Risk assessment and Impact assessment

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


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