Combined Environmental / Quality Manufacturing Process Audit

#11
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!
 
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Pinkpetall

#13
Karen R said:
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
 
K

Karen R

#14
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 :)
 
P

Pinkpetall

#15
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.
 
#16
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.
 

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J

jmurph01

#17
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
 
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