ISO 9001:2000 Internal Auditor System and Preparation - Schedule, Check Lists, etc.

L

Laura - 2003

#41
You realy don't wanna know

Chris, if you run a search and look for a thread entitled changing a culture, you'll see the problems I encounter.

It's an age old problem in a service based environment.
 
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J

Jamie

#42
Since I work for a small company our primary Internal Auditor is Me, Myself and I. We have one Auditor in addition to her "Normal" job duties conducts the audits for "processes" that I can't audit. I don't "provide" the information she needs. This is part of her responsibility to review the "related" current documents (specs, WIs, OPs, and forms) associated with the process she will be auditing, as well as a copy of the last audit report findings and any related Corrective Actions.

We are responsible for reviewing related data and then for creating an objective checklist, ensureing previous corrective actions have been closed and effective.

I can understand how it would be helpful to have all related information available for your auditors if they already have a "full" time job elsewhere in the company. If the company is anything like the one I work for, the QMS isn't on the priority list so getting the proper amount of time they'll need to conduct the audit for them will be almost to impossible.

I deal with a lot of the same things as Laura. It seems that "Audit" has become such a bad word. When I conducted my QMS training for the production employees they were all upset about what were the audits going to be over, what was I going to be asking, what was I going to be looking for. Trying to convince them this is no big deal and they shouldn't be that worried about it......that's a hopeless cause. I haven't been able to conquer yet. No matter how I enforce the same things you mentioned Laura. Everyone is more concerned with the findings and heaven forbid there be nonconformances. I can't seem to get people to NOT take them personally.

Anyway, my 2 cents worth. As most days in my situation, same day different stuff.

Jamie

:bigwave: :bigwave:
 
C

Chris May

#43
"Ok guys, we are going to do an Internal Audit on your part tomorrow".
Guys start to moan and wail.
"Hey Guys, I am doing a process review around this area tomorrow, can you help me for about an hour?
Guys, "Yes, not a problem. After lunch is best"

Actual conversation where I work, but an audit by another name.

Now this won't be true in all cases, but I thought I would try using a different approach instead of implying that the police were going to turn up and everyone acting as though they were about to get busted.

Our "realisation" processes are monitored in real-time anyway, and a weekly review is held informally to see how we are doing.
The "audit" for these processes are a once-a-month more formal review.......which appears to work for us.

Actually "auditing" a process every (say) six months could mean that you find you have been doing it wrong for 5.95 months.

Just my thoughts, FWIW
Regards,

Chris
 
L

Laura - 2003

#44
Jim Wade said:


Why's that then, Lau? What are their arguments?

rgds Jim
Our organisation is all changed out at the moment. Since April 2001. the organisation has gone through some major changes which has made all the people here, more than cyncial, about any new initiative or process.

Anything new at the moment will spark a cynical, maybe apathetic response.

Lau~.
 

barb butrym

Quite Involved in Discussions
#45
was skipping around this thread reading some (not all) comments and thought I would add a summary of what I was thinking.......

1st.....who sets out/collects the papers?
Whoever is responsible for determining the scope of the audit, and has the time. In most of my companies its the "Audit coordinator" (lead auditor/mgt rep etc...) that either lists or even sometimes gets the applicable documents.

2nd .......opposition.
Get the loudest opposers/auditees on the audit team, even as a support person, but even better when fully trained by an Outside Source (its all in their heads, but it works). Best approach I have used was to have all element/process owners trained as auditors.........they automatically become better auditees, and in most cases they audit their own areas before you get there as part of GMP...and therefore adds their own opportunity for Improvement to the Quality System.....not to mention ownership. Preventive Action instead of Corrective,,,if you will.....

3rd....scheduling
Plan an audit sweep day each Quarter....set up for lunch, invite all auditors, element owners...have all documents available, working papers, CA forms etc......You can plan as teams over morning coffee........It all gets done at once, you can even assign a team to follow up on last round CA closures. A consultant can be used here to help/lead/support the teams if resources are an issue...have a closing meeting at the end of the day to distribute/discuss reports (use lunch for "inprocess general discussion") Everywhere I use this has awesome success with it........and the registrars, DoD, FDA auditors love it.
 
R

RosieA

#46
Chris, a couple thoughts related to your original question...

Part of my audit plan for the year includes the scoping of each audit. That is published at the beginning of the year, so that everyone knows what the audits will consist of.

When the audit team comes to a mutually agreeable date with the auditee, an audit notification is published, again defining the scope. (mostly tier 2 work instructions + CAR follow-ups when required.)

All documentation is on-line, as are previous audit reports and CARs. No package is required. I tell them the scope, they pull the applicable work instructions and CARs to follow-up.

At the closing meeting I distribute an evaluation form to the auditee(s) and ask them to rate the audit in terms of its value and fairness. We have an Internal Audit Business Plan that lists the goals of the audit program, and bringing value to the organization is the key goal. We use the evaluation form ratings to determine the Audit programs effectiveness, and to address issues with individual auditors.

I've attached the evaluation form and business plan as examples.
 

Attachments

M

M Greenaway

#49
Rosie

Just wondering how your targets for internal audits relate to your companies objectives for quality ?

In other words if our internal audit programme meets all your targets what effect does this have on the overall improvement in the operation of the business ?
 
R

RosieA

#50
Dear "M",

The tie in to company quality objectives is very close, as I am involved in both programs. After the objectives are set each for the year, I factor them heavily into my audit plan.

My main objectives with the Business Plan was to 1. educate my audit team on their role in bringing value to the organization, (Many thought it was to be the audit police) 2. reduce the fear and loathing surrounding audits in the past, and 3. to move the audit program from being primarily remedial to being both remedial and improvement focused. I did lose two auditors after a year of auditing to the new biz plan. Both were "gotcha!" auditors and they didn't adapt well to the new focus.

When I joined this company 2.5 years ago, I was immediately struck by the "silo" effect. There were very few cross functional meetings, so I set out to break some of those barriers down, and the first one I tackled was my own Internal Audit team.

The results have been good. We have done a better job meeting company objectives, and we got through 4 ISO surveillances without any findings. (I did have several improvement notes when we did our 2000 upgrade, however) I thank my audit team every year at an appreciation luncheon. They do a great job!
 
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