"Managing Risk, Enhancing Culture and mproving Performance." ROOT CAUSE ANALYSIS LABORATORIES WORKSHOP CAPA

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1 "Managing Risk, Enhancing Culture and mproving Performance." ROOT CAUSE ANALYSIS LABORATORIES WORKSHOP CAPA Root Cause Analysisis Rootcause analysis is a completely separate process to incident management and immediate corrective action, although they are often completed in closeproximity. Root cause analysis (RCA) requires the investigator(s) to look beyond the solution to the immediate problem and understand the of non-conformances which sometimes results in them being suspended or test methods being removedfrom accreditation scope. Without an Root Cause Analysis Workshop methodologies and practicallaboratory related examples of root cause analysis, laboratory personnel can surely improve their management systemand technical services. genericproblem solving approaches to identify the technical root cause (the change that has occurred) as well as any systemic root causes (system failuresthat allowed the change to occur).corrective and / or preventive actions are then taken so that the performance can be restored to its previous,professional level. A control plan is then implemented to prevent the problem from ever returning. P s will learn several Root cause analysis tools that will allow s within their organis. WHO SHOULD ATTEND? This highly prac cal workshop for Laboratory analysts, professionals in Quality,Senior and Middle Level Managers from Laboratories of any type and size (QC Labs, Medical/Hospital Labs, Pharmaceu cal and Food industries Labs, Laboratory Technicians, Quality Assurance Managers and Senior Personnel Health and Safety Manager, Supplies Acceptance Labs, In-process Labs. COURSE OBJECTIVES. Introduc of a logical problem solving process applicable to issues and non conformi es of all sizes. To teach the members of this class how to effec ely analyze problems, determine their Root Causes and define appropriate Correc e Ac To impart a familiarity with analy cal tools u ed in the determina of Root Causes. To provide guidance to carry out proper Root Cause Analysis (RCA) with suitable quality tools. Determine whether a root cause analysis is required. Rela etween process & cause-and-effect. Correla and regression Risk assessment and failure modes. Risk, preven em solving. Iden fy Appropriate Correc ve Ac on Iden fica on of permanent solu Detec g Proficiency Test Failures in Laboratory. Iden fy the technical root cause(s) and any systemic root cause(s) preven f recurring failures. Detec f Nonconformity within the Laboratory and being communicated. To ensure all deficiencies in the laboratory's quality system and tes ac es are documented though its Documen g an incident various formats, Excel. (Laboratory Audit deficiency.) Iden fy and implement a control plan to assure you do not have this issue again. Roo g of the sequence of events within the laboratories. Any other relevant data or informa for example records, test results, informa from staff in the relevant area or complaints) ORGANIZATIONAL IMPACT Improved Performance Informed decision-making Delega and Produc ty Focused ac es Improved understanding of the maintenance process Elimina f Time-Was g ac es PERSONAL IMPACT Improved decision making abili es Clarity of vision Understanding of Consequences (Cause / Effect) Improved Maturity A new sense of certainty and confidence Empowerment and a results driven focus.

2 ROOT CAUSE ANALYSIS LABORATORIES WORKSHOP CAPA (Corrective Action / Preventive Action) TRAINING METHODOLOGY The training methodology is inter-active with numerous group exercises. The pace and level of the program is customized to the understanding of the delegates. Participants will learn that problem solving in laboratories is about identifying and eliminating specific causes. The simple three-step process benefits people at all levels in an organization (executives to front-line employees) by creating a visual picture of how to prevent past problems for the purpose of improving business performance. This Cause Map is a simple, visual tool for capturing these specific causes and making the information available throughout an organization. MEET YOUR FACILITATOR Prof JJ ( Koot ) Pieterse Prof JJ ( Koot ) Pieterse s career ineducation and research spans over 32 years and he has developed a niche in Root Cause Analysis, Lean Laboratory Management, Lean accuracy of laboratory results, Lean manufacturing, lean enterprise and service in South Africa and the world Academic Qualifications: BSc (University of Pretoria), HED (Universityof Pretoria), NH Dip (Pretoria Technikon), DTE (UNISA), MSc (University of Pretoria), PhD (University of Pretoria. He is a principal lecturer at NMMU Business School, teaching and supervising MBA and Doctoral students. Prof Pieterse was honoured with the annual National Lewerik Award for innovative research in 1990 in the South African defense industry. His research skills are further supported by his progressive research grant increases from the National Research Foundation. Prof Pieterse has published three books, including Leaning the South African Way and The Lean Service Toolbox: South African Edition, and acted as editor for the text book Implementing Lean in South African Industry. He has presented research papers at several conferences. Areas of expertise/ Specialties: Root cause analysis,lean Healthcare,Lean Administration,Implementation Lean. His years of experiencein analytical chemistry and other laboratories come in particularly handy.lean implementation and awareness training in manufacturing, healthcare and services. Lean, Manufacturing, Automotive Operations Management, Service Quality and Process Improvement. starting Rankine Engineering and later joining Wits University as a lecturer. From 1998 to 2006, he was employed by the Cement and Concrete Institute. He is an author and co-author of more than 40 papers published in accredited journals of science and engineering, international conference proceedings and books. DEAR DELEGATE, Laboratories play a very important role in the diagnostic phase of health care, public Health. The performance of any lab is assessed by the turnaround time for giving reliable test results. Any delay in giving test results or unreliable results could have adverse implications. Clinical labs need to invest more on medical and information technology, employ technically qualified staff, and closely monitor the lab operations in order to meet the increasing expectations from both the clinicians and the patients for a quick turnaround time for reliable test results. Success of labs in future would also increasingly depend on selecting appropriate strategies to provide accurate results and services. It is, therefore, essential to equip lab managers with a basic understanding of challenges in managing the delivery of quality lab services at affordable prices to patients, desired timely and quality reports to physicians, and ensure adequate financial returns to the labs. I have benchmarked existing programmes and applied my own experience in laboratory management, operations management. This interactive Root cause Analysis for laboratories Workshop will benefit lab owners, lab managers, pathologists, and senior technologists in improving turnaround time, inventory management, operational efficiency, quality practices and staff skills within the lab set up. As it is the notion that improved service quality, efficiencies, and professionalism in lab management will result in better delivering good quality services. We hope to see you there, Best regards, Prof JJ Koot Pieterse.

3 ROOT CAUSE ANALYSIS LABORATORIES WORKSHOP CAPA (Corrective Action / Preventive Action) Day One 8:00 10:00 INTRODUCTION. Introduce theorigins of RCA(Root Cause Analysis) Objec es and Components of RCA. (Root cause Analysis) Delineate a technical CAPA problem (Correc Preven e Ac Discuss common inves ga mistakes Introduce the first case study(exercise) Describe the Performance Problem(Categoris Develop a problem statement e Ac 13:00-14:00 14:00-16:30 LUNCH (NETWORKING) Step 3: Possible Causes. Develop a me-line of changes Search for differences Exercise 4 Iden fy changes associated with any difference Review the risk analysis Apply brainstorming techniques Exercise 5 Describe the problem in 8 dimensions Step 4: Test Possible Causes. Problem categoris Discovering the problem Characterising the problem Assessing the severity of the problem Test the possible causes against the facts Summarize the tes g on a contradic matrix The greatest detec e that never lived an historical perspec Exercise 6 C vidence. Selec g appropriate sources Selec g the appropriate tools (histograms, s r diagrams, check sheets) Exercise Team composi Team briefing Team dynamics Exercise 1 Step 5: Root Cause(s) Verify Assump Conduct studies / experiments Iden fy technical root cause(s) Iden fy systemic root cause(s) Exercise conduct Workshop 7 stemic 10:00-10:15 TEA BREAK (NETWORKING) 10:15-12 :00 Step 1: Describe the Problem (C Describe the processes under inves ga their inputs Exercise workshop 2 en fy Develop a me-line of events Develop the charter including the performance and cost savings goals 12:00 13:00 Step 2: Collect Data(C vidence) Determine what data is needed Examine data collec tools and techniques(histograms,s r,diagrams,check sheets)

4 ROOT CAUSE ANALYSIS LABORATORIES WORKSHOP CAPA (Corrective Action / Preventive Day Two 8:00 10:00 Topic: Determine C ve / Prev v Examine mistake-proofing techniques Apply varia educ miza techniques Determine correc e / preven e ac Evaluate the risk of adverse consequences Develop a control plan Action) Topic : Verify C ve / Prev v s. Implement and measure effec eness of correc e / preven e ac Evaluate the control plan Determine addi al preven e ac 10:00-10:15 TEA BREAK (NETWORKING) 10:15 12:00 Second Case Study Introduc Workshop to define the performance problem and iden fy possible causes Workshop to collect data Second Case Study (C 12:00 13:00 Workshop to test possible causes Workshop to determine correc e ac 13:00-14:00 LUNCH HOUR NETWORKING 14:45-15:30 The Finale Compare and contrast the inves ga methodology with the tradi al approac Shortcuts for simpler inves ga Handling difficult inves ga Ins tu alizing the methodology References for the journey. Researched & Developed By: For inhouse training contact Kelly / Jerome on: Tel: / Fax:

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