Routing – Operation Sequence & Resources

This topic is part of the SG Systems Global manufacturing & compliance glossary.

Updated October 2025 • Manufacturing Master Data • MES, Planning, QMS, Supply Chain

Routing is the formal definition of how work flows through the plant—the ordered list of operations, required resources (machines, tooling, labor, test equipment), time standards (setup/run/queue/move), in‑process checks, and quality interlocks that turn a BOM and recipe into a reliable, repeatable process. In regulated industries, routings are the backbone of the Master Manufacturing Record (MMR) / Master Batch Record (MBR) and the executed eBMR, ensuring that materials, people, and equipment are aligned with specifications, controls, and release requirements.

Think of routing as the plant’s contract with itself: which steps, in what order, with which resources and controls, to deliver the promised quality at the promised rate.

1) What a Routing Covers—Core Elements

• Operation sequence: the ordered steps from kitting and setup through build, inspection, labeling, and pack & ship.
• Work centers & machines: primary and alternate resources, capabilities, and calibration status interlocks.
• Tooling & fixtures: IDs, status, and changeover requirements.
• Labor & skills: roles, qualifications, and dual‑verification when required (dual verification).
• Time standards: setup, run rate, queue, move, and teardown; lot‑size and batch‑size factors; overlap and wait rules.
• Material events: where components are kitted, staged, issued, backflushed, or verified (directed picking, FEFO/FIFO).
• Quality gates & data collection: IPC points, SPC alert/action limits, poka‑yoke, sampling, and sign‑offs.
• Device integrations: scales (gravimetric weighing), vision (machine vision), barcode label verification/UDI.
• Traceability steps: lot genealogy, serialization, SSCC, and EPCIS event capture.
• Compliance interlocks: line clearance, cleanliness/HTS, expiry/quarantine, hold/release.

2) Routing vs BOM vs Traveler vs Production Order

• BOM lists what goes into the product; Routing defines how it’s made.
• A Production Order / Job Ticket instantiates the plan for a lot or work order using the routing + BOM.
• The Job Traveler operationalizes the routing—presenting step‑by‑step instructions, scans, device prompts, and sign‑offs in the MES.

In regulated operations, the routing, BOM, and specs are part of the MMR/MBR and drive the executed eBMR under 21 CFR Part 11 and EU Annex 11 requirements.

3) Operation Design—Granularity, Times, and Yields

Choose an operation granularity that supports planning, execution, and analysis without drowning operators in clicks. Typical attributes include:

• Setup/Changeover time: include family changeover rules and cleaning steps; log hold times when applicable.
• Run time standards: per unit or per lot; allow for scale effects and parallelization.
• Queue & move time: explicitly model waiting and transfer to inform WIP age and takt.
• Operation yield: expected % pass‑through; capture scrap/rework branches and NCR triggers.
• Overlaps & constraints: allow next operation to start after a % completion; model resource exclusivity when needed.

These parameters drive planning (MRP), finite capacity scheduling, and dispatching (finite capacity, MES dispatch), and they set realistic expectations for OEE improvement.

4) Resource Modeling—Work Centers, Alternates, and Capabilities

• Primary/alternate work centers: define equivalent machines and routing branches to absorb breakdowns or planned maintenance.
• Capabilities: speed ranges, force, volume, accuracy; tie to recipe parameters and OQ limits.
• Status interlocks: prevent start when assets are out of tolerance or overdue for calibration or when materials are in quarantine.
• Labor certification: enforce qualified operator roles and dual‑sign-offs for critical tasks.
• Tool life: integrate counters to force inspection or replacement at limits (poka‑yoke).

5) Material Flow & Warehouse Touchpoints

Good routing clarifies where materials are verified, issued, consumed, and moved:

• Kitting & staging: drive kitting tickets, reserve lots/serials by FEFO/FIFO, and stage to the correct bin/zone.
• Backflush points: tie component consumption to specific operations for accurate yield and cost.
• Verification: enforce barcode/UDI checks and weighing at the right station.
• Transfer & WIP moves: specify move transactions between cells; keep genealogy intact (genealogy).
• Pack & ship hooks: integrate labeling, SSCC, and ASN creation; validate ship sets.

These handoffs align MES with WMS to reduce misses and speed compliant order fulfillment.

6) Quality by Design—Controls in the Routing

Use risk tools like PFMEA to identify failure modes and drive control points into the routing via a Process Control Plan (PCP). Typical controls include:

• In‑Process Controls (IPC): spec checks with alert/action limits and auto‑holds.
• Integrated testing: vision, leak test, torque, balance; attach raw data to the eBMR.
• Label & content checks: UDI and claim verification to prevent mislabeling.
• Sampling: structured per your GMP/statistical plans.
• Release interlocks: enforce QA disposition criteria and restrict shipment until complete.

Embedding controls in the routing turns quality from a downstream gate into an in‑line, real‑time system of prevention and evidence (QbD, PAT).

7) Compliance & E‑Records

Route masters and their execution are controlled records. Manage them under Document Control, with versioning, approvals, and e‑signatures per Part 11/Annex 11. Align content with cGMP, device 21 CFR 820, and drug 21 CFR 211. Execution creates the eBMR/DHR, complete with audit trails, instrument data, and signatures for QC evidence and QA review.

8) Alternatives, Rework, and Exceptions

• Alternate routings: pre‑approved paths for different equipment, sites, or process variants.
• Rework loops: conditional branches driven by inspection results; attach NCR/CAPA references.
• Engineering trials: temporary variants under Change Control, time‑boxed and tagged as non‑standard.
• Make‑to‑order vs. make‑to‑stock: parameterized steps pull product options into the eBMR without proliferating master data.

9) Scheduling—From Plan to Dispatch

Routings are the engine for realistic scheduling:

• Capacity loading: setup/run standards convert orders into resource hours for finite scheduling.
• Sequence rules: family batching and changeover minimization; “hot” order bumping with controls.
• Dispatching: MES job queues push the next best job to each cell with right‑now material and tool checks.
• Release controls: don’t drop work until kitting and constraints are green (job release).
• Line balancing: use operation times to split work and level the line (line balancing).

This closes the loop with MRP, improving lead time, OEE, and OTIF.

10) Serialization & End‑to‑End Traceability

Where serialization is required, the routing defines the moment of serial assignment, print/verify, aggregation to cases/pallets (SSCC), and publication of EPCIS events. These steps must interlock with label content controls and shipment blocks until QA release is granted.

11) Governance—Versioning, MOC, and Periodic Review

• Version control: each routing revision is effective‑dated; old jobs complete on the version they started.
• Management of Change: every edit is assessed for risk and validated (MOC/Change Control).
• Periodic review: evaluate performance, deviations, RCA, and CAPA to refresh controls and times.
• Inspection readiness: retain route masters, approvals, and executed evidence per your Retention & Archival policy.

12) KPIs & Analytics—Proving the Routing Works

• Plan vs. actual time by operation and by work center; drive continuous improvement.
• First‑pass yield and top PFMEA risks by operation.
• Queue time & WIP age to reveal bottlenecks and over‑release.
• Changeover loss quantified for OEE.
• Right‑first‑time eBMR completion rate and OOS/OOT trends.

Make the routing your baseline: if the data says reality differs, either the process or the standard needs to change—with controls.

13) Implementation Blueprint—From Paper to Digital

1. Map the process: enumerate operations, resources, controls, and handoffs to WMS and QC.
2. Parameterize: define setup/run/queue/move, yields, alternates, and skill requirements.
3. Embed controls: pull PFMEA risks into the PCP and attach to routing steps.
4. Validate devices: integrate scales, vision, barcode, and labelers with OQ evidence.
5. Govern: route master approved under Document Control and change‑controlled.
6. Pilot & iterate: compare plan vs. actual, tune standards, then roll out.

Digitization culminates in a live, controlled eBMR/digital traveler that proves compliance and accelerates throughput.

14) How This Fits with V5 by SG Systems Global

V5 Solution Overview. The V5 platform is purpose‑built for validated execution. Configuration is version‑controlled, evidence is attributable, and cross‑module interlocks (identity, status, signatures) are testable and reportable—ideal for cGMP rigor and life‑cycle control.

V5 MES. Routing masters drive the digital traveler with effective‑dated steps, device prompts (scales, vision), IPC/SPC checks, line‑clearance, and e‑signatures. Interlocks stop execution when materials are expired or quarantined, or when equipment lacks valid calibration status.

V5 QMS. Route changes run through MOC/Change Control, linked to PFMEA/PCP updates and training acknowledgements, with periodic review packs ready for audit.

V5 WMS. Kitting, directed picking, FEFO/FIFO, bin/zone staging, and pack/ship are orchestrated off routing signals, ensuring materials arrive right‑first‑time and shipments carry validated labels, SSCC, and ASN.

Bottom line: V5 turns routing into a living control system—every interlock you design into the route is the same interlock that protects production tomorrow.

15) FAQ

Q1. How detailed should a routing be?
Detailed enough to schedule and collect evidence, but not so granular that it fragments operator focus. A good test: each operation should have a clear start/stop, a resource owner, measurable time, and at least one data/quality outcome.

Q2. What’s the best way to handle alternates?
Pre‑approve alternate work centers with capability limits and equivalent validations. Use routing branches with the same quality gates and device integrations, so switching doesn’t weaken controls.

Q3. How do routings connect to WMS?
Define kitting, staging, and backflush points in the routing and map them to real bin/zone locations. Enforce FEFO/FIFO, quarantine checks, and label verifications at those touchpoints.

Q4. Where should serialization occur?
At the point where unit identity is stable and labels can be verified—typically post‑test and pre‑pack. The routing should print/verify, aggregate to SSCC, and publish EPCIS events before any release to logistics.

Q5. How are rework loops governed?
As explicit, approved branches with entrance/exit criteria, limits on repeats, and links to NCR/CAPA. Evidence must show original failure, corrective steps, and retest pass.

Q6. Can we change the routing mid‑lot?
Only via controlled deviation or approved temporary change under Change Control. The eBMR/DHR must show the rationale, approvals, and impact assessment.

Q7. Who owns routing content?
Process Engineering authors the technical content; QA governs approvals and compliance; Operations owns practicality; IT/MES ensures validated execution. All under the QMS.

Q8. How do we prove the routing works?
Compare plan vs. actual times, yields, and defects by operation; verify device data capture and SPC performance; show that holds and release criteria are enforced, with retained evidence.

Q9. When should labels and UDI checks appear?
As dedicated operations with scan/verify and content rules, ideally downstream of any process steps that change identity or grade, and upstream of packing/aggregation to avoid relabel loops.

Q10. How often should we review routing standards?
On a defined periodic cycle and whenever deviations, CAPAs, or performance deltas exceed thresholds. Tie updates to PFMEA/PCP refresh and run through MOC.

Related Reading
• Execution Core: MES | Job Traveler | Job Queue & Dispatching | Finite Capacity Scheduling | Job Release
• Master Data: BOM | MMR | MBR | eBMR
• Quality Controls: PFMEA | Process Control Plan | IPC | SPC Limits | Poka‑Yoke | Quality Control (QC) | Quality Assurance (QA)
• Devices & Labels: Machine Vision | Gravimetric Weighing | Label Verification & UDI
• Warehouse & Shipping: WMS | Bin & Zone Topology | Directed Picking | Kitting | Pack & Ship
• Traceability: Lot Genealogy | Serialization | SSCC | EPCIS | ASN
• Governance: Document Control | Change Control | MOC | 21 CFR Part 11 | Annex 11 | cGMP