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Device History Records (DHR) Component Traceability / Serial Number Requirements

#1
Are Device History Records (DHR) required to contain serial numbers of components, e.g., pcb's, that are components of an assembly or is it sufficient to have the Device Master Record (DMR) that identifies the revision level, etc. of the component?
 

Al Rosen

Staff member
Super Moderator
#2
Re: Device History Records (DHR) component tracieability/serial number requirements

SteveTIB said:
Are Device History Records (DHR) required to contain serial numbers of components, e.g., pcb's, that are components of an assembly or is it sufficient to have the Device Master Record (DMR) that identifies the revision level, etc. of the component?
IMO, the DHR should include the s/ns or batch numbers.
820.184 Device history record.
Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any device identification(s) and control number(s) used.
 
#3
Re: Device History Records (DHR) component tracieability/serial number requirements

I interpreted that to mean when a finished assembly has an identification (e.g., revision level) or control number (e.g., serial number) associated with it, that's what must be included int he DHR.

So if understand wht you're saying, if a component in the device has a serial number that component's serial number needs to be included in the DHR, but if it only has a revision level associated with it, that's all that is required. Correct?
 
M

Microbe

#4
Hi

IMO I would have thought that for any finished device, that the components used in manufacture would have either their batch number or if they had one a serial number recorded in the DHF - recorded traceability all comes down to risk. If you don't know what goes into a finshed device what do you do if something goes wrong and you are in a recall situation. You will not be able to limit the size of recall, so you will have to recall everything. Of course this is worst case situation, but you have to think of these things
 

Al Rosen

Staff member
Super Moderator
#5
Microbe said:
Hi

IMO I would have thought that for any finished device, that the components used in manufacture would have either their batch number or if they had one a serial number recorded in the DHF - recorded traceability all comes down to risk. If you don't know what goes into a finshed device what do you do if something goes wrong and you are in a recall situation. You will not be able to limit the size of recall, so you will have to recall everything. Of course this is worst case situation, but you have to think of these things
:agree1: I agree with your philosophy.
 
L

Linda W

#6
I agree also...it all comes down to the manufacturer determining what needs to be traceable...risk management. If a safety failure occurs with a component will you be able to identify all devices that have that component?

Linda
 
#7
Thanks Al, Microbe and Linda W.

From the recall/risk perspective, as long as a component's revision level is known for a given assembly, I don't see how the ease of recall/risk would be improved by including serial numbers of component parts, unless the component is tested prior to incorporation into the overall assembly.
 
L

Linda W

#8
Steve you are correct...as long as you can show traceability that is all that is required. ISO and QSR are more on meeting the requirement objective rather than only one path one must follow. That I think is why this site is so important...giving us all alternate paths to go depending on our company culture and competencies of the personnel.

Linda
 
M

Madly RA'd Woman

#9
Hi All!

I am in the same boat as Steve right now, trying to set up proper documentation for component (sub-assembly) in-process :confused: quality records.

Can anybody advise if you use a form or a summary report on subassemblies, or a DHR-type form for every incoming component? For example, if you receive in 500 PCB's, do you record on paper each test result down to a serial number level, or would you prefer to create a summary report, including ranges, number of parts accepted, number of parts rejected, rework dispositions, etc - - at a job or batch level? The summary would tell you how many you got, who the inspector was, job number, that sort of thing, but you could probably get away with much less documentation

We have some flexibility under 13485 and QSR to move, but our QMS is boggin us down, and requiring we do DHR forms on every single board.

Comments, please!!!! I need some help.

Thanks,
Madly RA'd in Cheeseland
 
R

rohinibh

#10
I was wondering if you were able to set up a DHR system in your company... I'm currently trying to do the same for my company and need a starting point! Please Help!
 
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