Connect981 – Content Dev

Glossary Tag: process monitoring

  • Global KPI

    A global KPI is a key performance indicator defined at an enterprise or multi-site level so it can be measured and compared consistently across plants, lines, departments, or business units. It commonly refers to a metric with a shared definition, calculation method, scope, and reporting logic.

    In manufacturing and regulated operations, a global KPI is used to create a common view of performance across distributed operations. Examples may include on-time delivery, scrap rate, first pass yield, schedule adherence, or overall equipment effectiveness when those measures are governed with the same business rules everywhere they are reported.

    A global KPI is not just any metric that appears on an executive dashboard. The term usually implies standardization. If each site calculates the metric differently, it may be a corporate report metric, but it is not functioning as a true global KPI.

    How it shows up in operations and systems

    Global KPIs often sit above local operational measures. They may be rolled up from MES, ERP, QMS, CMMS, historian, or reporting platforms and used in enterprise dashboards, review meetings, and cross-site performance analysis.

    • At the site level: teams collect and validate source data.

    • At the enterprise level: organizations apply common definitions and aggregation rules.

    • In governance: owners typically define who can change the formula, time basis, exclusions, and data source hierarchy.

    This helps distinguish a global KPI from a local KPI, which may be useful for a single process or facility but not suitable for enterprise comparison.

    What it includes and excludes

    A global KPI commonly includes:

    • a standard metric name and definition

    • a documented formula or calculation logic

    • defined scope, such as site, line, product family, or enterprise

    • consistent time periods and units of measure

    • rules for exceptions, exclusions, and rollups

    It does not automatically include the full operational context behind performance. Supporting drill-down metrics, event data, and local process indicators are usually still needed to explain why the KPI moved.

    Common confusion

    Global KPI vs local KPI: A local KPI is optimized for a specific process, team, or asset. A global KPI is standardized for enterprise-level consistency.

    KPI vs metric: A metric is any measurable value. A KPI is a metric considered important enough to track against business or operational objectives.

    Global KPI vs benchmark: A global KPI is an internally defined measure used across the organization. A benchmark is a reference point, often external or historical, used for comparison.

    Global KPI vs OEE: OEE is a specific performance metric. It can be a global KPI only if the organization standardizes how it is calculated and interpreted across sites.

  • Inclusion/exclusion rules

    Inclusion/exclusion rules are documented criteria used to determine what should be included and what should be excluded within a defined scope. In manufacturing and regulated operations, the term commonly refers to boundary-setting rules for records, events, materials, transactions, inspection results, products, suppliers, or process steps.

    These rules help make scope decisions explicit and repeatable. They do not describe the full process by themselves. Instead, they define the conditions for whether something belongs inside or outside a stated category, workflow, calculation, report, or review.

    Where the term applies

    In operational and quality systems, inclusion/exclusion rules may be used in areas such as:

    • Reporting and analytics: deciding which work orders, lots, downtime events, or defects count in a KPI.
    • Quality records: defining which nonconformances, deviations, or inspection observations must be captured in a specific log or review.
    • Traceability and genealogy: determining which materials, serialized parts, or process steps are part of the as-built record.
    • System integrations: specifying which master data, transactions, or document revisions should pass between ERP, MES, QMS, or PLM systems.
    • Document control: clarifying which documents fall under a given procedure and which do not.

    What it includes and excludes

    Inclusion rules describe the characteristics that qualify an item for scope. Exclusion rules describe the characteristics that remove an item from scope, even if it appears related.

    For example, a production dashboard might include only released manufacturing orders for a specific plant and exclude canceled orders, simulation records, and test transactions. A quality review might include all shop-floor nonconformances opened during a date range and exclude supplier-owned issues tracked in a separate workflow.

    Common confusion

    Inclusion/exclusion rules vs. requirements: Requirements state what must be done. Inclusion/exclusion rules state what falls within the defined boundary of that requirement, report, or process.

    Inclusion/exclusion rules vs. permissions: Permissions control who can view, edit, approve, or execute actions. Inclusion/exclusion rules control what objects or cases are considered in scope.

    Inclusion/exclusion rules vs. filters: A filter is often a system-level implementation of the rules. The rules are the underlying criteria; the filter is the mechanism used to apply them.

    Operational meaning

    In practice, inclusion/exclusion rules often appear in procedures, report definitions, validation logic, interface mappings, and review checklists. Clear rules reduce ambiguity when multiple teams need to classify the same data or records the same way across systems.

  • process validation

    Core meaning

    Process validation commonly refers to the documented, systematic demonstration that a manufacturing or service process, when operated within defined parameters, can consistently produce outputs that meet predetermined specifications and quality attributes.

    In regulated manufacturing (such as pharmaceuticals, medical devices, and certain food or chemical sectors), process validation is a formal requirement and is closely linked to product quality, patient or user safety, and regulatory compliance.

    Key elements in industrial and regulated manufacturing

    Process validation typically includes:

    – **Defined process and inputs**: A clear description of the process steps, equipment, materials, and environmental conditions.
    – **Critical parameters and attributes**: Identification of critical process parameters (CPPs) and critical quality attributes (CQAs) that affect product quality.
    – **Planned studies and protocols**: A validation plan or protocol that defines the scope, methods, sampling, acceptance criteria, and responsibilities.
    – **Data collection across runs**: Execution of validation studies, often over multiple batches or lots, to demonstrate consistency and reproducibility.
    – **Analysis and justification**: Statistical and technical evaluation showing that the process is capable and under control.
    – **Documented conclusion**: A validation report or other records concluding whether the process is validated, including any conditions or limitations.

    Process validation is often supported by related activities such as equipment qualification, method validation, and ongoing process monitoring.

    Use in real workflows and systems

    In industrial operations, process validation is commonly applied to:

    – **Core manufacturing processes**: Mixing, filling, sterilization, assembly, coating, packaging, etc.
    – **Automated systems and OT/IT workflows**: Validating automated sequences controlled by PLCs, DCS, MES, or integrated MES–ERP workflows that influence product quality.
    – **Computerized systems (CSV/CSA context)**: While computer system validation focuses on software and systems, results feed into overall process validation when those systems control or record critical process steps.

    Data used for process validation may be generated and managed via MES, historians, LIMS, QMS, and ERP systems, and is subject to change control and configuration management.

    Boundaries and what process validation is not

    To reduce confusion, process validation:

    – **Is about the process**, not individual units or batches. It demonstrates that the process design and control strategy are capable, rather than merely testing outputs.
    – **Is not routine quality control**: QC tests verify that a specific batch meets requirements; process validation justifies that the underlying process can reliably produce conforming batches.
    – **Is broader than equipment qualification**: Equipment qualification (IQ/OQ/PQ) focuses on installation and operation of equipment; process validation covers the overall process using that equipment, including materials, methods, and controls.
    – **Is not limited to initial startup**: It often includes lifecycle activities such as revalidation, continuous verification, and periodic review when changes occur or performance shifts.

    Common stages and lifecycle view

    Many regulated environments describe process validation as a lifecycle that may include:

    – **Process design**: Defining the process, control strategy, and understanding sources of variability.
    – **Process qualification**: Confirming the process design at commercial or routine scale, often via a defined number of PPQ (process performance qualification) batches.
    – **Continued or ongoing process verification**: Monitoring the validated process during routine production to ensure it remains in a state of control.

    The specific terminology and required documentation vary by sector and regulator, but the lifecycle concept is broadly used.

    Relation to rework and repair (site context)

    In the context of rework and repair of nonconforming products:

    – **Rework** typically uses the original, approved manufacturing process or a pre-defined, validated variant. That means the rework process itself should be covered by process validation or equivalent documented studies.
    – **Repair** may involve ad hoc or limited-use modifications that do not fully restore original specifications. These activities may be controlled by different procedures and risk assessments and are not always treated as part of the validated manufacturing process.

    Thus, whether an activity is considered rework within a validated process, or a separate repair activity, can affect which validation, documentation, and approval requirements apply.

    Related terms and common confusion

    Process validation is often discussed alongside, but is distinct from:

    – **Method validation**: Demonstrating that an analytical or test method is suitable for its intended use.
    – **Computer system validation (CSV)** or **computer software assurance (CSA)**: Demonstrating that software and computerized systems are fit for intended use and operate as specified.
    – **Cleaning validation**: Demonstrating that a cleaning process consistently removes residues to an acceptable level.

    All of these may interact with process validation but address different scopes of risk and control.

  • Work In Process (WIP)

    Work In Process (WIP) commonly refers to all partially completed products within a manufacturing or industrial process that have started production operations but are not yet finished goods. WIP includes materials, subassemblies, and units currently being processed, queued between steps, or undergoing inspection or testing.

    Scope and what WIP includes

    In regulated and industrial environments, WIP typically includes:

    • Raw materials that have been issued to a work order or batch and had at least one value-adding operation performed
    • Parts or subassemblies located at workstations, in test cells, or between routing steps
    • Batches or lots in intermediate states, such as curing, cleaning, or environmental conditioning
    • Units on hold or under review that have not yet been scrapped or reclassified

    WIP usually excludes:

    • Unissued raw materials in warehouse or stockroom
    • Completed products that are in finished goods inventory or shipping
    • Tools, fixtures, and consumables that are not part of the bill of materials for the product

    WIP in systems and operations

    In manufacturing execution systems (MES), ERP, and other production IT/OT systems, WIP is represented as open work orders, batches, or units that have not yet reached a defined completion state. Typical operational representations include:

    • Open operations or routing steps on a work order or batch record
    • Units or lots with in-process status codes (for example: running, waiting, on-hold, under inspection)
    • Quantities physically located in production areas, test labs, cleanrooms, or outside processing

    WIP levels are often monitored for planning, capacity management, and compliance with internal procedures or industry standards. In regulated environments, WIP may require documented traceability, genealogy, and evidence of each processing step, including operator, equipment, materials, and test results.

    Financial and planning perspective

    From an accounting and planning viewpoint, Work In Process is a category of inventory that has accumulated direct materials, labor, and a portion of overhead but is not yet recorded as finished goods. It is used to:

    • Calculate inventory value and cost of goods manufactured
    • Support material requirements planning (MRP) and capacity planning
    • Analyze flow, lead time, and bottlenecks on the shop floor

    Common confusion and variants

    Work In Process vs. Work In Progress: In many manufacturing and industrial contexts, these terms are used interchangeably and both abbreviated as WIP. Some accounting practices use “Work In Process” for manufacturing and “Work In Progress” more broadly for long-term projects, but the distinction is not universal.

    WIP vs. finished goods: WIP covers items still in production, while finished goods are completed products ready for sale, shipment, or distribution.

    WIP vs. raw material inventory: Raw material inventory refers to materials not yet issued or processed. Once materials are issued to a job and processing begins, they typically become WIP.

    WIP in regulated and quality-focused environments

    In regulated manufacturing, managing WIP often involves:

    • Maintaining batch records or electronic device history records for in-process units
    • Tracking hold, rework, and deviation status at the unit, lot, or batch level
    • Ensuring traceability of materials, equipment, and process parameters during all in-process stages

    Operational controls on WIP, such as limits on in-process quantity or formal release steps between stages, are sometimes used to support consistent quality and audit readiness.

  • Pareto Analysis

    Pareto Analysis is a method for prioritizing issues, causes, defects, or cost drivers by ranking them from highest to lowest impact. It is commonly based on the Pareto principle, often summarized as the idea that a relatively small number of causes account for a large share of the effect.

    In manufacturing and quality contexts, Pareto Analysis is used to organize data such as defect types, downtime reasons, scrap causes, complaint categories, or nonconformance sources so teams can see which categories contribute the most. The output is often shown as a Pareto chart, which combines bars in descending order with a cumulative percentage line.

    Pareto Analysis does not by itself identify root cause, prove causation, or determine the correct corrective action. It is a prioritization and visibility tool. It helps answer which problems are most significant in the data, not why they occur.

    How it is used in operations

    Operationally, Pareto Analysis appears in continuous improvement, CAPA, NCR review, yield analysis, and production reporting. Teams may use it to compare:

    • top defect codes by frequency
    • largest scrap categories by cost
    • most common downtime reasons by minutes lost
    • highest-volume supplier nonconformance types

    The choice of measurement matters. A Pareto based on event count may lead to a different priority list than one based on cost, time lost, severity, or units affected.

    Common confusion

    Pareto Analysis is commonly confused with root cause analysis. Pareto Analysis ranks what matters most; root cause analysis investigates why it happens. It is also related to, but not the same as, a Pareto chart. The chart is the visual format, while the analysis is the underlying method of categorizing and prioritizing data.

    Example in manufacturing

    A plant may review one month of scrap data and find that three defect categories account for most total scrap cost. That result supports prioritization of improvement work, but further investigation is still needed to confirm process, material, training, or equipment causes.

  • FAIR

    A FAIR is a First Article Inspection Report, a structured document used in aerospace and other regulated manufacturing to demonstrate that a newly produced or significantly changed part meets all applicable design, drawing, and specification requirements. It captures the inspection results, traceability data, and approvals associated with a First Article Inspection (FAI) activity.

    What a FAIR includes

    In an aerospace context, a FAIR typically includes:

    • Part and assembly identification (part numbers, revisions, serial or lot numbers)
    • Customer, supplier, and purchase order information
    • Drawing and specification references, including revision levels
    • Ballooned (numbered) characteristics linked to inspection results
    • Measured values for each characteristic and pass/fail status
    • Material, special process, and test records references
    • Manufacturing process, operation, or router references
    • Signatures or electronic approvals by quality and/or customer representatives

    FAIRs are often generated to align with the AS9102 First Article Inspection standard, but the term is also used more broadly for similar reports in other regulated sectors.

    Operational use in manufacturing systems

    Operationally, FAIRs appear as controlled documents and dataset records that connect engineering, production, and quality systems. They may be:

    • Created from templates that follow AS9102 or customer-specific formats
    • Linked to bill of materials (BOM), CAD models, and ballooned drawings
    • Populated using data from MES, ERP, PLM, and measurement systems
    • Managed under document control and revision governance for repeat builds
    • Stored as part of the product or lot history for audit and customer review

    Digital FAIR forms often implement validation rules, required fields, characteristic libraries, and workflow enforcement to reduce manual errors compared with spreadsheet-based approaches.

    Common confusion

    FAIR vs. FAI: FAI (First Article Inspection) refers to the activity and process of verifying a part against design requirements. FAIR (First Article Inspection Report) refers to the documented record of that inspection. In practice, many people use FAI and FAIR interchangeably, but the report is the output of the inspection process.

    FAIR vs. general inspection report: A FAIR is specific to first article or initial production validation (for a new part, new supplier, or significant change). Routine in-process or final inspection reports are related but are not typically referred to as FAIRs unless they are fulfilling a first article requirement.

    Relationship to AS9102 and aerospace compliance

    Under common aerospace practices, a FAIR is structured to align with AS9102 requirements for First Article Inspection. This often includes standardized forms (such as separate forms for part identification, product accountability, and characteristic accountability) and consistent traceability to drawings, specifications, and manufacturing processes. Digital FAIR workflows may integrate with platforms such as MES, PLM, and customer portals to support submission, approval, and long-term retention.