1.Whether you work in a public area or a placeof business, when something unusual occursmost businesses and insurance companiesrequire an incident report to be filed. Anincident report is simply a written statement ofthe events and how they occurred. It isnt hardto write an incident report, but there are a fewthings you should know that will help you towrite a good one.

2. 1.Write the incident report in complete sentences and use simple language. Because you do not know if a third-party may be reviewing your incident report, keep the explanation of the events easy to understand and avoid using expertise language that could confuse the examiner who reads your report.2.State what happened in chronological order. Begin with what was happening just prior to the incident (if it is relevant), then list details of the event in the sequence they occurred. 3. 3. Notate whether you were the witness of theevent or if the details were reported to you. Ifyou did not see the incident or did not arriveuntil after it occurred, explain in your reportwho informed you about the incident andwhat steps you took after you were notified.4. List all witnesses and parties involved. Since the person that reviews the incident report may have further questions, include contact information for everyone that was involved and remember to notate any fire, ambulance or police units that responded, as well as when they arrived. 4. Incident reports should be written as soon aspossible after an event occurs. This will ensurethat important details are reported accuratelywhile they are still fresh in your mind. 5. The process of reacting to an existing product problem, customer complaint or other nonconformity and fixing it. 6. A process for detectingpotential problems ornonconformances andeliminating them. 7. Regulatory Requirements Both FDA and ISO require an active CAPA programas an essential element of a quality system. Customer Satisfaction The ability to correct existing problems or implementcontrols to prevent potential problems is essential forcontinued customer satisfaction Good Business Practice Quality problems can have a significant financialimpact on a company. 8. Implementing an effective and fullycompliant Corrective / Preventive actionprogram is a seven step process. Each step must be thoroughlydocumented! Properly documented actions provide importanthistorical data for a continuous quality improvementplan and are essential for any product that mustmeet the regulatory requirements demanded byFDA and ISO. 9. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 10. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 11. The initial step in the process is to clearlydefine the problem or potential problem. This should include: the source of the information, a detailed explanation of theproblem, Documentation of the availableevidence that a problem exists. 12. The specific source of the information isdocumented. There are many possible sources:Service requestsCustomer complaintsInternal quality audits Staff observationsTrend dataQA inspectionsProcess monitoringRisk analysis This information is important for theinvestigation and action plan, but also usefulfor effectiveness evaluation andcommunicating the resolution of the problem. 13. A description of the problem is writtenthat is concise - but complete. The description must contain enoughinformation so that the specificproblem can be easily understood. 14. List the specificinformation, documents, or dataavailable that demonstrates that theproblem does exist. This information will be very importantduring the investigation into the problem. 15. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 16. The situation must be evaluated to determineboth the need for action and then, the level ofaction required. An evaluation should include: Potential Impact of the problem. Risk to the company or its customers Remedial Action that may be required 17. Determine and documentspecifically why the problem is aconcern and what the impact tothe company and/or customersmay be. Concerns may includecosts, function, productquality, safety, reliability, and/orcustomer satisfaction. 18. Based on the result of the impactevaluation, the seriousness of the problem isassessed. The level of risk that is associated with theproblem will affect the actions that are takenand the priority assigned to the situation. 19. The potential impact and risk assessmentmay indicate a need for some immediateaction to remedy the situation until apermanent solution can be implemented. In some cases the remedial action may beadequate. If so, the CAPA can then beclosed, after documenting the rationalefor this decision and completingappropriate follow up. 20. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 21. A written procedure for doing an investigationinto the problem is created. This procedure should include: The objectives for the action An investigation strategy Assignment of responsibility andrequired resources 22. The objective is a statement of thedesired outcome(s) of thecorrective or preventive action. The action will be complete whenall aspects of the objective havebeen met and verified. 23. A set of specific instructions for determiningthe contributing and root causes of theproblem is written. This procedure directs a comprehensivereview of all circumstances related to theproblem and must consider:- equipment- materials- personnel- procedures- design - training- software - external factors 24. It is important to assign someone theresponsibility for each aspect of theinvestigation. Any additional resources(financial, equipment, etc) should beidentified and documented. 25. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 26. The investigation procedure is used to conductthe investigation into the cause of the problem. Every possible cause is identified andappropriate data collected. The results of the data collection are documentedand organized. Everything related to the problem must beidentified, but the primary goal must be to findthe root cause. 27. A list of all possible causes is created whichthen form the basis for collecting relevantinformation, test data, etc. The necessary data and other information iscollected that will be used to determine theprimary cause of the problem. 28. Data may come from a variety of sources: testingresults and/or a review of records, processes,service information, design controls, operations,and any other information that may lead to adetermination of the fundamental cause of theproblem. The data collected is organized into a useable form. The resulting documentation should address all ofthe possible causes previously determined. Thisinformation is used to determine the root cause ofthe problem. The effectiveness of the analysis willdepend on the quality and thoroughness of theinformation available. 29. Use the data to complete a Root Cause Analysis This involves finding the actual cause of theproblem rather than simply dealing with thesymptoms. Finding the primary cause is essential fordetermining appropriate corrective and/orpreventive actions. 30. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 31. Using the results from the analysis, the bestmethod(s) for correcting the situation (orpreventing a future occurrence) is determined. All of the tasks required to correct the problemand prevent a recurrence are identified andincorporated into an action plan. The plan includes changes that must be madeand assigns responsibility for the tasks. 32. List all activities and tasks that must beaccomplished to correct the existing problem oreliminate a potential problem, and prevent arecurrence. It is very important identify all actionsnecessary to address everything thatcontributed to or resulted from the situation. 33. Needed changes todocuments, processes, procedures, or othersystem modifications should be described. Enough detail must be included so it is clearlyunderstood what must be done and what theoutcome of the changes should be. 34. Employee training is an essential part of anychange that is made and should be made partof the action plan. To be effective, all modifications and changesmade must be communicated to allpersons, departments, suppliers, etc. that wereor will be affected. 35. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 36. The Action Plan that has beendeveloped is executed and allidentified tasks and activitiescompleted. The actions that were taken aresummarized and all modifications todocuments, processes, etc. are listed. 37. 1. Identification clearly define the problem2. Evaluation appraise the magnitude and impact3. Investigation make a plan to research the problem4. Analysis perform a thorough assessment5. Action Plan create a list of required tasks6. Implementation execute the action plan7. Follow Up verify and assess the effectiveness 38. One of the most fundamental steps in theCAPA process is completing an evaluation ofthe actions that were taken. This evaluation must not only verify thesuccessful completion of the identifiedtasks, but also assess the appropriateness andeffectiveness of the actions taken. 39. Have all of the objectives been met? (Did theactions correct or prevent the problem withassurances that the same situation will not happenagain?) Have all recommended changes been completedand verified? Has training and appropriate communicationsbeen implemented to assure that all relevantemployees understand the situation and thechanges that have been made? Has an investigation demonstrated that that theactions taken have not had any additional adverseeffect on the product or service? 40. Make sure that appropriate information hasbeen recorded that provides proof that allactions have been completed successfully. 41. A validation of the action is done. Thismust document that: The root cause of the problem has been solved, Any resulting secondary situations have beencorrected, Proper controls have been established to prevent afuture occurrence, The actions taken had no other adverse effects. Adequate monitoring of the situation is in place. 42. When the Follow Up has beenfinished, the CAPA is complete. It should be dated, and signedby appropriate, authorizedpersonnel. 43. Presenter: Ralph Williams, President SEI Authorized CBA IPI Lead Assessor (CMM) SCAMPI Lead AppraiserSM (CMMI)CMM and CMMI is registered in the U.S. Patent and Trademark Office.SMIDEALis a service mark of Carnegie Mellon University. 44. Special permission to reproduce and adapt portions of: Software Engineering Process Group Guide, CMU/SEI-90-TR-024, (c) 1990 by Carnegie Mellon University Capability Maturity Model Integration (CMMI), Version 1.1 (CMMISM-SE/SW/IPPD/SS, V1.1) Continuous Representation,CMU/SEI-2002-TR-011, (c) 2002 by Carnegie Mellon University Capability Maturity Model Integration (CMMI), Version 1.1 (CMMISM-SE/SW/IPPD/SS, V1.1) Staged Representation, CMU/SEI-2002-TR-012, (c) 2002 by Carnegie Mellon University Standard CMMISM Assessment Method for Process Improvement: MethodDefinition, Version 1.1 (SCAMPISM, V1.1),CMU/SEI-2001-HB-2001, (c) 2001 by Carnegie Mellon Universityis granted by the Software Engineering Institute.CMMI,CMM and Capability Maturity Model are registered in the U.S. Patent and Trademark Office.SMIDEAL and SCAMPI are service marks of Carnegie Mellon University. 45. The mission of Cooliemon, LLC is: helping organizations achieveexcellence through process improvementOur goal is to focus your process improvement efforts to: improve quality and productivity reduce operating costs (i.e., reduce rework, waste and duplicate effort) capture the market with high quality products and services help you become the industry standard by which your competitors measure themselves 46. Purpose:To identify causes of defects and otherproblems and take action to preventthem from occurring in the future. CMMIV1.1 SG 1: Determine Causes of Defects Root causes of defects and other problems are systematically determined. SG 2: Address Causes of Defects Root causes of defects and other problems are systematically addressed to prevent their future occurrence.SG = Specific Goal 47. Describe how CAR can be used to build SeniorManagement commitment for Quality. Overview of Jurans Quality ImprovementProcess - a practical example of the CAR aCMMI Process Area (PA). When to use Quality Tools (e.g., Pareto, Cause& Effect diagrams, Brainstorming, etc.) Answer any of your questions. 48. Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary 49. The cost of poor quality (COPQ): COPQ is the sum of all costs that woulddisappear if there were no qualityproblems. - Juran You can easily spend 15 - 20% of your salesdollars on the COPQ. - Crosby In most companies the costs of poor qualityruns at 20 - 40%. - Juran 50. Compile a list of improvement opportunities.Example sources: Accounting data on COPQ Benchmarking reports External customer complaints Internal customer complaints Process improvement suggestions Surveys Simply talk to people etc. 51. Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary 52. QC PAT(s)OrganizationSelect: Review/VerifyStrategy,Problem to Charter, Mission &be solved & PAT Team MembershipPATs Report Status: ProcessUnderstand,Support, Execute ProcessDirect & RecognizeTeam QC Updates Phase Out TeamImplement Solution &Recognize Team ControlsLessons Learned Monitor Solution to Hold the Gains Adapted from Juran, Leadership for Quality, 1989 53. Discover Root Causes (Diagnostic Journey):1. analyze the symptoms2. formulate theories3. test theories4. identify root causesDevelop Solutions & Controls (Remedial Journey):5. consider alternative solutions6. design solutions and controls7. address resistance to change8. implement solutions and controlsHolding the gains9. design effective quality controls10. audit the controls Adapted from Juran, Leadership for Quality, 1989 54. Selection Criteria to be considered: Chronic (a continuing problem) Vital Few (significant impact on company) Size (manageable problem