SOP Title:

AssureLab Medical Laboratory

Page 1 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

I. Purpose:
The purpose of this procedure is to establish and define an internal training program and to
ensure the competency of laboratory personnel. Training and training verification are key
factors for successful laboratory operations.
II. Policy:
This is a policy for the effective training in the use of re-usable medical devices. The policy identifies
the key duties and responsibilities of staff in respect of training, competence and documentation.
III. Scope:
This training procedure is used to ensure that training has taken place with each employee for
procedures and methods that the employee performs. The procedure applies to on-the-job
training, in-house training and new-hire training. The training is verified and recorded. The
training procedure is applicable to new employees, for the introduction of new procedures and
methods, for retraining of employees, and for reverification of employee performance.
IV. Responsibilities:
A. Laboratory Management
1. Ensures implementation of training procedure.
2. Ensures resources are allocated for identified training within budgetary constraints.
3. Responsible for the evaluation, training and growth of the technical and quality relate
skills of employees by establishing training schedule and rotation for all new employees
and by ensuring personnel receive training and demonstrate competence.
4. Maintains employee training records.
5. Ensures proper supervision of trainees until training completed.
6. Ensures training records are complete.
7. Monitors employee performance to identify the need for retraining or additional
continuing education.
8. Identifies training needs resulting from new or revised procedures and processes.
9. Authorizes personnel to perform specific laboratory activities.
10.Ensures and records continued competency of employees.
11.Has relevant knowledge of the technology, methods and procedures used, purpose of
each test, and an understanding of the significance of deviations found with regard to the
normal use of the items, materials, products, etc. concerned within their area of responsibility.

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 SOP Title:
AssureLab Medical Laboratory
Page 2 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

B. Quality System Manager (QSM):

1. Ensures training is conducted and recorded for quality management system policies and
procedures.
C. Staff:
1. Completes required training within specified timeframe.
2. Becomes and stays knowledgeable in procedures and methods performed , NOTE:
Employees are responsible for self-training, through reading current literature, technical
papers, publishing technical papers.
3. Ensures all FDA mandated training, i.e. annual ethics, computer security, etc., is
completed and certificate submitted to local training coordinator.
4. Reads and complies with standards, regulations, policies, procedures, and work
instructions.

V. Definitions and Abbreviations:

A. Procedure – This is a description of the sequence of steps leading to a

defined outcome or product. A procedure can be technical or administrative.
B. Retraining – Retraining is required when assessments show less than
satisfactory performance or whenever significant changes occur in procedures or
processes.
C. Reverification – This is a process that ensures employees remain at an
acceptable level of performance.
D. Trainer – Trainers are 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.
E. Training Methods - The process of training and criteria for success are
defined.
F. Training checklist – The training checklist is prepared from the procedure by
defining all steps to perform a procedure for the verification of employee’s
competency.
H. Training Verification – This is a systematic approach to demonstrate that the
training outcome is successful.

VI. Procedure:
6.1. Training and Competency Requirements

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 SOP Title:
AssureLab Medical Laboratory
Page 3 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

Before starting any work-related duties, the employee will be familiar with work related
documents. These documents include procedures, work instructions, applicable manuals and
regulations. Employees undergoing training are supervised until training is completed and
competency demonstrated.
A. Training requirements are outlined and documented on the basis of the position description
of duties and responsibilities.
B. New hires complete applicable Office of Training, Education, and Development (OTED)
New Analyst Training Curriculum.
C. Training and competency is determined by the employee’s educational qualifications,
experience, complexity of the test method, and knowledge of the test method performed.
D. The employee will not perform any procedure, inspection, or method until all applicable
training has been completed and competency demonstrated.
E. Employees may request training related to their duties. OTED posts training and
development services for ORS staff on an annual basis. Included in these services are
classroom courses, downlinks, lending library, certification and web-based courses.
F. Employees submit records to supervisor and/or training coordinator for filing upon
completion of training.
G. Training and competency records shall be maintained according to local policy.
H. The effectiveness of training is evaluated by but not limited to reviews performed by
management and performance evaluations.

6.2. Training Technique

A. The training process for technical procedures such as laboratory analysis consists of
the following steps:
1. Trainee reads the laboratory procedures, work instructions, or other applicable documents.
2. Trainee observes demonstration of the procedure by a trainer.
3. Trainee performs the procedure under observation by a trainer.
4. Trainee successfully completes the procedure independently.
B. The training process for non-technical procedures includes, but is not limited to:
1. Reading laboratory procedures,
2. Instructions,

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 SOP Title:
AssureLab Medical Laboratory
Page 4 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

3. Demonstrations,
4. Lectures and discussions,
5. Self-study,
6. Computer-based training,
7. Viewing videos, and
8. Manufacturer’s training or demonstration.
C. An employee’s performance is verified by measurement against a defined performance
standard. The measures used to verify an employee’s performance are assessment tools.

6.3. Assessment tools

A. Administration of a Written Evaluation.
B. Observation of Procedure, Process, or Outcome.
C.Verification of Response to Situational Problems or Calculations Related to the Procedure.
D. Response to Oral Queries Related to a Step or Procedure: Answers provided by
the employee to questions asked by trainer.
E. Testing Blind QC Samples.
F. Testing of Known Samples.
G. Testing Previously Analyzed Samples.

6.4. Demonstration of Competency

A. Competency assessment is one method to verify that analysts are competent to perform
testing and report accurate and timely results.
B. To be competent, an analyst must know how to perform a test, have the ability to perform
the test, be able to perform the test properly without supervision, and know when there is a
problem with the test that must be solved before reporting results.
C. The major technologies (at minimum the items on accreditation scope) require
demonstration of initial and ongoing competency by any of the following tools:
Competency Demonstration Examples

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 SOP Title:
AssureLab Medical Laboratory
Page 5 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

Examples Item Description Assessment Item

On-site review This is the actual observation of the Direct observation of test
analysis and maintenance procedures performance and instrument
and checks of instruments as it is being maintenance and function checks
performed by the analyst

Worksheet review & Review of results for the proper and Direct observation of test
FACTS entries correct recording and reporting performance and instrument
maintenance and function checks
QA spreadsheets (chem.) & This is as it is implied, review of Review of intermediate checks,
Pos/Neg controls (micro); checks, QC results, PT results, QC results, proficiency test
Control within acceptable results,
limits;
Evaluate results obtained Unknown samples Assessment of test performance
with known results through external/internal PT’s

6.5. Authorization of Personnel

A. Laboratory management authorizes personnel to perform specific laboratory activities as
defined in local policies and procedures.
B. When personnel are authorized for a portion of a method, the training records must
indicate which parts of the method the employee has received training.
6.6. Training and Competency Records
A. Training and competency records are maintained.
B. Training records should include a description of the training, the trainee name, the trainer,
dates of training, and indication of successful completion. Training records are archived for
exiting employees.

6.7. Retraining and Reverification

6.7.1. Retraining:
A. Employees will be retrained whenever significant changes occur in policies,
values, goals, procedures, processes, and methods or instruments.

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 SOP Title:
AssureLab Medical Laboratory
Page 6 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

B. Employees will be retrained when the level of performance is unsatisfactory.

6.7.2. Reverification.
6.8. Required Training
All analysts and laboratory staff members are to undergo training in a number of procedures,
policies and practices upon entry of employment and during their career with FDA. What
follows are types of required training and they may vary from employee to employee based
on duties.
6.8.1. Facility Orientation
A. New employees completing required administrative forms as part of initial processing.
B. Introduction to co-workers, personnel policies, working conditions, daily routine
issuance of manuals, quality assurance system and any miscellaneous matters.
6.8.2. Safety Training (may include the following topics):
A. Blood-borne pathogen standard.
B. Hazard communication standard (Right to Know).
C. Personal protective equipment.
D. Security briefing.
F. Safety briefing.
G. Radiation protection training.
H. Fire extinguisher training.
I. Emergency evacuation.
J. Safety practices in the laboratory.
K. Chemical Hygiene.
L. Hazardous Waste Management that includes annual training on handling storage,
and disposal of hazardous materials.
VII. Documentation Requirements:
None.

VIII. Written by:

Naba’ Matarneh.

IX. Reviewed and Revised by:

Sallam Alhassoon, B.Sc., M.Sc.

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 SOP Title:
AssureLab Medical Laboratory
Page 7 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

X. References:
A. FDA staff manual. Guide 3120.1 Personnel – Staff Development and Training.
B. ISO/IEC 17025:2017, General requirements for the competence of testing and calibration
laboratories, Section 6.2.
C. AOAC International Guidelines for Laboratories Performing Microbiological and
Chemical Analysis of Food, Dietary Supplements, and Pharmaceuticals – An Aid to
Interpretation of ISO/IEC 17025:2017; August 2018.
XI. Revised by:

Revised By Date Signature

XII. Document History Record:

Version Effective Date Reason For Change

XIII. Staff Acknowledgment Log

Name Title Date Signature

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 SOP Title:
AssureLab Medical Laboratory
Page 8 of 8 Training and Competency

Date Originated: December 6, 2020 SOP No. : P-General-2/R0

Approved By AssureLab Director: Review Date: Biyearly Revision No.: 0

Reviewed by Chief Quality Officer: Date/ Signature:

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Not to be Reproduced / Disclosed Without Prior Written Approval