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Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
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Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements
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documents and documentation (general), engineering changes, iso 13485 - medical device qms, medical device company or industry, observation checksheets, required documents, small companies (small businesses), training plan and training matrix, training requirements, training within industry (twi)
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  Post Number #1  
Old 2nd May 2012, 12:09 PM
REOQA's Avatar
REOQA

 
 
Total Posts: 12
Please Help! Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements

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?

Regards,

Jim

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  Post Number #2  
Old 2nd May 2012, 04:31 PM
gpainter

 
 
Total Posts: 1,194
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.
  Post Number #3  
Old 2nd May 2012, 04:45 PM
sagai

 
 
Total Posts: 1,094
Re: Training Within Industry modules - JIB's and 13485 Documentation Requirements

You guys are loving TLAs

Last edited by sagai; 2nd May 2012 at 04:52 PM.
  Post Number #4  
Old 2nd May 2012, 04:56 PM
REOQA's Avatar
REOQA

 
 
Total Posts: 12
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.
  Post Number #5  
Old 3rd May 2012, 12:22 PM
Jeff Frost

 
 
Total Posts: 646
Re: Training Within Industry modules - JIB's and 13485 Documentation Requirements

Though this is more than likely not what you looking for, below is a web address to the original training within industry materials from the war department.

http://www.trainingwithinindustry.net/
  Post Number #6  
Old 17th October 2017, 10:38 AM
rm3chris

 
 
Total Posts: 6
Re: Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements

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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