Planning and Scheduling Resources for Toxicity

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SEMLABS4_09Planning and scheduling resources for toxicitystudies 

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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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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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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