Equipment and suppliers

Equipment records identify production and laboratory assets by code, name, type and location. Calibration status can be Calibrated, Due Soon, Overdue or Out Of Service, with dates for the last calibration and next due date. Qualification status distinguishes IQ, OQ, PQ, Qualified and Not Qualified. These values let Equipment Coordinator and QA Manager see which asset needs attention before they assess an associated deviation or batch.

Suppliers records identify each supplier, material type, qualification status, qualification date and next audit date. Qualification can be Prospective, Qualified, Approved, Conditional or Disqualified. The record also holds a site state and a cGMP certification value. Supplier Manager maintains these facts so a change request can point to the correct supplier and quality reviewers can inspect its current standing.

• Equipment identity. Use a stable equipment code to distinguish assets with similar names.
• Calibration and qualification. Track the current status and due date as separate pieces of information.
• Supplier standing. Maintain the qualification decision and audit timing with the supplier record.

Choose who updates calibration status after a real calibration and where any underlying service evidence is kept. The Equipment record shows state and dates; if a service provider maintains certificates elsewhere, connect that source as part of operating setup. Agree when a Due Soon or Overdue item is discussed with QA Manager and how an Out Of Service asset is identified to production and QC Analyst.

For suppliers, settle the evidence needed for Qualified, Approved or Conditional status and who may change it. A change control can reference a supplier, but it does not replace the supplier qualification record. Review next audit dates as part of a routine supplier discussion. The team should understand the difference between the certification field and its own qualification decision.

A filling line has a calibration date approaching. Equipment Coordinator reviews the asset code, location and next calibration due date and marks the status Due Soon. If calibration lapses, the status becomes Overdue. QA Manager sees it on the Quality Exceptions & CAPA page and in the equipment attention view. If a deviation arose on a batch using that asset, the deviation can reference the equipment. The reviewer then has a path from the batch exception to the specific machine.

In parallel, Supplier Manager reviews a Conditional supplier with an upcoming audit. A change control concerning that supplier references the same record. The qualification status, audit date and change status can then be examined together before an affected batch decision.

• Equipment calibration attention — Assets due soon, overdue or out of service.
• Supplier qualification review — Suppliers whose qualification needs closer inspection.
• Open deviations — Investigations that may point to affected equipment.

See deviation to CAPA when an equipment issue becomes an investigation and change assessment for a supplier change.