audit

An audit is a systematic, independent, and documented examination of processes, records, and systems to determine whether they conform to defined requirements. In industrial and regulated manufacturing environments, an audit typically checks how operations, quality systems, and supporting IT/OT systems perform against internal procedures, external standards, regulatory expectations, or contractual obligations.

Key characteristics

In this context, an audit commonly includes:

• Defined scope: The boundary of what is being examined (sites, lines, products, processes, systems, or departments).
• Reference criteria: Requirements used as the basis for evaluation, such as internal SOPs, quality manuals, work instructions, or standards like ISO 9001, ISO 13485, or ISO 27001.
• Evidence-based review: Collection and review of objective evidence (records, system logs, batch documentation, training records, change controls, etc.).
• Independence: Auditors are not directly responsible for the activities being audited, to support objectivity.
• Documented outcome: A report that records what was examined, what was found, and any identified nonconformities or observations.

Common types of audits in manufacturing

• Internal audits (first-party): Performed by or on behalf of the organization to assess its own management systems and operations.
• Customer or second-party audits: Performed by a customer or their representative to evaluate a supplier’s capability, processes, and controls.
• Third-party or certification audits: Performed by an independent body to assess conformity to a published standard (for example, ISO management system standards).
• Regulatory or compliance audits: Performed by regulators or notified bodies to evaluate compliance with applicable laws, regulations, and guidance.
• Process and system audits: Focused reviews of specific processes (such as CAPA, change control) or systems (such as MES, ERP interfaces, electronic batch records).

Operational meaning in OT/IT and quality systems

In connected manufacturing environments, audits frequently examine:

• Data integrity and traceability: How production, quality, and maintenance data are captured, stored, secured, and linked to products, batches, or lots.
• System access and controls: User management, electronic signatures, audit trails, and segregation of duties in MES, LIMS, QMS, and ERP systems.
• Change management: How changes to equipment, recipes, software, and procedures are requested, approved, implemented, and documented.
• Document control: Availability and version control of specifications, SOPs, and work instructions used on the shop floor.
• Evidence management: How records needed to demonstrate conformity are created, stored, retrieved, and retained within defined scope.

Common confusion

• Audit vs. inspection: An inspection often focuses on products or physical conditions at a point in time (for example, product sampling, visual line checks). An audit is broader and evaluates systems and processes, not only the immediate product.
• Audit vs. certification: An audit may be part of a certification process, but the audit itself is only an assessment. It does not, by itself, guarantee or confer any formal certification or approval.
• Audit vs. monitoring: Monitoring is ongoing, routine observation of performance or conditions. An audit is a periodic, structured evaluation against defined criteria.

Relation to management system scope

In ISO-style management systems, the audit is conducted against a formally defined scope that specifies which sites, activities, products, processes, and exclusions are covered. Effective audits verify that day-to-day operations, records, and systems align with that documented scope and that any changes affecting scope are controlled and traceable.