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Laboratory Organization &
Personnel
KEMRI-Wellcome Trust Research Programme
2
Learning Objectives
At the end of this session, you will be able to
• Describe organizational elements needed for a GCLP
Laboratory.
• Discuss management roles and responsibilities in
organization.
• Describe the role of personnel in the organization.
• Develop a plan to train and verify employee
competency.
3
Learning Objectives
• Describe the steps involved in assessing and
maintaining employee competency.
• Identify potential sources of employee
performance problems.
• Able to explain a process to maintain
personnel records.
4
What is Organization?
• Social unit of people, systematically arranged and
managed to meet a need or to pursue collective
goals on a continuing basis.
• All organizations have a management structure
that determines relationships between functions
and positions, and subdivides and delegates roles,
responsibilities, and authority to carry out defined
tasks.
http://www.businessdictionary.com/definition/organization.html#ixzz17Ugx7ooN
5
Management Roles & Responsibilities
Organizational Structure
establish a working structure that
ensures sufficiency at all parts in the
laboratory work flow.
develop an organization chart, designate
responsibilities and roles.
6
Management Responsibilities
Develop Policies & Quality Systems (Improve)
• Implement and continuously improve the quality
system.
• Document and
communicate
to all personnel.
7
Management Roles & Responsibilities
Provide Leadership
• Exercising responsible authority, while
providing motivation and vision.
• Build the team that is cohesive.
• Influencing and encouraging staff
to good performance.
8
Management Roles & Responsibilities
Provide Resources
• Financial requirements/budget
• Review Personnel needs:
– additional staff
– skills, training needed
• Facilities, equipment,
supplies, computers
9
Laboratory Staff Responsibilities
Laboratory Staff
• Laboratory’s greatest
asset:
– critical to quality
– partners in public
health
– qualified professionals
10
Laboratory Staff Responsibilities
request training that may be needed as job
responsibilities increase;
maintain records of
personal professional
development
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PART 2
LABORATORY PERSONNEL
12
LAB STAFF TRAINING
• Why Train staff:
• To ensure that the staff is fit for purpose.
• To provide needed skills that meet service
requirements applicable to your organization’s
needs .
• To create awareness aimed at educating the
staff on relevance and importance of their
activities.
• To enable staff understand how they contribute
to achievement of quality objectives.
13
STAFF TRAINING
 Types of Training:
• Induction & Orientation
– Process by which a new staff is
integrated into organization's
system.
– All new staff should undergo
comprehensive induction program.
• Occupational Health &
Safety
– H & S enables staff to safely
undertake a task/role to comply
with Lab Bio-safety guidelines and
your organization’s safety policies.
– H&S Training should be mandatory
for both new & existing staff
• Job Training
– New staff is assigned to a Lab
section specific to the task.
– Staff on job training should rotate
through all areas of the Lab.
14
Orientation Training
15
Qualified New Employee
Job Description
Orientation
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
16
Methods of Training
• Coaching
– More intensive training.
– Involves a close working relationship between
an experienced employee and the trainee.
– Involves showing trainee how to do the job by
demonstration & providing instructions.
– Hands-on-the job
17
Methods of Training
• Workshops / tutorials
– Interactive learning in which learner &
facilitator share the learning activities.
– May involve online tutorials
– Certificate of attendance is issued after
successful completion of competency testing.
• Seminar / Conferences
– Training involves listening & questioning.
– Training is documented on attendance record.
18
When to perform staff Training!
• When staff is newly hired.
• When job responsibilities or duties change.
• When recommended as part of a corrective
action investigation.
• When new procedures are introduced.
• As part of annual training e.g fire drill
• After an unsuccessful competency
assessment.
19
COMPETENCY TESTING
• What is competency testing?
– A Systematic process that allows for a
measurable assessment of the staff’s ability to
perform required activities.
• Purpose of competency testing
– will assess the knowledge, skills and attitude
necessary to perform the job effectively.
20
When to initiate Competency Testing.
• After the initial On-Job training.
• Annually review that the staff maintains the
competence.
• When the roles and responsibility of the
staff changes.
21
Methods of Competency Testing
• Direct observation
– of routine assay or procedure performance.
– involve the observation of performance of
instrument maintenance and function checks.
• Blinded testing
– Assessments of test performance of previously
analyzed, well-characterized specimens.
– Previous EQA materials
22
Methods of Competency Testing
• vendors or suppliers competency
– Staff being trained by the manufacturer or
vendor
– involves the issuing of statement of competency
• Statement of Competency
– Based on long term experience known to Lab
management.
23
Competency Assessment Methods
• Direct Observation
checklists
Technologist Name
Procedure for
Evaluation
Procedure item
• Indirect Observations
– monitoring records
– re-testing
– case studies
Technologist Title
Evaluation Date
Accept
Partial
Evaluator
No
Comment
Read procedure
manual
Equipment set up
appropriately
Work area neat
Reagent preparation
Perform task
accurately
Perform task timely
Other: Specify
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Competency assessment documentation
• use standard forms
• date and keep
confidential
25
Competency Testing Ratings
Assessment Ratings should be defined
 3= competent to train and assess others.
 2= competent to perform the task independently
 1= needs more training
 Unsuccessful Competency Testing
– Corrective actions
– Sack/Fire?
26
DOCUMENTATION OF STAFF TRAINING
• Each trainee need Training Record Form
(TRF) in which every training will be
documented.
– The record will show the training activity,
– date of training initiation and completion
– and the name/initials of the trainer
• Training records filed in Personal Training
folder.
– Reviewed
– Audited
27
DOCUMENTATION OF STAFF TRAINING
• What is a Personnel Training File (PTF) ?
– Does any participant have the PTF?
• Provide evidence that an individual is fit to
perform the assigned tasks – correct
manner
– Possess appropriate education
– Are qualified
– Suitably trained
– Are experienced
28
Content of PTF
•
•
•
•
•
•
•
•
Formal qualification
Curriculum vitae
Job Description
Induction and Orientation Training
Record of Training Received- In house
Courses attended-Safety, QAQC, GCLP
Conferences & meetings attended
Record of Review
29
Job Descriptions
“Laboratory Management shall
have job descriptions that
define qualifications and duties
for all personnel.”
ISO 15189:2007
30
Job Description
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
31
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Job Description
• Describe the nature & level of work
performed.
• Define the purpose, responsibilities,
accountabilities and authorities of a job.
• Clear definitions of the line of authority
• Define knowledge, skills and abilities
required for the task
32
Job Description
• Each individual should have their own job
description.
• Signed and dated by individual staff and
their line manager.
• The current JD and the previous JD should
be retained in the individual’s training file.
33
CURRICULUM VITAE
• What is a Curriculum Vitae?
– Written summary of personal, educational
records and work history.
– Every staff member should maintain an updated
CV
• Purpose of CV
– CV speaks on behalf of an individual
34
Content of CV
•
•
•
•
•
•
•
Full name
Academic qualifications
Professional experience
Current & previous position held.
Achievements of relevance
Membership of relevant professional groups
Papers published
35
Personnel Records
Training Records
Performance
Appraisal
Competency Assessment
Kawuondo
Competency Assessmen
CONFIDENTIAL
36
Performance Appraisal
competencies
professional
behavior
adherence
to policy
observation
to safety
punctuality
customer
service
communication
37
37
Performance Appraisal Meetings
 formal
 regular
 constructive
 objective
 complete
 fair
 documented
38
38
Staff Equals
Workload
Job
Qualifications
Job
Descriptions
Performance
Appraisal
Personnel
Management
Continuing
Education
Orientation
Competency
Assessment
Training
39
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THANK YOU
COMMENTS !!
SUGGESTIONS !!
QUESTIONS ??
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