controls feels reassuring, but once the process is proven capable and stable, most of them no longer add any information: they lengthen the batch record and tie up the teams. Streamlining doesn't mean loosening — it's about concentrating the effort where the risk requires it.
The real problem
We test at the frequency of habit, not the frequency of risk.
IPC frequencies frozen for years, never tied to the process's actual capability or to the deviation history: that's operator and quality workload, a batch record that swells, a review that drags on — for near-zero added value when nothing drifts. Over-control isn't safety, it's waste in disguise.
The method
Justify the streamlining, step by step.
Every decision is tied to verifiable data — never to an isolated average.
Product / process review
Product criticality and selection of the "worst case" scenarios to challenge first.
Machine capability
The equipment's ability to hold the critical parameters within specification (Cpk).
Risk analysis (FMEA)
Assessment of the risks and of the machine safeguards actually in place.
New frequency (AQL)
A streamlining decision backed by an AQL sampling plan, documented and traceable.
The result
Fewer controls, same command.
At a pharmaceutical site in Morocco, the proof was in the data.
- 30 min → 1 h
- control frequency streamlined, with evidence to back it (2 h in phase 2).
- 0 OOS/OOT
- over 3 years on the parameters concerned: a stable process.
- High Cpk
- a highly capable, well-centered process: drift unlikely between two controls.
A cascading benefit: fewer samples means workload given back to operators and quality, a shorter batch record that's therefore reviewed faster, and a release lead time that tightens — all without degrading compliance, since the decision is traced and justified.
Go further
Proportion the control, everywhere.
Batch record
Reduce batch release time
A leaner batch record is reviewed faster: the same fight, on the flow side.
Read the article → Quality controlStreamline incoming controls
Same logic, on the raw-materials side: control proportioned to risk.
Read the article → ConsultingOperational performance
Assess the workload and de-risk your flows, from €5k.
See the approach →Frequently asked questions
Streamlining IPC, in practice.
An IPC (in-process control) is a check performed during production — weight, hardness, volume, etc. — to make sure the process stays within specification. Its frequency should depend on the risk and the stability of the process, not on a frozen habit.
Yes, as long as the decision rests on a documented risk analysis (history, process capability, FMEA) and a justified sampling plan. You don't remove the control: you adjust its frequency to the real risk, keeping traceability and rollback criteria.
On five building blocks: the review of the quality history and of OOS/OOT over several years, product criticality, machine capability (Cpk), an FMEA of the risks and safeguards, then an AQL sampling plan. The decision is tied to verifiable raw data (batch records, logbooks, deviations), never to an isolated average.
Workload given back to operators and quality, a shorter batch record that's reviewed faster, and a tightened release lead time — without degrading compliance. In our lessons learned, the frequency went from every 30 minutes to every hour, on a process with zero OOS/OOT in three years.
Stop over-controlling what doesn't drift.
Let's analyze your IPC and the workload you could streamline, with evidence to back it — no compromise on compliance.