ARGH Too Many Internal Audits

chris_gray1980

Involved In Discussions
Re: ARGH Too Many Audits

AndyN

Thhank you so much for your help, i have printed of the articles and im now going to make a cup of yorkshire tea and sit and have a read of them..

I do understand the process approach from my training but i have always seemed to fail when i try and impliment it, im not sure if im approaching it in the wrong way or starting at the wrong place.

This is where company 5 is quite good there procedures are written as process flow diagrams and there is one for each process so auditing is very good and logical i just end up with a lot in my reports which doesnt actually say anything really (if you get what i mean) i write out the question or what is required of the process and then i write what i have sampled BUT it seems very repetitive. i know auditing is going to repetitive to an extent but..

my CB hates the way the audits are BUT technically we are not doing anything wrong, everything we do complies with the standard its just the way we do it is utter rubbish.. he hates seeing check lists because yearly they say near enough the same things BUT they comply to the standard, he does try and advise me best he can but he knows what and who im up against. (we have had the same person from the same CB for the last 18 years... ive only been doing this job for 2 ish and i have NO previous quality experience i was shall we say 'thrown in the deep end')

Thanks again, keep the advice coming :rolleyes:

Chris..

Next time your in York i will by you a cup of tea and a scone :notme:
 

pkost

Trusted Information Resource
Re: ARGH Too Many Audits

Is there any justification for doing the audits twice a year? do they generate large numbers of non conformances each time? are there any audits that don't turn up many non conformances or are in less risky areas? These could be cut down to once a year or once per certificate renewal.

i wouldn't normally encourage cutting audits down to a minimum as they are beneficial, but in this case?!?
 

AndyN

Moved On
Re: ARGH Too Many Audits

Happy to help!

Firstly, you can audit a process, whether the documentation is process maps or not. It just takes preparation. I use a 'football' (rugger ball) diagram and each of the 'bubbles' (shown in the article diagram) is where I complete the information from the documents. This then replaces the old checklists.

On another point, I'd contest the assertion that you aren't doing 'anything wrong', technically or otherwise - the audits aren't being planned based on status and importance - if you are doing the same things over and again!

He's done you no favours by not raising this as an opportunity to look at things differently - in fact if he's looked at it for 18 years, he has copious evidence - he just has become 'comfortably numb'...

But let's focus on what will make your life easier, give management some benefit and engender an opportunity to recruit some others to assist in the deployment of a value-added internal audit service.

I'm off to make a mug of steaming Tetley...
 

chris_gray1980

Involved In Discussions
Re: ARGH Too Many Audits

PKost

This is something that i have considered, the external auditor has said plan your audits 3 months in advance and base them on a critical basis..

If im honest MOST of the audits i carry out do not raise non-conformance's (i suspect the questions on the check lists are written in that manor because i suspect there are issues - its all a load of rubbish if you ask me.. i want to erase ALL of them)

I understand what your saying but im not sure how i could approach it.. could you really not audit a non critical area for 3 years ? (in between certificate renewals) for example company 2 is a very small company and never have any problems with them at all i would be happy and confident to leave them and only audit them once a year but surely i would have to do it yearly? i would need a very good argument to put to my manager to explain why im not carrying out audits in certain areas, he likes to see my audits so he can see whats going on whether is the same yearly or not..

This also leads in to the management review it ends up being MASSIVE by the time i have analyses all the internal audits and actually is says nothing (if you get what i mean)

I would be interested to hear some more thoughts on this though...

I really need to sit down and get my head around all this..

MY HEAD HURTS NOW....
 

AndyN

Moved On
Re: ARGH Too Many Audits

Head hurts? = Learning new stuff!

The answer to the last post is in the process approach! Don't forget, you'll be touching between 60 - 80% of the processes each time you do an audit. Forget what your CB says about setting a schedule of 3 months ahead based on 'critical' - what the heck is that? Take a look at what I wrote about 'status and importance' or, in different words, 'risk and impact'.

It's highly unlikely that any process in a business won't have changes or performance issues in a 3 year period. If you use that as your criteria, you'll get on top of it.

Let's be honest and open here: Your auditor isn't helping you. He's made only vague statements about scheduling and checklists, and, if he really knew what he was talking about, you'd have made changes by now, because you'd have had to respond to NCs about the audit programme!
 

chris_gray1980

Involved In Discussions
Re: ARGH Too Many Audits

Head hurts? = Learning new stuff!

The answer to the last post is in the process approach! Don't forget, you'll be touching between 60 - 80% of the processes each time you do an audit. Forget what your CB says about setting a schedule of 3 months ahead based on 'critical' - what the heck is that? Take a look at what I wrote about 'status and importance' or, in different words, 'risk and impact'.

It's highly unlikely that any process in a business won't have changes or performance issues in a 3 year period. If you use that as your criteria, you'll get on top of it.

Let's be honest and open here: Your auditor isn't helping you. He's made only vague statements about scheduling and checklists, and, if he really knew what he was talking about, you'd have made changes by now, because you'd have had to respond to NCs about the audit programme!

HAHA yes learning new stuff but im ashamed of myself because this is stuff i should know...

I guess you could be right about the CB, im not sure.. but yes if there was an NC then changes would have been made.. by critical processors i assume he means high risk/impact.

i am also still trying to re-write ALL the procedures (re-jig or what ever is needed because they do not represent what we do now BUT its down to me even though is shouldnt be but i guess im stuck with that, i will have to sit and pester people to get things right but it has already taken MONTHS and got know where... ok feeling rather depressed now)

I need to back to my books i think and the planning will have to be done in my own time because i get bugger all time when im at work... in fact i am my own worse enemy because i FLIPPING HATE IT and i will try and avoid it but if it worked for me and the system i would be a lot more content and willing but.. some times i wish we would loose our certificate just to show top management what a bloody mess this system is because NO ONE listens to me.... but any way its Friday and i have 1 1/4hrs left and that's it im out of here to forget about it until Sunday when i will be dreading coming back for another horrid and frustrating week... how i wish i was a proper QA Manager...

Thanks again.. if you come across any literature that could help me PLEASE DO POST IT..

Chris
 

AndyN

Moved On
Re: ARGH Too Many Audits

Let me share something I learned while driving around metro Detroit back in the 90s...it is a key to success!

On AM radio, there used to be a show by Dr. Joy Brown. She's a clinical psychologist. People call in with all kinds of (bizarre) relationship questions (not the kind of thing I used to hear on BBC Radios 1-4!)

After a while you realize that she had approx 4 canned answers for all such callers. One of them was "If you want other people to stop doing something which annoys you, you have to do something different"!

What does this have to do with audits? Well, management don't take them 'seriously' - in many ways - lack of support for time, people, corrective actions. whatever. Audit process owners get frustrated. So what to do?

Do something different! If you don't involve management in planning the audits, start doing it! Stop focusing on ISO, focus on what keeps them awake at night or similar. Make them see you as doing things which affect them...

Try it - you might like it...:mg:
 
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pkost

Trusted Information Resource
Re: ARGH Too Many Audits

HAHA yes learning new stuff but im ashamed of myself because this is stuff i should know...

you shouldn't be ashamed of yourself, you are working in an impossible situation. Top management is giving you no resource or authority.

Your situation is exactly why top management is so critical to the effective implementation of a quality management system

Additionally you have already said that this is the first quality job and that you came into it with no experience. To me it seems like you are eager to do the job right and are just hitting a brick wall through no fault of your own.

You are in the right place to get information and support!
 

AndyN

Moved On
Re: ARGH Too Many Audits

pkost - thanks, you've prompted a thought.

The existing auditor courses, really don't give any clue as to how an audit programme should be managed. Sure, they teach (basic skills) but certainly not how to do all the other things ISO 19011 talks to. No shame in attending class, therefore and not 'getting it'.
 
B

Bunny

Re: ARGH Too Many Audits

Well, my first thought is "Where is your support from top management?" You need them to set the stage to get all department managers to take responibility for their own procedures and to get you proper resources.

If you do not have that, I can suggest that you decrease the frequency audits. Why do you audit every procedure twice a year? You should only audit the critical activities that often. For instance, if the company is heavy into design, audit that twice a year and do everything else once a year.

Regarding the checklists. I never use a checklist for each procedure, I use one checklist based off the standards I audit. That checklist has all elements listed from ISO 9001, ISO 13485, FDA regs, etc. I then write a summary report from the checklist data, but it is not detailed because the details are in the checklist. The external auditors review the checklist and the summary reports.

I also use a top down approach and group similiar functions together. So if I audit the production department, I can tie together identification, inspection, handling, documentation control, training, and calibration. When I audit the testing department, I may or may not cover training and calibration - it depends on the circumstances.

Does that help?
 
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