Increasingly strict regulatory measures are drawing attention to the systems and processes life sciences companies use to manage quality and delivery. Longer lifespans, increased level of inspection, rising customer demands and globalisation are all challenges that life science business needs to be able to adapt to in order to stay in business.
The goal of life science development activities is to design a product and processes to consistently deliver the intended performance and meet the needs of patients or consumers, regulatory authorities and customers’ requirements. Basically the expectation is that organisations need to have robust mechanisms to establish great process, put things right and keep it that way. Continuous improvement is a set of philosophies and tools that help support process development, problem solving and risk mitigation to ensure great quality, compliant products are produced every time.
This course is designed to explore the aspects of Continuous Improvement that work in the life sciences industry. Explore the theory and mind set required alongside practicing a selection of tools and techniques that will enable you to critically review and improve any process.
Over the 2 days you will go on a journey through a structured problem solving methodology. Using this structured approach you will carefully analyse a problem and learn how to generate effective solutions so that you can meet customer expectations and get it right first time.
Managers, quality professionals and practitioners that need to solve problems in the workplace to improve systems and processes.
Tutors will be comprised from the list below:
Vanessa Grant (Course Principal)
Director, VG Quality Solutions Ltd
Please note timings may be subject to alteration
|9.00||Welcome and Introduction|
|9.15||Continuous Improvement Introduction
An oversight of the scope, application and benefits of continuous improvement tools and techniques. An introduction to Lean principles.
|10.10||The Customer and Value
Specify value in the eyes of the customer and the business. Introducing Takt time.
|11.00||Value Stream Mapping
Identifying the value stream and eliminating waste. Practice creating a value stream map.
|13.15||Key Process Metrics
Consider process metrics - time and quality. Making your data count through use of control charts.
|14.00||Waste and Waste Identification
Identifying the 8 wastes and how to recognise them.
Understand why process maps are used and the types of process maps which are useful. Practice process mapping.
Introducing problem solving and pain point identification using our process maps.
|17.30||Close of day|
|9.00||Review of Day 1 and Questions and Answers
Discussion of issues raised by course delegates
|9.20||Root Cause Analysis
Understanding what root cause analysis is, why it is performed, the principles and tools available for use.
|10.45||Root Cause Analysis continued
Practical exercise in using the tools.
Understanding Failure Mode Effect Analysis as a proactive tool, how to perform FMEA and apply Risk Priority Number.
|13.30||Project Selection and Documentation
Approaches to project selection, defining and scoping the project. Exercise in writing a project charter.
Benefits of standard work, understanding flow and approaches to solution identification, generation and selection. Visual workplace, displays and controls are discussed along with types of mistake proofing.
Charging paradigms, solutions specifications and matrices are discussed.
|15.45||Taking People With You
Consider how to change to close the gap, Continuous Improvement leadership Gemba walks are discussed.
|16.30||Close of course|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities). If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Bed and Breakfast is £77*, dinner is £35* (* per night per person) - these can be selected during the booking process.