Monitor the transfer of materials in the biomanufacturing environment
Overview
This standard identifies the competences you need to monitor the transfer of materials for biomanufacturing processing operations, in accordance with approved procedures. You are required to check the readiness of the mechanical equipment used for lifting and moving. You will be required to work to the relevant standard operating procedures, legislation and organisational policy, and to follow Good Manufacturing Practice (GMP). You will also be required to present records and details of your biomanufacturing work to the appropriate people.
You will be required to check that the area and equipment are clear, cleaned and prepared correctly, and that the appropriate services are available as stated in the instructions and standard operating procedures you are given. You will also complete all the required documents and paperwork in accordance with these same instructions and procedures.
Your responsibilities will require you to comply with health and safety requirements and organisational policy and procedures for the biomanufacturing work that is undertaken. You will be required to report any problems with the biomanufacturing activities that you cannot personally resolve, or that are outside your permitted authority, to the relevant people.
Your underpinning knowledge will be sufficient to provide a sound basis for your work, and will enable you to adopt an informed approach to lifting and moving procedures. You will have an understanding of the preparations and checks used, in adequate depth to provide a sound background for carrying out the biomanufacturing activities to the required specification.
This activity is likely to be undertaken by someone whose work role carries out Science/Bio manufacturing work activities. This could include individuals working in the following industries, Chemical, Pharmaceutical and Life Science industries.
Performance criteria
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 biomanufacturing environment
P3 choose the right equipment/techniques to move the materials
P4 check that the weight of the materials does not exceed the safe lifting capacity of the equipment chosen
P5 check that the materials to be moved are correct, safely loaded and secure
P6 move the materials to their correct location, in accordance with instructions
P7 identify any problems with the material transfer
P8 take appropriate action to solve problems which are within your permitted authority/responsibility
P9 report any problems that you cannot solve or that are outside your permitted authority to the appropriate person
P10 return any equipment you have used to its correct location on completion of the activities, and leave it in a safe and reusable condition
P11 complete all required documents with the specified information, in the required format and at the appropriate time
P12 record all information accurately and legibly
P13 monitor and lead the quality and delivery of the above outcomes for yourself and your team
P14 communicate the required information about the work done, to authorised 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 biomanufacturing activities
K2 the implications of not taking account of legislation, regulations, standards and guidelines when conducting biomanufacturing activities
K3 the standard operating procedures, as set down in local biomanufacturing operating manuals
K4 the importance of following equipment manufacturers’ operating instructions
K5 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K6 the importance of wearing protective clothing, gloves and eye protection when handling materials (including biochemical substances, biological pathogens and/or antigens), and the equipment used to contain and process them
K7 the biomanufacturing materials and batch process tracking and records system
K8 the types of handling and sorting system, and the procedures used for materials undergoing processing in the manufacturing facilities
K9 the importance of correct identification, and any unique organisational or manufacturing numbers
K10 the organisational requirements for maintaining the security of the workplace
K11 the lines of communication and responsibilities in your department, and their 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
K13 how to monitor and lead the quality and delivery of materials in biomanufacturing process operations
K14 the area and the pieces of equipment which should be ready
K15 the documents that must be collated and verified for the movement of materials
K16 the procedures for checking the availability of materials
K17 the amount of materials required by the specification
K18 the procedures for reporting problems with documentation, materials check, materials availability and materials delivery
K19 the different types delivery procedure, and the documentation associated with each type
K20 the range of equipment used to move materials, and the handling techniques to use
K21 the quality standards of the required materials
K22 what to do with damaged and incorrect materials
K23 where materials, and the equipment used for their transport, should be stored
K24 the manual handling techniques that must be used in the workplace
K25 whom to inform on completion of the materials movement
Scope/range
1. monitor the following of standard operating procedures for lifting and moving that include all of the following:
1.1 health and safety regulations
1.2 lifting/moving equipment operating instructions
1.3 safe working practices
1.4 company standards and procedures
monitor the movement of materials by both of the following types of equipment:
2.1 hand operated
2.2 power operatedcarry out of all of the following checks on the materials to be lifted and moved:
3.1 they are the materials specified on the documentation
3.2 the materials are stacked safely
3.3 the materials are in a suitable condition for the moving operation
3.4 the materials in the load are secure
3.5 the are no restrictions/obstacles preventing movementmonitor the movement of all of the following categories of materials:
4.1 ingredients for fermentation/manufacture
4.2 finished manufactured products
4.3 consumable process materials
4.4 waste materialsmonitor the movement of material by manual lifting for three of the following conditions:
5.1 materials on the ground
5.2 materials below ground level
5.3 materials at waist height
5.4 materials above head heightmonitor the movement of materials by three of the following mechanical aids:
6.1 forklift truck
6.2 overhead cranes
6.3 pallet truck
6.4roller/ball conveyor surfacesrecord details of the preparation work, and communicate the details to the appropriate people, using:
7.1 verbal report
Plus one method from the following:
7.2 written or typed report
7.3 computer-based record
7.4 specific company documentation
7.5 electronic mail