Qualification support
We do not stop at handover. We stay with the project until the customer can face an inspection with that machine.
| Stage | Name | Content |
|---|---|---|
| DQ | Design qualification | Confirms the design specification meets the user requirement, with the risk assessment reflected |
| FAT | Factory acceptance test | Function and performance checked before shipment, witnessed by the customer |
| SAT | Site acceptance test | Repeated on site after installation under real conditions |
| IQ | Installation qualification | Drawings, certificates, utility connections and instrument calibration verified |
| OQ | Operational qualification | Functions and alarms checked across the full operating range |
| PQ | Performance qualification | Performance confirmed with consecutive batches of the real product |
Documents we hand over
- User requirement specification and design specification
- Mechanical drawings, piping diagrams, electrical and control drawings
- Material certificates, weld records and surface finish records
- Instrument calibration certificates and the calibration schedule
- IQ, OQ and PQ protocols with the executed reports
- Operation and maintenance manuals, parts list and the preventive maintenance plan
- Software version record and a description of the audit trail
Only equipment that has passed the factory acceptance test moves to packing.
Installation and training
Installation starts with the access route. Ceiling height, door widths, floor loading and utility positions are measured in advance so that nothing has to change on the day. After installation, operators and maintenance staff are trained separately.
- Operator training: running recipes, daily checks, cleaning procedures, responding to alarms
- Maintenance training: strip down and rebuild, consumable replacement, fault finding
- Quality training: what to check in the records, reading electronic records and the audit trail
Maintenance and parts
| Preventive maintenance | One or two site visits a year with a written report |
|---|---|
| Breakdown response | Domestic response within working days; overseas, the partner responds first with head office support |
| Remote diagnostics | With customer approval we connect remotely to review alarms and parameters |
| Consumables | Filters, gaskets, punches and dies, belts, with recommended replacement intervals |
| Spare parts | We aim to supply key parts for at least ten years after delivery |
Service contact: info@shinwongpharma.com