Which document I need to prepare when I altered the load pattern due to process. For lyo product we have to take a rubber stopper and trays load first and after comolwiof the lyo process we take a seal n trays load. But the combined load is validated for seal stopper and trays. We r following this process since last 3 yrs but this observation is give by auditor. Shall I prepare risk assessment for this or shall I go for impact assessment. Please comment
Risk assessment and determine what loads you have. You need to establish if your validated load covers your actual loads. If not adapt, validate more loads if necessary.