Hey everyone!

First time poster here, but I have been reaping a lot of good info from this site for a long time. Great site!

I'm wondering if anyone has any suggestions on how to conduct an ISO-14001 audit on a single manufacturing process. I am trying to come up with a format to conduct a combined TS-16949 / ISO-14001 manufacturing process audit. I have the quality side down, but I have only a very basic understanding of ISO-14001 at this point.

What I don't want is a long checklist of questions like "Does the organization have a documented quality / environmental policy". I've had my fill of those!

Any suggestions or (better yet) examples of combined audits or stand-alone ISO-14001 audits based on manufacturing processes would be greatly appreciated.

Thanks!

Your 1st step would be to see if environmental aspects related to the process have been identified. Next you could look to see if there were any regulatory requirements related to those aspect, and how the requirements were being met (records, training, monitoring, reporting, etc...) Ask people involved in the process they know of anything that could happen to the environment if the process wasn't managed accordingly and se if there are any guidelines or procedures that provide operating criteria to keep an impact from occurring.

Just continue to follow the above type of process throughout the requirements of ISO 14001 (52 in all of which you can't meet the 1st until the other 51 are accomplished).

If you look at 14K it's pretty much a process in and of itself.....follow the trail it lays down.

Thanks for the input Randy. I'll give it a try.

Randy has given some great advice (as usual), Ken!

Keep us updated on the progress and how the audit goes, please. I'll be doing the same at my site over the course of the next year and I'd love to hear your problems (and how you overcame them) and your successes!

I too would like to see your progress Ken. I'm facing a similar situation and I had decided to separate ISO from TS audits next year. (We are in the process of changing from QS) Our Auditors tended to conduct QS and ISO separately anyway, even though they were scheduled together. I learn a lot from the discussions here and may change my mind (again).

I too would like to see your progress Ken. I'm facing a similar situation and I had decided to separate ISO from TS audits next year. (We are in the process of changing from QS) Our Auditors tended to conduct QS and ISO separately anyway, even though they were scheduled together. I learn a lot from the discussions here and may change my mind (again).

Welcome to the Cove, Teresa! :bigwave:

If I may ask, why did you separate ISO from TS? (somewhat off the 14K topic...sorry guys) I would have thought that if you met the requirements of TS, you would have met the requirements of ISO.

Sorry, RC

I should have been more clear. :bonk: I separated ISO14001 from TS. It seems my auditors were not conducting a complete 14001 audit. They were treating it as an afterthought. I may combine the 2 systems again, later.... the problem may really be with my checklists.

Thanks for the welcome. :thanx:

I've learned so much here and hope to participate more.

We've been conducting fully integrated quality/safety/environmental audits for three years now quite successfully. Part of that comes from changing our overall attidute from looking at a task from "just a quality" perspective (or safety, or enviro...) to always looking at the safety, environmental, quality and business implications of any activity or process.

When we began the integrated audit process, we didn't use pre-written checklists. Instead we set up a process where the auditor prepared his own questions by: reviewing the control plan, reviewing the environmental aspects list, and reviewing the SOPs and related documents. Annually we also had a regulatory specialist from our corporate office conduct a compliance audit. This worked great.

Since TS we started down the road of pre-written checklists (based on our training, I'm thinking I'd like to get away from them, but many of the internal auditors like them...). Attached is an example of an integrated checklist (may need a bit more safety stuff added for 18001) and one of the related process flow diagrams.

Perhaps this will help. ... I'm also interested in feedback or any better ideas!!

Karen -

Thanks for the example!

I like that the checklist is very specific to the process, but I think that the checklist that I come up with will have to be more generic. I am doing internal audits for 8 different plants, and the manufacturing processes are not standardized between the plants. So what we end up doing, for example, is taking a control plan for the specific process being audited and walking it through the process to verify that the specific controls are in place. So the control plan actually becomes an input to the internal audit, but we don't necessarily write checklist questions based on any specific control plan. The question on the checklist would be something like "Are controls implemented according to the control plan?" I'm thinking that we would do the same type of thing with the environmental aspects lists and operational controls.

Does that make sense?

Yes, it does. In addition to carrying around the control plan and aspects list during the audit (I don't usually attach it to the audit records - unless I had problems and wrote those notes on it - it just adds paper and you can always refer to a copy), we also use the process flow diagram, which I do include as part of the audit notes.

We also have a more generic version of the checklist, which can be used for any process. Guess I could have attached that too :-) I also have a summary question sheet I use during auditor training, perhaps that will help, so I'll attach that too!

Karen -

I really like the chart format that you incorporated into the Auditee, Product, and Monitoring and Measuring Equipment sections. Keeps things well organized and easy to find.

This will help a lot. Thanks!

Always nice to be appreciated - especially in this job!! :D

We also have a more generic version of the checklist, which can be used for any process. Guess I could have attached that too :-) I also have a summary question sheet I use during auditor training, perhaps that will help, so I'll attach that too!

Hello Karen, I make some reading of your "audit plan blank", but here I have a question needing trouble you to free,

Does you mean it applys to all process in company, so I want to get know how you to identify your company activity?

Now our company have such process as like "document and data control" or "Supplier selection", it is just a support process, so if audit these two processes according to your audit plan, then which product producing from it, and what Monitoring and Measurement Equipment as Gauge/Measuring Device. As it is a not value-adding process, so what is its product?

Perhaps I have not well understand, I think I will get more wonderful thoughtness if I get your answer. :thanx:

Thanks
Pinkpetall

Good questions, Pinkpetall. We use the audit tool for each of our production processes, which have been identified on our master process flow, and key support processes - Purchasing, Maintenance and System Administration. Document and data control is audited as part of each process - if I audit the lab, for example, I will ensure that they have access to procedures, the procedures and forms are current, there are no uncontrolled documents in use that could impact the system, etc.

Once per year, when I audit System Administration, I will look at the document control process itself - do I have a documented procedure that complies with the standard, does the overall process appear to be effective, etc. When I do that, there is no "product" to trace, tho I suppose I could track several documents and ensure that they are properly controlled, updated, approved, revisions have been communicated, and the like. I don't though since I've done that a piece at a time when I look at each production process.

As far as supplier selection, that is part of the Purchasing Process, and audited then. For Purchasing, its product is the primary output of the process, which would be a completed purchase order and received product. For completed purchase orders the criteria would be appropriate approvals obtained, appropriate vendor selected (approved vendor for critical product, all vendor paperwork on hand), sufficient detail included on PO (specs, timeframe, if calibration - the calibration standard info is there). For received product I would make sure that all the steps for receipt and inspection were completed, inspection sheets in order, material received on time, and any discrepancies resolved. In our case, Purchase does have equipment subject to calibration - the tools used to inspect certain incoming material.

In summary, the product for any process is it's primary output - a controlled document, a completed purchase order, a received product, a training record - and it's criteria are whatever your process deemed critical. If a section of the form does not apply, like equipment calibration, you can simply note that it's not applicable.

Hope that helps! If you need more clarification, just ask :)

Thank your answer.

I see, this will be useful for me to improve the effectiveness of audit. It breaks the original checklist audit and just adapt to the activity of company. Sometimes only find a appropriate method for self, it should be operated well.

Thanks more. I got it.

All,

I went ahead and performed a combined manufacturing process audit a few weeks ago. I have attached the audit documents that we used.

The "Combo Process Audit Definition Form" is a form that BSI (our registrar) uses to define processes that they are auditing. I just made a few adjustments to include the environmental side of things. I figured that this was a good way to begin, so that the auditors get a good understanding of the process that is being audited.

The "Combo Process Audit Checklists" are organized so that every section of the process definition form has it's own set of questions. My thinking was that by doing it this way, it would show that we are basing the audit more from a process approach, not the standard element-by-element approach. As you can see, I just plucked out questions from the standards that would apply to a manufacturing process audit, and put them into their corresponding process catagories.

This is definitely still a work in progress, because I am not entirely happy with it. To me, it still smacks of your standard elemental checklist. I would like to work in some kind of a work sheet that would summarize the actual performance of the process against established quality and environmental goals. I have seen these types of worksheets for quality and the environment seperately, but I haven't come up with a combined one yet.

I think that the biggest obstacle we came across during the actual audit was that the quality auditor (me) and the environmental auditor on the team kept wanting to go our seperate ways. There are a lot more TS questions than ISO-14001 questions, so if we stayed together the environmental guy was just sitting there doing nothing much of the time. Since it was supposed to be a combined audit, I wanted to stick together as much as possible so that we could learn from each other. This didn't happen to the degree that I would have liked. It may have been complicated by the language barrier (the audit was performed in a Mexican plant, the environmental auditor is Mexican and doesn't know much English, and I'm your typical monolingual gringo). The obvious way to get around this is to have internal auditors qualifed in both standards, but I still think that there is a way to structure the audit so that a team of quality and environmental auditors could do an effective and efficient audit. I just haven't figured out the best structure yet.

Anyway, I apologize for the length of this post! Please give me your input if you have any.

Ken,

At first glance this looks really good. I will definately be reviewing it further as this is something I would like to do at our plant. I would deffinately agree that one auditor or a team of auditors that have knowledge on both QMS and EMS would give you better results. I have found that it is hard to get our QMS internal auditors to pickup on environmental or safety related non-conformances. During one of our first TS based audits we found a fan missing the cover and the fan blade was very wobely - I deffinately didn't want to stand near it for even a few minutes but this was directed at an employee (for cooling) who stood in front of it for 8 hours! I said we should put it as a NC and issue a corrective action but was faced with another auditor that said "but why, it's not a quality concern!". Point is, TS is a more comprehensive system that covers more broader spectrum then before. And if one looks at it as a "management system audit" then this clearly is poor management of a safety aspect.

Thanks for posting this!!! Please post any further improvements, as this is a big help to others style sorting through this issue!

Jennifer