Outsourced Call Center (for complaints) and depth of required GVP/ISO13485 training

MED-T1

Registered
My organisation has chosen to outsource the capture of complaints/safety information to an offshore call centre operation for Japan. Our local Japan QA team are telling the wider organisation that this call centre operations needs to have its agents trained to GVP and ISO13485. However, we are not getting any clarity on the depth of this training. My questions are:
1. Is it required under GVP that the outsourced organisation be training in GVP and ISO?
2. If 1 is true, then to what depth? For example, for ISO13485 would it be acceptable to have the training cover the scope of 13485, the relevant clauses related to the service (complaint capture) being provided and then a link between the clauses and the work instructions in use?

Thank you for any help/clarity you can provide.

Kind Regards
 

yodon

Leader
Super Moderator
I don't know Japanese regulations so this is just a discussion regarding 13485.

First, recognize that you're responsible for meeting all the regulatory requirements, even if tasks are outsourced. If there's a failure to comply with regulatory requirements, you are responsible, not your service provider.

Part of your supplier qualification and approval is to ensure that the personnel in the organization you are engaging with have the competency to fulfill the tasks they are assigned. If they don't, then if you're already tied to that supplier (is there an option to select a different supplier?), you need to take actions to ensure they develop the competencies. This could be through training that you provide. You would need to determine the "depth" of training necessary to ensure that they are able to fulfill all the regulatory requirements.

No matter what you do, it'll be incumbent on you to ensure that the service provider is, in fact, complying with the requirement. You can't just assume they are, you'll need to continuously monitor them and if you find they aren't meeting requirements, you need to take action to remediate.
 

MED-T1

Registered
Hi Yodon,

I absolutely agree that we need to meet applicable regulatory requirements and globally our complaint capture and handling processes have shown that in multiple audits. The 3rd party vendors we use follow our procedures for complaint capture and are regularly audited.

We are being told that GVP training and ISO training is required for the call centre agents, but not how much detail is required in the training.
 

yodon

Leader
Super Moderator
Who is telling you this?

They just need to be trained to the level of detail that enables them to consistently and properly (compliant) perform the tasks assigned. You'll have to assess effectiveness of the training so you'll essentially get feedback on whether the detail is sufficient. I could easily see some training where mock calls are made to see if they perform their tasks correctly.
 

MED-T1

Registered
Hi Yodon, What you are saying is my view and how we work worldwide. However, we are being told this locally that the ISO (plus GVP) training is required hence I'm interested in anyone else's experience with Japan.
Kind Regards
 
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