Training template - controlled document?

[maron16]

Hi,

We are a small medical devices company and recently we have been debating if our training template should be a controlled document or not.

If it should be controlled, why is that? If not, again, why?

Looking forward to hear your opinions.

Thank you.

 

[Jean_B]

When you say training template, what do you mean? What is generated from the template? Training slides, training attendance record, other?

For small companies I think there is little added value for controlling most training templates; there could be value in controlling training materials generated from such templates.

The reason is that controlling the template at best controls the format of training you give, and that documentation generated could meet your document/record control requirements. Controlling assembled training sets allows you to evolve it, preventing starting over from scratch, setting a review period on it to review it for suitability, or to verify what someone was told do when performing investigations into deviations.

 

[AndyN]

If it should be controlled, why is that? If not, again, why?

What do you understand by "controlled"? It helps to know what you are thinking is necessary...

 

[mattador78]

Are you talking about a record of peoples competency? If so we treat ours as controlled so that nobody could just tick they would be competent for everything. Or are you talking about documents for training showing people what to do?

 

[Edward Reesor]

I tend to "control" all documents as it maintains an internal process consistency and we don't have to then explain how we determine what gets controlled and what doesn't. Also, if you make changes to the document, you should ask yourself why that change was made (presumably as it captures more information/deletes redundant information or just makes the process "better"). This falls under process quality improvement which folds into your quality management system with minimal effort.

 

[normzone]

My policy when people ask me if a document should be controlled is to ask if they want the process to happen in a consistent manner.

If the answer is yes, then the answer is yes.

 

[John Broomfield]

Hi,

We are a small medical devices company and recently we have been debating if our training template should be a controlled document or not.

If it should be controlled, why is that? If not, again, why?

Looking forward to hear your opinions.

Thank you.

Maroon,

Training is only two-thirds of the story when it comes to competence. The other third is selection for the job based on each individual’s innate attributes and strengths that manifest themselves in behaviors. Training someone who has been wrongly selected is a waste of money.

That said your matrix is a tool for planning the training of each person named so they have the requisite skills and knowledge therefore this documented information should be controlled.

Is it also used to record the verifications that all those who are working without close supervision have the necessary behaviors, skills and knowledge in that they do their jobs well?

People are much happier when working to their strengths so how are the required behaviors, skills and knowledge fed into your recruiting and training processes?

 

[Edward Reesor]

My policy when people ask me if a document should be controlled is to ask if they want the process to happen in a consistent manner.

If the answer is yes, then the answer is yes.

That is such a concise answer, I want to have it printed and put on the door of my office so they receive the answer before they ask the question.

 

[Mike S.]

What level of control is required? There is "control" as in the formal configuration management system, with multiple approvals, etc. and then there is "control" as in control at the the local level, perhaps by the trainer alone. Don't make it more onerous than it needs to be.

 

[AndyN]

What level of control is required? There is "control" as in the formal configuration management system, with multiple approvals, etc. and then there is "control" as in control at the the local level, perhaps by the trainer alone

Why would anyone "configuration management for training templates? Document control is document control...