Solve engineering problems in a biomanufacturing environment
Overview
This standard identifies the competences you need to solve engineering problems in a biomanufacturing environment, in accordance with approved procedures. You are required to take prompt and appropriate action to rectify the engineering problem. 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 investigate the problem, obtaining all the necessary information to enable you to identify and evaluate possible solutions, and their effects on both the engineering process and the people involved. You will also be expected to decide on a plan of action, and to communicate this to the relevant people.
Your responsibilities will require you to comply with health and safety requirements and organisational policy and procedures for the problem solving 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 problem solving procedures. You will have an understanding of the engineering problem solving principles used, in adequate depth to provide a sound background for carrying out the activities to the required specification.
You will understand the safety precautions required when carrying out the biomanufacturing activities for scientific operations and processes. You will be required to demonstrate safe working practices throughout, and will understand your responsibility for taking the necessary safeguards to protect yourself and others in the workplace.
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 take prompt action to diagnose and rectify the operational problems, and keep all relevant people informed of progress
P4 obtain all relevant information relating to the problems
P5 identify correctly the nature and extent of the problems
P6 evaluate all realistic engineering solutions to rectify the problems
P7 identify the most effective engineering solution for rectifying the problems
P8 ensure that engineering solutions are implemented correctly and promptly
P9 ensure that the rectification complies with all relevant regulations and guidelines
P10 communicate the required information about the work done, to senior management and other authorised people, in accordance with 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 the standard operating procedures, as set down in local biomanufacturing operating manuals
K3 the importance of following equipment manufacturers’ operating instructions
K4 the principles of Good Manufacturing Practice (GMP) applied in the workplace
K5 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
K6 the manufactured product and batch process tracking and records system
K7 the types of handling and sorting system, and the procedures used for products undergoing processing in the manufacturing facilities
K8 the importance of correct identification, and any unique organisational or manufacturing numbers
K9 the organisational requirements for maintaining the security of the workplace
K10 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K11 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K12 how to obtain details of engineering problems
K13 the criticality of different types of problem, and how to prioritise the problems to be solved
K14 how to obtain and interpret drawings, charts, specifications, manufacturers’ manuals, history/maintenance reports and other documents needed for the problem solving process
K15 the engineering processes and operating procedures within the area of your responsibility
K16 the engineering principles and processes within the engineering function where the problem exists
K17 how to obtain any necessary ancillary equipment to support the investigation or solution to the problem under investigation
K18 the types and effects of engineering problems in the biomanufacturing environment
K19 the factors that have to be taken into account when selecting the solution to a problem
K20 the techniques used to obtain information on problems, and the sources of information
K21 the methods and techniques involved in problem solving
K22 the methods and techniques involved in evaluating information
K23 how to obtain and interpret legislative and regulatory documentation
K24 how to obtain and interpret company policy and personnel procedures
K25 how to retrieve necessary data from company information systems
K26 the types of monitoring systems/techniques available, and their application
Scope/range
1. carry out all of the following activities:
1.1. discuss/consult with the relevant people on the nature and extent of the problem
1.2. gather information from appropriate sources to help identify and define the problem
1.3. identify and evaluate possible solutions, considering temporary, short term and long term solutions
1.4. communicate the proposed solution to the relevant people, obtaining feedback where appropriate
1.5. prepare a plan of action for implementation of the appropriate solution
1.6. ensure that the agreed solution is implemented in an effective and timely manner
1.7. ensure that the agreed solution complies with appropriate regulations and guidelines
1.8. monitor the implementation of the solutions and make necessary revisions to the plan of action
take action to resolve engineering problems arising from four of the following:
2.1. packaging quality problem
2.2. material handling devices
2.3. equipment malfunction
2.4. ergonomic related
2.5. utilities supply (gas, electricity, water, air, etc)
2.6. safety related
2.7. personnel problem
2.8. external contractual problem
2.9. lack of resources/materials
2.10. environmental problem
2.11. change to customer requirements
2.12. design related
2.13. deviation from standard operating procedures
2.14. change in regulatory requirements
2.15. other (please specify)evaluate possible solutions to the problems, by considering all of the following:
3.1. operational effectiveness
3.2. ease of implementation
3.3. timescale for implementation
3.4. financial impact
3.5. functionality of the system
3.6. environmental impact
3.7. staffing implications
3.8. conformity with regulations
3.9. health and safety implications
3.10. other (please specify)obtain and use information on the problem from four of the following:
4.1. statistical data
4.2. historic records (such as maintenance/shift logs)
4.3. quality audits
4.4. external sources
4.5. feedback from users or colleagues
4.6. operating procedures/manufacturing manuals
4.7. company standard operating procedures
4.8. health and safety information
4.9. environmental monitoring documents
4.10. observationimplement engineering solutions that comply with:
5.1. regulatory requirements
For two of the following timescales:
5.2 temporary (interim solution)
5.3 short term (which require further action)
5.4. long term (permanent solution)record details of the problem solving work, and communicate the details to the appropriate people, using:
6.1. verbal report
Plus one method from the following:
6.2. written or typed report
6.3. specific company documentation
6.4. computer-based record
6.5. electronic mail