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.

Welcome to the Cove, Qualitywitch :bigwave:

Transferred your post to this section and am sure you will get better responses. :)

Hi Qualitywitch,

If you refer the QSR Manual, the EXHIBIT SECTION (http://www.fda.gov/cdrh/qsr/05prsnl.html#exhibits) states -

Training * All inexperienced employees shall be trained to perform their assigned jobs. On*the*job training shall be monitored closely by a supervisor. All employees shall be made aware of design and/or production defects, visible and invisible, in the device, labeling, and packaging that may occur from the improper performance of their jobs and defects that they should look for and detect.

You could have a Defect Library for specific parts and have the respective operator / quality engineer trained for defects.

Try the Defect >> Causes >> Effects method of people awareness and include as many pictures / video as you can to highlight the Effect. For example, Casting defects in automotive axels >>> accidents at high speed when loaded. (I just picked an ex from automotive, you could pick some medical examples of your own products) Seeing the ugly effects can bring in a lot of awareness about what could lead to what ........
Hope it helps ....
Somashekar
INDIA

You can also review trends with the manufacturing personnel - on a monthly basis, for example. These trends of causes should include those defects caused by employees or training issues. If you review the trends, then you can also get to the specific training issues. This can be in the form of a monthly report emailed globally.

I've even created training of this sort in Powerpoint, with a button in the Powerpoint presentation at the end of the presentation to get an email back from the individual after they have read the presentation. And, this can be the evidence. It was a fun idea!

You can also review trends with the manufacturing personnel - on a monthly basis, for example. These trends of causes should include those defects caused by employees or training issues. If you review the trends, then you can also get to the specific training issues. This can be in the form of a monthly report emailed globally.

I've even created training of this sort in Powerpoint, with a button in the Powerpoint presentation at the end of the presentation to get an email back from the individual after they have read the presentation. And, this can be the evidence. It was a fun idea!

If you dont mind, can you share with the Covers ?:)

Unfortunately, it was several years ago and I no longer work for that company - or have that presentation. Sorry! I could make an example and post the example. I'll see if I have the time.

QAGirl - that sounds like a great solution to just the problem we are having - training follow up. ANYTHING you can provide would be helpful Even if it were just the last page with the "email-launcher" button! Thanks again! :agree1: