TECHNICAL EXPERTISE AND DETAILED REVIEW
Filamatic's Good Manufacturing Practice (GMP) aligned Quality Policy is used internally to ensure that we produce a top quality product that meets the expected result.
Filamatic can offer a complete, reproducible and documented proof that the machine has been manufactured according to the purchase order, the proposal, design documents, and the specification.
Machine validation can include:
Installation Qualification (IQ) is the testing and documentation of selected criteria for correct machine construction. The following items can be included in the test schedule:
- Fulfillment of the customer order specifications
- Installation and identification of mechanical components
- Installation and identification of electrical components
- Installation and identification of the machine control (PLC)
- PID/RI diagrams
- Technical data sheets for the components
- Flowchart of the machine program
Operation Qualification (OQ) is the testing and documentation of selected criteria for correct machine construction. The following items can be included in the test schedule:
- Operational inspection of the machine control (PLC inputs and outputs)
- Operational inspection of the machine program
- Operational inspection of the operating panel
Typically, Filamatic structures the IQ/OQ documentation. If the customer wants Filamatic to execute the OQ, then please ask us to quote separately. Filamatic employs several contractors to execute OQ's to maintain impartiality.
Filamatic offers as a service to our customers the creation of FAT processes. Having served multiple industries, Filamatic is well versed in creating Pre-FAT and FAT documents for review and approval by you, our customer.
Program features and benefits:
- Speed up creation of specifications
- Decrease time to create protocols
- Significantly reduce post FAT list of changes