How to keep track of employee read-only training

racglobal said:

For example, while the Management Responsibility SOP doesn't directly involve the production employee, being in a small company of 10 people, they would still need to be aware of their responsibility to be in charge of their own area of the QMS and any corrective actions should be reported to management for purpose of management review. In this sense, while they are not directly involved in management responsibility and hence do not have to be tested, it makes sense for them to be aware of this. After all, the standard calls for risk-based thinking. At my previous company, everyone from CEO down to the maintenance worker had to take a quiz on design control, which didn't make sense to me if the maintenance person was never gonna be involved in design reviews. Nor does read-only training apply to them either.

Click to expand...

I question whether having the production employees reading the Management Responsibility SOP is the best way (or even a useful way) to convey that they "be aware of their responsibility to be in charge of their own area of the QMS and any corrective actions should be reported to management for purpose of management review". After all, it should already be in the production employee's process docs 1) their particular responsibilities for their area, and 2) what to do in case of a nonconformance. Having production employees try to intuit those from a Mgmt SOP seems a roundabout way of accomplishing this.

Indeed.

Run a workshop for top managers so they develop their presentations to explain their management system and their role in making it effective.

Video the first sessions and then edit an orientation for new employees eager to learn about their management system.

Much better than having the employees read the management procedures.

Help the leaders to show their commitment to requirements.

Due to the nature of the business and potential workplace incidents, ensuring competency is essential for us. We had to develop safeworkmethod statements for major tasks, which is similar to an SOP but steps out each process steps and assigns a risk factor. For high critical jobs we also developed a quiz as part of the competency assessment. When we first started each operator would read and sign off on the hard copy and we would put everything into an excel matrix. Worked really well at start but got cumbersome to maintain as we grew.

We are now using an online platform called Our Management Software Link. In short it combines a couple of digital management tools to help run our operations including our ISO system. One of them is a training system where we upload the training documents and can create custom quizes as well. For inductions we actually have created a custom form which includes a welcome video from our senior management.
We assign these training courses to our operators who receive an email and can then complete on phone or desktop computer. We can set the duration to renew automatically everything 12 months, 24 months etc. Also gives us competency % and we use it to track other things that can expire like forklift licenses as well as our company insurances. So to answer your question a Learning Management software(LMS) is what you need to look at.

With that said and depending how high risk your workplace is but SOPs in more of covering backside should something go wrong and should be considered as the starting point because at the end of day most employees will sign anything. What we found more effective is having continuous management involvement by doing daily safety walks and interactions with shop floor staff (which we record in Our Management). Furthermore we have KPIs to run at least 4 job assessments for each employee per year. This involves the manager/supervisor standing in-front of the workgroup area observing, assessing whether the employees are doing the job safely and correctly(quality) - again recorded. They would then consult with the employees afterwards on how they performed the job (good or bad).

Bumping this thread

Any training software solutions for a company making class II FDA CE med device both design and manufacturing? What companies have off the shelf configurable solutions that are good value?

Ed Panek said:

Bumping this thread
Any training software solutions for a company making class II FDA CE med device both design and manufacturing? What companies have off the shelf configurable solutions that are good value?

Click to expand...

Hi Ed, I have been looking for a training software package as well, cloud-based and configurable. I often have clients that need solutions. One that I came across a while back (at the time a bit early stage in device QA for my needs) that seems to have been evolving is Learnaboutgmp. Apparently, they began kind of organically from another forum and the founder decided to create a database of content, then collaborated with an IT firm to build out a platform. They are at least worth checking out; I have no skin in the game. They are too big for a current client (low-tech Class I device), but I am thinking about them for another.
I'm glad you revived this thread because I want to hear what others know. I just inherited an over-complicated ISO 13485 QMS with a headache-inducing manual training process that I need to overhaul.