What Happens if Nonconformities Are Found During Your Audit

What happens if nonconformities are found is less dramatic than most sites expect: findings are the normal output of an assessment, not a verdict on it. A first audit that raises nothing is unusual enough to be suspicious, and an assessor who finds nothing at a site that has changed equipment, staff and suppliers has not looked hard enough.

What determines the outcome is not whether findings are raised. It is what you do with them in the weeks afterwards.

At a glance

• Findings are expected. Most first assessments raise several.
• You hear them on the day, at the closing meeting, with the evidence stated.
• They are graded against a stated standard, not by impression.
• You respond with changes, not intentions.
• The certificate follows once responses and any verification confirm the gaps are closed.

What a finding actually is

A finding has three parts, and a well-written one states all of them.

• The requirement. What the applicable framework, or your own documented system, says should happen.
• The evidence. What was actually observed or recorded — specifically, with references. A batch number, a document revision, a date, an observation.
• The gap. The distance between the two, stated plainly, without adjectives and without naming an individual.

If a finding is missing any of the three, ask. “Documentation was inadequate” is not a finding; it is an opinion. “Procedure QP-14 rev 3 requires a second verification signature at line clearance; batch records 4471, 4478 and 4482 carry one signature only” is a finding, and it tells you exactly what to fix.

Major and minor nonconformity: what the grading means

Grading follows the evidence rather than the assessor’s mood, which is why a finding you disagree with is better recorded than argued. If you believe the assessor has misread a record, say so at the closing meeting — factual errors are corrected there and then.

Writing a response that closes first time

This is where sites lose the most time, and the difference between a response that closes and one that returns is almost always the same.

Correction

What you did about the specific instances found. The three batch records were reviewed and the missing verification obtained where possible, or the affected batches were quarantined pending assessment.

Root cause

Why it happened. Not “operator error” — that is a description, not a cause. The useful version explains why the system allowed it: the form had no designated space for the second signature, or the procedure was revised without the form being updated.

Corrective action

The change that stops recurrence. A change, not a promise. “The form was revised to include a designated verification field, effective from this date.”

Evidence

Records created after the change, showing it working. Ten completed forms from the new revision, not a copy of the revised blank form.

Verification

Who checked, when, and what they concluded.

The timing trap

An action implemented on Monday and evidenced on Tuesday has not been shown to work. Effectiveness evidence comes from a period of normal operation after the change, and there is no way to compress that below the time it takes for the evidence to exist.

Sites that understand this build the wait into their plan. Sites that do not submit early, get the response returned, and lose more time than the wait would have cost.

What happens if nonconformities are found and cannot be closed quickly

It happens, usually where the fix requires equipment, construction or a supplier change rather than a document revision.

The honest answer to what happens if nonconformities are found at this level is that certification waits. A certificate issued over an open major finding would not mean anything, and a buyer relying on it would be relying on nothing. What can be done is agree a realistic closure plan with dates, so the process is paused deliberately rather than drifting.

Sites in this position sometimes ask whether narrowing the scope would resolve it. Occasionally it does — if the finding affects one product line and that line can legitimately sit outside the initial scope, certifying the remainder and extending later is a genuine option rather than a workaround. Whether it applies depends entirely on where the finding sits.

Turning findings into something useful

The sites that improve fastest treat external findings as input to their own programme rather than as a hurdle cleared. Three habits do it.

• Feed every finding into the internal audit schedule. If an assessor found it, your next internal audit of that area should check the same thing.
• Look for the pattern. Three findings about records completed after the fact are not three problems; they are one, and fixing it once is cheaper than three times.
• Check the same gap elsewhere. A finding in one area is frequently present in two others that were not sampled.

That is internal audit method applied to somebody else’s findings, and it is what cGMP internal auditor training in Kuwait covers. A self-paced route runs through online cGMP internal auditor training, and the cGMP foundation course grounds the wider team. IAS also publishes a training schedule for Kuwait for sites that would rather book a scheduled session.

Reading a finding you disagree with

Occasionally an assessor raises something you believe is wrong. Handling that well is a skill, and handling it badly costs more than the finding. Separate three different objections — they get confused, and they need different responses.

The evidence is wrong

The assessor misread a record, or a document they could not find does exist. This is factual, and it is corrected at the closing meeting if you say so.

The requirement is misapplied

You believe the framework does not require what the finding says it requires. Worth raising, calmly, with reference to the clause. Sometimes you are right.

The grade is too high

You accept the gap but think it is minor rather than major. This is the least productive argument, because grading follows the evidence and impressions rarely move it. Ask for your view to be recorded.

What not to do. Arguing at length in the closing meeting with the whole management team present rarely changes an outcome and consistently damages the working relationship. Sending a lengthy rebuttal instead of a corrective action response wastes the response period and usually results in the finding standing anyway.

What works instead. Accept what is accurate, correct what is factually wrong, record what you dispute, and put your energy into the response. A well-evidenced response closes a disputed finding faster than a well-argued objection.

Quick definitions

• Nonconformity: a requirement not met, evidenced.
• Major: a gap affecting the system’s ability to deliver conformity.
• Minor: an isolated lapse that does not undermine the system.
• Observation: a matter worth attention, not a nonconformity.
• Correction: what you did about the specific instances found.
• Root cause: why the system allowed it to happen.
• Corrective action: the change preventing recurrence.
• Effectiveness evidence: records made after the change, showing it held.

Why manufacturers in Kuwait work with IAS

• Every finding stated at the closing meeting, with the requirement and the evidence, rather than appearing later in a report.
• Grading applied against a stated standard, so classification is explainable.
• Draft responses can be reviewed before formal submission, which is faster than a returned pack.
• Internal auditor training available alongside certification, so your team writes findings the same way.
• Fixed written quotation before any work begins, with the surveillance pattern stated.

Keeping the roles distinct: IAS examines systems and teaches people. Facility licensing and product authorisation belong to regulatory authorities, and a certificate never stands in their place.

Findings and their closure come up often enough that frequently asked questions covers them directly, IAS accreditation sets out what the certificate rests on, and the wider Kuwait service list sits on the Kuwait service index.