DMR/DHF/DHR/Batch Records/Master Batch Records

T

TJG954 - 2009

#1
Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:
Take a breath, Ted, it will be ok, I promise! :)
1) DMR - Device Master Record. This can be a matrix or index that identifies the pertinent documents/procedures/records/specs, etc. and their location.
2) DHF - Design History File. This is all the documentation that results from the design history - all the activities of the design team (planning, input, review, output, review, changes, transfer, etc.). This should all be included in the DHF.
3) DHR - Device History Records. These are all the records generated during the production, testing, review, inspection, etc. of the device(s). These can include production schedules, specs, inspection reports/records, NCRs, CARs, MRBs, deviations, etc. - anything relevant to the production of that lot/batch of device(s).
4) Master Batch Record. This is not a term we (current company) use, but it could be similar to the DHF or DMR. I'm not certain.
5) Batch Record. This is what I would consider to be the same as the DHR.

I hope this helps. :)
 
M

madannc

#3
Whew! :confused:

For those of you that eat and sleep quality regulations, this may seem to be real novice group of questions.

1.) DMR.... like an index showing where specific files are?
2.) DHF.... a file containing all the pertinent information about how you got to the point of producing the product?
3.) DHR.... individual records of each manufactured product or group of products (batch)?
4.) Master Batch Record.... Same as a DHF?
5.) Batch Record.... Same as a DHR?


It seems that these terms cause a lot of disagreement in my group. The argument centers around the differences between a record of plans (DMR, DHF, MBR) and in-process records (DHR, BR). :argue:


Can anyone make the definitions simpler? Thanks. :bonk:
My thoughts

Prob start at beginning

DHF - Design History File, this is the documents that were compiled during the design of the product, Customer requirements, System requirements, User Requruirements, prototyping, design reviews, risk analysis, verification etc etc
This document is for the design of a device and the inspectors use it to verify that input (requirements) match output (design effort). Updates to this are required if you amend the design of the device (and features, change specs etc)

DMR - Device Master Record, this is a compilation or listing of all the materials, drawings, labels, BOM's, SOP's, WI's that are needed to manufacture the device (think of a recipe card, a listing of all that is required to bake a cake)

DHR - Device History Record, this is a compilation of the records, charts, routing cards, etc etc that were used to during the manufacture of the device (if you had to complete a record for every stage of baking the cake, packing and shipping the cake, this would be your DHR)

Batch Record, this is a document that records what happened during a particular part of the process (you would have lots of these when baking your cake, oven prep, oven temp, lot number of flour used, name of hen who layed eggs you used...he he, guess you get the idea). These records are refenced in the DMR, completed ones are part of the DHR.

Master Batch Record, probably refers (I say prob cause not a term I am familiar with) to the controlled copy of a batch record held in an area that copies are made from for use when you manufacture, when there is an update to the batch record in question the current master becomes superseded and is replaced with this new master. These days master records are mostly held electronically and printed when required.

I hope this helps

Nigel :rolleyes:
 
T

TJG954 - 2009

#4
Thank you folks. I think. :cfingers:

Your answers confirmed my definitions. I think. :cfingers:

So, this should settle the arguments. I think. :cfingers:

I think, so therefor, I am. :cool:

"I am whats I am" quoth the Popeye. :lol:

I appreciate your help. :agree1:
 
Thread starter Similar threads Forum Replies Date
P DHF, DMR and DHR in MDR? EU Medical Device Regulations 6
V What is required in terms of the DHR, DMR, DHF? Other Medical Device and Orthopedic Related Topics 4
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
M DMR, DHR and DHF physical form 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
S Is an index necessary for DMR or DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
O Distributors and ISO 13485 - DHF and DMR Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 7
W Update DHF (Device History Record) when DMR (Device Master Record) changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
V Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required? EU Medical Device Regulations 6
D Device Master Record (DMR) checklist ISO 13485:2016 - Medical Device Quality Management Systems 1
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
R Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB ISO 13485:2016 - Medical Device Quality Management Systems 9
R DMR or Manufacturing Documentation - How detailed does the documentation have to be? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
D Design Outputs vs DMR (Design Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Quality Plan at a small Medical Device Company - Is the quality plan a DMR document ISO 13485:2016 - Medical Device Quality Management Systems 6
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
I DMR (Device Master Records) and similar for standalone software device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S DMR (Device Master Record) Management and Index questions Other US Medical Device Regulations 18
S Difference between DMR procedures vs. QMS procedures? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q DMR and DHR - Two requirements, One Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Incoming Inspection Plans under Design Control (part of DMR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
U Document Revisions Required in DMR Index? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
P DMR (Device Master Record) for Class I and Class II Dental Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Do I need to show fasteners in my BOM's/DMR etc? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
C Re-Verification of Nonconforming Product prior to closing our DMR AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
C When to submit a 510(k)? After the DMR (Device Master Record) is finished? Other US Medical Device Regulations 4
B Format for Discrepant Material Report (DMR) - Nonconformance Report (NCR) Document Control Systems, Procedures, Forms and Templates 1
J Contents of DMR (Device Master Record) when manufacturing is by 3rd party 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A DMR (Device Master Record): What is meant by these words - Software Specifications? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
D DMR (Device Master Record) Index as a Controlled Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S What do we need for a DMR? Importer of Record and Going Crazy! 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D What kind of DMR must a Medical Importer have? Other Medical Device and Orthopedic Related Topics 8
B Format of Device Master Record (DMR) for Combination Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Dealing with Outsourced Processes in a DMR ISO 13485:2016 - Medical Device Quality Management Systems 7
J Device Master Record (DMR) that was compiled by another company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J Which supplies/suppliers need to be listed in DMR? ISO 13485:2016 - Medical Device Quality Management Systems 4
C Technical Documentation, DMR, ISO 13485 vs. FDA, STED Document Control Systems, Procedures, Forms and Templates 10
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
W DMR (Device Master Record) Revision Requirements? FDA GMP Manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Medical Device DMR's - List of the Marketing or Market Penetration documents ISO 13485:2016 - Medical Device Quality Management Systems 14
M What Marketing/Market Penetration information should go on the DMR? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom