ARGH Too Many Internal Audits

chris_gray1980

Involved In Discussions
Hey all

Im looking for some advice but first a bit of background.

I am a Group Quality Manager, which means, i am the direct quality manager for 5 companies (i run them day to day mostly remotely) and them i look after the whole UK Group QA which means the Corporate Quality Manual, Group Procedures as well as Auditing the individual group companies quality system, plus i seem to get involved in other things with them as well.

As you can imagine am snowed under (you may have seen my other thread on here which was a cry for help, but im still plodding on)

All i seem to be doing is Auditing for auditings sake and i dont seem to get any time to do anything else, if i do something else my auditing falls behind (before any ones says it, im a one man band and trust me it will always be that way, there will NEVER be any chance of help or support)

For example my corporate audit check list is 12 pages long once i have asked the questions i then have to type it up as well as NCR's etc my internal audits well again they can range from 4 to 12 pages and i seem to do A LOT of them them..

Our system is OLD and was greated in the days when it was believed that MORE was BETTER when actually its has made things VERY difficult. so for example i have around 30 procedures for one of my companies (inherited, i am trying to re-write the system but i never get time) and there is a check list for EVERY procedure which IS A LOT OF WORK and that is just one of my companies and i have 5 in total... 2 of teh companies are small so i have managed to re-write their procedures and now i can easily carry out 2 audits a year and that is them done (unless there are any issues then i audit accordingly) but the others i cant get time to do anything because of the audits...

If im honest they are so long winded nobody even reads them, i produce paper after paper of reports for me to file them and NO ONE to take any notice other that the NCR's (in fact getting them to notice them is not an easy task)

WHAT AM I DOING WRONG.... WHAT CAN I DO TO PUT IT RIGHT

(believe it or not i am a trained lead auditor but with little experience, the course was so intense i feel i came away with a pass but no knowledge, i couldn't take it all in so i feel like i should know it and should be able to do it BUT I CANT I'M JUST BURIED).

Any help or advice would be brilliant, if there are any samples or anything which are proven that would be great also. i have SO MUCH to do but im so snowed under i dont even want to anything so i need to relieve the pressure a little and free up some of my time so i can make the improvements i need.

Oh and to add, my audits seem the same year in year out and there are very very little out comes so it just seems a waste of time..

Thank you so much in advance

Chris

I have just spottyed there is an ISO auditing section, if i have posted this in the wrong place please could you move it and accept my apologies
 
Last edited:

pkost

Trusted Information Resource
Re: ARGH Too Many Audits

Hi Chris,

I recall your earlier thread (it can be found here for people that would like to read through it: Old QMS... NEW QM.. I don't know where to start). I must say I'm impressed you are sticking it out..you are a better man than me!

With regards to you specific query in this thread and ignoring the previous I would suggest that as no additional resource is being given you should focus your efforts in the most critical areas. Yes audits are important and beneficial, but are there perhaps some that you could drop/shorten to take some of the burden away? This may free up some time for you to catch a breath or sort other things out.

Referring back to your original thread, I really would be actively looking for a new more rewarding job...your job is something that you do the majority of your life, it has to be something that you enjoy and if it isn't something that you want to get out of bed for, you should at least not get so stressed about it.

You had concerns about your experience and knowledge, this is not an issue and is your own fears. You said before that you had passed your lead auditors course, that proves you have the knowledge (even though you feel it doesn't). The work you are doing here is obviously extensive and intense; you will have gained countless skills from this that you can transfer to a new organisation that will appreciate your efforts, knowledge and skill
 
S

SteveK

Re: ARGH Too Many Audits

Hi Chris,

First off I do not think you should be auditing the quality system(s) – since you own it, 8.2.2 “Auditors shall not audit their own work”.

Next – why have you got check lists for your procedures – either they are followed or they are not? I am the QM for a small medical device company. Although it is obviously not as large a set up as yours, I still have 33 procedures (more are required due to ISO 13485 than the nominal 6 for ISO 9001). I accompany the Internal Auditor during an audit, which basically takes a couple of days a year (there is an overall audit check list to the standard(s) clauses – which can be a bit repetitive I must admit). With respect to the procedures – which are the main focus of the audit – the auditor will then typically go through the procedures with the ‘owner’. If it is Purchasing this involves sitting down with the Purchasing Manager and confirming what it says in the procedure is what he does. If it is – fine, if not rewrite the procedure to what actually happens (and log as a NC). Obviously you will be the relevant person to be asked if e.g. you follow the CAPA procedure as written, is this how you handle complaints procedure in practice, how do you control the quality documentation procedure etc? So going back to my first point, will you be just having lots of discussions with yourself? Or am I missing the point altogether?

Steve
 

chris_gray1980

Involved In Discussions
Re: ARGH Too Many Audits

Hi Pkost, Thank you for your post, i appreciate your support and words :) i am still considering my future but where i am is a secure as im going to get as far as a job goes and i cant risk loosing that so im trying very hard to get up and be positive i will admit it doesnt last long but i keep plodding on BUT this is something i really do not want to do for too much longer if i cant make things work and for where i am to be come enjoyable (or as close as)

Hi SteveK, Thank you for your post, i must add technically i do not audit myself, there is one person who audits me on a yearly basis but in some cases the audit only goes as far as a signature, but as far as the paper work goes im not auditing my own work.. as far as auditing other group companies they have their own quality systems which are written around the corporate quality manual so i am auditing them as quality managers and their quality systems so they do not audit their own work.

The only real audit my system gets is when the third party auditor come in to do their audit.

I do also have checklists which relate to the clauses which i do use but yes they are very repetitive but then so are the procedure audits. im not sure why there are checklists for both (i have a folder full of check lists), its just how it has always been (i want to change it but dont have the time)..

Within the companies i look after directly only one has managers who take responsible for their departmental procedures but the other 4 well they would rather ignore them and fob them of as being my problem and that i should make sure they are right, they wipe their hands of the quality system (my original post PKost posted) im up against a battle every day but i maintain the paper work which shows otherwise.. its like i live a lie and to be honest im sick of it but i keep trying to get other people to take responsibility but im not getting very far..

I keep attacking small chunks, so i need to get to grips with the auditing (the corporate auditing is OK its only once a year, its my internal audits thats the real problem)

Thanks again :)
 

AndyN

Moved On
Re: ARGH Too Many Audits

Firstly, the idea this system is your own work and you shouldn't audit it is - to be blunt - twaddle! It's like saying the QM does all the work in the organization! Really! We've hashed that one out so many times, in other threads. If the person didn't 'touch it', it's not 'their work' is it?:notme::rolleyes:

Chris, we need more information on what you're currently doing in terms of managing the audit program today - what's the schedule, frequency, scope and criteria, how many auditors you have etc.

I'm going to get my crystal ball out and assume that you're working to some kind of calendar of audits. The fact that you use such a checklist is also a recipe for disaster and something which should be ditched as soon as you can. I know if you're doing a lot of audits, you don't have time to plan, but as we say Proper Planning Prevents...

So, Chris, sanitize your audit calendar, post it here and we can give you some concrete help with a way out of the funny farm...
 

chris_gray1980

Involved In Discussions
Re: ARGH Too Many Audits

Hi AndyN

Right where to begin...

Auditors well there is ME.. i have one other auditor who i can use but basically to do one audit a year... So i dont have any auditors other than myself..

1.. Small group of companies made up of 5 divisions all of whom are local and i have grouped together so i have one audit plan for them.. This is a 12 month plan split to allocate 2 months of the year (6 months ish apart) to each company and allocating a month for prep work for the third party auditor and a month for the third party auditor (i spend 3 weeks of the year with a third party auditor traveling the UK to all the sites so i need to prepared for his visits)

the 6 documented procedures i must have are corporate procedures and are excluded from the numbers below

the audits within them companies comprise of:

Company 1 - Has 5 procedures i audit theses twice a year
Company 2 - Has 14 Procedures i audit these twice a year

these two are each, i do not use a check list as such, i basically run through the procedures one by one with the relevant person and do a write up.. This is the start of my new system and works very well for the smaller companies of which these 2 are

Company 3 and 4 - Both have 29 Procedures (the same procedures but 2 totally different companies.. no it doesnt work hence why im trying to change it) there is a check list for each of the 29 procedures. there are also 14 ISO clause audit check lists..

i aim to do as many of the above as i can for company 3 - 4 but these is WAY too many..

2.. Company 5 is a stand alone company (relatively new acquisition, their system / approval is not yet part of our multi-site certificate so they stand alone at the moment.. again there is a 12 month plan of which there is an audit every month (for each procedure) which isnt too bad but again i have check lists which seem to be extremely long for example i have just finished writing one up which was 9 pages plus a summary.. so in total they have 8 procedures which leaves spaces for follow ups and the third party auditor visits.

3.. I have to carry out 19 corporate quality audits which really are spread all over the UK.

So in total i have 3 audit plans one for comapnt 1 - 4, one for company 5 and one for my corporate audits... If i was to do ever audit check list that is within our system i would carryout, well a hell of a lot of audits which i do try and do and it drives me crackers and leaves me no time at all and i feel there is no useful out put 90% of the time...

----------------------------------------------------------------------------------------------------------
Does all the above make sense and give you an idea of my schedule? the schedule is historic i know that and im trying to change that.. one of the problems i do have is i get asked by my manager for example have you audited procedure ??? or Procedure ??? so his understanding of the system is that we audit EVERY procedure.. He has seen my new audit style with company 1 and 2 BUT no comments so i can only assume they are OK and to his satisfaction..

We have had ISO certification since 1987 and most of the procedures etc were written then and have just evolved since but back then we were a MASSIVE manufacturing concern and now we are no longer that size, the Group Quality manager had a team of around 20 people but every year there would be a cut back until now we are a smaller concern (still a large group of companies but run on a shoe string) so now there is the same system the same content within that system and just me, myself and I, there is no where enough work going through as there use to be so a lot of the procedures could may be removed, grouped or simplified BUT because everyone is under the impression is a quality department function (ME) they say well you do it.. i cant help you i dont have the time because like me they are all stretched as well so its an up hill battle...

Oh god i didnt want to rabbit on, sorry, im just trying to attack it bit by bit....

Thanks

Chris
 
Last edited:

AndyN

Moved On
Re: ARGH Too Many Audits

Ok, Chris - Wow, a huge undertaking!

The most obvious thing is that you shouldn't be auditing procedures! Your audit program should be auditing process(es) - take a look at this article to get an idea of what I mean: https://www.nqa-usa.com/resources/articles_detail.php?id=39

If you audit a process, you should, naturally, cross paths with other processes/procedures. Depending on the importance to the main process, these can be reviewed.

Think of it as taking a walking holiday around York - you'll follow a path which will get you around the city, but you will likely want to stop to take a look in shops, historical sites etc along the way (maybe even a tea room or chippy!). You'll continue by getting back onto the path. If you disappear up a sde street and into a pub, you won't complete the audit objective, will you? That's like getting side tracked in calibration...

This approach will tell you about the implementation of all those other processes too, without them being the focus of the audit, as they are now. Thus, you'll get about 60-80% of your audits accomplished each time - a huge saving!

Let me know if this isn't clear...or you need more info.
 

AndyN

Moved On
Re: ARGH Too Many Audits

And one more thing occurs to me - either fire your CB (or the blind/incompetent audit they send) or pull the plonker to one side and ask them what the h*ll they've been doing for the past however many years...;):mg:
 
Top Bottom