I. PURPOSE
To describe
the procedure for organizing and conducting technical training to all the
employees and to motivate towards Quality
standards at all the levels in the plant.
II. SCOPE
This
procedure is applicable to the employees of all the departments at, Unit-V.
III. RESPONSIBILITIES
Induction
Training – Personnel Department.
On the Job
Training – Department Heads.
GMP
Training – Quality Assurance Department.
Proficiency
Training – Quality Assurance Department.
VI. ACCOUNTABILITY
Head - QA
V. PROCEDURE
1.1
Concerned HODs shall ensure that the persons employed
for the functions have an appropriate combination of training and experience to
perform the assigned functions.
1.2
Department Head shall provide additional supervision
until the requirements have been met to perform the assigned functions.
1.3
Training shall cover the specific operations that the
employee is expected to perform the activities as per the cGMP.
1.4
Training shall also cover the importance of the
execution of the work as per the written procedures.
1.5
Identification
of training needs
1.5.1
Training shall be chosen to bring the employee to a
basic level of
understanding of skills needed to do the job.
1.5.2
Specific training shall be given to the following
employees
1.5.2.1
Those working in aseptic areas
1.5.2.2
Those handling toxic and inflammable materials
1.5.2.3
Those attending electrical works
1.6
Trainer
1.6.1
Trainer shall have good communication skills.
1.6.2
Trainer shall have sound knowledge of cGMP systems and
on the topic.
1.6.3
Asst. Manager and above level can give training
directly without the approval of Head QA.
1.6.4 Person below the Asst.manager level can also
give training by taking approval from Head QA.
1.7
Training
coordinator
1.7.1
Shall execute trainings as per approved schedule.
1.7.2
Shall maintain training records.
1.7.3
Shall evaluate the questionnaires.
1.7.4
Shall ensure that individual employee training records
are updated.
1.7.5
Shall update the training topics as per new amendments
in guidelines
1.8
Training
aids
1.8.1
Video Tape
1.8.2
Over Head Projector
1.8.3
Slides
1.8.4
White Board
1.8.5
Study Material
1.8.6
Liquid crystal display (LCD)
1.9
Training
Duration
1.9.1
Training duration shall not be less than 30 min and
not more than 2 hours.
1.10
Training
category
1.10.1
Trainings are categorized into four types
1.10.1.1
Induction Training
1.10.1.2
On- The- Job Training
1.10.1.3
GMP Training
1.10.1.4
Proficiency Training
1.11
Induction
Training
1.11.1
HRD department shall give Induction Training to all
the newly appointed employees.
1.11.2
This training shall be given for 1 to 2 days as per
‘Induction Training .
1.11.3
Finally
‘Induction training
shall be filed in HRD department.
1.12
On The Job
Training
1.12.1
This shall be provided by the respective department
Head.
1.12.2
Department Head shall prepare the ‘OJT Training
Schedule’ as per
Format No.: F01/SOPQA017-00.
1.12.3
OJT Training schedule shall be prepared in such a way
that all the SOPs are covered twice a year.
1.12.4
Training schedule duly signed by the concerned HOD
shall be sent to the Head QA for approval.
1.12.5
Controlled /Reference copies of SOPs shall be used to
give On the Job Training.
1.12.6
If the OJT training is conducted with in the
department, training attendance shall be recorded as per Format
No.:F02/SOPQA017-00.
1.12.7
If the OJT training is conducted in conference hall as
a group, training attendance shall be recorded as per Format No.:
F08/SOPQA017-00.
1.12.8 Approved training schedules can be changed if
required, after taking approval from
Head QA.
1.12.8
Department head shall prepare the ‘Training
identification matrix’ as per the
Format No.: F07/SOPQA017-00.
1.12.9 ‘Training identification matrix’ shall be
updated as per the changes in the
employee’s
job responsibility.
1.12.10 Employees shall undergo
training on SOPs as per the‘Training identification
matrix’.
1.12.11 The person who performs the
activity for the first time shall be treated as a new
trainee irrespective of their
previous experience.
1.12.10
All the new trainees shall receive direct training in
each task they are going to perform in their respective departments i.e. as per
the ‘Training identification matrix’.
1.12.11
OJT training direct evaluation shall be carried out as
per
Format No.: F10/SOPQA017-00 and Indirect evaluation shall be carried as
per
Format No.: F11/SOPQA017-00.
1.12.12
After taking evaluation, employee shall be allowed to
perform the related tasks as per respective SOP.
1.13
GMP
Training
1.13.1
All the
employees shall be provided training to know the importance of GMP aspects with
respect to their job activity.
1.13.2
QA shall prepare
‘GMP Training schedule’ as per Format No: F01/SOPQA017-00 and this shall
be approved by Head QA.
1.13.3
QA shall conduct the GMP trainings as per the
schedule.
1.12.9
GMP training shall be conducted in conference as a
group, training attendance shall be recorded as per Format No.:
F08/SOPQA017-00.
1.13.4
GMP evaluation can be oral, written or combination of
both.
1.13.5
GMP evaluation shall be carried out as Format No:
F03/SOPQA017-00.
1.14 Proficiency
Training (PT)
1.14.1
This training is categorized into Internal and
External training.
1.14.2
Internal training: The training, which is conducted
within the facility by internal or external trainers.
1.14.3
External training: The training, which is conducted by
the external trainer at out side the facility.
1.14.4
The objective of this training is to improve the
knowledge of the employee and expertise them in their respective areas.
1.14.5
Internal training attendance shall be recorded as per FormatNo.:F08/SOPQA017-00.
1.14.6
External training attendance shall be recorded as per
Format No.: F05/SOPQA017-00.
1.14.7
Internal training shall be assessed by oral/written or
combination of both.
1.14.8
External training need not be assessed.
1.15 Grading
1.15.1 Grading shall be given as per the below
table.
|
S.No.
|
Percentage
|
Grade
|
Category
|
Remarks
|
|
1
|
Below 70
|
C
|
||
|
2
|
70 - 80
|
B
|
Good
|
-
|
|
3
|
81 - 90
|
A
|
Very Good
|
-
|
|
4
|
91 - 100
|
A+
|
Excellent
|
-
|
*If the
person scores below 70%, he shall be retrained on the same topic.
1.16 List of
Formats
|
Format No.
|
Title
|
|
F01/SOPQA017-00
|
Training
Schedule
|
|
F02/ SOPQA017-00
|
Training
attendance record
(In
department)
|
|
F03/ SOPQA017-00
|
Training
Evaluation Record (GMP/PT)
|
|
F04/ SOPQA017-00
|
Employee
Training Record
|
|
F05/ SOPQA017-00
|
External
Training Record
|
|
F06/ SOPQA017-00
|
Circular
for Interoffice communication
|
|
F07/ SOPQA017-00
|
Training
Identification Matrix
|
|
F08/ SOPQA017-00
|
Training
Attendance Record
(In conference hall)
|
|
F09/ SOPQA017-00
|
Induction
Training Report
|
|
F10/ SOPQA017-00
|
On
the Job Training Evaluation (Direct)
|
|
F11/ SOPQA017-00
|
On
the Job Training Evaluation (Indirect)
|
VI. REVISION SUMMARY
|
Version No.
|
Revised on
|
Reason for Revision |
|
00
|
NA
|
NA |
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