These cookies are required for the website to function properly. They ensure security, enable basic features like page navigation, and store user session data. You cannot disable these cookies.
- Quality Management System
- Who it's for
- Regulated product teams
Regulated product teams
Teams working under named quality frameworks can connect active specifications, inspection outcomes, audit clauses and training assignments to the relevant standard. The records give reviewers a path from the item requirement to the observed result and the action taken after a serious issue.
How Quality Management System is set up for you
Standard reference
Record the applicable framework, version and effective dates, then link it to item specifications and audits.
Inspection evidence
Capture the parameter, method, observed value and result on the source inspection.
Audit response
Give each finding a clause, severity, response owner and due date, and verify the answer before closure.
Training action
A qualifying major or critical NCR closure can assign retraining to the source inspector when the linked specification resolves to a named framework.
Teams working under named quality frameworks can connect active specifications, inspection outcomes, audit clauses and training assignments to the relevant standard. The records give reviewers a path from the item requirement to the observed result and the action taken after a serious issue.
Choose a product with one active specification governed by the appropriate quality standard. Inspect a representative lot, record a defect and carry it through nonconformance, disposition and CAPA review. Show the Quality Manager both the source measurement and the effectiveness decision. Then rehearse a closure that qualifies for event-linked training and inspect the trainee, topic, standard and related issue on the assignment.
Set up the standard version and effective dates with the team responsible for the quality program. A framework label in a record supports traceability within this workflow; the organization defines its own approval and evidence procedures. Review the audit checklists and training records with the people who will maintain them after the first cycle.
Features to start with
Roles on the team
- Quality Engineer
- Facilitates RCA and owns specifications, inspection plans and root cause tooling; no disposition or closure authority.
- Quality Manager
- Owns NCR disposition, CAPA closure, effectiveness results, audit sign-off and supplier score certification.
- Auditor
- Runs own assigned audits through to Reporting; read-only everywhere else, no inspection edits, disposition or CAPA closure.
- Inspector / QC Operator
- Executes assigned inspections and records results, defects and NC rs; no disposition, plan design, audit or CAPA authority.
Set up Quality Management System your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.