Complaints¶

Once you ship product — even clinical trial material — you need a documented complaint-handling process. Inspectors ask for the complaint log early in any inspection of a commercial or late-clinical operation, and they cross-check it against deviations and CAPAs. QStack's opinionated flow is Intake → Triage → Investigation → Response → Closure, with confirmed quality issues escalating into a linked deviation.

If you're pre-clinical, this module may sit quiet for you for a long time — that's fine, it costs nothing to have ready. Once you reach commercial stage, it gives you a compliant process from day one instead of a spreadsheet.

You'll use this module as an Intake user logging a complaint as received, a Complaint Owner (typically a Quality role holder) carrying it to closure, an Investigator working the quality aspect, or a Quality role holder confirming triage and signing closure.

Log a complaint¶

Click New Complaint and fill in:

Field	What to enter
Received date	When the complaint reached the company
Received via	Phone / email / letter / field report / partner
Complainant	Name and contact details
Product, batch/lot	What the complaint concerns
Description	The complaint in the complainant's own words, plus context
Sample available?	Whether the complained-of unit can be returned for examination
Acknowledgement sent	Date the complainant was acknowledged

Submit. Quality role holders are notified immediately, and the triage clock starts.

GDPR

Complainant personal data is captured minimally — name and contact route — and is visible only to users with complaint access, subject to your tenant's retention policy. If a data-subject erasure request comes in, the complaint record survives in pseudonymised form: the quality content is a GxP retention obligation, but the personal identifiers are not.

Triage a complaint¶

Within a tenant-configurable window (default one business day), the Complaint Owner classifies the complaint:

Classification	Definition	Path
Not a quality complaint	Service, commercial, or out-of-scope issue	Closes with rationale and a Quality role signature
Quality complaint — Minor	Quality-related, but no patient-safety or batch implication	Investigate; a deviation is optional, with justification
Quality complaint — Major	Possible batch quality implication	Opens a linked deviation in Deviations & CAPA; product impact is assessed there
Quality complaint — Critical	Potential patient-safety or recall-relevant issue	Opens a linked Critical deviation immediately; Quality role notified the same day

Reportability to a regulator, and any recall decision, are human decisions made outside QStack — the triage form only records that the determination was made, by whom, and the outcome.

Investigate a complaint¶

For Major or Critical complaints, the linked deviation carries the investigation — root cause, product impact, CAPA. The complaint page shows the deviation's live status, so you don't have to duplicate updates.
For Minor complaints without a deviation, complete a structured investigation summary directly on the complaint, signed Reviewed and approved.
Either way, link the relevant batch records for review — batch evidence, CoAs, the retained-sample examination record.

Respond and close a complaint¶

As Complaint Owner, record the response sent to the complainant — attach the letter or email as a record.
Write the closure summary: confirmed or not confirmed, root cause (if found), action taken, response sent.
The Quality role signs closure with meaning Authorised for release.

Warning

If the linked deviation is still open, you can only close the complaint with a written justification — for example, "response sent, CAPA continuing." Otherwise, the complaint waits for the deviation to close first.

Complaint states¶

Open → In Triage → In Investigation → Response → Closed, with a shortcut from In Triage directly to Closed — not a quality complaint.

Cross-module linkages¶

A complaint rarely stays self-contained:

A Major or Critical triage opens a linked deviation in Deviations & CAPA — the complaint stays open until that deviation, and any CAPA it spawns, is resolved.
Batch evidence, CoAs, and the retained-sample examination record are linked in from Quality Records.
A confirmed root cause that points at a process, equipment, or supplier problem often leads to a change request in Change Control, linked back to the complaint.

The linked-items panel on a complaint shows every connected object, the same way it does on a deviation or a CAPA.

Complaint trending is a regulatory expectation in its own right:

Complaints per product per period, by classification
Recurrence — complaints sharing a root-cause category or batch
Time-to-acknowledge and time-to-close
Confirmed vs. not-confirmed ratio

This trending view feeds the Annual Management Review pack — see Notifications & Reporting.

Tenant configuration¶

A few things about how this module behaves are set once for your whole organization, typically during onboarding:

The triage window (default one business day)
Who holds the Complaint Owner duty (default: Quality role holders)
The acknowledgement-letter template text

If any of these need to change later, your Org Admin or a Quality role holder can update them — ask them if triage seems to be running to a different clock than what's described above.

What an inspector sees¶

QA shows the complaint log for the period, including "not a quality complaint" closures with their rationale. Picking a Major complaint, the inspector follows intake → triage → linked deviation → CAPA → response → closure signatures. If the inspector asks about other complaints on the same batch, the batch filter answers directly.

What this module doesn't do¶

It doesn't handle adverse events or pharmacovigilance — safety reporting belongs in a safety system. This module records quality complaints only, and the triage form prompts you to route suspected adverse events to your PV process.
It doesn't execute recalls — a recall decision is recorded here (and is usually paired with a Critical deviation and a change request), but recall logistics happen outside the system.
It doesn't notify regulators — reportability is a human, Quality role responsibility outside the system's scope.