Methodology for analyzing potential nonconformities (meets the requirements of ISO 9001)
1. In order to determine the quality of the process and ways to improve it, it is not enough to simply regulate the process with evaluation indicators. It is necessary to investigate possible causes of process failures. To do this, an analysis of potential non — conformities is performed-the risk of disruption of the process (activity) is assessed and the criticality of potential failures is assessed in particular.
2. Organization of » analysis of potential nonconformities»
2.1 To investigate the process, the owner creates a «process analysis Group». Specialists from various fields of activity can be invited to the group for analysis. It is desirable to invite responsible executors of the process, as well as specialists of departments whose processes directly depend on the process in question. It is also desirable to have a group of specialists of various specialties (technologist, mechanic, supply engineer, economist, etc.).
2.2 After selecting the «analysis Group», the process owner prepares an order on the organization of» analysis of potential inconsistencies » signed by the process owner. If necessary, the involvement of a specialist should be coordinated with his / her Manager. The order specifies the purpose of the work, the time of work of specialists and assigns a person responsible for organizing the assessment.
3. The potential nonconformity analysis System takes into account the following types of nonconformity assessments: