1. How to Implement, Process and Administer the Preventive Action Process
Partnering With You For Solutions
Preventive Action
How to Implement, Process and Administer the Preventive Action Process
Rev A Copyright Isocert Solutions 2008

2. 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
Rev A Copyright Isocert Solutions 2008

3. 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
Rev A Copyright Isocert Solutions 2008

4. 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
Rev A Copyright Isocert Solutions 2008

5. 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
Rev A Copyright Isocert Solutions 2008

6. Introduction to Preventive Action
Examples of 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
Rev A Copyright Isocert Solutions 2008

7. Introduction to Preventive Action
Types of Preventive Action Systems
Preventive Action Review Board
Preventive Action can be a vehicle for Continuous Improvement
Rev A Copyright Isocert Solutions 2008

8. 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?”
Rev A Copyright Isocert Solutions 2008

9. 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
Rev A Copyright Isocert Solutions 2008

10. 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!
Rev A Copyright Isocert Solutions 2008

11. 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
1980s – Total Quality Management becomes a basis for Quality Improvement and Preventive Action
Rev A Copyright Isocert Solutions 2008

12. 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
Rev A Copyright Isocert Solutions 2008

13. 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
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
Rev A Copyright Isocert Solutions 2008

14. 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
Rev A Copyright Isocert Solutions 2008

15. 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
Rev A Copyright Isocert Solutions 2008

16. 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
Rev A Copyright Isocert Solutions 2008

17. 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
Rev A Copyright Isocert Solutions 2008

18. 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
Rev A Copyright Isocert Solutions 2008

19. 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
Rev A Copyright Isocert Solutions 2008

20. 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
Rev A Copyright Isocert Solutions 2008

21. 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.
Rev A Copyright Isocert Solutions 2008

22. 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
Rev A Copyright Isocert Solutions 2008

23. 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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24. 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
Rev A Copyright Isocert Solutions 2008

25. 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
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26. 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
Rev A Copyright Isocert Solutions 2008

27. 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
Rev A Copyright Isocert Solutions 2008

28. 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
Rev A Copyright Isocert Solutions 2008

29. 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?
Rev A Copyright Isocert Solutions 2008

30. 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
Rev A Copyright Isocert Solutions 2008

31. 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
Rev A Copyright Isocert Solutions 2008

32. 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
Rev A Copyright Isocert Solutions 2008

33. 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
Rev A Copyright Isocert Solutions 2008