A form becomes a record when data is entered

Hi,

I have some incomprehensions about "forms", which is promoted by this statement:

--- ISO/TR 10013 - Guidelines for quality management system
documentation ---
3.2 form
document used to record data required by the quality management system
NOTE A form becomes a record when data are entered.

Click to expand...

In short, why should a filled form always become a record?

For me, a form is a mechanism for entering data that forces a user to enter the expected data in STRUCTURED manner, so the document is complete at end, resistant to free arbitrage about what the document should include or should not include, without any intentional or unintentional pretermissions.

Yes, in most cases "form becomes a record when data are entered", like when someone fills Document control form (DCF).

But, can I have a form for "Master document list", and the document "Master document list". Is MDL a record?

Now, someone will say why should I have a form for MDL at all, because its just another document to control. Better to have just the MDL document, and the structure elements (columns) of MDL to be defined in the procedure, if necessary.

The answer is because we have many different/separate places, that have same type of lists to be maintained. By defining a form, we force all the users to have unique lists. And we want the lists to be unique.



The other question is what are TEMPLATES in QMS practice? (I saw many times listed: forms, templates, logs, letters... in the same hierarchy level) Is template a kind of form, or a form is a kind of template? What is the essential difference?

In many cases we found empty forms (table like) pretty useless. For example, CEO wants to announce a new Management representative. How? In our case it's not to be expected that he himself invents 20 sentences from scratch to announce new MR. He wants a "template" where he replaces NAME and DATE. End.

Also, users always ask questions like this: "Do you have a model/pattern/sample how the report about a simulation of potential EHS accident should look like?"

That kind of document we now call "Template".

After all, we have two types of forms (feel free to comment or blame us , or suggest terminology corrections):
1. Forms - strict structure, table like, empty, used for generating records or documents.
2. Templates - more liberate structure, recommendatory text (ex, typical letters) or structure already entered (ex, for new procedure), used for generating mainly records.



Best Regards,
Vladimir Stefanovic

Re: "A form becomes a record when data are entered"

The reason why a filled form always becomes a record is that the definition of a form (see your cited standard) says that a form is used to record data required by the QMS. Everything else would be a template or such. It is not the strictness of the format that makes the difference but the type of data that is affected...

Best,

TWA

Re: "A form becomes a record when data are entered"

TWA said:

The reason why a filled form always becomes a record is that the definition of a form (see your cited standard) says that a form is used to record data required by the QMS. Everything else would be a template or such. It is not the strictness of the format that makes the difference but the type of data that is affected...

Best,

TWA

Click to expand...

A filled-out form might be only a temporary medium; the information recorded on the form may be transferred to another medium after which the form might be discarded.

There are no hard-and-fast rules for defining "form" and "template." As TWA suggests, if a "template" is used to record data required by the QMS, it becomes a record at least temporarily.

Re: "A form becomes a record when data are entered"

TWA said:

The reason why a filled form always becomes a record is that the definition of a form (see your cited standard) says that a form is used to record data required by the QMS. Everything else would be a template or such. It is not the strictness of the format that makes the difference but the type of data that is affected...

Best,

TWA

Click to expand...

Now my poor knowlenge of English language comes in foreground:
"document used to record data required by the quality management system".

Can it be that the word record has wider context than record as objective evidence? This is something we internaly had many discussions about.

For example, we have:
1. list of all devices that has to be calibrated, target dates, etc... (ie, its a kind of plan, and plan is a document, not record)
2. list, with noted all calibrations per single device (separate list for every item in list 1)

The second list is just a list, not an objective evidence. When we say in that list "Calibrated on dd.mm.yyyy." that still is not an objective evidence. The evidence is an integral document of calibration company, we are required to show the Auditor. The list 2 has the reference to that integral document, ie, where is it.

We have FORMS for list 1 and list 2, and neither we consider as record when filled so far.



Best Regards,
Vladimir Stefanovic

x-files said:

Hi,

I have some incomprehensions about "forms", which is promoted by this statement:



In short, why should a filled form always become a record?

For me, a form is a mechanism for entering data that forces a user to enter the expected data in STRUCTURED manner, so the document is complete at end, resistant to free arbitrage about what the document should include or should not include, without any intentional or unintentional pretermissions.

Yes, in most cases "form becomes a record when data are entered", like when someone fills Document control form (DCF).

But, can I have a form for "Master document list", and the document "Master document list". Is MDL a record?

Now, someone will say why should I have a form for MDL at all, because its just another document to control. Better to have just the MDL document, and the structure elements (columns) of MDL to be defined in the procedure, if necessary.

The answer is because we have many different/separate places, that have same type of lists to be maintained. By defining a form, we force all the users to have unique lists. And we want the lists to be unique.



The other question is what are TEMPLATES in QMS practice? (I saw many times listed: forms, templates, logs, letters... in the same hierarchy level) Is template a kind of form, or a form is a kind of template? What is the essential difference?

In many cases we found empty forms (table like) pretty useless. For example, CEO wants to announce a new Management representative. How? In our case it's not to be expected that he himself invents 20 sentences from scratch to announce new MR. He wants a "template" where he replaces NAME and DATE. End.

Also, users always ask questions like this: "Do you have a model/pattern/sample how the report about a simulation of potential EHS accident should look like?"

That kind of document we now call "Template".

After all, we have two types of forms (feel free to comment or blame us , or suggest terminology corrections):
1. Forms - strict structure, table like, empty, used for generating records or documents.
2. Templates - more liberate structure, recommendatory text (ex, typical letters) or structure already entered (ex, for new procedure), used for generating mainly records.



Best Regards,
Vladimir Stefanovic

Click to expand...

My take: A form is used to record the results of an activity. Once that has been done, it can be called a record.

A template is used for many things; for example, we have a template for work instructions which ensures that all the required elements are in place and that each WI has a similar identifying look.

Whatever works, not worth all this trouble IMO.

Re: "A form becomes a record when data are entered"

x-files,

english is not my native tongue either, however I still understand "record" as some kind of written documentation in the sense of objective evidence. Now if you have a list based on a form like in your examples then one could argue that these are still records as they document how you fulfilled the requirement of your QMS to have such a list. If your QMS tells you that this list must be always kept current then it becomes a controlled document, but in that case each previous, now invalid, revision would be a record to show how you meet your requirements of doc control...
Sorry if that now becomes a little bit philosophical.

Best,

TWA

Maybe only Jim Wynne will appreciate the irony of a guy [me] who spent hundreds of dollars for a complete set of the Oxford English Dictionary in the past who is now resorting to a quick google lookup of the entymology of "record."

record (v.) c.1200, "to repeat, reiterate, recite; rehearse, get by heart," from Old French recorder "tell, relate, repeat, recite, report, make known" (12c.) and directly from Latin recordari "remember, call to mind, think over, be mindful of," from re- "restore" (see re-) + cor (genitive cordis) "heart" (as the metaphoric seat of memory, cf. learn by heart); see heart.

Meaning "set down in writing" first attested mid-14c.; that of "put sound or pictures on disks, tape, etc." is from 1892. Related: Recorded; recording.record (n.) c.1300, "testimony committed to writing," from Old French record "memory, statement, report," from recorder "to record" (see record (v.)). Meaning "written account of some event" is from late 14c. Meaning "disk on which sounds or images have been recorded" is first attested 1878. That of "best or highest recorded achievement in sports, etc." is from 1883. Phrase on the record is from 1900; adverbial phrase off the record "confidentially" is attested from 1906. Record-player attested from 1919.
For my own part:
I think most people might agree that a "form" and a "template" might be considered interchangeable when it comes to using some sort of structure to assure sufficient data is considered and entered to form a record. Certainly "form letter" and "template" have been interchangeable in many offices since back in the 1960's when my firm bought its first "statistical typewriter" which used key punch cards to automagically enter boilerplate on a contract, then allowing specifics of a clause to be typed in by hand, then inserting another card for more boilerplate, and so on, until the contract was complete.

In the early 70's we invested $10,000 in another statistical typewriter, which used magnetic strips on cards instead of keypunched cards. It allowed us to create our own cards on the same typewriter instead of having a separate key punch machine.

Thus, instead of having a platoon of typists or a stockroom full of pre-printed forms, we had one typist for each shift (a lot was done on the graveyard shift), a skid of blank paper, and a crate of cards with magnetic strips which were filed once data was entered on the strips and retrieved when necessary to type a similar contract.

That one machine replaced four different machines and ten typists!

Re: "A form becomes a record when data are entered"

TWA said:

x-files,

english is not my native tongue either, however I still understand "record" as some kind of written documentation in the sense of objective evidence. Now if you have a list based on a form like in your examples then one could argue that these are still records as they document how you fulfilled the requirement of your QMS to have such a list. If your QMS tells you that this list must be always kept current then it becomes a controlled document, but in that case each previous, now invalid, revision would be a record to show how you meet your requirements of doc control...
Sorry if that now becomes a little bit philosophical.

Best,

TWA

Click to expand...

Sometimes the record is of "subjective" observation, not always "objective." Eyewitnesses to an event often have varying versions of the same event, depending on their point of view and their own previous knowledge. Thus, some might report "flying saucers" and others, seeing the same thing, describe "weather balloons" caught in a jet stream tens of thousands of feet up in the air. Both observations go into the record.

Wes,

you're right that the content of a record may not be objective. But even then it shows as objective evidence that something happened, e.g. that an incoming inspection had been performed (though the measured values were wrong) or a concept test was done even though the important things unfortunately were overlooked. I have always found that having such documentation is very helpful in an audit even if the content may be debated or is obviously wrong.

Best,

TWA