Glossary

Manufacturing process change

A manufacturing process change is a controlled modification to how a product is made, inspected, handled, or documented.

Data Integration, Security and Trust Data Integrity, Version Control and Audit Trails

A manufacturing process change is a controlled modification to how a product is made, inspected, handled, moved, or documented in production. It commonly refers to a change in the approved or established method of manufacturing, rather than a change to the product design itself.

Examples include changing a routing step, machine, fixture, work instruction, inspection method, process parameter, material handling method, or supplier-performed operation. In regulated or quality-sensitive environments, these changes are typically reviewed for impact on quality, traceability, documentation, training, and system records before being released for use.

Manufacturing process changes are commonly managed through QMS, MES, ERP, or PLM workflows, depending on the organization. They should not be confused with a nonconformance, which records that something did not meet requirements, or with a deviation, which is usually a limited, approved departure from the current process. A process change updates the intended way of working going forward.

Attach objective, traceable evidence that shows what was found, where it was found, what product or process is affected, and why the proposed disposition or corrective action is supportable. The exact package depends on customer flow-downs, QMS procedures, product risk, and how MES, ERP, PLM, and QMS records are controlled.

How do we ensure cross-trained operators do not perform unauthorized work?

Cross-training does not equal authorization. Plants usually control unauthorized work through a maintained qualification matrix, MES or traveler enforcement at the operation level, supervisor controls, audit trails, and change-controlled training records. The weak points are stale data, broad roles, overrides, and legacy system gaps.

How do I prove where a KPI number came from during an audit?

You prove a KPI by showing a traceable chain from the reported value back to source records, calculation logic, time window, filters, and any manual adjustments. If that chain is broken, undocumented, or spread across weak integrations and spreadsheets, the KPI may still be useful operationally but it is not strong audit evidence on its own.

How do I deal with late data that changes historical KPIs?

Do not pretend late-arriving data does not exist. Historical KPIs should be allowed to restate when source events arrive late, but only with clear versioning, cutoff rules, and auditability. The practical solution is to separate provisional from locked reporting, preserve original values, and make restatements traceable across MES, ERP, QMS, and manual sources.

Related Glossary

Configuration versioning

Configuration versioning is the practice of tracking changes to approved settings, rules, and system parameters over time.