Procedure corrective and preventive measures

The and include: 

  • ;  
  • ;  
  • Adjusting the production process in response to an perceived abnormality; 
  • Adjusting or destroying the in response to a perceived abnormality. 

Preventive measures:

A preventive measure is a measure which is taken to remove a possible future abnormality or other undesirable situation.

This includes the of product abnormalities by:  

The various measures are laid down in relevant instructions if necessary.

Laying down measures:

Reporting of every non-conforming and subsequent measures, among which: 

  • Specifics about the non-conformity, when it occurred and how it was identified.  
  • Details of the taken measures. 
  • Dates when the actions were completed.  
  • that the actions are completed and were effective. 
  • Cause and preventative action. 

Root cause analysis:

When errors happen, such as non-conforming products, product recalls, or non-conformity by audits, reoccurrence of these errors be prevented with the help of the root cause analysis. The root cause analysis should include: 

  • A set of parameters that will lead to the use of the appropriate tool (i.e. the site must define when the analysis will be completed if this is not required by the standard).  
  • Who is trained and / or qualified to complete the analysis. 
  • The methods that will be used to perform the analysis. 
  • The analysis and any subsequent preventative measures in detail. 
  • The methods for the verification of the completed actions.

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