Can I do Quality System Audit instead of Procedure Audit in this scenario?

andreww

Involved In Discussions
#1
Our organization has about 70 staff. There is about 170 quality procedures in QMS. These procedures covers 10 functions. (such as quality, manufacturing, engineering, sales, purchasing and etc.)

ISO 9001 QMS was finally built 4 years. Process owner reviewed quality procedures 4 years ago. Management assign me to do internal audit on quality procedures 3 years ago. The purpose of internal audit is to find if what we do is conform to what we say, and find any improvement opportunity.

I am only one internal auditor in my organization. So I can not audit my job/procedure. I am sure management will find another auditor from different department to audit my job in the future.

When I audit quality procedures and found a lot non-conformances, also a lot of procedures are not up to date to reflect what we are doing, although procedure have been reviewed before.

Management want me to improve efficiency of internal audit (do more audits). However I have other tasks to do. Currently I am doing procedure audit. (i.e. one procedure, one audit).

Now I am thinking maybe I can do quality system audit instead of procedure audit to speed up my internal audit process.

In this senario, can I do system audit to improve my efficiency. My concern is if I conduct system audit, maybe each clause of procedure can not be fully went though/covered during system audit.

Any suggestion. Thank you.
 
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Chance

#2
Re: Can I do Quality system audit instead of procedure audit in this senario?

You mentioned that there are instances where the procedure needs some update, it does not reflect what is done in reality.
You cannnot gurantee that your procedures would be perfect, they might be optimum this time but tomorrow they change. They are developed by humans who are not perfect.
Might be good to audit one department at a time instead of every procedure.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

Our organization has about 70 staff. There is about 170 quality procedures in QMS. These procedures covers 10 functions. (such as quality, manufacturing, engineering, sales, purchasing and etc.)

ISO 9001 QMS was finally built 4 years. Process owner reviewed quality procedures 4 years ago. Management assign me to do internal audit on quality procedures 3 years ago. The purpose of internal audit is to find if what we do is conform to what we say, and find any improvement opportunity.

I am only one internal auditor in my organization. So I can not audit my job/procedure. I am sure management will find another auditor from different department to audit my job in the future.

When I audit quality procedures and found a lot non-conformances, also a lot of procedures are not up to date to reflect what we are doing, although procedure have been reviewed before.

Management want me to improve efficiency of internal audit (do more audits). However I have other tasks to do. Currently I am doing procedure audit. (i.e. one procedure, one audit).

Now I am thinking maybe I can do quality system audit instead of procedure audit to speed up my internal audit process.

In this senario, can I do system audit to improve my efficiency. My concern is if I conduct system audit, maybe each clause of procedure can not be fully went though/covered during system audit.

Any suggestion. Thank you.
This scenario, even though a "system" has been in place for 4 years, is still indicative of an "immature" system, based on your description of things.

I really think it would benefit you to use a gap analysis checklist, and create an action plan to ensure conformance to the standard from an element standpoint, during which you can employ your internal audit program to check for process effectiveness. And be sure to select your audits based on status and importance, plus the results of previous audits, whether internal or external. These are indicators of when to properly schedule audits. Condition your program to "pull" your internal audits when problems arise with the system, do not "push" them as if they are just another task to be completed (unless you just want the glory of the certificate on the wall and nothing more).

A pre-cursor to this, of course, is to ensure your processes have been properly identified, their sequence and interactions known and communicated throughout, and if not already, your internal audit program re-engineered to focus on these processes, and not the departments. Competency and training of your future auditors is also key here. Only through close study of the interactivity between these system processes will your internal audits gain any real value, and as your system matures over time, a new culture of process-oriented improvement will emerge, which in turn will affect the quality of your product/service, and maybe even the bottom line (provided you can capture that information effectively).

Done right, it will encompass all these types of audits you seek to do (product, procedure, system, etc.) and bring them together under one unified umbrella. I can see this happening in a small organization like yours.

Hope I've Helped...:rolleyes:
Brian
 
S

ssz102

#4
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

I have a question: your procedure is 170, what are they documents? including WI and SOP and SIP?

most of documents is exsit, so you will read it and go on the site they are comply with the requirements of operation and standards or not

meanwhile, you need to make a checklist including audit document, record, training, the product realization, product identify, the maintaince of equipment and calibration for measurement device, continual improvement, the control of non-conformance and so on
 

insect warfare

QA=Question Authority
Trusted Information Resource
#5
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

I have a question: your procedure is 170, what are they documents? including WI and SOP and SIP?

most of documents is exsit, so you will read it and go on the site they are comply with the requirements of operation and standards or not

meanwhile, you need to make a checklist including audit document, record, training, the product realization, product identify, the maintaince of equipment and calibration for measurement device, continual improvement, the control of non-conformance and so on
What you are recommending is nothing more than a document / record audit and maybe a gap analysis. While this does not hurt, a lot more stuff needs to take place. The fact that Andreww posted

The purpose of internal audit is to find if what we do is conform to what we say, and find any improvement opportunity.
indicates to me that even their upper management may not be fully aware of the potentials of their internal auditing program. The whole "say what we do and do what we say" ruse simply does not address the multitude of variables (especially the negative ones) that can pop up due to process interactions, because when an internal auditor focuses on the documentation alone, they are in fact missing out on many other opportunities for improvement, which only helps to further the common misconceptions that internal auditing is usually attributed to.

We must remain aware that documentation is only part of a QMS, not the end-all...

Brian
 

Colin

Quite Involved in Discussions
#6
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

Andrew - the answer to your question is in what you wrote. To try and perform 170- audits/year against individual procedures will not produce the results you need from internal audits.

You mentioned 'functions' such as sales, engineering, purchasing etc. - that is what you should be auditing - the processes of the business. Now, I don't know your business and it may be that the functions you mention don't reflect the processes of the business so you need to do a bit of a review first.

Take each process and audit it - bring in whatever procedures are applicable to the process - whether that is 1 or 10 - it doesn't matter.

Also, try and schedule the audits in the general business flow e.g. start with sales, then design, then purchasing - or whatever your process flow is. That way, not only do you audit each process but you also get to see how effectively they link together (or not).

The result of this approach means that each audit will be much longer to do but there will be a fraction of the number to complete and more importantly, you will get much more meaningful information back.
 

andreww

Involved In Discussions
#7
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

Thank you very much! Colin. It is very great information for me. I will try and do it in my internal audit schedule.
 

andreww

Involved In Discussions
#8
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

Colin. "Take each process and audit it - bring in whatever procedures are applicable to the process - whether that is 1 or 10 - it doesn't matter.". If I start with Sales and sales got 10 procedures, which way is the best to perform audit on this process (sales)? Go though each procedures (10 procedure audits individually)? or combine 10 procedures together in one check list (It would be a big audit process)? or another way? Please advise. Thanks.
 

Colin

Quite Involved in Discussions
#9
Re: Can I do Quality System Audit instead of Procedure Audit in this senario?

Ask the auditee/departmental manager to explain what they do to in order to deal with enquiries and convert them into orders and cross check this with what the procedures say. Then, take a few of orders and follow them through the system to see if what they say and what the procedures say align with each other.

I would take a new one, an older one, a big one, a small one etc in order to get a good cross section.

Now, not everyone in this forum will agree with this but I would also cross check what they do, say they do, are proven to be doing, with what clause 7.2 requires (because it is sales). While you are there, you will also be checking records, some document control, responsibilities etc.
 
#10
Don't forget that in an audit you are seeking to determine what the companies practice is, that is, what are they actually doing. You may not get there by simply trying to audit to a checklist or to procedures.

As others have posted, in preparing for the audit, study the procedures as well as anything else there is available tell you how the process you are about to audit works, then determine what they are actually doing by interviewing and observing. The things that can tell you how that process works may include KPI, interaction charts, process flow charts, and (even as much as I disdain them they can sometimes be useful) turtle diagrams.
 
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