Un-Planned Deviation Example
Investigation Details for Incident No.:____________________________________
1.0 Product details
|Name of product|
|Batch stage||Granulation (Lubrication)|
Investigation team member details
|Warehouse In Charge|
Lubricated granules of the batch containing API (Clobazam) and excipients (MCCP PH 102, Cross Carmellose Sodium, Sodium Starch Glycolate, Starch, Talcum, Magnesium Stearate, Aerosil & Titanium Dioxide) was spilled on the floor during manufacturing process of the product at the time of Lubrication / Blending stage due to this reason, batch was rejected and canceled.
After investigation for all possible causes of Incident, it was found as under:
The production operator used the Double Cone Blender for Lubrication of Granules but during manual un-loading of the Blend from blender, total 10.522 kg material was spilled on the floor because the PU wheels (Polyurethane wheels) of the SS containers slipped and the entire blend fell on the floor instead of SS container. The Production supervisor stopped the process immediately.
The production supervisor simultaneously informed to QA, Production manager and QA Head
After that, QA Head gave instructions that all 10.522 kg spilled material, need to be collected and weighed and material need to be kept in quarantine with ‘Hold’ label until the final decision was taken in this matter.
QA head gave the decision; entire 10.522 Kg material got contaminated due to spillage on the floor and was not fit for consumer consumption. As such it should be rejected & destroyed, due to this reason, the batch was rejected and details of destruction shall be recorded in destruction record.
The root cause of the deviation is that the material was spilled on the floor due to the PU wheels (Polyurethane wheels) of the SS containers slipped during unloading of materials from blender to SS container and 10.522 kg granules fell on floor from Double Cone Blender.
Proposed corrective/ preventive action:
- All the spilled material (on the floor) was rejected.
- The training need to be given to all production operators, production technicians and QA about this deviation and counseling to all personnel about this accident.
- In future to prevent such kinds of deviations, it is required to verify and check tightness and proper working of PU wheels of the SS containers before use.
|Done By||Checked By||Approved By|
|Name/ Sign||Name/ Sign||Name/ Sign|