Quality Assurance at JunoPacific
Our quality system reflects the requirements of the FDA’s 21 CFR Part 820 quality systems regulation for medical device good manufacturing practices.
- Multiple Coordinate measuring machines (CMM)
- Multiple Micro-Vu and Smartscope precision vision measuring systems.
- Minitab software for statistical sampling plans
- Air gauges, micrometers, bore gages, drop gages, and all fixturing necessary to continuously track CpK and critical dimensions.
Meticulous care to accurate records eliminates costly trial and error mistakes, reduces implementation costs, and creates a smoother medical device certification process. The quality and consistency of our device design and manufacturing services hinges on careful documentation and process control studies.
Device History Record
In order to keep you abreast of your medical device's progress, JunoPacific maintains specific records. Your original CAD files, sketches and draft designs are kept 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.
Robust internal processes are in place to ensure nothing is missed in any aspect of your project's progress. We give you weekly progress reports, tool status reports and updated project planning checklist to keep you abreast of your project's testing, modifications, and certification process.
By keeping careful documentation of your medical device's development, testing and production in our device history record; we are able to offer you all of the information you will need for certification applications, funding analysis, and other committee reviews. Consistency and accuracy follow each project from start to finish, and for the lifetime of our relationship.
Statistical Sampling Plans
At JunoPacific we offer statistical sampling plans including C=0 and ANSI/ASQ Z1.4
C=0 sampling, or zero acceptance number sampling plans, are generally used for critical components with tighter tolerances. If there’s a single reject within the sample size, the entire lot is rejected. The ANSI plans evolved from the MIL-STD-105 plans. ANSI standards reward a history of consistency by graduating to reduced sample sizes and even skip lots while still maintaining the same AQL if the process has yielded no rejected lots in the past.
At JunoPacific, we tailor each individual customer needs into the quality plan based on the specific requirements of the product.
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 happen in several distinct phases:
- An initial qualification of the equipment used and the provision of necessary services -- also known as installation qualification (IQ);
- 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);
- Establishment of long term process stability -- also known as performance qualification (PQ);
- 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
JunoPacific facilities are certified to ISO 9001 Quality Management Systems and ISO 13485 Quality Management System Requirements for Regulatory Purposes. Surveillance audits are conducted on a regular basis to maintain ISO certification. Our capabilities include:
- Capability Studies
- Gage R & R
- Statistical Process Control (SPC)
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.