WOWork Order
A Work Order (WO) is the formal authorisation to execute a defined unit of manufacturing or maintenance work, against a defined specification, with defined materials, by trained personnel, against a recorded set of conditions.
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In regulated manufacturing the WO is the linkage between the planned (MMR / device master record) and the actual (BMR / DHR / batch production record). Grounded in ISA-95 (the enterprise → shop-floor model) and ISA-88 (batch control). Evidenced by 21 CFR 211.188 for drugs, 21 CFR 820.184 + ISO 13485 §7.5 for devices, and 21 CFR 117.135 for food. In V5 the WO IS the unit of regulated execution.
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How does WO apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What a WO is
A WO authorises execution. It carries:
- Reference to the MMR / device master record / recipe (immutable version pinned at release).
- Quantity, target batch size and bracket (planned + acceptable yield range).
- Site, line / cell, planned start + end, target campaign sequence.
- Materials list with reserved lots (FEFO / FIFO / specific-lot per recipe).
- Operator + supervisor role assignments + training prerequisites.
- Equipment + facility assignments (vessels, packaging line, controllers).
- Sampling plan + IPC schedule.
- Release criteria + signing roles (preparer, reviewer, QA release).
02The mmr_snapshot rule
21 CFR 211.188 requires the batch record to be "an accurate reproduction of the appropriate master production and control record". The standard implementation:
- At WO release, the full MMR (every step, every component, every tolerance, every IPC, every release criterion) is copied into a JSONB snapshot stored against the WO.
- The MMR is now decoupled from the WO. If the MMR is revised mid-run, the WO continues against the snapshot.
- Reports (BMR PDF, regulated artefacts) render from the snapshot, never from the live MMR.
- If a recipe change is required mid-run, the WO is closed (or paused, deviation raised) and a new WO opens against the new MMR version.
03WO lifecycle states
- Draft — being built; materials may not be allocated; not executable.
- Released — MMR snapshot taken; materials reserved; operator-facing kiosk tile appears.
- In Progress — first operator action recorded; partial-execution data accumulating.
- Paused — execution suspended (deviation, line clearance failure, queued for next shift); reason captured.
- Completed — last step executed; awaiting review.
- Under Review — Quality Unit reviewing the executed batch record against the master.
- Released to Stock — QA released; finished-goods inventory created; lot genealogy locked.
- Rejected — non-conforming; deviation + CAPA; disposition recorded.
- Cancelled — never started; materials returned to inventory.
04Operator execution at the kiosk
The kiosk tile for the WO surfaces only what the operator needs:
- Current step + instructions (the snapshot version, with no scrolling past steps in the future).
- Material to dispense — name, target weight, tolerance band, expected lot, scale identification.
- Capture fields — weighed mass, container ID, equipment used, e-signature.
- Real-time guards — out-of-tolerance dispense triggers deviation; missing prerequisite (training, equipment status, line clearance) hard-blocks step start.
- Interlocks — equipment with status "under maintenance" or "calibration due" cannot be selected.
- Two-person e-sig for critical steps (recipe-mandated double-check, sterile-area entries, dispense rounding).
05Scheduling + capacity
WOs are scheduled into the production calendar with constraints:
- Equipment availability — non-overlap on a single unit; campaign-grouping for changeover-heavy products.
- Material availability — required-by-date back-scheduling triggers MRP / purchase suggestions.
- Operator availability — trained-operator headcount per shift.
- Sterile or contained operations — cleanroom changeover + line-clearance windows.
- Cross-WO sequencing — same recipe campaigns reduce SMED time; allergen / cross-contamination guards force order in food + supplements.
06Industry-specific naming
- Pharma — manufacturing order; batch record references the WO ID.
- Medical device — production order or routing order; DHR maps to the WO ID.
- Food / supplement — batch ticket or batch record; HACCP / HARPC controls fire off WO steps.
- Discrete manufacturing — work order or build order; routing operations are the unit of execution.
- Maintenance — maintenance WO; CMMS-equivalent record against the equipment asset.
V5's industry-profile system swaps the terminology so a discrete-profile tenant sees "Build Order / Routing" while a process-profile tenant sees "Work Order / Batch". The underlying schema is shared.
07Common mistakes
- Snapshot at release missed — BMR renders from live MMR; later MMR revision retroactively changes "executed" record.
- WO release allowed without training-prerequisite check — operator executes against an SOP version they never trained on.
- Equipment status not interlocked — calibration-due scale used; release blocked at QA review weeks later.
- Material reservation released on WO cancel but not on completion variance — phantom inventory.
- Cross-WO sequencing ignored — allergenic line run after non-allergenic without sanitation step.
- Mid-run MMR revision implemented against the live WO — Part 11 + 211.188 violation.
- WO closed with open deviations — review-state state machine bypassed.
- Lot genealogy not finalised at release-to-stock; downstream finished-goods cannot trace back to inputs.
08How V5 Ultimate handles WOs
Frequently asked questions
Q.Can a WO be edited after release?+
The MMR snapshot is immutable. Operator-recorded execution data is editable only via formal deviation + two-person e-signature, with the prior value retained in the audit trail. The WO itself can be paused, cancelled or have its yield/timing edited within strict permissioned workflows.
Q.What happens when the MMR is revised mid-run?+
Nothing happens to the in-flight WO — it continues against the snapshot. New WOs released after the MMR revision will snapshot the new version. This is exactly what 21 CFR 211.188 "accurate reproduction" requires.
Q.Does the WO automatically pull materials from inventory?+
Yes — material reservations are placed at WO release and consumed as the operator records each dispense. Reservation release on WO cancel / completion variance / partial yield is automatic and audit-trailed.
Q.Is one WO = one batch?+
Usually, but not always. V5 supports campaign WOs (one WO that produces multiple sequential batches on the same equipment with intermediate cleaning), and split WOs (one batch that splits into multiple downstream batches at a unit operation).
Q.Does V5 distinguish manufacturing WOs from maintenance WOs?+
Yes — manufacturing WOs run against a recipe (MMR); maintenance WOs run against an asset under the CMMS workflow with calibration / PM / corrective work, all evidenced under 21 CFR 211.67 + 820.70(g).
Primary sources
Further reading
Explore this topic
WO sits inside 2 overlapping topic clusters in our glossary. Every neighbour is one click away.
Where each shop-floor system fits and what it owns vs the ERP above it.
Material requirements planning, BOM explosion, net requirements, scheduling and demand signals that drive what the floor makes next.
Want to see how WO could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.