Lean Lab - Speed, Productivity and Quality? AOAC Europe NMKL NordVal International Symposium 2015, Stockholm

Lean Lab - Speed, Productivity and Quality? AOAC Europe NMKL NordVal International Symposium 2015, Stockholm

Do We Need Lean???? Nearly 25 years ago, a joke about a McKinsey consultant proposing saving opportunities at the Berlin Philharmonic Orchestra in Berlin made is round in Germany It s quintessence was an extremely shrunk orchestra playing Beethoven s 9 th symphony in 20 minutes instead of 1 hour by e.g. avoiding all demisemiquaver notes What is this joke telling us? It needs a whole lot of professional know how and experience to make good proposals. 2

Labour Productivity in Germany Does your laboratory perform accordingly? 3

Do We Need Lean???? Lean: Increasing quality, decreasing costs, increasing delivery Optimizing space, time, and activity to improve the physical paths of workflow Laboratories are not the same as manufacturing environments Relatively low volume of samples High degree of variability and complexity While most of the key principles apply, there are many unique challenges involved in effectively implementing them in laboratories. Implementing Lean in a laboratory environment needs careful adaptation of the techniques thorough understanding of laboratory processes 4

Some Experience Since 1984 I have been responsible for quality control and laboratory operations in 5 pharmaceutical companies Since 1989 these companies initiated numerous optimisation projects, assisted by A.T. Kearney Boston Consult PIMS Associates Ltd Tefen Ltd. Porsche Consult and various internal projects Deloitte Consulting Horváth AG PA Consulting TQU/Steinbeis McKinsey However, most of the projects were not or only partially successful Especially when it came to optimisation in the laboratories 5

Laboratory Efficiency In pharmaceutical industry, quality budgets are mainly driven by personnel costs QA activities app. 90% QC lab operations app. 60 70% Only app. 40% of all laboratory activities may be directly allocated to work orders including method set up activities like SSTs Tefen, PharmTech, 2004 Benchmark QP Council South 2004, 2008, 2010 6

Capacity Planning Physico-chemical laboratory planning data (2009-2010) Only the yellow part of the cake is linked to production output Can efficiency be improved without corrupting reliability of the results? Volatile workload either results in over- or understaffing and traditionally in typical staffing levels slightly above mean workload Excess cost or additional capacity 7

Laboratory Automation Throughout the 1990s Laboratory Automation was highly promoted as the silver bullet to increase laboratory efficiency Numerous papers and events circling around that topic Only few successful examples Extremely high sample throughput Very formalised and standardised tests o North West Waters, UK Water Analysis o Lufthansa, SkyChefs Microbiological Testing of Catering Food using Laboratory Robots 8

Laboratory Automation Two fully automated robot systems for release testing of X-ray contrast media - Byk Gulden (Takeda), 1998 Needed total re-engineering of the test procedures! Project re-evaluation after 5 years Reduced lead times, buffer capacity for high demands due to continuous operation, easy coping with different volumes and concentrations Higher costs! 4 laboratory staff replaced by 2 engineers High investment costs charged to every test High reliability of results less OOS results! 9

Lab Process & Performance Parameters There are different possibilities how companies define process or performance metrics for laboratory activities One basic metrics is Actual time needed to perform test compared to standard Based on LIMS records Anonymous (workers council!) evaluation of data Wide scatter of time actually needed ( 25 %) o No obvious deviations or errors, requiring repeated testing o Positive effects of sample batching ( pooling ) eliminated o Periodic readjustment of target times So why do we experience that wide variation of test time? That s where you should start your Lean project! 10

The Efficiency Funnel To get more data, operators had to write down actual activity in a 15 minutes frequency Needs buy in of staff Not for longer than 1 month! Needs approval by workers council (at least in Germany!) Result: Times needed for activities close to, during and in parallel to equipment driven processes o are very close to the predefined planned time o do not scatter widely ( 10 %) The earlier in the process, the higher the variability of the actual time needed between staff members 11

Buy In of Staff Be open and respectful to your staff! Why? How? What? 12

The Efficiency Funnel Highest contribution to variability Test set up Collecting items Getting reagents & standards Sample pre-treatment From last dissolution step to result calculation only small differences between operators Exception: Calculation errors make sure calculation in SOP or testing procedure is easy to follow 13

Value Stream Mapping Track the movement of an individual sample and all reference standards, reagents, solvents etc through the entire process Track the movement of the operator at each work station Highlight the wasted activities and times Break down the time spent in each of the process steps Document the current state with a map, work balance chart and spaghetti diagrams Reviewing the entire flow for each test process in the laboratory may be extremely tedious But very effective as it exposes enormous amounts of waste Use 80:20 methodology to gain quick wins 14

Value Stream Mapping Lab processes and procedures are taking on a life of their own Pre-Lean Post Lean 15

Improvement Opportunities Based on improvements identified, the team will have to adopt common working techniques to reduce variation, including General improvements and Individual improvements by learning from the best in class Again needs to buy in from staff and approval by works council General improvements and individual improvements may both be achieved by using well known Lean Tools 16

Improvement Opportunities General Improvements Opportunity Redundant work Multiple handling Excessive walking Excessive clutter Excessive searching for missing items & materials Lean Tool Standardize processes Standardize processes Area lay out, flow 5 S Area lay out, point of use storage But There might be regulatory restrictions! Point of use and controlled storage of reference standards 17

Improvement Opportunities Individual Improvements Opportunity Redundant work & multiple handling Excessive walking & excessive searching for missing items & materials Excessive clutter at individual working places Missing material Lean Tool Standardize processes according to best in class Area lay out, flow according to best in class, included in instructions and SOPs Strict implementation and enforcement of 5 S Use KANBAN methodology Main problem: Laboratory staff tends to feel restricted 18

Laboratory Efficiency (OLE) Determine lab activities during day/shift using same approach 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 9-10 10-11 11-12 12-13 13-14 14-15 15-16 16-17 Baxter BioScience OPEX program (Tefen ), 2003 19

Laboratory Efficiency Sample Transport Track the movement of operators & sample e.g. for sample logistics Complicated due to different types of samples and historical structures 20

Laboratory Efficacy Sample Transport Post Lean Only one type of sample 21

Cycle Time Analysis Optimise scheduling Prioritize linked activities Consider dedicated equipment even if not fully utilized! Better control external or partner labs Better align different analytical tests running in parallel 22

The Magic Triangle Costs Result Reliability Lead Time 23

Thank you! Questions? Dr. Bernd Renger Bernd Renger Consulting Mögginger Steig 28 78315 Radolfzell bernd.renger@br-consult.eu http://renger-consulting.com/ 24