Risk management Part 6 – Unwanted effects

The ISO 9001:2015 standard requires that once the Issues to be considered in the Quality Management System have been defined, the Desirable Effects should be increased and undesirable Effects should be prevented or reduced; furthermore, the actions taken should be proportionate to the potential impact.

 

When analyzing the Effects of the Issues on the processes in the Quality Management System processes, all clients must be taken into account:

  • Effects on the end user
  • Effects on the following process.
  • Effects on OEMs.
  • Effects on laws and regulations.

 

It is important that the organization bases its Risk Analysis on the appropriate information for each of the effects, such as:

  • FMEA of Design, Critical Features in Design Registrations.
  • Rejects in process, rework, repairs, and waste data.
  • Customer complaints, resident staff information, etc.
  • Names, laws and regulations applicable to the product, process, industry, transport, etc.

 

IATF 16949:2016 requires organizations to consider the Issues that are essential to maintaining production outputs and ensuring that customer requirements are met. When the possible impact on the customer is the interruption of the supply of the product to the customer, Contingency Plans must be defined that:

  • They should include a process of communication with the client and stakeholders.
  • They should be tested regularly to confirm their effectiveness.
  • It should be reviewed and updated.
  • Documented information must be documented and retained.

 

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