I received this by E-Mail.
Lets help .

Hello!

I couldn't find where I would begin a thread, so I thought I'd go this route.

Our company produces the pigments for glass, ceramic, plastic, etc. We're a Tier III contributor for Ford, GM and DaimlerChrysler. Our company downsized, and I am now the "lead" auditor; however, I'm not real familiar with each process center.

How do I process audit but still make sure I cover all the "shall's" in the standard?

Should I make lists of questions pertaining to standard for the Quality Manager then zero in on customer complaints?

Then make a list to take out to our production area to find inputs, outputs, SOPs, take a portion of an SOP and audit, a product from the area then follow it back through the process through customer service?

Would you happen to have any sample process audits that would give me an idea of how I should set them up and what I should look for?

Thanks for any input you can relay.

Howard,

At my last quarterly audit we switched over to a "process oriented audit" format and ran into the same concern you have (especially since I have a single audit format to audit two ISO9K2K facilities and one QS/TE facility). Our solution was to use a specialized interview sheet (attached below). We have close to 20 different processes, therefore 20 different customized interview sheets. Perhaps this will help a little.

:bigwave: Thank you Mr. Atkins and Mr. Nix for your help. I appreciate the Process Audit Interview Sheet. The questions for our Manufacturing area actually cover exactly what you have outlined. I like the format that you have.

:confused: Once I complete my audit sheet, I am assuming I log it into my audit schedule. I listed my main processes (HR, Purchasing, Receiving, Manufacturing, etc.) across the top of an Excel spreadsheet along with the Manufacturing process areas (Requisitions, Tunnel Kilns, etc.) and the APQP, SPC, FMEA, PPAP and MSA. Vertically, I have listed each element of the standard. I will then put the corresponding report number into the corresponding box. It is divided into quarterly audits since we conduct Central Quality Committee meetings quarterly.

Does that sound like I've set it up properly or is it too much? If anyone has any suggestions, I would appreciate them. Thanks.

How do I process audit but still make sure I cover all the "shall's" in the standard?
#1 - You do not have to cover all the shalls of the specification in a process audit. There are three types of audits required; QMS, Mfg. process, and product audits.

#2 - Attached is a "turtle" diagram that can be used to determine the contents of the process. Even if the process is already eastblished you can use this tool to familiarize your self with the process.

#3 - Once you are familiar with the process, use the tool that Rob attached for your audit.

:thanx: Thank you for your assistance!

:o I previously posted a question as to my audit schedule. I think it's a little overkill. I think what I'm doing is reading too much into it to make sure I cover ALL bases.

Would there happen to be a list showing the process area of, for example, Purchasing, and which elements are applicable to it? Then, one for HR and its applicable elements, etc.

Our company produces the pigments for glass, ceramic, plastic, etc. We're a Tier III contributor for Ford, GM and DaimlerChrysler. Our company downsized, and I am now the "lead" auditor; however, I'm not real familiar with each process center.

Out of curiousity, Jodi, have you had any formal training to be a Lead Auditor? Some of your questions could probably be answered if you attended a Lead Auditor course (i.e., process-based approach, developing a suitable schedule, etc.). :)

Roxanne:

No, I haven't taken the Lead Auditor course, only the Internal Auditing with Emphasis on ISO/TS. Actually, I took the class in Dec '02. Our 3rd party TS auditor required that I retake the same class in Dec '03 because Ford changed their Internal Auditor requirements. There was no one on site who was qualified to audit to TS.

He actually recommended I take the Lead Auditor course during 2004.

Jodi

I don't know if I'm asking the same thing as Jodi, but here goes...

Okay, I've taken the Lead Auditor course, and now I'm sitting at my desk thinking about the necessary 'complete internal audit cycle' required for ISO:9K2K certification ... and trying to create an internal audit schedule. I'm trying to figure out how to break our process into auditable sections. I'm also trying to figure out how to ensure that resources, mgmt responsibility, and measurement/analysis are accounted for in this schedule. (We're a mfg company, not eliminated from any of the section 7 clauses.)

If I think along the lines of order procurement, potentially to r&d, then order placement, checking of material availability & work order entry, processing (batchmaking), packaging, shipping...is that a fair way to break apart my system? Is that a sufficient set of "auditable chunks", or am I missing the boat here?

I have a feeling this is going to stir up all of those "only you can answer that, Rachel..." responses. For a while I thought I was on the ball...now I'm back to the overwhelmed/"left field" feeling. :frust:

Cheers,
-R.

Rachel:

I've attached a chart that maybe helpful. It shows a typical mfg process along with the associated ISO clauses. You may not have the exact same set of processes but you can use it as a starting point to get the idea.

Al,
That is an *excellent* chart. It's really helpful...

From that - how do you formulate your internal audit schedule? What are the divisions/clauses? Are most people still auditing to clauses - I mean, does someone take 7.1 as a process, then someone else takes 7.2 as a process, and so on? How are people dividing up the task of internal auditing?

Cheers,
-R.

Thank you. The Typical Manufacturing Enterprise sheet is very informative.

I am taking the Process Audit Interview Sheet that Rob attached and, for instance,
- going to Customer Service to audit how they receive their order and
process it and tracking where it goes throughout the organization.
- I'll go to Purchasing to gather information on the raw materials that go into
the product and see if they are readily available and if the supplier is ISO
9001:2000 qualified.
- I'll go to the lab to gather testing information and each production process
to see their process.
- I'll check each of the operators training records in HR to determine their
qualifications on the machinery.
- Gather information on scales and equipment and check their calibration
status.
- Then, follow it through Shipping to determine if it was finished and
delivered on-time.

This is my train of thought on auditing the process. While I'm out in the production and lab areas, I'll check for proper labeling, cleanliness of the plant, make sure everyone has their proper safety equipment on, etc.

Al,
That is an *excellent* chart. It's really helpful...

From that - how do you formulate your internal audit schedule? What are the divisions/clauses? Are most people still auditing to clauses - I mean, does someone take 7.1 as a process, then someone else takes 7.2 as a process, and so on? How are people dividing up the task of internal auditing?

Cheers,
-R.
Rachel:

After you identify each of your processes, determine the clauses that apply. For example, you may have a manufacturing process. The clauses that are related may be 7.5.1, 7.5.2, 7.5.3, 8.2.4, and 8.3. When you perform your audit verify the process to the related clauses. Detetrmine the schedule based on the process you want to audit. I try to audit based on process flow. For example, I have a receiving inspection process that flows into a store materials process. I schedule an audit of receiving inspection followed by an audit of the stock room.

We really struggled with this whole issue, too, moving from QS "procedure" type audits to process auditing. Ultimately we took the list of "processes relevant to the QMS" that the management team decided upon from the very beginning (which later became a "process map" showing interaction/sequence) and used that LIST to schedule audits, with emphasis on the customer oriented processes. In auditing every process from that list we also audit every aspect of the standard, though we did assign one person (the Lead Auditor) to check off a list at the end of the audit itemizing every clause of the standard that just got checked.

I think what I'm having trouble with is trying to factor everything in. I mean, the main goal/focus is product realization for us - obviously, or we'd make no money. :) But, then, the trouble is adding in the "8's" to the audit - the CA/PA stuff, specifically. We've got a number of internal auditors, and some are great at dealing with CARs, and some....well, aren't. We've got some people that think that "operator was instructed to pay more attention next time" is a corrective action. I shudder to think of each internal auditor looking at the CAR system through his/her own eyes and assessing its effectiveness. But, then, if you look at it separately it's like auditing to clauses rather than to processes.

Excuse my confusion - I've been trying to convert mediocrely-worded SOPs to flowcharts all day and I don't think I can write my own name at this point. Let's try...

Cheers,
-Rachel

ps: is "mediocrely" a word?

From an audit standpoint, can you designate one person (the lead auditor?) on the team to oversee the CARS from the audit? That works well for us, we have one person oversee the CARS to make sure they are DECENT and are handled with some consistency. Otherwise, like you say, one guy thinks a corrective action is "hide the bad coil before the next audit" while another goes through a real 8D process.

Oh, right, yeah, we do have that. (That's me.)

What I'm talking about is auditing the CAR system itself.

I'm overcomplicating things and thinking too much about the little things - so I think I'm starting to msis the point altogether. Let me sit on this and if I'm still out to lunch by this time tomorrow, I'll get back to you. :(

Cheers,
-R.

I think I should put my very simplistic view here :)

Yes we had great problems getting into the swing of 'process auditing' having been used to the old procedure way.

Our certification body had a great tutor at our auditor transition training course, and he could see the light bulbs lighting up as he went through the course. :D

Applying that to our company has been another story.

We find many instances where we actually are 'dragged back' to management review, which if you think about it is a vital part of the management system. This is a good place to see how the preventive action is dealt with!!!!

The audit 'process' is described as 'vertical auditing' by our certification body, and we are finding the many elements of the standard are covered by multiple audits. This years udit plan is now completely different to last years and is actually simpler. We have one basic process, to which the others are subservient. Ok it is a big audit and it takes a few days, but then the compulsory clauses (procedures) are covered at the same time and individually.

It is late at night as I write this, and I think my brain has just died.

If the above makes sense then great. If not i apologise and will try again when at least 10% awake

Chris

How exactly is your audit plan written? I believe I have the process audit questions figured out and can say to what part of the standard they are linked to, but I cannot figure out how to get the audit schedule together - I haven't reached the ah-ha! moment yet.

I don't have any internal auditors for TS yet, but as far as the CA's, Rachel, maybe if those particular auditors were pulled aside and prompted to keep asking "why?" until they can't think of any further answers to their questions. Like, why didn't the operator do the job correctly? Training? Well, was he/she trained properly? Are their SOPs? Are they not following them? Do we need to add an additional section in the SOP that states exactly what actions are supposed to take place so that each operator is doing the testing or measuring the exact same way? That is how we were able to revise many of our SOPs and reduce operator error...along with mistake-proofing and our employee participation program.

Good point - I've often used the why?why?why? approach myself but haven't tried to pass it on yet. I'm just so new in this company (4 months this week!) that I'm still hesitant to push new ideas around...lack of authority and all that. (Ironic, isn't it, that I'm responsible for the CAR program, then?)

My only worry with that approach is that it will *undoubtedly* result in SOP revisions - a good thing in many cases, but the tendency for us (from what I've seen so far) is to *overdocument everything*. I've seen very little evidence of the "competence" factor in our SOPs - goes back to the theory that you don't write a "How to Insert an IV" SOP for a nurse, because she's assumed to be competent. That train of thought doesn't always apply here - and I really hesitate to dumb down the SOPs to that level. In some work areas it would make sense, b/c of the high turnover and so on - but in others it's already more of a hindrance.

I get your point, though, Jodi - it's a good one. In terms of writing CARs up properly, it's a great technique, and I should spread it around. How I deal with overdocumentation is my own issue.

Note: here's one for you guys - I'm in the process of converting our SOPs to flowcharts - I'm working on a section of the process right now that I'm finding is not only double-documented, but *triple-* and sometimes **quadruple-**documented. :mad: ridiculous!

Cheers,
-R.

Note: here's one for you guys - I'm in the process of converting our SOPs to flowcharts - I'm working on a section of the process right now that I'm finding is not only double-documented, but *triple-* and sometimes **quadruple-**documented. :mad: ridiculous!

Cheers,
-R.Rachel,

I thought this post deserved a thread of it's own and copied part of its contents to a new thread in the Documentation and Forms (http://elsmar.com/Forums/forumdisplay.php?f=16) forum, under the name Overdocumentation. (http://elsmar.com/Forums/showthread.php?t=8020) Have a look.

/Claes

Jodi G,

Our Audit plan is based on the clauses of the standard, not our process(s).

Essentially We are auditing to the standard.

We have the one main process, Injection moulding, with lesser processes serving this, so it makes things very straight forward.

From your proces analysis and the interrelation of these, it should be very apparent the whole lot are linked. Using that bit of information allows you to choose where you look to meet the standards requirements.

Eg. For us, to cover Customer property (mainly mould tools and the finished goods), we start in the warehouse, choose a number of items on the shelves. Now this includes Preservation of product (look at all of the racks etc), identification and traceability (labelling etc). The chosen samples are then followed for an audit rail (via our software) to the job cards, which have the in-process inspection and testing details recorded. From these the material issue can be traced and the goods receiving function can be verified (or not). The one audit has touched and included many elements of the standard.

If all is ok then fine and dandy, look for improvements etc.

If a problem shows in an area, or things are a little 'vague' we follow that.

Non-conforming material may be included in the above if the software identifies this has been needed. Bingo corrective action rears its ugly head.

I think I have rambled on enough.

Hopefully it gives you an idea on my statement 'one big audit'.

The above touches many processes, and therefore do not restrict yourself to the processes or you will end up 'auditing to proceedures' just like the previous standard!!

I am willing to be chewed up and spat out with the above!!!

Chris

How exactly is your audit plan written? I believe I have the process audit questions figured out and can say to what part of the standard they are linked to, but I cannot figure out how to get the audit schedule together - I haven't reached the ah-ha! moment yet.

I don't have any internal auditors for TS yet, but as far as the CA's, Rachel, maybe if those particular auditors were pulled aside and prompted to keep asking "why?" until they can't think of any further answers to their questions. Like, why didn't the operator do the job correctly? Training? Well, was he/she trained properly? Are their SOPs? Are they not following them? Do we need to add an additional section in the SOP that states exactly what actions are supposed to take place so that each operator is doing the testing or measuring the exact same way? That is how we were able to revise many of our SOPs and reduce operator error...along with mistake-proofing and our employee participation program.

Internal Audit Plan

There are two ways we can conduct a process audit at my location.

Method 1 - Final Product through Raw Materials

This entails taking the Audit Team out into the Warehouse and blindfolding the Lead Auditor. After spinning said Lead around a few times, which ever bundle the Lead places his/her hand on is the one that will be followed through the system. (pssst...the blindfolding and spinning around part isn't true...but the selection of a bundle of finished product is)

Following the history of the product through the process backwards is what is done. Finding the papertrail. Finding out if the product was ever quantined. Finding out how production knew what characteristics that product was to have. Finding out how it rolled. Finding out how it was cast and where in the billet yard it was stored. Finding out how it was know what the chemical properties were to be. Finding out what alloys and additions were included to ensure the grade(s) was(were) met. Finding out how the equipment used to make the final product was properly maintained. Finding out when it will be delivered. And so on. Lots of time and lots of walking around.

Method 2 - Mini-process audits

Our overall company process flow shows the key departments that are directly involved in the raw materials to finished product process and the relationship of the support departments to the main departments.

From there, each departments has their own individual process flow, with their own inputs, outputs, resources requirements, etc.

A mini-process audit looks at the output of a depart and follows it back to the input (or vice versa...takes the input and follows it through the system until it is an output).

Comments

Both methods entail multiple Clauses being touched upon...it's not as simple as the old Element audits used to be and I find it entails a lot more questions from the Auditor (and questions that go beyond a simple yes/no response).

There are pro's and con's for either method. The bigger audit is at a higher level and maybe won't see all the subtle details of a department's process. But it does provide a big, overall picture as to the health of the Management System.

The mini-process audits allow for details to be seen and a picture of the health of the Management System within the department. If all departments are okay, we can assume that the company overall is okay, but mini-process audits don't easily allow for checking the links between the deparments to validate this assumption.

Handling Internal Audit Findings

My organization lets the departments address their own Internal Audit Findings. All Findings are entered into our Nonconformance System, along with all other abnormalities like unscheduled downtime, payroll errors, held material, etc. A discrepancy is a discrepancy, no matter what its origin is.

They are assigned to the appropriate person - in some cases, this may be the Department Head or a Supervisor or a Facilitator. That person is trained to address the problem accordingly. Sometimes, a root cause analsys is required, sometimes not...we have a Nonconformance Guidelines Matrix to be used to help determine the suitable action to take.

All discrepancies in our Nonconformance System are closed at our Key Indicator meetings where all Supervisors, Management Committee, and QA are present to validate the root cause (where appropriate), the actions taken, an the verification plan/results (where appropriate). If okay'd by the group, only then can the issue be deemed closed.

But it is up to the recipient to address and ensure adequacy. They don't want to bring an unsuitable finding to a meeting and have the group waste their time.

This process has ensured accountability for all abnormalities in the company - be it from an audit or another source

Reading through the posts I find several good ideas as to the plan for auditing, burt find no reference to ISO 19011.
If you supply to GM you must have an auditing process that is compliant with ISO 19011, plus be competent in understanding and applying the Process a of auditing, including the core tools. If not you could receive a major NCR.

If you supply to Ford you should be trained and evaluated in the specification, core tools, CSR's and the automotive process approach to auditing. If not, could be a major.

If you supply to DCX, there are no requirements.

Other European automaker CSR's may also apply.

Internal Audit Plan
There are two ways we can conduct a process audit at my location.
Method 1 - Final Product through Raw Materials
This entails taking the Audit Team out into the Warehouse and blindfolding the Lead Auditor. After spinning said Lead around a few times, which ever bundle the Lead places his/her hand on is the one that will be followed through the system. (pssst...the blindfolding and spinning around part isn't true...but the selection of a bundle of finished product is)

Roxane,
This is the style I select more often than not. It helps take out the 'white areas' i.e those areas between processes (Output to Input) thta rae often neglected because it seems to fall between department boundaries. I tend to perform these audits myself as it gives me a good overall picture of the company.

[Method 2 - Mini-process audits
These are the audits we are doing more of now. My new auditors are doing these in departmnets other than their own and they and the company are benefitting as different ideas are adopted and the plant is being seen thru different sets of eyes. It is a good learning curve fall both the auditor and audittee.

[Comments
Both methods entail multiple Clauses being touched upon...it's not as simple as the old Element audits used to be and I find it entails a lot more questions from the Auditor (and questions that go beyond a simple yes/no response).

Handling Internal Audit Findings

My organization lets the departments address their own Internal Audit Findings. All Findings are entered into our Nonconformance System, along with all other abnormalities like unscheduled downtime, payroll errors, held material, etc. A discrepancy is a discrepancy, no matter what its origin is.

They are assigned to the appropriate person - in some cases, this may be the Department Head or a Supervisor or a Facilitator. That person is trained to address the problem accordingly. Sometimes, a root cause analsys is required, sometimes not...we have a Nonconformance Guidelines Matrix to be used to help determine the suitable action to take.

I like this idea of putting them (NCs) all together and then selecting a remedial action person for close out with central reporting. It would show all of the departments, processes against each other. It allows the entire company to see the state they are in. Currently, (at my company) only the department that is audited knows what has occured. I think it is important that everyone knows. I will be recommending this type of reporting to my review team next month.

Great post (as usual Roxane)

Greg B

I have been dealing with how to transition from the old standard in my internal auditing.
Our company is a electronic component test house so all jobs have a job folder that is created when the parts are received and goes with the job through all the processes, then is filed.
Now I have been thinking that I could audit by taking a completed job folder for each of the process flows we perform, then, starting at the RFQ(request for quote) stage and follow it through that process checking to make sure all requirements are met.
Before I was auditing each area, such as, Management, Quoting, Sales, Production, Manufacturing, Etc.

I have been dealing with how to transition from the old standard in my internal auditing.
Our company is a electronic component test house so all jobs have a job folder that is created when the parts are received and goes with the job through all the processes, then is filed.
Now I have been thinking that I could audit by taking a completed job folder for each of the process flows we perform, then, starting at the RFQ(request for quote) stage and follow it through that process checking to make sure all requirements are met.
Before I was auditing each area, such as, Management, Quoting, Sales, Production, Manufacturing, Etc.That sounds like a good plan to audit what happened in the past. How about following a folder in real time from the moment the parts hit your shop? That way you can ask those interesting questions:

"Do you know where this has been before it gets to you?"
"Do you know where it goes next?"
"What value is added to the process at this station?"
It may not be strictly a part of your audit, but aren't you interested in how and why the parts came to your shop? Is the billing correct and timely? How about feedback from the customers after the parts (or the reports) leave your shop? Seems to me what happens in-house is only part of the process.

What will there be about your audit that can lead to improvement of the process?

Thanks for your input.
Actually We are sending out customer surveys on a 6 month schedule and I'm creating a survey to be sent to the customer when we are given a job, what we call when job is awarded. So we can ask questions about what propted the customer to give us the job (price, leadtime, previous job history, etc)

I will be auditing Management Responsibility this afternoon and I have a question. I have developed my checklist to include all requirements of Section 5. While auditing 5.4.1 Quality Objectives, I plan on asking the VP what is tracked/measured for each department, interviewing the employee who is responsible for reporting, the employee who is responsible for actual tracking and the employee(s) who gather the information to determine if they are aware of how they contribute to the objective. Will this satisfy the process audit requirement as far as ojectives are concerned? :thanks:

I will be auditing Management Responsibility this afternoon and I have a question. I have developed my checklist to include all requirements of Section 5. While auditing 5.4.1 Quality Objectives, I plan on asking the VP what is tracked/measured for each department, interviewing the employee who is responsible for reporting, the employee who is responsible for actual tracking and the employee(s) who gather the information to determine if they are aware of how they contribute to the objective. Will this satisfy the process audit requirement as far as ojectives are concerned? :thanks:

I would ask the following of both the VP and the employee you speak with:


How do the Quality Objectives tie into what is being tracked/measured?
What are the links between the tracked/measured items, Quality Objectives, and the Quality Policy?


It not only establishes that there actually are links, but that all of the information, including the links, are known at the relevent functions and levels.

Thanks for the speedy response. I have found that the organization gathers a lot of data but improvement objectives have not been clearly defined. Upon conclusion of this audit, I am going to request that goals be set for the following at a minimum:

Nonconforming Product - reduction amount (i.e. from 50,000 to 25,000)
Customer Complaints - (this one could be difficult as we do not get many)
Product Returns - reduction amount
Efficiency - what percentage are we aiming for
On-Time Delivery Performance - what % are we aiming for
Accuracy of Deliveries - what % are we aiming for

Thanks for the speedy response. I have found that the organization gathers a lot of data but improvement objectives have not been clearly defined. Upon conclusion of this audit, I am going to request that goals be set for the following at a minimum:

Nonconforming Product - reduction amount (i.e. from 50,000 to 25,000)
Customer Complaints - (this one could be difficult as we do not get many)
Product Returns - reduction amount
Efficiency - what percentage are we aiming for
On-Time Delivery Performance - what % are we aiming for
Accuracy of Deliveries - what % are we aiming for

At my organization, objectives such as those will be found at the department level.

At the corporate and Management level, there 4 objectives. Keeping in mind that we have Business Management System...not just a Quality Management System...


Improve ROCE (Return On Capital Employed) - Inital Value = xx%, Goal = yy%
Improve Customer Satisfaction - Initial value = 1 Complaint / xxxx T shipped, Goal = 1 Complaint / yyyy T xhipped
Reduce Medical Aids - Initial Value = xx / year, Goal = yy / year
Improve commitment to the Environment - Initial Value and Goal (can't find them right now)


Initial Values are the values from 2003. The Goals are what we wish to achieve for 2004.

All projects worked on by Departments must touch upon at least one of these Objectives with the intent to help the Organization achieve the Goal.

If a project does not relate to any of the objectives, its existence is questioned.

And as we keep a history on everything here, we are able to show improvement throughout our Organization, at almost every level. Our Auditor loves looking at this stuff and is always impressed with what she sees.

If goals are not achieved, we indicate why and implement countermeasures to get us back on track (where practical and/or possible).

It's a complex process, but when someone from Corporate comes here, they just need to look at our plans and no only immediately know what our current state, but how close we are to meeting Goals and Objectives.