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ENERGETIC MATERIALS Co. Root Cause Analysis Guidelines 1.

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Presentation on theme: "ENERGETIC MATERIALS Co. Root Cause Analysis Guidelines 1."— Presentation transcript:

1 ENERGETIC MATERIALS Co. Root Cause Analysis Guidelines 1

2 ENERGETIC MATERIALS Co. 2 Complete Problem Description  The problem description is a narrative, using the initial problem description as the starting point.  Who reported the problem?  What is the specific problem or non-conformance, including actual data?  What requirement is violated?  What are part numbers, lot numbers, serial numbers?  Where/when was the problem identified?

3 ENERGETIC MATERIALS Co. 3 Immediate Containment Actions  Define and implement containment actions to isolate potentially non-conforming material from internal or external customer until corrective/preventive action is implemented and verified effective.  Containment actions must be implemented within 24 hrs. of notification. Consider internal, customer and supplier locations.  Containment actions should be listed in chronological order.  Containment actions should identify what took place, who took the action and when actions were taken.  Potential risk of hardware previously produced must be evaluated as part of containment.

4 ENERGETIC MATERIALS Co. 4 Verification of Containment Actions  Describe the results of the containment actions (results of sorts, rework results, risk assessment, etc.).  These actions must completely isolate the concern from the customer.

5 ENERGETIC MATERIALS Co. 5 Root Cause and Verification  A root cause analysis tool (5 Why, Fishbone, Pareto Analysis, DOE, etc) must be used.  Avoid the symptom approach.  The root cause is tested against the problem description.  Verify the root cause by turning it on and off if possible.

6 ENERGETIC MATERIALS Co. 6 Permanent Corrective Action and Verification  Determine and implement permanent actions to prevent the root cause from recurring.  Do not implement any permanent corrective action until the root cause has been determined and verified.  The team should brainstorm potential corrective actions.  Once corrective actions are identified, an implementation plan must be developed.  What actions and who is responsible for the actions must be documented as well as expected completion dates.  The verification plan must be included in the corrective action plan.  As actions are implemented, they are recorded as verified with documented evidence.

7 ENERGETIC MATERIALS Co. 7 Preventive Action and Verification  Modify Management Systems, Operating Systems, Procedures, etc. required to prevent recurrence of the problem.  What was done to ensure the problem will not recur in the future?  What documentation was modified?  Was the issue resolved enterprise wide?  What Training is required?  Was the training documented?  What follow up is required?

8 ENERGETIC MATERIALS Co. 8 Criteria for CAR Acceptance  There is evidence that a root cause analysis tool was used.  There is evidence that containment/potential risk has been evaluated.  The CAR is filled out completely.  There are completion dates and responsibilities clearly identified for containment and corrective actions.  There is a plan to monitor and verify the effectiveness of corrective actions incorporated in the corrective/preventive action section.


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