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.
