Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello. According to ISO 13485:2016, 8.2.2 Complaint handling, the procedure must include responsibilities for 'handling of complaint-related product'. Does anyone know if there is an exact process that must be adhered to or is it up to each company to decide and document? Thank you in advance.

​Means for addressing the requirement of ISO 13485:2016 8.2.2(e) - handling of complaint-related product - is left to each company to decide, and is typically captured in the relevant procedures of the organization's Complaint Handling Unit.  The 'established and documented' SOPs formally designate an individual by role or position with the authority to ensure the returned product is suitably labelled as non-conforming product, segregated, and following the complaint investigation, appropriately preserved or dispositioned.  Particular attention is to be paid to product that fails to meet specifications, or conforms to specifications but poses problems in use, and certainly those items involved in adverse events (death, injury, malfunction, or unidentified hazards/ harm).

Production, test, service, and complaint records may be reviewed, and similar devices or related models inspected as part of the complaint investigation; these activities may be directly relevant to the decision whether the returned product should be, for example, subjected to destructive testing or downloading of fault logs that may interfere with or over-write the event logs. Exceptions would be where such testing may cause further damage to the affected unit - for example, by applying power to a damaged unit.

The procedures should additionally guide service personnel/ technicians on specific measures to be taken for safeguarding product coming in for service/ repair that meet the definition of a complaint. Pertinent data should be collated and entered on the complaint form.

Where there is any possibility of a claim or litigation, the safe handling of complaint-related product is paramount to limiting liability.

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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
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Original Message:
Sent: 12-Jun-2018 11:24
From: Anonymous Member
Subject: Handling of Customer Related Product

This message was posted by a user wishing to remain anonymous

Hello. According to ISO 13485:2016, 8.2.2 Complaint handling, the procedure must include responsibilities for 'handling of complaint-related product'. Does anyone know if there is an exact process that must be adhered to or is it up to each company to decide and document? Thank you in advance.

This message was posted by a user wishing to remain anonymous

Very helpful! Thank you for your response.
Original Message:
Sent: 12-Jun-2018 19:41
From: Homi Dalal
Subject: Handling of Customer Related Product

​Means for addressing the requirement of ISO 13485:2016 8.2.2(e) - handling of complaint-related product - is left to each company to decide, and is typically captured in the relevant procedures of the organization's Complaint Handling Unit.  The 'established and documented' SOPs formally designate an individual by role or position with the authority to ensure the returned product is suitably labelled as non-conforming product, segregated, and following the complaint investigation, appropriately preserved or dispositioned.  Particular attention is to be paid to product that fails to meet specifications, or conforms to specifications but poses problems in use, and certainly those items involved in adverse events (death, injury, malfunction, or unidentified hazards/ harm).

Production, test, service, and complaint records may be reviewed, and similar devices or related models inspected as part of the complaint investigation; these activities may be directly relevant to the decision whether the returned product should be, for example, subjected to destructive testing or downloading of fault logs that may interfere with or over-write the event logs. Exceptions would be where such testing may cause further damage to the affected unit - for example, by applying power to a damaged unit.

The procedures should additionally guide service personnel/ technicians on specific measures to be taken for safeguarding product coming in for service/ repair that meet the definition of a complaint. Pertinent data should be collated and entered on the complaint form.

Where there is any possibility of a claim or litigation, the safe handling of complaint-related product is paramount to limiting liability.

------------------------------
Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand

Original Message:
Sent: 12-Jun-2018 11:24
From: Anonymous Member
Subject: Handling of Customer Related Product

This message was posted by a user wishing to remain anonymous

Hello. According to ISO 13485:2016, 8.2.2 Complaint handling, the procedure must include responsibilities for 'handling of complaint-related product'. Does anyone know if there is an exact process that must be adhered to or is it up to each company to decide and document? Thank you in advance.

Each company should determine the appropriate process. Remember that many complaints do not involve "complaint-related product". I infer this means a product return.

 

Set up an RMA process to help trigger the process below. You want to identify the returned product upon receipt.

 

The returned product is customer property, so follow your process to implement clause 7.5.10.

 

Returned product is identified and distinguished from conforming product, so follow your process to implement the last paragraph of clause 7.5.8.

 

Because the returned product could be contaminated, follow your procedures to implement clause 6.4.2.

 

Clause 6.4.2 include contamination of personnel. The standard approach uses a set of techniques called  "universal precautions". Be sure they are implemented starting when the return product appears on the receiving dock. For US companies there are OSHA requirements that need to be implemented.

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Dan O'Leary
Swanzey NH
United States
------------------------------

Original Message:
Sent: 12-Jun-2018 11:24
From: Anonymous Member
Subject: Handling of Customer Related Product

This message was posted by a user wishing to remain anonymous

Hello. According to ISO 13485:2016, 8.2.2 Complaint handling, the procedure must include responsibilities for 'handling of complaint-related product'. Does anyone know if there is an exact process that must be adhered to or is it up to each company to decide and document? Thank you in advance.