Held lot 24-331 on Line 3 at Op 30.
Seal torque out of range on the in-process check
Solutions · Operations
The line is held.The decision is on a call.
QA dispositions, engineering calls and lab results are chased through email and escalation calls, so holds stall and nobody can say later why a lot moved. Unifize runs the hold, the review and the release on one record the next shift can read.
Hold placed at the line
Runs wherever the line has to keep moving
If it stops the line, it has a home here.
The operations work plants actually run, as governed workflows: holds with an owner, releases with a reason, and commitments that change on the record instead of on a call.
Holds and disposition
Material held, reviewed and released, from receiving dock to returned goods.
- WIP Hold and Material Disposition
- Inbound Inspection and Quarantine
- Warehouse and Inventory Hold/Release
- Product Returns and RMA Processing
Running the line
The schedule, the changeover and the record of what each lot went through.
- Production Schedule Change and Exception
- Line Changeover and Process Setup
- Cleaning Validation and Changeover Verification
- Lot Traceability and Serialization
Equipment and facility
The equipment, environment and safety programmes the line depends on.
- Equipment Qualification and Calibration
- Environmental Monitoring and Facility Control
- Environmental Health and Safety Compliance
- Waste Management and Controlled Destruction
Commitments and transfer
What the plant promises, and what it takes on from development.
- Capacity Planning and Commitment
- On-Time Delivery and Shipment Commitment
- Technology Transfer Governance
- Design for Manufacturing
- Packaging Specification Management
- Shipping Documentation and Distribution Control
The lot moved. Nobody wrote down why.
The failure modes we see inside operations. None of them is a missing feature. All of them are decisions made on the floor that never reached the record.
- Production hold disposition stalls on documented rationaleThe call decides. The reason catches up days later, or never.
- Shop-floor decision rationale lost between shift handoffsThe next shift inherits the consequence without the reasoning.
- Travellers and batch records exist in paper plus three systemsPaper, MES, ERP and QMS each hold part of the batch.
- Standard work drifts from documented version on the lineThe document changes. The line keeps doing what works.
Lines held while the decision is chased through calls. Every held hour is the coordination tax.
Measure your coordination tax →Release the hold on the record, not on a call.
Most plant systems record that a lot was held and released. Unifize holds the disposition itself: the evidence, the review board's call and the signed release, on one record the next shift reads.
Execution and maintenance, on one record.
The Manufacturing Execution System runs the work orders, travellers and lot records; the maintenance product keeps the equipment they depend on calibrated and running.
Manufacturing Execution System
Work orders, travellers, inspections and lot records, signed at every operation.
- Work Order Management
- eTravellers
- FAI & Control Plan Execution
- Inspections, Forms & Checklists
- Electronic Batch/Lot Records
Maintenance management (CMMS)
Preventive maintenance, breakdowns, calibration and downtime on the same record.
- Preventive Maintenance Scheduling
- Breakdown & Work Order Management
- Calibration Management
- Asset Management and Tracking
- Downtime Reporting
- Spare Parts Inventory
- Labour Hours Tracking
It sits on the stack you already run.
Keep the ERP that holds orders and inventory, and the quality and lab systems that hold their records. The holds, dispositions and handovers between them run on Unifize, released with a 21 CFR Part 11 signature.
Proof, to the standard you'd hold us to.
A signed baseline, plus the plants that run their floor on Unifize, in their own words.
- Customer-attested · medical devices41%lower non-conformance coordination cost, measured in year oneMedical-device manufacturer$81,350 a year recovered against a signed $198,150 baselineSigned baseline, anonymized
Biovation LabsJesse Kolstad, Director of QualityBlending error decided on the floor instead of held
Mikala HukkaFinished-good lot process from half a day to 10 minutes
Dave AndersonConstructionOff shifts get decisions without first-shift engineers
Dave AndersonConstructionScan the ticket's barcode to open the part's conversation
Seth BozmanConstruction15 remake cards in 15 minutes, not an hour and a half
Harmonic BionicsMichael Hogan, Mechanical EngineerLinked records act as a virtual router for every part
Jarod MarkleyMedical Devices30-day calibration notice to ops, OOT opens an NC
When the line stops.
Each of these starts a clock, and each routes into a governed workflow, so the response is decided on the record it will be judged by.
Production hold pending disposition
Routes to Work Order Management · Nonconformance · owned by Production · QA · Engineering
Shortage-driven line stop
Routes to Work Order Management · owned by Planning · Operations · Procurement
MRB backlog
Routes to Nonconformance · Material review · owned by Quality · Engineering · Materials
Release the hold. Keep the reason.
Bring one real hold, a stalled disposition or an aging review-board queue, and see it run on your own work in a 30-minute walkthrough.