Definition Form vs. Record - What is the Difference between a Form and a Record

Sidney Vianna

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#31
Re: What is the Difference between a Form and a Record

My point was, and is, as Randy said, "Records can Change".
Change of results or data in records should be a very rare exception. Definitely NOT the rule. Records are supposed to capture the factual data of an activity. Thus, they should not change, unless it became apparent, at a later time, that the results were mis-recorded.

If you look at this document, part of the ISO 9000 support package, you will read:
e) Records:
- Examples of records specifically required by ISO 9001:2000 are presented in Annex B.
- Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
- Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2000.
If you then look at ISO 9001, 4.2.4, you read:
4.2.4 Control of records
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 identification, storage, protection, retrieval, retention time and disposition of records.
I don't read anywhere in the Standard the need for the revision of records. Simply because it is NOT supposed to happen.
 
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Patricia Ravanello

Quite Involved in Discussions
#32
Re: What is the Difference between a Form and a Record

Sidney,
For the purposes of this discussion, please refer to my attachment above.
I think you would agree, that in order to know how to manage documents, you have to know what kind they are.

1) Do you agree that those "items" listed under Tier/Level 5 are Records?

2) If they're not Records, what are they? and Where do they belong in the documentation hierarchy. Please demonstrate on your own model if necessary.

I still contend that there are 2 kinds of Records... those Records that are "Controlled" are treated like Procedures, Work Instructions and Forms, and for them, it is necessary:
a) to approve documents for adequacy prior to issue
b) to review and update as necessary and re-approve documents
c) to ensure that changes and the current revision status of documents are identified
d) to ensure that relevant versions of applicable documents are available at points of use
e) to ensure that documents remain legible and readily identifiable
f) to ensure that documents of external origin are identified and their distribution controlled
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

And yes, these RECORDS can change.


Records that are "Uncontrolled" are treated like 4.2.4 (...identify, storage, protection, retention period....etc.)

Thanks for providing the Reference sources. I guess you can call them what you want...employees just need to know how to handle and manage them.

Patricia
 
Last edited:

michellemmm

Quest For Quality
#35
Re: What is the Difference between a Form and a Record

Hi Michellemmm,
The number of documentation tiers/levels is not in contention. I concur that that decision is left to the discretion of the organization.

Please see attachment in my last post for further clarification.

My point was, and is, as Randy said, "Records can Change".

Patricia Ravanello
Hi Patricia,

Thank you for your response.

Your classification records may be very beneficial for large organizations...I just cannot see any benefit of such system for small and medium organizations. >80% of organizations in US are classified as small.

Regarding your statement; Record can change, Sidney has covered this issue in terms of ISO. Personally during the last 28 years, I have not experienced changing records and if I see it, I consider it as red flag. I have worked in Medical manufacturing where traceability and record keeping were crucial.

I encourage everyone to perform a 5S on their archives. According to one study I saw recently (I can't recall where), each record cost around $40 per year to maintain. Many individuals keep records and rationalize their actions through "just in case" reasoning. I call it "record hoarding". Some have no idea why they are keeping certain records...Others keep ancient documents to prove past accomplishment and use them as trophies.

More emphasis should be placed on future of QMS. Simple systems are more flexible and manageable for me.

Best Regards,
Michelle
 

Patricia Ravanello

Quite Involved in Discussions
#36
Re: What is the Difference between a Form and a Record

Hi Patricia,

Thank you for your response.

Your classification records may be very beneficial for large organizations...I just cannot see any benefit of such system for small and medium organizations. >80% of organizations in US are classified as small.

Michelle...the attached Model is as applicable to an organization of 50 as to 500...as a matter of fact, it's from a company of 35 employees...numbers and tiers are irrelevant. The ISO Standard defines the types of documents required, I didn't. The number of classifications is irrelevant. What's important is that employees understand the differences.​

Regarding your statement; Record can change, Sidney has covered this issue in terms of ISO. Personally during the last 28 years, I have not experienced changing records and if I see it, I consider it as red flag. I have worked in Medical manufacturing where traceability and record keeping were crucial.

Well, here's another example: A Business Plan/an Engineering Drawing, an Org chart are all CONTROLLED RECORDs, by default (since they're not System Manual, SOPs, WIs, or Forms). They provide evidence that a mandatory process has occurred and demonstrate compliance to a requirement. They might not change in a year, or they could change 10 times...it's still a controlled record, and it should be recognized and handled as such. By the way....not all records are recorded on FORMS (in response to someone else's distinction between records and forms).​

I encourage everyone to perform a 5S on their archives. According to one study I saw recently (I can't recall where), each record cost around $40 per year to maintain. Many individuals keep records and rationalize their actions through "just in case" reasoning. I call it "record hoarding". Some have no idea why they are keeping certain records...Others keep ancient documents to prove past accomplishment and use them as trophies.

I agree.

More emphasis should be placed on future of QMS. Simple systems are more flexible and manageable for me.

Best Regards,
Michelle
Michelle, please see Red Text above for responses to specific comments.

Patricia​
 

michellemmm

Quest For Quality
#37
Re: What is the Difference between a Form and a Record

<B>
Well, here's another example: A Business Plan/an Engineering Drawing, an Org chart are all CONTROLLED RECORDs, by default (since they're not System Manual, SOPs, WIs, or Forms). They provide evidence that a mandatory process has occurred and demonstrate compliance to a requirement. They might not change in a year, or they could change 10 times...it's still a controlled record, and it should be recognized and handled as such. By the way....not all records are recorded on FORMS (in response to someone else's distinction between records and forms).​
</B>​

Patricia
Patricia,

The documents you cited, are rev sensitive and become obsolete if they are changed. But, you cannot change a rev n document and leave it at rev n. Hence xyz rev 2 is not the same as xyz rev 3. They are distinctly different.

In the case of org chart, date determines the revision level.

By the way, why would you need to archive an old copy of an org chart?
 

Patricia Ravanello

Quite Involved in Discussions
#38
Re: What is the Difference between a Form and a Record

Hi Michelle,
Of course, I agree, the previous version of a Business Plan/Org Chart is obsolete if there is a change (Controlled records are treated just like SOPs, WIs and Forms in that regard).

Whether or not they keep an old Org Chart, or SOP or Policy Statement, or for how long is up to the organization...or sometimes it is defined by their customer-specifications, as is the case with "Customer Purchase Orders" in the automotive world, or sometimes they are kept for historical reference (like Business Plans, so you can compare them from year-to-year).

Whether a document is controlled or uncontrolled, your procedure on the Control of Documents and Records should provide guidance of how they are handled (including storage, retention periods, etc).

Bottom line is...Employees need to understand what kind of document they're dealing with, and handle it according to their organization's Management Operating System.

Patricia
 
P

potdar

#39
Re: What is the Difference between a Form and a Record

Well, here's another example: A Business Plan/an Engineering Drawing, an Org chart are all CONTROLLED RECORDs, by default (since they're not System Manual, SOPs, WIs, or Forms). They provide evidence that a mandatory process has occurred and demonstrate compliance to a requirement. They might not change in a year, or they could change 10 times...it's still a controlled record, and it should be recognized and handled as such. By the way....not all records are recorded on FORMS (in response to someone else's distinction between records and forms).
I will try to answer the question you have been repeating consistently. The five levels that you have listed are not exhaustive. There will be two more catagories at least:

  • other documents
  • documents of external origin

The controlled records that you have listed shall fall in the other documents catagory.

Again your contention that anything that is not Manual / SOP / WI / Form is a not a document is not supported anywhere. :nope:

Let's agree for a moment that an engineering drawing is a record because it provides evidence that a mandatory process has occurred and demonstrates compliance to a requirement. Whats wrong with a typical WI10 rev02 then? This also should be a record. It shows that the mandatory control of documents procedure has been followed and is the proof of it. Why do you call it a document then? ISO 9001 doesn't.:confused:

Maybe you could have a sit back and a rethink.

And yes, I don't think Randy agrees to what you said (thats being presumptious). I think I was acting a trainer, to which he was replying like a typical weatherbeaten auditor who has been there, seen it.;)
 

Patricia Ravanello

Quite Involved in Discussions
#40
Re: What is the Difference between a Form and a Record

I will try to answer the question you have been repeating consistently. The five levels that you have listed are not exhaustive. There will be two more catagories at least:

  • other documents
  • documents of external origin

The controlled records that you have listed shall fall in the other documents catagory.

Again your contention that anything that is not Manual / SOP / WI / Form is a not a document is not supported anywhere. :nope:

Let's agree for a moment that an engineering drawing is a record because it provides evidence that a mandatory process has occurred and demonstrates compliance to a requirement. Whats wrong with a typical WI10 rev02 then? This also should be a record. It shows that the mandatory control of documents procedure has been followed and is the proof of it. Why do you call it a document then? ISO 9001 doesn't.:confused:

Maybe you could have a sit back and a rethink.

And yes, I don't think Randy agrees to what you said (thats being presumptious). I think I was acting a trainer, to which he was replying like a typical weatherbeaten auditor who has been there, seen it.;)
Dear Potdar,
What an interesting twist...now there are more categories of documents...that I missed!!
and no, I didn't overlook "Documents of External Origin", I just called them all
"Records" instead of "Documents"...see the attachment. Maybe this could be resolved if I changed my Tier 5 to Records, References and Documents. Again, I say, I don't care if you call them Records or Documents...it's how you manage them that's important.

So why don't you map out your Document/Record "whatever" hierarchy, and show me what you're talking about.

Frankly, I've about exhausted my time, and we're not getting anywhere.

Thanks for trying,
Patricia

P.S. -As for Randy, he probably should speak for himself.​
 
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