PROBLEM SOLVING AND ROOT CAUSE ANALYSIS TWO DAY WORKSHOP

-     Introduction

-      Learn how CAPA and Root Cause relates to a GMP State of Control

-      Define the elements of State of Control

-          Focus on the concept of all work is a process

-          Output identification

-          Input identification

-      Cover the four categories of inputs that control a process

-          Facilities and Equipment

-          Training and knowledge

-          Procedures

-          Performance Standards

-      Five Step method approach to problem solving

-          Define the situation

-          Fix the Nonconformance

-          Identify the root cause(s)

-          Take corrective action

-          Evaluate and follow-up

-     Introduce the tools to eliminate nonconformance

-          Fish bone

-          Flow charting

-          Brainstorming

-          Group Voting

-          Collecting information

-          Explain the history of measurement

-          What we measure

-          Measurement techniques

-          Displaying Information  (Participants use Spicer data to plot run charts and make histograms)

-          Pareto chart

-          Run chart

-          Check sheets

-          Histograms

-          Planning chart

Review nine steps in the process

-    Step 1    Procedural requirements

-    Step 2    Identify data/information sources

                                        internal sources

                                        external sources

-    Step 3    Data analysis

-    Step 4    Challenging the data system

-    Step 5    Utilizing appropriate methodologies

-    Step 6    Conducting failure investigations

-    Step 7    Action assessment

-    Step 8    Taking action

-    Step 9    Information dissemination

-          Summary and Evaluation