Typical fragmented quality process
- Defect logs, NCR spreadsheets, and CAPA trackers live in separate files.
- Containment decisions are delayed because issue ownership is unclear.
- NCR review and MRB disposition steps are manually coordinated through email.
- Hold and release decisions are hard to trace back to the original issue.
- FPY and Pareto trend analysis depends on manual weekly data consolidation.
- Customer and compliance audits require manual evidence collection.