can anyone send send me a Process Audit template which has been tried and tested, the current document I use is a mis-mash between a QS/Process/Product audit.

thanks in advance

As I recall there was some information on this in the Free Files Directory - (click on 'Files' at the top of the page).

If your interested.... you might want to check-out the information listed for the Membership & Preimum Membership file sections

I was just wondering..how many of those certified to ISO 9K2K audit using the clause process and how many use the department process? I would really like anyones input on the pros & cons of each technique.

Just sitting on the fence....again!:confused:

Russ,

I have always used a modified department approach to audits. But this was mostly because whichever plant I was working for was large enough to make doing an audit by clause difficult to manage without larger audit teams.

We are not yet certified in my current division, but are working on it. We have scheduled our audits for "mini-processes". Basically we've just broken the larger process down into its logical smaller areas based on geography and/or subprocess. i.e. we audit purchasing and supplier quality assurance processes together as well as getting into a little of receiving inspections, then as we audit the first stages of production line we finish up on receiving inspection and catch 6, 7, and 8. Managers are interviewed within the subprocess plus one audit dedicated to management responsibility.

Our plant is over 1,000,000 sq. ft. plus we have various administration/office buildings for the departments, so auditing an entire clause or department gets to be more involved than any of us want to face at one time and I don't like pulling that many people off the line at one time. We run very lean so if I pull three people in to audit, I make sure that they are not all in one area or crew. We have scheduled 15 audits, with three auditors each (because most of them are new to auditing and they are teamed 2 newbies to one experienced auditor). I have 24 auditors total for a facility of around 350.

This works really well for us, but I have friends who use the clause or full department method in their industries and wouldn't change a thing. So, basically use whatever method works for you and fits with the philosophies and mindsets of your management and audit team.

Have a good one!

Maybe...

I just attended an ISO 9001:2000 Transition Seminar for auditors. We were briefly introduced to developing checklists for process audits. This was new to me, but I can see where with the new standard, auditors could use this approach especially to verify compliance to clause 4.1 company wide. The method we discussed looked like a flowchart of processes by department with inputs and outputs for each process including measurements and objectives.

I would like to find more information on creating this style of process audit checklist. I've searched and searched but can't find anything helpful. Does anyone have any information or links that they would be willing to share?

Best Regards,
Hank Fowler

:frust:

Hank, sounds like you went on a course very similar to the one I attended.

I wasnt sold on the idea of generating the 'process' style checklists as I felt it could quite easily miss the compliance requirements of the standard.

The infor from this course is in paper format unfortunately, so is not easily transmitted at present. If you are desperate I will scan it all for you.

Mr. Greenaway,

I agree that you would have to be very careful with this type of audit not to miss some of the requirements. I have created a list of clauses and associated records along with departmental responsibilities for that very reason.

The only thing my seminar had was a 1 page sample checklist with 3 process blocks on it. I can email you my fax number if that would be easier. I really would like to see more on this subject.

Best Regards,
Hank Fowler

Hank

I will scan and e-mail you the relevant bits from the course handouts within a day or two.

I found an interesting article on Quality Systems in Small or Medium Size Companies. Part 2 talks about how audits will need to shift to a "process focus" style rather than a "clause compliance" style. I have provided the link below.

http://www.iqa.org/htdocs/quality_centre/iso9k2kworkbook_part2.html

I've started developing an outline to help me in planning and preparing departments for an internal audit of this type.

Meet with each department to determine:
their processes;
- the inputs, outputs & objectives,
- the sequence and interaction,
- criteria and methods of control,
- the collection and analysis of data to monitored and measure the effectiveness and continual improvement,
- documentation requirements and the control of, and
- required records, the control, retention & disposal of.

Meet with each department to determine:
whether they have any procedures and how they are controlled
their status toward;
- ensuring the provision and availability of resources,
- determining the necessary competence for personnel,
- provision of training or other actions to satisfy competency,
- evaluation of effectiveness of training or other actions,
- the maintenance of records of education, training, skills and experience.

I hope this information is helpful.

Best Regards,
Hank Fowler

Ok you are auditing processes instead of single clauses, however you still have to remain compliant to clauses.

This is no shift for me as it is the approach I have used for years.

Yea I've got to agree. I've just got out of a traing session for a new group of internal auditors and I made the same presentation I created 4 years ago. Follow the process, are they being followed? Look at the controls, are they adequate? Then determine which clauses are applicable.

Same old same old.

I developed a checklist for process audits that includes 2 'categories' of questions: the first section is questions that we ask about every process, such as:

-- is the process clearly defined?
-- is there sufficient documentation/information for effective operation and control of the process?
-- are there sufficient resources provided for the process?
-- has criteria for effectiveness been determined?
etc.

Then the second section is process-specific, that is, if we are auditing the Order Management process, we ask questions from 7.2 in the Standard; if we are auditing the Design process, we ask questions from 7.3. Setting this up for each Key Process (there were 8 I believe) was not difficult, and it only has to be done once.

These checklists ensure that all of the processes are being audited in a 'closed loop' way, and that we are ensuring that the process itself is in control and effective, and that it meets the requirements of ISO 9001.

Caveat: the auditors use the checklists as a guide only, and more experienced auditors don't need them much at all. These are not the questions that the auditors ask; they are simply a reminder of what to look for. The auditors ask questions about the procedures and sub-processes that support the Key Processes (I like the method of writing questions directly on the procedures, esp. if those procedures are flowcharted and have plenty of white space.)

Comments on this method?

Julie

ISO/TS16949:2002- 8.2.2.2 MANUFACTURING PROCESS AUDIT.
I'm looking for information on this requirement but whilst there are volumes written on QMS /Internal audits; I'm finding comparatively little on Process Audits.

The TS requirements seem to have evolved from the goal of bridging the gap between the European Standards such as VDA and QS9000.

The best reference I've found is the VDA6.3 Process Audit standard, but I would like to find some commentary or analysis on the subject of Process Audits.

From my reading, an audit to VDA 6.3 seems quite narrow in scope,(it's not intended as an audit of the entire QMS) and shouldn't be confused with the process approach to auditing advocated in ISO9001:2000.

In what way should it differ from QMS Internal Audits?
What are the benefits of the Process Audit?
Any thoughts on the scope of these audits?

Regards,
Steve.

Attached copy of VW supplier demands which include a questionnaire and explanation of the needs for a process audit.
I cannot remember where I downloaded it but I beleive that I am not breaking copyright by posting.

I really dont know but I think an example showing how one audit base on version 1994 and 2000 would help to explain the approach. Let say we focus on Purchasing Department...how would audit (or the checklist) be using the 1994 version differ from the 2000 version.

johnnybegood said:

I really dont know but I think an example showing how one audit base on version 1994 and 2000 would help to explain the approach. Let say we focus on Purchasing Department...how would audit (or the checklist) be using the 1994 version differ from the 2000 version.

Johnnyb,

Good request. I've tried this before in the Cove, but guess what? We seem to be heavy on theory but nobody is willing to stick their neck out on the specifics and give us something to hang our hat on. Know why? They will get chopped to pieces by the purists who can critique but cannot give examples. My specific questions like yours, always go unanswered. Instead we get lectures and training classes that vaguely point you in the direction you should go. Hey, consulting will cost you. If you can't front the cash, expect to get hash. I expect to hear from people on this, but when is the last time you saw an exact answer to a post like this? I asked to be specifically audited in areas and I get, "well, you should consider this and that" Give me some real questions. Let me answer and you rebutt or accept. You don't see that. :p Fire away, boys and girls.
:ko: :smokin:

Attached (hopefully) is a copy of the Purchasing Dept. checklist that I developed for our internal auditors to use next week. It is for auditing compliance to ISO 9001:2000. There are plenty of checklists for the 1994 version if you want to compare the differences. If you look at my comments earlier in this discussion, it will give you an idea of how I developed it through interviews with each department during the audit planning phase. I developed a pre-audit checklist to use in my departmental interviews. I have developed checklists for each individual process and at the same time tried to make sure that all relevant clauses of the standard were covered.

We are a small privately owned company with most people wearing several hats. Our Quality Dept. consists of just me. This is our first internal audit, so it does sort of "hit the high spots".

Best Regards,
Hank Fowler




:)

Hank,

That's what I'm talking about. I printed it out and gave it to our Purchasing person so that he can see where there may be a problem. Granted, there will always be other areas where an Auditor may go, but stuff like this covers a lot of territory and gives us novices a place to start. I'd like to see more of this in the Cove. Real and actual working material from real companies. Not text book references. Rest assured that after our first audit, I would gladly post the information that worked, as well as what knocked us on our a**. Thanks:bigwave: :ko: :smokin:

Looks like you've figured it out already Danny!

Hank, I've printed out your audit checklist for the Purchasing and Receiving process. It looks very similar to a 1994 checklist by referencing the various clauses of the standard and appears like a simple "departmental" 1994 audit.

Things like having job descriptions on file I would think would be audited as part of the human resource and training process...and doc control as part of the doc control process (if you have identified one as we have). Also Corrective and Preventive actions (if you have identified as processes) would be looked at for ALL departments as a function of its own process audit.

I look at the process audit as taking everything that fits that category and auditing it across all departmental lines.

For our own purchasing and receiving, we have major input and output issues with the Operations department as well as Tooling, so they would be audited as well as the purchasing dept. and receiving warehouse.

Since I don't know how you have identified your processes, perhaps I'm off the mark on this. And I agree that identifying the clause requirements is beneficial, and there is nothing that says you can't audit to several different processes at the same time on the same checklist.

Job descriptions:
When auditing the Resource Management Process (which includes HR) you would ensure job descriptions have been written and might inquire what the process for writing them are.

Including this question in the Purchasing Process Audit is also relevant, to ensure that the positions within the process do in fact cover all the responsibilites expected.

If you have a process description (Scope, Goals, Inputs, Activities, Output, Interactions, Measureables and Records) you should be able to review job descriptions to see where responsibilities lie.

Records of education/training/skills/experience:
I would only look for these in the Purchasing Process Audit if there were requirements that would make it necessary. i.e., The Purchasing manager must ensure XXX training is achieved by all personnel doing YYYYY.

energy said:



... They will get chopped to pieces by the purists who can critique but cannot give examples....Instead we get lectures and training classes that vaguely point you in the direction you should go.
:ko: :smokin:

Lucinda,

You are not off the mark. When I performed the pre-audit interview of the Purchasing/ Production Planning/ Shipping/ Receiving Manager, it was more like you are referring to. See the attached. I have looked for some good examples of process audits, but have not found one suitable or that covered all of the requirements of the ISO 9001:2000 Standard.

Since we are a small company, we don't have an HR Dept. per se. Nor do we have any one dept. or individual responsible for document control.

Best Regards,
Hank Fowler

At the AIAG "TS rollout" a question was asked concerning auditing of processes.
There response was that they "did not envision the use of the standard compliance checklists that have been used in the past"
At that point the Ford rep. took over and gave a 15 minute disertation on process audits.
I will try and describe as best as possible.

"- Element-by-element approach, (TS16949 1st ed), focus on compliance verificationof the Who,What,Where,When and How basically asking have you dotted the i,s and crossed the t's?

- Process Approach,(TS16949 2nd ed) focus on identifying the the key processes within the organization and evaluating the company's performance according to their planned arrangements. The key question being "Why".

Moving from an elemental approach to a process approach means the "landmarks" that normally assisted you and the supplier to navigate the suppliers quality management system have changed somewhat. What was once a static checklist that could not adjust to accommodate an individual supplier's conditions, has now evolved to an dynamic evaluation method. The process approach is designed to assist you and the supplier to make cooperative judgements based on the on-site facts as they present themselves - within the constraints spelled out via the supplier contract." (Whew, My sigh)

Now with that said, and don't everyone gasp at once, the process approach is described by a method called "The Octopus".
Draw a circle,say three inches in diameter, then from a point outside the circle draw a line to a point inside the circle, make a short turn and come to a point adjacent to the staring point. What you have drawn should look like the letter "U" over the circumference of the circle. At the end of each leg draw a circle and label "O" and "I". Draw several of these "U's" around the circumference. You now have a series of what is called "Customer Oriented Processes" (COP's). The number of COP's you have around the circle illustrates the multiple nature of customer/organization intersections. At some point in time the process becomes dynamic and the legs of the "U's" become conected. From this you would then develop sub COP's.
Process characteristics-
1- A process owner exists
2- The process is defined
3- The process is documented
4- The process linkage is established
5- The process is monitored
6- Records are maintained

The automotive world divides into two types of processes,
1- Customer Oriented Processes (COP's)
2- processe that support COP'S
The QSA for TS 16949 has been revised to include this method
This is also the method that will be used for all TS 16949 auditor training classes.

Ok Energy I am out on the limb, star cutting.



:smokin: :bonk:

Sam said:

Ok Energy I am out on the limb, start cutting.

:smokin: :bonk:

Not me, Sam. I don't have a clue what you're talking about.:bonk:
:ko: :smokin:

ok energy, here ya go
Purchasing:
1. Do they buy good stuff from known good suppliers and keep a record of it?

:biglaugh:
seriously I don't "DO" check lists. I pull the procedure, do a doc review for any gaps from the standard...highlight iimportant points and things I want to check out, records, commodities to look at /review etc.....make notes to consider/ask on an audit trail (CARs, N/C, audit findings etc....) and head in.

Points to consider (1994):
Approved suppliers, with criteria for adding and to remove...as well as feedback/periodic evaluations..records available and verify several POs to AVL Only, and how do they handle the exceptions

If hard copy POs are used/approved,who, when, how, what exclusions, evidence is required?
What are they approving/reviewing? Do they clearly id the item and requirements for that commodity (typically look at several commodity types/needs) check with INC/rec to see that they look for those requirenments if critical...how does rec know to deliver the stuff to INC Insp if noyt all stuff goes there (and we know it doesn't!!) If no hard copy, how is review and accuracy of requirements covered?

How is order entry done? Does it tie to a job #? How? What about bulk?

Points to consider (2000)
SAME As above
What are the goals of the purchasing department that support the Quality policy? How do you measure them? (see also the above 1994 control of suppliers, cause I bet its there already ...price delivery and quality?)


Ok so now the process debate? What is the process?
A need to purchase is identified (MRP?)
Buyer send out RFQ
Chooses supplier...approved of course (spin off process)
generates PO...buys the stuff, communicates the PO Approval loop?
waits for the stuff to get here,
calls to expedite if required

Input: MRP or requisition etc
output The purchase....
scope: Raw material? or other commidity
Responsibilities: Approvals needed?who can buy what? who is the keeper of the records? who does order entry etc
training needs? an experienced buyer or what ever is needed..do you need a training program to teach a buyer how to buy? NOT usually. The procedure/flow chart will tell them the company specifics


so whats the mystery? I know there are details missing, but I don't know your company.

there you have it, a direct answer........nanananana na

barb butrym said:

ok energy, here ya go

Blah Blah Blah.......

there you have it, a direct answer........nanananana na

barb,

Yup and real good one. Thank you.:bonk: :ko: :smokin:

anytime ....my friend

I am trying to develop a Process Audit Form for use in my internal audits. I have attached a copy of one I'm currently developing. Does anyone have another example that they would be willing to share. I would also be interested in in good books or articles on "Planning Process Audits".

Best Regards,
Hank Fowler

HFowler said:

I am trying to develop a Process Audit Form for use in my internal audits. I have attached a copy of one I'm currently developing. Does anyone have another example that they would be willing to share. I would also be interested in in good books or articles on "Planning Process Audits".

Best Regards,
Hank Fowler

Hank,

I used your Process Audit form to see how easy it was to format. I used the "Posting in the Cove" process. I'm not sure that this is how it would be used. Check it out!:vfunny: :ko: :smokin:

[QUOTE] energy said:

I used your Process Audit form to see how easy it was to format. I used the "Posting in the Cove" process. I'm not sure that this is how it would be used. Check it out!:vfunny: :ko: :smokin: ______________
Energy, I think you're downright incorrigible! Okay, enough with the compliments.

You're computer monitor must be lots better than mine. Those little avitars are so small and low in resolution on my screen that it is hard to tell sometimes what I'm looking at. Now, I have no doubt that Lucinda is just as wonderful as you insinuate, but I just can't tell much from the avitar. Are you sure you don't have some other pictures or something? Maybe Lucinda sent you an autographed "fan club" picture or something?:vfunny: :thedeal:

Mike S.

My monitor is 17" at work and 14" at home. All avitars are clear as a bell. Lucinda is wearing a diving mask and she is underwater. Clear as a bell!:eek: :ko: :smokin:

Energy,

Thanks for the feedback!!
I like your idea of showing one completed, or at least partially completed in my case, so I am showing one using Management Review as an example. I would really like to see what others are doing.

energy said:

My monitor is 17" at work and 14" at home. All avitars are clear as a bell. Lucinda is wearing a diving mask and she is underwater. Clear as a bell!:eek: :ko: :smokin:

Oh come on, energy...admit it's the wet t-shirt that grabs your attention!:biglaugh:

HFowler said:

Energy,

Thanks for the feedback!!
I like your idea of showing one completed, or at least partially completed in my case, so I am showing one using Management Review as an example. I would really like to see what others are doing.

Hank,

On your Mgt Review, I would have your inputs located across from Conduct Management Review. Same for Outputs. The intial box input would be "Management Directed" or "Published Management Review Schedule". Output would be to "Notify Mgt Review Participants". JMHO. Hey, I just came from a processing map seminar. What do you expect?:vfunny: :ko: :smokin:

Lucinda said:

Oh come on, energy...admit it's the wet t-shirt that grabs your attention!:biglaugh:

Oh Lucinda, I'm so embarrassed you found me out! You betcha!:bigwave: You're a good sport about it.:ko: :smokin:

i love it...........energy you are just too much...thank goodness for the 'light at heart"

the form is similar to one I have had for years to plan an audit, I give it out in auditor training as a tool for the tool box..i called it a process flow planning tool...don't even remember where I got it from now, probably a compliation.....i think mine has a responsibility/authority column too.... I forget about it until I do the training sessions, I rarely used it, but many new auditees love it...I make them use several tools in the tool box in class.

energy, have you ever viewed your avitar on a 21"? :eek:

db said:

energy, have you ever viewed your avitar on a 21"? :eek:

Even bigger. All avitars begin as a full size photo. They lose something when you reduce to 60 x 60 pixels, no? The current avitar is my man with an Arafat type head dress. But, you alrady knew that. The avitar that we talked about previously must be awesome viewed full scale! Oh, no, here I go again.;) :ko: :smokin:

Now you've done it. Lucinda had given up diving and taking up old maid spinster solo dance classes. Sorry, Lucy!:bigwave: :ko: :smokin:

energy said:

Now you've done it. Lucinda had given up diving and taking up old maid spinster solo dance classes. Sorry, Lucy!:bigwave: :ko: :smokin:
You're losin' it, Energy! Lucinda's new avitar doesn't look like any "Old Maid Spinster" to me!!! Or, if it is, old age might not be so bad after all! Both ladies look quite fair to me.

For some reason avitars look much clearer on my monotir today. I did increase the brightness some, but this looks like something else at work, too. This is good. Unless Energy goes back to that Ape again!:vfunny:

Of course, this thread has gotten a little off track (sorry Marc). Unless, of course, you can say we're auditing avitars!

Regardless, I hope we're not making Lucinda uncomfortable. If we are, I for one apololgize.

Mike S.

I think he's got you there, Energy... If you call that the old spinster look, I suggest a pair of new glasses before your next audit...

Let's see you wriggle out of this one... :D

/Claes

energy said:

My monitor is 17" at work and 14" at home. All avitars are clear as a bell. Lucinda is wearing a diving mask and she is underwater. Clear as a bell!:eek: :ko: :smokin:

You know what they say about guys that talk/brag about their monitor sizes! :vfunny:

Har har har. You guys crack me up!:vfunny: No, I'm not embarrassed, but you know what? It was time for a change. Salt water isn't the best thing for the skin over long periods of time.....
especially at my age!

Mike S. & Claes,

If you visited the Cove more you would have seen the dancing spinster. But, Lucinda dispatched with that avitar faster than firing an unreasonable Registrar. The neck one, I mean new one, is rather nice. I have to go now because my monitor, ISO Guy, is acting up. . I will replace my new avitar as soon as possible. Meantime, enjoy my new look!:biglaugh:

Marc, Sorry we got way off thread, but sometimes we all just go wild, especially when we have something to get wild about. :eek:
See you necks time!:ko: :smokin:

[QUOTE] energy said:

Mike S. & Claes,

If you visited the Cove more you would have seen the dancing spinster. But, Lucinda dispatched with that avitar faster than firing an unreasonable Registrar. The neck one, I mean new one, is rather nice. I have to go now because my monitor, ISO Guy, is acting up. . I will replace my new avitar as soon as possible. Meantime, enjoy my new look!:biglaugh:
_________________
Oops, sorry Energy. Looks like I spoke too soon. I thought maybe too much time with ISO and the new sheriff and not enough time fishing had started to adversely affect your eyesight and logic (it's happened to me!). :bonk:

Regardless, Energy, I like your new avitar much better than any of your previous ones!:)

And Lucinda: Thanks for being a good sport and giving us nutso guys something other than ISO standards and goofy bosses to think/talk about for awhile! You're a peach!

Mike S.