1. Quality Management System
  2. Frequently asked questions
FAQ

Questions, answered

Answers about inspections, nonconformance, CAPA and starting a pilot.

Quality Management System

10 questions

Can't find it? Write to support@erp.ai.

How do I get started?

Click Get started, then use Proto to configure Quality Management System for your business. Begin with one product, its active specification, an inspection plan and a representative lot.

What starts a nonconformance report?

An inspection marked Fail or Conditional can create a report linked to that inspection. The report can also record other issue sources through its source field.

How is severity chosen?

The worst cited defect severity sets the report’s severity when defect citations are added or changed. Critical and major issues require root cause work.

Who approves disposition?

Quality Manager owns the decision. The report records the selected disposition, approving user and approval time.

What happens after a serious issue?

A major or critical nonconformance can create a corrective CAPA once. Assigned tasks and root cause analysis carry the longer work.

What if corrective action does not work?

A not effective result reopens the CAPA and creates fresh corrective and verification tasks for another cycle.

How are audits recorded?

Audits carry scope, standard, schedule and auditor. Clause checklists record observations, while findings have their own response owners and due dates.

What happens when an instrument is out of tolerance?

Inspections that referenced it on or after its last calibrated date are flagged for Quality Manager review.

Can I review supplier quality by period?

Supplier score records hold a period, date range, quality measures, score and grade linked to the supplier.

How do training assignments connect to issues?

A training record can link to an NCR, CAPA and standard. Qualifying serious NCR closures can create retraining for the source inspector.

Set up Quality Management System your way.

Start free, then use Proto to change fields, steps and approvals before your team goes live.

How to get started