Document and Record Matrix - A controlled document?

B

benyblanko

#1
Hi everyone, this is my first thread...

I am appointed as quality responsible in my company (CNC machining metal parts) and ''earn'' legacy of already implemented QMS. Right now I am trying to get rid of documentation (procedures, work instructions, forms,...) that is not used and to implement idea of paperless documentation as much as possible.

Anyway, we have document and record matrix which I want to combine and I found few good examples here, Thanx for that, but browsing through them I got little confused about wheather this matrix should be treated as per 4.2.3 or 4.2.4?
 
Elsmar Forum Sponsor

harry

Super Moderator
#2
Re: Document/record matrix is controlled document?

........................ Anyway, we have document and record matrix which I want to combine and I found few good examples here, Thanx for that, but browsing through them I got little confused about wheather this matrix should be treated as per 4.2.3 or 4.2.4?
Welcome to the Cove.

These are actually 'management' issues and common sense has to come in - you make that decision (it has to be rational). To me, these are 'aids' to make filing/recording/searching/monitoring of documents easier. They fall into neither 4.2.3.or 4.2.4. They are something not required by the system but serves to make life easier for those involved.
 
B

benyblanko

#3
Re: Document/record matrix is controlled document?

Thanks Harry, but I noticed also that acctually everyone that chose to use this matrix actually use them to answer to most of the standard requirements from 4.2.3 or 4.2.4 (e.g. for 4.2.4 identification, protection, retention, retreival, disposition). Those information is not then only for to make life easier, since this is I suppose the only place were this information is stored, so it is then definately a part of procedure and procedure must be controlled?
 

harry

Super Moderator
#4
Re: Document/record matrix is controlled document?

All these depends on how your system is structured and how your procedures are written. As I say, there are no hard and fast rules. You decide - if you think you need to control it, just do it (controlling doesn't really add much work).


p/s: If you do control it, be aware that some treat it as a 'live' document which will be subjected to continuous updating.
 
Last edited:

Big Jim

Super Moderator
#5
Re: Document/record matrix is controlled document?

Welcome to the Cove.

These are actually 'management' issues and common sense has to come in - you make that decision (it has to be rational). To me, these are 'aids' to make filing/recording/searching/monitoring of documents easier. They fall into neither 4.2.3.or 4.2.4. They are something not required by the system but serves to make life easier for those involved.
I disagree. It is clearly a document that should be controlled.

While on this topic, I think it is confusing to combine your master list of documents and your record matrix.
 

Randy

Super Moderator
#6
Current matrix = document (subject to change/revision)

Old matrix = record (the way it was in the past)


What's all the hub-bub? This is clearly defined in 9000:2005
 
D

DrM2u

#7
Hi everyone, this is my first thread...

I am appointed as quality responsible in my company (CNC machining metal parts) and ''earn'' legacy of already implemented QMS. Right now I am trying to get rid of documentation (procedures, work instructions, forms,...) that is not used and to implement idea of paperless documentation as much as possible.

Anyway, we have document and record matrix which I want to combine and I found few good examples here, Thanx for that, but browsing through them I got little confused about wheather this matrix should be treated as per 4.2.3 or 4.2.4?
I venture to guess that you are subscribing to the ISO 9001 standard based on what you have mentioned. Today I feel like I'm full of questions (or something else), so here are a few for your consideration:
- where in the standard are a document and/or a record matrix required?
- why do you need them?
- can you achieve easy document identification via other means?

Here is something that I have been using extensively with success:
- I name all documents and the electronic files (manual, procedures, instructions, forms) by whatever they are (i.e. Quality Manual, Internal Audit, Assembly Instruction, Inspection Form, etc)
- I use the save date as the revision date for the document and i include that as a field in the document's footer (it will update every time the document is saved)
- I organize documents in electronic forlders by category: policies, procedures, instructions, forms, records, etc
- I use the Details listing in an electronic folder to see a list of all documents or records in a folder by the last save date; I can also look at Properties for the creation date and could turn on document history record if wanted/needed
- in addition to the Record Control procedure I use a list of the records retained, minimum retention period, primary and alternate storage area/method & disposition method

This method has been working for me just fine for years. I have also experimented with html to create and improve document and record navigation & linking. Some other Cove users have successfully experimented with wiki software for their document control & distribution. Browse around and see if you find something that tickles your interest and don't be affraid to 'think outside the box'.
 
H

hoef17

#8
Hi everyone, this is my first thread...

I am appointed as quality responsible in my company (CNC machining metal parts) and ''earn'' legacy of already implemented QMS. Right now I am trying to get rid of documentation (procedures, work instructions, forms,...) that is not used and to implement idea of paperless documentation as much as possible.

Anyway, we have document and record matrix which I want to combine and I found few good examples here, Thanx for that, but browsing through them I got little confused about wheather this matrix should be treated as per 4.2.3 or 4.2.4?

In our QMS system we have a Master Document List and a Record Retention Matrix, both are controlled. Depending on how it is structured I would say combining both may be some what confusing to users of the documents.

Hope this helps.
 
J

JaneB

#9
Hi everyone, this is my first thread...

I am appointed as quality responsible in my company (CNC machining metal parts) and ''earn'' legacy of already implemented QMS. Right now I am trying to get rid of documentation (procedures, work instructions, forms,...) that is not used and to implement idea of paperless documentation as much as possible.

Anyway, we have document and record matrix which I want to combine and I found few good examples here, Thanx for that, but browsing through them I got little confused about wheather this matrix should be treated as per 4.2.3 or 4.2.4?
If you can & in spirit of reducing paper, consider getting rid of the matrix and using electronic means of control (eg, store in a controlled directory). Then the list is the folder contents.
 
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
I Engineering Drawing = Record or Document? Document Control Systems, Procedures, Forms and Templates 8
S What is the difference between record and document? Document Control Systems, Procedures, Forms and Templates 14
S Proper Record/Document Manipulation Document Control Systems, Procedures, Forms and Templates 2
T Information Gathering Documents and Document/Record Control Requirements Document Control Systems, Procedures, Forms and Templates 9
C Do Emails count as a Document/Record Document Control Systems, Procedures, Forms and Templates 6
D DMR (Device Master Record) Index as a Controlled Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
J The best way to address this Document and Record Control scenario! Document Control Systems, Procedures, Forms and Templates 9
T Stamping Original Paper Document 'Record Copy' in Red Ink - Document Control Document Control Systems, Procedures, Forms and Templates 4
C PPAP Submission - Point in Time Record or Live Document APQP and PPAP 4
K Form 42-2 for Document Initiation and Change Record - Template wanted Document Control Systems, Procedures, Forms and Templates 3
L Do Memos have to be under Version (Document or Record) Control? Document Control Systems, Procedures, Forms and Templates 17
R Definition Document vs. Record in ISO 9001 Procedure - Differences between and Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 20
GStough Approved Supplier List (ASL): Document or Record? Supplier Quality Assurance and other Supplier Issues 29
M Document Disposition - Is a Control Plan a Record or Document IATF 16949 - Automotive Quality Systems Standard 11
B Responsibilities for Record and Document Management, Development and Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D The difference between a Document and a Record? IATF 16949 - Automotive Quality Systems Standard 6
M Examples of DCR (Document Change Record) Log and Document Controlled Log Document Control Systems, Procedures, Forms and Templates 3
H Is software code a document or record or neither of the two? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
D The Difference between a Document and a Record - Training Plan Document Control Systems, Procedures, Forms and Templates 11
M Medical and Administration department Document and Record Retention policy Document Control Systems, Procedures, Forms and Templates 8
X The Difference between a Document and a Record Document Control Systems, Procedures, Forms and Templates 5
J Document / Record Archive Vendors (Suppliers) Document Control Systems, Procedures, Forms and Templates 7
J Document and Record Control - One Procedure or Two? TS 16949 Document Control Systems, Procedures, Forms and Templates 9
D Is a PFMEA (Process FMEA) a record or document? FMEA and Control Plans 10
D Documenting Revision History - Single ?Revision Record? Document Document Control Systems, Procedures, Forms and Templates 4
L LOGS - Record or Document? How to control logs? Document Control Systems, Procedures, Forms and Templates 10
R DFMEA (Design FMEA) - Document or Record? Document Control Systems, Procedures, Forms and Templates 3
E Document and record retention periods for the different OEM's Customer and Company Specific Requirements 2
M Is a Quality Plan a document or record? Document Control Systems, Procedures, Forms and Templates 7
M Is Key Performance Measure/Indicator a document or a record? Records and Data - Quality, Legal and Other Evidence 4
M Blank Form vs. Completed Form - A document or record? Records and Data - Quality, Legal and Other Evidence 11
I The Document List and Record List contain...? Records and Data - Quality, Legal and Other Evidence 3
D Document vs. Record - What's the Difference under TS 16949? Records and Data - Quality, Legal and Other Evidence 6
D Supplier Surveys - A controlled document? I say it's a Record Supplier Quality Assurance and other Supplier Issues 19
V Document vs. Report vs. Record - What are the differences? Document Control Systems, Procedures, Forms and Templates 11
R Typical Document / Record Transaction and Archive Volumes Document Control Systems, Procedures, Forms and Templates 4
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 4
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 14
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom