Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Training

[christophermix]

We are updating our 6.2.2 Competence, Awareness and Training procedures and we are unsure how to document, and when, our use of temporary labor in our warehouses.

The "temps" are primarily used to load/unload truck trailers. How much training do they receive? If they are only here for a few hours do they get the same training as our hourly loader/unloaders? Can we document how and when we train temporary labor? We are concerned we will not meet the letter of the standard for ISO13485 and FDA 21CFR820.25(b) Training. We do not wish to waste training resources if we do not have to train our temporaries as exhaustively as we train our own people.

Thanks for any insight you can provide!

 

[AndyN]

Re: Training Requirements for Temporary Laborers

We are updating our 6.2.2 Competence, Awareness and Training procedures and we are unsure how to document, and when, our use of temporary labor in our warehouses.

The "temps" are primarily used to load/unload truck trailers. How much training do they receive? If they are only here for a few hours do they get the same training as our hourly loader/unloaders? Can we document how and when we train temporary labor? We are concerned we will not meet the letter of the standard for ISO13485 and FDA 21CFR820.25(b) Training. We do not wish to waste training resources if we do not have to train our temporaries as exhaustively as we train our own people.

Thanks for any insight you can provide!

Welcome to the Cove! The issue of when and what to train has been covered many times and if you care to perform a search or refer to the listed threads at the bottom of this page you'll see related topics.

The simple answer is to not train anyone, until you have determined their competencies to perform these tasks. I know that 13485 is based on ISO 9001, so the same basic principles apply. Competencies come first, followed by whatever action is required, which might include some training.

 

[christophermix]

Re: Training Requirements for Temporary Laborers

I limited my searching to the ISO 13485 and FDA 21CFR820 forums and I did not go into the ISO 9000 areas. I will review the links and if I need anything else I will let you know.

I was hoping to get some feedback from other Medical Device companies to see how they managed training temps to satisfy ISO13485, CMDCAS, EU MDD, and TGA requirements.

We were concerned because we thought we would fill the training database with temporary employees that were only here for a few hours. We do not want to waste training resources on someone who will not be here.

 

[SteelMaiden]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

Things an employee needs to know how to do - things the employee can do now = training that needs to be done.

OK, simplistic, but it works. You cannot know what to train people on if you don't understand what they need to be able to do.

 

[christophermix]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

After reviewing all of the posts in this thread and other threads I am planning on completing the following actions:

1. Discard the use of the word "temp" to describe short term workers. We will refer to them as "contract employees" in the QMS.

2. We will consider having our Temporary Labor agencies perform the quality training for us to include basic safety and quality indoctrination training for the affected positions. Then the contract employee would show up already trained with a copy of their training certificate provided by the Temporary Agency. We would only need to keep a copy of their certificate then and only put them into our training database if they became a permanent employee.

3. The Competence, Awareness and Training procedure will be written to document these actions.

4. The Temporary Agencies will be placed into our Supplier List as an Approved Medical Services Supplier the same as our Contract Manufacturers.

 

[AndyN]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

After reviewing all of the posts in this thread and other threads I am planning on completing the following actions:

1. Discard the use of the word "temp" to describe short term workers. We will refer to them as "contract employees" in the QMS.

2. We will consider having our Temporary Labor agencies perform the quality training for us to include basic safety and quality indoctrination training for the affected positions. Then the contract employee would show up already trained with a copy of their training certificate provided by the Temporary Agency. We would only need to keep a copy of their certificate then and only put them into our training database if they became a permanent employee.

3. The Competence, Awareness and Training procedure will be written to document these actions.

4. The Temporary Agencies will be placed into our Supplier List as an Approved Medical Services Supplier the same as our Contract Manufacturers.

Are you going to pay for this training? I'm guessing any agency who does this is going to charge you for it! Don't forget, it's competencies that need to be defined and demonstrated, not just training. We all know that training (alone) doesn't get you the 'right' people - we dodge them on the roads every day!

 

[christophermix]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

We will not know how the agency will reply until we approach them. It would be a benefit to them to provide the training. I believe most agencies already complete some assessment and training for candidates and this might help to provide us with more competent contract employees.

Once we speak with the agencies in Ohio and California I will let you know.

 

[SteelMaiden]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

We all know that training (alone) doesn't get you the 'right' people - we dodge them on the roads every day!

Andy, your argument here is somewhat lacking, as these same fools have been adjudged competent by the state licensing authority.

 

[AndyN]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

Andy, your argument here is somewhat lacking, as these same fools have been adjudged competent by the state licensing authority.

Wow, do you mean I was off in my expectations? I though the 'test' was to see if they passed their driver 'training'! You mean they really showed competency? Well, in that case I must lower my standards forthwith!:mg:

I vow never to shower slurs and epithets on those who drive and make turns without a signal, tailgate me, ignoring other road users while holding deep, meaningful and annimated phone conversations (or texting!) or other, similar things which I had, hitherto, held as contemptable driving behaviours!!

 

[Jen Kirley]

Re: Temporary Laborer Training Requirements - 6.2.2 Competence, Awareness and Trainin

The rule we follow at my workplace is to make sure these employees receive safety training appropriate for the work, other training as required by law (this may vary among the states - contact your state Dept of Labor to be sure) and whatever they need to learn to do their jobs in a way that supports the requirements and intent of the QMS.

Boom, that's it - it is easy to overthink this process.