Is the Quality Objective for Company-wide Training as >90% too high?

O

onpoint

#1
Hello Forum,
My company just received a non-conformance related to a failure to meet our Quality Objective for Company-Wide Training, which is currently set at >90%.

My data shows that in general Operations, Engineering and Quality are spot on. So I have no worries as it relates to product, etc. The areas that are consistently bring down the overall average is the Sales and Administrative Teams (Finance / HR), who don't typically interface with the Quality System.

I understand that per the regulation employees must be trained prior to performing a specific task, so I am not looking for what the regulatory requirements is. What I need, is feedback from the forum on what others are doing around establishing a Company-Wide Training Objective, Why, and if 90% is maybe an unrealistic goal.

Your insight is appreciated.
Mary
 
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B

bigqman

#2
Hi onpoint. A couple of questions: Company-Wide Training - on what? What knowledge, skills, and behaviors is the training trying to impart? Are the knowledge, skills, and behavior needs the same in Operations, Engineering, and Quality as in Sales and Admin?
 

normzone

Trusted Information Resource
#3
Question - what standard is your company referencing for this requirement?

I'm not surprised that Sales is not your compliance star - coddled bunch of babies if you ask me ;-)

But that doesn't mean that you can't get them trained up. Devise a method to handle it remotely.

But your question was about the goal, and is it too high. How was this goal level set?

In my mind, I either have a process that has a high compliance rate, so I set the number wherever I damn well please, or I have a process that has a low compliance rate, and so I set the number at exactly where it is today and then begin trying to figure out why it's so low.

This is not of any help to you, but at least I got to slam Sales today, so at least I have something to feel accomplished about :)

Oh, and the person running the sales and admin areas are your reason for low compliance - task that person with getting it together.
 
O

onpoint

#4
Hi onpoint. A couple of questions: Company-Wide Training - on what? What knowledge, skills, and behaviors is the training trying to impart? Are the knowledge, skills, and behavior needs the same in Operations, Engineering, and Quality as in Sales and Admin?
The Company-Wide training is related to the Quality System (E.g. Quality Manual, SOPs, Work Instructions etc.). The level of knowledge / skills are different based on the various functions. Our system takes into account by assigning the "Level" of training required: Level 1: OJT / Cass Room; Level 2: Self - Read & Understand; Level 3: Awareness - I know there is a procedure and it's purpose, but I don't perform the process. The procedures folks are required to train on is based on their Job Function / Description, to ensure that employees are required to train on more or in a fashion that is inconsistent with their responsibilities.
 
O

onpoint

#5
Question - what standard is your company referencing for this requirement?

I'm not surprised that Sales is not your compliance star - coddled bunch of babies if you ask me ;-)

But that doesn't mean that you can't get them trained up. Devise a method to handle it remotely.

But your question was about the goal, and is it too high. How was this goal level set?

In my mind, I either have a process that has a high compliance rate, so I set the number wherever I damn well please, or I have a process that has a low compliance rate, and so I set the number at exactly where it is today and then begin trying to figure out why it's so low.

This is not of any help to you, but at least I got to slam Sales today, so at least I have something to feel accomplished about :)

Oh, and the person running the sales and admin areas are your reason for low compliance - task that person with getting it together.
The standard / regulations are 21 CFR part 820 and ISO 13485. Thanks for the input on setting it at demonstrated level for compliance, then figuring out how to bring it up.
 
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