Link the scenario, control requirement, tested configuration and verification evidence. Keep unresolved checks visible when reviewing the claim that a control works.
All blueprints
Connect every risk control to the evidence behind it.
Keep risk scenarios, controls, verification and new operational evidence connected. Ask neil to investigate gaps and prepare controlled improvements.
A named control is not evidence
that it works.
Vessel overfill: follow the high-level signal to the inlet valve.
- Required response
- Inlet closes
- Observed in this example
- Inlet remained open
The failure leads back to the control.
Link the failed result to an investigation and the affected control. Assess the cause and define the verification needed after the change.
Follow the failure back to the control.
A failed verification should lead to the requirement it challenges, the configuration tested and the work needed next. In Seal, those can be linked records—not references someone has to reconcile across spreadsheets.
Keep the original observation. An investigation can change the explanation or the proposed control; it should not rewrite what happened in the test. Reviewers decide which checks must be repeated and whether the remaining risk is acceptable.
New evidence can challenge an old assumption.
A complaint, maintenance finding or production deviation may change the basis of a risk assessment. Connect the source to the affected scenario and retain why it belongs in the review.
The related complaint example below separates the original report from the technical investigation and safety assessment. A reported malfunction is evidence to assess, not a confirmed cause or a risk conclusion.
Keep the denominator with the estimate.
Fewer failures do not necessarily mean less risk. In this related CAPA example, failures fall from 12 to 5, but use falls from 150 to 60 runs. The observed rates are 8.0 and 8.3 per 100 runs.
Seal’s configured chart keeps the comparison visible. Assess the population, observation period, uncertainty and competing explanations before using it to revise an estimate. These observations alone do not establish a causal effect.
Ask neil to prepare the follow-up.
Give neil the risk file, the changed requirement or the new evidence. It can investigate permitted records and author proposed assessments, verification cases and workflow changes in Seal.
The useful deliverable is inspectable work: source-linked reasoning, explicit gaps and a proposed change your team can test. People approve the technical scope, run verification and make the risk decision.
Investigate a challenged control
“Find the requirements and scenarios linked to this failed verification. Compare the tested configuration with the current one.”
A proposed impact assessment with source versions, competing explanations and the evidence needed to distinguish them. Missing evidence becomes linked follow-up work.
Prepare the next verification
“Turn the proposed control change into requirements, capture fields and verification cases.”
Inspectable configuration and proposed cases covering the intended response, failure paths and missing evidence. Include verification of the configured workflow itself before publication.
Review the operating evidence
“Compare the relevant complaints and service findings with the assumptions in this risk file.”
A source-linked comparison with population and exposure limits, candidate affected scenarios and proposed review tasks. No unsupported incidence estimate or automatic risk acceptance.
Illustrative requests and proposed outputs. The captures on this page do not demonstrate neil execution.
Capabilities
Keep the source population, exposure, observation period and uncertainty with the estimate. Apply your defined criteria without turning incomplete counts into incidence claims.
Connect complaints, service findings and deviations to the scenarios they may challenge. Preserve source wording and distinguish reported facts from conclusions.
Follow a changed requirement into the instructions, capture fields, qualification and verification that depend on it. Record the assessment scope and rationale.
Give each unresolved question an owner, source and follow-up. Ask neil to prepare source-linked assessments and proposed work for your team to review.
Define which evidence will test a control improvement, and when. Keep work completion separate from the later assessment of whether the change helped.
Related line-clearance example: a native verification plan links a procedure and change to planned checks. No vessel-control execution is shown.
Open full-size image in a new tabConnected records
Entity hierarchy
What it records
Kind
Hazard
Potential source of harm, with its product or process context and supporting evidence.
entity
Energy Hazard
Electrical, mechanical, thermal, radiation. Physical energy transfer that can cause harm.
template
Biological Hazard
Biocompatibility, infection, contamination. The device meets the body.
template
HAZ-2024-017
Fictional reprocessing scenario: surface geometry may retain contamination and needs assessment.
record
Use Error
Misuse, abnormal use, use environment. The surgeon's hand strength can't generate 2N.
template
Risk
Assessment of a scenario using the defined criteria, evidence and uncertainty.
entity
Risk Control
Measure intended to reduce risk, linked to its requirement and verification.
entity
Design Control
Design measure intended to reduce risk, with its rationale and verification scope.
template
CTRL-2024-001
Fictional time-based stop requirement. Implementation, operating conditions and evidence require review.
record
Protective Measure
Protective measure such as a guard, alarm or interlock, with a defined response and evidence.
template
Information Control
Information for safe use, with its intended audience, scope and assessment of limitations.
template
Residual Risk
Assessment of the risk remaining after controls, with rationale and required review.
entity
Post-Market Data
Operating evidence that may support or challenge the assumptions in the risk file.
entity
FMEA
Analysis of functions, failure modes, effects, causes and controls within a defined scope.
entity
Process FMEA
Process-step functions, failure modes, effects, causes, existing controls, estimates, actions, verification, and residual decisions.
template
Risk Management Plan
Scope, lifecycle, roles, activities, methods, criteria, verification, information sources, review, deliverables, and change triggers.
entity
ISO 14971 Risk File
Medical-device lifecycle plan, analyses, scenarios, controls, verification, residual and overall risk, report, and post-production review.
template
ICH Q9 Quality Risk Assessment
Pharmaceutical quality question, risk method, evidence, analysis, control, communication, review, and formality proportional to risk.
template
Use & Process Context
Intended use, users, patients, environments, workflows, interfaces, maintenance, reprocessing, service, disposal, and foreseeable misuse.
entity
Risk Scenario
Hazard, initiating event, sequence, exposure, hazardous situation, harm, severity, probability elements, evidence, and uncertainty.
entity
Questions and answers
No. Your team defines the criteria, context and required review. Seal holds the versioned assessments, evidence and decisions; a passing verification does not itself accept residual risk.
Use distinct templates for the methods your process needs. They can reference common functions, controls, requirements and source evidence while retaining their own terminology and assessment criteria.
Retain the failed result and tested configuration. Link the investigation and proposed correction to the affected control, then define the verification needed after the change. Review the residual risk separately.
Configure the categories, definitions and criteria for your context. Record their version and the basis for each estimate so reviewers can understand what the assigned values mean.
Link relevant complaints, deviations or service findings to the assessment. Configure ownership and review triggers, and retain why each source was included or excluded. A similarity is not a confirmed cause.
neil can analyse supplied documents and permitted records, prepare source-linked assessments and follow-up work, and author proposed requirements, capture fields and verification cases. People verify the configuration and approve the decisions.
Not automatically. Keep the applicability, configuration and supporting evidence explicit for each assessed scope. A shared reference helps identify the affected products; reviewers determine whether the evidence applies.
Action completion and risk acceptance are different decisions. Review implementation, verification, remaining uncertainty and any required effectiveness evidence before recording the authorised conclusion.
Related blueprints
GxP Computer System Validation (CSV) & Computer Software Assurance (CSA) Software
Control regulated-system inventory, intended use, function risk, supplier evidence, right-sized testing, releases, changes, and periodic review without turning validation into a document factory.
Medical Device QMS & Manufacturing Software
ISO 13485, EU MDR, FDA 21 CFR 820. Design controls through post-market surveillance. When the auditor asks to see requirement 47, you click once.
Product Recall & Market Action Management Software
Run health-hazard evaluation, affected-lot and unit scope, recall strategy, authority communication, consignee notification, response tracking, product reconciliation, effectiveness checks, status reporting, and termination.
Pharmaceutical Process Characterization Software
Configure and execute process characterization studies in Seal. Connect protocols, actual conditions and analytical results to the evidence behind operating ranges and controls.
Chemical Inventory, SDS & EHS Management Software
Chemical approval, inventory, SDS versions, GHS labels, storage compatibility, quantity limits, risk assessment, exposure controls, inspections, incidents, hazardous waste, emergency inventory, and jurisdiction-aware reporting.
GxP Deviation & Investigation Management Software
Connect the event to the batch, sample and original evidence. Ask neil to investigate the history, test competing explanations and prepare the next controlled change.
See your process in Seal.
Tell us about your workflow. We’ll show you how neil and Seal can help your team.
Book a demo