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

Elsmar Forum Sponsor

Patricia Ravanello

Quite Involved in Discussions
#42
Re: What is the Difference between a Form and a Record

Simple.
  1. Documents - Minimum two defined types. Manual + Procedure(s).
  2. Records



Fully agreed.
Hi Potdar,

Earlier, you stated that my 5 categories were not exhaustive, and that "there are two more categories, at least"...and then, you offer a "2-Tier Model"...I'm sorry, but I don't get it.

I've added the word "Document" to my Tier 5 Classification on the attached Model. It works for my customers, and it works for me....and yes, that's my final answer.

I fear that further rhetoric on this subject will only serve to confuse the neophytes among us. Thanks for engaging in this discussion with me.

Patricia​
 

Attachments

Jim Wynne

Staff member
Admin
#43
Re: What is the Difference between a Form and a Record

Randy is correct.

There are two types of records:

1) Controlled Records (those subject to review and revision, and usually have a Revision Level on them)
Examples:
Purchase Orders​

Organizational Chart​

Business Plan​

Communication Plan​

Training Plan​

Business Operating System Model​

Engineering Drawings​

Engineering Standards​

Material Specifications​

Bill of Materials​

Policy Statement​
2) Uncontrolled Records (those that are not subject to revision, and don't have a revision level):
Examples:
Design Review Records​

Production Part Approval​

Inspection & Test Results​

Audit Records​

Time Cards​

Non-conformance Records​

Management Review Records​

Calibration Records​

Training Records​
Sorry Randy...I'm not trying to answer for you...just supporting your perspective.

Patricia
I'm late to the party here, because I've been very busy lately and haven't had time to get involved.

A "record" (as a noun) is a written (or otherwise recorded) account of events or facts, which is preserved for as long as it might be useful (or required). Engineering drawings, purchase orders or other contracts, BOMs, etc. are not records, at least upon initial use. A PO or drawing might become a record once it's been used for its initial purpose, and in that sense should never change, unless the change is intended to correct errors in the original.

A form is a device for the controlled creation of records, and may or may not be controlled in the document system.
 

Jim Wynne

Staff member
Admin
#44
Re: What is the Difference between a Form and a Record

Your right...it's a matter of definition. I've never seen the term "instructive" as a distinguishing or required attribute/characteristic of a document...(but that's germane to this discussion...).


Call them what you will, but assuming the following, fairly typical System Documentation Hierarchy, where do the "Controlled Records" which I identified above, fit??
Level 1 - System Manual

Level 2 - Procedures

Level 3 - Work Instructions

Level 4 - Forms

Level 5 - Records (controlled & uncontrolled) and References (controlled and uncontrolled)​
...or explain/show where they fit in your system documentation hierarchy.
Patricia Ravanello
Perhaps the mistake here is a category error. In other words, we shouldn't have to assume that a typical hierarchical system is (a) all inclusive, or (b) a good idea. I've personally never seen the purpose behind tiered "systems," and this thread provides ample reason to avoid them. An engineering drawing, for example, doesn't fit in any of those five categories, and trying to shoehorn it into "Records" doesn't help anything. It seems like what you're proposing is that we must use those five categories or tiers (or something like them), so anything that doesn't naturally fit into one of them will be forced in. Why not just discourage the use of exclusive categories altogether, and encourage rational decisions?
 

Randy

Super Moderator
#45
Randy speak for himself? Novel idea.:lol:

My being weather beaten doesn't come from auditing (that's when I rest and relax). My being weather beaten comes from standing on my feet for well over 1,000 hours every year teaching this kind of stuff to hundreds of people.


Guys, you have taken something very simple and make it so complicated and so convoluted that black has become white and right is now left.

Good job:applause:
 
A

amanbhai

#46
Guys, you have taken something very simple and make it so complicated and so convoluted that black has become white and right is now left. :applause:
what does it mean? :cool:
 

Randy

Super Moderator
#47
It means "Who's on first?".

That seems to be where we're at now with forms and records.

Here are the definitions straight fron the ISO.

ISO 9000:2005, 3.7.6 record
document (3.7.2) stating results achieved or providing evidence of activities performed
NOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification (3.8.4), preventive action (3.6.4) and corrective action (3.6.5).
NOTE 2 Generally records need not be under revision control.

ISO 14001:2004, 3.20, record
document (3.4) stating results achieved or providing evidence of activities performed

ISO 17021 3.2 form
document used to record data required by the quality management system
NOTE A form becomes a record when data are entered.
 

Stijloor

Staff member
Super Moderator
#48
Randy speak for himself? Novel idea.:lol:

My being weather beaten doesn't come from auditing (that's when I rest and relax). My being weather beaten comes from standing on my feet for well over 1,000 hours every year teaching this kind of stuff to hundreds of people.


Guys, you have taken something very simple and make it so complicated and so convoluted that black has become white and right is now left.

Good job:applause:
Right on Randy!

In Dutch this is called: "Van een scheet een donderslag maken."
Translation: "Making an explosion out of a fart."

I hope I did not offend...:D

Stijloor.
 
Thread starter Similar threads Forum Replies Date
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Form and Form/Record Numbering in an Excel Spreadsheet Excel .xls Spreadsheet Templates and Tools 2
G Is it mandatory to record all processes in form 2 of AS9102 FAI report AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
x-files A form becomes a record when data is entered ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R Electronic Training Record Form (Template) Document Control Systems, Procedures, Forms and Templates 6
K Form 42-2 for Document Initiation and Change Record - Template wanted Document Control Systems, Procedures, Forms and Templates 3
D Vendor (Supplier) Audit Form as a Controlled Form and as a Record Supplier Quality Assurance and other Supplier Issues 15
R Retention of records - Original Order Form vs. Computer Entry record - ISO 13485 Records and Data - Quality, Legal and Other Evidence 12
M Blank Form vs. Completed Form - A document or record? Records and Data - Quality, Legal and Other Evidence 11
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
S Transitional Adolescent A and B - "CDRH PREMARKET REVIEW SUBMISSION COVER SHEET FORM FDA 3514" Medical Device and FDA Regulations and Standards News 1
P AS9102 Form 3 Inclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
John C. Abnet VDA 6.3 questionnaire form VDA Standards - Germany's Automotive Standards 1
K Generic preventive maintenance form wanted Document Control Systems, Procedures, Forms and Templates 2
M Is it Necessary to Use Health Canada Form when Reporting? Canada Medical Device Regulations 1
M "Issue & continuous improvement" columns in AIAG-VDA PFMEA form FMEA and Control Plans 4
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
I Form templates for software (iso9001) Document Control Systems, Procedures, Forms and Templates 0
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
D New Equipment form / template Document Control Systems, Procedures, Forms and Templates 5
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B EMPB (Erstmusterprufbericht) VDA form confusion + PSW VDA Standards - Germany's Automotive Standards 2
gunnyshore Form FDA 3500A MedWatch eSubmitter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M AS9102B Detail Part/Assembly FAI Form 1 box 13; AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M AS9102 FAI Report formats - Boxes in form 1, 2, 3 of AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C AS9145 Appendix D PPAP Approval Form APQP and PPAP 2
L Form-dependent position prevention control FMEA and Control Plans 1
Y Blank Fields on CAPA Form Document Control Systems, Procedures, Forms and Templates 21
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
M How to complete structure Analysis and Function analysis sections' columns of AIAG-VDA DFMEA form FMEA and Control Plans 0
P AS9102 Form 3 Dimension Results Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
B Documenting hardware on Form 2 of AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
Sidney Vianna Interesting Discussion Interesting article form the UNIDO Magazine - CSR: a wolf in sheep’s clothing? Sustainability, Green Initiatives and Ecology 16
R Process Specification - What is the name of this PPAP form? APQP and PPAP 15
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G I-chart form for GM GP-12 Customer and Company Specific Requirements 2
M Informational US FDA – Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples Medical Device and FDA Regulations and Standards News 0
B AS9102 COTS Form 1 vs. 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Incoming (Receiving) Inspection - General form for incoming part inspection Document Control Systems, Procedures, Forms and Templates 17
S C of C release with accompanying EASA Form 1 for EASA Part 145 EASA and JAA Aviation Standards and Requirements 0
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 4
M What are the differences between "Process Flowchart form" and "Process Flow Diagram form"? IATF 16949 - Automotive Quality Systems Standard 4
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
Ron Rompen Source needed for Spline Form gauge (GO and NOGO members) General Measurement Device and Calibration Topics 3
T NAFTA request for form with no part numbers showing Supply Chain Security Management Systems 0

Similar threads

Top Bottom