Quality assurance

Submitted by biomerics_dev on Thu, 03/24/2022 - 08:37

We use a variety of quality tools and control systems to ensure we meet your quality needs and finished product specifications. From incoming raw material inspection to finished product release and validation testing, our quality team and enterprise resource planning (ERP) system control all aspects of the production process.

Our process of quality assurance starts with the design of the product and production system. Our engineers collaborate with you and recommend materials, tools, and design modifications to improve product manufacturability. Our suppliers and partners are all carefully qualified and managed to ensure raw materials meet the required standards. We also use corrective and preventive action (CAPA), complaint handling, and process controls to ensure that we produce high-quality, conforming components.

We understand that a carefully constructed process should be methodically validated, audited, and improved—which is why we use advanced technologies and methodologies throughout each production run to ensure that components and devices meet the required standards.

  • Problem-solving & operational quality
    • Six Sigma problem-solving tools (DMAIC, 8D)
    • Work flow diagrams/Process mapping
    • 5 Whys
    • Ishikawa diagrams
    • Cause and effect matrix
    • Is/Is not analysis
    • Pareto analysis
    • Control plans/charts
    • Standard work documentation
  • Development & validation
    • Design development planning
    • Risk analysis and risk assessment (AFMEA, DFMEA, PFMEA)
    • First article layouts and approvals
    • Process capability studies (Cpk, Ppk, tolerance intervals)
    • IQ, OQ & PQ validations
    • Lab testing for analysis and compliance
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Development & validation

Design development planning
Risk analysis and risk assessment (AFMEA, DFMEA, PFMEA)
First article layouts and approvals
Process capability studies (Cpk, Ppk, tolerance intervals)
IQ, OQ & PQ validations
Lab testing for analysis and compliance
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