NOE Human Error Reduction: Schering Plough (Brinny ) Donal O’Callaghan & Julie Wade

Agenda Definition of Human Error Human Error Data from Brinny Types of Human Error Error Reduction Hierarchy The HEAT Tool The results to date…..next steps

What are Human Errors ? “An inappropriate action or response by a person resulting in an undesired outcome”

NOE Data 2008 33 % of NOEs Root Cause was Human Error

What did the data tell us? Human Error NOEs consistently accounted for 33% of total NOEs Training Common Response – Investigate & Train Many errors not due to lack of skill or knowledge. Number of Human Errors were not reducing Similar issues re-occurred over and over again  re-training is NOT working. Training can only solve a Human Error when the cause is lack of skill or knowledge

??? Human Error Factors Training 18 % Statistics indicates that Training was the cause for poor performance in 18% (*) of the case. What are the their factors affecting human performance? (*) Often we put training as the solution, but it isn’t. You may ask them « what happens if training was not the solution? ». When the only solution of training it is a waste of time and money and sense of frustration for the employee or trainer. Refer back to TTT course, train only when required. As a group, using the key indicators in the participant manual,discuss : what affects human performance or how can one factor affect human performance Wrap-up using the next slide. 18

Human Error Factors Training Physical or mental capacity? Recognition Support? Clarity of instruction? Working conditions = Provide time, materials, equipments; allow opportunity to practice to practice and develop skills; allow time to do the job properly Feedback = Monitor Performance; need to ‘be on the floor’ Recognition support = listen to their concern, encourage them, motivate them, show empathy and address their suggestions to improve their work environment Clarity of instruction = procedure written for and usable by the employee; provide worksheet that are clear and easy to follow Physical or mental capacity = modify the working environment to optimise the utilisation of their capacity, minimize distraction, work ergonomic, etc Clarity of expectation = set clear goals and objectives, improve quality of communication Clarity of expectations? Working conditions? Feedback 18

Brinny : Human Error Categories* on Trackwise Learning Gap – don’t know or don’t understand – no training or poor quality training Memory Gap – know, but don’t remember – after break, after holidays, long absence – after recent change not reinforced Application – know, but did not use correctly – over burden - stressed (*Source Talsico ; www. Talsico.com )

Brinny : Human Error Categories* on Trackwise Attention- know but distracted by other factors – wrong position – visual inspection units wrong place Omission – know, but missed a step – overburden, pressure Decision – incorrect decision is made – decisions are emotional why was wrong one made? Procedure – inconsistent performance due to poorly documented procedure (*Source Talsico ; www. Talsico.com )

HUMAN ERROR ANALYSIS TOOL ( HEAT ) HEAT Tool is a combination of 5 Whys Method for getting people to think about true root cause Prevents the investigation team from being satisfied with superficial solutions that won’t fix the problem in the long run Gets to real Human Error Category Recommended Actions V’s Talsico Human Error Category’s

Corrective Action :Error Control Hierarchy Mistake-Proof (Poka-Yoke control) – eliminate potential for errors – Engineering Controls e.g Machine won’t start unless door is locked Error Prevention (Poka-Yoke warning) – SPC, alarms, dress code signs, yellow lines e.g Alarm sound if car lights left Error Detection – Ability to “catch” error before accident or batch release e.g Batch Record review, visual inspection Redundancy – Duplication of effort e.g. multiple checks

The Data : 2009 Human Error Training Introduction of HEAT Tool Year to Date Human Error NOEs 24 % Human Error Training Introduction of HEAT Tool

Success & Next Step Next Steps Downward Trend Human Error NOE’s down from 33 % to 24% of total NOEs Inclusion Employees engagement & satisfaction Knowledge Better understanding of Human Factors and error Next Steps Review effectiveness of CAPAs and quantify Is the 5 Whys best tool or do we need a more diagnostic tool for drill down