The importance of training as part of a quality management system

The employees are the ones who produce the medical devices. The employees are the ones who are sitting in front of the machines, in front of the computers, in front of your customers, or assembling the products in the manufacturing halls. Industries and services today are becoming more and more different than before. The products and services supplied to customers are more complex. The organization must combine the two together: the human resources and the knowledge. The purpose of the training is to give your employee the opportunity to perform his job like it is planned.

Training today, is an integral part of your product. Your employee must be provided with the knowledge to produce a medical device that meets the requirements. The organization must initiate the trainings and provide them to your employees.

Paragraph 6.2.1 – General requirements

This paragraph is an introduction to the chapter. Specific requirement appear within the next paragraphs. 

Paragraph 6.2.2 - Competence, awareness and training
While planning the human resources for the realization processes, the organization shall refer to the next issue:

Training may be expressed with the following:

• Refreshing work instructions and work procedures
• Trainings about quality procedures
• Trainings about new working procedures
• Trainings about new developments in the industry
• Trainings about innovations within the organization (new software, new regulations, new projects, etc)
• Trainings about special, specific events within the organization (special projects, or special visits in various sites)
• Coaching employees (that's hot today!!!)
• Trainings required by your customers
• Training about complaints
• Trainings required by any kind of legal regulations
• Trainings required by any structural changes within the organization  

Training plan

To achieve all of the above you must create for any function in your organization (which is related to the product, of course) a training plan. This plan must be periodic (yearly, quarterly, monthly – that is enough periodic resolution). We personally recommend that someone with experience in a specific field would write the training for any fields in your organization: a department manager or a technical manager – someone who is aware of any problems and special situations your employees must face during daily tasks of its function. He must include these problems and special situations within the training plan. The purpose is to create an effective training; a training that would assist your employees and provide them with tools and knowledge for their everyday work. The plan must not be inflexible - au contraire - you may update it at any time. There is no requirement that the plan must be documented. But there is a requirement to show evidence of performing one and there is a requirement to supervise the execution of the plan. The reason is that you may identify any gaps between the plan and the execution. Complicated? We know so. Just make a plan - it will save you explanations.

Quality objectives

As well, the training plan must cover the organization's objectives and (of course, what else) the regulatory requirements. Within the quality manual you are required to define quality objectives. Trainings are here to assist you achieving these objectives. If you define your objectives as something like meeting customer (or regulatory) requirements or reducing manufacturing errors,  your are required to provide with your employees the techniques to achieve these objectives: review of possible manufacturing disruptions, the latest most fresh regulatory requirements – assist them in achieving the objectives that you set. 

Types of trainings

There is no requirement to perform the training in the traditional way as frontal courses or lectures – you may define training as self learning or tutoring employees. You can also define a training plan for specific employees who are responsible for specific fields in your organization. The actual purpose is to plan trainings for every function in the organization that has a direct effect on the product's quality. Here are examples for types of trainings:

• Established frontal trainings
• External courses
• A visit to exhibitions, conferences or conventions
• A visit to suppliers' facilities
• A suppliers' training about his products (very important! especially in commerce)
• E-learning courses
• Purchasing literature or special training software 

It is possible to define within the training plan more parameters such as:

• The location of the training: meetings room, auditorium
• The length of the training
• Who is the tutor

You are free to determine whatever you like as long as you follow the next requirements:

• The plan must include dates (you are not required for a specific dates – periods of the year is enough)
• A minimal specification of the topics for the training
• The subjects of the training – for whom it is appointed
• The training would be based upon the organization's requirements to produce his product or service (if you are a software designers, you won't define a flowers growing training or how to farm in the desert)
• The training plan must be with correspondence to the organization's quality objectives 

Evaluating the training

Training is a big expense. Expenses for the tutor, the employees' working hours, even the coffee that employees are drinking during the training… Training expenses are not done right after the training is over. When an employee makes a fatal mistake during the medical device production processes, it's because he didn’t pay attention during the training – that's expenses. And they cost! When you set trainings for your employees you expect to get the return on the investment. After the training, the employees are supposed to do the job better, more efficiently and with fewer mistakes. 

After conducting the training the organization shall evaluate the training. You must also evaluate the tutor. He can be a very nice person, who dresses real nice and has beautiful presentations but eventually no one understand a word he is saying.
You must evaluate the topics of the training. The employees understood all, the tutor is professional but the information is not relevant what so ever. The training won't contribute to the medical device's quality.
Thus, training must be evaluated. The organization must evaluate its effectiveness. You must verify the following:

• Evaluate the relevancy of the training to your medical device. This is why the training must be planned by professionals who have experience in producing the medical device. This is exactly where their added value is at use.
• Evaluate the employees. Check if they assimilate the training. You may check it by an exam at the end of the training, production analysis in a defined period or any way you choose. It is always recommended to examine the surface than to gather information from the employees themselves. See for yourself what is going on. 
• Evaluate the tutor. Does he really know what he is talking or that he just wastes your time and money?
• Evaluate whether the training is updated. In our modern world changes occur any day and any hour. What was right a year ago could be totally wrong today. Perhaps the organization is providing a whole new set of products but the trainings are referring to the old products. Another example is regulatory requirements. They tend to change from now and then. Any way, you are required to update your documentation regularly referring regulatory requirements. Do it also to your trainings.

Other documentation requirements for human resources

The organization must document the employee's suitability to the job. The organization must prove that this employee is capable of performing the work. It is highly crucial regarding medical devices.  Evidence can occur as:

• Records of education - where the function is a lab technician o- you must present his education as a lab technician or something relevant.
• Records of certification for the job - according to the certification process (internal or external)
• Records of trainings (internal or external) according to a prior definition (the plan)
• Medical examination (according to regulatory requirements)

Usually these requirements are maintained by the human resources department, but these are the ISO 13485 requirements.

ISO 13485 vs. ISO 9001 

The only additional requirements is when there are regional or national requirements for any human resources training, the organization must maintain a documented procedure that will identify these needs. What does it mean?  For example: When there is a regulatory requirement that a medicine factory is required to hire only a certified pharmacist, this requirement should be documented in a procedure. Which procedure? Of course the one related to hiring employees. Say what? The ISO 13485 does not require maintaining a special procedure regarding employing the personal unless (!!!) any regulatory requirement applies the employment of a special personal. Then, and only then the organization is required to maintain a procedure that describes who shall be hired and how.

Read our next article about the infrastructure  requirements.