Background -
A product was sent out containing an ingredient that was not specified in the specification. The R&D technician did not properly update the file, therefore, leaving the old formulation which was used to make a lot of material.
Sales asked the R&D Tech to make the change to the file orginally, and did not complete a Specification Review Document. This was all done through email instead. If a Spec Rev Doc would have been completed, the R&D Technicians work would have been reviewed and the error would have been noticed.
The Specification for this formulation was also in the file. The QC Technicians and QC Managers are suppose to review this document when the product is running and immediately prior to shipment. It was not reviewed closely enough. If so, they would have seen that the wrong ingredient was used and stopped the shipment.
Now I have a SCAR to complete. I am at a loss of what to document because the customer has listed the following:
Root Causes to be avoided
The following are commonly identified as root causes, but are only symptoms to the true root cause and should be avoided in the SCAR response:
? Human error
? Procedures not followed
? Equipment malfunction
? Improper performance
? Method not validated
? Multiple batches in process at the same time
? Equipment with expired calibration
? Out of trend point
Corrective Actions to be avoided
The following are commonly identified as Corrective Actions to attack the root cause, but are only simple spot fixes and should be avoided in the SCAR response:
? Train a non-trained operator
? Reject and destroy a failing product
? Rework nonconforming material
? Repair broken piece of equipment
? Properly connect alarm to machine
? “Use-as-is” nonconforming product
A lot of bad things happened in this situation - but how am I to respond? I will of course want to retrain everyone.
Thoughts?
A product was sent out containing an ingredient that was not specified in the specification. The R&D technician did not properly update the file, therefore, leaving the old formulation which was used to make a lot of material.
Sales asked the R&D Tech to make the change to the file orginally, and did not complete a Specification Review Document. This was all done through email instead. If a Spec Rev Doc would have been completed, the R&D Technicians work would have been reviewed and the error would have been noticed.
The Specification for this formulation was also in the file. The QC Technicians and QC Managers are suppose to review this document when the product is running and immediately prior to shipment. It was not reviewed closely enough. If so, they would have seen that the wrong ingredient was used and stopped the shipment.
Now I have a SCAR to complete. I am at a loss of what to document because the customer has listed the following:
Root Causes to be avoided
The following are commonly identified as root causes, but are only symptoms to the true root cause and should be avoided in the SCAR response:
? Human error
? Procedures not followed
? Equipment malfunction
? Improper performance
? Method not validated
? Multiple batches in process at the same time
? Equipment with expired calibration
? Out of trend point
Corrective Actions to be avoided
The following are commonly identified as Corrective Actions to attack the root cause, but are only simple spot fixes and should be avoided in the SCAR response:
? Train a non-trained operator
? Reject and destroy a failing product
? Rework nonconforming material
? Repair broken piece of equipment
? Properly connect alarm to machine
? “Use-as-is” nonconforming product
A lot of bad things happened in this situation - but how am I to respond? I will of course want to retrain everyone.
Thoughts?