Document code:  PRO-0079.05  Security level:  Internal  Effective date:  30/05/2016  Preventive and risk-based approach to management  The need for preventive action can be identified also in relation with the handling of raised  nonconformities and the identified root causes as described in PRO-0015 and in HAN-0018.  3.2. Preventive action process  The preventive action process shall ensure that the causes of potential nonconformities are  effectively eliminated or controlled.  The Process Owners are responsible for preventive actions related to their processes. They  involve the Quality Assurance Officers and Quality Manager.  Depending on the action, the Senior Management, DCM, Programme Boards, the Quality  Steering Committee or relev ant bodies of ECHA’s Security Organisation (ED/03/2015) are  involved.  3.2.1. Identification of potential deviations, shortcomings or failures  Potential issues could be identified by any staff member and could originate inter alia from: • stakeholder/customer feedback  • internal or external audits and assessments, including environmental reporting  • project planning  • analysis of nonconformities  • analysis of process performance and trends  • analysis of environmental performance and trends  • review activities  • monitoring of changes in applicable legislation and other requirements.  3.2.2. Assessment of the need for preventive action  Depending on the concern identified, the Process Owner or the Senior Management decides  whether action is necessary to prevent the issue from occurring. If so, s/he decides on the  appropriate action to be implemented.  The assessment of the need for a preventive action includes a cause analysis. Preventive  action shall be taken where an increased risk for nonconformity is identified. The decision  on the kind of action can be based on a cost-benefit analysis.  Preventive action shall also be taken when performance data shows a trend that objectives  or the intended quality/environmental performance will not be achieved.  3.2.3. Implementation of preventive action and progress monitoring  The Process Owner plans the preventive action, defines a suitable timeframe and progress  monitoring scheme and assigns the responsibilities for the implementation.  The preventive action planning can include the establishment of controls to ensure actions  are effective.  TEM-0129.01  Uncontrolled copy once printed. Ensure that the right version is in use.  Page  3  of  6