Corrective and Preventive Actions So What Is The Difference

1
Corrective and Preventive Actions / So What Is
The Difference?

• Quality Systems Enhancement, Inc.
• 1790 Woodstock Road
• Roswell, GA 30075
• 770-518-9967
• www.enhancequality.com

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Why The Confusion?

• Unclear definitions / inaccurate practices
• Corrective action has a built-in prevention which
  is to prevent reoccurrence
• Prevent reoccurrence appears to be preventive
  action
• Auditors adding fuel to the fire
• Incomprehension of conceptual difference

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Vocabulary

• Nonconformity
• Correction
• Corrective Action
• Root Cause
• Prevent Reoccurrence
• Preventive Action
• Potential Cause
• Effectiveness

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What is the Difference?

• Corrective Action
• Eliminate an existing nonconformity
• Preventive Action
• Eliminate a potential nonconformance /
  nonconformity

5
What is the Difference?

• Corrective Action
• Dont let it happen again
• Preventive Action
• Dont let it happen at all

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What is the Difference?

• Corrective Action
• Local in nature
• Preventive Action
• Global in nature

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What is the Difference?

• Corrective Action
• Prevent reoccurrence
• Preventive Action
• Prevent potential occurrence

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What is the Difference?

• Corrective Action
• Reactive
• Preventive Action
• Proactive

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What is the Difference?

• Corrective Action
• Eliminate the cause of a detected nonconformity
• Preventive Action
• Eliminate the cause of a potential nonconformance

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Sources of Corrective Action

• Suppliers
• Processes
• Manufacturing
• Non-manufacturing (support)
• System (internal audits)

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Corrective Action Examples

• Existing Problem
• 16 of the received raw material was
  nonconforming
• 20 of todays production off of a machine did
  not meet customer specifications
• 25 of customer orders were inaccurately
  documented by one order taker
• 15 of the shipments were late to a specific
  customer one month
• Five customer complaints were not addressed for
  period of 90 days

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Corrective Action Process

• Accurately define an existing problem
• Investigate all root causes
• Identify the most probable cause
• Determine accurate corrective action
• Implement corrective action
• Follow up / effectiveness / closure
• Verify a minimum of twice prior to closure
• Allow at least one month between each
  verification for corrective action effectiveness

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Sources of Preventive Action

• Quality records / trends
• Design failures
• Feasibility studies
• Suppliers
• Processes
• Audit results
• Customer complaints

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Preventive Action Example

• Potential Problem
• Electronic circuit board in machine number 305,
  Flexo Folder / Gluer failed after 100 hours of
  operation. There are three other machines of the
  same model purchased at the same time with a
  potential for similar failure.
• Internal audit reveals one machine operator does
  not know how to accurately complete a
  comprehensive quality verification form.
  Potential exists for several other operators

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Preventive Action Process

• Accurately define a potential problem
• Investigate all potential causes
• Identify the most probable potential cause
• Determine accurate preventive action
• Implement preventive action
• Follow up / effectiveness / closure
• Takes longer time to effectively close a
  preventive action
• Always verify a minimum of three times with at
  least one month interval prior to closure

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Corrective Action Impact or Preventive Action ?

• Potential in other areas
• Other suppliers of same or similar material /
  services
• Other machines of similar functionality
• Other areas of similar design failures
• Other customers with similar applications
• These situations appear to be applications of
  preventive actions ?
• Yes or No
• What do the third party auditors say ?

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Time Frame to Effectively Close C/P Actions

• How long does it take to eliminate an existing
  nonconformance or nonconformity?
• How long does it take to eliminate a potential
  nonconformance or nonconformity?
• Educate the internal and external auditors for
  effective results

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Summary

• Definitions clearly understood
• Application of concepts not fully understood
• Lack of conceptual application training
• Auditors comprehension inconsistencies
• Inadequate number of examples during training
• Realistic improvement not focused