ISO 13485:2016 Identification & Traceability

Mary O'Malley

Registered
Hello all,

We are a small, custom-made medical device manufacturer, our products include:

Orthotic insoles
Ankle/foot orthosis
Knee orthosis
Knee/ankle/foot orthosis
Hip/knee/ankle/foot orthosis


which are class I, low risk devices. Per recent audit ISO 13485, (clauses 7.5.8 ,7.5.9), we were given an OFI to expand the identification and traceability requirements of our QMS for raw materials involved with the manufacturing process i.e., consider linking our parts and raw materials to the custom-made medical devices we supply. This would be beneficial in the event of a device recall (however through my monitoring and vigilance of MHRA and HPRA sites, there has never been an FSN issued in respect of orthotic insoles or lower limb orthosis).

To implement the OFI, we have adopted the following processes: we apply a traceability number to all raw materials and parts on arrival, once passed goods inwards inspection, and then record these manually on the Bill of Materials section of our device specification through the manufacturing process. Populating a spreadsheet with all BOM info at end of each day appears to be the only means of capturing this data for all devices; in the event of a recall, the data could be easily filtered down as required. However, daily BOM data input would be a time consuming task and due to the extensive list of materials of varying types and densities and the number of devices manufactured, the spreadsheet / workbook will quickly become cumbersome and slow.

While we recognise that we would obtain some valuable information from such a spreadsheet, we are seeking advice on how best manage this based on above or is there any other alternative approach to this?

Thanks in advance.
 

yodon

Leader
Super Moderator
Before going too crazy, take a step back and ask yourself if it's really necessary. An OFI is just something an auditor saw and thought you may benefit from it.

Why is traceability implemented in the first place? It's so you know what all went into product in the event you need to notify people or conduct a recall. Is there any foreseeable event with your product that would require you to do so based on the raw materials? (I'm not saying there isn't - biocompatibility could certainly be a consideration.) Do you need it for ALL raw materials? If you need it at all, consider where it may be a relevant case. You could do a risk analysis to support your decisions.
 

XRAY_3121

Compliance and Regulatory Rx Distributor
I believe the intent of traceability and CoAs on critical raw materials is to help identify source of non-conforming raw material and to ensure integrity of your supply chain. Some manufacturers may have multiple sources of raw materials if they are commonly available. That's just my opinion of why it's required, I never had to debate that one with an auditor.
 

XRAY_3121

Compliance and Regulatory Rx Distributor
I hadn't seen Yodon's response - yes, I agree that critical raw materials should be established vs. non-critical!
 

somashekar

Leader
Admin
Hello all,

We are a small, custom-made medical device manufacturer, our products include:

Orthotic insoles
Ankle/foot orthosis
Knee orthosis
Knee/ankle/foot orthosis
Hip/knee/ankle/foot orthosis


which are class I, low risk devices. Per recent audit ISO 13485, (clauses 7.5.8 ,7.5.9), we were given an OFI to expand the identification and traceability requirements of our QMS for raw materials involved with the manufacturing process i.e., consider linking our parts and raw materials to the custom-made medical devices we supply. This would be beneficial in the event of a device recall (however through my monitoring and vigilance of MHRA and HPRA sites, there has never been an FSN issued in respect of orthotic insoles or lower limb orthosis).

To implement the OFI, we have adopted the following processes: we apply a traceability number to all raw materials and parts on arrival, once passed goods inwards inspection, and then record these manually on the Bill of Materials section of our device specification through the manufacturing process. Populating a spreadsheet with all BOM info at end of each day appears to be the only means of capturing this data for all devices; in the event of a recall, the data could be easily filtered down as required. However, daily BOM data input would be a time consuming task and due to the extensive list of materials of varying types and densities and the number of devices manufactured, the spreadsheet / workbook will quickly become cumbersome and slow.

While we recognise that we would obtain some valuable information from such a spreadsheet, we are seeking advice on how best manage this based on above or is there any other alternative approach to this?

Thanks in advance.
It is Simple.
You need to have a documented procedure for traceability (7.5.9.1)
Within this you have to detail the extent of traceability (check what your regulatory requirements dictate) and maintain records of traceability.
If you have not done this, then it's a NC
Identification is different and you need to have a documented procedure for identification (7.5.8)
It is possible that you have one procedure that address both these.
Now please tell us what is the extent of traceability you have documented in your procedure ??
 
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