Exemptions

Exemptions

A controlled record for every concession, deviation, or temporary waiver — with combinable scope (time, product, batch, serial), risk-tier approval, and an audit-ready print report.

For
Quality Managers, exemption owners
Find it at
Sidebar → Exemptions
Reading time
6 min

In one sentence

An exemption is a controlled deviation from a standard requirement — scoped narrowly (a specific batch, a specific date range, specific serial numbers), risk-assessed, approved through a routed chain, and preserved in the register even after it expires.

Three things to remember
  • Scope is combinable. An exemption can be time-based and batch-scoped and product-scoped — useful for the "this product family, at these serial numbers, until next quarter" pattern.
  • Approval routing is risk-based. A high-risk exemption gets more approvers; a low-risk one routes faster. Set per-org at Admin → Approval Routing → Exemption tab.
  • Expired exemptions stay in the register as Approved — Expired. They can't be used as evidence for new work, but the audit trail is intact.

Creating an exemption

  1. Click New Exemption from the list.
  2. Select the document the exemption is against.
  3. Set title, description, and exemption type.
  4. Set start and end dates.
  5. Configure scope types (below).
  6. Set facility and department scope.

Scope types

Each exemption can declare what it applies to, via checkboxes on the Details tab:

Scope typeWhat it limits
Time-basedThe start / end date window only
ProductSpecific products
BatchSpecific batches or lot codes
Specific serialNamed serial numbers

Combine as needed. A free-text Scope detail field captures the specifics — which products, which batches, which serial numbers.

The exemption Details tab showing scope checkboxes and the free-text scope detail field

save as: public/docs-screenshots/exemptions/scope-types.png

Detail tabs

TabWhat lives here
OverviewAccess summary, quick status
DetailsCore fields and scope types
RiskRisk assessments on the exemption
ApprovalsApproval chain status
ActionsCorrective and follow-up actions
AttachmentsSupporting files
LinksConnections to other records — and a Linked Products card for tying the exemption to the parts or SKUs it covers
AccessPer-record access control (if you have the capability)
HistoryThe unified record-history feed — see Record history

Approval

Exemptions use the shared approval workflow with routing driven by the controlling document and the assessed risk level — up to three serial approvers, with delegation support and an emergency fast-track lane for urgent exemptions. See Approvals for the chain mechanics.

If your organization has Require passkey for approvals turned on, approving an exemption prompts for a fresh passkey confirmation. The confirmation lasts 5 minutes. The approver must have at least one passkey enrolled — see Auth policy and Passkeys.

Regulatory standard reference

On the Details tab, the Regulatory standard picker points the exemption at the clause it's deviating from. Two fields:

  • Standard — a dropdown of the standards your org has turned on at Admin → Regulatory Standards. Adding a new standard there makes it available everywhere the catalog is used: exemptions, the document editor's compliance-mapping picker, and the audit question bank, all reading from the same source.
  • Clauses — once a standard is picked, the clause field becomes a multi-select drawn from that standard's catalog. Pick one or several; each clause is rendered as a chip with the full clause title.

If an admin later deactivates a standard that an exemption already cites, the existing reference is preserved — nothing on the exemption changes. The picker just shows the entry with a (deactivated) suffix and an amber inline note, so the next editor knows the org has moved off it. The deactivation confirm modal at Admin → Regulatory Standards lists how many active exemptions still cite the standard (alongside audit questions, gap analyses, and documents), so the admin doesn't deactivate by accident.

The Print Report button at the top-right of the exemptions list opens a print-optimized report at /exemptions/report in a new tab. The report carries the current filter state through — status, type, risk level, search — so the printed output matches exactly what you were looking at on the list.

app.qformance.io/exemptions/report?status=active

The print-optimized report showing exemption cards with badges, scope, justification, approval chain, and linked records

save as: public/docs-screenshots/exemptions/print-report.png

Each matching exemption renders as a card with:

  • Number, status, type, and risk-level badges.
  • Requirement reference — the controlling document or standard clause.
  • Validity dates.
  • Scope (time / product / batch / serial).
  • Justification (the description).
  • Approval chain with dates and approvers.
  • Linked records (NCRs, risks, MOCs).

Built for print and PDF

  • On-screen Print / Save PDF button at the top.
  • Fixed header with the report title, the active filters that produced this set, and the generation date — repeats on every printed page.
  • Fixed footer with page numbers.
  • Page-break-aware layout — exemption cards never split across pages.

To produce a PDF, click Print / Save PDF and choose your browser's Save as PDF destination. Reports can be archived alongside the exemption register for audit submissions or steering-committee packs.

Expiry

Time-bound exemptions flip automatically to Approved — Expired when the end date passes. Expired exemptions:

  • Can't be used as evidence for current work.
  • Remain in the register, fully searchable.
  • Keep their approval chain and rationale intact for audit reconstruction.

Admin: exemption settings

Exemption approval routing is configured at Admin → Approval Routing → Exemption tab (the standalone Admin → Exemption Settings page now redirects there).

Finding exemptions in the list

The exemptions list page has a filter for every column right in the table header — narrow by type, risk level, status, scope, and so on, all at once. A count of matching exemptions sits in a footer strip below the table, so you always know how big the set you're looking at is. (The Print Report button carries that same filter state through to the printed output.)

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