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FM 341.12/08-05-02 (Replacing FM341.11/06-07-01)
Title: Product/Process Information: D0 Symptom(s): D0 Emergency Response Action(s): Verification/Validation: D1 Team (Name, Dept., Tel) Champion: D3 Interim Containment Action(s): D4 Root Cause(s) and Escape Point(s) D5 Chosen Permanent Corrective Action(s) D6 Implemented Permanent Corrective Action(s): Validation: D7 Prevent Actions: D7 Systemic Prevent Recommendations:
Date Implemented:
Date Closed:
Reported by:
D0 D1 D2 D3 D4 D5 D6 D7 D8
Consider emergency response action (ERA); decision to use, and preparation for, this or the more detailed approach,. Establish the team and use teamworking approach, if required. Describe the problem. Develop, validate and implement the interim containment action (ICA), if required. Find, define and verify root cause(s) and escape point(s). Choose and verify permanent corrective actions (PCAs) for root cause and escape point. Implement and validate permanent corrective actions (PCAs). Prevent recurrence of this and possible similar failures, also identify systematic improvement opportunities. Recognise team and individual contributions, as appropriate.
DISCIPLINE D0
You are aware that something has gone wrong, and you dont know the reason why. Before you can describe the problem accurately and thus find root cause(s), you may need to protect the customer (internal or external) from continuing to experience the symptom, if this has not already been done.
All inventory was accounted for. Lot 1 remaining samples put in quarantine.
Possible Actions
WIP on hold WIP checked Warehouse stock on hold Warehouse stock checked Deliveries in transit identified Deliveries in transit checked Deliveries at customer checked Verify control plan controls are properly working Review all past inspection data Other actions
Note:
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Dates
DISCIPLINE 2
PROBLEM STATEMENT
Define very simply What is wrong with what i.e. what object has what defect? Use the techniques of Sub Dividing and Stair Stepping to assist you, to show the relationship of the Problem Statement to the symptom. Note: See Instruction Book for guidance at each discipline.
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FM 341.12/08-05-02 (Replacing FM341.11/06-07-01)
DISCIPLINE 2
Before trying to define the root cause or jump to solutions stop and take time to describe the problem, using as much data and facts as you can gather. Use the questions below to guide you and, if it helps, draw a diagram on the next page. It is possible that the problem was not described correctly on the complaint/DMR you received. If so re-state the problem correctly.
DESCRIPTION AREA
DESCRIPTION DATA
QUESTIONS CHECKLIST
WHAT
Object? Defect? What object has the defect? What is the defect?
WHERE
Seen on object?
Where specifically on the object do you see the defect? Where geographically is defective object observed? the
Seen geographically?
WHEN
First seen? By the customer? When did we make the part? When seen since? When in time, was the defect first observed?
Operating cycle?
Life cycle?
HOW BIG
How many objects have the defect? How many/much defect(s) per object? How many objects have the defect?
How much or how many defect(s) per object? (ie are all bad parts defective to the same extent?) How has the trend developed since first observation and what is it now? (e.g. stable/erratic, getting better/worse) Could this problem affect other similar parts: on other lines, in other plants with the same process, other parts with the same materials/process? List those areas or parts you consider at risk, and inform the Champion to enable communication with others.
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D2 continued
DISCIPLINE 3
Now that you have completed D2, review the emergency response action to see if it can be used as an ICA or improved in order to allow production to continue while still detecting and containing all defective output, giving you time to analyse root cause. If it cant, then identify a better containment action. (Do not remove Interim Corrective Action until permanent corrective action is implemented and verified) Note: In some circumstances an ICA may not be needed.
IS AN IS
ERA OK AS AN ICA?
IF YOU CONSIDER
IF YOU PROPOSE CHANGE(S), REPORT TO CHAMPION AND OBTAIN APPROVAL OF CONTROL PLAN, WORK INSTRUCTIONS AND AUDIT SHEETS.
10
11
12
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D4 continued
Consider the Cause of Effect Diagram. Then create some Root Cause Theories that explain a strong logical link to the Problem Statement and Problem Profile recorded at D2. Document your theories as complete sentence statements.
1 2 3 4 5
D4 continued
LOGIC TEST
Consider each theory in turn. Eliminate those which are not logical when you consider the Time Line of Events and/or the Problem Profile. Record your reasons for elimination.
THEORY REF.
D4 continued
ESCAPE POINT
DO WE HAVE AN INSPECTION/CONTROL POINT THAT SHOULD HAVE ENSURED THAT NON-CONFORMANCES WERE FOUND? YES OR NO?
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D4 continued
FM 341.12/08-05-02 (Replacing FM341.11/06-07-01)
For the theories which pass through the Logic Test, show the logical links (steps) between the root cause theory, the problem statement and the symptom. Do this for each theory. Repeatedly ask why? to show the links.
WHY?
WHY?
WHY?
WHY?
WHY?
Ref
1 2 3 4
Task
Who
When
Outcome?
If you find after these tests that you have not been able to discover cause(s), then take this workbook to your Champion so that the Champion can get you specialist advice.
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DISCIPLINE 5
WHAT ARE YOUR IDEAS FOR PERMANENT CORRECTIVE ACTIONS? (This is one of the most important steps in effective problem solving. At this step it is imperative that appropriate time is alloted to thoroughly prove out the proposed solution(s). It should be verified on multiple machines, across all production shifts, etc. A rush to conclusion here can lead to ineffective corrective action and recurrence of the problem).
AL
Take the workbook to your Champion for the PCA to be reviewed and proposal(s) approved. IMPLEMENT PERMANENT CORRECTIVE ACTIONS
DISCIPLINE 6
Define the precise actions you will need to take to implement and validate effectiveness of the PCA (use Key Tasks Action Plan and Monitor.) List which documents will need to be formally changed, as a result of these actions.
DISCIPLINE 7
PREVENT ACTIONS
Take a moment to look back at this problem. Why did it happen in the first place? What lessons can be learnt? What changes need to be made to ensure that this and similar problems never happen again? Also note down some specific improvements that need to be made in areas such as systems, procedures, machinery, maintenance, people and training.
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DISCIPLINE 8
Make sure that you have completed this workbook, presented it to your Champion to enable communication with others. Express thanks to those who have helped you in dealing with this problem.
Ref.
Task
Who
When
% Complete
25 50 75 100
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DISCIPLINE 4
Brainstorm all possible causes of the problem and record them using the area headings to guide you. List all your ideas and do not criticise any at this stage. After your first attempt, take time to think and add any other possible cause(s).
METHODS/PROCESSE
EQUIPMENT
PEOPLE
Note:
ENVIRONMENT
MATERIALS
If you need any further advice or help, seek out someone in the Quality Assurance Department who has been trained to a more detailed level of problem solving.