Partnering With You For Solutions
Preventive Action
How to Implement, Process and
Administer the Preventive Action
Process
Rev A
Copyright Isocert Solutions
2008
Table of Contents
• 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
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2008
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
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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
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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
• 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
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Introduction to Preventive Action
• Examples of Types of Preventive Action
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Customer Requirements
Equipment needed to conduct business
Product protection,
Technological improvements
Preventive Maintenance Programs
Safety
Management Requested Preventive Action
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Introduction to Preventive Action
• Types of Preventive Action Systems
– Preventive Action Review Board
• Preventive Action can be a vehicle for
Continuous Improvement
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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?”
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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
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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!
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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-Std1520, Corrective and Preventive Action
– 1980s – Total Quality Management becomes a basis for
Quality Improvement and Preventive Action
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The History of 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
• 2000 – 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
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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.
– The document ed procedure for Preventive action shall define
requirements for;
– A documented procedure shall be established to define the requirements
for
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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
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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
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Potential Quality System nonconformities
Potential product nonconformities
Potential customer dissatisfaction (complaints)
Potential returned material or field failures
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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
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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
– 8 step summary
• 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
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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
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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
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2008
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
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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
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2008
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?
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2008
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
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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
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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
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Implementation and Administration of
the Preventive Action Process
• Implementation
– Identification of a Preventive Action
Coordinator
– Creation of and training in the Preventive
Action procedure
• 1 of 6 required by ISO 9001:2008
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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
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2008
Implementation and Administration of
the Preventive Action Process
• The first step is to Define the Potential Problem
• The next step, if serious enough, is to implement a
containment action if the problem is encountered
– 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
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2008
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
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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?
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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
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2008
Implementation and Administration of
the Preventive Action Process
• The final step is for the PAR 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
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2008
Tools for Preventive Action
Not every Preventive Action Request will require
these, they are examples of tools available to you
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8-step problem solving process
PAR Cause matrix
Parking lot
Nominal group techniques
Affinity Diagrams
Process mapping and capability studies
Flow charting
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2008
Benefits of Preventive Action
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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
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Copyright Isocert Solutions
2008