FIELD LANGUAGE
Terms that connect directly to evidence.
This glossary explains how common electrical and automation terms are used in field records. It does not reproduce normative definitions or replace the applicable standard.
22 CORE TERMS
From system identity to controlled recovery
Every term includes the field evidence that makes it useful in a troubleshooting, commissioning or controlled-change record.
- PLCProgrammable logic controller
- The controller that executes automation logic and exchanges I/O and network data. Capture: exact model, firmware, program revision, controller state, fault log, I/O state and time source.
- HMIHuman-machine interface
- The operator-facing display and command layer. Capture: screen name, alarm text, user level, recipe or setpoint version, timestamp and the corresponding PLC tag.
- SCADASupervisory control and data acquisition
- A supervisory system for monitoring, command, alarms and historical data. Capture: point identity, quality, source timestamp, command authority, communication path and historian gap.
- VFDVariable-frequency drive
- A power-electronic drive controlling motor speed or torque. Capture: drive and motor identity, trip code, DC-bus and output data, load condition, parameter set and restart mode.
- BESSBattery energy storage system
- A system combining cells, racks, DC paths, conversion, controls, thermal management and protection. Capture: rack/string identity, BMS and PCS events, auxiliary power, isolation, thermal status and quarantine boundary.
- LOTOLockout/tagout
- A hazardous-energy control process used during servicing and maintenance. Capture: energy-source survey, isolation points, lock/tag responsibility, stored-energy release, verification method and shift transfer.
- InterlockCondition-dependent prevention
- A hardware or software condition that prevents or changes an action. Capture: hazard, input device, logic, output path, feedback, reset behavior, bypass state and proof-test result.
- Proof testDemonstration of required function
- A planned test showing that a function responds under defined conditions. Capture: approved method, initial state, stimulus, expected result, observed result, tolerances, failures and restoration.
- As-found / as-leftBefore-and-after condition
- The recorded state before intervention and the verified state after work. Capture: settings, wiring, labels, alarms, versions, temporary measures, test results and approver.
- AHJAuthority having jurisdiction
- The organization or official responsible for interpreting and enforcing applicable requirements. Capture: jurisdiction, adopted edition, permit, inspection point, deviation approval and release record.
- RollbackControlled return path
- A prepared method to restore the previous approved configuration or operating state. Capture: baseline backup, trigger condition, responsible person, time limit, verification and data reconciliation. Rollback restores an authorized system state; it does not by itself release a batch or product.
- Safe stateDefined condition after a demand or fault
- The state assigned by the safety concept—not simply “off.” Capture: hazard analysis, required outputs, stored energy, motion or process behavior, timing and restart inhibition.
- CommissioningEvidence before operational release
- A structured process confirming installation, configuration and function before use. Capture: prerequisites, drawings, calibration, loop and functional tests, punch items, acceptance authority and as-built package.
- Trip sequenceOrdered event evidence
- The time-aligned order of protective, control and process events around a shutdown. Capture: synchronized clocks, first-out indication, relay or drive events, PLC sequence, process trend and operator action.
- Time qualityConfidence in event timestamps
- The evidence that clocks and timestamps are accurate enough to compare events. Capture: time source, synchronization state, offset, time zone, daylight-saving rule, sequence resolution and gaps.
- BatchIdentified manufacturing quantity and record boundary
- A site-defined quantity made under stated conditions and represented by controlled records. Capture: batch identifier, product/material, process step, equipment/room, time window, status, affected records and named disposition authority. Do not infer release from equipment RUN, cycle completion or repair success.
- RecipeControlled process instruction set
- The approved parameters, sequence, limits and version used to execute a process or equipment cycle. Capture: recipe identity and revision, source and download path, equipment binding, parameter differences, approver, effective time and batches executed.
- Source dataFirst recorded evidence for reconstruction
- The original record or verified true copy needed to reconstruct an activity and decision. Capture: generating system/device, record identifier, user, timestamp and time quality, value and unit, metadata, transformation, interface path and retention location.
- Audit trailComputer-generated history of relevant actions
- A secure, time-stamped record used to reconstruct creation, modification or deletion of relevant data and configuration. Capture: system and object identity, actor, old/new value where available, reason, timestamp, review scope, exceptions and linkage to the affected batch or change.
- Change controlAuthorized impact-to-release process
- A controlled process for proposing, assessing, approving, implementing, verifying and closing a change. Capture: change ID, intended outcome, product/process/facility/data impact, approved baseline, implementation evidence, tests, deviations, rollback readiness and acceptance authorities.
- DeviationDocumented departure requiring disposition
- A departure from an approved instruction, expected result or controlled state that requires recording, assessment and an authorized decision. Capture: requirement and actual result, time and affected boundary, immediate containment, product/batch impact, investigation linkage, corrective action and approver.
- Quality releaseNamed authority accepts the evidenced state
- The site quality decision that an affected system, process or batch may move from hold to its approved next state. Capture: decision scope, reviewed records, deviations and restrictions, validation/qualification status, batch impact, approver, time and residual ownership. Technical completion is not quality release.
PHARMA · BIOPHARMA EVIDENCE RELATION
Keep system recovery separate from quality disposition.
These terms form one reviewable chain, but they do not collapse distinct engineering, validation and quality authorities.
| Evidence layer | Question | Minimum relationship |
|---|---|---|
| Operating identity | What product, batch, equipment and approved recipe were active? | Batch and recipe fix the affected boundary. |
| Record provenance | What original evidence shows what occurred and who changed it? | Source data and audit trail preserve reconstruction. |
| Controlled intervention | Was the impact assessed and every unexpected result dispositioned? | Change control contains authorized scope; each deviation remains visible. |
| Recovery and decision | Was the system restored, and who may accept the next operating or batch state? | Rollback restores an approved system state; quality release is a separate named decision. |
Confirm the applicable country, product authorization, pharmacopoeia, site quality system, approved SOPs, validation/qualification plan, AHJ, permit, OEM instructions and qualified decision-makers. The terms above do not supply universal acceptance limits or authorize batch disposition.
PRIMARY REFERENCES
Where formal definitions and requirements live
Check current publication status, adopted edition and jurisdiction before applying any requirement.
- IEC Electropedia — International Electrotechnical Vocabulary
- OSHA 29 CFR 1910.147 — Control of Hazardous Energy
- NIST SP 800-82 Rev. 3 — OT Security
- ISA/IEC 62443 series overview
- eCFR 21 CFR Part 211 — United States drug CGMP requirements
- FDA — Data Integrity and Compliance With Drug CGMP
- European Commission — EudraLex Volume 4 EU GMP