Planning and Scheduling Resources for Toxicity
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SEMLABS4_09Planning and scheduling resources for toxicitystudies
SEMLABS4_09 Planning and scheduling resources for toxicity studies 1
Overview This unit covers the competences you need to plan and schedule resources for
toxicity studies and projects, in accordance with approved procedures. You arerequired to identify the toxicological study objectives and its scope, and to
develop a detailed project plan for its delivery. You will be required to identify
staff with the individual skills and abilities for the project. You will also be
expected to determine and agree the individual roles and responsibilities of the
staff, and to set realistic and achievable goals for both the individuals and the
study team as a whole.
You will be expected to obtain the appropriate authority and support for the use
of these resources, people, work space/work area, documentation and
information. You will be required to work to the relevant standard operatingprocedures, legislation and organisational policy, and to follow Good
Laboratory Practice (GLP) and/or Good Clinical Practice (GCP)/Good
Manufacturing Practice (GMP). You will be required to present your evaluation
to the appropriate people.
Your responsibilities will require you to comply with organisational policy and
procedures for planning and scheduling toxicology projects, and to report any
problems that you cannot personally resolve to the relevant authority. You will
be expected to work unsupervised, either on your own or as part of a team,
which you may lead or direct, taking full responsibility for your actions and,
possibly, for the work of colleagues or subordinates.
Your underpinning knowledge will provide a good understanding of general and
discipline-specific toxicological study principles and processes, as well a good
project planning and management methodology. You will also be fully
conversant with organisational procedures and systems. You will understand
research planning principles, and the process and methodology for toxicity
studies, in sufficient depth to enable you to carry out the planning and
scheduling activities to the required standard.
You will be fully aware of any health, safety and environmental requirements,
and the appropriate legislative and regulatory frameworks, applicable to your
area of responsibility. You will be required to ensure that safe working practices
are maintained throughout, and will understand the responsibility you owe to
yourself and others in the workplace.
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Performancecriteria
You must be able to: P1 ensure that your work is carried out in accordance with standard
operating procedures
P2 wear the appropriate personal protection equipment (PPE) when working
in the laboratory environment
P3 work safely at all times, complying with health and safety and other
relevant regulations and guidelines
P4 develop a plan which accurately identifies the project aims and
objectives
P5 form the project team, comprising the right mix of personnel to deliver the
study objectives
P6 determine and agree individual roles and responsibilities within the studyteam
P7 obtain authority and support for the release of the necessary resources
to carry out the project
P8 deal promptly and effectively with any problems within your control and
report those that cannot be resolved
P9 record and communicate the outputs from the toxicological study to the
appropriate people
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Knowledge andunderstanding
You need to know and
understand:
Sector specific
K1 the health and safety requirements of the area in which you are carrying
out the laboratory activities
K2 the implications of not taking account of legislation, regulations,
standards and guidelines when conducting laboratory activities
K3 the standard operating procedures, as set down in local laboratory
operating manuals
K4 the principles of Good Laboratory Practice (GLP) and/or Good Clinical
Practice (GCP)/Good Manufacturing Practice (GMP) applied in the
workplace
K5 the Home Office regulations for the use of animals in scientific
procedures (such as Animals (Scientific Procedures) Act)
You need to know and
understand:
Organisation specific
K6 the importance of wearing protective clothing, gloves and eye protection
when handling laboratory samples for analysis
K7 the laboratory sample reception, records database and tracking system
K8 the types of handling and sorting system used, and the procedures and
practices used for transferring specimens/samples within the laboratory
while undergoing processing
K9 the importance of using the correct identification, and any uniqueorganisational or laboratory numbers for specimens/samples
K10 the organisational requirements for maintaining the security of the
workplace (eg, workplace access and laboratory sample containment)
K11 the lines of communication and responsibilities in your department, and
the links with the rest of the organisation
K12 the limits of your own authority and to whom you should report if you
have problems that you cannot resolve
You need to know and
understand:
Equipment/Process specific
K13 the purpose and context of the toxicity studies within the project
K14 the requirements of your scientific and regulatory objectives
K15 how to identify the project scope to determine the resource requirements
K16 how to develop specific, measurable, realistic project objectives and
deliverables, allowing progress to be monitored and measured
K17 the tools and techniques available for project planning and monitoring
K18 how to communicate effectively, listen and question, provide feedback,
support and coach others
K19 how to break the project down into individual deliverable tasks
K20 how to form and develop the project team required to meet the identified
objectives
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SEMLABS4_09 Planning and scheduling resources for toxicity studies
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K21 how to allocate specific tasks and responsibilities to the project team
members, according to individual skills and abilities
K22 how to determine the specialist help you may require in the project, and
how this can be obtained
K23 how to conduct a planning and scheduling meeting
K24 how to present information effectively to management, peers, team
members and customers
K25 how to solve problems and overcome barriers/difficulties encountered
K26 with whom to liaise, and from whom to obtain relevant and specific
information to support and assist you in scheduling resources
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Additional InformationScope/range
related toperformancecriteria
You must be able to:
1 develop project plans for all of the following:
1.1 full cost of the resources
1.2 timescale required for the project
1.3 resources required
1.4 individual tasks within the project
1.5 milestones and deliverables to be met
1.6 study data collection and format
2 identify and quantify requirements for five of the following resources:
2.1 staff
2.2 animals
2.3 technological
2.4 compound
2.5 facilities required
2.6 other (please specify)
3 collect and communicate key project information from/to all of the
following:
3.1 management
3.2 colleagues in your peer group
3.3 staff involved in the study/project
3.4 toxicology customers
4 record details of the work done, and communicate the details to the
appropriate people, using both:
4.1 verbal reportPlus one method from the following:
4.2 written or typed report (e.g. laboratory notebook)
4.3 specific company documentation
4.4 computer-based record
4.5 electronic mail
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SEMLABS4_09 Planning and scheduling resources for toxicity studies
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Developed by SEMTA
Version number 1
Date approved January 2009
Indicative reviewdate
December 2014
Validity Current
Status Original
Originatingorganisation
SEMTA
Original URN O45NLAB4-09
Relevantoccupations
Associate professionals and technical oc; science and mathematics; science;
science and engineering technicians
Suite Laboratory science suite 4 2009
Key words laboratory; workplace; toxicity; studies; planning; scheduling; resourcing