Reason for determining no adverse effect on reworked product

[newblues]

Hello everyone,

I work for medical device company in Japan.
I got to this wonderful web site searching for information. I found some relevant threads here, but they are not just what I'm looking for. So, please let me start a new thread.

Section 8.3 of ISO13845 requires documentation of adverse effect by rework on products.
When determining there's no adverse effect, you will state so on the rework procedure. At this time, are any reasons to determining "no adverse effect" must be documented? I mean, if the requirements in clause 8.3 includes documentation of REASON for determining there's no adverse effect or not. That is, if it will be a non-conformity when only stating like "no adverse effect".

Maybe in some occasion it would be good to document reasons for employees to understand the nature of the rework. However there are also cases where it's obvious no adverse effect.
For example, when manually removing foreign materials on the product as rework, you may agree in most cases it's clear there's no adverse effect on the product. In such a case to document reasons for determining no adverse effect is pointless. So, I'd like to have it just an option or recommendation to document reasons for determining no adverse effect.
Any thoughts?

Thank you.

newblues

 

[somashekar]

Please look at some of the interacting processes as required by the ISO13485.
1. You shall establish documented requirements for risk management throughout product realization. Records of this shall be maintained.... (7.1)
2. Prior to rework approval determination of adverse effects of rework upon product shall be made and documented... (8.3)
3. The availability of documented procedures, documented requirements, work instructions ~~~ .... (7.5.1)
4. To review and approve documents for adequacy prior to issue ...(4.2.3)
Rework upon product is within product realization.
Your work instruction contents will be coming from the determinations of risk management. Your rework process work instruction hence will also be coming from a risk management. Risk management document is live and is always subject to review when new processes are to be made, like a rework process for example.
So determination of any adverse effects is a part of risk management within the product realization. You can change your view from 'No adverse effects' to a rating from your risk management practice that will indicate Nil or negligible risks.
A good amount of inputs to adverse effects of the rework upon product will come from the risk management records of the product realization itself.
You are the master of your risk management. So use all your information and resources and consult with medical device experts when you attempt risk management.
Think safety of patient and user ...

 

[newblues]

Hi Somashekar,

I get your point. Determination of adverse effect on rework product is just a risk management.

Well, provided the determination is made in several ranks and if you say it's a negligible risk, how about the reason for determining so?
When the reason is not documented, can you take it as a non-conformity?

Rgds,

newblues

 

[Ronen E]

Hi Somashekar,

I get your point. Determination of adverse effect on rework product is just a risk management.

Well, provided the determination is made in several ranks and if you say it's a negligible risk, how about the reason for determining so?
When the reason is not documented, can you take it as a non-conformity?

Rgds,

newblues

Hi,

The risk management process defined by ISO 14971 is quite methodical in building and capturing the reasoning behind the evaluations made. If you follow it closely there should already be ample documentation of why a risk of adverse effects is acceptably low (or nil).

Cheers,
Ronen.

 

[Mark Meer]

Hi newblues,

I'm also considering how to best approach this at the moment, to make our system more efficient. I was considering a "Rework Assessment" spreadsheet, that allows consideration of broader categories to be assessed. Each time a new rework is identified, a row is added.

So, to use your example, a row might be:

Rework: Remove foreign material using compressed air
Applicable Parts/Sub-Assemblies: Any plastic or metal parts
AE* Assessment: No effect. Compressed air does not affect any of the plastics or metals used.
Assessment By/Date: Jim Personnel, 2015-03-14
*AE = Adverse Effect

Now, each time this rework is done on any plastic or metal during assembly, the rework personnel need not document an assessment of any adverse effects, because it has already been done and documented.

Basically, the idea is to generalize adverse effect assessments to broader categories of rework, so they only have to be documented once.

 

[newblues]

I totally agree with Ronen E's comment.
Determination of AE on reworked product should be done in risk management manner. Then the reason for determining no/low risk should be documented.

And, Mark Meer's idea is fantastic. I've had a similar idea, which is to state possible NC, rework procedure for each NC, determination of adverse effect etc on rework instructions. But Mark's is better.

Now I'm quite determined on how to document adverse effect when reworking.

However, the intention of my original question is "Not to document can be a non-conformity or not". In other words, will you judge it as a non conformity, if you are an auditor and find the reasons for determining no/low risk are not documented?
Probably you can recommend to do this in RM manner to auditee to improve their QMS, but can you say it a non-conformity?

Regards,

newblues

 

[somashekar]

I totally agree with Ronen E's comment.
Determination of AE on reworked product should be done in risk management manner. Then the reason for determining no/low risk should be documented.

And, Mark Meer's idea is fantastic. I've had a similar idea, which is to state possible NC, rework procedure for each NC, determination of adverse effect etc on rework instructions. But Mark's is better.

Now I'm quite determined on how to document adverse effect when reworking.

However, the intention of my original question is "Not to document can be a non-conformity or not". In other words, will you judge it as a non conformity, if you are an auditor and find the reasons for determining no/low risk are not documented?
Probably you can recommend to do this in RM manner to auditee to improve their QMS, but can you say it a non-conformity?

Regards,

newblues

If you have not determined and documented the adverse effects of rework prior to doing the rework, then it is a NC for sure.
If you have, then the auditor cannot question the depth of your adverse effects assessment, unless it is so very superficial and saying that there are just no adverse effects at all.
Coming to the example from Mark Meer ...

AE* Assessment: No effect. Compressed air does not affect any of the plastics or metals used.

Make sure you have such air pressure limits set which is determined good to remove foreign material based on your own judgement and experience, and yet not damage or effect the other working parts that are subjected to such air pressure. Compressed air can be destructive otherwise. Such are the type of controls that one expects to see from determination of adverse effects of rework, within the risk management.

 

[newblues]

Thank you, Somashekar.

Understood well.

 

[Debra]

Hello everyone,

I work for medical device company in Japan.
I got to this wonderful web site searching for information. I found some relevant threads here, but they are not just what I'm looking for. So, please let me start a new thread.

Section 8.3 of ISO13845 requires documentation of adverse effect by rework on products.
When determining there's no adverse effect, you will state so on the rework procedure. At this time, are any reasons to determining "no adverse effect" must be documented? I mean, if the requirements in clause 8.3 includes documentation of REASON for determining there's no adverse effect or not. That is, if it will be a non-conformity when only stating like "no adverse effect".

Maybe in some occasion it would be good to document reasons for employees to understand the nature of the rework. However there are also cases where it's obvious no adverse effect.
For example, when manually removing foreign materials on the product as rework, you may agree in most cases it's clear there's no adverse effect on the product. In such a case to document reasons for determining no adverse effect is pointless. So, I'd like to have it just an option or recommendation to document reasons for determining no adverse effect.
Any thoughts?

Thank you.

newblues

Basically you use the Risk Assessment you have already completed (per ISO 14971) for your device, to reference and verify no adverse effects after rework.