Re: Competence, awareness and training
Hi - just my 2 cents. Sorry for the lenght of this response, but it is a narrative on my whole training and competency procedure. Hope you find it helpful.
For the sake of example, I will use a service employee in this scenerio.
A service employee must know how to answer the service line, log a call, trouble shoot the issue to resolution and close the call. In addition they must also know the procedure for identifying and escalating a complaint.
In my organization, the Service Manager is reposbile for the day to day activities of all service employees and of the implementation of the Service procedure. The whole management team is responsible for ensuring that 1) the Service Manager is trained and competent. and 2) The staff as a whole is well trained and operating in a manner to ensure the highest level of product quality and patient safety.
A new service employee is hired. (I would use the exact same steps to clean up a training record issue for an existing employee)
a) determine the necessary competence for personnel performing work affecting product quality - Depending on your company this can be handled in a few ways. I use the following: 1) Each position has a job description. The job description of a service employee will list required skills - the employee must have good communication skills and skills specific to our device for the purpose of trouble shooting, etc. The job desription will list service employee responsibilities - identify and escalate complaints to the quality department. log and close customer calls. 2) When each new hire starts, we create a training plan. This is a one page list (singed off my the employee's manager and me (the management rep) lising all the required training for the employee. It also includes appropriate timeframes for the training. It will be the SOPs, tools, etc. that employee needs to be trained on. I make sure that everything in the job description is included on this plan. The plan is reviewed every year during an employees annual review. Every year there is a new plan created for an employee.
The job description and the plan should be included in the employees training and competency file.
b) provide training or take other actions to satisfy these needs, - We make sure that all training is well documented. I use a simple training record that lists the subject mater of the trianing and includes the date & and name and signature of the trainee and trainer. Each record is included in the training and competency file.
c) evaluate the effectiveness of the actions taken, I handle this in a few ways. They are all documented in my training and competency procedure.
The simplest piece that satisfies the requirement is this step: The manager responsible does an evaluation after training. The training record asks the question, does the employee demonstrate a proficient understanding of the subject matter? Yes or No It goes on to ask Is re-traning required? Yes or No. then it requires the Service Managers signature. (*Note: I have the manager responsible discuss the subject with the trained employee. I try to have this done a few days AFTER training. Not immediately. I want to ensure that the material has "stuck" with the employee.) This step may not be practical in every company. This could be done by any trainer - doesn't have to be the manager. But in my organization, we're small enough that I have the luxury of hands on managment from the whole team all the way up to the CEO.
Another method that I use is the internal audit (as mentioned above by another poster) I say in my training procedure that the internal audit is a good measure of training effictiveness and competency. It is through the intrnal audit that systemic breakdown and lack of competence and awareness will be identified... blah, blah, blah. In my opinion that's the most cumbersome method to maintain because when I collect data for management review on training, I need to incorporate the internal audit results. And that gets tricky for me. Internal audit results are then used for multiple data points in management review. I guess that depends on how you structure your management review meetings and organize the data. I also don't like the internal audit to take too much responsiblity for this piece because it is only looking at a sample. You usually don't sample every employees work. Weak links may fall through the cracks, etc.
I have used a lot of different methods to meet this requirement. I've used rally complex training matrices, I've done testing (which I HATE because I don't find them to give accurate results), I've done things like demonstration of proficiency - where the "plan" is for each employee to receive hands on training for 30 or 60 days and then be evaluated by the managment team. But what I outlined above for you seems to be the most effective method that I've found.
To answer your question about my interpretation of the requirement - I think the requirement is pretty simple. ISO wants to ensure that you have taken neessary steps to ensure that you don't have your janitor performing engineering tasks or the like. Even though you've hired someone to perform a job, you need to go a step further and ensure that you have the right person in the position. So its on you as the manufacturer to monitor and ensure proper competency.
Hope this helps.
