Quality management systems (QMS)
A quality management system (QMS) records how quality is controlled and demonstrated: inspections, nonconformances, corrective and preventive actions, controlled documents and audits.
Its records serve as evidence, so corrections are added with history and originals are kept.
Table of Contents
Summarize with:
Key facts
- Workflows may include review and approval; electronic signatures apply where required by the relevant rules or policy.
- Documents are versioned, with effective dates.
- Relevant standards include ISO 9001, AS9100, 21 CFR Part 11 and sector rules.
- For closed systems within the scope of 21 CFR Part 11, section 11.10(e) states that audit trails must be secure, computer-generated and time-stamped, and record changes shall not obscure previously recorded information.
- Quality records kept apart from production break the trace at the boundary.
What it covers
| Aspect | In this category |
|---|---|
| Records | Kept with full correction history |
| Workflow | Review, approval, electronic signature |
| Documents | Versioned, with effective dates |
| Standards | ISO 9001, AS9100, 21 CFR Part 11 and sector rules |
| Audit | Retrospective, under time pressure |
Who uses it
| Role | What they do |
|---|---|
| Quality manager | Owns nonconformances, corrective actions and audits |
| Inspector | Records inspections at receipt and during production |
| Operator | Raises issues and follows controlled instructions |
| Document owner | Writes and revises controlled documents |
| Auditor | Reviews records for a past period |
What makes it hard to design
Corrections. Correction is a separate recorded action. The original stays visible.
Signatures. Signature steps state what is being signed.
Links to production. Nonconformances are linked to lot, operation and supplier.
Ownership. Corrective actions have owners, due dates and status.
Design implication
Rare, urgent use
Audits are retrospective and run under time pressure, so the screens auditors use cannot depend on training.
Trade-offs
- Building for the strictest regulation adds steps that unregulated customers experience as friction. Making the depth configurable avoids that, at the price of testing every setting twice.
Common mistakes
- Quality records kept in a system separate from production. A nonconformance cannot link to its lot, and the trace breaks at the boundary.
- Edits that overwrite history
- Signature dialogs that do not say what is being signed
- Corrective actions with no owner or due date
Sources: eCFR, 21 CFR 11.10