Building the QMS (Quality Management System): Getting Started

J

jbrelle

#1
Dear all,

I'm new here in the Cove, registered 1 month ago and I've been reading many topics so far, even though I feel like I haven't even started to see the top of the iceberg... Please apologize for my bad English, I'll do my best to be understandable! As my post title says, this is about getting started with the QMS, and by this I really mean GETTING STARTED :rolleyes: Let me explain: I am not a quality expert at all, no experience in this field, I've been working in a R&D lab developping new alloys so far, and untill now "Quality" was for me the boring guy with useless requirements :notme: Now I joined what I considered as the dark side of the Force and I will try to be a useful guy with very helpful requirements leading the continuous improvement! Here is the situation: we are a very young (little more than 2 years old) company, fast growing (19 people, probably around 25 at the end of the year), and of course with absolutely NOTHING set for the QMS so far. Which means I have to figure out how I will start building the QMS :confused: First of all, as I told you, I'm not an expert at all, and I will try to improve a little at the beginning of next month by attending a 3-days intensive course on ISO 9001 in services companies. I will probably attend another course in June, more specific to what we plan to obtain, i.e. the DIN EN 9120 certification (maybe I should have started saying that, but again, so difficult to know where is the first step!). Well, that was a long speech, sorry for that, I hope there are still some of you reading at this point :bonk: Maybe the last word to explain what we do: we're buying titanium products from our mother company and selling them to our subsidiaries all around the world, with a large majority of aerospace applications. We are only doing "paper job", meaning that the material is delivered directly to the subsidiary. We are dealing with sales and purchase orders, and are also responsible for the reporting, accounting and marketing. I will warmly receive any advice to help me get started in my journey to the promise land of a well-mastered QMS... :thanx:

Julien
 
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SteelMaiden

Super Moderator
Super Moderator
#2
Re: Building the QMS: getting started

Welcome :bigwave:

Your English is quite acceptable, good job! It looks like you are doing the right things, reading the forums, getting training, those are the things I always recommend. Have you found the lists of related topics at the bottom of each thread? It is very useful when you are reading threads, and there is a search function in the nav bar near the top of the page that I'm sure you've seen while you have been studying the Cove? As far as your business model, it seems that you operate similarly to a brokerage? You have described that you just sell something your sister division has, so I am assuming you do none of the inspection/testing on it? Sit down, list out step by step what your division's process is, then you can start to narrow down what your responsibilities are under ISO 9001.

We are glad you found us, enjoy the journey (on the dark side?:mg:) and let us know what we can help you with.
 
J

jbrelle

#3
Re: Building the QMS: getting started

Thanks SteelMaiden! Indeed, I had seen the "search" function, and I have been using it intensively, but there is such a huge amount of topics in the Cove that you easily get lost around the corner... It happened that I left the office at the end of the day and could not remember what I had been searching for in the first place:bonk: Yesterday I had terrible headache reading the passionate debate about CAPA and how to distinguish CA from PA... And I finally decided to keep in mind only one thing: as long as you adress both issue and it works for you, that's fine! Anyway, I started a new thread just to be able to have the more important information at one place, and eventually ask for assistance now and then as I proceed with the implementation of the QMS. By the way, you're totally right, we're not doing any inspection or testing, the only proof of conformity that we get are the certificates: is that acceptable? That's another thing I found a bit difficult when thinking of the best way to start, it appears that most of you guys are dealing with "real" stuff, you have production plants and engineering departments to work with. Here it is somehow different and not always easy to figure out how the general rules may apply to us. But I'll find my way sooner or later :rolleyes:
 
C

ChrissieO

#4
Re: Building the QMS: getting started

That's another thing I found a bit difficult when thinking of the best way to start, it appears that most of you guys are dealing with "real" stuff, you have production plants and engineering departments to work with. Here it is somehow different and not always easy to figure out how the general rules may apply to us. But I'll find my way sooner or later :rolleyes:

You are not alone, even with 11 years in Q/S/E/MSs I stil get a little lost with some of the topics as I work in a purely service industry, Customer service/logistics/warehousing and distribution across 4 sites and approximately 350 people, although we are now dipping our toes into the strange world of manufacturing and I am having to get myself back up to speed on these things quickly and have found the Cove my best source of knowledge.

I think you are doing things right by having the correct training to start with, things will become a lot clearer to you after that, so I wouldn't stress too much at this point. You may find on your course that it slants towards manufacturing processes etc as there will probably be people from these industries attending. Do not be afraid to ask the trainer questions about how to relate the standard to service industry.

One tip before you got on your course, get into the habbit of where you see the word "product" within 9001 train your eyes to see "service" i.e. Product Realisation = Service Realisation.

By the time you go on your course you will be so used to it the course may make more sense.

Chrissie x
 
J

jbrelle

#5
Re: Building the QMS: getting started

You are not alone, even with 11 years in Q/S/E/MSs I stil get a little lost with some of the topics as I work in a purely service industry
Good to know I'm not alone :) But also means that I will still be lost in 11 years :mg: Well, that is probably the driving force for continuous improvement: never feel like you master your job!

You may find on your course that it slants towards manufacturing processes etc as there will probably be people from these industries attending.
Should not be the case, as the course is specific to purely service companies (French title, if it means something to you: "Guide Pratique de l'ISO 9001 - Spécial Services"). But you're right, after all "services" are just a particular type of products. Put this way it's sometimes easier to apply some of the discussions here in the Cove to our daily work.

Thanks Chrissie for the help! :thanks:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
It can look daunting, so I would start by simply listing my customers and their requirements, by category of product and service, or how to find the requirements. This way you have determined what they want. Next thing is to lay out the means to make sure they get what they want.

From there it seems worthwhile to use ISO 9001 as a guide to organize the many things you probably already do by subject, and establish or refine those which do not seem adequate. Unless you are making nuclear reactors or replacement heart valves, simpler is probably better.

When writing processes or procedures I would start with flow charts. When recording more detailed write-ups I would avoid saying what I think the system wants, but instead say what is being done. After that is completed these processes and their documents can be run through a "gap analysis" to see if critical activities or aspects are missing or need to be changed.

I would closely involve the process experts as consultants. Whatever written procedure evolves needs to be accurate but also easy to use so they won't ignore it.

I would also consult with process people when developing and monitoring key metrics - what tells us if things are going well or not - and encourage open thought and communication as to what can be improved, because process problems are very often not caused by people who work the processes; we have internal customers too, so a seemingly small issue to one group can present a huge problem to the group who receives it in handoff.

I would celebrate as groups, because, metaphorically speaking, this ship sinks or arrives with pretty much everyone on it.

I hope this helps!
 
J

jbrelle

#7
Hi everyone,

Still 2 weeks before I attend this course on ISO 9001, I really hope it will be helpful. But of course I'm not sitting in my office doing nothing until then! :D

I thought the first step would be to write a draft for the "Control of documents" procedure, because all other documents that we will be writing will have to follow this procedure. Make sense to you experts? As I said in my first post, I'm starting from scratch and try to figure the best way to build the QMS. I will probably submit this procedure to your kind review in a few days, but for now I'm waiting for the purchase of SmartDraw (I used the trial version to practice and found it really easy to use) to be able to insert my flow-charts without a "Trial Version" stamp printed on it:rolleyes: And guess what? I wrote a form for "Software Purchase Request"... Sounds a bit like the snake biting its own tail, since I need this form to request the purchase of the software, and need the software to write my procedure, which I should have used to write the form... :frust: But no big deal I guess...

Well, lot of (bad English) writing again, sorry, here comes the problem bringing me to the Cove today: I'm trying to see where are the borders of our activity, finding the inputs and outputs. And I feel like we are on a really particular case... As I explained, we buy all material from our mother company, i.e. no supplier selection (I mean, except for the coffee or the office furnitures). And we sell only to our sister companies (and THEY sell to the final customers), which are dealing with contract review. So basically we are converting PO from our sister companies to PO to our mother company, and then going back with SO from our mother company to SO to our sister company... :confused: Writing things this way, I feel lost... It seems to me that many of the fields addressed by the standard are not relevant for us, e.g. determination/review of requirements related to the product: this is done by our sister companies, we are "only" forwarding their POs. But would that be acceptable to exclude those clauses? Same for "verification of purchased product": as the material goes directly from mother company to sister company, we are not in a position to control it. Again, this job is done by the sister companies... Am I completely off the track with thoughts? :confused: I hope I didn't bother you too much with my endless writing and messy thinking :rolleyes:

Have all a good day!
 
J

jbrelle

#8
Hi everyone,

Me again... I've been attending my course and I'm still trying to get the best of it: many documents were given to us and I didn't have time to read them all so far. But I think this will be useful and I'm now a little bit more familiar with ISO, even though still very far from being an expert as you are in the Cove... :rolleyes:

I'd like to have your opinion on the document attached. I was thinking the first step in creating a QMS from scratch shall be to define how we will control our documents, and that's why I wrote this procedure first. I tried to follow the guidelines found by reading previous topics, but I've been reading this document so much that I can't see anything new and that's why I'm asking for your help. Please don't be too severe, this is the first procedure I've ever written :(

Thank you for your helpful comments! :thanx:
 

Attachments

B

Brunetta

#9
I read your procedure, and was curious as to what the catalyst is to review, update and re-approve existing documents in your organization?
 
J

jbrelle

#10
I read your procedure, and was curious as to what the catalyst is to review, update and re-approve existing documents in your organization?
I'm sorry Brunetta but I'm afraid I don't understand your question... Could you please rephrase it? Are you looking for the "starting point" of the reviewing process?
 
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