Charting event$s after corrective action

Steps to use this tool:

1) First thing! Save two copies on your computer with a unique name for each.
2) In Line 2, Column B, enter the process name. This example is for FMEA process.
3) Enter the owners' name(s) in the cells titled "owner", Line 1.
4) Enter the name of items being evaluated: document names, people, tools, etc in Line 2.
5) In the gray cell (Line 3, Column B) enter a question if you have one, such as: "Sampled in previous audit?"
6) In Column B, list your assessment questions. Notice that this example includes positive findings.
7) Very important! In Column S (Yellow cells) assign a score that reflects how important each question is. In this example, negative
numbers subtract from a possible perfect 100, and positive numbers add to the possible score. This it is possible to score more than
100.
8) The assessment results are entered as numbers reflecting every time a finding was noted for each question in each evaluated item
being sampled.
9) In Line 3 (gray cells) enter a "Y" or "N" to show if the item was sampled in the last audit.
10) results will automatically calculate and show up in the charts below.

Line FMEA results: Last time

Score

Totals
Count
Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner
1 FMEA owner
FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name
Average

2 FMEA -

3 (1) FMEA was sampled in previous audit? N N N N Y Y Y N N N Y Y Y Y N 5%

4 (-) (8) Missing one or more Potential Effects of Failure entry 5 1 1 1 1 1 -90 -450
(-) (12) Recalculated RPNs should be using columns to the right of
5 Actions Taken IAW BIQ training. SP-34075 does not specify where to 5 1 1 1 1 1 -30 -150
recalculate RPNs, only that it will be done. DIS #1062
(-) (2) Severity Rating(s) do not align with SP-34075: 6.1.9 and
6 Attachment I. (see DIS #1024) 4 1 1 1 1 -90 -360
(-) (3) RPN calculation is missing, or does not conform to
7 SP-34075: 8.1.5 0. (see DIS #1024) 3 1 1 1 -80 -240
(-) (4) Classification (C or S) of Potential Failure Mode (PFM) does not
8 conform to SP-34075: 6.1.10 (see DIS #1024) 3 1 1 1 -80 -240
 (-) (11) Should include a Potential Cause of Failure, an Occurrence
number, Current Process Control and Delectability Rating for listed
9 Failure Modes as per 2 1 1 -80 -160
SP-34075: 6.1.6, 6.1.7, 6.1.11 and 6.1.12.
(-) (13) No documented action plan found for RPN >200 as per
10 SP-34075, 8.1.18. DIS #1062. 2 1 1 -70 -140
(-) (14) Recommended Action does not address the process to reduce
11 RPN as per SP-34075, 6.1.14 DIS #1062 2 1 1 -50 -100
(-) (15) Entries should be added to Actions Taken column when new
12 controls change risk factors that impact RPN. 2 1 1 -30 -60
(-) (5) Missing a Recommended Action and/or completion date for high
13 RPN 10 as per SP-34075: 6.1.14 (see DIS #1025) 0 -40 0
(+) (7) Was updated after being listed under QAR #06006, DIS #1024 /
14 #1025 6 1 1 1 1 1 1 100 600
15 (+) Zero discrepancies 5 1 1 1 1 1 100 500

(+) (9) Updated to capture recent learnings: good example of

16 FMEA as a “living document” 3 1 1 1 30 90

(+) (6) Recalculated RPN in right hand columns correctly shows

17 risk abatement from Actions Taken. 2 1 1 30 60

(+) (10) Comment blocks give details that show details and/or
18 how the FMEA has changed with process updates: good example 1 1 20 20
of FMEA as a “living document”

19 Score for FMEA -42 130 -200 100 100 200 -150 -260 -120 -170 -10 200 -280 10 -20 -160 280

Line FMEA results: After corrective action

Score

Totals
Count
Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner

Owner
1 FMEA owner FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name

FMEA name
Average

2 FMEA -

3 (1) FMEA was sampled in previous audit? N N N N Y Y Y N N N Y Y Y Y N 5%

4 (-) (8) Missing one or more Potential Effects of Failure entry 2 1 1 -90 -180

(-) (12) Recalculated RPNs should be using columns to the right of

5 Actions Taken IAW BIQ training. SP-34075 does not specify where to 4 1 1 1 1 -30 -120
recalculate RPNs, only that it will be done. DIS #1062

(-) (2) Severity Rating(s) do not align with SP-34075: 6.1.9 and
6 Attachment I. (see DIS #1024) 3 1 1 1 -90 -270
 (-) (3) RPN calculation is missing, or does not conform to
7 SP-34075: 8.1.5 0. (see DIS #1024) 3 1 1 1 -80 -240
(-) (4) Classification (C or S) of Potential Failure Mode (PFM) does not
8 conform to SP-34075: 6.1.10 (see DIS #1024) 2 1 1 -80 -160

(-) (11) Should include a Potential Cause of Failure, an Occurrence

number, Current Process Control and Delectability Rating for listed
9 Failure Modes as per 3 1 1 1 -80 -240
SP-34075: 6.1.6, 6.1.7, 6.1.11 and 6.1.12.
(-) (13) No documented action plan found for RPN >200 as per
10 SP-34075, 8.1.18. DIS #1062. 1 1 -70 -70
(-) (14) Recommended Action does not address the process to reduce
11 RPN as per SP-34075, 6.1.14 DIS #1062 2 1 1 -50 -100
(-) (15) Entries should be added to Actions Taken column when new
12 controls change risk factors that impact RPN. 3 1 1 1 -30 -90
(-) (5) Missing a Recommended Action and/or completion date for high
13 RPN 10 as per SP-34075: 6.1.14 (see DIS #1025) 0 -40 0
(+) (7) Was updated after being listed under QAR #06006, DIS
14 #1024 / #1025 3 1 1 1 100 300
15 (+) Zero discrepancies 3 1 1 1 100 300
(+) (9) Updated to capture recent learnings: good example of
16 FMEA as a “living document” 2 1 1 30 60

(+) (6) Recalculated RPN in right hand columns correctly shows

17 risk abatement from Actions Taken. 3 1 1 1 30 90

(+) (10) Comment blocks give details that show details and/or
18 how the FMEA has changed with process updates: good example 2 1 1 20 40
of FMEA as a “living document”

19 Score for FMEA ### 30 -50 30 -110 230 -160 -170 -120 -50 -40 200 -290 -30 10 -160 280

FMEA: count of observations

FMEA results: Last time FMEA results: After
corrective action

0 1 2 3 4 5 6

(-) (8) Missing one or more Potential Effects of Failure entry

 0 1 2 3 4 5 6

(-) (8) Missing one or more Potential Effects of Failure entry

f Actions Taken IAW BIQ training. SP-34075 does not specify where to recalculate RPNs, only that it will be done. DIS #1062

(-) (2) Severity Rating(s) do not align with SP-34075: 6.1.9 and Attachment I. (see DIS #1024)

(-) (3) RPN calculation is missing, or does not conform to

SP-34075: 8.1.5 0. (see DIS #1024)

(-) (4) Classification (C or S) of Potential Failure Mode (PFM) does not conform to SP-34075: 6.1.10 (see DIS #1024)

ial Cause of Failure, an Occurrence number, Current Process Control and Delectability Rating for listed Failure Modes as per
nd 6.1.12.
(-) (13) No documented action plan found for RPN >200 as per
SP-34075, 8.1.18. DIS #1062.

(-) (14) Recommended Action does not address the process to reduce RPN as per SP-34075, 6.1.14 DIS #1062

(-) (15) Entries should be added to Actions Taken column when new controls change risk factors that impact RPN.

(-) (5) Missing a Recommended Action and/or completion date for high RPN 10 as per SP-34075: 6.1.14 (see DIS #1025)

(+) (7) Was updated after being listed under QAR #06006, DIS #1024 / #1025

(+) Zero discrepancies

(+) (9) Updated to capture recent learnings: good example of FMEA as a “living document”

(+) (6) Recalculated RPN in right hand columns correctly shows risk abatement from Actions Taken.

ails that show details and/or how the FMEA has changed with process updates: good example of FMEA as a “living document”

FMEA owner FMEA

FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
namename
(1) FMEA was sampled in previous audit? N N N N Y Y Y N N N Y Y Y Y N
FMEA results: Last time -42 ### ### ### ### ### ### ### ### ### -10 ### ### 10 -20 ###
FMEA results: After corrective action ### 30 -50 30 ### ### ### ### ### -50 -40 ### ### -30 10 ###
### 100 ### 70 210 -30 10 -90 0 ### 30 0 10 40 -30 0
FMEA owner FMEA
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
name
FMEA
namename
0
(1) FMEA was sampled in previous audit? N N N N Y Y Y N N N Y Y Y Y N 0
Improvement ### ### 150 -70 ### 30 -10 90 0 120 -30 0 -10 -40 30 0

FMEA scores March 07

300

200

100

-100

-200

-300
FMEA name N FMEA name N FMEA name N FMEA name N FMEA name Y FMEA name Y FMEA name Y FMEA name

FMEA score changes after CA

300

200

100

-100
 -100

-200

-300
FMEA name N FMEA name N FMEA name N FMEA name N FMEA name Y FMEA name Y FMEA name Y FMEA name
 Count Count

Average Average

(-) (8) Missing one or more Potential

5 Effects
2 of Failure entry

(-) (12) Recalculated RPNs should

5 be using
4 columns to the right of Actions Taken IAW BIQ training. SP-34075 does not specify where to recalculate RPNs, only that it

(-) (2) Severity Rating(s) do not4 align with 3SP-34075: 6.1.9 and Attachment I. (see DIS #1024)
(-) (3) RPN calculation is missing, or does not conform to
SP-34075: 8.1.5 0. (see DIS #1024)
3 3

(-) (4) Classification (C or S) of3Potential Failure

2 Mode (PFM) does not conform to SP-34075: 6.1.10 (see DIS #1024)

(-) (11) Should include a Potential Cause of Failure, an Occurrence number, Current Process Control and Delectability Rating for listed Failure Modes as per
SP-34075: 6.1.6, 6.1.7, 6.1.11 2and 6.1.12.3
(-) (13) No documented action plan found for RPN >200 as per
SP-34075, 8.1.18. DIS #1062.2 1

(-) (14) Recommended Action does

2 not address
2 the process to reduce RPN as per SP-34075, 6.1.14 DIS #1062

(-) (15) Entries should be added

2 to Actions3 Taken column when new controls change risk factors that impact RPN.

(-) (5) Missing a Recommended

0 Action and/or
0 completion date for high RPN 10 as per SP-34075: 6.1.14 (see DIS #1025)

(+) (7) Was updated after being6 listed under

3 QAR #06006, DIS #1024 / #1025
(+) Zero discrepancies 5 3

(+) (9) Updated to capture recent

3 learnings:
2 good example of FMEA as a “living document”

(+) (6) Recalculated RPN in right

2 hand columns
3 correctly shows risk abatement from Actions Taken.

(+) (10) Comment blocks give details

1 that 2show details and/or how the FMEA has changed with process updates: good example of FMEA as a “living document”
Score for FMEA -42 -45.33
name