Process Audit - Internal and External - ISO9000 - A Definition

[Marc]

Subject: Re: Process Audit /Farrugia/Arter
Date: Thu, 30 Sep 1999 16:43:28 -0600
From: ISO Standards Discussion

>Can anyone describe what a Process Audit is and what to look for during
>such audit?

Disclaimer: These are Arter's thoughts and do not reflect the current literature. That's because there is no literature on the process audit! There is no standard, national or international. The topic receives little or no attention in the popular quality audit texts, including mine.

Process audits examine one or more processing steps. They are an in-depth evaluation of the process and those universal affectors of methods, machinery, manpower, material, measurement, and environment. They provide assurance that the process is being implemented as planned. They may also provide information on the ability of the process to produce a quality output. Done properly, a process audit is much more than verification that procedures are being followed. (There are five other affectors that should be examined.) Although preparation can take a day or two, actual audit time is about two hours per shift per application. The report should be about one page. (Leave the completed checklists in the file cabinet.)

In a compliance audit application, a process audit verifies performance of the process in accordance with defined requirements. In a management audit application, a process audit examines the ability of the process to achieve desired results.

Yours truly will be leading a session or two on this topic at the next ASQ Quality Audit Division conference, March 2-3, in Reno.

Dennis R. Arter

Maybe I have my head in the sand, but I never thought a process audit needed a definition.

Why do I say that?

Well, first of all, you need to identify a process. If and when you do that, you know what needs to be audited. If there's a start, if something happens to something, and there's an ending, that process can be flowcharted. Once flowcharted, you can see opportunities for efficiency improvements; you can see compliance or noncompliance. That is, you can audit.

Is the real question, "what is a process?"? If you cannot pick it up and hold it or walk around it, you probably do not have a product on which to hold a product audit. If "it" is something you can flowchart, you have a process and can perform a process audit.

Notice that by this definition, virtually anything can have a process audit. The process of reviewing contracts, the process of ordering raw materials, the process of receiving raw materials, the process of paying the invoice, the process of invoicing the customer for goods or services provided, and on and on. Any further questions?

[Marc]

Several years later and 'The Process Approach' is de rigeur, thanks to ISO 9001:2000.

Your thoughts on 'This Old Thread' in today's world?

[Sam]

As do processes, process audits also need to be defined. Mr. Arter's definition or explanation of a process audit seems to be as good as any

[eallen]

I am new to this site and have been given to sole responsibility of trying to implement this system into our company (needless to say I am struggling) Im sure I will have many more questions in the near future as I have been running through some of this great dialogue - but my first question to anyone out there is if they have any enlightenment on the process/product audit clause and any forms/template examples you can sent to aide me in this area.


Thanks In advance

Esther
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[Al Rosen]

Originally Posted by eallen

I am new to this site and have been given to sole responsibility of trying to implement this system into our company (needless to say I am struggling) Im sure I will have many more questions in the near future as I have been running through some of this great dialogue - but my first question to anyone out there is if they have any enlightenment on the process/product audit clause and any forms/template examples you can sent to aide me in this area.


Thanks In advance

Esther
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Esther, welcome to the cove. If you do a search, you will find that there have been many documents posted. Here is one to get you started Process Audit Worksheets for ISO9001
Of course you will have to tailor anything you use to your own processes.

[betterlife]

Process based audit is one of many methods used for carrying out audits. Other methods can be, Procedure based audits or Risk based audits. After issue of year 2000 version of ISO 9001, Procedure based audits are no longer preferred. I prefer a blend of Process based and Risk based approach for audit. This approach is very effective in identifying areas for improvement and also taking care of potential risks and utilizing opportunities for future development of comapny's business.

As far as coining a definition for Process audit is concerned, I really don't feel any need for it. The guidelines for carrying out audits are already detailed in ISO 19011. Every auditor develops a personalized system of carrying out audit.

[Marc]

Also see: Process Audit discussion threads and Automotive Process Audit.