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

[CliffK]

Re: How to Stucture My Organization to Support the Quality Management System?

We should be developing optimized processes

No disagreement whatsoever

, and the details need to be documented.

yes, but see below

There should be a standardized method for operating each process, a method that's been proven to work as intended.

Absolutely. Best practices all the way.

No one can do do things by the book if there is no book, or if everyone's "book" is different.

Okay, but I don't think everything in the world needs to go into the book. So many quality systems seem to be an attempt to describe the universe and give two examples.

Not that I think anyone is advocating such an approach; I just want to make sure the danger is noted.

Here's a real life example of an unnecessary work instruction. There is a device called a ribbon blender that mixes powdered materials together. The accompanying work instruction (I've seen more than one) boils down to this, once you strip away all the extraneous words:

Fill hopper with material.
Put receptacle under chute.
Turn blender on.
Run until hopper is empty.
Turn blender off.
Take receptacle away.

I think we can agree that there is no need to memorialize this operation in a work instruction. Yet so many organizations have WIs like this, cluttering up the system and making it unmanageable.

 

[Jim Wynne]

Re: How to Stucture My Organization to Support the Quality Management System?

Here's a real life example of an unnecessary work instruction. There is a device called a ribbon blender that mixes powdered materials together. The accompanying work instruction (I've seen more than one) boils down to this, once you strip away all the extraneous words:

Fill hopper with material.
Put receptacle under chute.
Turn blender on.
Run until hopper is empty.
Turn blender off.
Take receptacle away.

I think we can agree that there is no need to memorialize this operation in a work instruction. Yet so many organizations have WIs like this, cluttering up the system and making it unmanageable.

You're right--we can agree.

 

[Eric ng]

Re: How to Stucture My Organization to Support the Quality Management System?

I worked for a SME (Small-Medium Enterprise) electronic assembly plant for seven years. The basic functional organization consists of Marketing & Sales, Purchasing, R&D, Production Engineering, Test Engineering, Quality Assurance, Human Resource, Finance/Account, IT. Before we embarked on a formal Quality Management System based on ISO 9001:2000, we already have lots of documents written by each indidual department governing their operations. And each department manage and control their own documents, except for documents relating to manufacturing, which are managed by Quality Assurance assisted by a document control clerk reporting to QA engineer. The reason for embarking on a formal QMS must be sold to top management and secure their full support, otherwise don't even start.

To ensure 100% compliance, all existing documents must be edited, and create new ones to ensure they meet the intent of each relevant ISO clause.
Responsibility to ensure all documents are current are clearly stated in each document. QA form an inter-departmental audit team who follow an established audit schedule to make sure no obsolete documents are being used, and no extra operations are carried out without approved documents.

QA has the authority to stop any operation or process, or stop shipment of products if any major deviation is found through audit or normal routing QA monitoring and inspection.

One last point, a very important one is Management Review, where the effectiveness of document control is presented by QA, and corrective actions are generated on major deviations found.

Hope my experience helps!

Eric

 

[JaneB]

Re: How to Stucture My Organization to Support the Quality Management System?

Going back to your question, Scotdail, yes I see that I did misunderstand your question, & that it's more to do with maintaining.

My meaning is what structure do I need to create to maintain the quality management system? Our documents have been created using an ISO 9000 format, using Microsoft windows folders with controlled read/write access, but these must be maintained and kept vital. We must have an audit schedule, trained auditors, manage that activity, and then drive continuous improvement.

Do any of you have a dedicated resource to maintain this, or do you drive it as the manager? I am having challenges with keeping track of all this, and am looking at how others have approached system maintenance. Is it done via a clerical function? Do you have a person in your department who is an ISO / QMS adminstrator? Other ideas for a small manufacturing firm?

There isn't a single answer to this, but you are quite right that it is a challenge. At least as much of a challenge as: how do I get the Billing done, who does the books, the invoicing, the accounts payable? who does the Sales? how do I make sure that product gets shipped? etc.

Some of the more active posters in the forum have or appear to be a dedicated resource for Quality. In a small firm, it's virtually impossible to have a dedicated resource. Some possible answers are:

• share it among others - I very much like & support Jim's suggestion of sharing it among managers. And the best systems I see are those where the managers themselves drive and support it.
• outsource some of it
• get a consultant to do some of it - various of my clients do this;
• have one role wear 2 or more hats - a number of my clients do this

I favour sharing it around, and getting the 'right' roles to do the things that are 'right' for them - ie, a good fit. For example, you might delegate some of the more administrative/clerical things to someone who's good at that. But I would always, always aim to have the Managers involved and responsible - yes, I may well provide clerical/admin help to them, but I keep them responsible.

We can't always assume that organizations are culturally prepared for having a structured quality system... scotdail's question about how to structure the organization makes sense, and is probably mostly overlooked when implementations are planned.
Whenever any new business system is introduced, the planning has to include what will be needed in the form of new resources and training in order to make it work. ...A full-time administrator is nice to have, but might be considered too much of a luxury in many companies.

Jim makes, as so often, some excellent points. Most small companies simply can't support a FT person.

By the way, I do disagree with Cliff about Share Point Portal - 2 of my clients have recently implemented systems based on it, and they both LOVE it, & use it for all their documentaiton, as well as their issues and actions.
OpenOffice is nice - but in my experience you mostly gets what you pays for.

 

[Sunday]

Re: How to Stucture My Organization to Support the Quality Management System?

I have worked with several small companies of approximaely your size and type and have seen 2 basic organizational structures:

1) There is a single, dedicated person in charge of all documents (usually a technician level). This person handles both internal (e.g. work instructions) and external documents (e.g. part drawings).

2) The Sr Engineer or Quality manager manages document control. This tends to be in instances where control is critical, however volume of change is low.

In either case, the document control function is stressful. It is important to have a good software tool to help the process. There are many out there, but few that are simple and affordable. The company I work for just released a new document control manager combined with employee training management. We offer free demos from our website. Check out the links in my profile for more info.

Hope this helps.

 

[CliffK]

Re: How to Stucture My Organization to Support the Quality Management System?

I don't want to start a flame war, but I do want to explain the reasons for mys statements about Microsoft.

By the way, I do disagree with Cliff about Share Point Portal - 2 of my clients have recently implemented systems based on it, and they both LOVE it, & use it for all their documentaiton, as well as their issues and actions.

At one time Microsoft seemed like the antidote to IBM--remember those days? What's happened, though, is that the cure has become worse than the disease.

MS has been found guilty in the US and EU of abusing its monopoly power. That may seem remote, but in fact it has real consequences for every organization that uses MS software: the software costs more than it should.

MS uses file formats that are incompatible with other software vendors. There's an ISO standard, which MS could easily implement, but MS chooses not to. This action locks MS users into continuing to use MS software.

MS file formats are not even always compatible between different versions of their software. Thus users are chained to an upgrade treadmill that turns another cycle every time MS launches a new version.

There is more, but I'm not going to belabor the point. It's just that all of these things add unnecessary cost; some visible, some hidden.

It reminds me of the old saying: once you've paid the danegeld, you never get rid of the Dane.

OpenOffice is nice - but in my experience you mostly gets what you pays for.

Not to belittle your experience or the lessons you've taken from it, but perhaps it is not entirely applicable in this case. For example, check out all those software logos at the bottom of this web page. Four of the five are for free software. The exception is the Mac; the free software does the heavy lifting, though.

 

[JaneB]

Re: How to Stucture My Organization to Support the Quality Management System?



Cliff, I actually agree with much of what you say about Microsoft, and I"m distinctly less than happy with innumerable aspects of their software, etc. But I DO think that subject is off topic, and quite possibly not very helpful for the OP.

Happy to debate it elsewhere if you wish. Why not take it to another thread, such as pros & cons of commercial vs free software for example?