Effective date: Standard Operating Document No:

Procedure for employee SOP/QMS/002

training
SOP Author: Rev:V1

Revision History

Date Version Author Change Summary

V1 Initial release

Author Reviewed By Approved By

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Signature & Date
Effective date: Standard Operating Document No:
Procedure for employee SOP/QMS/002
training
SOP Author: Rev:V1

1. TITLE:
Standard operating procedure for conducting training of employee.

2. PURPOSE:
2.1. To establish a process for conducting training of employees when necessary
and to assign roles and responsibilities for their implementation.
2.2. To ensure that personnel performing work that may affect product quality or
other functions are competent enough to accomplish the task.

3. SCOPE:
3.1. The procedure covers all the employees of the organisation who are
responsible for carrying out any Good manufacturing practices(GMP)
compliant activities.

4. EXCLUSIONS:
4.1.

5. REFERRENCES:
Sl Document Title Document No. Document
No. location/path
1 Quality Manual
2 Employee training form
3 ISO 13485

6. DEFINITIONS:
6.1. Competence: Ability to apply knowledge and skills to achieve intended
results.
6.2. People development: Encouragement of employees to acquire new or
advanced competence by creating learning and training opportunities with
circumstances to deploy the outcomes that have been acquired.
6.3. Knowledge: human or organizational asset enabling effective decisions and
actions in context.
6.4. Skill: learning capacity to perform a task to a specified expectation.
6.5. Trainee: Person who is being trained on a specific subject or activity.
6.6. Trainer: persons that are knowledgeable in and regularly perform the
procedures in which they instruct others.Necessary attributes include good
verbal skills,demonstrated attention to detail and objectivity.
7. ROLES & RESPONSIBILITIES:
Role Responsibilities

Quality manager 1. Identifies need for training

2. Monitors the process.
3. Acts as process owner.
Effective date: Standard Operating Document No:
Procedure for employee SOP/QMS/002
training
SOP Author: Rev:V1

4. Prepares the trainer list as per their

qualification,training skills,experience of
work .
Dept. Head 1. Identifies any additional training reqd.
for any employee(s) under his/her dept.
Trainer 1. Responsible for training design and
delivery.
2. Responsible for planning the
competency assessment of the provided
training.
Trainee 1. Responsible for attending the training
provided.
2. Responsible for reviewing their
competency with their manager to
determine if additional training is reqd.
3. Responsible for giving feedback to the
trainer.
Functional group Responsibilities

Executive management 1. Ensures that training processes are

part of management review.
2. Ensures that any necessity required for
conducting the process are in place.
3. Acts as approver of the trainer list.
Quality Assurance 1. Responsible for monitoring the
process.
2. Ensures that training processes are
conducted according to this SOP.
3. Responsible for preparing and
updating the trainer list at timely interval.

All employees 1. Responsible for attending the training

provided for their timely closure.
2. Participate fully in the process.
3. Should have a general understanding
of this procedure .

8. PROCEDURE:
8.1. Need for training may arise as a result of events including but not
limited to the following :
8.1.1. Recruitment of new employee:
8.1.1.1. Induction training shall be given to each employee prior to
his/her joining which includes company history, policies,
procedures&role details.
Effective date: Standard Operating Document No:
Procedure for employee SOP/QMS/002
training
SOP Author: Rev:V1

8.1.1.2. On job training such as training on required SOPs and

operational training shall be identified based on the
activities/functions that to be handled by the personnel.
8.1.1.3. Any additional training shall be given to the employee after
assessing his/her competency.
8.1.2. Release of a QMS document or a new version:
8.1.2.1. Training shall be given to all relevant employees of an
organisation after a new QMS document or a new version of
existing document is released.
8.1.3. Specific issues observed in audit findings,CAPA or management
review:
8.1.3.1. Training shall be given to relevant employees after any specific
issue or non conformance is found from audits,CAPA or
management review.
8.1.4. A role change or role extension of an existing employee:
8.1.4.1. Training shall be provided to an existing employee if any new
role is assigned to his/her.
8.1.4.2. Training shall comprise of SOPs, work instructions,instrument
operating procedures.
8.2. Trainer approval:
8.2.1. The training program shall be conducted by an approved trainer.
8.2.2. Department head shall be considered as an approved trainer by virtue
of his/her designation and experience.
8.2.3. Any other employee can be selected as an approved trainer if he/she is
certified on a particular field.
8.2.4. QA team has to prepare an approved trainer list based on their
qualification with consultation from required functions.
8.2.5. Approved trainer list shall be reviewed and updated at a particular time
interval.

8.3. Conducting and monitoring the training:

8.3.1. When the need for training is identified according to section 8.1 of this
SOP, QA shall assign a training date after consultation with required
functions.
8.3.2. Employee training form shall be issued by QA team.
8.3.3. Trainer has to plan the training depending on the audience and the type
of training.
8.3.4. Different training processes include but not limited to the following:
8.3.4.1. Trainee observes demonstration of the procedure by a trainer.
8.3.4.2. Demonstration through presentations,videos.
8.3.4.3. Computer based training
8.3.4.4. Manufacturer’s training or demonstration.
8.3.5. Trainer has to ensure that all trainee are attending the training session
and has to record the attendance.
8.3.6. At the end of training session trainee has to fill up a feedback form
provided by the trainer.
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Procedure for employee SOP/QMS/002
training
SOP Author: Rev:V1

8.3.7. QA team has to maintain all records related to training.

8.4. Training Evaluation:

8.4.1. After completion of training,trainer has to evaluate the effectiveness of
training.Following options may be considered for evaluating the
effectiveness of training.Depending upon the complexity of the training
the option can be finalised.
8.4.1.1. Written Evaluation: Written evaluation can be used in areas
where verification of a participant’s knowledge is required.
Knowledge of theory of principles,problem solving ability,logical
sequence used may be ascertained.
8.4.1.2. Observation of procedure,process: Observation by a trainer of
an employee performing or demonstrating a procedure.
8.4.1.3. Response to oral queries related to a step or procedure:
Answers provided by the employee to questions asked by trainer.
8.4.1.4. On the job observation: Trainer observes the trainee’s
performance and behaviour at work for evaluating how the training
has influenced trainee’s performance and delivery at work.
8.4.2. Trainer has to set the passing criteria for his/her training.
8.4.3. Any trainee failing in the criteria has to attend the training process
again.
8.4.4. QA shall assign another date for retraining in consultation with
required functions.
8.5. Effectiveness check:
8.5.1. Quality department has to ensure that all training related processes are
being followed as per this SOP.
8.5.2. Quality department has to ensure that all mentioned roles and
responsibilities are addressed to the respective function and personnel
8.5.3. Quality has to ensure that the SOP is being reviewed at a particular
time interval.

8.6. Management Responsibility:

8.6.1. Management has to ensure that all required tools,facilities for the
training are provided.
8.6.2. Management has to ensure that feedback forms are part of management
review meetings.
8.6.3. Management acts as approver of the Approved trainer list.

9. Risk management:

Hazards Risk control measure

1.Employees are assigned tasks for which Training records are maintained so that
they have not been trained. managers can identify the suitable
employee to perform a particular job.
2.Training is delivered but is not effective Training effectiveness is assessed with
comprising the effectiveness of the QMS each training session and is also
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Procedure for employee SOP/QMS/002
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SOP Author: Rev:V1

considered during internal audits.

3.Competency of the trainer Trainer has to be chosen based on his
qualification and experience.Feedback
form has to be assessed for keeping track
of trainer’s competency.