Root Cause Analysis Guidelines

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ENERGETIC MATERIALS Co.
Root Cause Analysis Guidelines
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ENERGETIC MATERIALS Co.
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?
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ENERGETIC MATERIALS Co.
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.
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ENERGETIC MATERIALS Co.
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.
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ENERGETIC MATERIALS Co.
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.
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ENERGETIC MATERIALS Co.
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.
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ENERGETIC MATERIALS Co.
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?
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ENERGETIC MATERIALS Co.
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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