Quality Systems
Pacific Plastics & Engineering sets in place numerous quality assurance systems. Meticulous care to accurate records eliminates costly trial and error mistakes, reduces implementation costs, and creates a smoother certification process for our medical device customers. The quality and consistency of our services hinges on careful documentation, process control studies.
Learn more about:
Device History Record
In order to keep you abreast of your medical device's progress, PPE maintains specific records inside a Tool/Assembly Tracking folder. Your original CAD files, sketches and draft designs are kept inside as well as any adjustments made to the original design. Meeting notes between designers, engineers, and you are all archived as well as all communications that pass between us.
Process Validation: IQ, OQ, PQ, PPQ
Process validation begins with demonstrating that when a process in operated within specified limits, it will consistently produce product complying with predetermined (design and development) requirements.
Activities for process validation fall into three phases:
1) an initial qualification of the equipment used and the provision of necessary services – also known as installation qualification (IQ); 2) a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters – also known as operational qualification (OQ); 3) establishment of long term process stability – also known as performance qualification (PQ); and 4) where possible, a demonstration that part performance testing under conditions that simulate actual use, and should be conducted using product manufactured from the same type of production, equipment, methods, and procedures that will be used for routine production - also known as part performance qualification (PPQ).
Cpk and DOE Studies
PPE is certified by Lloyd's Register Quality Assurance (LRQA) to ISO 9001:2000 Quality Management Systems and ISO 13485:2003 Quality Management System Requirements for Regulatory Purposes. A surveillance audit is conducted twice a year to maintain ISO certification status. PP&E has an open door policy. Our capabilities include:
- Statistical Process Control – SPC
- Cpk Studies
- Gage R & R
- DOE
This quality data maintenance program ensures efficiency and strict quality standards are met on every project. Let us share our experience in supporting you and your critical needs in your IQ/OQ/PQ/PPQ qualification process.
