ISO 13485 Competence, Awareness and Training Requirements

P

pangchiaboon

#1
Dear Sirs,
ISO 13485 says we shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,

We do conduct training on both practical and procedure, but not always followed with assessment. We have annual appraisal, but not everybody get appraised in a year. In this case, we will have problem to fulfill (c).

Please share your practice and what you understand about the requirement. Thank you.
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Competence, awareness and training

Most companies I've worked with claim compliance to c) by doing periodic employee performance reviews... mostly annually.

I like to take a little more aggressive stance and include evaluting the effectiveness of training during internal audits - through observation and interviewing employees.

Another method of evaluating training is is to give a quiz after the training to make sure the key point were understood.
 

somashekar

Staff member
Super Moderator
#3
Re: Competence, awareness and training

Dear Sirs,
ISO 13485 says we shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,


We do conduct training on both practical and procedure, but not always followed with assessment. We have annual appraisal, but not everybody get appraised in a year. In this case, we will have problem to fulfill (c).

Please share your practice and what you understand about the requirement. Thank you.
Make it very simple for you.
People get trained and as they perform the assigned tasks, the same people do report to some responsible manager. You have a mechanism that generates effectiveness of each personnel's such training from their responsible manager, in some simple format that says that x y z training were found effective in case of a b c persons. In case any training is reported as not effective for a person, assess if that person needs to be retrained, and if yes, retrain him and have the same loop continued.
Finally get the responsible managers to commit about training effectiveness as they measure periodically, and get the same responsible managers to first plan the training requirement.

Annual appraisal considers a whole lot of stuff like attitude, behaviour, punctuality, helpful nature, peer group acceptance, team work attitude and sometimes even business trend, and in this specific trainings gets lost somewhere.
 
Last edited:
Q

QA_RA_Lady

#4
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.
 
M

MRWardell

#5
I think the process QA RA Lady has laid out is great. As an auditor, I would find this process both effective and capable of demonstrating that the standard has been met. I am in the process of rewriting our training procedure and will "borrow" several aspects of her process. I also agree that the compentency demonstration process should be outside the annual review, or perhaps the annual review would be a part, but not all, the method of demonstrating competency. I have used the internal audit process myself to determine if training has been effective and if the personnel are competent.
 
#6
The requirement is to evaluate the effectiveness of the action taken. So, following the training (or other activity), can the people perform? If you hire a new operator, what do you do? You put them on a probabationary perior. Why? To see if they will work out. Part of that assessment is to determine their competency. You can easily apply the same to training. When someone is trained go through the same basic steps as with a new hire (but normally you won't boot them if they fail to perform). If after a given amount of time, you are comfortable and confident in their performance, then you have met the requirement. Although documenting this may be arguable, it can easily be done.
 
M

meimei

#7
Dear Sirs,

Good Day.:)

Regards to training, the ISO 13485 standard did not put in the requirement of training duration or completion period for new employee.

1) Do we need to include the completion period into the procedure? My HR colleague told me that the external audit rise question about it during their Stage 2 audit.

2)What will be the reasonable completion of training? Within the probation period?

I have little experience with ISO 13485, will very appreciated for your advice. Thank You
 

Mark Meer

Trusted Information Resource
#8
1) Do we need to include the completion period into the procedure? My HR colleague told me that the external audit rise question about it during their Stage 2 audit.
2)What will be the reasonable completion of training? Within the probation period?
There is nothing in the ISO 13485 standard prescribing deadlines on training or probation periods.

So, in terms of ISO audits, if your company has decided to to establish training deadlines and probation periods (even though not mandated by the standard), the only concerns I'd have would be if:
a) You are not following your own procedures (e.g. deadlines you've set for yourself are not being met), or
b) The way you've established deadlines raises concerns about the effectiveness of training. (IMHO this is unlikely)

Personally, I'd keep your procedures flexible, and not limit your system by prescribing strict deadlines. ...because really training and competency should be handled on a case-by-case basis - some people require more training than others...

For extended, supervised training (e.g. over a probation period), we simply record the start date and end date. The "end date" is simply the date where both the supervisor and employee are confident that the employee has reach a sufficient level of competency to handle their responsibilities unsupervised. Both the supervisor and employee sign and date to attest to this, and the record is closed...
 
K

kd7074

#9
At my last company which was a corporate 500 medical device company, we had to record the start and finish time of each training session. We had to have X amount of hours of training per employee each there. This included Quality Systems related training, training specific to our job, health and safety, regulatory compliance, etc. All procedures were set up for annual review. Some could be self trained, some were video content that was established for 1.5 hours of training and some was in person training. We had a lot of training every year. And this type of annual training required completion within 2 weeks. Past due notices were sent when needed, and escalated to management if ignored. Not sure which outside regulation drove this but they took it very serious.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
At my last company which was a corporate 500 medical device company, we had to record the start and finish time of each training session. We had to have X amount of hours of training per employee each there. This included Quality Systems related training, training specific to our job, health and safety, regulatory compliance, etc. All procedures were set up for annual review. Some could be self trained, some were video content that was established for 1.5 hours of training and some was in person training. We had a lot of training every year. And this type of annual training required completion within 2 weeks. Past due notices were sent when needed, and escalated to management if ignored. Not sure which outside regulation drove this but they took it very serious.
Sounds horrible :mg:
Training should be about its results, not about quotas.
Oh well, big organisations...

Welcome to the Cove and thanks for sharing!
 
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