I'm still not grasping the idea of Process Based Internal Audits

[noboost4you]

Hi Everyone

Prior to posting this thread I have searched high and low through various threads and all throughout the free files directory. I'm still not grasping the idea of process based audits.

According to my consultant, we need to provide any third party auditor with a Process-Based Audit Form. All the forms I have seen thus far look different and keep racking my brain.

I have gone through a few departments over the past few months and have come up with hundreds of work instructions. We don't do nearly 70% of those work instructions on a daily basis. We have them for reference for people who need to do something or to train new people. Here are a few things we do everyday: Create Orders, Print Orders, Pull Orders, Calibrate Order Items, QC Order Items, and Ship Items. Those tie in together with Order Processing/Production/Shipping Departments. Would those be areas in the Process Audit? We have work instructions covering all those areas.

What about other departments? Such as Engineering, Accounting, Customer Service, IT, Quality Control?

Sorry if these questions have been asked and answered several times, but I used and abused the search engine and I'm still very unclear.

[SteelMaiden]

Originally Posted by noboost4you

Hi Everyone

Prior to posting this thread I have searched high and low through various threads and all throughout the free files directory. I'm still not grasping the idea of process based audits.

According to my consultant, we need to provide any third party auditor with a Process-Based Audit Form. All the forms I have seen thus far look different and keep racking my brain.

I have gone through a few departments over the past few months and have come up with hundreds of work instructions. We don't do nearly 70% of those work instructions on a daily basis. We have them for reference for people who need to do something or to train new people. Here are a few things we do everyday: Create Orders, Print Orders, Pull Orders, Calibrate Order Items, QC Order Items, and Ship Items. Those tie in together with Order Processing/Production/Shipping Departments. Would those be areas in the Process Audit? We have work instructions covering all those areas.

What about other departments? Such as Engineering, Accounting, Customer Service, IT, Quality Control?

Sorry if these questions have been asked and answered several times, but I used and abused the search engine and I'm still very unclear.

First question - what are you referring to when you say audit form? a checklist? If so, you need to audit inputs, outputs, controls, etc.

As far as a process audit, take one of the processes you have mentioned, and audit the activities that take place during that process.

I think maybe your consultant could do a better job of explaining to you what s/he is talking about.

[Sidney Vianna]

Originally Posted by noboost4you

According to my consultant, we need to provide any third party auditor with a Process-Based Audit Form.

That is not correct.

Originally Posted by noboost4you

What about other departments? Such as Engineering, Accounting, Customer Service, IT, Quality Control?

You need to stop think departments and start thinking processes. For example, the New Product Introduction process might involve functions from several Departments, such as engineering, manufacturing, purchasing, quality, etc...
If you are certified to ISO 9001 or a similar standard, your quality manual must have the macro processes of your quality system identified, because it is a requirement of those standards. So, check your Quality Manual. Also, see if the following documents are of any help to you:
Understanding the process approach

ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach for management systems (document ISO/TC176/SC2/N544

[noboost4you]

Thanks for changing the title of the thread. I didn't know how else to word it.

The action items list our consultant gave me just states "Process-Based Audit Form" along with other forms which I have. I imagine it can be in any format that works.

So then I know the standard doesn't mention the number of processes to audit, so would the fair amount be what we actually do on a daily basis? Each department may have 10-20 processes done every day. Would I need to develop a process audit form/checklist for each department listing all those different processes? What kind of questions would I ask about those processes? Even though each department has different processes, wouldn't auditing them all be done the same way? How would I incorporate any clauses from the standard?

[ScottK]

Thanks for the links Sidney.
We just completed a team gap analysis and the next round of audits in a couple of months will be process based. I'll be sending these links to my audit team.

[noboost4you]

We are not certified yet, nor do we have a completed Quality Manual. I'm just trying to get everything situated prior to our audits in June/July.

[ScottK]

Originally Posted by noboost4you

Thanks for changing the title of the thread. I didn't know how else to word it.

The action items list our consultant gave me just states "Process-Based Audit Form" along with other forms which I have. I imagine it can be in any format that works.

So then I know the standard doesn't mention the number of processes to audit, so would the fair amount be what we actually do on a daily basis? Each department may have 10-20 processes done every day. Would I need to develop a process audit form/checklist for each department listing all those different processes? What kind of questions would I ask about those processes? Even though each department has different processes, wouldn't auditing them all be done the same way? How would I incorporate any clauses from the standard?

Don't get hung up on the form or checklist. Just because a consultant says you need one doesn't necessarily make it right.

I don't use checklists unless I'm doing a gap analysis. Neither do any of our external auditors for ISO or EU PED.

I start with a documented flow - like a flow chart or procedure or manaul or process diagram. If there is no documented flow I sketch one out as the process owner walks me through the process.
Then I review the appropriate parts of the standard to see if the process covers the requirements.

[Greg B]

Hi and welcome to the cove. I agree that you should not get hung up about the actual form for a 'process audit' it should not differ from a standard audit. My company does not do formal audits of the standard, as such. What I mean is that we do not audit individual clauses like we used to in the 90's. The old standards prevailed upon us to audit criteria as laid down..i.e document control, records, contract review etc and it seemed that everyone (especially the registrars) concentrated not so much on what the business made but how they measured up against the paper war called the STANDARD. The standard did not really improve a business as if you made rubbish before being certified you could still make rubbish with certification. (IMHO)
The process approach lets us now concentrate on OUR business. It lets us value add to the process by reviewing and inspecting the actual process rather than worrying about documents and if the wording of a particular clause has been met to the utmost....A waste of time IMHO. I have always concentrated on WHAT we DID rather than WHAT we SAID!!!
I designed the Process Mapping presentation to highlight the breakdown of Processes to my staff and employees. It also showed the audit team what we wanted to audit and the structure of a process.
As steel maiden said... We want to look at the three main parts of a process
INPUT - Including resources
PROCESS - The actual task
OUTPUT - Results
Now the presentation is more a training toll and exercise for people to understand a process but as I said it helps auditors understand how to break a process down for audit purposes.

INPUT: We look at raw materials, Customer input, Internal/External customer, specs, gap (the Grey area between where it came from and when it arrives - Transport, storage, handling etc),
PROCESS: How is it manufactured?, How are the raw materials inspected and utilised, streamlining the process, double handling, value adding, Downstream customer requirements, documentation, training
OUTPUT: Downstream customer requirements, handling, storage, packaging, docs etc

These are some of the things we look at and some auditors use a checklist, some use the work instructions and some flow chart the process as they follow the product or process flow...It is an individual thing.

Our Quality Steering Committee (Management Review group) sets the audit schedule three months in advance. They take into account problem areas (review NCs and CARs), new processes, last years audits results etc and establish the schedule. It concentrates on work processes from the work instructions PLUS they may say audit the gap between process areas to see if we can improve product flow or storage etc. They always look to improve the business rather than auditing for audits sake. We don't want numbers in a box we want results. Our Audits IMPROVE our processes they do not POLICE our processes.
Look at page 10 and 11 of my presentation and it shows you how we manage our processes and ask questions of it. We need to meaure it and part of that is the auditing
Here is our VERY simple yet VERY effective Audit Report and our equally simple and effective Audit Procedure. I hope this helps in some way.