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Introducing Clo-Sur Plus P.A.D. Anti-Microbial Barrier

An Effective, Non-Invasive Approach to Hemostasis

CE 0344

Quality Management System

Frequently Asked Questions.

Quality

  • Does the company have a documented quality system? Yes
  • Does an internal audit program exist? Yes
  • Does an external audit program exist? Yes

Materials

  • Do written procedures exist for incoming material inspection? Yes
  • Are non-conforming incoming raw materials segregated and documented? Yes
  • Is there a raw materials supplier review program in place? Yes
  • Are lot numbers or batch records traceable? Yes

Manufacturing Process

  • Are controls in place to accurately identify and route materials through manufacturing? Yes
  • Are there written procedures for in-process inspection? Yes
  • Are inspection points documented and are results recorded? Yes
  • Is non-conforming product segregated and documented? Yes
  • Are statistical sampling techniques and methods implemented when appropriate? Yes
  • Are corrective actions taken as appropriate? Yes
  • Are preventive actions taken as appropriate? Yes

Equipment

  • Is there a scheduled preventative maintenance program? Yes
  • Are preventative maintenance measures and necessary repairs documented? Yes
  • Is housekeeping performed and documented throughout the plant? Yes

Safety

  • Are employees trained to safety regulations? Yes
  • Are employee safety procedures documented and followed? Yes

Documentation

  • Are control drawings and specifications documented? Yes
  • Are job changes or revision changes documented? Yes
  • Are Certificates of Conformance for final product available to customer? Yes