Removal of Obsolete copies of Controlled Documents

P

pinnochio

#1
I have a very simple question but I just want to get some different ideas.

How do you ensure that all obsolete versions of a document are destroyed to prevent their use inadvertently?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Copies of controlled documents

I have a very simple question but I just want to get some different ideas.

How do you ensure that all obsolete versions of a document are destroyed to prevent their use inadvertently?
Don't print/copy them.

Stijloor.
 
R
#3
Re: Copies of controlled documents

I have a very simple question but I just want to get some different ideas.

How do you ensure that all obsolete versions of a document are destroyed to prevent their use inadvertently?
Track their distribution.:cool:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
More information is needed, but I assume you are referring to paper documents. Correct?
 

Jim Wynne

Staff member
Admin
#5
I have a very simple question but I just want to get some different ideas.

How do you ensure that all obsolete versions of a document are destroyed to prevent their use inadvertently?
The title of your post alludes to "controlled documents." If the documents in question are controlled you will know to whom copies were issued, and you should be able to retrieve them when new versions are issued. Verifying locations of controlled documents should be included in your internal audit process.
 
R

Roland Cooke

#6
I have a very simple question but I just want to get some different ideas.

How do you ensure that all obsolete versions of a document are destroyed to prevent their use inadvertently?

Destroying all obsolete versions of a document within the timeframe you are legally obliged to retain them (e.g. 5 years for manufacturing procedures under the MDD) would be a bad move....

Destroying all copies, whilst retaining the master original in a secure, traceable location, would be a good move....
 
M

MIREGMGR

#7
Back in the Bad Old Days before we had an effective QMS, we occasionally discarded All Of The Prior Versions Of A Document, only to subsequently discover that we needed one of those versions for a valid reason.

For instance, because an auditor wants to review the state of a requirement at a prior time, or because that prior version is relevantly referenced in the specifications of a process or product that we hadn't run in a while.

Now we definitely don't discard prior documents.

We do of course maintain proper controls over where and why paper copies exist, and over their use for controlled purposes. For all documents that might be subject to later review, we also maintain a chronological effectivity record.
 

Ajit Basrur

Staff member
Admin
#8
I suppose you would have a distribution matrix listing where the controlled copies have been distributed, right ? This

So when a new version is available, replace the old ones with new ones.

Retain the master copy for future reference and shred the remaining copies.
 

DanteCaspian

Quite Involved in Discussions
#9
Ours are held digitally in a document library managed by our ERP system. Old ones/expired documents are flagged for action. Drawings, contracts and MSDS are just some examples.

We still lack a procedure that reduces errors for the flow of information however, so if a product dies, the drawing, and all reference documentation does not always get plucked for the system right away, but at least it will not get released.
 
Thread starter Similar threads Forum Replies Date
A Who pays for correction and removal actions? Other Medical Device Regulations World-Wide 2
S Clarity on requirements for a 510k exempt Class I device - Suture removal kit US Food and Drug Administration (FDA) 9
K Class II Medical Device Compatibility Issue - Removal or Market withdrawal? US Food and Drug Administration (FDA) 2
R Customer Complaint - Samples vs. Removal - FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ron Rompen Sintered Metal Machined Parts Rust Removal Methods Manufacturing and Related Processes 8
W CE Mark unapproved Medical Devices - Ear wax removal CE Marking (Conformité Européene) / CB Scheme 3
E Composites - Metal Bond - Removal of excess film adhesive Manufacturing and Related Processes 1
N IATF Appeals on ISO/TS16949 Rules - 4th Ed. - Removal of Site Extensions IATF 16949 - Automotive Quality Systems Standard 2
D Using R-Chart to justify removal of part from the study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
S Correction and Removal - Include Device used in Non-Production Environment? US Food and Drug Administration (FDA) 5
M Market Withdrawal or a Removal? Replace product in the field with an improved version Other US Medical Device Regulations 3
L API (American Petroleum Institute) Monogram - Applying and Removal Process Oil and Gas Industry Standards and Regulations 5
C Medical Device Reporting procedure - Correction and Removal (21 CFR 806) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N IMDS Warnings - Customer Requesting Fix (removal of warnings) RoHS, REACH, ELV, IMDS and Restricted Substances 17
M Where do you address Stock Recovery? In your corrections and removal procedure? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
W Is it required to stamp obsolete hard copy DHR's "obsolete"? ISO 13485:2016 - Medical Device Quality Management Systems 6
L Do you need to save hard copies of obsolete documents? Document Control Systems, Procedures, Forms and Templates 10
A UDI on medical device: Does it make other markings obsolete? EU Medical Device Regulations 2
J Obsolete or Delete - Accepted Components from Suppliers RoHS, REACH, ELV, IMDS and Restricted Substances 3
xcanals_tecno-med.es ISO 14969 (Now Obsolete) --> ISO 13485 handbook ISO 13485:2016 - Medical Device Quality Management Systems 16
T Master Document List - Obsolete Documents Document Control Systems, Procedures, Forms and Templates 23
T Handling of Obsolete Material Work Instruction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Difference between Obsolete, Void and Inactive Document Control Systems, Procedures, Forms and Templates 2
D AS9100C 4.2.3 - Obsolete Electronic ERP Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
W Control of Obsolete Documents Document Control Systems, Procedures, Forms and Templates 21
T Document Control Master List for Obsolete Documents Document Control Systems, Procedures, Forms and Templates 6
D Do we need to take a SA for a standard that is going to be obsolete? Other ISO and International Standards and European Regulations 2
B Reusing paper of Obsolete Documents to Control Waste Document Control Systems, Procedures, Forms and Templates 12
S Can you "Obsolete" a record (inspection reports)? Records and Data - Quality, Legal and Other Evidence 13
I How to Reuse an Obsolete Document? Quality Manager and Management Related Issues 7
A How to Reuse Obsolete Documents - Guidance needed Document Control Systems, Procedures, Forms and Templates 8
L Easy Access of Obsolete Documents - Corrective Action help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
I When was IEC 60601-1-4 made obsolete? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
apestate How do you sell a DCMA Inspector on replacements for obsolete items? Various Other Specifications, Standards, and related Requirements 9
T Obsolete Document References in other Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Save Obsolete Documents in Plant Closing? Document Control Systems, Procedures, Forms and Templates 15
T Obsolete Uncontrolled Electronic Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A How do you retain Obsolete Documents? Document Control Systems, Procedures, Forms and Templates 18
E Particular standard IEC 60601-2-40 references obsolete EMC standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Marc 12 Things That Became Obsolete This Decade - 2000 - 2010 Coffee Break and Water Cooler Discussions 13
Jerry Eldred Guildline 9975 DC Comparator Resistance Bridge Manual Needed (Obsolete) General Measurement Device and Calibration Topics 2
P Obsolete Quality Records - Approval Prior to Disposal Records and Data - Quality, Legal and Other Evidence 15
P AS9100 4.2.3 Control Of Documents - Requirement to retain Obsolete Documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Component supplier electrical test requirement - Obsolete Components Other Medical Device and Orthopedic Related Topics 2
T Reasons for retaining Obsolete Documents and Retention Time Document Control Systems, Procedures, Forms and Templates 13
R Obsolete a DoC if NB (Notifying Body) changed EU Medical Device Regulations 3
K 93/42/EEC Obsolete Document Retention requirements - New timeframe? Document Control Systems, Procedures, Forms and Templates 3
Jerry Eldred Document Retention of Obsolete Calibration Procedures General Measurement Device and Calibration Topics 4

Similar threads

Top Bottom