Maintaining Component Traceability in DHR (Design History Record)

W

WoodDuck

#1
#1
Hello All,

We're developing a device that will be a large capital equipment purchase for our customers. We anticipate that over it's life there will be several components that will require replcament due to wear from normal usage. I'm wondering how other manufacturers are maintaining component traceability in this situation. For example, we have a part that occurs in 4 separate locations within the device. Initially they all come from the same lot. If 1 of the 4 require replacement there will be 2 lots involved. Future replacements continue to add new lots to the DHR. Here are what I see as options. Should we insist that all 4 are replaced together (expensve to customer), mark each individual part with its lot number so it is identifyable (difficult for us), or simply keep track of which lots are used in the device (increased risk, no way to identify part to its lot)? How are others making these decisions? Am I missing an easy solution to maintain traceability to the parts?
:bonk:
 
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Ronen E

Ronen E

Problem Solver
Moderator
#3
#3
Re: Maintaining Component Traceability in DHR

Hi,

I am not aware of a formal regulatory requirement to keep updating the DHR once a device has been delivered, installed and comissioned, regardless of size, complexity and/or price.

In my understanding it will be the institution (e.g. hospital etc.) responsibility to keep track of replaced components, either with or without lot traceability (based on their specific policies and considerations). if you believe that this is imporatnt, you could highlight it in the user/maintenance manual or the like, but make sure to stress that it is their responsibility. If you believe it is essential for fulfilling the Intended Use of the device, make sure to state it clearly.

Cheers,
Ronen.
 
W

WoodDuck

#4
#4
Re: Maintaining Component Traceability in DHR

Thanks Ronen. I should clarify that installation and maintenance of the device will be performed exclusively by our company or approved agents. My concern is if a need arises for a field corrective action or recall, we may not have the ability to locate all the suspect components. This could force us to implement action for a much larger population.

Regards,
Jim
 
M

Mark Meer

Trusted Information Resource
#5
#5
Re: Maintaining Component Traceability in DHR

We include a "Replaced Parts" table in our servicing form. The table has the following headings:

| Part Replaced | Qty/Placement | Batch Deviation |

The "Batch Deviation" column is for parts replaced that are different from the original lot (different shipment, different supplier, new revision etc.). If the part is identical the column gets "N/A". If the part is different, we put the new purchase order (PO) number for the part in the column.

All service forms get filed in the DHR. So, even though it'd be tedious, we can still track down which units have suspect parts in worst case.
 
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