POET is not designed to serve as the system of record for regulated processes, therefore not subject to GxP requirements. It is designed to enable cross-organizational collaboration and process orchestration, while the system of record for each process remains within the respective enterprise systems.

Type = Troubleshooting,; Topic = Multienterprise Information Network Tower (MINT),;Persona = TraceLink Administrator, User,; Orchestration = Manufacturing, Logistics, Commerce, Transportation, Clinical Supply,; Function = Supply Chain, IT, Procurement,

Manufacturing Incident

A manufacturing incident is any unexpected event during production that may impact product quality, safety, compliance, timelines, or supply.

What is a manufacturing incident

A manufacturing incident is any unexpected event that occurs during the manufacturing process and has the potential to affect product quality, patient safety, production time-lines, regulatory compliance, or supply continuity. For e.g. process deviations, equipment failures, contamination, labeling errors, human mistakes, or system malfunctions.

Types of manufacturing incidents

  • Deviation: Unexpected variance from approved procedures, instructions, or process parameters.

  • Contamination: Introduction of unwanted substances that compromise product integrity or safety.

  • Equipment Failure: Breakdown or malfunction of machinery that disrupts the manufacturing process.

  • Labeling or Packaging Issue: Errors in labeling or packaging that may lead to misidentification or noncompliance.

  • Material Issues: Problems related to the quality, identity, or suitability of raw or packaging materials.

  • Process Errors: Mistakes in executing manufacturing steps or process controls.

  • Human Error: Operator mistakes due to oversight, lack of training, or failure to follow procedures.

  • IT or System Fault: Failures of computerized systems that support manufacturing or quality operations.

How to use the manufacturing incident marketplace solution

Before configuring and using the manufacturing incident marketplace solution, Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution. Once saved, Solution Designers can modify and release them into their Company Catalog. For more information about using marketplace solutions, see OPUS Solution Environment Help Center.

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