Getting the audit procedure in my head (learning it)

F

fishtruk

#1
Hello,
I am assisting our QA person. I'm trying to get the audit procedure in my head. Is there any resource out there which could help a lay person with this? Something similar to a pre-takeoff checklist? Any plain English information would help. I know the why...not the what, and distilling needed info from 2500 pages will take too much time.


I'm not happy with the consultants we get from EU and Canada (notified bodies?). All our outside advisors seem to say, "Just put this document in your Quality Manual", and the like. Kinda like the priest blessing your bible then telling you to put it on the top shelf of your closet and forget it.

Thanks a Lot!
 
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John Broomfield

Staff member
Super Moderator
#2
Hello,
I am assisting our QA person. I'm trying to get the audit procedure in my head. Is there any resource out there which could help a lay person with this? Something similar to a pre-takeoff checklist? Any plain English information would help. I know the why...not the what, and distilling needed info from 2500 pages will take too much time.


I'm not happy with the consultants we get from EU and Canada (notified bodies?). All our outside advisors seem to say, "Just put this document in your Quality Manual", and the like. Kinda like the priest blessing your bible then telling you to put it on the top shelf of your closet and forget it.

Thanks a Lot!

fishtruk,

I take it that your "QA Person" is a competent auditor. As assistant you may observe but not audit until you are trained. After training you may audit under supervision until the combination of your behaviors, skills and knowledge amount to you demonstrating your competence to audit.

These safeguards protect auditees and the reputation of the audit process.

Top management may bring the results of their assessments of opportunities and risks to determine the objectives of their audit programme. You may see the auditor receive the resulting audit objective from whomever is initiating the audit (this person is known as the audit client). From this the auditor recommends the audit criteria and the scope and duration of the audit for the approval of the audit client.

The auditor then plans the audit by deciding where and with whom to sample the verbal, documentary and visual evidence. This plan shows the auditee the location and timing the auditor needs to collect evidence of process/system effectiveness and conformity sufficient to fulfill the audit objective. From this the auditor researches the applicable requirements and may prepare checklists so the auditor knows what evidence to seek and why it is being sought. The auditor also allows time in the plan for evaluating the evidence and preparing the report ready for the closing meeting with the auditee.

The auditor provides a copy of the plan to the auditee so the auditee can arrange for the right people to be available and to request any necessary changes. Auditor changes the plan provided it will still fulfill the audit objective. Auditor also ensures he/she (and possibly the audit team) have any necessary security protocols, safety training and equipment.

The auditor chairs an opening meeting with the auditee to confirm the plan and any arrangements. With the auditee, the auditor moves into the workplace per the plan and seeks evidence of effectiveness within the scope of the audit, sufficient to fulfill the audit objective. The auditor observes the work environment and the work processes and their results and keeps excellent notes of the what, why, who, where, how and when and confirms the facts with the auditee each step of the way.

The auditor is careful not to make any part of the system depend on audit for is proper functioning. This means the auditor provides no advice even if asked. Repeated requests for advice may be evidence of an ineffective system. And the auditor is polite and seeks and expresses facts not opinions.

The evidence is evaluated by the auditor as the audit progresses predictably in accordance with the plan to result in findings. Evidence of positive findings may be highlighted for inclusion in the final audit report. Notes of failures of the system to fulfill requirements are also highlighted after agreement of the pertinent facts with the auditee.

If the notes indicate only minor findings then the auditor may advise the auditee accordingly so senior management need not attend the closing meeting. Major nonconformity may result in the auditor briefing the top manager on the system weakness privately before the closing meeting.

Note: "blame the system not the person".

The audit report is prepared for presentation at the closing meeting. The report includes the audit objective, the findings and the audit conclusion based on the findings. The closing meeting's review of the report includes no surprises because all possible misunderstandings were ironed out, before the closing meeting, during the audit investigation with the relevant auditee.

The nonconformities are then evaluated by the auditee for correction and the costly nonconformities initiate value-added corrective action by the auditee. The auditee verifies the effectiveness of corrections and corrective actions before asking for close-out of the reports.

Even internal auditors retain their independence (try not to get involved) so they remain impartial and objective.

Enjoy observing your first audit,

John
 
F

fishtruk

#3
Thanks John,

That info is very helpful. I've been present at the last outside audit by what I take is our "notified body" from Europe. A fellow from Canada also comes down to take care of that market.

From what I've seen, the auditor picks a couple products at random and assures that the document chain is intact and protocols are being followed. Of course follow up of system nonconformities (missing data in maint. logs on the previous audit for example) is done to make sure problems were rectified. They look at the various meeting logs as well.

Thanks again
 

John Broomfield

Staff member
Super Moderator
#4
Thanks John,

That info is very helpful. I've been present at the last outside audit by what I take is our "notified body" from Europe. A fellow from Canada also comes down to take care of that market.

From what I've seen, the auditor picks a couple products at random and assures that the document chain is intact and protocols are being followed. Of course follow up of system nonconformities (missing data in maint. logs on the previous audit for example) is done to make sure problems were rectified. They look at the various meeting logs as well.

Thanks again
fishtruk,

You're welcome.

Notified Body inspections are not really audits. More like product inspections instead of the audits of a management system and its processes as I described above.

John
 
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