ChecklistGuro Quality Assurance and Quality Control (QA/QC) Management
Streamline your pharmaceutical manufacturing with our end-to-end Quality Assurance and Quality Control (QA/QC) Management workflow. Ensure total regulatory compliance, optimize batch testing precision, and maintain rigorous GMP standards through automated monitoring, streamlined documentation, and proactive risk mitigation for uncompromised product integrity.
Start
Start of the Workflow/Process.
1. Create Inspection Record
Initialize a new QA Inspection entry in the Inspection Data Model to track a new quality check event.
2. Assign Inspector
Create a task for the QA Technician to perform the physical inspection as defined in the inspection record.
3. Update Inspection Status
Update the status of the Inspection Entry to 'In Progress' once the inspector begins the task.
4. Fetch Product Specifications
Retrieve the required tolerance and dimension values from the Product Master Data Model for comparison.
5. Get Defect Log
Retrieve any existing historical defects associated with the specific batch/lot being inspected.
6. Calculate Variance
Execute a formula to calculate the difference between the measured value and the allowed tolerance.
7. Create Non-Conformance Report (NCR)
If a failure is detected, create a new entry in the Non-Conformance Data Model.
8. Assign Corrective Action
Create a task for the Production Manager to investigate the root cause of the non-conformance.
9. Update Inspection Result
Update the Inspection Entry with 'Pass' or 'Fail' based on the outcome of the check.
10. Calculate Batch Defect Rate
Aggregate all inspection entries for the current batch to calculate the percentage of failed units.
11. Notify Quality Manager
Send an email to the Quality Manager when a critical non-conformance is identified.
12. Alert Production Lead
Send an SMS alert to the Production Lead if the defect rate exceeds the predefined threshold.
13. Generate Daily QA Summary
Generate a summary report containing all completed inspections and identified defects for the day.
14. Close Non-Conformance
Update the NCR entry status to 'Closed' once all corrective actions are verified.
15. Remove Draft Inspection
Delete an incomplete or erroneous inspection entry that was created by mistake.
End
End of the Workflow/Process.
Start of the Workflow/Process.
Initialize a new QA Inspection entry in the Inspection Data Model to track a new quality check event.
Create a task for the QA Technician to perform the physical inspection as defined in the inspection record.
Update the status of the Inspection Entry to 'In Progress' once the inspector begins the task.
Retrieve the required tolerance and dimension values from the Product Master Data Model for comparison.
Retrieve any existing historical defects associated with the specific batch/lot being inspected.
Execute a formula to calculate the difference between the measured value and the allowed tolerance.
If a failure is detected, create a new entry in the Non-Conformance Data Model.
Create a task for the Production Manager to investigate the root cause of the non-conformance.
Update the Inspection Entry with 'Pass' or 'Fail' based on the outcome of the check.
Aggregate all inspection entries for the current batch to calculate the percentage of failed units.
Send an email to the Quality Manager when a critical non-conformance is identified.
Send an SMS alert to the Production Lead if the defect rate exceeds the predefined threshold.
Generate a summary report containing all completed inspections and identified defects for the day.
Update the NCR entry status to 'Closed' once all corrective actions are verified.
Delete an incomplete or erroneous inspection entry that was created by mistake.
End of the Workflow/Process.
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