CorridorIQDocumentation risk assessment

How the work is run, and what it will not tell you.

An assessment can end up in a disclosure bundle. It is written on that assumption. This page sets out how findings are reached, how material is handled when the party commissioning the work does not own the documents, and where the limits sit.

Methodfive stages

Five stages, in order.

  • Scope. Establish what documents exist, and what documents are referred to. These are different questions, and the gap between them is usually the first finding.
  • Determine. Establish whether the product falls in scope, and which party carries the manufacturer obligation.
  • Decompose. Values, intervals, terms, hazards and compliance claims into addressable rows, each carrying the document and clause it came from.
  • Run. The cross-document rules across the whole set, plus an item-by-item assessment against the applicable contents requirements.
  • Report. Findings with severity, each cited to the clause behind it and quoted from the client's own wording, with a specific remedy and a sequenced plan.

The report is version-controlled and document-numbered, because the people who read it work that way.

Evidenceno assumed values

Nothing is inferred to fill a gap.

Where a value, a criterion or a claim cannot be traced to a source, it is recorded as absent rather than reconstructed from what it probably should be. An evidence gap is a finding in its own right, and in most sets the gaps are worse than the errors.

Every finding quotes the client's own wording. A finding that cannot be checked against the document it came from is not a finding.

Confidencethree parties

The NDA is signed first. Then the documents arrive.

An assessment is frequently commissioned by a party other than the manufacturer that wrote the documents. That changes what has to be agreed before anything is received.

  • A non-disclosure agreement is in place before any technical material is sent. Yours or ours, whichever your legal team prefers.
  • The commissioning party confirms it is entitled to share the material it supplies, and on what basis.
  • Findings are reported to the commissioning party only, and to nobody else without written instruction.
  • Material is used solely for that engagement. It is not shared, and it is not used as an example, a portfolio piece or a demonstration.
  • Findings are not aggregated across a portfolio, anonymously or otherwise, without written agreement.
  • Material is returned or destroyed on request at the close of an engagement, with confirmation in writing.
The worked example on this site is built on an invented machine for exactly this reason. Demonstrating a real document set, particularly one with defects in it, is not something worth asking a client to agree to.

Toolingand who signs

Automation may produce a finding. CorridorIQ signs it.

Cross-document rules are run mechanically, because that is the only way two contradictory rows in a large set reliably meet each other. What the rules produce is a candidate, not a conclusion. Every finding in a report has been read, judged and accepted by CorridorIQ before it is issued, and the practice stands behind it.

Where a client's terms restrict how their material may be processed, those terms govern the engagement and are agreed before anything is received.

Limitsstated, not implied

Where an assessment stops.

  • It is not a conformity assessment, certification or approval, and CorridorIQ is not a notified body.
  • It does not compile or sign off a technical file, and does not draft or approve a declaration of conformity.
  • It is not legal advice on liability, obligation or interpretation.
  • It covers the documents supplied. What was not supplied is listed, not assumed.

A determination is a reasoned position with its evidence and its limits stated. Where a question belongs to a notified body or a legal adviser, it is flagged rather than answered. A flagged question is useful; an answered one from the wrong party is a liability.

Conflictsdeclared

Conflicts of interest are declared before an engagement begins.

CorridorIQ both assesses document sets and authors them. Where an assessment is commissioned on a manufacturer for whom CorridorIQ holds or has held an authoring engagement, that relationship is declared to the commissioning party before the work is accepted, and the work is declined where the conflict cannot be managed.

Remediation authoring that follows an assessment is a separate engagement, priced separately, and never a condition of the assessment.

Send one product family. We will tell you what sits between the documents.

A non-disclosure agreement is in place before any technical material is received.

  • The manufacturer and the product family involved
  • Which documents exist, and which are referred to but not held
  • Whether this is pre-bind, renewal, a risk improvement condition, or a claim
  • Your timescale