The product realization and measurement are the core processes. The process management here refers to these processes.
The quality department is responsible for the IQC process which is used to control suppliers, verify incoming materials and handle material quality problems. This prevents nonconforming product material to be unintentionally used.
• Perform approved vendor checklist
• Evaluate supplier quality records
• Perform sampling and inspection of incoming materials
• Monitor quality control of inspected properties and alert engineering staff of deviations
• Continuous enhancement of the IQC process
The IPQC process is used to control the manufacturing process, assembly and testing, helping to decrease the occurrence of defects and to document how any defects that occur should be handled.
Specific tasks of IPQC includes:
• Perform inspections on assembled and in-process materials according to inspection STD
• Conduct in-line automated and manual inspections in the production process
• Ensure the conformance of process setup
• Utilize statistical control techniques and watch for significant deviations
• Perform in-process audits to ensure methods are up to standard and to identify factors needing improvement.
The quality department is also responsible for the FQC process. FQC is a comprehensive inspection that evaluates the products whether they are acceptable or not with IQC and IPQC which ensures the validity of previous processes.
Specific tasks of FQC includes:
• Perform visual and functional inspection
• Apply sampling-based or 100% inspection
• Conduct reliability testing
• Submit failure analysis reports and alert engineering staff
• Archive DHR document
As a contract manufacturer, Jenitek understands and pays close attention to ensure provided products meet quality and medical device regulatory standards.
Jenitek always puts quality first. We create and implement various test procedures to give the utmost attention in project development to our customers. Every parameter goes through strict inspection and all key processes are validated and re-verified.
Our quality processes are not static and continue to be updated to meet the most stringent global standards.
From initial planning to assuring on-time delivery, Jenitek effectively manages the supply chain in accordance with requirements of ISO9001, ISO13485, ISO14001, FDA 21CFR Part 820, and EU MDD 93/42/EEC. We develop, verify and approve our suppliers as well as monitor and measure any changes to products.
Supplier control is a key link for our supply chain management system. It ensures that all critical suppliers maintain a quality management system. Supplied components are appropriately qualified, safe, meet customer requirements and are effective in medical devices. Within the supplier control, if any links of the supply chain are broken, it could slow customer market time or even wipe out the whole plan which is completely unacceptable.
In addition to building close relationships with an approved supplier, all key materials, components and new technology must be reviewed and verified in advance. For further risk reduction, all key materials and components must have two or more approved suppliers.
Validation begins with the product development phase. The initial validation development begins with a collaborative review between Jenitek's and customer's design teams or Jenitek alone doing a drawing review. Attention at this phase is focused on Critical to Quality (CtQ) design attributes as identified by the customer.
Utilizing this information, the project team weighs and considers various process options that will impact manufacturability. This exhaustive Design for Manufacturability (DfM) review provides a high level outline of the manufacturing process including materials, equipment, and environmental controls that will be the focus of subsequent validation.
This is followed by Installation Qualifications (IQ), Operational Qualifications (OQ), and Process Qualifications (PQ) for each process. Also, Design of Experiments (DOE) is frequently conducted to investigate a range of possibly significant input variables.
After refining and optimizing inputs, a stable process with maximum reproducibility and conducted statistical controls, including Gauge R&R studies to monitor process variation and improve capability is completed.
Lastly, data collected throughout the process validation is analyzed to provide insight on effectiveness of current sampling plans and lot acceptance criteria.
The OQC is the last gate before products are delivered to customers. This very important process ensures our shipments are defect-free, DHR is reviewed, and the delivery information is checked. Products are permitted to be released after the quality manager signs the confirmation.
• Perform visual, dimension and functional inspection
• Apply sampling based or 100% inspection
• Review and finish DHR document
• Check delivery information
• Quality manager authentication
Jenitek is committed to supplying products and services that meet the needs of customers, comply with statutory and regulatory requirements, increase customer satisfaction and maintain the effectiveness of the quality management systems through continuous improvement in products, processes and services.
Compliant with ISO 13485:2016, ISO 9001:2015, and FDA 21 CFR Part 820 quality system, we have established complete quality system documents, including manuals, procedures, work instructions and recorded documents.
Our quality activities such as production, inspection, product development, process validation, supply chain management and continuous improvement are well controlled.
6 Sigma Quality Team
Jenitek quality team understands the system are not only the foundation of quality management but also paramount to the importance of our customers, product development, production, and process improvement. Our 6 Sigma black belt engineers have extensive experience with quality management and use a range of methods and tools, including IQ/OQ/PQ, FMEA, and DOE to support in product development and process improvement.
When NPI goes into the pre-production phase, process validation is carried out. Through the IQ/OQ/PQ, we validate product & process design, equipment, tooling, material, environment, personnel, inspection plan, and measurment system to ensure the products meet the customer's requirements.
Material ComplianceBesides special medical grade materials, we utilize non-hazardous materials which comply with REACH and RoHS directives.
If there are questions as to whether or not a potential change may impact the quality of a finished device, we require prior written notification and approval from our customer to review and update any changes to our entire supply chain providing materials, critical components, assemblies or services.
Device History Records
We establish Device History Records (DHR) for each lot of products. Each DHR contains documentation of the processes, material certifications, certification of outside processes, finishing certifications and lot inspection records. This includes in-process and final inspections along with any other quality assurance documents pertinent to a particular lot.