ITF Consult

Closing findings after an audit

Your audit raised findings, and we help you find the real cause of each one and write a response the evidence supports.

Every response
Correction, cause, corrective action, evidence
Deadline
Set by your certification body
Cause analysis
Traced on the floor, not in a meeting room
Effectiveness
Checked after the action has had time to work
Also for
Customer and regulator audit findings

After a certification audit, findings must be answered with a correction, a cause analysis and a corrective action, within a deadline set by your certification body. We help you find the real cause and write a response aimed at it, so the fix reaches the reason the finding happened and not only the record.

Three audit visits raising the same missing calibration record finding, each closed by adding the record, then the third traced back through why the calibration was not done and why nobody booked it to a root cause of no owner for the calibration schedule, with panels below showing a response part by part and the usual reasons a response is sent back.THE SAME FINDING, THREE VISITSVISIT 1RECORD MISSING, RECORD ADDEDVISIT 2ANOTHER RECORD, SAME FIXVISIT 3ANOTHER RECORD, CAUSE TRACEDEACH RESPONSE FIXED THE RECORD, NOT THE REASON IT WENT MISSINGTRACED BACK, ONE QUESTION AT A TIMETHE FINDINGNO CALIBRATION RECORDWHY?CALIBRATION NOT DONEWHY?NOBODY BOOKED ITROOT CAUSENO OWNER FOR THE SCHEDULETHE RESPONSE, AND WHY ONE COMES BACKTHE RESPONSE, PART BY PARTCORRECTIONCALIBRATE, FILE THE RECORDEXTENTEVERY INSTRUMENT CHECKEDCAUSENO OWNER FOR THE SCHEDULEACTIONSCHEDULE GIVEN AN OWNEREFFECTIVENESSNEXT DUE DATES METWHY RESPONSES COME BACKCAUSERESTATES THE FINDINGACTIONRETRAIN THE OPERATOREVIDENCEA PROMISE, NOT A RECORDEXTENTONE INSTANCE ONLYCHECKDONE THE SAME DAY
The same finding, three visits, one causeEach response fixed the record, not the reasonSwipe to pan
  1. 01 Enquiry
  2. 02 Gap analysis
  3. 03 Plan
  4. 04 Build
  5. 05 Embed
  6. 06 Internal audit
  7. 07 Close out
  8. 08 Management review
  9. 09 Handover

Closing findings after an audit sits at step 7 of the readiness cycle. You receive a closed corrective action log.

01

Why the same finding comes back

A repeat finding usually comes from a response that fixed the instance and left the cause alone.

The pattern is familiar. The cause analysis restates the finding: records were missing because they were not kept. The corrective action is to retrain the operator. The evidence is a signed training sheet. The response is accepted, the record is fixed, and at the next visit the same gap turns up somewhere else.

Training is sometimes the cause. Far more often the process let the mistake happen: no owner, no trigger, no check. Retraining a person inside a process that still allows the error changes nothing about the process.

Speed makes it worse. A response written in the week before the deadline settles on the quickest plausible cause. A cause found on the floor, by following the gap back to where the process let it through, takes longer and holds.

02

What a response has to contain

Certification bodies differ in format. The content they look for does not.

PartWhat it saysWhere it usually fails
CorrectionWhat was done about the instance the auditor found: the record completed, the product held, the instrument calibrated.Treated as the whole response
ExtentWhether the same gap exists elsewhere: other instruments, other lines, other sites.Skipped
Cause analysisWhy the process allowed it, traced back until the answer is something the organisation controls.Restates the finding
Corrective actionThe change to the process that removes the cause, with an owner and a date.Retrain the operator
Evidence of closureRecords showing the correction and the action were done, not a statement that they will be.A promise, not a record
Effectiveness checkA dated check, after enough normal work has passed, that the gap has not come back.Done the same day
03

What goes back with your response

01

The cause analysis per finding

The chain from the finding back to its cause, with the evidence for each step, written so an auditor can follow it.

02

The corrective action plan

Each action with an owner, a due date and the evidence that will show it is done.

03

The evidence of closure

Records, revised documents and photographs where they help, collected and indexed against each finding.

04

The effectiveness schedule

The date each action will be checked again, so closure is tested by normal work before the next visit.

04

How we work a finding

  1. 01

    Read the finding

    The finding, the evidence it cites and the requirement behind it. If the wording is unclear, you ask the auditor to clarify before anyone writes a cause.

    First
  2. 02

    Go where it happened

    We follow the gap back through the process on the floor, with the people who run it.

    On site
  3. 03

    Find the cause

    Why the process allowed it, asked until the answer is something you control.

    Same visit
  4. 04

    Write the response

    Correction, extent, cause, corrective action and evidence, in the format your certification body uses.

    Before the deadline
  5. 05

    Date the check

    The effectiveness check scheduled for after the action has been tested by normal work.

    Weeks later
05

A calibration finding, closed three times

A company had the same finding at three visits in a row: calibration records missing for measuring equipment.

Each response fixed the record. The instrument was calibrated, the certificate filed and the finding closed. Each time, a different instrument turned up without a record at the next visit.

We trace the gap back. The calibration was missed because nobody booked it. Nobody booked it because the schedule was a spreadsheet that had belonged to someone who left. The cause is that no one owns the calibration schedule.

The corrective action gives the schedule an owner, puts it on the master list and adds a monthly check of what falls due. The response carries the correction, the cause chain, the action and the evidence, with an effectiveness check dated for after the next round of calibrations.

06

Deadlines, disagreements and retraining

Q01

How long do we have to respond?

Your certification body sets the deadline and states it with the findings. Major findings usually carry a shorter window and may have to be verified before a certification decision is made.

Q02

Is retraining a valid corrective action?

Sometimes, when a person genuinely was not trained. Usually it is not: the process let the mistake happen, and retraining leaves the process as it was. An auditor who sees retraining offered for a process failure will usually ask why.

Q03

What if we disagree with a finding?

Say so, with evidence, when the finding is raised or in the response. Accredited certification bodies are required to run an appeals process. A disagreement backed by evidence gets a hearing, and one without it rarely does.

Q04

Can you deal with the certification body for us?

The response goes from you, in your name. We help you prepare it and can be present when you discuss it with the auditor.

Q05

Do you help with customer and regulator findings too?

Yes. The method is the same. The deadline, the format and who judges the response are different, and we work to theirs.

Send us the findings

Send the audit report and the deadline. We will read the findings, say which ones need a site visit and which can be answered from records, and start with the earliest deadline.

Send us your findings