Ingenieurbüro Uwe Röhrig – Engineering und Qualifizierung

Impact assessment
SYSTEM IMPACT ASSESSMENT The process of influence assessment is carried out in two steps: Assessment of influence of a system on productivity Assessment of system components with direct influence on product quality (critical or non-critical)		Critical components within a system with direct influence on product quality are subjected to qualification procedures. All the others are subject to the usual engineering processes. System influence System with direct influence System with indirect influence System without any influence

Step 1 Assessment of system influence Identification of systems Definition of system boundaries Assessment of influence in consideration of the following questions: >> more The assessment of system influence is documented by means of a matrix: System influence assessment		Step 2 Assessment as to how critical components are The second step helps to assess if a component within a system is "critical" or "non-critical". The assessment and subsequent classification in "critical" or "non-critical" is based on certain questions and is documented accordingly: >> more Impact assessment - Components Critical components Non-critical components

Summary The following points explain the connection between systems and components: >> more