7.5.3.2 Traceability - How much traceability is required?

[Matthies]

Dear all,

For the medical ISO 13485 our company wants this certification.
But how much traceability is needed?

We configure computers to orders for hospitals.
(e.g. If we need to place a hard drive, we put a sticker on it that will be linked to the HD model and type. but is it needed to link the HD serial number with the sticker we put on it?)

 

[SuperGirl]

Re: 7.5.3.2 Traceability, how much traceability is this required?

It depends. Traceability mean that you know or can find out exactly where your product is, fairly quickly, if needed. If you can no precisely where it is without linking the serial number then no, but if you can't located it (fairly quickly) then yes you will need to.

 

[Ronen E]

Re: 7.5.3.2 Traceability, how much traceability is this required?

Hi,

It's a matter of risk management. List down what could go wrong if you don't enhance your traceability beyond what you currently have; how likely it is to happen; and what could be the consequences (for any stakeholder). Then assess the risk against the cost of implementing enhanced traceability, and against your statutory / regulatory obligations.

As an example, if your HD supplier notifies you one day that a certain batch of HD has a flaw that will cause X, what will be the consequences for devices in service? Will you be able to track their locations in case you decide to initiate a replacement? Etc.

Cheers,
Ronen.

 

[Mark Meer]

It's a matter of risk management. List down what could go wrong if you don't enhance your traceability beyond what you currently have; how likely it is to happen; and what could be the consequences (for any stakeholder). Then assess the risk against the cost of implementing enhanced traceability, and against your statutory / regulatory obligations.

Well said. It is essentially a balancing act, and up to you to weigh worst-case probabilities and consequences versus the overhead to trace. It'd help to consider the worst-case that a recall is required:

For example, you could decide to completely relax traceability on the HD. If in the future, however, there is a known issue with a certain batch of HDs, with potentially catastrophic results, you would have to recall ALL devices as you'd have no idea which ones went into which devices.
On the other hand, if you evaluate the probability of this scenario as totally remote, then relaxed traceability might be justified. ...ultimately your call.

 

[Matthies]

Thanks all! We have implemented traceability for HDD with S/N in our system to prevent catastrophy in worst case scenarios

Now i do have some other questions,
if we use a certain glue or cable ties in the assembly process, is glue/cable ties needed to be in BOM?

And what about the boxes we pack our systems in, the tape we use, the pallet we stack the systems on... does that also need to be traceable?

thanks!

 

[Ronen E]

Thanks all! We have implemented traceability for HDD with S/N in our system to prevent catastrophy in worst case scenarios

Now i do have some other questions,
if we use a certain glue or cable ties in the assembly process, is glue/cable ties needed to be in BOM?

And what about the boxes we pack our systems in, the tape we use, the pallet we stack the systems on... does that also need to be traceable?

thanks!

My opinion is that everything that goes into the device itself should be on the BOM, so yes - glue and cable ties should be there.

Regarding what needs to be traceable - it's as I noted befroe: assess the risk of not having it. I assume the risk in not having pallet traceability is quite negligible in your case.

Cheers,
Ronen.

 

[Mark Meer]

if we use a certain glue or cable ties in the assembly process, is glue/cable ties needed to be in BOM?
And what about the boxes we pack our systems in, the tape we use, the pallet we stack the systems on... does that also need to be traceable?

Once again: what Ronen E says.
All comes down to you assessing the potential risk first and foremost to the end user, and secondarily to your company.

Conceivably you could have a bunch of packaged (taped) units in inventory and discover that the adhesive from a certain tape order was old and doesn't hold the boxes shut properly. You'd then have to re-tape all the boxes... Is this a big deal? Is it probable? Probably no & no...

My feeling:
HDD: Traceable
Glue and Ties: On BOM, but no need for full traceability
Pallets & Tape: Unless packaging is critical in some way, don't worry about these...