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Internal Auditing in small Engineering company

O

oldmanian

#1
First time post so be gentle. We are a small engineering company in Australia, who are 9001 certified (three years).I have been involved since the beginning writing the QMS and assisting to write most of the procedures and processes. Recently we were audited by a customer who is in the Medical instrumentation industry. Their auditor pointed out during the audit that as the QA officer I should not be auditing the QMS or procedures. We have two people trained at auditing myself and one other. Is what he is saying correct? We don't have enough spare people to do the work any other way that we can see at present, if I am excluded - other than using outside auditors for Internal audits.

All help greatly appreciated.
 
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somashekar

Staff member
Super Moderator
#2
Their auditor pointed out during the audit that as the QA officer I should not be auditing the QMS or procedures.
Over and over we have been saying here that we audit the process and not the procedure.
Auditing QMS is the whole internal audit gamut.
You are fine if you do not audit your own work.
Even if you are the one who wrote up the procedures, when you audit, you see and audit the process, and can question your own written procedure.

~~~ WELCOME HERE oldmanian ~~~
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Recently we were audited by a customer who is in the Medical instrumentation industry. Their auditor pointed out during the audit that as the QA officer I should not be auditing the QMS or procedures.
Isn't the customer always right? :sarcasm:

I agree with Somashekar - sounds like misinformed auditing here, lacking objective evidence for starters. Was this something he/she just "pointed out" as an observation, or did they record it as an actual finding? If it was the latter, maybe you can post the written statement here for kicks.

And welcome :bigwave:

Brian :rolleyes:
 

qusys

Trusted Information Resource
#4
First time post so be gentle. We are a small engineering company in Australia, who are 9001 certified (three years).I have been involved since the beginning writing the QMS and assisting to write most of the procedures and processes. Recently we were audited by a customer who is in the Medical instrumentation industry. Their auditor pointed out during the audit that as the QA officer I should not be auditing the QMS or procedures. We have two people trained at auditing myself and one other. Is what he is saying correct? We don't have enough spare people to do the work any other way that we can see at present, if I am excluded - other than using outside auditors for Internal audits.

All help greatly appreciated.
It could be useful to also know which kind of evidence he caught to raise the nonconformity. Remember that the choice of auditor and the conduction of the audit shall assure the impartiality and the objectivity of the audit process. The auditors shall not perform audit on their own job.
I undestand the point that you are a small company and also your customer auditor should manage this issue taking into account the current status. As a suggestion , you could also propose external auditor to do it ( but this is a cost) or to use second part audit to assess some processs where there could not be the "impartiality" and agree this with your customer too.
 
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O

oldmanian

#5
When checking the Internal audits he noticed I was involved with all audits. This was what brought the comment. Yes Auditors should not audit there own job, however I am not the main auditor when looking at the QMS. I assist the other auditor.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#6
When checking the Internal audits he noticed I was involved with all audits. This was what brought the comment. Yes Auditors should not audit there own job, however I am not the main auditor when looking at the QMS. I assist the other auditor.
Auditors shall not audit their own work per 8.2.2 - although you can audit the activities pertaining to your job provided that you do not create a conflict of interest in doing so. This is to eliminate the possibility that you might act favorably in the context of an audit situation regarding your own work.

Do you always pair up with the other auditor during these assignments? Have you thought of letting the other auditor work solo (assuming he/she is competent enough) and audit the work you are directly responsible for? That may be one way of answering back.

Brian :rolleyes:
 
O

oldmanian

#7
Yes this appears to be the only way to overcome this. I will stand back and let the other auditor do the work in relation to my areas.
 
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