偏差调查过程中，对于偏差的影响范围至关重要，直接影响到对于所有涉及的产品/设备/设施等影响判定，并可以立即采取措施，避免潜在受影响产品被释放或者持续异常的出现:

初始影响范围可以考虑

Initial scope:

1. Product/materials
2. Lot/batch/campaign
3. Equipment/train

Review all current known information

With the Responsible Person, perform initial assessment of risk:

Determine if additional testing is required to more thoroughly assess impact

identify and implement any required status changes for  batches/lots in scope (e.g. Hold)

Identify if previously released material is implicated

影响范围评估时，初始影响范围考量包括：

Record:

1. Outcome of risk evaluation
2. Any product/material/batches/etc., implicated that are not listed already
3. Status of material and rationale for the status
4. Rationale if multiple batches are impacted with different status/dispositions
5. Any decision regarding continued manufacturing/operations
6. Rationale for no product/lot/batch impact

在进一步判定影响范围时，需要考量：

1. Review documentation: Batch Records, Protocols, etc.
2. Review materials used: raw materials,                                                   
3. packaging & labeling materials, closures, containers , etc.
4. Review vendor/contractor information
5. Do you need information from other groups?
6. Do you need to contact other sites? API, packaging
7. Review Engineering, Utilities and Mechanical issues

1. Review SOPs and instructions for compliance
2. Identify all impacted lots
3. If necessary identify any material samples by testing
4. Interview personnel regarding facts, timings, contributing factors
5. Review raw materials, other materials and components
6. Review equipment usage 
7. Review environmental factors and facilities
8. Review cleaning/maintenance/use  logs for timeframes: