Questions about an Internal Audit Checklist for our QMS

[thira7]

Hi all,

I am straggling to plan an Internal Audit for our QMS and I have some questions about the audit checklist and how we will conduct the audit. My questions are:

a)for every process which is included in our QMS do we have to make a different checklist which will controls all the steps of that process

b)Do we have to use a checklist based on ISO guidelines?

c) We are a small organization(20 employees) who do you think is better to conduct the audit the person who is responsible for the QMS or someone else. Here is good to mention that i am responsible for the QMS but i am an intern, however no one in the organization has experience of conducting audits.

Thank you

 

[lk2012]

hi,
is this the first time your company have introduced QMS? Which standard are you working against? Are you a qualified Auditor?

 

[thira7]

Yers is the first time that the organization implements the QMS.

As i wrote before i am an intern and not a qualified auditor. There is not a qualified auditor in the organization.

We are using the ISO 9011:2008

 

[lk2012]

:mg: <gulp> there are no qualified auditors in the company? The nearest exit may be located behind you...
No seriously, you might want to speak to the Quality Manager (providing there is such a person) or the General Manager / Owner about getting someone with qualification on board or arranging training for you.
Once you're trained, you'll see that you actually may not need a checklist in the end.
You can start by looking at the turtle diagram (I'm sure there's a thread about it here). This helps you understand the process/area you are auditing and works as a sort of a checklist.
Give it a try and see how you get on.
Best of luck :

 

[thira7]

The organization does not want to spend money on this this is why gave the project to an intern(me).

 

[RoxaneB]

I was a summer student when I led the implementation of ISO 9001 with a company. I was NOT a qualified auditor but my supervisor - who was Quality Manager and was trained to be auditor - and I developed the in-house critieria for what an auditor would mean for us.

As for the checkist, again, I'm all for developing a tool that will add value to your organization.

Some auditors like having a pre-defined checklist to refer to. I find that this results in the auditors having a poor understanding of the process in advance of the audit. This also led to some auditors auditing off the checklist word-for-word and not gathering proper evidence or exploring the audit trail in detail.

By having the create their checklist in advance, this requires the auditor to become familiar with the process and associated activities, inputs, outputs, etc. in advance.

What was standardized was the template and the completion of it.

 

[thira7]

Thta was my feeling about the checklist, it must be focused on pur processes and not be something general, otherwise it does not make sense to use a general checklist.

Thank you.

 

[AndyN]

The organization does not want to spend money on this this is why gave the project to an intern(me).

Warning, warning, warning!

It appears that there is a MAJOR problem here. WHatever you do, it's going to cost and it may cost dearly. Is the organization ISO 9001 certified? Do you have to do this auditing to satisfy keeping a certificate on the wall? I'd be very cautious about any organization which tells you they don't want to invest to find out what risks they have in place which may lead to problems with customers etc later on. Have they heard of the 1:10:100 ratio of problems?

 

[RoxaneB]

Warning, warning, warning!

It appears that there is a MAJOR problem here. WHatever you do, it's going to cost and it may cost dearly. Is the organization ISO 9001 certified? Do you have to do this auditing to satisfy keeping a certificate on the wall? I'd be very cautious about any organization which tells you they don't want to invest to find out what risks they have in place which may lead to problems with customers etc later on. Have they heard of the 1:10:100 ratio of problems?

Andy raises a good point regarding the cost and allocation of financial resources on this project.

When I was implementing an ISO-focused QMS as a summer student, it was with the understanding that *I* would not receive external training to be an auditor as I was not a permanent employee. The honour of external auditor training went to those employees who were permanent.

That being said, I did go on to work for the same for 3 consecutive summers, implementing and enhancing their ISO-focused QMS at two plants. At the end of time with the company, there was a firmly established system shared - in many areas - by the two locations that the Quality Manager was able to sustain with his existing internal resources.

And how do I know it was sustained? Because years later my ex-brother-in-law worked for the same company and shared some documentation with a colleague, not knowing the colleague knew me, and my name still appeared on the documentation. It was still in use and applicable and relevant...although, by now, it should have evolved.

What I'm trying to say is that thira7 indicates that his/her position is an intern. That implies - to me - a non-permanent position. Spending money on thira7's ISO education may have little return-on-investment.

Thira7 can still do an excellent job at capturing the essential aspects of the tiny shop, as long as there is someone who understands the requirements a little higher up should guidance or support be needed.

 

[Golfman25]

In a company that size, they will need to get a few of their people trained to be internal auditors. Nothing fancy. Lots of resources out there. Pretty easy training.

We have the three department managers trained up. At audit time, they basically audit each other. Unfortunately, they audit the same areas each year because every time we tried to switch up, we ended up with a conflict in auditing part of their own work.

But here is what they did. They began creating their own "checklists." They would start with the procedures/standards that they where auditing. They would create questions and check points for what they where looking for. At each audit they would tweak the checklist. After several audits they ended up with a comprehensive roadmap. It is now so easy, even a caveman can do it.

Good luck.