Q
Hi - I've searched other threads and couldn't find anything on this topic.
Can anyone tell me how they ensure that they have met the regulatory requirement that: "As part of their training, personnel shall be made of device defects which may occur from improper performance of their specific jobs"?
We have a large globally spread workforce and could look at a number of options:
Defect awareness training template - so people can adapt for specific jobs
Ensure defect awareness is made a feature of training on SOPs
Include a generic: "you must explicitly follow SOPs" as part of induction (in addition to other defect training).
What else?
My concerns are:
a) that people understand the implications of getting it wrong - for customer/patients/themselves and;
b) that we can show objective evidence of this
I don't want to do a sterile "we've ticked the box" exercise I want to get to hearts and minds.
Any ideas would be warmly welcomed.
Thank you.
Can anyone tell me how they ensure that they have met the regulatory requirement that: "As part of their training, personnel shall be made of device defects which may occur from improper performance of their specific jobs"?
We have a large globally spread workforce and could look at a number of options:
Defect awareness training template - so people can adapt for specific jobs
Ensure defect awareness is made a feature of training on SOPs
Include a generic: "you must explicitly follow SOPs" as part of induction (in addition to other defect training).
What else?
My concerns are:
a) that people understand the implications of getting it wrong - for customer/patients/themselves and;
b) that we can show objective evidence of this
I don't want to do a sterile "we've ticked the box" exercise I want to get to hearts and minds.
Any ideas would be warmly welcomed.
Thank you.
