Monitor and evaluate performance data from a Manufacturing Information Management System
Overview
This standard covers the competences you need to monitor and evaluate performance data in a Manufacturing Information Management System (MIMS), in accordance with approved procedures. You are required to access and analyse MIMS data against performance target set for manufacturing. 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 obtain and interpret manufacturing data and records, obtaining all the necessary information to enable you to identify and evaluate performance against the production targets set, where these targets are not met and their effects on both the biomanufacturing 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 organisational policy and procedures for the monitoring and analysis of manufacturing performance data that is undertaken. You will be required to report any problems with the performance 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 monitoring and analysing manufacturing performance data. You will have an understanding of the MIMS, the manufacturing methods and principles used, in adequate depth to provide a sound background for carrying out the biomanufacturing 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 use correct passwords to access the relevant manufacturing databases, and maintain the security and integrity of information
P3 use correct search procedures to locate the appropriate performance data on the Manufacturing Information Management System (MIMS)
P4 select the correct manufacturing data files and compare expected plant and equipment performance target against actual performance
P5 select the correct manufacturing data files and compare expected production output and operating times against actual performance
P6 compare expected staff utilisation against actual utilisation and identify inconsistency
P7 investigate deviations from expected resource performance and take appropriate action in accordance with defined procedures
P8 communicate manufacturing information 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 standard operating procedures, as set down in the local manufacturing process operating manuals
K7 the data security requirements for different computer applications, and the accessing and storage of data
K8 how to access and store data, in accordance with standard operating procedures and organisational practices
K9 why it is important to maintain accurate batch and departmental records for products manufactured
K10 the policies and procedures for the accurate registration of new batches/products on the Manufacturing Information Management System (MIMS)
K11 the specific safety precautions to be taken when working with computer systems (to include such things as safety guidance relating to the use of visual display unit (VDU) equipment and workstation environment (including lighting, seating, positioning of equipment), repetitive strain injury (RSI); the dangers of trailing leads and cables; how to spot faulty or dangerous electrical leads, plugs and connections)
K12 why it is important to maintain good housekeeping arrangements (including putting disks, manuals and unwanted items of equipment into safe storage; leaving the work area in a safe and tidy condition)
K13 the importance of correct identification, and any unique organisational or manufacturing numbers
K14 the lines of communication and responsibilities in your department, and their links with the rest of the organisation
K15 the limits of your own authority and to whom you should report if you have problems that you cannot resolve
K16 the correct start-up and shutdown procedures to be used for the computer system
K17 how to use the Manufacturing Information Management System (MIMS) database access manufacturing performance data
K18 the sources of performance information within the MIMS and how this data can be retrieved for analysis and evaluation purposes
K19 how to select and interpret data from customer service delivery and works orders
K20 how to select and interpret data from production schedules and manufacturing specifications
K21 how to select and interpret data on product specifications
K22 how to select and interpret data on work-in-progress records
K23 how to select and interpret data on quality audits and control records
K24 how to prepare and present information on manufacturing performance
K25 the application of the business’s key measures of competitiveness (including delivered right first time, delivery schedule achievement, people productivity, stock turns, overall equipment effectiveness, value added per person, floor space utilisation)
Scope/range
1. review performance data for four of the following:
1.1. customer service and delivery
1.2. plant and equipment records
1.3. manufacturing output records
1.4. quality audit reports
1.5. allocation of staff records
1.6. stock control records
1.7. manufacturing costs
1.8. operating procedures/manufacturing manuals
1.9. company standard operating procedures
1.10. health and safety information
1.11. environmental monitoring documents
1.12. other (please specify)
analyse performance for all of the following:
2.1. operational effectiveness
2.2. delivered quality
2.3. allocation of time and resources
2.4. financial impact
2.5. process flow
2.6. training and development
2.7. environmental impact
2.8. staffing implications
2.9. conformity with regulations
2.10. health and safety implications
2.11. other (please specify)record details of work done, and communicate the details to the appropriate people, using:
3.1. verbal report
Plus one method from the following:
3.2. written or typed report
3.3. specific company documentation
3.4. computer-based record
3.5. electronic mail