Document Change Control for a Very Small Business

Hello All! I work for a very small company that is not regulated in any way, we are a garment manufacturer. I however came from a Medical Device company, so sometimes that experience gets in the way of creating a quality system for my current company. I am looking for the easiest, yet best way to implement a document control and change process. I want to make sure we are complying with the intent of ISO9001, but I also don't want to initiate any undue burden on department managers (and honestly myself as the sole quality person and by default the only Document Control person).

I should also add that I had issued a form to complete that identifies and describes the changes being made along with approval signatures and a review to see if it affects other documents and I was informed by the executives that was too much work.

Thank you in advance!
M

Personally, I like a DCN type form. It can be nearly the whole 9 yards of what you need for document control - but I haven't seen yours! Some people (like your bosses) just don't take to document control, because they never did it before and it "smells' like a bureaucracy to them. So you may have to do some education. You could set it up that you have them fill in a form, which they use all the time, then tell them they have to do it again, because you had copied the wrong one! They may get the idea...

When I sold cars for a living, we had a credit application form which had a line scribbled on the bottom for the applicant to sign on. Non-one noticed until many, many credit apps had been taken, that the form was actually double sided and had a legally-required declaration which the customer should have really been signing to acknowledge - on the back side! Oooops! Very dangerous from a regulatory point of view!

I should also add that I had issued a form to complete that identifies and describes the changes being made along with approval signatures and a review to see if it affects other documents and I was informed by the executives that was too much work.

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It seems that your executives need a seminar or about ISO 9001:2008 implementation there...What you did there is standard in ISO9001. I am not a documents guy but I am attaching a file which is actually a questionnaire "diagnostic tool" for ISO9001:2008 implementation. Part 4 is for Documentation. It's a good read for them I hope.

You can do it! Have faith. Maybe some of the gurus here can help you more! Good-luck

melissa237 said:

Hello All! I work for a very small company that is not regulated in any way, we are a garment manufacturer. I however came from a Medical Device company, so sometimes that experience gets in the way of creating a quality system for my current company. I am looking for the easiest, yet best way to implement a document control and change process. I want to make sure we are complying with the intent of ISO9001, but I also don't want to initiate any undue burden on department managers (and honestly myself as the sole quality person and by default the only Document Control person).

I should also add that I had issued a form to complete that identifies and describes the changes being made along with approval signatures and a review to see if it affects other documents and I was informed by the executives that was too much work.

Thank you in advance!
M

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I agree with Andy to the extent that any document or form should be understood by the person completing it to help focus on the following points:

1. Why is this necessary?
2. Who will see this?
3. What are the consequences (to the organization AND to the individual) if the document or form is not completed or has errors?

Any quality professional has a bag full of horror stories of what can go wrong when an organization has DISORGANIZED documentation. In my consulting, when I encounter sloppy or even nonexistent documentation, I simply ask a question of the top boss, "What happens to your organization if you produce a lot of product to obsolete specifications?"

Usually, it's pretty easy to lead them to a system which will be suitable and effective for their organization.

The basics of ANY document management/control system are really just common sense. Nine years ago, I posted the following in the Cove. It's still valid and will give you an idea that sometimes "simple" really has a lot of details to consider for it to be effective. I used the term "Configuration Management" to describe another term for document management/control. The basics of any document system, of course, are just:

1. keep documents safe from loss, damage, or unauthorized alteration
2. have an effective system of retrieval of documents when needed
3. have a system to remove obsolete documents and replace them with authorized new versions
4. have a system to review and dispose of or destroy documents no longer pertinent to the organization.

The basis of Configuration Management is to do the following, more or less simultaneously:

1. go through a formal process of revision and approval when you change any aspect of the part or document
2. make a determination about the compatibility of the changed part or document with all the other Associated Documents (a specific term)
3. determine if any of the Associated Documents must be revised to be compatible in form, fit, or function with the original changed document
4. notify all parties who may be concerned about the change and get acknowledgment that change is implemented and obsolete documents or processes are withdrawn
5. monitor the process to ensure all the changes work together

That may seem overly complicated. Let's explore a very simple change and see how the steps above would fit in.

One of my favorite examples I frequently use (to carry a premise of saving on assembly cost) is switching from Phillips Head fasteners to Torx drive or square drive fasteners for more efficient assembly. (Form and Fit of thread profile and length are the same, fastener Function remains - service personnel may need notice to add Torx driver to kit, but can replace with current stock of Phillips head)

On the surface, this is a simple change, but consider:

1. organization needs to make a formal document change on the part, checking and approving the change.
2. We check the compatibility with the mating parts, but we also have to
3. change work instruction, assembly tools, inventory (use up old inventory first?), purchasing (same or different supplier? same or different price?), repair instructions sent to field personnel, pricing on the final product, advertising, etc.
4. notify all parties - quality inspectors, assembly workers, quality inspectors at customer, suppliers, inventory clerks, repair stations, decide whether repair stations can continue to repair with Phillips head in inventory or must implement new Torx, decide whether recall is necessary to change out old parts,
5. continue to monitor how all parties adapt to and implement change and decide whether further modification of any of the steps is necessary

All of us go through these steps consciously or unconsciously. The key is to do the steps purposefully and consistently and to record the steps as they are completed to assure optimum efficiency. (It would be foolish to scrap or sell off all the old Phillips head fasteners and order in all new Torx ones, only to discover no one had thought to order new Torx drivers.)

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melissa237 said:

Hello All! I work for a very small company that is not regulated in any way, we are a garment manufacturer. I however came from a Medical Device company, so sometimes that experience gets in the way of creating a quality system for my current company. I am looking for the easiest, yet best way to implement a document control and change process. I want to make sure we are complying with the intent of ISO9001, but I also don't want to initiate any undue burden on department managers (and honestly myself as the sole quality person and by default the only Document Control person).

I should also add that I had issued a form to complete that identifies and describes the changes being made along with approval signatures and a review to see if it affects other documents and I was informed by the executives that was too much work.

Thank you in advance!
M

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Melissa,

Your new employer already operates as a system to determine and fulfill customer requirements.

...otherwise it would be out of business.

Coming from your background you have an overwhelming desire to do something useful.

Why did you choose document control as your first task? Are your colleagues currently making decisions based on invalid information?

Have you spent any time appreciating the management system you have already got? Have you worked with the top manager/owner to figure out what it does with its customers and suppliers to get work, do work and get paid?

From this you'll determine the business processes that are key to your employer's success. You may even determine the processes that need to be improved. But I suggest you develop the management system first so then it can prioritize what needs improvement and then be used to secure the most important improvements first.

And you may learn that you are not the "sole quality person". Better to stop separating quality from the people doing the work.

John

melissa237,

If you are referring to the software / logistics aspect of implementing a document control system, maybe this would help:

Background - I currently work within a ISO9001 environment heading towards ISO13485. Historically my team members (of which all were let go) did an extremely poor job of maintaining a document control system with a form of change control. One of my first tasks upon coming on board was to develop an immediate remedy plan to correct this and in such develop a "band aid" solution until we implement Master Control. For a large company it is very hard to maintain but for a smaller company (< 100 procedures) it should not be any issues. This is what I did:

1) Develop a spreadsheet which has a DCR (document change record) number, date, document status, etc
2) Develop a DCR form - this acts essentially as a permission slip to write / modify / etc an SOP or document
3) Develop an SOP template

I've attached templates for each of the above for reference.

The sequence is as follows

Author of an SOP completes a DCR and submits to QA for a DCR # (Document Control template already has DCR #'s). --> QA assigns DCR number and gives back to SOP author. --> SOP author writes SOP and distributes for signatures. --> once all sign off on SOP, it comes back to QA and I finalize it in document control (as Approved). I then take the word document, convert it to a pdf and insert a hyperlink into the spreadsheet to the pdf file. The word document is stored on a secure server which only I and my manager have access to. Everyone has access to our document control - so anyone can pull up any SOP.

I print out a FINAL copy and stamp it as CONTROLLED, date and sign and keep it in the SOP binder as an official controlled version and of course if viewed electronically through document control they are considered controlled as well.

It's a simple but effective process and is approved by our most recent ISO 9001 auditor (two weeks ago was reviewed).

Hope this helps a bit - if you have any other questions feel free to reach out.

Thanks!
Mike

melissa237 said:

Hello All! I work for a very small company that is not regulated in any way, we are a garment manufacturer. I however came from a Medical Device company, so sometimes that experience gets in the way of creating a quality system for my current company. I am looking for the easiest, yet best way to implement a document control and change process. I want to make sure we are complying with the intent of ISO9001, but I also don't want to initiate any undue burden on department managers (and honestly myself as the sole quality person and by default the only Document Control person).

I should also add that I had issued a form to complete that identifies and describes the changes being made along with approval signatures and a review to see if it affects other documents and I was informed by the executives that was too much work.

Thank you in advance!
M

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Have you heard of wikis?

Not Wikipedia. Just regular wikis. They are tools that give you effortless document control, and great collaboration capability. I think your executives will be happy to learn that no forms to record changes are required, and they can decide what, if any, approvals are necessary. For a great QMS that will be useful for more than the certificate, give it a shot.

Pancho, do you know of a Document Control wiki that I could access? I think I vaguely understand the concept of a wiki, but I have never tried editing or contributing to one such as Wikipedia. If I could experience how one works,this would help "sell" me on it better, and I'd invest into learning it and using it in our company. Even just a skeleton of a wiki, with a couple "dummy" documents, would help me understand the best practices for setting up the wiki structure right, the first time.

I should mention, that was my 1st post ever! If I'm doing something wrong, please let me know!

dalecw said:

Pancho, do you know of a Document Control wiki that I could access? I think I vaguely understand the concept of a wiki, but I have never tried editing or contributing to one such as Wikipedia. If I could experience how one works,this would help "sell" me on it better, and I'd invest into learning it and using it in our company. Even just a skeleton of a wiki, with a couple "dummy" documents, would help me understand the best practices for setting up the wiki structure right, the first time.

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Hi Dalecw, welcome to posting!

To get more comfortable with wikis, try editing wikipedia or a wiki in this list. All wikis have document control: Identification, format, distribution, availability for use and change control are automatic in a wiki. Protection, preservation, retention and disposition are easily implemented with, say, regular backups.

Review and approval is the aspect of document control in a wiki to which folks often object. But it can be done in a number of ways. At my company we allow the editor of a document to self-approve, and the process owner reviews after the changed document is live. This has worked great for us for nearly 10 years and multiple 2nd and 3rd party audits for ISO 9001, 3834 and BS OSHAS 18001. Other companies implement workflows with wiki plugins or procedurally.

You also touch upon one of the toughest challenges with a QMS on a wiki: organization. Wikis tend to grow organically. As users add pages, there is no guarantee that all new info will remain accessible or unduplicated. You could easily end up like a baby eating spaghetti. Our solution was to implement a procedure for adding pages. Any time a new page is added, a link to it must also be added to its process index page. Similarly a new page must always contain ("include") its full process index page as a sidebar menu. This insures that the growing inventory of pages remains a "very small world network". The index pages are sidebar menus and every page is always only a few clicks from every other.

You can read a bit about using a wiki for quality management here:

Using a Wiki to implement a QMS - revisited
Using a Wiki for Document Control
Sample QMS Wiki Organization

Good luck!