Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
D7 - Preventive Actions
No. Action Description Resp Date Validation (Methods and Results)
Target Comp
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430567609.xls QRCM Summary
Operations Lead
If applicable
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considered uncontrolled.
430567609.xls Action Plan
Number Issue / Action Item Responsible Target Status Action Status / Results
Completion
Date
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430567609.xls Action Plan
Number Issue / Action Item Responsible Target Status Action Status / Results
Completion
Date
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430567609.xls Alert
QUALITY ALERT
Tracking No: Date Initiated:
Concern Description
CONTAINMENT REQUIREMENTS
NO. LOCATION AND/OR DESCRIPTION OF SPECIAL ACTIONS START RESP.
PROCESS POINT DATE/TIME
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considered uncontrolled.
430567609.xls Containment Data
CONTAINMENT CHART
Tracking No.
Date Initiated
Please follow the quality alert
for containment criteria
SHIFT
@ Inspected
Customer
Rejected
In transit to Inspected
Customer
Rejected
Supplier Inspected
Rejected
In transit Inspected
from
supplier Rejected
In plant Inspected
location 1
Rejected
In plant Inspected
location 2
Rejected
In plant Inspected
location 3
Rejected
In plant Inspected
location 4
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430567609.xls
In plant Containment Data
location 4
Rejected
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430567609.xls 5-why
5-WHY ANALYSIS
Problem Statement:
Why
Because the
Why
Because the
Why
Because the
Why
Because the
Predict - Why did the planning process not predict the nonconformance?
Why
Because the
Why
Because the
Why
Because the
Why
Because the
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430567609.xls 5-why
5-WHY ANALYSIS
Problem Statement:
Prevent - Why did the manufacturing process not prevent the nonconformance?
Why
Because the
Why
Because the
Why
Because the
Why
Because the
Protect - Why did the quality process not protect from the nonconformance?
Why
Because the
Why
Because the
Why
Because the
Why
Because the
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430567609.xls Is-Is Not
Problem Statement:
Problem Description:
Last Updated:
WHAT
What object has defect? (part / family
name)
What object has defect (part number)
WHERE
Where the concern is on the object (be
specific - LH/RH, inside/Outside,
top/bottom, front/rear, location, which
end, scatter or concentration diagram)
WHEN
When was the problem initially
reported? (date, time)
When was the problem first
experienced / observed (date operator,
machine)
When else this problem was seen (if
multiple occurrence, then attach a
detailed spreadsheet in the workbook
and narrate book-ends here)
HOW BIG
Describe size of the problem on an
individual component) - magnitude,
size, spread (how much of each part
affected), severity, penetration, etc. - If
data are not 100% factual, actions are
to be defined to get facts)
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430567609.xls Hypothesis Development
A 0
B 0
C 0
D 0
E 0
F 0
G 0
H 0
I 0
Click to RunMacro to
Update Trial Run of
Possible Causes
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430567609.xls
Click to RunMacro to Hypothesis Development
Update Trial Run of
Possible Causes
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430567609.xls Hypothesis Development
10
11
12
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430567609.xls Hypothesis Development
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
TOTAL 0
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430567609.xls Hypothesis Development
Theory "B" explains the "Is" statement? Theory "C" explains the "Is" statement?
True or False True or False
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
0 0
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
Theory "D" explains the "Is" statement? Theory "E" explains the "Is" statement?
True or False True or False
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
0 0
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
Theory "F" explains the "Is" statement? Theory "G" explains the "Is" statement?
True or False True or False
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
0 0
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
Theory "H" explains the "Is" statement? Theory "I" explains the "Is" statement?
True or False True or False
This document is Electronically Controlled in the Policies and Procedures website on Imagine. Printed copies are considered uncontrolled.
430567609.xls Hypothesis Development
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Cause and Effect Diagram
Measurement Materials Method
Problem
Statement
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Environment Manpower Machine
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DETERMINING SYSTEM INADEQUACY
RESPONSIBLE FOR HUMAN ERROR
No STANDARD FAILED
No
Do standards / procedures Are they clear / practical Yes Standards /
exist for the task?
Yes procedures not
responsible
No TRAINING FAILED
No LEADER FAILED
No
Yes Did Leader(s): Yes
Did leader(s) enforce Make on-the spot corrections?
standards?
Leader not
Emphasize by the book
responsible
examples and opportunities?
Take action when appropriate?
INDIVIDUAL FAILED
No
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430567609.xls 3x5
3 x 5 Worksheet
P1
Why did the planning process not predict
the non-conformance?
P2
P3
Predict
P4
Planning process -
informational content P5
in FMEAs and CPs
P-RC
M1
Why did the manufacturing process not
prevent the non-conformance?
M2
M3
Prevent
M4
Manufacturing process -
standardized work and
error proofing M5
M-RC
Q1
Why did the quality process not protect
from the non-conformance?
Q2
Q3
Protect
Q4
Quality process -
detection &
responsiveness Q5
Q-RC
K3
K4
K5
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430567609.xls Read-Across Matrix
Not Completed
t
Plan
Systemic Issue Systemic Systemic
4
1
3
Champion Due Date
t
t
Plan
Plan
Plan
Plan
in
5 Why? Root Cause (RC) Corrective Actions
With
PREDICT
PREVENT
Why did the
manufacturing process
Document Verification/ Validation
not prevent the
nonconformance?
PROTECT
Why did the quality
process not protect the
customer from the non-
Document Verification/ Validation
conformance
Key Findings
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