Establish and implement quality assurance processes in life sciences and related industries
Overview
This standard is about developing and implementing quality assurances
processes and procedures. You will be expected to identify and
develop the processes and procedures that are relevant to the
organisation. You will use your technical knowledge and skill to
ensure that the company meets all external requirements. You will
organise and monitor internal procedures and liaise with any
external body as required. You will be expected to take
responsibility for overall courses of action. You will exercise autonomy
and judgement within fairly broad parameters and understand
different perspectives or approaches used within the workplace.
Quality assurance is fundamental to many organisations. Efficient
systems that all employees adhere to are essential if the company is to
maintain the quality of its products and its reputation. Failure to
implement rigorous quality assurance system can result in essential
operating licences being withdrawn.
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 and quality procedures are maintained throughout,
and will understand the responsibility you owe to yourself and others in the
workplace.
Who this standard is for
The standard is recommended for more experienced staff, who may be
taking on more supervisory roles.
Performance criteria
You must be able to:
P1 ensure that your work is carried out in accordance with workplace procedures
to protect yourself and others
P2 establish processes that deliver scientific or technical outcomes based on
organisational goals and aims
P3 establish clear and precise criteria for assuring the quality of processes
and procedures for activities
P4 identify suitable quality assurance methods and techniques
P5 ensure that the specified quality assurance processes and procedures are
implemented correctly
P6 obtain accurate information from valid sources on the processes and
procedures being quality assured
P7 assess accurately the required processes and procedures quality against
actual execution
P8 recommend improvement to the quality of the processes and procedures
and/or the activities
P9 identify and determine appropriate quality monitoring arrangements for the
processes and procedures
P10 present the results of the work done to the appropriate people, in accordance
with departmental and organisational procedures
Knowledge and Understanding
You need to know and understand:
K1 the health and safety requirements of the area in which you are carrying out
the activities
K2 the legal and regulatory frameworks within which you are working and the
implications of failing to comply with either
the organisational requirements for maintaining the security of the
K3 the workplace business aims and goals and the planning process
how to identify and assess the scientific or technical requirements of your work
roles
K4 the different ways in which you are set your agreed personal work objectives
K5 how your scientific or technical activities add value through delivering
workplace products, services and processes
K6 the different perspectives and approaches that are important when exercising
autonomy or judgement about scientific or technical activities used
K7 the types of investigation initiated and used to review the effectiveness or
appropriateness of methods, action and results of your scientific or technical
work
K8 the quality criteria that could be used for different types of scientific or technical
processes and procedures
K9 the quality assurance methods that are available
K10 the methods used for recording and analysing scientific or technical processes
and procedures
K11 the relevant sources of valid information on scientific or technical
processes and procedures
K12 who should be involved in the scientific or technical quality assurance process
K13 who requires information on scientific or technical quality assurance, and the
procedures for informing them
K14 the types of recommendation that could emerge from the quality
K15 assurance process
K16 methods of presenting scientific or technical quality assurance
recommendations for improvements