Forms vs Records

[rogerpenna]

One question we always struggled in the company is the difference between forms and records.

• Form Template: This is a document that is revised and version-controlled. For example, FQP-ADM-001.
• Record Type Document: This document tells us how records of a certain type should be handled, stored, retained, and scrapped. We code this document as RQP-ADM-001.
• Individual Records: When a form template (FQP-ADM-001) is filled out, it generates individual records. Do you code these records sequentially as RQP-ADM-001-0001, RQP-ADM-001-0002, RQP-ADM-001-0003, etc?

My main questions are:

1. Common Practices: Is it standard practice to have a single document (RQP-ADM-001) that describes the management of all records of this type, and then have individual records (RQP-ADM-001-0001, 0002, 0003, etc.) based on this template?
2. Identification of Records: How do companies typically manage the identification of individual records? Are numbers pre-assigned, or does a system automatically generate them?
3. Paper Form Handling: On paper, how do employees know which sequential number to assign to each new record when filling out a form?
4. Multiple Codes on Records: Should the printed record include both the form template code and revision (e.g., FQP-ADM-001 Rev 2.0) and the individual record code (e.g., RQP-ADM-001-0001)? If so, how is this typically formatted to avoid confusion?
5. External Records: How do companies manage records generated outside the company that don’t come with unique codes and numbers? What are the best practices for integrating these external records into the internal system?
6. Computer Records and Forms: Does your company have specific Record Type Documents that describe the management of computer-generated records and forms? How are these handled differently from paper records?

Any insights, examples, or best practices your company follows would be greatly appreciated.





ps: as we move more and more from paper to digital, all of these questions, except for 6, maybe lose meaning or relevance... but some paper forms and records still persist.

 

[Bev D]

OMG.

I will answer only one question: records do not need their own number. The date of when the form was filled out to become a record is the only ID you need. (And perhaps what product sku, number or serial number is involved depending on the type of thing you are recording. You are way overthinking this…forms become records when they are filled out. There should be no question or debate about this.

Think about driver licenses, marriage licenses even your ISO certification. These are records.

 

[rogerpenna]

Yes, that's basically how we deal with them. I only was curious if anyone would create specific numbers for the records. I read an article but I thought it was way overkill and bureaucratic.

forms become records when they are filled out

Yeah, that I get. My question was how other companies deal with this errr... "transformation", since the form has a document code and in theory, the record it becomes has another code.

 

[Tidge]

Yeah, that I get. My question was how other companies deal with this errr... "transformation", since the form has a document code and in theory, the record it becomes has another code.

(Blank) "Forms" are typically subject to a document lifecycle... depending on the authority. Think of the difference between an income tax form and a baseball scoresheet.... The blank tax form almost certainly is "revision controlled" whereas the blank scoresheet is probably not.

"Records" do NOT have a document lifecycle. What they are a record of should be self-evident. There may be requirements around the storage and handling of records, depending again on the authority.

 

[rogerpenna]

(Blank) "Forms" are typically subject to a document lifecycle... depending on the authority. Think of the difference between an income tax form and a baseball scoresheet.... The blank tax form almost certainly is "revision controlled" whereas the blank scoresheet is probably not.

"Records" do NOT have a document lifecycle. What they are a record of should be self-evident. There may be requirements around the storage and handling of records, depending again on the authority.

I get that Tidge. So I guess I am not explaining my self well. English is not my first language, so I always assume it's my fault.

ISO 9001:2008 separated more specifically the question of documents and records

1. Control of Records (Clause 4.2.4)​

• Identification: Records must be clearly identified to ensure their traceability.
• Storage: Records must be stored in a manner that ensures they are easily retrievable and protected from damage, deterioration, or loss.
• Protection: Records must be protected to prevent damage and ensure they remain legible, readily identifiable, and retrievable.
• Retention: Records must be retained for a specified period as required by the organization or regulatory authorities.
• Disposition: Records must be disposed of in a manner that ensures confidentiality and complies with legal and regulatory requirements.

​

So, records must be properly identified. If not individually, by the group of records. For example, Management Review records may have the code REC-QMS-001 for the group of records of management review. Individually, each management review has a date and maybe a number so that's enough.

But again, the RECORDS of management review are REC-QMS-001. While if you use a template for the Management Review Meeting Minute, you may call that template something else (let's say FORM-QMS-001.)
So in Management Review template has the code FORM-QMS-001. But after the meeting minute has been finalized and filled with info of the review, it becomes a record REC-QMS-001.
That's what I am asking. You guys use both codes in the same page, one identifying the form and the other identifying the record type?

 

[Bev D]

No one that I know uses codes for individual RECORDS. Only the form itself. As I said the record is uniquely identified by the date record type name, product sku/name, lot or batch number or serial number etc. it is the data itself that uniquely identifies a record.

Using codes for records will rapidly become complex and confusing (as the code number will have no meaning other than sequence). It is not necessary.

 

[rogerpenna]

No one that I know uses codes for individual RECORDS. Only the form itself. As I said the record is uniquely identified by the date record type name, product sku/name, lot or batch number or serial number etc. it is the data itself that uniquely identifies a record.

Using codes for records will rapidly become complex and confusing (as the code number will have no meaning other than sequence). It is not necessary.

Bev D, I am not talking about individual records. I am talking about groups of records.

So in Management Review template has the code FORM-QMS-001. But after the meeting minute has been finalized and filled with info of the review, it becomes a record REC-QMS-001

Notice in my quote above I am telling all Management Reviews become record type REC-QMS-001. REC-QMS-002 would not be the 2nd management review, but something entirely different, like maybe Calibration Records, whatever.
Even if you do not give it a code, it's still a Management Review Record (identified by name alone, no code), based on a Management Review template FORM-QMS-001

 

[Bev D]

Sorry - records shouldn’t get codes. I don’t understand why you think this is necessarry or helpful. Are you thinking about ‘storage’ locations? Sure records of management review are management review and records of calibration are calibration records and records of inspection are inspection records but so what? What are you trying to accomplish? We do it understand what you are really asking…because - and I will repeat this again - no one uses codes for records…

Perhaps it is helpful if you remember that since the ‘record’ is a filled out form the controlling grouping is by the code number for the form…this is the typical way of doing it…

Also, most forms have their ‘code’ on them, so when you fill it out and it becomes a record the record has the form code on it…so what exactly are you trying to accomplish with a seperate unique record code???

 

[Randy]

1st - do it any way you want, just be consistent and maintain control, it's nobodies business but yours.

2nd - a blank piece of paper or a blank screen can constitute a "Form", once you put a "." on it, it becomes a record.

 

[rogerpenna]

Sorry - records shouldn’t get codes. I don’t understand why you think this is necessarry or helpful. Are you thinking about ‘storage’ locations? Sure records of management review are management review and records of calibration are calibration records and records of inspection are inspection records but so what? What are you trying to accomplish? We do it understand what you are really asking…because - and I will repeat this again - no one uses codes for records…

Perhaps it is helpful if you remember that since the ‘record’ is a filled out form the controlling grouping is by the code number for the form…this is the typical way of doing it…

Also, most forms have their ‘code’ on them, so when you fill it out and it becomes a record the record has the form code on it…so what exactly are you trying to accomplish with a seperate unique record code???

This makes sense... but how did you guys were compliant with ISO 9001:2008... I am probably mixing the requirements themselves with some practices, usually from software.

But it was very common for companies to have Master List of Documents and Master List of Records.
The Master List of Records usually specified

• Identification: Records must be clearly identified to ensure their traceability.
• Storage: Records must be stored in a manner that ensures they are easily retrievable and protected from damage, deterioration, or loss.
• Protection: Records must be protected to prevent damage and ensure they remain legible, readily identifiable, and retrievable.
• Retention: Records must be retained for a specified period as required by the organization or regulatory authorities.
• Disposition: Records must be disposed of in a manner that ensures confidentiality and complies with legal and regulatory requirements

These questions I am asking is because of the inherited system based on a Master List of Records. That control was done in Excel and from 2009 onwards in a QMS software where we should tell if the "document" was a Document or a Record.

If it was a record, it had fields for code, to telling how it was stored, protected, reten...ted? and disposed.

So I am not saying my way is right or even best. Quite the contrary, I would love ideas to simplify it.

I am giving the history on my company for you guys to understand where my logic for it is coming from.

In the software, we created a code for each Record type, as well as info where that record was stored, how long it should be kept, etc.
AND the list of Records in the software had a code while at the same time we also had folder with FORMS, which are controlled documents, and we would reference the form in the record.
I suppose we still need a document telling how to deal with how records are identified, stored, protected, etc? Just a general document? How is it done if you guys don´t have a master list?