Role · Quality & validation leadership

You answer for reviews you were not present for

Quality owns the question of whether a deliverable was properly checked, and inherits it from disciplines that did the checking. standrdX makes the answer a lookup rather than an investigation.

The position

The work was done. Proving it is the job you actually have.

Discipline teams review properly. What they rarely produce is a record that survives contact with an auditor eighteen months later.

So quality carries an obligation it has no direct means of satisfying, and satisfies it by asking people.

Why it is hard

Review quality is managed by whoever performs it. Review assurance belongs to someone who was not there.

The obligation sits with one role and the evidence sits with another.

The investigation

What answering a simple question costs today

Nobody is withholding anything. The evidence exists, distributed across a mailbox, a spreadsheet, a transmittal and somebody's recollection.

Answering it today

Find who reviewed it

Which assumes they are still with the business.

Ask what they checked it against

From memory, months after the fact.

Locate the evidence

A mailbox, a spreadsheet, a shared drive, a transmittal.

Rebuild the trail

And hope it reconstructs to the same answer.

What changes

The basis is recorded while the review happens

Nothing is compiled later. The clause and the reviewer are attached at the moment of the ruling, so the answer is retrieved rather than rebuilt.

WHAT IS AVAILABLE WITHOUT ASKING
WHATWhich deliverables were reviewedAnd which were never included in a runCOVERAGE
AGAINSTThe clause each one was judged againstWith the revision in force at the timeCLAUSE
WHOThe reviewer who ruledAnd the justification on any overrideNAMED
OUTA package for the inspectorProduced by the review, not before itEXPORT

FAQ

Questions from quality and validation

Where does this sit relative to our QMS?

Alongside it. The QMS holds a nonconformance once it has been raised; this is what brings it to light while the deliverable is still in review.

Are you a validated system?

Settle that in a documentation review with your own team. Ask for the pack and you will get it in writing rather than as a claim.

Can I see coverage without going to each discipline?

Yes. Documents included in a run and those never included are both visible per project, which is the distinction a finding count alone hides.

What if a reviewer disagreed with a finding?

The rejection is part of the record, with the reason given. A disagreement that was reasoned is stronger evidence than a clean sheet.

How far back does this help?

As far back as the reviews you run in it. It does not reconstruct history, which is the honest argument for starting on a live project rather than waiting.

Who can see what?

Access is role-based and scoped per project. The role model is set out under Security & Governance.

Next step

Pick the project you would least like to be audited on.

Run it there. The gap between what you believe was checked and what can be shown is the thing worth measuring.