ISO 9001:2000 Process Based Internal Quality Audit Plan

M

Martin Bailey

#1
We are currently registered to ISO 9001:1994, working towards the Year 2000 revision. As part of our efforts we have decided to trial/work towards a process based audit, whist maintaining our commitment to 9001:1994.

I have classified various activities within the company and formed the processes required, in the past we audited clauses within the standard.

I've have then pulled out the applicable clauses of the new standard, tied these together both with audit areas and relevent clauses of 9001:1994.

The net result to date is a more comprehensive audit plan seeking to improve activities within the organisation.

The first audit has been completed and we have more constructive observations previous audits ever identified. I am very pleased with the results so far.

Are any other forum users also 'experimenting' in this manner?

Best regards

Martin :bigwave:
 
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gpainter

Quite Involved in Discussions
#2
We started with system audits only, once we became registered we went to process audits. They take more time and you get more bang for the time. We also call out Opportunities for Improvement, which allow the auditors and auditee to express things that can be improved. To this point it has worked well.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
> We started with system audits only, once we became
> registered we went to process audits.

This is my recommendation as well.
 

Russ

Quite Involved in Discussions
#4
Martin,
Can you post an example of how you put together the process audit within the 1994 requirements. I am in the transition process to 9K2K and this is my weakest point right now. I want to start auditing by process now and work into 9K2K so any examples you could give me would be appreciated.:biglaugh:
 

RCW

Quite Involved in Discussions
#6
Okay, I have to ask.

What is a "system" audit versus a "process" audit?

I think I know the difference but I need somebody to confirm my hunch.:confused:
 

RCW

Quite Involved in Discussions
#7
Okay, I have to ask.

What is a "system" audit versus a "process" audit?

I think I know the difference but I need somebody to confirm my hunch.:confused:
 

E Wall

Just Me!
Super Moderator
#8
Q9000-2000 Reference

These definitions are provided in the Q9000-2000 normative reference:
3.2.1 system - set of interrelated or interacting elements

3.4.1 process - set of interrelated or interacting activities which transforms inputs into outputs. (Notes 1/2/and 3 apply)

Note 1: Inputs to a process are generally outputs of another process.

Note 2: Processes in an organization (3.3.1) are generally planned and carried out under controlled conditions to add value.

Note 3: A process where the conformity (3.6.1) of the resulting product (3.4.2) cannot be readily or economically verified is frequently referred to as a "special process".
 
A

Al Dyer

#9
System Audit:

Just what you think, audit of your quality system like a registrar would perform.

Process Audit:

Review one of the processes that you perform. Usually involves taking a control plan down to a "production" cell and ensuring that all process steps are being followed.;)
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#10
Process Audit

Originally posted by Al Dyer

Process Audit:
Review one or more of the processes that you perform. Usually involves taking a control plan down to a "production" cell and ensuring that all process steps are being followed.
Do bear in mind most non-automotive companies do not have 'Control Plans' per se.

A process audit is the check of the Do What You Say part of the Say What You Do, Do What You Say dittie. So - whatever process documents you use, relevant records, relevant procedures (as well as undocumented procedures), are audited. How far you go with an audit, including samples and sample sizes, is supposed to be defined during the planning phase of the audit in the Audit Scope.

A 'systems' audit is harder to define because of semantics. Many people hear 'systems' audit and think 'compliance to the standard'. This is because some folks associate the word 'process' in Process Audit with 'production' - their paradigm distinguishes between production and purchasing in the form of a Production Process vs. a Purchasing System (which is also technically a process).

What you define as a process and what you define as a system is often a matter of point of view and your point of reference. If I'm at a sub-process in - well, let's say purchasing - I might look 'up' and call the entirity of the purchasing function the purchasing system. But if I'm looking down at the company as a whole I might call purchasing (as a whole) the purchasing process (or I could use the word system - either word *could* be used). I write this only as a caution to watch definitions - what I call a system, you may call a process. If I said to some people: "...I'm going to do a process audit in purchasing..." they might be very confused as they associate the word process with production.

To me, looking from the top down (my point of reference), there are:

Compliance Audits - do we address requirements set forth in the standard (Say What You Do)
Systems Audits - high level internal departmental system (Do What You Say)
Process Audits - low level internal departmental sub-systems (Do What You Say)

Also see http://Elsmar.com/Audit/ and http://Elsmar.com/Imp/ for more thoughts.

I did a Search here in the forums with the following keywords 'process and audit and definition' (note the 'and' between the keywords) and came up with two pages of threads. You might also check some of the other threads for more details.

Of course, then there are Product Audits and Dock Audits. Take it away, Al! :thedeal:
 
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