Summary
- The problem
- One report feeds product quality, safety review and complaint handling, and a single record forces them into one status and one conclusion.
- Seal’s approach
- The reporter’s wording stays as submitted. The technical investigation, safety assessment and follow-up are separate records, each with its own status, pointing to the same source version of the complaint.
- What changes
- Unknown identity stays unknown until confirmed, conclusions keep their limitations, and recurring complaints are compared by product population and exposure rather than by counts.
- Where to start
- One complaint type: the procedure, a representative report and the records it touches. Book a demo.
Keep one source and separate the decisions.
A single complaint report often raises several questions at once. In the example above, the reporter says the device stopped during use, the patient needed assistance and the packaging has gone. Product quality needs to examine the device, a qualified safety reviewer needs to assess the patient event and the complaint coordinator needs a lot or serial number. Put all three into one case with one status and it becomes hard to tell which question has been answered. A standalone complaint system usually does exactly that, and then asks investigators to fetch the batch, device history and prior complaints from other systems; in Seal the report, its separate follow-ups and those records are linked on one platform.
In Seal the original report stays as submitted, and each follow-up is its own record pointing to INT-031 v1. In this fictional example, the device has not been examined, the safety assessment is open and product identification is still requested. Progress on one record does not close the others.
A case form that copies the report and tracks a single workflow to closure loses both the exact wording and the separate accountability. Keeping the source apart from the work it creates lets each reviewer see what they are assessing, and lets an auditor see who decided what, on which evidence.
Investigate the reported failure with evidence.
Start with a question and the evidence that could answer it. Confirm the product identity and conditions of use, keep custody of any returned product, and retain the observations, tests and limitations behind the technical conclusion.
If the product cannot be returned, record why and what remains untested. Keep a reporter’s statement, an observed fact and an investigator’s inference distinguishable. Missing identity stays unknown until evidence supports it; do not infer a lot number from a similar complaint.
Give neil the whole case to work from.
Using supplied documents and permitted records, neil can investigate related history, prepare the linked follow-up work and author the workflow for the next complaint. Ask it for source links, competing explanations and the evidence that would distinguish them, so its output can be checked against the case.
People review the proposed work, verify configuration and approve its use. Technical conclusions, safety assessment and any required reporting decisions remain with the authorised reviewers.
Prepare the missing-evidence work
“Read this report. What do quality, safety and product identification each need next?”
Prepare separate linked requests and investigation tasks, with the source statement and unresolved question attached. Preserve missing facts and ownership for review; do not invent a lot, patient outcome or completed assessment.
Investigate comparable complaints
“Find reports with this symptom. Which similarities are meaningful, and what would distinguish the possible causes?”
Compare permitted product history, configurations, part lots and examination evidence. Prepare an assessment with supporting and conflicting evidence, suggested matches and gaps. Similar wording is a lead to investigate, not a confirmed common cause.
Configure the intake and review workflow
“Turn our complaint procedure into linked intake, investigation and review records in Seal.”
Author source-preserving fields, separate issue records and role-specific review states. Prepare verification cases for missing identifiers, new facts and unresolved handoffs. Stage the configuration for testing and approval before operational use.
Close the case with its reasoning intact.
Reconcile the investigation, follow-up, communications and required assessments before closure. Retain what was concluded, the limitations and who authorised the decision. When new facts arrive, record a revised conclusion alongside the earlier one instead of overwriting it.
For recurring complaints, compare the relevant product population, exposure and reporting period rather than raw counts. Link a reviewed signal to the investigation or quality action it requires. Closing individual cases does not establish that a systemic issue is controlled.
ACapabilities
| Capability | What it covers |
|---|---|
| Source-preserving intake | Keep the original narrative, receipt time and source attachments with the case. Separate what was reported from what has been verified, and retain unknown identity explicitly. |
| Awareness and triage | Record when information arrived and route unresolved questions to the appropriate reviewers. Configure the awareness and review workflow for your process; the intake timestamp alone is not a reporting decision. |
| Complaint investigation | Plan examination around a specific question. Connect the source allegation to the device identity, use conditions, custody and evidence needed before a technical conclusion can be reviewed. |
| Returned product control | Keep return requests, custody, condition and examination scope with the investigation. Where a product is unavailable, record the reason and resulting limitation instead of implying a completed examination. |
| Governed reportability | Keep the relevant facts, applicable criteria and reviewer’s rationale together. Configure the assessment and review requirements with qualified people, preserving missing information and later revisions. |
| Quality–Safety handoff | Share the original source without merging accountability. Quality and safety reviewers retain their own questions, evidence and decisions while follow-up stays connected to the intake. |
| Exposure-aware trending | Compare events against the relevant population and reporting period. Retain source records and denominator assumptions; a count change or similar wording alone does not establish a causal defect. |
| Closure reconciliation | Review the technical conclusion, required assessments, communications and remaining actions together. Preserve limitations and the authorised closure decision; new facts can require further review. |
BConnected records
CQuestions and answers
What if one report raises several concerns?
Keep one original intake and link separate follow-up work for the concerns it raises. Each reviewer retains the source wording, their unresolved question and their own decision.
Can the intake date determine a reporting deadline?
Record receipt and awareness events explicitly. Qualified reviewers establish the applicable criteria and date basis; configure and verify that workflow for the products and jurisdictions in scope. This example does not calculate a deadline.
What if the lot or serial number is missing?
Keep the identifier unknown and request a verifiable source. Do not infer a product lot from a similar complaint or fill a required field with a guess.
What if the device cannot be returned?
Record the reason, follow-up attempts and investigation limitation. Plan other relevant evidence where available, without representing it as an examination of the reported device.
What can neil prepare?
neil can read supplied documents and permitted records, investigate related history, prepare linked follow-up work and author templates, fields and review states. People review the work, verify configuration and approve its use.
Can neil decide the safety assessment?
The qualified reviewer retains responsibility for safety and any required reporting decisions. Proposed classifications or related cases are inputs to review, not approved conclusions.
Does Published mean the complaint is closed?
No. In these captures it identifies a saved version. The technical investigation, safety assessment and product-
How should recurring complaints be compared?
Retain the relevant product population, exposure, period and coding context. Explain missing denominators and uncertainty. A reviewed pattern can lead to investigation or quality action without being treated as proof of a common cause.