1. Training

2. Corrective Action Training
How to Implement, Process and Administer the Corrective Action Process

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

4. Introduction to Corrective Action
Corrective Action is not just an ISO 9001 requirement
It is a fundamental management tool for ensuring your organizations vitality and growth
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 C

5. Introduction to Corrective Action
Corrective Action versus Preventive Action
Corrective Action is taken to eliminate the cause of nonconformities in order to avoid recurrence
In other words correcting something that has already happened
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
A Quality System deals with 2 unique requirements – actuality versus potentiality
Isocert Solutions © Rev C

6. Introduction to Corrective Action
Types of Corrective Action
Customer Requested Corrective Action
Returned Materials, Field failures or design errors are examples
Quality System Corrective Action
Third Party Audit
Second Party Audit
Internal Audit
Supplier Corrective Action
Management Requested Corrective Action
Have the class give their own examples of corrective versus preventive actions
Isocert Solutions © Rev C

7. Introduction to Corrective Action
Who Should be involved with Corrective Action
The entire organization
The entire Product Development Team
Chaired by the Quality Assurance department
Most of all YOU!
Isocert Solutions © Rev C

8. Introduction to Corrective Action
Types of Corrective Action Systems
Corrective Action Review Board
Failure Analysis Review Board
Material Review Board
Returned Material Review Board
Corrective Action can be a vehicle for Continuous Improvement
Isocert Solutions © Rev C

9. The History of Corrective Action
1930s – Joseph M Duran and W Edward Deming formalize the Corrective 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
Corrective Action was formalized in the Creation of Mil-Std-1520, Corrective Action
1980s – Total Quality Management becomes a basis for Quality Improvement and Corrective Action
Isocert Solutions © Rev C

10. The History of Corrective Action
1987 – ISO 9000 establishes an international requirement for corrective action in clause 14, Corrective/Preventive Action
1996 – DOD and NASA accept its’ version of corrective action making Mil-Std-1520 obsolete
2000 – ISO 9001 adopts the Plan-Do-Check-Act formula and process approach of TQM and forms Corrective Action as a basic business process
Formalizes Customer Satisfaction as a means of Continuous Improvement and Corrective Action
Isocert Solutions © Rev C

11. The ISO 9001:2008 Standard’s Requirement for Corrective Action
The requirement states:
8.5.2 Corrective Action
The organization shall take corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action shall be appropriate to the impact of the problem encountered.
The document ed procedure for corrective action shall define requirements for;
Identifying nonconformities (including customer complaints)
Determining the causes of nonconformity
Evaluating the need for actions to ensure that nonconformities do not recur
Determining and implementing the corrective action needed
Recording results of action taken
Reviewing corrective action taken
Isocert Solutions © Rev C

12. The ISO 9001:2008 Standard’s Requirement for Corrective Action
What does this mean?
Identifying nonconformities
Based upon objective evidence
Can be based upon a single occurrence or a trend
Quality System nonconformities
Product nonconformities
Customer dissatisfaction (complaints)
Returned material or field failures
Isocert Solutions © Rev C

13. The ISO 9001:2008 Standard’s Requirement for Corrective Action
Determining the causes of nonconformity
What went wrong
Getting to the root of the 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 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 corrective action
Isocert Solutions © Rev C

14. The ISO 9001:2008 Standard’s Requirement for Corrective Action
Determining the causes of nonconformity
Is it a one time occurrence?
Has a trend developed?
If so, what are the common characteristics of the 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 Corrective Action Cause Matrix
Review example of a corrective action matrix
Isocert Solutions © Rev C

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

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

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

18. The ISO 9001:2008 Standard’s Requirement for Corrective Action
Recording the results of action(s) taken
What did you do to implement the corrective 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 C

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

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

21. Corrective Action Process Flow
Isocert Solutions © Rev C

22. The Corrective Action Process
Reviewing the Corrective 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 C

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

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

25. Isocert Solutions © Rev C

26. Implementation and Administration of the Corrective Action Process
Timeliness of Corrective 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 C

27. Implementation and Administration of the Corrective 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 Corrective 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 C

28. Implementation and Administration of the Corrective Action Process
Define and Analyze the root cause
How was the root cause verified
Plan and implement a solution
What is the Corrective 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 C

29. Implementation and Administration of the Corrective 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 C

30. Implementation and Administration of the Corrective 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 C

31. Implementation and Administration of the Corrective Action Process
The final step is for the CAR Coordinator to verify the corrective action
If the 8-step process was used to determine the corrective 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 C

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

33. Conclusion
Corrective Action is the process by which you handle problems and issues arising during the course of conducting business
The manner in which the problems are handled is, in part, a measure of the effectiveness of your Quality Management System
Isocert Solutions © Rev C

34. Conclusion
The resources required for an efficient, cost effective Corrective Action process currently exist within your organization
You are already performing corrective actions, just not in a formal manner
They just need to be defined, controlled and most importantly, be consistent
Isocert Solutions © Rev C

35. Conclusion
The following requirements apply to both the organizational commitment to corrective action and to the individual actions taken
Requirements of the process are clearly defined
Responsibilities are assigned
Monitoring of data is appropriate and consistent
Resources are allocated
Objectives are established
The causes of problems are investigated fully
Isocert Solutions © Rev C

36. Conclusion Requirements Continued
Action plans, when required, are well developed
Criteria for implementing actions are determined
Mechanisms for verification are in place
Provisions for follow-up are developed
Records are developed and maintained as defined in your Quality Management System
Isocert Solutions © Rev C

37. For more information visit our website Isocertsolutions.com
We are a full service provider of products and services to support Quality Assurance in any industry.
Isocert Solutions © Rev C