1. Quality Management System
  2. Implementation
Reference

How a Quality Management System rollout works

Start with one product and inspection path, then add issue and audit cycles.

  1. Set the quality basis

    Confirm products, active standards, specifications, defect codes and users.

  2. Configure inspection

    Choose an inspection type, effective plan, sample rules and calibrated equipment for a pilot item.

  3. Rehearse an issue

    Record a result, defect, nonconformance, containment and Quality Manager disposition.

  4. Run corrective work

    Assign CAPA cause, tasks, verification and effectiveness review.

  5. Add oversight

    Schedule an audit, follow a finding and review supplier and training records.

What the customer provides

Bring item codes, current specification versions, lot sampling policy, instrument IDs, applicable standards and the names of people who inspect, review and approve. Choose a representative receiving or production case. The Quality Manager should bring the disposition procedure and a real example of an effectiveness check. Supplier Quality Engineer can add a supplier and period score for the next rehearsal.

Changing it afterwards

When a specification, plan or standard changes, review its effective dates and inspect an example at the boundary. Keep prior inspection results linked to the versions used for their decisions. Review any changed role authority against an existing NCR and CAPA. Rehearse an out-of-tolerance instrument and a failed effectiveness result before expanding the process. Continue to get started when the first cycle is ready.

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