Formal authorization to accept and use or release nonconforming product or deviation from specified requirements under defined conditions.
In industrial and regulated manufacturing, **concession** commonly refers to a formal authorization to:
– Accept and use nonconforming product, material, or component, or
– Depart from specified requirements (e.g., drawings, specifications, procedures)
under clearly defined conditions, usually for a limited quantity, time period, customer, or batch.
A concession is normally based on an assessment that the nonconformity or deviation does not invalidate the intended function, safety, or regulatory requirements of the product or process, as judged by competent technical and quality authorities and, when required, by the customer.
In practice, a concession may be:
– **Requested** when inspection or in-process checks detect a deviation from requirements and scrap or full rework is not considered necessary or feasible.
– **Evaluated** by engineering, quality, and sometimes regulatory functions to determine impact on form, fit, function, safety, and compliance.
– **Authorized** by defined roles (e.g., quality manager, design authority, customer quality representative) before the affected items move to the next process step or to shipment.
– **Recorded** in quality systems, MES, or ERP as part of nonconformance and deviation management, often linked to specific lots, serial numbers, or work orders.
– **Communicated** to downstream users and customers, sometimes via documented waivers, deviations, or customer approvals.
In MES or ERP systems, concessions are often captured as:
– A specific **nonconformance disposition** (e.g., “use-as-is with concession”), or
– A **deviation record** tied to particular orders, material IDs, or configurations.
A concession:
– **Is** a controlled, documented exception to product or process requirements.
– **Is usually temporary** or limited in scope (per batch, serial range, or time-bound).
– **Is applied after** a deviation is known (reactive authorization for specific occurrences).
A concession **is not**:
– A permanent change to the specification, drawing, or process (that would be a design or process change, engineering change order, or specification revision).
– A generic risk acceptance document unlinked to specific product or batch.
– An informal verbal agreement without traceable documentation.
– The same as routine tolerance variation that is already allowed by the specification.
The term **concession** is often confused or used interchangeably with:
– **Deviation permit / production permit**: Frequently used for prior authorization to depart from requirements before production or before the nonconformity occurs. A concession is more commonly used when the nonconformity already exists, though some organizations treat the terms as equivalent.
– **Waiver**: In some sectors, a waiver is used similarly to a concession (customer-approved acceptance of nonconforming product). Other organizations reserve “concession” for internal approval and “waiver” for customer approval.
– **Nonconformance report (NCR)**: An NCR documents the nonconformity; a concession is one possible outcome (disposition) of that NCR (e.g., scrap, rework, regrade, or use-as-is under concession).
When precision is needed, it is helpful to clarify whether “concession” means:
– Acceptance of already-produced nonconforming items, or
– A pre-approved deviation from requirements for upcoming production.
In regulated industries and quality-managed environments (e.g., aerospace, pharmaceutical, medical devices, automotive, food and beverage), concessions are:
– Managed through documented **nonconformance and deviation control processes**.
– Subject to defined approval authorities and, where applicable, **customer or regulatory notification or approval** requirements.
– Tracked for **traceability** to affected product, lots, and batches, supporting audits, recalls, or investigations.
Quality systems may require that concessions be:
– Linked to risk assessments, impact analyses, or technical justifications.
– Reviewed periodically to identify recurring patterns that may warrant design or process changes instead of repeated concessions.
Within the context of industrial operations, OT/IT integration, and MES/ERP environments, **concession** typically appears as:
– A **disposition code** or record type for nonconforming material or in-process product.
– A structured **workflow** that routes nonconformance records for evaluation and approval.
– A data element used for **quality reporting**, trend analysis, and compliance evidence.
Concession records in these systems provide traceable documentation that specific nonconforming or deviating products or processes were reviewed and deliberately accepted under controlled conditions.