Control of Documents Procedure - Audit Nonconformance

S

SuperGirl

#21
Qusys,

they see it as a QUALITY problem and because i am the QUALITY manager its my problem and will be my fault if anything happens to our certification.
From what I see, right here is your issue. Quality is everyone's responsibility, but you already know that, what you need to do is find a way to get you top managment to see it. To do that you may to dig into what makes them tick: is your organization sales based- then focus on the increased customer satisfaction of good quality. If they are very price different- show them the cost of poor quality (repacks, loss of business, ect.).

Here's an part of an article I wrote for our company news letter after we recieved our initial ISO certification:
The benefits of the ISO certification cannot be overlooked. Here we take a look at some of the benefits of ISO Certification.
1. Better control over our resources. With our systems in place we can improve performance in areas such as timeliness in getting products to market, reducing costs, decreasing number of errors, lessening wastage, better utilization of time and resources, and lowering product failures.
2. Reduce losses that can come about because of the production of products that are below business standards or that fail in reaching the specifications of our customers.
3. Customers are also more assured when buying products from an ISO certified company.
4. Keep focused on the value of the business. We should search for strategies which improve our services and products for the satisfaction of our customers and to meet our objectives.
5. Implement procedure that are flexible to match what we do while meeting ISO requirements. We should not try to put into effect a certain process purely for the reason of showing an auditor. They should add to the value of a business and when auditors look at them, they will be satisfied.
6. Everyone will be on the same page. If you know what you are doing, have a documented procedure and work instructions to follow, you will be more confident in what you are doing.
7. Cross-Training will be more effective. With documented procedures, others in the office can pick up and help out if needed.
8. Systematic Approach for when thing get really busy. Let?s face it, we are already busy, and ISO certification coupled with a strong sales force and a good product line with help us grow. By having our procedures documented, we will be able to handle more, because we have a systematic approach.

Hope that helps.
 
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LUV-d-4UM

Quite Involved in Discussions
#22
I agree with Super Girl. Quality is everyone's responsibility. Top Management owns it. You (like me) are the Messenger. It is not your fault. If there is something wrong with your Quality System- Blame the Top Management not you.
 

chris_gray1980

Involved In Discussions
#23
Thank you everyone who has contributed to my thread, i fully understand everything you are all saying but no matter what i do nothing will change here, yes i could spend months trying to put figures to failings in the system but the fact is i just do not have any time at all, i have to have the system brought up to date by the 10th April and all i seem to be doing at the moment is wasting days 'trying' to come up with some sort of action plan which i am struggling to do.

I appreciate all your support, its the only support i do receive from any where.

Thanks
 
S

SuperGirl

#24
i have to have the system brought up to date by the 10th April and all i seem to be doing at the moment is wasting days 'trying' to come up with some sort of action plan which i am struggling to do.
Would the auditor accept an action plan in place for updating the system by April 10th, if you can show evidence of the start of the action plan being executed? From what you have been saying, there is going to need to be a lot more done to bring compliance besides updating the system to truely eleminate that root cause of the issue. You can have the best system in the world written down, but if you don't have top management buy in, and thus a company culture to drive the system, the system is going to be useless.

That's just my :2cents:, but for what it is worth, I have been there. I'm fairly new to this side of the game. I was hired were I work, because they were a small ,start up, sales driven medical device company, that did not have a any quality system in place... At first setting up the system was a struggle. The company was/ is a sales busines, the owner thought of quality as something that was a roadblock to getting product to market fast to make more money. Three years later, we still have our struggles, but quality is a way of life and we are ISO certified. It can be done, but it will take time, persistence, and patience.
 

chris_gray1980

Involved In Discussions
#25
Thanks SuperGirl,

Unfortunately i put a plan in place over 18 months ago to demonstrate a way forward to eliminate any action from the CB but after about 6 months he noticed that progress was slow so i got given a minor NCR then a further 12 months on nothing had progressed at all so he raised it to a Major so unfortunately i dont believe an action plan will be enough.

I know i will end up producing paper work to satisfy the CB but will be meaningless..

All i want out of life is to succeed and make a difference but this is getting me so down now that my drive has just diminished and every day is a battle with myself as well as anyone else in this stupid company. I wish i could leave here with good experience but the truth of the matter i am going backwards and my chance of leaving and increasing my life goals is diminishing with every day, i have such a lack in my own confidence with my abilities i couldn't possibly sell myself as anything other than bloody useless...

Thanks for everyone support
 

qusys

Trusted Information Resource
#26
Thanks SuperGirl,

Unfortunately i put a plan in place over 18 months ago to demonstrate a way forward to eliminate any action from the CB but after about 6 months he noticed that progress was slow so i got given a minor NCR then a further 12 months on nothing had progressed at all so he raised it to a Major so unfortunately i dont believe an action plan will be enough.

I know i will end up producing paper work to satisfy the CB but will be meaningless..

All i want out of life is to succeed and make a difference but this is getting me so down now that my drive has just diminished and every day is a battle with myself as well as anyone else in this stupid company. I wish i could leave here with good experience but the truth of the matter i am going backwards and my chance of leaving and increasing my life goals is diminishing with every day, i have such a lack in my own confidence with my abilities i couldn't possibly sell myself as anything other than bloody useless...

Thanks for everyone support
Hi Chris,
after reading your post and successive details, I see no exit way for this this. From what you wrote, it seems that management of the organization does not care at all of the quality systems and its certification. It could be interesting to know at this point what your customers think about this. Did they ever audit your organization? Do they have interest and require your organziation to be ISO certified? Reading at your posts, it seems to me a very paradox situation, almost to the border of fantasy world, considering that it last since almost two year. As last thing you may remember to your mgmt that you are paying yur Registrar for an unuseful service, looking at the result, but I do not know how to suggest for real...
 

chris_gray1980

Involved In Discussions
#28
I wish i could come up with some sort of eye opener, just to make them aware but to be honest if i did that they would probably look at it as its my system so my fault and i had better sort it out.. They just don not fully understand what a quality system is and a quality manager should do but i feel its far to late in the day to change things, they have been this way for years.. And every one knows better than what i do, i just cannot win when i get in to a 'discussion' with any one here.. i get the 'that's the way we have always done it' ARGHHH no one will accept change..

A lot of it is probably my fault, i never wanted to be a QAM i was just given it and i had no prior training or experience and the training i was given i struggled with, if i was better and more intelligent like a lot of you guys i wouldn't be letting my company down like this, i wish there was a way i could better myself and knowledge, i have tried reading articles and research but to be honest its all to complicated, i try and put it in to my businesses every day workings and nothing works.. I wish i could expand my knowledge and be a better person.

A lot of our customers are repeat customers and we never really get audited, when we do we seem to get through with a load of waffle and good quality biscuits. We do provide a very good product and we have good customer feedback and very few customer complaints (well the ones i know about) but that doesn't mean we are successful and actual make any money.

I have often been asked 'what benefit is ISO 9001 to our company' i often answer for us i do not see a benefit unless a customer asks for it (which a lot don't) so in that respect its useless, but i follow it up by saying that if management and employees actually gave a S^&T ISO 9001 could be an extremely useful tool but i get the only thing it does is generate paperwork, one of teh old guy even says we've got to keep the auditor happy don't we when he puts paper work in his file but he has no idea what's so every what that piece of paper means or is used for saying that at least he has that piece of paper because most don't, they just say what's the point in it and half the time i just don't know...

Well its almost that time again, the best time of the day and day of the week so a double bonus.. How i cant wait until Monday and coming back to this ****
 
#29
I wish i could come up with some sort of eye opener, just to make them aware but to be honest if i did that they would probably look at it as its my system so my fault and i had better sort it out..
I'd suggest that a) you give it a try (no one can predict the outcome) b) you relate it to revenue and then c) you take it to the senior finance people and explain to them. If you have a (credible) case for saving money in today's economy (in the UK) they will listen, or you should get your c.v out anyways... You should do it if for no other reasons than it will confirm they aren't interested and it will be good on your c.v.
 

qusys

Trusted Information Resource
#30
I wish i could come up with some sort of eye opener, just to make them aware but to be honest if i did that they would probably look at it as its my system so my fault and i had better sort it out.. They just don not fully understand what a quality system is and a quality manager should do but i feel its far to late in the day to change things, they have been this way for years.. And every one knows better than what i do, i just cannot win when i get in to a 'discussion' with any one here.. i get the 'that's the way we have always done it' ARGHHH no one will accept change..

A lot of it is probably my fault, i never wanted to be a QAM i was just given it and i had no prior training or experience and the training i was given i struggled with, if i was better and more intelligent like a lot of you guys i wouldn't be letting my company down like this, i wish there was a way i could better myself and knowledge, i have tried reading articles and research but to be honest its all to complicated, i try and put it in to my businesses every day workings and nothing works.. I wish i could expand my knowledge and be a better person.

A lot of our customers are repeat customers and we never really get audited, when we do we seem to get through with a load of waffle and good quality biscuits. We do provide a very good product and we have good customer feedback and very few customer complaints (well the ones i know about) but that doesn't mean we are successful and actual make any money.

I have often been asked 'what benefit is ISO 9001 to our company' i often answer for us i do not see a benefit unless a customer asks for it (which a lot don't) so in that respect its useless, but i follow it up by saying that if management and employees actually gave a S^&T ISO 9001 could be an extremely useful tool but i get the only thing it does is generate paperwork, one of teh old guy even says we've got to keep the auditor happy don't we when he puts paper work in his file but he has no idea what's so every what that piece of paper means or is used for saying that at least he has that piece of paper because most don't, they just say what's the point in it and half the time i just don't know...

Well its almost that time again, the best time of the day and day of the week so a double bonus.. How i cant wait until Monday and coming back to this ****
Let us keep informed with the new updates and future development of the issue. I hope you will have had some idea and confidence from the suggestions and helps from this forum.
 
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