Definition Process Audit - Internal and External - ISO9000 - A Definition

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
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
 
Elsmar Forum Sponsor
D

David Guffey

#2
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

Hunkered Down for the Duration
Staff member
Admin
#3
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?
 
S
#4
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
 
E

eallen

#5
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
undefined
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#6
eallen said:
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
undefined
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.
 
B

betterlife

#7
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.
 
Thread starter Similar threads Forum Replies Date
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
V Process and Internal Audit Criteria matrix wanted Internal Auditing 8
E How do I create a FMEA for the Internal Audit process? Internal Auditing 11
R AS9100D Internal Audit Process Checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Internal Audit Matrix Process Query ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
N Internal Process Audits - 7.1 Planning - How do YOU audit it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W Internal Audit of the Internal Audit Process Internal Auditing 15
L Request APQP Process Internal Audit checklist APQP and PPAP 2
K Process Owners signing Internal Audit Reports Internal Auditing 6
R On Auditing Internal Audit Process - How Independence can be Established Internal Auditing 4
R Auditing a process outside the realm of the formal Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Can I skip Payment Process audit for TS16949 Internal Audit? IATF 16949 - Automotive Quality Systems Standard 4
C ISO 17025 Internal Audit of an "Internal Audit Process" ISO 17025 related Discussions 6
N Internal Audit Process for small Medical Device company Internal Auditing 9
M Auditing the Internal Audit Process - 8.2.2 General Auditing Discussions 2
J Auditing the Internal Auditing Process - Audit Nonconformance General Auditing Discussions 3
P Company Conducted Internal Audit Offsite using a Document Review Process Internal Auditing 65
F Airport Internal Audit Checklist (Cleaning, Project Process, Maintenance, etc) Internal Auditing 3
P Internal Audit Corrective Actions - Can a CB write an NC on an in-process CA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
B Can I use Internal Audit Checklist to do Process Audit? Process Audits and Layered Process Audits 9
K When is the best time to Audit the Internal Audit Process? Internal Auditing 25
R Process Internal Audit Checklist for Service Organizations wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P Internal ISO 9001 Audit - Process Audit Checklist Internal Auditing 31
G Performing an Internal Audit on the Cost Estimating Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Internal Audit schedule & Process Audit Checklists Internal Auditing 3
T Internal Audit questions for Statistical Process Control and Process Control Internal Auditing 14
Casana How to document Internal Audits done via the "Process Audit" methodology Internal Auditing 9
P Problems with Internal Process Audit integration due to different CSR IATF 16949 - Automotive Quality Systems Standard 3
V Internal Audit - Process based vs. Procedure based AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
H Internal Audit Plan - Seperate audit plans for system, process, and for products IATF 16949 - Automotive Quality Systems Standard 4
M How to Internal Audit the Calibration Process Internal Auditing 12
tony s Let the Registrar audit the Internal Audit process Internal Auditing 45
A External Audit CAR when Internal Audit CAR is in process? General Auditing Discussions 34
T Internal audit checklists related to the software development process Internal Auditing 3
D Can Internal Auditors Audit the Internal Audit Process / System? How? General Auditing Discussions 12
M Showing the Effectiveness of the Internal Audit Process System - AS9100B Clause 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Need Example of Metrics for Internal Audit Process. Internal Auditing 6
K Defining Internal Audit Process Goals & Objectives Internal Auditing 49
C Audit Differences - Process, Product, Internal? (4 questions) - TS 16949 General Auditing Discussions 7
M Internal Auditing of our APQP Process - Who can audit APQP? IATF 16949 - Automotive Quality Systems Standard 5
T Process Internal Audit - Requirement on Monitoring Objectives & Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Process Effectiveness Metric for the process ?Internal Audit? Internal Auditing 25
Joe Cruse Internal Audit format - Idea of the process approach to the audit Internal Auditing 16
E Internal Process Audit Sampling using MIL-STD-105-E - 500 operators on 3 shifts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
I ISO 13485 Practical Internal Audit Checklist - Standard vs. Process Based Internal Auditing 26
Gman2 ISO 9001:2000 Internal Audit: Someone PLEASE find me the "Shall" on "Process Audits" Process Audits and Layered Process Audits 37
Claes Gefvenberg Internal Audit Process Flow Chart - Please Review Mine and Comment! Internal Auditing 27

Similar threads

Top Bottom