SOP for TRAINING AND CERTIFICATION OF ANALYST

1.0     Objective:

To lay down guidelines for training of new entrants and periodic retraining of technical staff.

2.0       Scope:

To define role/responsibility of various functions responsible for technical training.

3.0       Responsibility:
3.1.      QA Manager is responsible for conducting internal and external training as per the annual

            schedule

3.2.      Departmental Head shall give training for the analysis of the sample and documentation.

3.3       Technical Manager is Overall responsibility to assess the training needs and ensure that   

training is conducted as per the annual schedule with QA.

3.4       The Technical Manager with the help of QA Manager shall give GLP training.


4.0       Procedure:

4.1.      New Entrance:

4.1.1    New entrants to the organization shall be given induction training by departmental wise and a brief introduction training for ISO 17025/GLP training by TM/QAM within 10 days of joining.

4.1.2    New entrants should be given technical training (need based) by the Departmental Head

            depending upon the nature of job for one month.

4.1.3    New entrant should be instructed to observe the activity in the recruited department for

            one month after the initial induction program.
4.1.4    A written feedback is collected from new entrants after the training to ascertain his/her

            competence in both technical and GLP skills.
4.1.5    QA Manager shall prepare a regular annual schedule for training/retraining of technical      staff.
4.1.6    The Qualified trainer who has conducted the training should review and assess the

feedback.
4.1.7    Based on the assessment, trainer shall identify training retraining needs.
4.1.8    Individual Training record should be maintained for each new entrant along with their

feedback.
4.2       Regular Training:
4.2.1    Based on the need/requirement, a schedule along with a module should be prepared for the

staff and accordingly training session should be conducted.
4.2.2    A training session by the QA Manager should be conducted for the following.

i) If any critical changes are made in the Standard Operating Procedure, training has to be

   conducted to the concerned departmental personnel

ii) If any new equipment is installed, the staff and the operator has to be trained on the

    operation, cleaning, Maintenance and trouble shooting for the equipment.

4.2.3    List of participants with their signatures should be documented during the training session

            by the Quality Assurance department.
4.2.4    For any minor changes in SOP or process, the Qualified Trainer should give training at the

            work place and the same should be documented.

4.3       Training schedule:

4.3.1    New entrant
General Laboratory rules and GLP –1 week.
Technical training – one month 

4.3.2    Regular training for staff.

4.3.2.1 GLP/ISO 17025- Once in 6 months.

4.3.2.2 Technical training – Once in 6 months.

4.3.3    A training session by an External Agency shall be conducted as and need/opportunity

            arises.
4.3.4    Apart from the schedule, training/retraining sessions will be conducted as and when need

            arises.

4.3.5    TM  should write the evolution about training .

5.0              Documentation:

Annexure 1       Training Programme            XXX/QF/0000

Annexure 2        Training Record                  XXX/FRM/000-00
6.0       History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

ANNEXURE 1

RECORD OF PLANNING AND EXECUTION TRAINING    XXX/QF/0000

Sr. No.	Name of Employee (Designation)	Training particular	Training Planned	Internal / External	Training executed date	Date of Evolution	Remark signature of TM

Annexure-2

TRAINING RECORD

Name of Trainee:	Date:
Name of Trainer:	Department:
Duration:   From :                        To:	Subject:

DETAILS ABOUT TRAINING: (Working / Operation)

EVOLUTION ABOUT TRAIINING :

Sign of Trainee:                                                                                      Sign of Trainer:

SOP Reference: XXX/SOP/000-00                                              Format No. : XXX/FRM/000-00