QUALITY FRAMEWORK
Turning intelligence into
FDA-aligned process control
External FDA signals tell you where risk is. These three tools show whether your process is in control — the evidence FDA expects to see.
Illustrative educational tools. These examples are not a validated regulatory decision system.
1 · FMEA — risk prioritization
Rank failure modes by Severity × Occurrence × Detection. Use FDA 483 trends to inform Occurrence and Detection scores.
2 · Control charts — stay in control
Monitor critical quality attributes and process parameters; investigate points beyond control limits or non-random trends.
Observation 12: 116 — beyond UCL.
Reconstructed illustrative data. Control limits describe process behavior; USL and LSL describe specifications. This example does not implement every statistical process-control detection rule.
View illustrative chart data
| Observation | Value |
|---|---|
| 1 | 96 |
| 2 | 100 |
| 3 | 97 |
| 4 | 101 |
| 5 | 96 |
| 6 | 99 |
| 7 | 97 |
| 8 | 103 |
| 9 | 100 |
| 10 | 103 |
| 11 | 108 |
| 12 | 116 · Beyond UCL |
3 · Process capability — Cp & Cpk
Show the process can consistently meet specifications, not just that it is stable.
Cp = (USL − LSL) / (6σ)
Cpk = min(USL − μ, μ − LSL) / (3σ)