4.4 Calibration and Adjustment
Calibration isand adjustment are mandatory final assembly steps that ensure the product's functional parameters meet the specified tolerance limits. This process corrects accumulated manufacturing variation (tolerance stack-up) in components and assemblies. Failure to perform traceable calibration results in reduced accuracy, performance degradation, and non-compliance with system specifications.
4.4.1 Calibration Flow and Process Mandate
Calibration must be integrated into the final refinementassembly thatflow, transformslinking adirectly functionalto programming and safety testing.
A) Flow Integration
Calibration must occur after the device intois one that delivers precision with confidence. By comparing each unit to a trusted reference under controlled conditions, subtle offsetsprogrammed and driftsfunctional, arebut corrected so performance lands safely within specification. This process ties measurement integrity tobefore the serialfinal number,safety with traceable records of “as-found” and “as-left” states that prove not only compliance but also stability over time. When performed with disciplined environments, reliable references, and straightforward math, calibration becomes less about chasing errors and more about building trust into every product shipped.
4.4.1 What this is (and isn’t)
Calibration compares the unit to a known reference and finds error.
Adjustment changes the unit (coefficients, trims, pot turns) to bring it into spec.
Do both with traceable references, in the right environment, and record as-found/as-left to the serial.gate:
4.4.2 Where it sits in the flow
Program (25.3) →– Functional smokeSmoke (25.1) →– Calibration/Adjustment →– Re-verify →– Safety (25.2) → Closeout.
If cal is part of FCT, the script must clearly mark cal steps vs verification steps.
4.4.3 Environment & measurement basics
- Warm-up:
DUTBoth the Unit Under Test (DUT) and the instrumentstomust reach thermal steady state (typ.typically10–10 – 30min).minutes - ) before measurement begins to prevent thermal drift from contaminating readings. Ambient
capture:temperature/RHlogmust be captured and logged.
B) Instrumentation and Standards
The accuracy of the calibration process is entirely dependent on the test equipment used.
Temp/RHTraceability Mandate:—somespecsAllapplyprimarycorrection.instruments (DMMs, sources, chambers) must be under a strict, scheduled calibration cycle and traceable (NIST/ISO 17025).- Test Accuracy Ratio (TAR):
referenceThe measurement uncertainty≤of25%the reference instrument must be significantly smaller than the tolerance of the DUTtolerance(4:1rule;ratio10:1orideal)better). Instruments in cal:Hookups:per18.24-wire (Kelvin) method; station blocks run if a certisout-of-date.Stable hookups:Kelvinmandatory for low-ohms;ohm/low-voltageshieldedcritical measurements to eliminate lead resistance error. Shielded leads are required for sensitive mV/RF;RFavoid hand heat on sensors.measurements.
4.4.42 ReferencesThe &Closed-Loop fixturesAdjustment (pick the right yardsticks)Protocol
Electrical:Calibration
precisionisDMM,aDCcontrolled,sources,closed-loopelectronicsequenceloads,executedvoltage/currentviastandards,automateddecadetestresistors,software,timebase/OCXO/GPSDO.Sensors:temperature chambers/blocks, precision pressure/vacuum source, gas standards, light source panel.RF/Comms:power meter, calibrated attenuators, spectrum/network analyzer (or golden radio + shield box).Mechanicals:force/weight, linear scalescompensating forencoders,variancetorqueintestersspecific domains.A) Calibration Patterns (The Math)
The mathematical model for
motors.Fixtures:compensationshort,mustrepeatablebepaths;keptmatingsimpleconnectors;andguided nests;no clip leadson production.
stable.
4.4.5 Common calibration patterns (use the lightest that works)
- Offset-
onlyOnly (Zero):(zero): measureMeasure at 0(V or knownnull),null, store the offset. - Two-
point gain/offset:Point:measureMeasure at low&and high points; solve the linear equation (y =m·m \cdot x +b.b) to find the gain (m) and offset (b). - Multi-
point linearization:Point:3–9Forpoints;highlyfitpiecewise linearorpoly; ensuremonotonicLUT. Ratiometric/bridge:calibrate excitation first; then sensor span.Timing:trim RTC/clock viappm offsetagainst a reference (GPSDO or calibrated counter).RF power/PA bias:step drive, measure output, buildgain tablevs channel/temp.
Tip: keep math simple and stable; prefer piecewise non-linear over high-order polynomials on small MCUs.
4.4.6 Domains & quick recipes
Voltage/Current rails
Source known value(s). 2) Read DUT. 3) Compute gain/offset. 4) Write constants →CRC. 5) Re-read to confirm≤ spec.
ADC/DAC
ADC: short/known referencesensors (e.g.,0 V & Vref/2)thermistors),computeuseoffset/gain.DAC: set codesthree tolow/high,ninemeasure with DMM; solvem/b; limitpoints tocodefitrange.
Temperature
Two-pointlinear(ice/ambient blockfunction orchamberlook-upsteps): store slope/offset; log ambient.If using thermistors, verifytableindexmatches curve(Beta/R-T table)LUT).
B) Adjustment Discipline
Pressure/FlowMeasure (As-Found):- Apply
two or threea knownpoints;stimulus.zeroTheatsystemvent; store span; runmustleak checkif relevant.
Timing/RTCCount edges vs reference for≥10 s; compute ppm trim; write; recheck≤ spec ppm.
RFSet known channel/power; measure after attenuator; store cal factor; verifyACL R/EMCsanity in shield box if in scope.
Displays/LEDsUse light panel or sensor; set white/time-out levels; store per-color factors; eyeball uniformity.
Motors/encodersHome to hard stop or sensor; storezero offset; verify count per rev.
4.4.7 Adjustment discipline (don’t chase noise)Averageaverage N readings (e.g., 10–32)attoeachreducepoint;noise.useLog themedianAs-Foundif spiky.value.GuardCalculate & Adjust: Compute the constant; electronically write it to the dedicated NVM partition.- Verify (As-Left): Re-measure to confirm the final As-Left value is within spec and meets the guard band
:adjust to hit(center ofspec,spec, not theedge.edge). Write-protectLimit the Wrench:calFor physical adjustments (trimpots), the adjustment must be minimal. After completion, the trimpot must be sealed with an approved compound (e.g., varnish) and marked with a paint dot to prevent vibrational drift.
- Apply
4.4.3 Data Protection and Traceability
The calibration constants must be permanently protected against field erasure and linked to the unit's identity.
A) Data Storage and Security
- NVM Partitioning: Calibration data must reside in a separate NVM partition from the application firmware. This prevents field updates from accidentally wiping the constants.
- Protection: The calibration region
withmust be write-protected and include a CRC/Hash;recipecalculation.refusesThe system must refuse to run if the calibration region's CRC fails. As-foundRegionvs as-leftFlags:alwaysCalibrationcaptured—evendataif(constants,noregionadjustmentflags)wasmustrequired.Limitmatch thewrench:physical label kit and safety test selection.
B) Logging and Audit Mandates
The complete set of data must be logged and linked to the unit's identity for the audit trail.
- Mandatory Record:
forThephysicalMEStrims/pots,logapplymust be bound to the unittorque limitsSN andmark with paint dot after.
4.4.8 Data & traceability (what the record must hold)
Attach toinclude: unit SN:
- Recipe ID,
firmware hash,cal algorithm version. References/instrumentswithinstrument cert numbers& expiry.Ambient Temp/RH,warm-upambienttime.Temp/RH, As-Found error, As-Left value, and the calculated coefficients/LUT snapshot.As-foundRetries:values/errors;as-leftvalues/errors; coefficients/LUT snapshot.CRC/hashof cal region;operator/fixtureIDs; timestamp.- Any retries or anomalies (e.g., slow chamber
rampramp)slow).must be captured in the final record.
StoreFinal
plots for long tests (e.g., temp sweep), at least for NPI and sample lots.
4.4.9 Throughput without cheating
Automate:scriptedpoints, auto-calc, auto-write, auto-verify.Ping-pong fixturesorparallel stationsfor long soaks/chamber steps.Pre-calmodules(sensors, radios) at subassembly level when allowed; perform ashort verifyin box build.Cache chamber setpoints andtest short profiles(two-point instead of five) when the spec permits.
4.4.10 Acceptance cues (fast eyes)Checklist
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Traceability |
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Process Flow |
| Warm-up timer |
Data Protection |
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Adjustment Discipline | As-Found |
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Measurement Integrity |
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SN Logging |
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4.4.11 Common traps → smallest reliable fix
4.4.12 Pocket checklists
Before
SKU/Variantscan→ cal recipe & limits loadedInstrumentsin cal; references warmed; ambient loggedDUT at temp; power stable; fixture latched
Run
Measureas-found; saveExecute points (two/multi) → compute →write coeffsCRCof cal region OK; lock if requiredVerifyas-leftmeets spec with guard band
After
Results (coeffs, errors, plots)to MES by SNSticker/metadata updated (if required by customer/spec)If fail: raiseticket(module swap or MRB), don’t over-tweak