Preventive Action Training How to Implement, Process and Administer the Preventive Action Process

What we will cover Introduction to Preventive Action Preventive versus Corrective Action Types of Preventive Action History of the Preventive Action Process The ISO 9001:2008 Standard’s Requirement for Preventive Action The Preventive Action Process Implementation and Administration of the Preventive Action Process Data Gathering, Measurement and Analysis Tools for Preventive Action Isocert Solutions © Rev B

Introduction to Preventive Action Preventive Action is not just an ISO 9001 requirement It is a fundamental management tool for ensuring your organizations vitality and growth It’s about change and controlling it without chaos Preventive Action offers you the choice of deciding if a POTENTIAL event will have a positive or negative impact to your organization Isocert Solutions © Rev B

Introduction to Preventive Action It is the orchestration of various activities within the organization to assure the business processes function smoothly A process has no end, it is continuous A formal process that has been defined and controlled with Management Involvement The key words are that it is a PROCESS and MANAGEMENT INVOLVEMENT Isocert Solutions © Rev B

Introduction to Preventive Action Preventive Action versus Corrective Action Preventive Action is taken to eliminate POTENTIAL nonconformities in order to Preempt their occurrence To keep them from happening in the first place It deals with abstractions, inhabiting the realm of “potentiality” Examples are Failure Modes Effects Analysis, Packaging Design, or Mistake Proofing; there are many more examples Isocert Solutions © Rev B

Introduction to Preventive Action Can relate to products, processes or systems Corrective Action is taken to eliminate the cause of nonconformities in order to avoid recurrence In other words correcting something that has already happened A Quality System deals with 2 unique requirements – actuality versus potentiality Isocert Solutions © Rev B

Introduction to Preventive Action Types of Preventive Action Customer Requirements Equipment needed to conduct business Product protection, Technological improvements Preventive Maintenance Programs Safety Management Requested Preventive Action Have the class give their own examples of Preventive versus preventive actions Isocert Solutions © Rev B

Introduction to Preventive Action Types of Preventive Action Systems Preventive Action Review Board Preventive Action can be a vehicle for Continuous Improvement Isocert Solutions © Rev B

Introduction to Preventive Action Preventive action can be viewed as a form of “Risk Management” It requires process owners and managers to internalize and ask the question “what risks are involved with changing or not changing a process, product or feature of the Quality Management System?” Isocert Solutions © Rev B

Introduction to Preventive Action It requires vigilance in identifying internal and external factors that affect the organization and may require a response to avoid a problem Diminishes the chance you will be surprised by an unpleasant event that could have been anticipated Reduces the chance of potential financial loss Isocert Solutions © Rev B

Introduction to Preventive Action Who Should be involved with Preventive Action The entire organization The entire Product Development Team Chaired by the Top Management Most of all YOU! Isocert Solutions © Rev B

The History of Preventive Action 1930s – Joseph M Duran and W Edward Deming formalize the Preventive Action Process It is institutionalized in Japan after WW2 Quality concepts were rejected in the United States after WW2 1960s – With the advance of the space era, the Defense Department and NASA determined a Quality System was necessary for their contractors Preventive Action was formalized in the Creation of Mil-Std-1520, Corrective and Preventive Action Isocert Solutions © Rev B

The History of Preventive Action 1980s – Total Quality Management becomes a basis for Quality Improvement and Preventive Action 1987 – ISO 9000 establishes an international requirement for Preventive action in clause 14, Corrective/Preventive Action 1996 – DOD and NASA accept its’ version of Preventive action making Mil-Std-1520 obsolete 2008 – ISO 9001 adopts the Plan-Do-Check-Act formula and process approach of TQM and forms Preventive Action as a basic business process Formalizes Customer Satisfaction as a means of Continuous Improvement and Preventive Action Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action The requirement states: 8.5.2 Preventive Action The organization shall determine action to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventive action shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define the requirements for Determining potential nonconformities and their causes Evaluating the need for actions to prevent occurrence of nonconformities Determining and implementing the action needed Recording results of action taken Reviewing Preventive action taken Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action What does this mean? Identifying potential nonconformities Based upon objective evidence Can be based upon a single occurrence or a trend Potential Quality System nonconformities Potential product nonconformities Potential customer dissatisfaction (complaints) Potential returned material or field failures Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action The steps to take to achieve preventing a potential nonconformity The potential problem is articulated based upon evidence (data) The cause of the potential problem is investigated A plan of action is developed and implemented The results of the action taken are reported The outcome is reported to management Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Determining the causes of potential nonconformities What could go wrong Getting to the root of the potential problem, not a quick fix Identifying the nature and risk involved with the cause Can involve the 8-step Problem Solving Process, depending on the nature of the problem In looking at the cause it is useful to look at the common thread that runs through the analysis of the potential cause of the problem This thread represents a logical process that can be obvious, presumed inherent by the nature of the situation, or incorporated into the preventive action Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Determining the causes of potential nonconformities Could it be a one time occurrence? Could a trend be developed? If so, what are the common characteristics of the potential cause and how are they related? Use data analysis to determine the cause Collect data to use and create charts A useful tool is the Preventive Action Cause Matrix Review example of a Preventive action matrix Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Evaluating the need for actions to ensure that potential nonconformities do not occur This is commonly referred to as “prevention as to cause” May involve a Preventive Action Plan depending upon the complexity of the potential cause of the nonconformity Training is NOT a Preventive Action It is a band aid. You need to look at the process to correct the nonconformity Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Determining and implementing the Preventive action needed The Preventive Action required is dependent upon the nature of the nonconformity Determine what resources are necessary to to carry out the Preventive Action Personnel, machinery, documentation, technology What is the timeframe for determining and implementing the Preventive Action Review example of a Preventive action plan Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Determining and implementing the Preventive action needed Is customer communication or approval required Who will ultimately authorize this action plan Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Recording the results of action(s) taken What did you do to implement the Preventive action? What actions did you take in response to the data that was collected? Were they effective? What is the objective evidence? Is it documented? Review the CAR Plan and show how the data needs to be analyzed, depending upon the problem, and show its’ effectiveness. Isocert Solutions © Rev B

The ISO 9001:2008 Standard’s Requirement for Preventive Action Reviewing the Preventive Action Taken This is referred to as Verification and Follow up A good tool to is to create a Preventive Action Verification and Effectiveness Matrix ( depending upon the nature of the nonconformity) Some Preventive actions are simple, such as correcting the procedure or modifying the work instruction. These would not require a Preventive Action Verification and Effectiveness Matrix Isocert Solutions © Rev B

The Preventive Action Process Let’s review the flow of Preventive Action now that we have seen what is involved in the steps to taking effective Preventive Action. Go to Visio/Word flowchart Isocert Solutions © Rev B

The Preventive Action Process Reviewing the Preventive Action taken Management Review Depending upon the nature of the nonconformity, this can be just the area manager or, if it is serious enough, senior management Should always be a positive experience for everyone Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process 5.1 Management Commitment Top management shall provide evidence of its commitment to the development and improvement of the quality management system Preventive Action cannot be effectively implemented and administered without Management Commitment Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process Identification of a Preventive Action Coordinator Creation of and training in the Preventive Action procedure 1 of 6 required by ISO 9001:2008 Show the Junior CAR Log Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process Timeliness of Preventive Action Responses Includes an escalation process Management MUST respond when the escalation process is implemented Can be either area management or senior management Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process The first step is to Define the Problem The next step, if serious enough, is to implement a containment action What must we do to protect the customer Depending upon the nature of the Preventive Action Request, data gathering for analysis is implemented There are many tools available for data gathering Measurement analysis of the data to determine the trends or isolate the root cause Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process Define and Analyze the root cause How was the root cause verified Plan and implement a solution What is the Preventive Action Plan and what is its’ current status Evaluate the solution This is the verification by the team or responder that the solution worked Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process Standardize the solution How does the solution work for all situations for which it has been identified to fit Can the solution be deployed elsewhere in the organization? Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process Review, reflect and report This is the review of the results versus the problem statement What lessons have we learned? Can we apply this to other problems we identified along the way? Should we do it again? If the solution isn’t 100%, the answer is yes Isocert Solutions © Rev B

Implementation and Administration of the Preventive Action Process The final step is for the CAR Coordinator to verify the Preventive action If the 8-step process was used to determine the Preventive action, a formal presentation to Management needs to be made as part of the verification Can be part of the Management Review process Isocert Solutions © Rev B

Tools for Preventive Action Not every Preventive Action Request will require these, they are examples of tools available to you 8-step problem solving process PAR Cause matrix Parking lot Nominal group techniques Affinity Diagrams Process mapping and capability studies Flow charting Isocert Solutions © Rev B

Benefits of Preventive Action Improved processes Decreased variability in product and processes Reduced waste Cost savings Time savings Improved internal and external communication Better linkage within the chain of processes More efficient allocation of resources Detecting problems before your customers do Improved marketability Isocert Solutions © Rev B

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