Training Matrix Need to Be Proceduralized?

R

rm3chris

#1
Is it a requlatory requirement for Training Matrices to be proceduralized? We have a company wide training procedure and each department has what we call "certifications" which are nothing more than a bunch of required sop's lumped under one umbrella. Each area has several functional certifications depending on which manufacturing line they are working on. For example, Certification A has three SOP's for sterilization. Certification B has five SOP's for boxing, etc.

All of the certifications are maintained and controlled by the Training Department. Area Leaders meet with us frequently to ensure they are updated and accurate....which docs should be added or removed or stay the same. The plant has read-only access.

Does my plant wide training procedure need to change revisions each time a document changes within a certification? And, does each certification need to be it's own procedure?
 
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yodon

Staff member
Super Moderator
#2
My knee-jerk reaction is that there's not even a requirement for training matrices! That's a good and common method, but the requirement is that employees are competent to perform the tasks they are assigned. How you demonstrate this is up to you.

One additional note: the updated standard places more emphasis, based on risk, on the method used to check effectiveness of actions taken (including training) to ensure competence. Make sure you factor this in when organizing your training programs.
 
R

rm3chris

#3
Thanks so much! I was actually asking if the training matrices need to be proceduralized or not. My thoughts is if the Training team maintains them, no one has access to change it in a secure drive.

Are there any regulatory requirements for them to be proceduralized or just good practice.
 

yodon

Staff member
Super Moderator
#4
Again, no requirements for specifically how you manage this as long as you can clearly demonstrate what competencies are required, personnel have the required competence, and any actions taken are assessed for effectiveness.
 
L

locutus

#5
As yodon said, there is no regulatory requirement for having a "Training Matrix". If you read the standard (ISO 13485 2016 version) Section 6.2 states that organisation shall determine necessary competency for employees and then to provide training or actions to maintain this competency. No where in the standard (or ISO 9001) standard does it state a training matrix is required.

Now, one of the easier ways to show who is supposed to be trained on what, is to have a training matrix. This can be done however an organisation wants. Even myself as an auditor, I will ask to see the training matrix. But if they don't have one, then yes, as an auditor it will actually take me time to think and not use a bloody checklist to figure out how they determine competency and training thereof.

Now if your own procedure states that you create, maintain, and update a Training Matrix for personnel, then you do need to follow your procedure. How you determine competency, roles, responsibilities, authority, training requirements, training effectiveness, etc. etc. is completely up to you. So to answer your question rm3chris, no there is no regulatory requirement that requires a proceduralised training matrix unless you do this, but is it a good method? Yes. And if you do use a training matrix, then it should be a form/template in your procedure describing how it is generated and maintained. I can not speak directly to how you are doing without seeing your entire processes and interactions, but it sounds ok.
 
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