Training In The Organization

ISO 13485 emphasizes a lot on the training of all employees to be competent and skilled in their job functions. US FDA 21 CFR 820 also requires a lot of training as well.

Training is another important part of medical device’s quality system. Ideally all personnel must be trained well to perform their daily works. Therefore, a procedure to handle training is warranted.

The purpose of this training procedure is to provide a system, assign responsibilities, identify training needs, provide the required training and  maintain training record.

The objective of a robust training program is to ensure all employees acquire the knowledge and skills when performing their jobs. They should be conversant with the relevant requirements of the quality system pertaining to their job functions.

The training blog is subdivided into 1) Company-wide Training and Awareness Programs 2) Departmental Training and 3) Training Effectiveness and Evaluation and 4) Training Record and Documentation.

 1)    Company-wide Training and Awareness Programs

Company-wide training and awareness programs are discussed sub-categorically into the following sections. One of the great training tool is to have a training matrix for each individual employee. This training matrix shall include general orientation, quality system, safety training and department specific training. In that case, it is comprehensive.

1.1  General Orientation and Quality System Training

Normally, the human resource department provides for the general orientation while training department provides the quality system training. This training make the employees familiar with administrative rules, employee program and benefits, 401K plan, vacation policy, sexual harassment etc. The training also explains the medical device products, product requirements and the quality system. The product and quality system should comprises of the following:

 ·       Discussion of the Quality Policy. Normally, even the employee badge has the quality policy printed.

·       Overview of the company’s company system. For example, 21 CFR 820 quality system for medical device plus perhaps ISO 13485.

·       Training on each product the company make. Each employee shall be trained on each product on critical quality characteristics and ramification of a failure or malfunction of the device. How the product is made etc?

·       An explanation of how individual employee contributes to the well-being of the company quality system.

1.2  Safety Training

Safety training is also important in the organization. Many of the medical devices manufacturing processes and tool, for examples can cause serious harm to the employees during production. You do not want to start a fire to burn down the facility.

Therefore, all employees are trained in safe work practices, first aid, use of personal protective equipment, emergency procedures, fire extinguisher handling, as applicable. Safety training is provided by the individual responsible for Human Resources or directly by departments. Human Resources maintain these records.

1.3  Company-Wide System

Examples of company-wide system are Trackwise system. Trackwise system is used to record CAPA, Laboratory Investigation and Deviations. Other systems are Windchill, SAP, material-coding and bar-code system.

 1.4  External Training

Many medical device sponsors have educational reimbursement policy for employees to participate in seminars, conferences or even getting another advance degree or certification pertaining to the industry. For example, project manager might take the Professional Management Professional (PMP) certification to efficiently handle a project. Or an employee who is getting a M.Sc in Regulatory Affairs to know more of the regulatory affairs.

1.5  Quality and Regulatory Certification

Company encourages personnel to be certified as Regulatory Affairs Certification (RAC) especially if you are in or planning to move to the Regulatory Affairs department. Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) are also useful as a quality professional like in auditing. There are also other certification like Clinical Research Associate and the list go on and on.

 2)    Departmental Training

Each department is responsible to provide the necessary training to ensure employees are skilled, capable, and competent to perform their functions in the department in question. For example, if you are in the manufacturing, may be, more training on production process validation, process capability, out of specification training, verification and validation related activities training.

On-the-job training (OJT) is another important and efficient way to train less experienced employees. There are simply not easy to learn from a procedure and protocol. OJT must be used more often. Experience in the industry tells me that OJT is important, there may be things which are difficult to be captured in the procedure.

3)    Training Effectiveness and Evaluation

Training effectiveness is often not being paid more attention. After each employee is trained and it does not mean he or she is effectively trained. Often times, employees do not think it is important. They attend the training and sign the document and considered trained. Therefore, to gauge the effectiveness of the training regiment, the approaches are shown below.

This evaluation assesses whether a particular training has achieved its objectives and if the employee is competent and skilled to perform the new job function. The evaluation is taking test and performing several productions to gauge how many products have defects. Results of all the evaluation are recorded and is kept with the original training record.

 4)    Training Record and Documentation

All training records can be kept virtually and in a cabinet. In this day and age, there are many training software to be deployed so that to keep all training records like Master Control. This is particularly important for sponsor which employs thousands of employees.

Reference	Criteria
ISO 13485 6.2.1	Are personnel performing work affecting product quality competent on the basis of appropriate education, training, skills, and experience?
ISO 13485 6.2.2 .a	Has the company determined the necessary competence for personnel performing work affecting product quality?
ISO 13485 6.2.2 .b	Does company provide training or take other actions to satisfy these competence needs?
ISO 13485 6.2.2 .c	Does the company evaluate the effectiveness of the training and other actions taken?
ISO 13485 6.2.2 .d	Does the company ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?
ISO 13485 6.2.2 .e	Does the company maintain appropriate records of education, training, skills and experience?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.