Pbi marcus evans sept2011presentation


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Advanced Laboratories Sept 2011

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Pbi marcus evans sept2011presentation

  1. 1. Reengineering Laboratory Processes To Accelerate Business Output Mini Workshop Michael McNamara MSc MRACI C Chem Marcus Evans Conference: Advanced Laboratories, Melbourne September 2011 PBI Consultancy Services ph 03 94997193 mobile 04077137681michael.mcnamara@live.com.au PBI
  2. 2. Reengineering Laboratory Processes Mini Workshop - Learning Objectives  Review approaches to efficiency improvement  Review their application to the laboratory environment  Focus on 2 key tools – scheduling in the laboratory – process mapping particularly value stream mapping  Apply these tools in a smaller group setting to a case study  Review as what has been learnt from the case study exercises as a larger group “I hear and I forget. I see and I remember. I do and I understand.” Confucius2
  3. 3. Reengineering Laboratory Processes Mini Workshop - Program  Overview of Efficiency Improvement – 3 Ps, Toolkit including lean Six Sigma and BPR 35 minutes  Case Study – Workgoup Activity – Applying the toolkit 35 minutes  Workgroup Review – What have we learnt 20 minutes3
  4. 4. The Laboratory Environment A Quick Look Back  In 1970s in a laboratory do an assay to measure something – assay SOP and specification  An anlyst did what the supervisor told them to do  In 1980s/1990s sees introduction or strengthening of – Complex technologies and IT systems – HR Systems eg EEO, EBA, KPIs, – OHSE – Industry specific Quality Standards  eg GMP, GLP, FSANZ etc – General Industry standards ISO 9000, 9001 etc – Regulatory Standards eg ICH  Improvements in efficiency focussed on – People managment by KPI – New technology especially IT  Often these changing standards and environment left companies with complex inefficient business processes4
  5. 5. The Laboratory Environment The Scene Today  In 1990s/2000s focus on efficiency improvement through quality – ISO 9000/9001 – TQM/JIT – Business Process Reengineering – Six Sigma – Lean Manufacturing – Lean Six Sigma/Lean Laboratory – Application of Advanced Statistical Approaches  Eg Multifactorial DOE experimentation – Industry specific approaches eg QbD in the pharma & biotech industries5
  6. 6. Success in Introduction of New IT 2000 23% 49% 28% 1998 28% 46% 26% 1995 40% 33% 27% 1994 31% 53% 16%30,000 application projects in large, medium and smallU.S. companies since 1994. Succeeded ChallengedSource: The Standish Group International, Extreme Chaos, FailedThe Standish Group International, Inc., 2000
  7. 7. Key Success Factors in Introduction of IT – Rank Order 1. Executive Support 2. User Involvement 3. Experienced Project Manager 4. Clear Business Objectives 5. Minimized Scope 6. Standard Software Infrastructure Source: The Standish Group International, Extreme Chaos,7 The Standish Group International, Inc., 2000
  8. 8. Introduction of New Technology & IT Systems Planning Selecting or Customising IT System Reengineer Business Processes Integration New IT system New Business Processes Validation New IT system New Business Processes8 Change Management
  9. 9. Improving Laboratory Performance The 3 Keys – 3Ps •PEOPLE •PRODUCT9 •PROCESS
  10. 10. Improving Laboratory Performance The First Law Quality Time Cost PICK TWO !10
  11. 11. Improving Laboratory Performance The First Law – Revised Quality Time Cost CHANGE THE SYSTEM11 TO IMPROVE ALL 3!
  12. 12. Improving Laboratory Performance Changing the System New Existing Environment Improve People Outsource to lower efficiency costs of existing workforce Environment Business Invest in Streamline New Existing Technology Process12
  13. 13. Improving the Process The Toolkit -1 Lean Six Sigma Business Process Lean Laboratory Reengineering Advanced Statistics TQM DOE QFD QbD13
  14. 14. Improving the Process Six Sigma – the approaches DMAIC DMADV (also called Design for Six Sigma Used for improving existing processes Creating new product or process designs •DEFINE (the problem) •DEFINE •MEASURE (the current state) •MEASURE (CTQ Attributes) •ANALYSE (cause and effect) •ANALYSE (DESIGN ALTERNATIVES) •IMPROVE (or optimise process) •DESIGN DETAILS •CONTROL (the future state) •VERIFY (BUILD PROTOTYPE)14
  15. 15. Improving Laboratory Performance Six Sigma – the methods  5 Whys  Quantitative marketing research through  Accelerated life testing use of Enterprise Feedback  Axiomatic design Management (EFM) systems  Business Process Mapping  Root cause analysis  Cause & effects diagram (also known as  Scatter diagram fishbone or Ishikawa diagram)  SIPOC analysis (Suppliers, Inputs,  Check sheet Process, Outputs, Customers)  Control chart  Stratification  Cost-benefit analysis  Taguchi methods  CTQ tree  TRIZ  FMEA  Statistical Methods (About 20 or so) including Design of experiments  Histograms  Pareto analysis  Pick chart  Process capability  Quality Function Deployment (QFD)15
  16. 16. Six Sigma – the 5 Whys (as used within Toyota for TPS)  My car will not start. (the problem)Why? - The battery is dead. (first why)Why? - The alternator is not functioning. (second why)Why? - The alternator belt has broken. (third why)Why? - The alternator belt was well beyond its useful service life and has never been replaced. (fourth why)Why? - I have not been maintaining my car according to the recommended service schedule.(5th why, a root cause)Why? - Replacement parts are not available because of the extreme age of my vehicle. (sixth why, optional footnote) I will start maintaining my car according to the16 recommended service schedule. (solution)
  17. 17. Lean Laboratory (derived from Lean Manufacturing)  Lean Laboratory Principles Improve the process  Identify and map the value stream, streamline the process  Make value flow, create pull and eliminate non-value add – Improve sample and test scheduling  prioritise samples (customer must start dates then FIFO)  smooth sample flow  optimise resource use  Level the load & mix (often the critical step) – Eliminate waste – Manage performance  Two key activities in lean laboratory (80% of the cost & efficiency gains) – Process improvement – Test Scheduling17
  18. 18. Improve the Process Business Process Reengineering - 1  fundamental re-thinking & radical re-design of organisation or business  Redesigns the way work is done – to better support the organisations mission, improve quality and timeliness and reduce costs. – Focus on integration of business units eg laboratory – Develop a well-integrated business  starts with a high-level assessment of the organisations mission, strategic goals, and customer needs.18
  19. 19. Business Process Reengineering -2  Basic questions are asked (Define) eg, – Does our mission need to be redefined? – Are our strategic goals aligned with our mission? – Who are our customers?  focuses on the business processes (Measure) – how resources are used to create products and services that meet the needs of particular19 customers or markets
  20. 20. Business Process Reengineering -3  Re-engineering systematically identifies, analyzes, and re-designs an organizations core business processes (Analyse and Improve)  Aims to achieve dramatic improvements in cost, quality and time  Defragments and streamlines overall process  Can be applied to whole of organistaion or specific business units – in the context of a holistic view of organisation20
  21. 21. Business Process Reengineering – Process Maps Process Map Type Purpose Positives Negatives High-Level Process Map or Perspective, big-picture, Management, Quality not enough details Flow Chart Systems Manual, good for adding metrics Low-Level Process Map or Sub-processes, small- Understanding flow, unclear responsibilities, Not Flow Chart picture procedures, details SIPOC, alternative flow Cross Functional or “Swim Responsibilities HR, job descriptions, job alternative flow Lanes” Map training, procedures Document Map or SIPOC Data management Document and record not enough activity detail Map control Activity Map or Value Process Improvement granular details good for OK for training and Stream Map work instructions and communications procedure writing Work Flow Diagram Training, communications More realistic great for training and communications Rendered Process Map Training, communications Most realistic great for training and communications21 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part I
  22. 22. Process Maps – High Level Process Map - Order Production (JIT) Cash22 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part I
  23. 23. Process Maps – Low Level Process Map A/R Cycle Legend23 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part I
  24. 24. Process Maps Cross Functional Map (Swim Lanes Map) 24 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part II
  25. 25. Value Stream Map Value Add step Clearly Wasteful  step Possible Waste Step 4+1= Total Steps + Value Add Steps25 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part II
  26. 26. Process Maps – Low Level Process Map Legend26 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part I
  27. 27. The Toolkit Work Flow Diagram 27 Originally published in 2009 by Bizmanualz, Inc. under the title Seven Types of Process Maps – Part III
  28. 28. Business Process Reengineering - Process Analysis Checklist  Reduce handoffs (one person handles as many tasks as possible)  Centralize data (single point for holding data, minimise data entry)  Reduce delays /eliminate wait steps (streamline workflow)  Free resources faster  Combine similar activities28  Use rendered maps to sell changes
  29. 29. Business Process Reengineering Example Simplified schematic outline of using a business process approach, exemplified for pharmaceutical R&D: 1. Structural organization with functional units 2. Introduction of New Product Development as cross-functional process 3. Re-structuring and streamlining activities, removal of non-value29 adding tasks
  30. 30. Lean Laboratory Schedule Levelling – Define  majority of the workload (85-95%) is driven by 2-3 products. Pareto Analysis – Sample workload  Product A and C same product family, same tests and could be tested together at the same time.  Product B accounted for 19% of the sample volume but not 19% of the labs workload only 2 very simple tests, A and C needed 9 tests.  Focus exclusively on A and C (80-90% of the labs workload) - the main priority of the site  Process Map - approval and release activities carried out after the batches30 Ref: http://bsm.ie/blog/andrew-harte/improving-lab-performance-six-sigma were fully tested is significant part of effort
  31. 31. Lean Laboratory Schedule Levelling – Measure Fig 2: Product A Cycle Times  Product A spread of times centred around 11-15 days (Jan - Apr)  Corresponded to target cycle of 15 days.  66% of samples met the 15 day target /33% late.  Vast bulk of the resources were occupied by test x  The results of test x were required by a separate department to proceed with their process.  Laboratory heavily resourced test x to test every sample every day – inefficient variable workload  Eg Day1 five analysts might test 12 samples Day 2 test 4, (67% drop in productivity)  Strategy needed to level resources without increasing cycle times ie control the numbers tested each day.31 Ref: http://bsm.ie/blog/andrew-harte/improving-lab-performance-six-sigma
  32. 32. Lean Laboratory Schedule Levelling – Analyse  Data Analysis:  Daily: 1 and 17 samples per day average of 7.  Weekly: 25 to 45 samples per week average of 36.  Weekly incoming workload much less volatile (coefficient of variance 0.2 versus 0.6).  Predictability per week is good ie approximately 36 samples.  Weekly control is possible therefore develop a weekly testing pattern  the weekly average rate for each test was determined.  The number of samples for each test would be different as Product A received some tests that product C did not and vice versa.32 Ref: http://bsm.ie/blog/andrew-harte/improving-lab-performance-six-sigma
  33. 33. Lean Laboratory Schedule Levelling – Improve  Strategic Approach Adopted:  A fixed, weekly repeating pattern of tests  Testing at the weekly average every week i.e. testing at the weekly rate.  Every test would be run every week.  Samples would be tested in FIFO (first in first out) order33 Ref: http://bsm.ie/blog/andrew-harte/improving-lab-performance-six-sigma
  34. 34. Lean Laboratory Schedule Levelling – Standard Tasks  Design standard roles that make good use of resources – Define the combination and sequencing of tasks based on people who are productive because they organize their work well, rather than because they move fast.  Do a design on paper with a team, then try, refine and deploy -Involve analysts in an iterative process to design productive roles that meet the requirements of your train or rhythm wheel34
  35. 35. Lean Laboratory Schedule Levelling – Control Set Analyst Roles Standard Tasks covering: • The activities required for the test role. • The best order in which to complete them. • Clear break targets. KPI’s (key performance indicators) • printed and posted weekly • before six sigma lean lab project 66% of samples were tested inside the 15 day target time. • After project target was changed to 10 days, and all samples within target • An average lead time of 8 days. •There was an annualised 3.9 fold return on investment for the project35 Ref: http://bsm.ie/blog/andrew-harte/improving-lab-performance-six-sigma
  36. 36. Lean Laboratory Schedule Levelling the Outcome36
  37. 37. The Critical Step Change Management • Poor Change management is cause of > 70% failures of improvement projects Change management Improvement Consolidate initiative gains37
  38. 38. Reengineering Laboratory Processes To Accelerate Business Output Questions and Comments38
  39. 39. Reengineering Laboratory Processes To Accelerate Business Output Workgroup Activity39
  40. 40. Reengineering Laboratory Processes Mini Workshop - Program  Overview of Efficiency Improvement – 3 Ps, Toolkit including lean Six Sigma and BPR 30 minutes  Case Study – Workgoup Activity – Applying the toolkit 40 minutes  Workgroup Review – What have we learnt 20 minutes40
  41. 41. Reengineering Laboratory Processes To Accelerate Business Output Workgroup Discussion41
  42. 42. Workgroup Discussion – Exercise 1 Scheduling Talking Points  Testing Lab Organisation structure  Quarterly rather than monthly scheduling  Multi-skilling inappropriately applied to analysts revise approach  Priorities are first customer definition then42 FIFO
  43. 43. Workgroup Discussion – Exercise 1 Scheduling43
  44. 44. Workgroup Discussion – Exercise 1 Scheduling44
  45. 45. Workgroup Discussion – Exercise 2 Process Map Talking Points  Overall organizational relationships and roles  QA and OHSE and customer relations simplification using multi-skilling  OHSE advisor approval (currently OHSE manager only approves – so cut him out)  Direct analyst/coordinator contact with customer for re-sampling requests  Parallel reviews with Analyst OHSE and QA45 to renew SOPs following revalidation etc
  46. 46. Michael McNamara Biography  Formed PBI in 2009 as a consultancy focussed on improving management processes with a special interest in innovation  Improvements to laboratory management – increasing output by 30% – with a 10% reduction in cost  Clients include companies from start ups to large multinationals located in Australia, Europe and the US  Client Industries include biotechnology, pharmaceuticals, agriculture, consumer goods, defence and aerospace  Qualifications: BSc (Hons) Melbourne, MSc LaTrobe, Grad Dip Pharm Sci & Drug Reg Melbourne, Grad Cert Tech Mgmt APESMA LaTrobe  Over 20 years senior management experience in multinational agriculture, biotechnology and pharmaceutical companies  Specialist in management of innovation at all phases of product lifecycle – from research and product concept – through to product launch and lifecycle management46
  47. 47. Reengineering Laboratory Processes To Accelerate Business Output Miniworkshop Michael McNamara MSc MRACI C Chem PBI ph 03 94997193 mobile 040771376847 michael.mcnamara@live.com.au PBI