Corrective Action
Corrective Action
Corrective Action
Terminology
CORRECTIVE ACTION: Action to eliminate cause of a detected nonconformity Corrective action is taken to prevent recurrence Correction relates to containment Corrective action relates to the root cause PREVENTATIVE ACTION: Action to prevent occurrence of a potential defect Long term cost / risk weighted action taken to prevent a problem from occurring
Reviews (contracts, purchasing, processes, designs) Statistical Process Control (SPC) Analysis Software Validation and Verification Supplier Surveillance Preventive Maintenance & Calibration Controls Management Review of Quality Management System Capability Studies, FMEA Employee Training Programs Disaster Recovery Planning Trend Analysis Benchmarking
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An initial response concerning CONTAINMENT activities is required within 24 hours. Please be sure to include containment of your inventory as well as containment of any product that may be intransit to Lord. Please provide a Returned Goods Authorization # at that time if parts are to be returned to you. A full response with known root causes and permanent corrective actions is required within 20 days. Identify the ROOT CAUSE of the nonconformance(s). Identify the ROOT CAUSE of the escape. Identify the weakness in your Quality System that permitted the nonconformance(s) to remain undetected, such as training, inspection or measurement methods. Identify the actions you have taken to correct the specific nonconformance(s). Make sure that the actions taken also involve verification that the nonconformance has been corrected.
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System that permitted the nonconformance(s) to remain undetected. These actions could include increased inspection, additional training of personnel, improved inspection methods, process improvement, etc.
6. Identify the actions you have taken to prevent the recurrence of the
ROOT CAUSE of the nonconformance(s). These actions must be positive and conclusive. (i.e., thread example, just changing the tap is not effective Corrective Action). Examples include monitoring tool life; updating inspection procedures, control plans, or manufacturing methods; or altering process parameters.
7. Determine if other similar products/processes may share the
same/similar nonconformance and identify the actions you have taken regarding this product.
8. Identify the effectivity date for implementation of the identified
corrective action(s).
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8D Approach
The 8D Process is a problem solving method for product and process improvement It is structured into 8 steps (the D's) and emphasizes team 8 D is short for Eight Disciplines which originated from the Ford TOPS (Team Oriented Problem Solving) program. (First published approximately 1987) Of course, different companies have their different twists on what they call the steps, etc.
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8D Process Steps
1. Use Team Approach
Establish a small group of people with the knowledge, time, authority and skill to solve the problem and implement corrective actions. The group must select a team leader.
7. Prevent Recurrence
Modify specifications, update training, review work flow, improve practices and procedures to prevent recurrence of this and all similar problems.
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times, why the failure has occurred in order to get to the root cause/causes of the problem.
Made popular in the 1970s by the Toyota Production
System
Strategy involves looking at any problem and asking:
Example:
You are on your way home from work and your car stops: 1. Why did your car stop? Because it ran out of gas. 2. Why did it run out of gas? Because I didn't buy any gas on my way to work. 3. Why didn't you buy any gas this morning? Because I didn't have any money. 4. Why didn't you have any money? Because I lost it all last night in a poker game
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Fishbone Diagram
Known as cause-and-effect diagram Analysis tool that provides a systematic way of looking at effects and the causes that create or contribute to those effects Categorizing the many potential causes of problems or issues in an orderly way (brainstorming) Dr. Kaoru Ishikawa, a Japanese quality control statistician, invented the fishbone diagram
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Failure to determine the root cause assures that you will be treating the symptoms of the problem instead of its cause, in which case, the issue will return and you will continue to have the same problems over and over again
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Questions/Comments
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