Document Control
This type of document must be reviewed and approved before use and kept up to date.
SOPs
This activity ensures equipment works correctly before being used in production.
Calibration or verification
This process is required for handling customer dissatisfaction or reported product issues.
Complaints
Central Biomedia's retention time for records.
25 years
CAPAs are required to start with this investigation step.
Determining the root cause
This process identifies potential hazards and how to reduce them.
Risk assessment
This evaluates whether an SOP was read and understood.
Competency questions
This ensures you can trace who changes a document and why.
Change control
CBI documents this to ensure that personnel can consistently perform critical tasks.
Proficiency maintenance
In a CAPA investigation, this tool evaluates whether the chosen corrective action fully addresses the root cause rather than the symptom.
Effectiveness verification
Before a supplier can be approved, they must complete this.
Supplier Questionnaire
These Quality checks ensure that personnel training programs are effective and procedures are being followed.
Internal audit