How to document Internal Audits done via the "Process Audit" methodology

[Casana]

I'm struggling with how to document internal audits done via the "Process Audit" methodology, how do others handle this?

We have available a Lotus Notes based system called "QSI" for documenting audits, but for some reason its setup to record by element. So even though I could do a process audit, the audit report can ONLY be documented on an element basis.

The owners of this system (not me) have just accepted this quirk but I'm starting a new Quality System with another group and would rather NOT document on an element by element basis. QSI does allow one to create customized checklists. The way I see it I have these choices:

1- use current system as is (i.e. document audits by element instead of process)
2- create my own checklists for each process then document these in the system
3-use some other system for recording audit results (other than QSI). (please feel free to recommend, preferably a CHEAP system).

Anyone have advise?? TIA!
-Ana

 

[Qwatcher2]

Re: DOCUMENTING Internal audits

One way to handle this and still work within your recording system is to do a process matrix to the ISO requirements. Using an excel spreadsheet, put the elements across the top as column headers and then list the processes down the left side column. Then 'x' the elements that each process touches on. This is used by one of the registrars I audit for and I also use it in my company. It allows me to do process audits and yet still evidence that I have audited all elements of the standard. Some organizations list only high level processes while others list all processes.

Hope this helps.

 

[Casana]

Re: DOCUMENTING Internal audits

Thanks for the reply, Qwatcher2.

My question actually follows from your suggestion - yes, I plan to have a matrix of process vs. element. But if I have several auditors auditing several processes, how to document their results?

For example, auditor 1 looks at Doc control for process 1. Auditor 2 looks at doc control for process 2.

Do I have each auditor open the checklist for element 4.2.3 and add in their findings (good or bad), or do I create two checklists one for each process?

 

[Coury Ferguson]

Re: DOCUMENTING Internal audits

Thanks for the reply, Qwatcher2.

My question actually follows from your suggestion - yes, I plan to have a matrix of process vs. element. But if I have several auditors auditing several processes, how to document their results?

For example, auditor 1 looks at Doc control for process 1. Auditor 2 looks at doc control for process 2.

Do I have each auditor open the checklist for element 4.2.3 and add in their findings (good or bad), or do I create two checklists one for each process?

Some type of report. Something to reflect which processes were looked at. Doesn't have to be special. A simple memo in Lotus notes should do in my opinion. Don't make this hard. Keep it simple.

 

[AndyN]

Re: DOCUMENTING Internal audits

With respect - the greatest kind - internal audits are not supposed to be done to any third party reporting model - the idea of covering all the elements etc is a 'legend in it's own lunch time". It's not a requirement of a good system - only something dreamed up or made a contractual requirement of a CB auditor!

There is little substitute for effective planning for each audit. Simply put, you have to sit down and, armed with a scope and some criteria for the audit, it shouldn't be too difficult to come up with what has to be audited. It occurs to me that we have very few questions here about helping to define audit 'scope' and 'criteria' - it's always 'a process', 'procedure' department' or something simple, and the scope if always ISO or a procedure! Doesn't have to be that way!

So, that's why I created the football metaphor for helping auditors to plan their way through the 'sequence and interaction' of the processes of the QMS so they could address which apsects have to be audited.

For myself the best documentation of an audit, is the 'working documents' like a checklist etc which has the auditors scribbles, dirty thumbprints and "dogearedness" that kind of shows someone did an audit.

Your comments about the QSI software validate my comments to ISOClaire (in another thread) about why such tools don't work!!

 

[Casana]

Re: DOCUMENTING Internal audits

Andy, I agree on creating a checklist before the audit (prefer to actually). My confusion was, now that I have an open field, how best to use it

I prefer to document our results online, so its available to all. But I think you answered my question in a roundabout way - checklist per process is probably the way to go. Preferably created from scratch prior to the actual audit (after doing the paper audit, etc.)

Thanks!

 

[Helmut Jilling]

I'm struggling with how to document internal audits done via the "Process Audit" methodology, how do others handle this?

We have available a Lotus Notes based system called "QSI" for documenting audits, but for some reason its setup to record by element. So even though I could do a process audit, the audit report can ONLY be documented on an element basis.

The owners of this system (not me) have just accepted this quirk but I'm starting a new Quality System with another group and would rather NOT document on an element by element basis. QSI does allow one to create customized checklists. The way I see it I have these choices:

1- use current system as is (i.e. document audits by element instead of process)
2- create my own checklists for each process then document these in the system
3-use some other system for recording audit results (other than QSI). (please feel free to recommend, preferably a CHEAP system).

Anyone have advise?? TIA!
-Ana

yes, the age old question...

My best suggestion is to get some good training in ISO process-based auditing. I have put together a tool my classes use and the feedback is often, "Gosh, I wish we had this before, it would have made it so much easier to audit..." There are some good trainings available, and that is my best suggestion.

Beyond that, here are some additional thoughts:

Follow Andy's suggestions regarding planning. It's a bit of a fetish for him,but the old boy is right.

Divide the list of processes into logical groups - ie: doc and record control goes well together, audit it at the same time.... Manufaturing and Maintenance... process measuring, data analysis, management processes... and so on. have each audit team tackle a cluster.

After planning, each process audit should address three stages:
* the inputs and outputs to the interacting processes, metrics for each process,
* the sequence and steps of the process itself, as shown in the procedures, flowcharts and work instructions,
* The effectiveness of the interactions to the supporting processes.
Every audit should address these three stages.

To your specific question about auditing the document process, one of the teams would be assigned the actual audit of the document process, and all the other audit teams would only address and examine some sample links. That way, the process gets audited, and the links get checked whenever appropriate.

Hope this helps, but give serious thought to getting some good training on how to do this. It will pay for itself in spades.

 

[AndyN]

Helmut - thanks for the compliment - I take 'old' to mean 'sage', 'experienced', 'wise', 'worldly'......etc!! Especially since we're about the same age.......

 

[Helmut Jilling]

Helmut - thanks for the compliment - I take 'old' to mean 'sage', 'experienced', 'wise', 'worldly'......etc!! Especially since we're about the same age.......

...umm...er...yeah...yeah, that's what I meant guv'na... PS: have a great Christmas!

 

[Caster]

I'm struggling with how to document internal audits done via the "Process Audit" methodology, how do others handle this?

3-use some other system for recording audit results (other than QSI). (please feel free to recommend, preferably a CHEAP system).

The much discussed and often hated turtle approach offers a way to document a process audit.

Take a look here for two files that describe the concept very well.

http://www.terrapeneintl.com/support/documents.html

I'm not sure how well the software works, or even its cost, but the files are well worth a read!

I made up a simple Excel file with a tab for each part of the turtle. Observations are recorded on the spreadsheet, and evidence is either pasted right in or hyperlinked.

The last tab is a closing meeting and link to agreed actions. Free is good.