How to Structure My Organization to Support the Quality Management System?

scotdail · Oct 12, 2007

Hi Folks:

I need some help in determining how to stucture my organization to support the quality management system.

I am the Quality Manager of a small JV manufacturing facility for agricutural drive train components, with about 80 production employees and 30 office support. We do machining and assembly on-site, but no design.

We are NOT currently seeking certification to ISO9000 or TS16949, but ARE interested in maintaining compliant internal processes. Our policies and procedures are structured in an ISO format, but there are no dedicated resources maintaining them. We do internal audits, lead by the quality group, and our internal audits show that document control is poor and requires improvement. Procedures are not always up to date or current, and rev level control is inconsistent in some areas. We are struggling to bring this under control, so I have recommended to staff that we add a resource to support better document control.

Staff has requested that I study organizations of similar size and structure to see how they maintain thier document control system. SO - that is my question!

To those of you working in small companies with ISO compliant processes - how are you structured to effectively support the document control requirements?

Design is provided by our parent companies, and they submit electronic design documents to us in Pro/E and .pdf format. Policies and procedures are Microsoft Word docuements. Most of the documentation I seek to control are the policies and procedures, inspection records, contract reviews, quality planning activity, etc. Thanks in advance for your comments and suggestions!

kreco · Oct 12, 2007

Re: What is your ISO org structure?

I'd be curious to see other responses as well. I am new to an organization of the about the size you are in. My first task is not only to ensure we are compliant, but actually get registered within the year.

Document Management has been a hot issue for me lately, as rather than manage paper dox, it appears they just simply stopped referencing their work instructions all together. We are currently looking at using lotus notes with a web based interface to manage and communicate all documents electronically.

It has been my experience that paper documents are almost impossible to maintain.

By the way as the Quality Manager I will be 100% in charge of document management. Obviously other managers and supervisors will review and approve the released documents, but I will manage all revisions.

Pazuzu - 2009 · Oct 12, 2007

Re: What is your ISO Organization Structure?

scotdail said:
Hi Folks:

I need some help in determining how to stucture my organization to support the quality management system.

I am the Quality Manager of a small JV manufacturing facility for agricutural drive train components, with about 80 production employees and 30 office support. We do machining and assembly on-site, but no design.

We are NOT currently seeking certification to ISO9000 or TS16949, but ARE interested in maintaining compliant internal processes. Our policies and procedures are structured in an ISO format, but there are no dedicated resources maintaining them. We do internal audits, lead by the quality group, and our internal audits show that document control is poor and requires improvement. Procedures are not always up to date or current, and rev level control is inconsistent in some areas. We are struggling to bring this under control, so I have recommended to staff that we add a resource to support better document control.

Staff has requested that I study organizations of similar size and structure to see how they maintain thier document control system. SO - that is my question! To those of you working in small companies with ISO compliant processes - how are you structured to effectively support the document control requirements?

Design is provided by our parent companies, and they submit electronic design documents to us in Pro/E and .pdf format. Policies and procedures are Microsoft Word docuements. Most of the documentation I seek to control are the policies and procedures, inspection records, contract reviews, quality planning activity, etc. Thanks in advance for your comments and suggestions!

So, I'm the QM for a 140 person manufacturing plant that is ISO certified so I think I'm a good candidate to answer.

Here, quite simply, I own the document and records control process. All work instructions, forms, procedures etc...are held in a program called Sharepoint which I'm sure you could obtain through the web for a nominal fee (I'm not sure since that's out IT's area of expertise...I just use the damn thing). Basically it's a small intranet that you can put folders, departments, processes into and keep very well organized (much like tree folders in your computer).
The bonus is that it's linked to all the computers so everybody as access to what they require. How it's controlled is that I have two sites: 1, that controls the word and excel copies in which only I have access and do all the revisions in, and 2, the one everyone sees that houses all the .pdfs once I print them over.

As for records, they get scanned in by the filing department under applicable areas...I could go on for pages talking about that one.

One tip I have is not to have hardcopies of instructions around unless direly needed. Should it change they immediatley become obsolete and heaven forbid if the process owner neglects to update it!

Hope that helps a bit...it's hard to explain without actually seeing it in action.

kreco · Oct 12, 2007

Re: What is your ISO Organization Structure?

Good to hear sharepoint works great for you in this application, as we are considering that as an alternative to lotus notes. Sounds like they are pretty similar. Personally I used lotus notes previously, so I'm hoping for that one since I'm familiar with it. We have nothing in place currently and I'd welcome anything at this point!!!!

Stijloor · Oct 13, 2007

Re: What is your ISO Organization Structure?

scotdail said:
Hi Folks:
To those of you working in small companies with ISO compliant processes - how are you structured to effectively support the document control requirements?

Hello scotdail,

Contact qualtrax.com.

Stijloor.

AndyN · Oct 15, 2007

Re: How to stucture my organization to support the Quality Management System?

One of the challenges facing you is that document control is not 'fun', 'sexy' or remotely interesting to management, however, it is easy pickings for auditors. True, document control is useful and as necessary for sustaining a business as electricity/gas etc.

I'd suggest that if you want to get management's attention about the effects of document control in your organization, you should focus the auditors not at the symptom but have them look at the result of out of date etc. documents.

For example, they should be asking, "What did people have to do as a result of not having the correct document?" "Were a bunch of parts scrapped to the wrong revision?" "Did you ship and tick off a customer because the wrong revisions being made." "Do you have obsolete parts on hand because some were made wrong and you're holding them 'just in case'.........?"

By pitching the results to management instead of symptoms, you're giving them the story in terms they understand and what the cause is - like a good employee. They won't have a clue what to fix and you can - but just telling them they have bad doc. control isn't helpful!

(If you need help with retraining your auditors to look past symptoms, I'd be very happy to help!!)

scotdail · Oct 16, 2007

Re: How to stucture my organization to support the Quality Management System?

Hi Andy:

I think management recognizes the need for document control (but explaining the impact always helps), they are looking for a proposal on what we should do to improve it. It is more of "what is the improvement plan, what do we need to fix this?" rather than the message "this is not important to us". They want a manpower and/or resource strategy. I am looking for what others have done to address this.

Whatever solution we come up with, I hear and agree it will need a cost/benefit. We can propose adding a resource based on the cost that resulted from poor document control systems and practices...

Thanks, Scot

Jgryn · Oct 16, 2007

Re: How to stucture my organization to support the Quality Management System?

In setting up a similar sized company I set up the following for company structure. We had an engineering / purchasing / corporate office in the US that conducted design, purchasing activities.

1 - Had the department heads (these people were also entire departments on their own as well) agree to a business model.

2 - From there I expanded the business model to the point that we would need procedures. I aligned the standard (ISO/TS 16949) to match our business model at this point to ensure I met those requirements, but I did not match our business model to the standard.

3 - Simple document control using Microsoft office and controlled files for read only access and the "uncontrolled if printed" statement. Department heads could update their procedures and email them to me as a record of approval.

4 - For live documents, like Job Instructions, I had a blank template in the document control system and then had one person (plant IE) (sometimes two if we had student help) who had sole control of the folder and the posting of job instructions on the floor. Similarly I had a job instruction binder in the quality lab for lab specific stuff that our senior technician had control of. These documents still required approvals by department heads and a quality rep.

Jen

akalbulus · Oct 17, 2007

Re: How to stucture my organization to support the Quality Management System?

Jgryn said:
I

3 - Simple document control using Microsoft office and controlled files for read only access and the "uncontrolled if printed" statement. Department heads could update their procedures and email them to me as a record of approval.

4 - For live documents, like Job Instructions, I had a blank template in the document control system and then had one person (plant IE) (sometimes two if we had student help) who had sole control of the folder and the posting of job instructions on the floor. Similarly I had a job instruction binder in the quality lab for lab specific stuff that our senior technician had control of. These documents still required approvals by department heads and a quality rep.

Jen

Hi Jen,

i'm interested in controlling and not controlling the documents.

CONTROLLED COPY : is this mean that the Document Controller must have the MASTER COPY of all documents?

UNCONTROLLED COPY : is this mean that if a document have the "UNCONTROLLED COPY" status, all staffs or management could make a copy of it without report it to the Document Controller?

Thanks

Jgryn · Oct 17, 2007

Re: How to stucture my organization to support the Quality Management System?

akalbulus said:
Hi Jen,

i'm interested in controlling and not controlling the documents.

CONTROLLED COPY : is this mean that the Document Controller must have the MASTER COPY of all documents?

UNCONTROLLED COPY : is this mean that if a document have the "UNCONTROLLED COPY" status, all staffs or management could make a copy of it without report it to the Document Controller?

Thanks

Controlled copies: Are microsoft word (or even better .pdf) documents available in a folder that is read only to everyone but yourself. You IT person can help you with that, or perhaps someone else here can. There is no paper MASTER COPY. I would keep a copy of the email as the approval (use voting buttons "approve, not approve"). People can have copies, they are just uncontrolled and should know to access the system for the latest and greatest.

Uncontrolled copies are ANY that are printed. Include a footer on all templates that states: This is an uncontrolled document if printed. If a CONTROLLED copy needs to be printed and posted somewhere (on an enclosed bulletin board for example). Te document controller would do that, but to simplify the system I suggest to not allow that. Everyone has access to the folder copy.

How to Structure My Organization to Support the Quality Management System?

scotdail

kreco

Pazuzu - 2009

kreco

Stijloor

AndyN

Moved On

scotdail

Jgryn

akalbulus

Jgryn

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