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Author Topic:   Data control
warshe
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posted 13 April 2001 03:35 AM     Click Here to See the Profile for warshe   Click Here to Email warshe     Edit/Delete Message   Reply w/Quote
What can one understand under the term „dataš in ISO 9001:1994 ? I looked through the ISO dictionary and some books and could not get the answer. Please help me with the term „dataš and give your ideas concerning the procedure of „documentation and data controlš. Thank your for your help.

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Roger Eastin
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posted 13 April 2001 08:16 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
This has been discussed in this forum before, so you might want to try a search on this topic. In short, "data" refers to programming information used to run machines (NC machines, for example). You have to have a system for controlling this data, since it could impact the quality of your product. Some different methods have been discussed before, hence the recommendation to do a search.

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warshe
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posted 13 April 2001 12:17 PM     Click Here to See the Profile for warshe   Click Here to Email warshe     Edit/Delete Message   Reply w/Quote
Would you be so kind to give the refference to topic. I could not find one. Please, give a help.
In the book from Ronald A.Radice „ISO 9001š page 151 has been given the following explanation of „dataš-
„Note that the standard suggests that „dataš are also subject to this 4.5.2. clause. The standard does not specify which data. However, it can be assumed to mean either data within a subject document or data to which a subject document refersš.
I understood Radice‚s explanation of „dataš that way- contract, for example, is considered as a document and all the terms which are contained in the contract - time of delivery, requirements to product, terms of payment are data. Is my intepritation of term „dataš right ? Please give your thoughts.

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Al Dyer
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posted 13 April 2001 12:44 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
Listen to Roger,

Data relates to electronic media.

CNC programs
SPC programs
Gage programs

The best example is from Roger, CNC programming. How do you control the electronic programs that tell the process how to function?

Documents are documents. When you think data, think computers and electronics.

ASD...

[This message has been edited by Al Dyer (edited 13 April 2001).]

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energy
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posted 13 April 2001 01:37 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Al,
Another good example is the storing of procedures, forms, records and instructions on a company's intranet system. This "data" is to be backed up periodically and access controlled. At first when I read Roger's and your response to WARSHE, I was ready to reply "Bu..Sh..". After researching several reference libraries, I noticed that any type of electronic records are referred to as "data". So I also learned the difference, as it is understood to mean today. I'm not too sure if that is what it meant when the term Document Control was changed to Document and Data Control in the 1994 Standard. WARSHE, if you can't fight them, join them. I have.
energy

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warshe
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posted 13 April 2001 03:06 PM     Click Here to See the Profile for warshe   Click Here to Email warshe     Edit/Delete Message   Reply w/Quote
Sorry, I do not know what mean CNC programs, SPC programs, Gage programs. Please, explain me these abbreviations.
The only program which I use is SCALA, which deals with stocks control (Warehousing Department) and finances (Finance Department). By using of our SCALA we can obtain the information about item stock price and about the items which are at the moment available in our stocks. Is this program, I mean our SCALA, should be covered by requirements of 4.5. element about data control ? Please, give me the example of proper documents and data control. Or may be there are references to the topics in this Forum where the discussion of this matter yet took place. Please give the reference.

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Al Dyer
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posted 13 April 2001 04:21 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
CNC: Computer Numerical Control (paraphrased)

SPC: Statistical Process Control

Gage Program: An electronic (computer) program to collect data on gage performance and trends.

How do you control the revision level, content, accuracy etc... of your "SCALA" computer program?

I've never heard of it but it falls under the same umbrella of data control.

ASD...

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Al Dyer
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posted 13 April 2001 04:27 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
Energy,

Right on track, thanks for looking at the reference libraries before giving me the big one! It's been a rough week.

ASD...

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warshe
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posted 14 April 2001 07:13 AM     Click Here to See the Profile for warshe   Click Here to Email warshe     Edit/Delete Message   Reply w/Quote
I can not describe the functions of our program SKALA in details. The only thing I know is that a operator of Warehousing Department enters the information about the incoming item (for example, metal tube)-price, short description, quantity in SKALA, and the member of supply Department can obtain the information about the current stocks by means of opportunities of SKALA.
Please, give me the example of proper documents and data control or the reference to the topic in Forum. I will be very obliged for your help.

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Al Dyer
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posted 14 April 2001 02:44 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
Anybody else want to take a shot, I'm out of ideas! I think I'm on the right course but not getting my thoughts across.

ASD...

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Marc Smith
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posted 14 April 2001 07:22 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I've moved this to this forum as I an closing the 1994 forum to new entries. We're moving on.

In so far as the topic of data goes, it's the same in both standards.

->The only thing I know is that a operator of Warehousing
->Department enters the information about the incoming item
->(for example, metal tube)-price, short description,
->quantity in SKALA, and the member of supply Department can
->obtain the information about the current stocks by means
->of opportunities of SKALA.
->I can not describe the functions of our program SKALA in
->details.

I think everyone has tried to respond as closely as they can without having more details.

Go to your IS people and ask them how they control the SCALA program and the data it accumulates. Both the program and the data it accumulates must be controlled.

**However - There is a definite question as to whether this actually falls under ISO requirements if you are only looking at number of items in stock or other 'non-quality related' aspects of your systems.

This said, if you use the system to account for any customer related product, it is definitely a 'quality' related issue (4.7 in the old standard and 7.5.4 of the new standard).

If you are already ISO registered (I assume you are because you cited the 1994 standard) you should be looking at what you have defined as quality records and controlled documents. In the largest sense, data is many things, including those cited above. But also, consider the following from the 1994 standard:
*****************
4.6.3 Purchasing data

Purchasing documents shall contain data clearly describing the product ordered, including where applicable:

a) the type, class, grade or other precise identification;
******************

So - in this case, data is what is input into the purchase order or other purchasing document. Now consider this:

************
4.10.4 Final inspection and testing
....No product shall be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.
**************

When I think of data, I think of a form or database where you are entering data. Data is typically variables. It can be a computer program or it can be inspection results. Even a pass/fail can be data. A test report can be considered data.

Consider:

*****************
4.11 Control of inspection, measuring and test equipment

4.11.1 General
.....Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.
******************
And:
*****************
4.16 Control of quality records
....Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor shall be an element of these data.
*******************

The 2000 version of 9K says:

********************
8.4 Analysis of Data
The company shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

a) Customer satisfaction (see 8.2.1),
b) Conformity to product requirements (see 7.2.1),
c) Characteristics and trends of processes and products including opportunities for preventive action, and
d) Suppliers.

******************

If you look at 9K as a whole, and look where the word data is used, you should be able to look at your system and decide what is appropriate.

That said, consider:

quote:
Originally posted by Al Dyer:

Listen to Roger,
Data relates to electronic media.
1. CNC programs
2. SPC programs
3. Gage programs
The best example is from Roger, CNC programming. How do you control the electronic programs that tell the process how to function?

Documents are documents. When you think data, think computers and electronics.


Well, yes, sorta. QS pressed this I believe. It is common now for data to 'include' electronic files in a broad sense.

Roger said:

->"data" refers to programming information used to run
->machines (NC machines, for example).

This correlates with my interpretation in that these are all variables.

The thing to watch is what you look at in the sense of what is a document and what is a record.

1. A purchase order (which eventually contains data) is first a form. Even computer screens have controlled 'forms' such as database front ends. These forms are controllable as documents under 4.5 (now 4.2.3).

2. Then, when you enter data it becomes a 'quality record' controllable in accordance with the old 4.16 (now 4.2.4).

Roger and Al used control software (such as a CNC program) which you control as a document would be controlled - it is revision sensitive. Al specifically cited programs.

CNC data - input into the CNC machine is an input (as opposed to 'process' software such as an SPC program which processes data). It is variable data but I would not call it a record. We want to be sure we distinguish the CNC program (call it data or call it the input Ų some folks call the input into a CNC the őprogram whilst some call it data {either way they‚re variables}) from the CNC machine‚s interpreter.

Data taken to be analyzed in an SPC program is a process output and it is data. This data input into the SPC program is typically a 'quality record' and the data output from the SPC program is arguably also a quality record and data.

Let's look at an SPC program closer. Probably it is canned (many companies do not develop their own in-house SPC program) so you have very little control with the exception of the yearly upgrade that software companies depend upon. Whoever installs and maintains the software are typically responsible for the control aspect. You can verify output, technically, although with canned software this is a questionable issue - usually the company which wrote the software verifies the accuracy and 'correctness' of the software output.

If you develop your SPC program in-house it's output has to be verified AND the program has to be controlled like you would a procedure - history and revision control. BUT - the output of the SPC program is data - again, a 'quality record'.

So data can be many things. As I said, of more importance is how you classify something which is the determining factor of what you have to do to control it.

As a procedure or as a record.

[This message has been edited by Marc Smith (edited 14 April 2001).]

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rrramirez
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posted 17 April 2001 10:25 AM     Click Here to See the Profile for rrramirez   Click Here to Email rrramirez     Edit/Delete Message   Reply w/Quote
Since 1996 I used as a reference for the word "data" in the ISO 9001:1994 standard the criteria or definition of the ASQ Chemical and Process Industrie Division (ISO 9000 Guidelines for Chemical and Process Industries):
The word "data" has been added and refers to numerical information such product specification, formulation, process setting, data base, or product schedule

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CarolX
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posted 17 April 2001 10:47 AM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
My 2 cents worth -

I have always considered data to mean information contained in a record or file. And anything related to product quality fall under document and data control.

We cover control of the job file system under our engineering procedures. Our job file system is computerized, and a lot of the information does not relate to product quality, BUT....because some of it does, we addressed the whole system in our procedures, i.e. access control, back up procedure, etc. This was much easier than trying to break out those parts that did not apply.

CarolX

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energy
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posted 17 April 2001 12:55 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by energy:
Al,
I'm not too sure if that is what it meant when the term Document Control was changed to Document and Data Control in the 1994 Standard. WARSHE, if you can't fight them, join them. I have.
energy

Well, that's what I get for capitulating.

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rrramirez
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posted 17 April 2001 04:13 PM     Click Here to See the Profile for rrramirez   Click Here to Email rrramirez     Edit/Delete Message   Reply w/Quote
Let me repeat what i wrote in one of my training in the Juran Institute in 1986 regarding "data":

INFORMATION COLLECTED ABOUT PRODUCT, SERVICE, PROCESS, PERSON, OR MACHINE IS CALLED DATA. fOR EXEMPLE, IF WE COLLECT DATA ABOUT WEIGHT OF PARTICULAR GRADE OF PAPER, WE CAN MONITOR AND UNDERSTAND THE PRODUCTION PROCESS..so what we (or i) could understand as data is not only related with IS. Data could be any kind of information registered as a consequence of fact (or observation)that can be used for action.
In my understanding, an specification on a document (recorded,described or written) of a product or service is "data".
The word data has existed since 1860 when the quincux was invented.

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Al Dyer
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posted 17 April 2001 05:27 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
I guess it boils down to how the terms are defined in your system documentation. We have choosen to seperate the two terms and define how each is controlled.

ASD...

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James Gutherson
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posted 17 April 2001 08:39 PM     Click Here to See the Profile for James Gutherson   Click Here to Email James Gutherson     Edit/Delete Message   Reply w/Quote
I have to agree with rramirez, data is not particually electronic but is the information contained in your records (we had data a long time before computers were designed to analyse and perform calculations on data).

With warshe's problem, we are not talking about controlling the SCALA program itself (that can always be reinstalled) but the information (data) about your products you have entered into SCALA. This is what needs to be contolled. Don't worry about whether it is 'Quality related' or not, ask yourself "Do we need to be sure this information is accurate and retriveable?" If it is, it needs to be contolled somehow.
You are probably already doing it by some means, have a look at how and ask whether you can make any improvements.

Sorry about the spelling, I'm very tired.

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Al Dyer
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posted 17 April 2001 11:08 PM     Click Here to See the Profile for Al Dyer   Click Here to Email Al Dyer     Edit/Delete Message   Reply w/Quote
I have been reading many comments about data being the evidence of a process. Under ISO-9000:1994, element 4.5, section 4.5.3 there is the following statement:

"Changes to documents and (not and/or) shall be reviewed and approved........."

1: I can see documents being revised and changed as appropriate.

2: If data is evidence of a process output does that mean we can change the data/evidence as long as the original approving functions/organizations approve the change?

(I want to change the data so we have a Cpk of 2 instead of 1.67?)

I guess that SPC data gathered as data/evidence of process control can be changed at our whim?

Let's use common sense and define the terms to meet business practices.

ASD...

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Marc Smith
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posted 18 April 2001 12:17 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I think we've reached the absurd to ask if there might be a case where altering data or selecting only 'acceptable' data from a process is acceptable. That's simply silly and in most cases it is outright fraud.

At this point I think you folks are going far beyond the requirement in this discussion. If you do a search through ISO 9001:2000 you find the word data only in 8.4. The clause is in my reply above and I believe it is very evident from the clause what data means with respect to ISOI 9001 (NOT neccessarily what it means in QS-9000, but then QS-9000 is a bastard document anyway).

Many folks are reading too much into what constitutes data in my opinion. If the word data was used in many clauses in the standard I could better understand the confusion, but it no longer is.

To relate data control to document control is far off the mark. You control data but not in the sense of how you control a procedure. Control of data is more of a requirement to have a system where data is collected, filed and analyzed. In addition, you have to state how long you're gonna keep it, you have to make sure it stays 'legible', etc. There is no implication that data is revision sensitive as a procedure is, or that there will be a change in data.

For one last aspect, let's look at 4.2.4:

->4.2.4 Control of Records
-> NOTE: There are no new
->requirements for Control of Records from the 1994 version.
->Also see: 4.2.1e, 5.6.1
->
->Records shall be established and maintained to provide
->evidence of conformity to requirements and of the
->effective operation of the quality management system.
->Records shall remain legible, readily identifiable and
->retrievable. A documented procedure shall be established
->to define the controls needed for the (1) identification,
->(2) storage, (3) protection, (4) retrieval, (5) retention
->time and (6) disposition of records.

They're talking about data here. Records can be data. They are not necessarily all numerical data, but data none the less. I do not agree with rrramirez whose definition limits data to numerical data, but that is a typicaly and generally accepted definition, I believe.

And what data (records) are required?

5.6.1 -- Management review minutes / etc.
6.2.2 (e) -- Education, training, skills and experience. (Text or numerical?)
7.1 (d) -- Evidence that the realization processes and resulting product fulfill requirements. (Numerical?)
7.2.2 -- Results of the review of requirements relating to the product and actions arising from the review. (Text?)
7.3.2 -- Design and development inputs. (Text and numerical?)
7.3.4 -- Results of design and development reviews and any necessary actions. (Text and numerical?)
7.3.5 -- Results of design and development verification and any necessary actions. (Text and numerical?)
7.3.6 -- Results of design and development validation and any necessary actions. (Text and numerical?)
7.3.7 -- Results of the review of design and development changes and any necessary actions. (Text and numerical?)
7.4.1 -- Results of supplier evaluations and actions arising from the evaluations. (Text and numerical?)
7.5.2 (d) -- As required by the company to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement. (Numerical?)
7.5.3 -- The unique identification of the product, where traceability is a requirement. (Text?)
7.5.4 -- Customer property that is lost, damaged or otherwise found to be unsuitable for use. (Text?)
7.6 (a) -- Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist. (Text?)
7.6 -- Validity of previous results when measuring equipment is found not to conform with its requirements. (Numerical?)
7.6 -- Results of calibration and verification of measuring equipment (Numerical?)
8.2.2 -- Internal audit results.
8.2.4 -- Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product. (Numerical?)
8.3 -- Nature of the product nonconformities and any subsequent actions taken, including concessions obtained. (Text and numerical?)
8.5.2 -- Results of corrective actions. (Text and numerical?)
8.5.3 -- Results of preventive actions. (Text and numerical?)

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