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Preventive Action Training
How to Implement, Process and Administer the Preventive Action Process
What we will coverO Introduction to Preventive Action
O Preventive versus Corrective ActionO Types of Preventive Action
O History of the Preventive Action ProcessO The ISO 9001:2008 Standard’s Requirement for
Preventive ActionO The Preventive Action ProcessO Implementation and Administration of the
Preventive Action ProcessO Data Gathering, Measurement and Analysis
O Tools for Preventive ActionIsocert Solutions © Rev B 3
Introduction to Preventive Action
O Preventive Action is not just an ISO 9001 requirementO It is a fundamental management tool for ensuring
your organizations vitality and growthO It’s about change and controlling it without chaos
O Preventive Action offers you the choice of deciding if a POTENTIAL event will have a positive or negative impact to your organization
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Introduction to Preventive Action
O It is the orchestration of various activities within the organization to assure the business processes function smoothly O A process has no end, it is continuousO A formal process that has been defined and
controlled with Management InvolvementO The key words are that it is a PROCESS and
MANAGEMENT INVOLVEMENT
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Introduction to Preventive Action
OPreventive Action versus Corrective ActionO Preventive Action is taken to eliminate POTENTIAL
nonconformities in order to Preempt their occurrenceO To keep them from happening in the first place
O It deals with abstractions, inhabiting the realm of “potentiality”O Examples are Failure Modes Effects Analysis, Packaging Design, or
Mistake Proofing; there are many more examples
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Introduction to Preventive Action
O Can relate to products, processes or systemsCorrective Action is taken to eliminate the
cause of nonconformities in order to avoid recurrenceO In other words correcting something that has
already happenedO A Quality System deals with 2 unique
requirements – actuality versus potentiality
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Introduction to Preventive Action
O Types of Preventive ActionO Customer Requirements O Equipment needed to conduct businessO Product protection, O Technological improvementsO Preventive Maintenance ProgramsO SafetyO Management Requested Preventive Action
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Introduction to Preventive Action
O Types of Preventive Action SystemsO Preventive Action Review Board
O Preventive Action can be a vehicle for Continuous Improvement
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Introduction to Preventive Action
O Preventive action can be viewed as a form of “Risk Management”O 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?”
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Introduction to Preventive Action
O It requires vigilance in identifying internal and external factors that affect the organization and may require a response to avoid a problem
O Diminishes the chance you will be surprised by an unpleasant event that could have been anticipatedO Reduces the chance of potential financial loss
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Introduction to Preventive Action
O Who Should be involved with Preventive ActionO The entire organizationO The entire Product Development TeamO Chaired by the Top Management
O Most of all YOU!
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The History of Preventive ActionO 1930s – Joseph M Duran and W Edward Deming
formalize the Preventive Action ProcessO It is institutionalized in Japan after WW2O Quality concepts were rejected in the United
States after WW2O 1960s – With the advance of the space era, the
Defense Department and NASA determined a Quality System was necessary for their contractorsO Preventive Action was formalized in the Creation
of Mil-Std-1520, Corrective and Preventive Action
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The History of Preventive ActionO 1980s – Total Quality Management becomes a basis for
Quality Improvement and Preventive ActionO 1987 – ISO 9000 establishes an international
requirement for Preventive action in clause 14, Corrective/Preventive Action
O 1996 – DOD and NASA accept its’ version of Preventive action making Mil-Std-1520 obsolete
O 2008 – ISO 9001 adopts the Plan-Do-Check-Act formula and process approach of TQM and forms Preventive Action as a basic business processO Formalizes Customer Satisfaction as a means of
Continuous Improvement and Preventive Action
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O The requirement states:O 8.5.2 Preventive ActionO 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.
O A documented procedure shall be established to define the requirements forO Determining potential nonconformities and their causesO Evaluating the need for actions to prevent occurrence of
nonconformitiesO Determining and implementing the action neededO Recording results of action takenO Reviewing Preventive action taken
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O What does this mean?O Identifying potential nonconformities
O Based upon objective evidenceO Can be based upon a single occurrence or a
trendO Potential Quality System nonconformitiesO Potential product nonconformitiesO Potential customer dissatisfaction (complaints)O Potential returned material or field failures
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O The steps to take to achieve preventing a potential nonconformityO The potential problem is articulated based
upon evidence (data)O The cause of the potential problem is
investigatedO A plan of action is developed and implementedO The results of the action taken are reportedO The outcome is reported to management
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O Determining the causes of potential nonconformitiesO What could go wrong
O Getting to the root of the potential problem, not a quick fix
O Identifying the nature and risk involved with the causeO Can involve the 8-step Problem Solving Process,
depending on the nature of the problemO 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
O This thread represents a logical process that can be obvious, presumed inherent by the nature of the situation, or incorporated into the preventive action
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O Determining the causes of potential nonconformitiesO Could it be a one time occurrence?O Could a trend be developed?
O If so, what are the common characteristics of the potential cause and how are they related?
O Use data analysis to determine the causeO Collect data to use and create chartsO A useful tool is the Preventive Action Cause Matrix
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O Evaluating the need for actions to ensure that potential nonconformities do not occurO This is commonly referred to as “prevention as to
cause”O May involve a Preventive Action Plan depending
upon the complexity of the potential cause of the nonconformity
O Training is NOT a Preventive ActionO It is a band aid. You need to look at the process to
correct the nonconformity
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The ISO 9001:2008 Standard’s Requirement for Preventive ActionO Determining and implementing the Preventive action needed
O The Preventive Action required is dependent upon the nature of the nonconformity
O Determine what resources are necessary to to carry out the Preventive ActionO Personnel, machinery, documentation, technology
O What is the timeframe for determining and implementing the Preventive Action
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O Determining and implementing the Preventive action neededO Is customer communication or approval
requiredO Who will ultimately authorize this action plan
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The ISO 9001:2008 Standard’s Requirement for Preventive Action
O Recording the results of action(s) takenO What did you do to implement the Preventive
action?O What actions did you take in response to the
data that was collected?O Were they effective?
O What is the objective evidence?O Is it documented?
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The ISO 9001:2008 Standard’s Requirement for Preventive ActionOReviewing the Preventive Action Taken
O This is referred to as Verification and Follow upO A good tool to is to create a Preventive Action
Verification and Effectiveness Matrix ( depending upon the nature of the nonconformity)
O 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
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The Preventive Action Process
O The Preventive Action ProcessO Let’s review the flow of Preventive Action now
that we have seen what is involved in the steps to taking effective Preventive Action.
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The Preventive Action Process
O Reviewing the Preventive Action takenO Management Review
O Depending upon the nature of the nonconformity, this can be just the area manager or, if it is serious enough, senior management
O Should always be a positive experience for everyone
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Implementation and Administration of the Preventive Action ProcessO 5.1 Management Commitment
O Top management shall provide evidence of its commitment to the development and improvement of the quality management system
O Preventive Action cannot be effectively implemented and administered without Management Commitment
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Implementation and Administration of the Preventive Action ProcessO Implementation
O Identification of a Preventive Action Coordinator
O Creation of and training in the Preventive Action procedureO 1 of 6 required by ISO 9001:2008
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Implementation and Administration of the Preventive Action ProcessO Timeliness of Preventive Action ResponsesO Includes an escalation process
O Management MUST respond when the escalation process is implemented
O Can be either area management or senior management
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Implementation and Administration of the Preventive Action ProcessO The first step is to Define the ProblemO The next step, if serious enough, is to implement
a containment actionO What must we do to protect the customer
O Depending upon the nature of the Preventive Action Request, data gathering for analysis is implementedO There are many tools available for data gathering
O Measurement analysis of the data to determine the trends or isolate the root cause
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Implementation and Administration of the Preventive Action ProcessO Define and Analyze the root cause
O How was the root cause verifiedO Plan and implement a solution
O What is the Preventive Action Plan and what is its’ current status
O Evaluate the solutionO This is the verification by the team or
responder that the solution worked
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Implementation and Administration of the Preventive Action ProcessO Standardize the solution
O How does the solution work for all situations for which it has been identified to fit
O Can the solution be deployed elsewhere in the organization?
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Implementation and Administration of the Preventive Action ProcessO Review, reflect and report
O This is the review of the results versus the problem statement
O What lessons have we learned?O Can we apply this to other problems we
identified along the way?O Should we do it again?
O If the solution isn’t 100%, the answer is yes
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Implementation and Administration of the Preventive Action ProcessO The final step is for the CAR Coordinator to
verify the Preventive actionO 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
O Can be part of the Management Review process
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Tools for Preventive ActionNot every Preventive Action Request will require these, they are examples of tools available to youO 8-step problem solving processO PAR Cause matrixO Parking lotO Nominal group techniquesO Affinity DiagramsO Process mapping and capability studiesO Flow charting
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Benefits of Preventive ActionO Improved processes O Decreased variability in product and processesO Reduced wasteO Cost savingsO Time savingsO Improved internal and external communicationO Better linkage within the chain of processesO More efficient allocation of resourcesO Detecting problems before your customers doO Improved marketability
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O For more information visit our website Isocertsolutions.com
O We are a full service provider of products and services to support Quality Assurance in any industry.
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