Training, Learning, and Competency Management

The Right Approach for the Right Solution. How we are different.

Training, Learning, and Competency Management

The FDA’s harmonization and modernizing of the Quality System Regulation (QSR) to align with ISO 13485:2016, what does this mean for my training department?

Many training departments never addressed training beyond read and understand with an exam to determine if an individual was trained to do his/her job;
Software vendors tell you that the exam is proof that the individual is competent to perform the task and no additional training documentation is required.

You do not want your company cited by the FDA because the level of training documentation you have does not prove competency of an employee for a given task. Are you prepared to defend that position or would an automated quality management system that manages every aspect of employee competency on one platform work for you?

Interested in hearing more?

Challenge:

You log into the quality management solution your company purchased to manage all aspects of personal qualifications and realize that all it tracks is training, not the three key regulatory requirements of: training, education, and experience. If you are a midsize or larger organization, you can always go to the human resource department to obtain the additional information required.

You may have opened the HR department to potential FDA scrutiny.
The bigger issue, not all the information is in one place to make decisions when time is critical.

Your QMS or learning management system that has the training records;
The HR system has the education, experience, and ongoing assessment of qualifications;
The spreadsheets have the training requirements.

But you have not addressed one key factor. How do you determine competency when everything is in different systems, in spreadsheets, or on paper and the auditors are asking for the information?

Does this sound like your world? We can help

Solution:

Azimuth examined the ISO standards to ensure the solution we recommend to our customers meets all the requirements of the standard and any governing body. When considering the right solution for your organization, you must ensure the following items are addressed:

The organization must determine the necessary competence;
Ensure that these individuals are competent;
Take actions to acquire the necessary competence;
Evaluate the effectiveness of actions taken;
Ensure that these persons are competent based on appropriate education, training, skills, and experience;
Ensure every job has job description that is tied to the employee’s appropriate education, training, skills, and experience;
Retain documentation as evidence of competence;
Provide a way to prove whether the training was effective (test for understanding), and to measure how aware employees are of how relevant and important their activities are to achieving quality management goals;
Provide assessments of employees’ performance and measurement of competency to perform assigned tasks.

The solution we recommend does this and more. It connects training, education, experience, performance evaluations and more, all on one platform.

Azimuth Compliance Consulting can provide your organization the guidance and training you need to reach your organizational goals.

Your Options:

I am looking to purchase a new or replace an existing QMS solution to take advantage of iBPM technology

I need help with my setting up a training program and am searching for an organization that understands my concerns and regulatory needs