REOQA

Inactive Registered Visitor
#1
I work for a ISO 13485 certified small medical device contract manufacturer. We would like to implement the Training Within Industry modules of JI, JR, and JM. I would appreciate some help from someone else who is 13485 certified and using TWI. I am unsure of how to proceed with documentation requirements concerning the job breakdown sheets, training plan (or training matrix) and observation checksheets. Does it really require an engineering change to create and then modify these documents?:confused:

Regards,

Jim
 

gpainter

Quite Involved in Discussions
#2
Re: Training Within Industry modules - JIB's and 13485 Documentation Requirements

Purdue University Technical Assistance Program (TAP) has a TWI program. TWI was a result of the war program and was developed from private industry. It is designed for Supervisors and front line Leaders. Biggest feedback was training time is reduced, union shops had reduced grievences. Followed by reduction in hours, icreased production and reduced scrap. TWI was used extensively in the 40's&50's. in the past 10 years there has been a resurgence.
 

sagai

Quite Involved in Discussions
#3
Re: Training Within Industry modules - JIB's and 13485 Documentation Requirements

You guys are loving TLAs :tg:
 
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REOQA

Inactive Registered Visitor
#4
Re: Training Within Industry modules - JIB's and 13485 Documentation Requirements

Thanks gpainter. Your post was not helpful. I already know that Purdue sells training for TWI. I was hoping someone with actual experience in their company that is ISO 13485 certified and actively using a successful implementation of TWI would reply to the documentation issue.
 
#6
This thread is very old, so I'm unsure if anyone will read this.

We use Job Instruction at my company. Auditors were pleased with this training methodology, especially the use of the four step method. We have shown that this can be useful in training effectiveness and competence.

I believe you would be just fine utilizing TWI and several companies will work through your implementation, especially within a regulatory environment.
 

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