Chapter 2: Core Manufacturing Concepts and Terminology

Introduction: Speaking the Language of the Shop Floor

Picture this: You're in a conference room at a mid-sized automotive supplier. The VP of Operations says, "Our OEE is at 68%, mainly due to availability losses during changeovers. We need better backflushing from MES to ERP so our BOM accuracy improves and MRP doesn't overorder components."

If these terms sound like alphabet soup, you're not alone—but you can't afford to be confused. In manufacturing, precision in language equals precision in execution. Misunderstanding "lead time" versus "cycle time" can result in a $2M inventory miscalculation. Confusing "discrete" and "process" manufacturing can lead you to propose entirely the wrong system architecture.

This chapter is your Rosetta Stone for manufacturing IT consulting. We'll decode the essential concepts, define the critical terminology, and show you how to speak fluently with plant managers, engineers, and C-suite executives. Mastering this language isn't just about communication—it's about credibility, accurate requirements gathering, and designing solutions that actually work.


Manufacturing Process Types: Understanding the Fundamentals

Not all manufacturing is created equal. The way products are made fundamentally shapes the IT systems, data models, and KPIs that matter. Before you recommend any technology, you must understand which type of manufacturing your client operates.

Discrete Manufacturing

Definition: Production of distinct items that can be counted, touched, and disassembled. Each unit has a unique identity.

Examples:

  • Automotive: Cars, engines, transmissions
  • Aerospace: Aircraft, satellites, turbines
  • Electronics: Smartphones, computers, circuit boards
  • Industrial Equipment: Pumps, motors, HVAC systems

Characteristics:

  • Bill of Materials (BOM): Hierarchical structure of components
  • Assembly: Parts come together to form a product
  • Serialization: Often tracked by serial number or lot number
  • Variability: High-mix, low-volume OR low-mix, high-volume
  • Quality: Measured per unit (pass/fail, defects per million)

IT Systems Emphasis:

  • PLM (Product Lifecycle Management) for complex BOMs
  • Work order management and routing
  • Serialization and traceability
  • Capacity planning and scheduling

Table 2.1: Discrete Manufacturing KPIs

KPIDescriptionTypical TargetIT System Source
Units Per Hour (UPH)Throughput rateVaries by productMES, SCADA
First Pass Yield (FPY)% of units passing without rework>95%MES, QMS
Takt TimeAvailable time / customer demandMatch demandMES, ERP
Changeover TimeTime to switch from Product A to Product B<10 min (SMED)MES, operator logs
Scrap Rate% of materials wasted<2%MES, ERP

Real-World Example: At a John Deere tractor assembly plant, each tractor has a unique configuration—cab color, engine type, tire size, GPS package. The BOM has 5,000+ line items, and no two tractors might be identical. IT systems must track which specific components went into serial number XYZ123 for warranty, recall, and compliance purposes.


Process Manufacturing

Definition: Production where ingredients are combined through chemical reactions, heating, fermentation, or other transformations. The final product cannot be disassembled back into its components.

Examples:

  • Food & Beverage: Beer, yogurt, cereal, soft drinks
  • Chemicals: Paints, adhesives, petrochemicals, fertilizers
  • Pharmaceuticals: Tablets, injections, biologics
  • Cosmetics: Shampoos, lotions, makeup

Characteristics:

  • Recipe/Formula: Specifies ingredients, quantities, and process steps
  • Batch or Continuous: Produced in discrete batches (beer) or continuously (gasoline refining)
  • Homogeneity: Product is uniform; individual units aren't unique
  • Quality: Measured by sample testing (viscosity, pH, potency)
  • By-Products and Waste: Often produce secondary materials

IT Systems Emphasis:

  • Recipe management and versioning
  • Batch genealogy and traceability (which ingredients went into which batch)
  • SPC (Statistical Process Control) for quality
  • Process historians for time-series data (temperature, pressure)
  • Clean-in-Place (CIP) and sanitation tracking

Table 2.2: Process Manufacturing KPIs

KPIDescriptionTypical TargetIT System Source
Batch YieldActual output / theoretical output>98%MES, SCADA
First Pass Right (FPR)% of batches passing spec without rework>95%QMS, LIMS
SPC Cp/CpkProcess capability indicesCpk >1.33QMS, SPC software
CIP Cycle TimeTime for cleaning between batchesMinimizeMES, SCADA
Shelf Life Compliance% of product within expiry targets100%ERP, QMS

Real-World Example: At a Coca-Cola bottling plant, the syrup recipe is tightly controlled. Each batch (say, 10,000 liters) must have exact proportions of water, sugar, flavoring, and carbonation. If a quality issue arises, the system must trace back to the specific batch of sugar (Lot# S-45321) and water treatment run (Run# W-2024-05-18-03) to identify the root cause.


Continuous Manufacturing

Definition: A subset of process manufacturing where production runs 24/7 without stopping. Product flows continuously through the process.

Examples:

  • Oil refining
  • Steel production
  • Chemical plants (ammonia, ethylene)
  • Pulp and paper mills
  • Power generation

Characteristics:

  • Never Stops: Shutdowns only for maintenance (every 1-5 years)
  • High Volume, Low Variability: Same product for weeks/months
  • Capital Intensive: Facilities cost billions of dollars
  • Safety Critical: Process upsets can be catastrophic
  • Real-Time Control: Millisecond-level adjustments via DCS (Distributed Control Systems)

IT Systems Emphasis:

  • DCS and advanced process control (APC)
  • Real-time historians (OSIsoft PI, Honeywell PHD)
  • Predictive maintenance (equipment failures halt entire plant)
  • Energy management and optimization
  • Safety instrumented systems (SIS)

Key Difference from Batch:

  • Batch: Start → Process → Stop → Start next batch
  • Continuous: Always running, product constantly flowing

Hybrid Manufacturing

Many modern manufacturers blend discrete and process approaches, known as hybrid or mixed-mode manufacturing.

Examples:

  • Automotive: Painting (process) + assembly (discrete)
  • Electronics: SMT soldering paste application (process) + component placement (discrete)
  • Food: Dough mixing (process) + cookie cutting and packaging (discrete)
  • Pharmaceuticals: Drug formulation (process) + tablet pressing and packaging (discrete)

IT Challenge: You need systems that handle both discrete work orders (with BOMs and routings) and process batch records (with formulas and process parameters). This is why platforms like SAP S/4HANA and Siemens Opcenter offer both MES-Discrete and MES-Process modules.


The Core Data Structures: BOM, Routing, and Work Orders

These three structures are the backbone of manufacturing planning and execution. Understanding them deeply is non-negotiable.

Bill of Materials (BOM)

Definition: A structured, hierarchical list of all components, sub-assemblies, and raw materials required to manufacture a product.

BOM Structure Example: Office Chair

BOM Types:

BOM TypePurposeManaged ByExample
Engineering BOM (EBOM)Design intent from CADPLM (Product Lifecycle Management)All components as designed, regardless of how they're procured
Manufacturing BOM (MBOM)How it's actually builtERP + MESMay group components into kits; reflects assembly sequence
Service BOMSpare parts and maintenanceService Management SystemIncludes wear items, consumables
Sales BOMCustomer-facing configurationsCRM, Configure-Price-Quote (CPQ)Options and add-ons customers can select

BOM Attributes:

AttributeDescriptionExample
Parent ItemThe finished good or sub-assemblyFG-CHAIR-001
Child ItemComponent or sub-assemblySC-100 (Seat Cushion)
QuantityHow many of the child per parent4 bolts per seat assembly
Unit of Measure (UOM)How the component is measuredEach, kg, liters, meters
Scrap FactorExpected waste percentage2% scrap on fabric cutting
Lead Time OffsetWhen component is needed relative to startInstall cushion at Step 3
Effectivity DatesWhen this BOM version is validEffective from 2024-06-01
Phantom ItemsSub-assembly not stocked, built on-the-flyKits assembled just-in-time

Common BOM Challenges:

ChallengeSymptomIT ImpactSolution
BOM InaccuracyMRP orders wrong quantitiesStockouts or excess inventoryRegular BOM audits, engineering change control
EBOM vs MBOM SyncEngineering changes don't reach productionBuilding obsolete designsPLM ↔ ERP integration, change workflows
Configuration ExplosionMillions of possible combinationsUnmanageable SKU countModular BOMs, variant configuration
Phantom Item MisuseInventory discrepanciesPhysical stock doesn't match systemClear phantom policy, regular cycle counts

Real-World Scenario: An aerospace manufacturer makes engine control units with 200+ variants based on aircraft model, engine type, and customer options. Instead of maintaining 200 BOMs, they use a super BOM with variant options. During work order creation, the configurator selects the correct components based on order specifications, generating a configured BOM on-the-fly.


Routing

Definition: The sequence of operations, work centers, and resources required to manufacture a product.

Routing Structure Example: Office Chair Assembly

Table 2.3: Routing for Office Chair (FG-CHAIR-001)

Op #Operation DescriptionWork CenterStd Time (min)Setup Time (min)MachineLabor RequiredQuality Check
10KittingWC-KIT-0150Manual1 operatorVisual inspection
20Attach Gas Cylinder to BaseWC-ASM-01210Pneumatic press1 operatorTorque check
30Install CastersWC-ASM-0130Manual1 operatorN/A
40Assemble Seat to BackrestWC-ASM-0245Manual + fixtures1 operatorAlignment check
50Mount Seat Assembly to BaseWC-ASM-0230Manual1 operatorLoad test
60Final InspectionWC-QC-0120Test rig1 QC inspector15-point checklist
70PackagingWC-PACK-0150Manual1 operatorShipping label scan

Key Routing Attributes:

  1. Operation Number: Sequential identifier (10, 20, 30... allows insertions like 15, 25)
  2. Work Center: Where the operation is performed (links to capacity planning)
  3. Standard Time: Expected duration per unit (used for costing and scheduling)
  4. Setup Time: One-time preparation before a batch (e.g., tooling changes)
  5. Resource Requirements: Machines, labor, tooling, fixtures
  6. Quality Gates: Inspection points and acceptance criteria

Routing Types:

TypeDescriptionUse Case
Linear RoutingEvery product follows the exact same sequenceHigh-volume, standardized products
Network RoutingConditional branches based on options"If customer selected leather, go to Op 42; if fabric, skip to Op 50"
Alternate RoutingMultiple ways to make the same productBackup work centers if primary is down
Overlapping RoutingNext operation starts before previous finishesContinuous flow, reduce lead time

MES Role: The MES (Manufacturing Execution System) dispatches work orders based on routings, tracks which operation is currently in progress, collects actual time vs. standard time, and enforces quality gates.


Work Order

Definition: An instruction to produce a specific quantity of a specific product using a defined BOM and routing.

Work Order Lifecycle:

Work Order Structure:

FieldDescriptionExample
Work Order NumberUnique identifierWO-2024-05-12345
Product (SKU)What to produceFG-CHAIR-001
QuantityHow many units500 units
BOM VersionWhich BOM to useBOM-CHAIR-001-Rev.C
Routing VersionWhich routing to useRTG-CHAIR-001-Rev.B
Planned Start DateWhen to begin2024-06-01 08:00
Planned End DateWhen to finish2024-06-05 17:00
PriorityRelative urgencyHigh / Normal / Low
Work CenterWhere it's made (first operation)WC-ASM-01
StatusCurrent stateCreated / Released / In Progress / Completed
Parent OrderSales order or forecast driving demandSO-123456

Work Order Reporting Methods:

MethodDescriptionProsConsTypical Use
BackflushingAutomatically deduct components when WO is completedFast, low operator burdenAssumes BOM accuracy, no scrap trackingHigh-volume, stable processes
Preflush (Forward Flush)Deduct components when WO is releasedSimple inventory reliefInaccurate if WO is canceledKitting operations
Point-of-UseDeduct as each operation consumes materialsAccurate WIP trackingRequires scanning at each stepAerospace, pharma (high traceability)

Confirmation Data Captured:

When a work order is completed, the system captures:

  • Actual Quantity Produced: Good units, scrap units, rework units
  • Actual Time: Labor hours, machine hours per operation
  • Actual Materials: Component lots consumed (for traceability)
  • Quality Results: Inspection measurements, pass/fail status
  • Downtime Events: Reasons and duration of stoppages
  • Operator IDs: Who performed each operation (for training, certification)

ERP ↔ MES Integration:


Material Requirements Planning (MRP)

Definition: A system for calculating material needs based on demand, inventory on-hand, and lead times, then generating purchase requisitions and production orders to meet that demand.

MRP Logic Flow

Table 2.4: MRP Calculation Example

Assume we need to produce 1,000 Office Chairs (FG-CHAIR-001) by June 30.

ItemLevelQty per ParentGross RequirementOn-Hand InventoryScheduled ReceiptsNet RequirementOrder QuantityOrder Due Date
Office Chair01,000500950950June 30
Seat Assembly119502000750750June 28 (2 days LT)
Base Assembly11950100500 (PO in-transit)350350June 25 (5 days LT)
Gas Lift Cylinder2135000350400 (round up to MOQ)June 18 (7 days LT)

MRP Parameters:

ParameterDefinitionImpact
Lead TimeTime from order placement to receiptDetermines order due date
Safety StockBuffer inventory to handle variabilityIncreases order quantity
Lot SizingHow much to order (Fixed, EOQ, Lot-for-Lot)Balances setup costs vs. holding costs
Minimum Order Quantity (MOQ)Vendor-imposed minimumMay order more than needed
Scrap FactorExpected waste percentageIncreases gross requirement

MRP Limitations:

LimitationExplanationSolution
Assumes Infinite CapacityDoesn't check if work centers are availableUse APS (Advanced Planning & Scheduling)
Fixed Lead TimesDoesn't account for queue time variabilityDynamic lead time models, finite scheduling
No Consideration of WIPTreats everything as "not started" or "done"Real-time MES feedback to ERP
NervousnessSmall demand changes cause large order swingsDampening parameters, planning fences

Real-World Challenge: A consumer electronics manufacturer ran MRP daily, and every day it rescheduled thousands of purchase orders, confusing suppliers and increasing costs. Solution: Implement planning time fences—within 2 weeks, MRP can't automatically reschedule; beyond 2 weeks, it can. This reduced supplier chaos by 70%.


Time-Based Metrics: Takt Time, Cycle Time, and Lead Time

These three metrics are constantly confused but are fundamentally different. Mastering them is critical.

Takt Time

Definition: The rate at which finished products must be produced to meet customer demand.

Formula:

Takt Time = Available Production Time per Period / Customer Demand per Period

Example:

  • Customer orders: 400 units per day
  • Available production time: 8 hours/day = 480 minutes
  • Takt Time = 480 min / 400 units = 1.2 minutes per unit

Meaning: To meet demand, you must complete one unit every 1.2 minutes.

Takt Time is:

  • Demand-Driven: Set by the customer, not by your process capability
  • A Target: The pace your process must achieve
  • Used for Line Balancing: Each workstation should take ≤ Takt Time

IT Application: MES systems can display real-time Takt vs. Actual Cycle Time on Andon boards, alerting operators when they fall behind.


Cycle Time

Definition: The actual time it takes to complete one unit through a specific operation or the entire process.

Example:

  • Operation 20 (Attach Gas Cylinder): 2 minutes per unit
  • Operation 30 (Install Casters): 3 minutes per unit

Cycle Time is:

  • Process-Driven: Based on your current capability
  • Measurable: Collected by MES, operators, or sensors
  • Variable: Can change due to operator skill, machine condition, etc.

Ideal State:

Cycle Time ≤ Takt Time

If Cycle Time > Takt Time, you can't meet demand without overtime or adding capacity.


Lead Time

Definition: The total elapsed time from order placement (or start of production) to delivery (or completion).

Types of Lead Time:

TypeDefinitionExample
Manufacturing Lead TimeTime from WO release to WO completion5 days for a batch of 1,000 chairs
Procurement Lead TimeTime from PO issuance to receipt30 days for imported components
Customer Lead TimeTime from order to delivery10 days quoted to customer
Cumulative Lead TimeSum of all sequential lead timesLongest path through BOM + routing

Lead Time Components:

Total Lead Time = Queue Time + Setup Time + Run Time + Wait Time + Move Time
ComponentDescriptionTypical %Improvement Opportunity
Queue TimeWaiting for the work center to be available60-80%Better scheduling, level loading
Setup TimePreparing machine/tools5-15%SMED (Single-Minute Exchange of Die)
Run TimeActual processing10-20%Process optimization, automation
Wait TimeWaiting for next operation or inspection5-10%Overlapping operations, batch size reduction
Move TimeTransportation between work centers1-5%Cell layout, automated material handling

Shocking Reality: In many job shops, value-added time (run time) is only 10-15% of total lead time. The other 85-90% is waste.

IT Impact: Real-time production tracking (MES) exposes where time is being lost, enabling targeted improvement initiatives.


Table 2.5: Takt Time vs. Cycle Time vs. Lead Time Summary

MetricDriven ByMeasuresTypical ValueIT System
Takt TimeCustomer demandRequired production pace1-5 minutes (high volume)ERP demand, MES display
Cycle TimeProcess capabilityActual production pace per operationVaries by operationMES, SCADA, time studies
Lead TimeEntire value streamOrder-to-delivery durationDays to weeksERP, MES, supply chain system

Overall Equipment Effectiveness (OEE): The Gold Standard

OEE was introduced briefly in Chapter 1, but it deserves deeper exploration as it's the single most important shop-floor metric.

OEE Formula Breakdown

OEE = Availability × Performance × Quality

Let's walk through a real production shift:

Scenario: 8-Hour Shift, Producing Widgets

ParameterValue
Shift Duration480 minutes
Planned Downtime (breaks, meetings)30 minutes
Planned Production Time450 minutes
Unplanned Downtime (breakdowns, changeovers)50 minutes
Operating Time400 minutes
Ideal Cycle Time0.5 min/part
Total Parts Produced700
Good Parts (no defects)665

Availability:

Availability = Operating Time / Planned Production Time
             = 400 / 450 = 88.9%

Performance:

Ideal Production (if running at full speed for 400 min) = 400 / 0.5 = 800 parts
Actual Production = 700 parts
Performance = 700 / 800 = 87.5%

Quality:

Quality = Good Parts / Total Parts
        = 665 / 700 = 95%

OEE:

OEE = 88.9% × 87.5% × 95% = 73.8%

Interpretation:

  • 73.8% OEE is below world-class (>85%) but above poor (<60%)
  • Top loss: Availability (11.1% loss) due to unplanned downtime
  • Action: Prioritize predictive maintenance to reduce breakdowns

The Six Big Losses

OEE losses fall into six categories:

Table 2.6: Six Big Losses Framework

CategoryLoss TypeExamplesOEE Component AffectedIT Solution
Downtime1. Equipment FailuresBreakdowns, crashesAvailabilityPredictive maintenance (IoT sensors, ML)
Downtime2. Setup & AdjustmentsChangeovers, warm-upsAvailabilitySMED techniques, digital work instructions
Speed Losses3. Idling & Minor StopsJams, sensor blockagesPerformanceRoot cause analysis (MES event tracking)
Speed Losses4. Reduced SpeedRunning below rated speedPerformanceProcess optimization, SPC
Defects5. Startup RejectsScrap during ramp-upQualityStatistical process control, auto-adjustments
Defects6. Production RejectsScrap during steady-stateQualityAI quality inspection, closed-loop feedback

Real-World Example: A food packaging line had OEE of 62%. Pareto analysis (from MES data) revealed:

  • 40% of losses: Availability (mostly jams in the labeling machine)
  • 35% of losses: Performance (line ran at 85% of rated speed)
  • 25% of losses: Quality (inconsistent seal quality)

Solution:

  1. Installed vision system to detect jams early → +8% OEE
  2. Upgraded servo motors for consistent speed → +5% OEE
  3. Added inline seal inspection → +4% OEE

New OEE: 79%, a 27% improvement in effective capacity.


Lean Manufacturing and Continuous Improvement

Manufacturing isn't static—it's a continuous journey of eliminating waste and improving flow. IT consultants must understand Lean principles to design systems that enable, not hinder, improvement.

The Eight Wastes (DOWNTIME)

WasteDescriptionIT Enabler
DefectsProducing scrap or reworkAI quality inspection, SPC alerts
OverproductionMaking more than neededPull systems (Kanban), real-time demand signals
WaitingIdle time between operationsMES scheduling, bottleneck visibility
Non-Utilized TalentNot using people's skills/ideasCollaboration platforms, digital suggestion systems
TransportationUnnecessary movement of materialsAGVs, warehouse management systems
InventoryExcess stockReal-time inventory tracking, JIT replenishment
MotionUnnecessary movement of peopleErgonomic workstation design, pick-to-light
Excess ProcessingDoing more than customer requiresValue stream mapping, standard work

Six Sigma and Statistical Process Control (SPC)

Six Sigma Goal: Reduce process variation to achieve ≤ 3.4 defects per million opportunities (DPMO).

Process Capability Indices:

Cp (Process Capability):

Cp = (USL - LSL) / (6 × σ)

Where:

  • USL = Upper Specification Limit
  • LSL = Lower Specification Limit
  • σ = Process Standard Deviation

Cpk (Process Capability Index, accounting for centering):

Cpk = min[(USL - μ) / (3σ), (μ - LSL) / (3σ)]

Table 2.7: Process Capability Interpretation

Cpk ValueInterpretationDPMOQuality LevelAction
< 1.0Process not capable>2,700UnacceptableImmediate improvement required
1.0 - 1.33Minimally capable2,700 - 63AcceptableMonitor closely, improve
1.33 - 1.67Capable63 - 0.6GoodMaintain, continue monitoring
> 1.67Highly capable<0.6ExcellentPossible over-engineering; relax tolerances?

SPC Control Charts:

Control charts visualize process stability over time.

Example: X-bar Chart for Widget Diameter

   UCL (Upper Control Limit) ─────────────────── 10.05 mm
                                    •
                              •         •
   Target (Mean) ────────── • ─ • ─ • ─ • ────── 10.00 mm
                          •           •
                                    •
   LCL (Lower Control Limit) ─────────────────── 9.95 mm

   Sample:  1   2   3   4   5   6   7   8   9

Rules for Out-of-Control:

  1. Any point outside UCL/LCL → Special cause variation
  2. 7+ consecutive points above or below centerline → Process shift
  3. Increasing or decreasing trend → Tool wear, drift

IT System Role: QMS and MES systems automatically collect measurements, calculate control limits, and alert when processes go out of control—enabling real-time intervention.


Kaizen and Continuous Improvement

Kaizen (改善): Japanese for "change for better." A philosophy of continuous, incremental improvement involving everyone from the CEO to frontline workers.

Kaizen Event Structure

Table 2.8: Typical 5-Day Kaizen Event

DayActivitiesDeliverables
Day 1Kick-off, current state mapping, gemba walkProblem statement, baseline metrics
Day 2Root cause analysis (5 Whys, Fishbone), brainstormingList of improvement ideas
Day 3Implement quick wins, test solutionsPilot implementations
Day 4Refine solutions, create standard workUpdated procedures, visual controls
Day 5Validate results, document, present to leadershipImproved metrics, sustainability plan

IT's Role in Kaizen:

  • Before: Provide baseline data (OEE, defect rates, cycle times) from MES/SCADA
  • During: Support rapid testing of new workflows in systems
  • After: Update standard work in digital systems, track improvement sustainability via dashboards

Data and Interoperability: Bringing It All Together

Manufacturing concepts only matter if the data flows correctly between systems.

The Master Data Challenge

Master Data = The nouns of manufacturing:

  • Products (SKUs, part numbers)
  • BOMs and routings
  • Customers and suppliers
  • Equipment and work centers
  • Locations (warehouses, bins)

Transactional Data = The verbs:

  • Work orders, purchase orders, sales orders
  • Inventory movements, shipments
  • Quality inspections, maintenance tickets

Challenge: Master data is maintained in multiple systems (ERP, PLM, MES, QMS), and discrepancies cause chaos.

Common Discrepancies:

IssueExampleImpactSolution
BOM MismatchPLM has Rev. D, ERP has Rev. CBuilding obsolete productsSingle source of truth (PLM master, sync to ERP)
Routing DriftMES has 7 operations, ERP has 6Incorrect costing, schedulingChange control workflow, periodic reconciliation
Duplicate PartsSame gasket as PN-1234 and GSKT-5678Inventory bloat, missed opportunities for consolidationData stewardship, deduplication tools
Stale DataDiscontinued parts still activeMRP generating purchase reqs for obsolete itemsLifecycle management, automated archiving

ISA-95 Data Flows

Recall from Chapter 1 that ISA-95 defines five levels. Data must flow bidirectionally but with clear governance.

Table 2.9: ISA-95 Data Exchange Examples

DirectionData TypeExampleFrequencyProtocol
ERP → MESWork OrderProduce 500 units of SKU-123HourlyREST API, OPC UA
MES → ERPProduction ConfirmationCompleted 480 units, 20 scrappedPer shiftREST API, message queue
PLM → MESWork InstructionsUpdated assembly procedure (Rev. E)On changeFile transfer, API
MES → QMSQuality ResultsInspection measurements, lot#Per testDatabase replication, API
SCADA → MESEquipment EventsMachine X stopped, reason code = jamReal-timeOPC UA, MQTT
MES → SCADARecipe/SetpointLoad Recipe 42, set temp to 185°CPer batchOPC UA

Security and Compliance: Terminology Edition

Electronic Records and Signatures (FDA 21 CFR Part 11)

In regulated industries (pharma, medical devices), manufacturing records must meet strict criteria.

ALCOA+ Principles:

PrincipleMeaningIT Implementation
AttributableRecord linked to person who created itUser authentication, digital signatures
LegibleReadable throughout retention periodArchival formats (PDF/A), metadata
ContemporaneousCreated at the time of activityTime-stamped entries, no backdating
OriginalPrimary record (not a copy)Master database, audit trails
AccurateTruthful, error-freeData validation, review workflows
+CompleteAll data presentNo selective deletion, full context
+ConsistentChronological sequence preservedImmutable logs, blockchain (emerging)
+EnduringDurable for retention period (often 10+ years)Backups, disaster recovery
+AvailableAccessible for audits/inspectionsSearch, reporting tools, export functions

Example: A pharmaceutical MES must log:

  • Who: Operator ID (Jane Smith, badge #4321)
  • What: Added 50 kg of Ingredient B to Batch XYZ
  • When: 2024-05-18 14:32:17 UTC
  • Electronic Signature: Reviewed by Supervisor (John Doe, badge #1234) at 14:35:22 UTC

This record must be tamper-evident and retrievable for FDA inspections up to 10 years later.


KPIs and Metrics Glossary

Table 2.10: Essential Manufacturing KPIs

KPIFormulaTargetSystem Source
OEEAvailability × Performance × Quality>85%MES
First Pass Yield (FPY)(Good Units / Total Units) × 100%>95%MES, QMS
Scrap Rate(Scrap Units / Total Units) × 100%<2%MES, ERP
On-Time Delivery (OTD)(Orders Delivered On-Time / Total Orders) × 100%>95%ERP
Schedule Adherence(Actual Production / Planned Production) × 100%>98%MES
Mean Time Between Failures (MTBF)Total Operating Time / Number of FailuresMaximizeCMMS, MES
Mean Time To Repair (MTTR)Total Downtime / Number of FailuresMinimizeCMMS
Inventory TurnsCost of Goods Sold / Average Inventory Value6-12 (varies)ERP
Dock-to-Dock TimeTime from receiving materials to shipping finished goodsMinimizeERP, MES, WMS
Cost per Unit(Labor + Materials + Overhead) / Units ProducedMinimizeERP

Implementation Checklist: Building a Strong Foundation

Implementing systems that accurately reflect these concepts requires discipline:

Phase 1: Data Foundation

  • Define and publish a Manufacturing Data Dictionary (200+ terms)
  • Establish BOM governance: Who can create/change, approval workflows, revision control
  • Standardize numbering schemes for parts, work orders, batches, equipment
  • Implement unit of measure (UOM) conversions (kg ↔ lbs, meters ↔ feet)
  • Map master data ownership (PLM owns EBOM, ERP owns MBOM, etc.)

Phase 2: Process Standardization

  • Document standard routings for top 80% of products
  • Define work center calendars (shifts, holidays, planned downtime)
  • Establish lead time standards by product family and supplier
  • Create quality inspection plans tied to routings
  • Implement change control process (ECO/ECN workflows)

Phase 3: System Integration

  • Map PLM ↔ ERP integration for BOM/routing synchronization
  • Design ERP ↔ MES integration for work order dispatch and confirmation
  • Connect SCADA → Historian → MES → ERP data pipeline
  • Integrate QMS ↔ MES for inline quality data capture
  • Build dashboards for OEE, FPY, OTD by plant/line/shift

Phase 4: Training and Adoption

  • Train planners on MRP logic, lead times, lot sizing
  • Train engineers on BOM/routing creation and change control
  • Train operators on work order reporting, quality data entry
  • Train supervisors on OEE interpretation and Kaizen facilitation
  • Establish data stewardship roles and KPIs (e.g., BOM accuracy >98%)

Common Pitfalls and Mitigations

Table 2.11: Terminology Pitfalls

PitfallConsequencePrevention
Using "Lead Time" AmbiguouslyProcurement orders parts too lateAlways specify: Customer LT, Mfg LT, Procurement LT
Confusing Takt Time and Cycle TimeOver-capacity or under-capacity investmentsTakt = demand-driven; Cycle = capability-driven
BOM InaccuracyMRP generates wrong ordersRegular BOM audits (target: >98% accuracy)
Ignoring Scrap FactorsChronic material shortagesBuild scrap% into BOM, track actual scrap in MES
No Definition of "Downtime"Inconsistent OEE across plantsPublish downtime taxonomy, enforce in MES
Mixing Discrete and Process LogicWrong system architectureIdentify hybrid areas, use appropriate MES modules
Phantom Items Without GovernanceInventory discrepanciesClear policy on when to use phantoms, cycle count frequently

Conclusion: The Foundation for Everything Else

If Chapter 1 was the "why" of manufacturing IT, this chapter is the "what." You now understand:

  • The difference between discrete, process, and continuous manufacturing and how it shapes IT architecture
  • BOM, routing, and work orders as the core data structures that drive planning and execution
  • MRP logic and why it's both powerful and limited
  • Time-based metrics (takt, cycle, lead time) and how to use them correctly
  • OEE as the definitive shop-floor metric and how to calculate and improve it
  • Lean and Six Sigma fundamentals that inform how systems should enable continuous improvement
  • Master data governance as the backbone of accurate systems
  • Compliance terminology (ALCOA+, 21 CFR Part 11) critical for regulated industries

Mastering this terminology isn't about memorization—it's about thinking like a manufacturer. When a client says "Our Cpk is below 1.33 on the seal width, and it's driving scrap," you should immediately know:

  1. They have a process capability issue (Cpk < 1.33 = barely capable)
  2. It's affecting quality (scrap)
  3. You should look at SPC data to see if it's common cause (process design) or special cause (external factors)
  4. The solution might involve process re-engineering, better sensors, or tighter supplier controls

This fluency transforms you from an IT vendor into a trusted advisor. In the next chapter, we'll apply these concepts to specific manufacturing verticals, each with their own unique terminology, regulations, and IT demands.


Chapter Summary

ConceptKey PointsIT Impact
Manufacturing TypesDiscrete (BOMs, assembly) vs. Process (recipes, batches) vs. Continuous (24/7 flow)Determines MES architecture, data models, and integration patterns
BOMHierarchical list of components; EBOM (design) vs. MBOM (as-built)PLM ↔ ERP sync is critical; inaccuracies ripple through MRP and costing
RoutingSequence of operations, work centers, timesDrives MES dispatching, capacity planning, and labor costing
Work OrderInstruction to produce; lifecycle from Created → ClosedERP ↔ MES integration for dispatch and confirmation is foundational
MRPCalculates material needs based on demand and lead timesLimited by assumptions (infinite capacity, fixed LT); needs real-time MES data for accuracy
Takt / Cycle / Lead TimeTakt = demand pace; Cycle = actual pace; Lead = total durationConfusion causes capacity errors; MES must track and display all three
OEEAvailability × Performance × Quality; composite measure of lossesReal-time MES calculation is the #1 shop-floor KPI for improvement initiatives
Lean & Six SigmaEliminate waste, reduce variationIT systems must support visual management, SPC, and rapid experimentation
Master Data GovernanceSingle source of truth for BOMs, routings, partsWithout governance, systems diverge and decisions are based on bad data
ALCOA+ (Regulated Industries)Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, AvailableShapes MES and QMS design for pharma, medical devices, food

Discussion Questions

  1. BOM Accuracy: What processes and tools would you implement to achieve and maintain >98% BOM accuracy in a multi-plant organization?

  2. MRP vs. APS: When is MRP insufficient, and when should you recommend Advanced Planning & Scheduling (APS)?

  3. OEE Barriers: What organizational or cultural factors prevent companies from accurately measuring OEE, and how can IT help overcome them?

  4. Hybrid Manufacturing: How would you design a system architecture for a facility that does both discrete assembly and process batch operations?

  5. Time Metric Confusion: How would you explain the difference between takt time, cycle time, and lead time to a non-technical stakeholder?


Exercises

Exercise 1: BOM Explosion

Given this BOM for a Laptop Computer:

  • Laptop (FG-LAPTOP-001)
    • Motherboard (MB-001) — Qty: 1
      • CPU (CPU-i7) — Qty: 1
      • RAM (RAM-16GB) — Qty: 2
    • Display (DISP-15) — Qty: 1
    • Battery (BAT-6CELL) — Qty: 1
    • Keyboard (KB-US) — Qty: 1

Question: If you need to produce 500 laptops, how many of each component do you need? (Assume no scrap, no inventory on-hand.)

Exercise 2: OEE Calculation

A production line runs for 10 hours (600 minutes). Planned downtime for lunch is 30 minutes. Unplanned downtime (breakdowns) is 60 minutes. The ideal cycle time is 1 minute per unit. The line produced 450 units, of which 430 were good.

Calculate:

  1. Availability
  2. Performance
  3. Quality
  4. OEE

Exercise 3: Takt Time vs. Cycle Time

Customer demand is 200 units per day. Available production time is 8 hours (480 minutes). Current cycle time is 2.5 minutes per unit.

  1. What is the takt time?
  2. Can the process meet demand?
  3. If not, what are three options to close the gap?

Further Reading

  • BOM Management: Ernie Orr, Bill of Materials Management. APICS, 2018.
  • MRP and ERP: Thomas Vollmann et al., Manufacturing Planning and Control for Supply Chain Management. McGraw-Hill, 2011.
  • Lean Manufacturing: James Womack & Daniel Jones, Lean Thinking. Free Press, 2003.
  • Six Sigma: Mikel Harry & Richard Schroeder, Six Sigma: The Breakthrough Management Strategy. Currency, 1999.
  • ISA-95 Standard: https://www.isa.org/standards-and-publications/isa-standards/isa-standards-committees/isa95

Next Chapter Preview:

Now that you speak the language, Chapter 3 will apply these concepts to specific manufacturing verticals—automotive, aerospace, food & beverage, pharmaceuticals, and more. Each vertical has unique regulations, quality expectations, and IT system requirements. Understanding these nuances is what separates generalist IT consultants from manufacturing specialists.