WOWork Order

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).

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.

• 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.

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).

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.

• 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.

• 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.