posted 13 April 2001 12:44 PM               

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...

posted 13 April 2001 04:21 PM               

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.

posted 13 April 2001 04:27 PM               

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

posted 14 April 2001 07:22 PM               

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.

---

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 ö some folks call the input into a CNC the Îprogram whilst some call it data {either way theyâre variables}) from the CNC machineâs 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.

posted 17 April 2001 10:47 AM               

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.

posted 17 April 2001 12:55 PM               

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

---

posted 17 April 2001 08:39 PM               

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.

posted 17 April 2001 11:08 PM               

"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.

posted 18 April 2001 12:17 AM               

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?