However this freedom does not affect the basic directives; which mandates, the documented need for the suite of documents to start at the VP then the URS and on through the VRA, DQ, IQ, OQ to the PQ.
These regulatory requirements exists and must be complied with.
The most compelling reason for introducing process innovations was the pressure exerted by large sophisticated customers with whom the interviewed firms have had long-term relationships.
Learn about the complex components Owens Industries has machined for a number of clients by reading through the Case Studies below.
From small intricate parts for medical devices to a collimator with approximately 1000 small holes -each hole machined at a different angle than the proceeding hole to create a single focal point- Owens achieves incredible tolerances “normal” machine shops cannot accomplish.
Each document should be constructed to a format and with a content that will satisfy the regulatory expectation for such a document.
The regulations leave a certain amount of freedom to manipulate tests and inspections to save unnecessary retesting and ease access and downtime requirements.
The term machinery relates to any metal moving or removing equipment which is largely mechanical in operation, but may have software management or recording facilities. Many other countries also have an agency to manage this requirement and those that don’t usually rely on the World Health Organization (WHO).
Examples; could be metal working machinery such as CNC machining centers, milling, turning, drilling and packaging machinery. Machinery Validation requires a suite of inter-related documents to be put into place.
A KCV1000 and a VP600, 5-axis machines from OKK USA Corp., are essential to machine many of their parts.
Our company was looking for a back-up system for all the programs we use in our machines, CNC, Grinders, Gear Hobbers, Gear Cutters etc.
As soon as management has agreed to proceed with the CR, approval should be issued to produce a Validation Plan (VP). It must give assurance that all aspects of the proposed CR have been studied and the CR impact on existing facilities, utilities, product and personnel have been defined and the approptiate corrective or support actions planned for.
(Product Design & Development, Jan 2015) Lincoln Park Boring contracted Konecranes Machine Tool Service (MTS) to remanufacture one of their horizontal floor-type boring mills.