Risk Management

Risk Management

Risk management of processes that have or may have an impact on quality of products and services is very important and includes not only manufacturing and packaging processes but also design of products and processes, change management, outsourcing etc.

I can help you to set-up a new risk management process and integrate risk management elements into relevant processes.

In addition, I have experience in facilitating FMEA for products as well as various types of production processes including:

  • Handling and loading of raw materials
  • Injection and blow molding
  • Assembling and filling processes
  • Packaging Processes
  • Coating
  • Manufacture of PCBs
  • Silkscreen
  • Clean room production

I often use an extended version of FMEA, which also contains elements from HACCP.

In addition, I can help you to establish procedure and supply contingency plans.

Risk management is carried out according to the requirements in:

  • ISO 9001
  • ISO 31000
  • ISO 15378
  • ISO 13485
  • ISO 14971