The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Elsmar Cove Discussion Forums Main Page
Welcome to what was The Original Cayman Cove Forums!
This thread is carried over and continued in the Current Elsmar Cove Forums

Search the Elsmar Cove!

Wooden Line
This is a "Frozen" Legacy Forum.
Most links on this page do NOT work.
Discussions since 2001 are HERE

Owl Line
The New Elsmar Cove Forums   The New Elsmar Cove Forums
  Documentation
  Controlling Level 4 Documents

Post New Topic  Post A Reply
profile | register | preferences | faq | search

UBBFriend: Email This Page to Someone! next newest topic | next oldest topic
Author Topic:   Controlling Level 4 Documents
JParrish
Lurker (<10 Posts)

Posts: 5
From:St. Marys, PA
Registered: Oct 1999

posted 30 October 1999 07:07 AM     Click Here to See the Profile for JParrish   Click Here to Email JParrish     Edit/Delete Message   Reply w/Quote
We have yet to gain control of all the forms that are used in our facility. I beleive this is something that needs to be done, but not sure how to get started. Our facility is around 600 - 700 people, and the amount of forms used could be very extensive. I am also not sure how to determine if that form directly affects quality. Where do you draw the line? Any ideas on how to control these forms and when to control them!

IP: Logged

David Guffey
Forum Contributor

Posts: 49
From:St. Joseph MI, USA
Registered: Oct 1999

posted 01 November 1999 11:33 AM     Click Here to See the Profile for David Guffey   Click Here to Email David Guffey     Edit/Delete Message   Reply w/Quote
In my experience, you definitely need to control the revision level of the FORM itself. If it's a form to be completed into a quality record, the quality record then needs to be controlled per 4.16.

The problem with controlling the blank form is that there may be so many copies out in the world available for use. If a form is revised, all those copies need to be rounded up, destroyed, and replaced. Using this method, we usually miss a few that are stashed away in somebody's desk.

To get around that most of the time, try to change forms so that previous editions could be used if necessary. Then, make sure your release documentation clearly states "previous revision may be used until depleted" or something similar. If the change is such that the world will fall apart if the old form is used, an extra effort must be undertaken to search for and find the newly obsoleted forms. You have to figure out how to do that within your own system.

One thing I doubt you want to do is get to the point of "issuing" forms. Avoid that at all costs if you can.

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 01 November 1999 01:02 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
This is a tough one. A couple of thoughts come to mind.

Don't get too analytical about which ones affect quality and which ones don't. Personnel or accounting forms may not affect product quality, but there is valid reasons to control them. It's easier to control "all" forms than make a decision. Once people know "all" forms are controlled, then they get used to whatever system you put in place.

The previous suggested about "valid until depleted" only brings to mind how many revisions back? If you pull one out of you desk that is "valid until depleted" it can be a couple versions old, not just one, so be careful.

As a possible suggestion - we established "document control areas" -(file cabinets) that were out in manufacturing areas as well as office areas. Each dept. was given the flexability of determining how to manage them - how many to have etc. Copies of blank forms were kept in these files and it was the resp. of the person who updated the form (authorized personnel who reviewed and approved) to purge the folder. Users of the forms were trained NOT to make their own copies - we used a RED "QS9000" in the corner of controlled copies - and no color copiers were available.
Some departments actually kept only 30 days worth of forms and knew on the 1st of the month the file should be empty - and they replenished it (daily use forms). In most cases the files are closer than the nearest copier, so eventually the system took hold and worked. Another method of control was to only revise on the 1st of the month if possible, and copy the 1st month's worth in a differenct color as a visual indicator. FYI -if your're thinking - were too big, too dirty etc - this was implemented in a 3200 person facility with Die cast, machining, plastic injection molding, heat treating etc.
Not sure if this helps or not...
All manual systems take training and time. People invent their own systems when the system in place doesn't work for them. Get the users of the forms involved - make sure they understand the requirements, and let them come up with what will work. Make the forms easily accessible and controlled, and they will have less reason to work around it.

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 01 November 1999 01:06 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
JP,

You may find this useful.

You are setting out to purge the system of useless documents. While a huge task, once clean, keeping it clean may even be larger. Either way, it is nice to clear the slate.

What level 3 documents need to be controlled? As stated earlier, any form that becomes a Quality Record needs to be controlled. So what other documents?

Well, any document referenced in the QM or in Level 2 documents, these should be controlled. For other documents you collect, they need to be put to the test you mentioned; what effect do they have on the system? You may want to use a Risk Analysis tool (maybe create your own), such as an FMEA, to determine the level of risk involved. Low risk, low chance that it needs to be controlled. However, this is not a fast rule. Developing an RPN uses three criteria, Severity, Occurrence, and Detection. For Risk Analysis on Forms, I believe you need to pay particular attention to the Severity and Occurrence factors. Severity deals with direct impact of the failure. The higher, the more consideration should be given. The same is true of Occurrence. Many small failures add up to a big failure in the eyes of auditors. For this reason, even if the Severity rates low, a large Occurrence would drive me towards controlling the document.

I think you will find that many forms in your system are more in tune with working documents. This should make your document control more simplified. However, it is a good idea to make sure your internal auditors routinely challenge the form classification, in either direction.

I hope this helps. Any other ideas out there?

Regards,

Kevin

IP: Logged

barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
Registered:

posted 01 November 1999 05:34 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
watch yourself...don't make a mountain out of a mole hill...is the form just used to collect data for electronic entry? don't control it..... Is it used to track efficiency just within the area? don't control it..... Local control by a supervisor can be controlled easily within the area, and not bog down the doc system..keep it simple guys....some people get carried away

IP: Logged

Sam
Forum Contributor

Posts: 244
From:
Registered: Sep 1999

posted 02 November 1999 09:00 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
I have experimented with control of forms and documents, on a small scale, at the point of use,i.e., manager,supervisor,team (cell). Each person/team would have a master list of their forms/documents, also a copy is given to the document control clerk. When changes are made the DCC reviews the master list and distributes copies as required.
This process was surprisingly effective, however I haven't implemented plant wide as of yet.

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 02 November 1999 10:07 AM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
It was amazing to me the extent people went through to keep there own "stash" of forms before we implemented the above system. Once they knew they can get their hands on what they needed, they spent the time doing their job instead of at the copier. Work benches, desks got cleaner in line with our work-place organization efforts that coincided.
While I agree with "don't make a mountain out of a mole hill" build system that can be recognized from one dept to the next. At least where I was, when employees moved from dept to dept - they knew what to look for. The majority of the forms were tied to a PCP reference. Rather than have a "master list" we had a document matrix (by department) that listed the forms and where the master was kept. The master was then the reference "or equivlent" to the master list, and you didn't have to update the list when you update the master. Level 1,2 & 3 documents used the master list.

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 02 November 1999 10:12 AM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
re Barb ..."is it used to track efficiency in the area... don't control it"

Not sure I agree here. Is that because efficiency isn't a "quality goal"? QS requires a business plan. Most business plans have efficiency goals. Could efficiency be an indicator for a quality goal....100% on-time delivery for example. It would seem that that's where you get involved in the "is it or isn't it" conversation in the original question.

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 02 November 1999 01:27 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
From my perspective, I see that data or information collected as part of an efficiency is not a controllable document. This is what I would classify as a working document. The need for the document is to compile information, but otherwise, is not subject to the document life cycle.

From the perspective of the Business Plan, and how it is stated in the governing SOP, controlling the form used to gather information as part of a Quality Record, then you might want to control the document. Here I would think that the only thing that would be controllable would be the format of the document, where data entry might be critical. This would be consistent I think with 4.5.2.a.

Back to the group...

IP: Logged

Andy Bassett
Forum Contributor

Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 06 November 1999 12:14 PM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Interesting point this.

As regards blanks or masks i find it easy to standardise or control all documents rather than just the Quality Documents. It avoids the obvious question 'what is a Quality Record then?'. This is really difficult to answer if as part of your QMS you have been telling the staff that Quality is everyones business.

Note 1- Have all your forms stored in one location on the company server ie File 'Forms' .Makes it a lot easy to change or monitor.

Note 2- Create standardised 'Base Forms' that everyone should use when creating a form. You will probably need 4, a Portrait and Landscape in Word and Excel. In the Standardise 'Base Form' is all the things that turns an ISO person on. Revisions Levels, Issue dates etc.

Whilst i am on the subject, can anyone help me by summarising in two sentences how you differentiate between element 5 Document and Data Control Control and element 16 Control of Quality Records.
I normally treat this as one subject 'Documentation'

------------------
Andy B

IP: Logged

barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
Registered:

posted 06 November 1999 02:43 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
doc and data refers to the procedures and form masters.

Records are filled in forms with the appropriate information/evidence that the procedure was followed.

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 08 November 1999 09:11 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Andy,

Interesting point that you make about which documents are part of the Quality System, especially in light of the fact that Quailty IS everyones responsibility.

Barbs summary is pretty good. I think the only thing that I would like to add is a pictoral reference, expanded on in the PDF files of the Cove.

Document and Data control relates to the Quality Program, the written plan.

Quality Records relate to the Quality System, the plan being executed by the folks within the system.

Records are generated to prove that activities are carried out in accordance with the the plan/program. Proof of effort. Also, proof of accuracy.

Regards,

Kevin

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 08 November 1999 06:56 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
So data in terms of Element 4.5, is input information, and quality records is resultant information? I debated this today.
Another wasy I was looking at it is data used for instruction....specs, or for example data from a chem. lab, while a quality record may be instructional data for a dept that needs to adjust plating tanks. Changes must be "reviewed and approved" prior to use as data. But at the end of the day, is it a quality record, data, or both?

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 08 November 1999 07:40 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
The content (fields if you will) of a form is the subject of 4.5's 'controlled document'. If you revise the 'content' (add or omit 'significant' fields) you have to go thru revision. Otherwise, use up all old forms is an option. Updating the look should not be a significant factor, but you (obviously) can go that route is a copyright or logo is an issue.

After data is taken and written on a form the form becomes a 4.16 quality record.

There is a simple document matrix here ---> /pdf_files/Doc_Matrix.pdf <--- which illustrates the concept. In the matrix you will see where there is a controlled document (a 4.5 controlled form - which is a document) on a line. I think there is the word Original in parenthesis. On the next line the same 'form' is listed but it is no longer a form but is, in fact, a 4.16 quality record. I think I made the text red and put the word Completed there in parenthesis as above.

It was a controlled form (4.5 document) and transforms (automagically with data) into a 4.16 controlled record.

The 4.5 control is control over form content (layout is actually unimportant).

IP: Logged

Roger Eastin
Forum Wizard

Posts: 345
From:Greenville, SC
Registered:

posted 09 November 1999 07:51 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
In Element 4.5, "data", as I understand it, refers to data used to make a part or perform a service. I guess you could call this "input", as Laura suggested. Examples are data used in an NC program for a lathe or data used to calculate a value used in designing a part.

IP: Logged

Kevin Mader
Forum Wizard

Posts: 575
From:Seymour, CT USA
Registered: Nov 98

posted 09 November 1999 09:00 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Laura,

To your question:

"So data in terms of Element 4.5, is input information, and quality records is resultant information?"

To expand on something Marc stated. A blank check is not a quality record. But the format of a check might be controllable to the extent that the "fields" are important to the user. For example, where do you date the check, sign the check, put a memo? Additionally, you will write checks on several occasions, to different people, and for different amounts. Still, you could probably fill out a check in the dark; signature lower right, date top right, memo lower left. Errors can occur if the check format (fields) were moved to new locations. We are creatures of habit. However, the information put into the field is not controllable.

Yet a completed, cashed check becomes a record. You performed a required task, paying a bill, and this becomes the proof of your transaction. If you have an bank error against you, you have a document to argue your point.

Here a document, with controllable fields (format), becomes a record. The same is true of many documents (level 3, forms or reports) that become quality records (level 4).

In many organizations, customer information is captured on computer screens here and there. It won't take long for a customer service associate to complain about a new computer program (different looks on the screens, new/different informational requirements). What is done in your organization to prevent against incorrect data collection? How do you ensure the accuracy of this information?

I agree with Roger in stating that your view point of 4.5 as "input information" is a good one. 4.5 relates to the program, how quality system information is effectively communicated and protected against distribution of erroneous information.

I hope this helps.

Regards,

Kevin

IP: Logged

barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
Registered:

posted 09 November 1999 06:27 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
"4.5 data " is not data that has been collected.....it is electronic media (data) used as a document would be used..... as in software that controls the process/tests and has revision levels, and the like. Also 'online " instructions and published stuff...as in technical support.....Also Electronic forms, data bases (for inputs)

The same stuff documents (hard copy?) do, only in electronic format (ergo...data)

Then 4.16 is that same form with the data( evidence) entered

[This message has been edited by barb butrym (edited 09 November 1999).]

IP: Logged

Andy Bassett
Forum Contributor

Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 12 November 1999 07:14 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
To the Group

Thanks for your help with the differences between element 4.5 and 4.16.

Although i detect some small differences between the group i can now understand the essential points.
I went back to the standard to correlate your comments, and in general i still find your advise clearer than the elements of the standard.

With this in mind i think i may have been not so far off rolling the two elements together and treating them as 1 subject 'Documentation' with my clients.

Marc i like the way you use colours to differentiate between Documentation and a Quality record in your documentation matrix, i just might steal this idea.

------------------
Andy B

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 12 November 1999 07:24 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I like that matrix as I think its a pretty fair example of Simplicity appropriate for a small company (Motorola is a bit big, for example, for this simplicity).

IP: Logged

Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 18 November 1999 03:47 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
The 'data' thing just did come up in some conversations with a client.

barb, you say:

quote:
4.5 data is not data that has been collected.....it is electronic media (data) used as a document
Ummm, well, then in 4.6.3 'Purchasing Data', only
quote:
electronic media (data)
is applicable. Is that what you're saying?

I read from 4.5.1 general:

quote:
Documents and data can be in the form of any type of media...
Now - does this tie into 4.16? Nope - it shouldn't because it's in 4.5.

Roger says:

quote:
In Element 4.5, "data", as I understand it, refers to data used to make a part or perform a service.
which I think is the 'answer'.

Now - real quickly - let's look at the CD2 draft. 5.6.6 Control of Documents. There is absolutely no mention of data. What does this tell us?

OK, folks - tear me up! But remember - be nice - I'm old and lame - I have the 'old timers' disease.

[This message has been edited by Marc Smith (edited 18 November 1999).]

IP: Logged

Laura M
Forum Contributor

Posts: 299
From:Rochester, NY US
Registered: Aug 1999

posted 18 November 1999 11:06 AM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
I agree, with Roger's quote and your summary.

Do registrar's agree? I took a lead assesor course last week and this exact discussion took place. The instructor didn't clarrify it the way we did here. He said he always believed it to be "numbers" including inspection data (which I call a quality record) In so much that you may use the data to make a decision, you may want some "approval" but that is accounted for in the inspection and quality records elements. He did say later that his colleagues have convinced him that it is more that just "numbers" but didn't separate the two, as I would, and will continue to do.

Laura

IP: Logged

All times are Eastern Standard Time (USA)

next newest topic | next oldest topic

Administrative Options: Close Topic | Archive/Move | Delete Topic
Post New Topic  Post A Reply Hop to:

Contact Us | The Elsmar Cove Home Page

Your Input Into These Forums Is Appreciated! Thanks!


Main Site Search
Y'All Come Back Now, Ya Hear?
Powered by FreeBSD!Made With A Mac!Powered by Apache!