Process Audit Checklist - Generic vs. Process Specific

O

Obstacle3

#1
Hello I am a little bit lost here, I am setting up checklists to accompany scheduled process audits and I am uncertain whether to go with a generic one, or process specific one.

I fear that locking into a process specific one, there may be a tendency to not check beyond what is on the checklist.

On the flipside, the processes are fairly complex and not having a process specific one may lead to some things being overlooked.

An example of what I mean by "generic":

Process (Process, Implemented, Controlled)
1 Is there a documented procedure for "XYZ"?
2 Is the procedure comprehensively implemented and complied with?
3 Is the procedure reviewed and updated appropriately?
People (Organisation, Qualifications, Training, Accountability, Roles)
4 Does the organisation and structure cater for "XYZ"?
5 Are resources adequately qualified for the process?
6 Have resources been trained/briefed in the procedure, (is it adequately understood)?
7 Have relevant authorities and accountabilities been clearly assigned?
8 Do role descriptions of accountable people include relevant aspects of the "XYZ" process?
Measures (Measuring, Monitoring & Reporting)
9 Have deliverables and performance measures been established for the engineering design "XYZ" procedure? (eg request turn arounds, change request rates)
10 Is there a systematic process for collecting performance data?
11 Is performance measured and reported regularly to both management and customers?
Tools (Systems, Forms, Records, Utilisation)
12 Adequate support systems and tools (eg databases, information systems)
13 Appropriate forms / templates with adequate details and sign off
14 Appropriate record keeping processes (physical & IT)
15 Support systems and tools are well understood and comprehensively used?
 
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O

Obstacle3

#2
Re: Process audit checklist - generic vs process specific

Example of what I mean by "specific":

Are all specifications in the book approved?
Uncontrolled when printed stamp on pages ?
Are Specifications appropriately version controlled?
All fields are populated appropriately?
Distribution book is completely correctly – team leader names etc?
Specification delivered on time?
Distribution book signed for by appropriate person?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
There are some of us out here.

What is your over all plan for the future and how many processes do you have?

I would say that a generic audit sheet will be OK as long as it is comprehensive. If I was making the decision, it would depend upon the business/product. For example, if I was in medical devices I would be inclined to be more specific with respect to process audits than if I was making pencil erasers. Another aspect to think about would be how many similar processes do you have?

How did you come up with the 15 criteria on your 'generic' list? Is the list comprehensive enough to cover all aspects of your processes?

Comments from other will be very welcome.
 
O

Obstacle3

#5
Thanks Marc.

There are over 80 key processes at a guess, I am still yet to map all of them out due to new software impacting on many of them I haven't bothered mapping the current state in instances where it will change significantly.

We are in the business of delivering transportation operational plans which involves both hard copy and database creation. It is a very very complex series of processes so my fear with the generic was that if I gave it to somebody off the street would they be able to drill into it bearing in mind the amount of complexity of the processes and their interactions.

I was thinking about even combining the generic process items with process specific questions on the same checklist.

The value of generic would be that you would be jsut saying "refer to the process map, does it comply?, is it adequately implemented?" etc.

That was just a draft I had for questions I thought I could apply to across the board.

Anymroe feedback would be muchly appreciated, I need to get going on this :(
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
The value of generic would be that you would be jsut saying "refer to the process map, does it comply?, is it adequately implemented?" etc.
I'm not a process audit specialist, so hopefully others will lend a voice, but from the information given if a process map exists I would think a 'generic' sheet would work well. I used to see that a lot where the auditor essentially had a generic check list and essentially audited to the existing process map(s). The generic check list was used to check that the process map had all the required elements and to ensure the process map was understood and followed by the operators.

As you know, the problem that comes into play is where there aren't process maps for an operation/process. That's when you have little choice but to use a generic assessment sheet. But, I've seen that work quite well in the past as well. If the auditor knows what they're doing a generic sheet should allow the auditor to determine whether the operator (or who ever) understands and is following the process requirements. I used to see that a lot in places which did OJT (on the job) training and had no specific process maps to follow.
 
O

Obstacle3

#7
When you say generic for the instances where there are no process maps what does that include?

I would have thought where there were no process maps specific would be ideal?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#8
When you say generic for the instances where there are no process maps what does that include?
Well, an example might be an aluminum caster. Let's say there are 30 lines. Each line does essentially the same process. You have a smelter at the start and at the end the operator taking the part out of the mold. But here, for one part there may be extra steps, depending on the part. Maybe take a part out of a mold and grind off the gate stub. Or, it may be where there are multiple parts in a mold and extra steps would be to separate the parts. One could do a high level, general process map, but when you come to specific part numbers there can be a lot of variation in what the operator at the end of the line is responsible for, including inspection criteria.

Your generic list pretty much covers all the aspects. There are a couple of confusing ones like "4 Does the organisation and structure cater for "XYZ"?", but all in all it looks OK. Looking at your 'specific' list, you could combine the two. Both are relatively 'standard' with the exception of "Distribution book" aspects you mention which I assume are specific to your company.

I would have thought where there were no process maps specific would be ideal?
Well, not every company makes process maps. Although they are very nice and valuable in my opinion, they are not a requirement with exception of a couple of standards. I think TS 16949 requires them and ISO 9001 expects them. That said, I don't get my hands wet much these days so I'll let the experts here confirm or refute.

I'm a fan of process mapping so to me to have them is ideal. Depending upon the level, they are very good for process evaluation and auditing.

One thing to remember is there are different levels of process mapping. There are high level maps which tend to be more general with lower levels sometimes represented as 'black boxes' in them, and you go down to where you are making a process map for an operation.

In my past life I was very into Process Flow Charts and Process Mapping. The 'complexity' I mentioned is somewhat illustrated here: The Organization as a System.

I hope this helps a bit.
 

Colin

Quite Involved in Discussions
#9
Taking a slightly different view of the question, I would ask "why are you using a checklist"?

Now, I am not saying don't have one, but what is it for? To me a checklist helps to organise the audit, makes the auditor better prepared, helps with note taking, provides evidence of what the auditor planned to do as well as what s/he did do, etc.

I think there are some good strong points for having a generic checklist which helps the QM ensure that certain basics are covered in every audit such as some of those you list e.g. have they got access to the procedure, is it the correct version, etc.

On the other hand, there is a danger that if you give the auditor a fully pre-prepared checklist, s/he will simply turn up and ask the questions you have written without putting any effort in. This will lead to audits being just a list of stale old questions which the auditee knows in advance and the audit turns into a paperwork exercise just to satisfy the standard.

My personal preference is to have a simple framework to ensure the basics are covered and then encourage the auditor to put his/her own slant on things. This way you get a different perspective of the process depending on who does the audit too.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#10
<snip> My personal preference is to have a simple framework to ensure the basics are covered and then encourage the auditor to put his/her own slant on things.
Please give us an example of what you are calling a 'framework'.

And how does an auditor 'put a slant on things'? Again, an example would be nice.
 
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