The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > Documentation Control Systems, Procedures, Forms and Templates
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access

Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
design history record (dhr), forms and templates (general), iso 13485 - medical device qms
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 7th March 2005, 04:20 PM
stef2004 stef2004 is offline
Inactive Registered Visitor

 
Registration Date: Mar 2005
Location: Canada, Quebec
 
Posts: 2
Thanks Given to Others: 0
Thanked 1 Time in 1 Post
Karma Power: 39
Karma: 15
stef2004 has less than 100 Karma points so far.
Hehehe... Device History Record (DHR) Templates or Examples Wanted

Hi!

I am presently building our company's documentation structure, in the process of preparing for our ISO:13485 certification. Is there anywhere I can find templates for a DHR?

Sponsored Links
  #2  
Old 7th March 2005, 10:05 PM
Al Rosen's Avatar
Al Rosen Al Rosen is offline
Super Moderator

 
Registration Date: Jun 2002
Location: Lawn Guyland
Age: 64
 
Posts: 3,549
Thanks Given to Others: 71
Thanked 746 Times in 457 Posts
Karma Power: 418
Karma: 7230
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Send a message via AIM to Al Rosen
Quote:
In Reply to Parent Post by stef2004

Hi!

I am presently building our company's documentation structure, in the process of preparing for our ISO:13485 certification. Is there anywhere I can find templates for a DHR?
FYI, there is no such thing as a DHR template. Simply because, it is unique to your device and system. It's the collection of documents and records of the fabrication, assembly, processing, inspection and testing of the device.

__________________

Al

Last edited by Al Rosen; 7th March 2005 at 10:12 PM.
Sponsored Links

  #3  
Old 7th March 2005, 10:37 PM
stef2004 stef2004 is offline
Inactive Registered Visitor

 
Registration Date: Mar 2005
Location: Canada, Quebec
 
Posts: 2
Thanks Given to Others: 0
Thanked 1 Time in 1 Post
Karma Power: 39
Karma: 15
stef2004 has less than 100 Karma points so far.
Quote:
In Reply to Parent Post by Al Rosen

FYI, there is no such thing as a DHR template. Simply because, it is unique to your device and system. It's the collection of documents and records of the fabrication, assembly, processing, inspection and testing of the device.
Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health Canada lists the following:

proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity manufactured
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the DMR.

Would that list cover everything, or just about?

Thanks
Thanks to stef2004 for your informative Post and/or Attachment!
  #4  
Old 8th March 2005, 12:28 PM
Al Rosen's Avatar
Al Rosen Al Rosen is offline
Super Moderator

 
Registration Date: Jun 2002
Location: Lawn Guyland
Age: 64
 
Posts: 3,549
Thanks Given to Others: 71
Thanked 746 Times in 457 Posts
Karma Power: 418
Karma: 7230
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.Al Rosen is appreciated, and has over 1700 Karma points.
Send a message via AIM to Al Rosen
Quote:
In Reply to Parent Post by stef2004

Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health Canada lists the following:

proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity manufactured
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the DMR.

Would that list cover everything, or just about?
Thanks
That covers it.

__________________

Al
  #5  
Old 23rd March 2005, 04:49 PM
pbojsen's Avatar
pbojsen pbojsen is offline
Involved in Discussions

 
Registration Date: Nov 2003
Location: Grand Rapids, MI
 
Posts: 51
Thanks Given to Others: 21
Thanked 161 Times in 21 Posts
Karma Power: 50
Karma: 908
pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.pbojsen is appreciated, and has over 900 Karma points.
DMR and DHR

The Device Master Record should list all of the documents and procedures used to make the product.

The Device History Record is usually a folder that contains (at least in our medical device plant):

* either a copy of the documents the product was made to or a traveler that lists the documents, revisions, and dates of manufacture.

* quality assurance documentation, such as label reports with an actual label on the report

* a form filled out by QA as final inspection of product, and one for final inspection of folder

* BOM product was made to, etc.

The list is not all-inclusive, but you get the idea. Documents in the DHR map back to the requirements of the DMR. Does that help?

Last edited by pbojsen; 23rd March 2005 at 04:51 PM.
Thanks to pbojsen for your informative Post and/or Attachment!
  #6  
Old 9th October 2013, 03:18 PM
deidrajohnson40 deidrajohnson40 is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Oct 2013
 
Posts: 1
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 4
Karma: 10
deidrajohnson40 has less than 100 Karma points so far.
Re: Wanted: Device History Record (DHR) Templates

Quote:
In Reply to Parent Post by Al Rosen View Post

That covers it.
Hi Al,
I was wondering if you had an DHR procedure template I can use. I understand what required to go into the DHR and I understand about all of the forms used on the manufacturing floor for a finish device product, but the actually procedural process written into a SOP or DHR procedure. Are you able to help me. I am writing a DHR procedure for a medical device company. Deidra
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > Documentation Control Systems, Procedures, Forms and Templates

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record QE US Medical Devices (21 CFR part 820) 45 25th June 2014 03:00 PM
Who owns the DHR (Device History Record) for the Medical Device? RCW US Food and Drug Administration (FDA) 4 22nd June 2012 09:37 AM
DHR's (Device History Record) for Class 1 and 2 Medical Devices Not Required? Bill Goss US Medical Devices (21 CFR part 820) 4 20th October 2010 12:46 PM
How much detail in DHR (Device History Record) is too much? QA_CRM US Food and Drug Administration (FDA) 3 29th June 2010 11:43 PM
DHR (Device History Record) for Medical Device Software ic007832 US Medical Devices (21 CFR part 820) 6 28th May 2009 05:28 AM



The time now is 05:12 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".