New to Internal Process Auditing - Seeking Sample Process Audits

[Howard Atkins]

New to Internal Process Auditing

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.

 

[Rob Nix]

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.

 

[Jodi G]

Thank you.

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.

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.

 

[Sam]

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.

 

[Jodi G]

Thank you for your assistance!

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.

 

[Jodi G]

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.

 

[RoxaneB]

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.).

 

[Jodi G]

New to Process Auditing

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

 

[Rachel]

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.

Cheers,
-R.

 

[Al Rosen]

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.