ISO 22400ISO 22400 — KPIs for Manufacturing Operations Management

ISO 22400 — full title "Automation systems and integration — Key performance indicators (KPIs) for manufacturing operations management" — is the international standard, published in 2014, that defines a closed set of manufacturing-operations KPIs with formulas, units, time-model boundaries and aggregation rules. It exists because ISA-95 Part 3 names performance analysis as one of the eight MOM activity groups but deliberately stops short of specifying the KPIs themselves; ISO 22400 is the document the standards community wrote to fill that gap.

The standard is in two main parts, plus a technical-report companion.

• ISO 22400-1:2014 — Overview, concepts and terminology. Defines the time model (the way calendar time is decomposed into loading time, planned production time, actual production time and the various downtime categories), the KPI element vocabulary, and the formal way a KPI is described (name, ID, formula, time element, scope, application, unit, range, trend direction, audience).
• ISO 22400-2:2014 (Amendment 1, 2017) — Definitions and descriptions of 34 named KPIs across the four MOM domains. Each KPI is given an ID (KPI-001 through KPI-034 in the base set), a formula in standardised symbols, a unit and an interpretive description.
• ISO/TR 22400-10:2018 — A technical report describing how the KPIs are computed in practice (event sources, sampling, aggregation across time windows).

Before any KPI in 22400-2 can be computed, the time model in 22400-1 has to be in place. The standard decomposes calendar time as follows (simplified; the standard names each element and gives it a symbol).

Every downtime event in the MOM platform has to be classified into one of these buckets. The single most common subtle error in industry is misclassification: counting a planned changeover as unplanned (inflating availability loss), or counting a public-holiday shutdown as loading time (deflating OEE). 22400-1 is the document that prevents the argument.

The headline 22400 KPIs are the OEE family — Availability, Performance, Quality, OEE, NEE and TEEP — derived directly from the time model above.

The three-way decomposition A × P × Q is the source of OEE's diagnostic value: a falling OEE always lives in one of three buckets, and the bucket tells the maintenance / production / quality manager which one is theirs to fix. Lump them together and the KPI tells you nothing actionable.

Beyond the OEE family, 22400-2 names KPIs across the four MOM domains. The list below is the working set most regulated manufacturers actually report; the standard's full catalogue covers 34 named indicators.

Production KPIs

• Throughput rate — produced quantity / APT. Units per hour, the conversational "speed".
• Allocation ratio — APT / loading time. How much of the work week the asset was actually producing.
• Setup ratio — setup time / PBT. The changeover overhead KPI.
• Technical efficiency — APT / (APT + technical-cause downtime). Isolates equipment reliability from organisational downtime.
• Production process ratio — (production order execution time) / (production order total time). Order-throughput health.
• Worker efficiency — actual worker time / planned worker time. Labour-side OEE.

Quality KPIs

• Quality ratio (Q in OEE) — good quantity / produced quantity.
• First Pass Yield (FPY) — units passing inspection first time / units started. The right-first-time KPI; the single most important quality metric in batch / process.
• Scrap ratio — scrap quantity / produced quantity. Cost-of-poor-quality driver.
• Rework ratio — rework quantity / produced quantity. Hidden-factory KPI.
• Fall-off ratio — fall-off quantity (in-process loss) / produced quantity.
• Right First Time (RFT) — batches released first pass / batches started. The batch-level equivalent of FPY.

Maintenance KPIs

• MTBF — Mean Time Between Failures = total APT / number of failures. Reliability KPI.
• MTTR — Mean Time To Repair = total repair time / number of failures. Maintainability KPI.
• MTTF — Mean Time To Failure = total uptime / number of failures (non-repairable assets).
• Corrective maintenance ratio — corrective maintenance time / total maintenance time. Inverse of the PM-discipline KPI.
• Equipment failure rate — number of failures / total operating time.

Inventory KPIs

• Inventory turnover — annualised cost of goods sold / average inventory value. The working-capital KPI.
• Fill rate — orders filled complete / orders received. Customer-service KPI.
• Finished-goods ratio — value of finished goods / value of total inventory.
• Other loss ratio — inventory shrinkage / total inventory movements.

ISO 22400 is not the only KPI standard in the manufacturing world. The two it most often gets compared with are SEMI E10 (semiconductor equipment availability) and VDMA 66412-1 (German parallel MES KPI standard).

For a regulated manufacturer building a new MOM platform in 2026, ISO 22400 is the only credible default. Industry-specific standards (SEMI E10, VDMA 66412-1) are kept around where customers ask for them, but the formulas are now interoperable with the 22400 set.

ISO 22400 is not a regulation, and no health authority (FDA, EMA, MHRA, PMDA, NMPA, ANVISA, TGA, etc.) requires it. It earns its place in regulated manufacturing because of how the KPIs are used downstream.

• 21 CFR 211.180(e) / EU GMP Chapter 1 — annual product review / product quality review. Both regimes require periodic review of process performance and quality trends. The KPI set used for that review needs unambiguous definitions; 22400 is the canonical source.
• ICH Q10 — pharmaceutical quality system. Q10's continual-improvement loop (process performance and product quality monitoring) is computed on KPIs whose definitions need to be defensible at an inspection. 22400 is the document referenced when a defence is required.
• ICH Q9(R1) — quality risk management. Risk-based decisions on hold / release / market action depend on quality KPIs (FPY, RFT, scrap ratio); inconsistent definitions break the risk argument.
• 21 CFR 820.250 / ISO 13485 — statistical techniques. The standards require sound statistical methods; OEE-family decomposition into A × P × Q is a textbook statistical technique with a defined formula set.

A defensible 22400 implementation does not start with the KPI dashboard. It starts with the time model and the event classification. The dashboard is the easiest part; the classifier is the hard part.

1. Build the time-model classifier first. Every downtime event needs a deterministic mapping to planned-outage / planned-downtime / unplanned-downtime / running-with-scrap. Without that mapping, no 22400 KPI is computable.
2. Pick the KPI working set. Six to ten KPIs across the four domains. More than that and nobody can read the dashboard.
3. Bind each KPI to its 22400-2 ID in the documentation. The discipline is what makes the KPI defensible in twelve months when the original engineer has left.
4. Decide the aggregation cadence. 22400 lets you compute the KPIs over any time window; the convention is shift / day / week / month / quarter. The MOM platform should produce all five from the same event base, not five different roll-ups.
5. Wire the KPI breaches into the QMS. An OEE drop, an FPY drop, an MTBF drop should trigger an investigation in the CAPA workflow — not show up only in next quarter's slide deck.

Mistake 1 — Comparing OEE across plants with different denominators

Plant A computes OEE against planned busy time; plant B computes it against calendar time. The numbers cannot be compared. The fix is to publish the 22400 ID alongside every reported KPI.

Mistake 2 — Treating Performance as actual / nameplate speed

Nameplate speed is the marketing spec from the equipment vendor. Ideal cycle time is what the equipment actually achieves under best conditions in your plant. 22400-2 uses ideal cycle time. Substituting nameplate inflates the loss.

Mistake 3 — Counting rework as good output

Rework that eventually passes inspection is sometimes counted in the Quality numerator. 22400 is clear: Quality is first-pass-good / produced. Rework is captured separately as Rework Ratio. Conflating the two hides the hidden factory.

Mistake 4 — Annual OEE only

An annual OEE number cannot drive a shift-team decision. The KPI is most useful at shift / day / week cadence. The MOM platform should expose all aggregation windows on the same event base.

Mistake 5 — KPI breaches without an investigation trigger

A KPI that falls and triggers nothing is decoration. 22400 is silent on the trigger; ICH Q10 / ISO 9001 / ISO 13485 are not — they require continual improvement loops. Bind the KPI breach to the CAPA workflow.

V5's KPI layer is built against ISO 22400-2. The four MOM domains all feed events into a common time-model classifier; the KPIs are computed as SQL views with the 22400 ID and formula bound to each view.

• Time model — every downtime event captured by the kiosk / device bridge is classified into 22400-1 buckets. PBT / APT / AUPT are first-class fields, not derived spreadsheet columns.
• KPI library — Availability, Performance, Quality, OEE, NEE, TEEP, FPY, RFT, scrap ratio, rework ratio, MTBF, MTTR, throughput, fill rate, inventory turnover all ship with the platform.
• Aggregation windows — shift, day, week, month, quarter, year — all from the same event base. No reconciliation between roll-ups.
• Validation evidence — the KPI Definition Module in V5's Validation Pack maps each KPI to its 22400 ID, formula and source view; the inspector gets one PDF instead of a week of explanation.
• CAPA wiring — KPI-breach rules (an OEE drop > 10 %, an FPY drop > 5 %, an MTBF drop > 20 %) create CAPA records automatically in the QMS — closing the ICH Q10 / ISO 9001 continual-improvement loop.