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  • 1.  Whether you work in a public area or a place of business, when something unusual occurs most businesses and insurance companies require an incident report to be filed. An incident report is simply a written statement of the events and how they occurred. It isn’t hard to write an incident report, but there are a few things you should know that will help you to write 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 the event or if the details were reported to you. If you did not see the incident or did not arrive until after it occurred, explain in your report who informed you about the incident and what 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 as possible after an event occurs. This will ensure that important details are reported accurately while 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 ornonconformance’s andeliminating them.
  • 7.  Regulatory Requirements  Both FDA and ISO require an active CAPA program as an essential element of a quality system. Customer Satisfaction  The ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction Good Business Practice  Quality problems can have a significant financial impact on a company.
  • 8.  Implementing an effective and fully compliant Corrective / Preventive action program is a seven step process. Each step must be thoroughly documented!  Properly documented actions provide important historical data for a continuous quality improvement plan and are essential for any product that must meet the regulatory requirements demanded by FDA 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 clearly define the problem or potential problem. This should include:  the source of the information,  a detailed explanation of the problem,  Documentation of the available evidence that a problem exists.
  • 12.  The specific source of the information is documented. There are many possible sources: Service requests Customer complaints Internal quality audits Staff observations Trend data QA inspections Process monitoring Risk analysis This information is important for the investigation and action plan, but also useful for effectiveness evaluation and communicating the resolution of the problem.
  • 13.  A description of the problem is written that is concise - but complete. The description must contain enough information so that the specific problem can be easily understood.
  • 14.  List the specific information, documents, or data available that demonstrates that the problem does exist.  This information will be very important during 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 determine both the need for action and then, the level of action 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 document specifically why the problem is a concern and what the impact to the company and/or customers may be.  Concerns may include costs, function, product quality, safety, reliability, and/or customer satisfaction.
  • 18.  Based on the result of the impact evaluation, the seriousness of the problem is assessed. The level of risk that is associated with the problem will affect the actions that are taken and the priority assigned to the situation.
  • 19.  The potential impact and risk assessment may indicate a need for some immediate action to remedy the situation until a permanent solution can be implemented. In some cases the remedial action may be adequate. If so, the CAPA can then be closed, after documenting the rationale for this decision and completing appropriate 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 investigation into the problem is created. This procedure should include:  The objectives for the action  An investigation strategy  Assignment of responsibility and required resources
  • 22.  The objective is a statement of the desired outcome(s) of the corrective or preventive action. The action will be complete when all aspects of the objective have been met and verified.
  • 23.  A set of specific instructions for determining the contributing and root causes of the problem is written. This procedure directs a comprehensive review of all circumstances related to the problem and must consider: - equipment - materials - personnel - procedures - design - training - software - external factors
  • 24.  It is important to assign someone the responsibility for each aspect of the investigation. Any additional resources (financial, equipment, etc) should be identified 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 conduct the investigation into the cause of the problem. Every possible cause is identified and appropriate data collected. The results of the data collection are documented and organized. Everything related to the problem must be identified, but the primary goal must be to find the root cause.
  • 27.  A list of all possible causes is created which then form the basis for collecting relevant information, test data, etc. The necessary data and other information is collected that will be used to determine the primary cause of the problem.
  • 28.  Data may come from a variety of sources: testing results and/or a review of records, processes, service information, design controls, operations, and any other information that may lead to a determination of the fundamental cause of the problem. The data collected is organized into a useable form. The resulting documentation should address all of the possible causes previously determined. This information is used to determine the root cause of the problem. The effectiveness of the analysis will depend on the quality and thoroughness of the information available.
  • 29.  Use the data to complete a Root Cause Analysis This involves finding the actual cause of the problem rather than simply dealing with the symptoms. Finding the primary cause is essential for determining appropriate corrective and/or preventive 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 best method(s) for correcting the situation (or preventing a future occurrence) is determined. All of the tasks required to correct the problem and prevent a recurrence are identified and incorporated into an action plan. The plan includes changes that must be made and assigns responsibility for the tasks.
  • 32.  List all activities and tasks that must be accomplished to correct the existing problem or eliminate a potential problem, and prevent a recurrence. It is very important identify all actions necessary to address everything that contributed to or resulted from the situation.
  • 33.  Needed changes to documents, processes, procedures, or other system modifications should be described. Enough detail must be included so it is clearly understood what must be done and what the outcome of the changes should be.
  • 34.  Employee training is an essential part of any change that is made and should be made part of the action plan. To be effective, all modifications and changes made must be communicated to all persons, departments, suppliers, etc. that were or 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 been developed is executed and all identified tasks and activities completed. The actions that were taken are summarized and all modifications to documents, 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 the CAPA process is completing an evaluation of the actions that were taken. This evaluation must not only verify the successful completion of the identified tasks, but also assess the appropriateness and effectiveness of the actions taken.
  • 39.  Have all of the objectives been met? (Did the actions correct or prevent the problem with assurances that the same situation will not happen again?) Have all recommended changes been completed and verified? Has training and appropriate communications been implemented to assure that all relevant employees understand the situation and the changes that have been made? Has an investigation demonstrated that that the actions taken have not had any additional adverse effect on the product or service?
  • 40.  Make sure that appropriate information has been recorded that provides proof that all actions have been completed successfully.
  • 41.  A validation of the action is done. This must document that:  The root cause of the problem has been solved,  Any resulting secondary situations have been corrected,  Proper controls have been established to prevent a future occurrence,  The actions taken had no other adverse effects.  Adequate monitoring of the situation is in place.
  • 42.  When the Follow Up has been finished, the CAPA is complete. It should be dated, and signed by appropriate, authorized personnel.
  • 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.SMIDEAL is 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: Method Definition, 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 achieve excellence through process improvement”Our 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 Senior Management commitment for Quality. Overview of Juran’s Quality Improvement Process - a practical example of the CAR a CMMI® 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 would disappear if there were no quality problems.” - Juran• “You can easily spend 15 - 20% of your sales dollars on the COPQ.” - Crosby• “In most companies the costs of poor quality runs 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 Team Implement 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 <12 months)• Measurable (impact must be measured)• Urgency (how urgent is the problem to the organization?)• Risk (what are the risks?)• Resistance to Change (how high is resistance to change?)
  • 55. Example: Selection Criteria PROBLEM A B C CRITERIA SCALEStrategic Goal 5 = Most SupportivePoints = 25 1 = Least SupportiveReturn on Investment (ROI) 5 = Most SignificantPoints = 20 1 = Least SignificantFrequency of Occurrence 5 = Most ChronicPoints = 15 1 = Least ChronicUrgency 5 = Most UrgentPoints = 15 1 = Least UrgentMeasure of Potential Impact 5 = Most ImpactPoints = 8 1 = Least ImpactRisk Management 5 = Least RiskPoints = 7 1 = Most RiskSize 5 = Most ManageablePoints = 5 1 = Least ManageableChange Management 5 = Least ResistancePoints = 5 1 = Most Resistance
  • 56. QC PAT(s) OrganizationSelect: Review/VerifyStrategy,Problem to Charter, Mission &be solved & PAT Team MembershipPATs Report Status: Discover RootUnderstand, CausesSupport,Direct & Recognize Develop SolutionsTeam & Controls Phase Out Team Implement Solution &Recognize Team ControlsLessons Learned Monitor Solution to Hold the Gains • Adapted from Juran, “Leadership for Quality”, 1989
  • 57. Charters can include the following information:• name of team• mission statement and desired results• activities and functions• deliverables• authorization (QC - signatures)• team members• estimated return on investment• start date and end date• team ground-rules
  • 58.  Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary
  • 59. QC PAT(s) OrganizationSelect: Review/VerifyStrategy,Problem to Charter, Mission &be solved & PAT Team MembershipPATs Report Status: Discover RootUnderstand, CausesSupport,Direct & Recognize Develop SolutionsTeam & Controls Phase Out Team Implement Solution &Recognize Team ControlsLessons Learned Monitor Solution to Hold the Gains • Adapted from Juran, “Leadership for Quality”, 1989
  • 60. Jurans Quality Improvement ProcessDiscover 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 gains:9. design effective quality controls10. audit the controls
  • 61. Discover Root Causes - 1Definitions:Symptom: A symptom is the outward observable evidence of aproblem. — Juran Institute, Inc.Root Cause: A root cause is the source of the problem, which, whenremoved, will sharply reduce or eliminate the deficiency. — JuranInstitute, Inc.A root cause is an antecedent source of a defect such that if it isremoved, the defect is decreased or removed itself. — CMMI V1.02
  • 62. Discover Root Causes - 21. Analyze the Symptoms: understand fully the nature and extent ofthe problem to be solved.Tools: Flow Diagram, Data Collection, Pareto Analysis2. Formulate Theories: a PAT should speculate about the cause of theproblem versus jumping to a solution.Tools: Brainstorming, Cause-Effect
  • 63. Purpose: Role Role Role SUPPLIER(S) Input(s)The process The processbegins with . . . ends with . . . CUSTOMER(S) Output
  • 64. Discover Root Causes - 33. Test Theories: Before accepting any theory as true, a PAT shouldsystematically test it with data. Tools: Data Collection, Graph/Charts, Histogram, Pareto Analysis, Scatter Diagram, Stratification4. Identify Root Cause(s): Does the data help determine the root causeof the problem? Tools: Data Collection, Graph/Charts, Histogram, Pareto Analysis, Scatter Diagram, Stratification
  • 65.  1. Formulate good questions 2. Consider appropriate data analysis tool 3. Define data collection points 4. Select unbiased collector 5. Understand data collectors & their environment 6. Design data collection forms 7. Document instructions 8. Pilot/test forms and instructions 9. Train data collectors 10. Audit the collection process & validate results
  • 66.  Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary
  • 67. QC PAT(s) OrganizationSelect: Review/VerifyStrategy,Problem to Charter, Mission &be solved & PAT Team MembershipPATs Report Status: Discover RootUnderstand, CausesSupport,Direct & Recognize Develop SolutionsTeam & Controls Phase Out Team Implement Solution &Recognize Team ControlsLessons Learned Monitor Solution to Hold the Gains
  • 68. Jurans Quality Improvement ProcessDiscover 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 gains:9. design effective quality controls10. audit the controls
  • 69. Develop Solutions & Controls - 15. Consider Alternative Solutions: identify possible remediesand evaluate each alternative solution in terms of impact on theproblem.Tools: Brainstorming, Data Collection, Selection Matrix6. Design Solutions & Controls: design the remedy which willentail documentation of the solution (e.g., process, procedures,standards) and controls.Tools: Control Spreadsheet, Control Chart
  • 70. Control How Where Who Who What isVariable Measured Measured Standard Analyzes Acts done • Juran Institute
  • 71. Develop Solutions & Controls - 27. Address Resistance to Change: identify likely sources of resistance(barriers) and support (aids). Identify counter measures to the vital fewbarriers.Tools: Barriers/Aids, Brainstorming8. Implement Solutions & Controls: implementing a change includes:developing a plan - involving relevant stakeholders, training and explaining“why” the change.Tools: Planning Matrix, Tree Diagram
  • 72.  Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary
  • 73. QC PAT(s) OrganizationSelect: Review/VerifyStrategy,Problem to Charter, Mission &be solved & PAT Team MembershipPATs Report Status: Discover RootUnderstand, CausesSupport,Direct & Recognize Develop SolutionsTeam & Controls Phase Out Team Implement Solution &Recognize Team ControlsLessons Learned Monitor Solution to Hold the Gains
  • 74. 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 gains:9. design effective quality controls10. audit the controls
  • 75. 9. Design Effective Quality Controls: determine how actual performancewill be compared to the standard (i.e., record data) in order to evaluate the effectof the change.Tools: Control Chart, Control Spreadsheet, Flow Diagram10. Audit The Controls: develop systems for reporting results.Tools: Control Chart, Control Spreadsheet, Data Collection, Graphs/Charts, Pareto, Stop Light Charts
  • 76.  Proof of the Need Selecting a Strategy, Problem & PAT Determine Causes of Defects Address Causes of Defects Holding The Gains Summary
  • 77. The Language of Senior Management is $money$ - CARcan be used to “grab” managements attention.A practical example of CAR Process Area is the JuransQuality Improvement Process: • Discover Root Causes (CAR SG 1) • Develop Solution & Controls (CAR SG 2) • Holding the Gains (CAR SG 2)Look for “low hanging fruit” for the first few problems tosolve.Know when to use the appropriate tool in the QualityImprovement journey.
  • 78. “The competitor to be feared is onewho never bothers about you atall, but goes on making his ownbusiness better all the time.”