Company Confidential

San Diego, CA 2012

1

Registration Management Committee (RMC)

Database Committee Report January 2012

(Data from 2011)

San Diego, CAJanuary 10-11, 2011

R. Darrell TaylorRaytheon

Registration Management Committee (RMC)

2

Executive Summary• Not all 2011 data is in Database (app. 65%)

• Reviewed a 12 month rolling number

Registration Management Committee (RMC)

3

Agenda• CRB Activity• OASIS Entries – Audits• OASIS Nonconformities• AS9100 Elements• Feedback

Company Confidential 4

Registration Management Committee (RMC)

CRB Activity

San Diego, CA 2012

Registration Management Committee (RMC)

5

CB Scores as of 1/1/2012 using Performance Metric

No Action ANAB Info ANAB Report Needs Action02468

10121416

11

16

75

Registration Management Committee (RMC)

6

8 D Approach• Threshold Violations:

– (This section will contain a list and description of the thresholds that were violated

– Note: It is not about the individual thresholds, the Corrective Action is being issued because there are multiple threshold violations which may be indicative of a systemic issue with your process)

Registration Management Committee (RMC)

7

8 D Approach• Identify Team:

– (Because of the nature of this corrective action we recommend that this corrective action not be an individual’s responsibility, this block should identify who was involved in the process)

• Describe the Problem:– (Given the information provided, we

recommend formulating a problem description based on what you know about your process and the systemic issues identified above.)

Registration Management Committee (RMC)

8

8 D Approach• Implement and Verify Short Term Corrective

Action:– (This section should identify what is being

done immediately to solve the problem, and what was done to verify that those actions were put in place)

• Define and Verify Root Cause:– (This section should identify the Quality

Science tools used to investigate the problem and how you verified the root cause does in fact exist)

Registration Management Committee (RMC)

9

8 D Approach• Verify Corrective Actions:

– (This section should contain a look back at the already implemented containment corrective actions and reevaluate them in light of the root cause analysis.)

• Implement Permanent Corrective Actions:– (This section should contain the corrective

action plan, with milestones, ownership and expected outcomes including a verification and validation plan)

Registration Management Committee (RMC)

10

8 D Approach• Prevent Recurrence:

– (This section should contain the actions taken to prevent this from re-occurrence, with milestones, ownership and expected outcomes including a verification and validation plan)

• Future Steps:– (This section should contain the steps being

taken for the future, monitoring the process)

Company Confidential 11

Registration Management Committee (RMC)

Entries – Audits

San Diego, CA 2012

Registration Management Committee (RMC)

12

Comparison of Entries 2007 -2011

• Entries:– 2007 – 5114– 2008 – 5972 ^16%– 2009 – 6969 ^17%– 2010 – 7502 ^7.6%– 2011 – 4848

» As of 12/1

2007 2008 2009 2010 20110

1000

2000

3000

4000

5000

6000

7000

8000

5114

5972

6969

7502

4848

Total Entries

Suspect at this point app. 65% of the data is in Database

Registration Management Committee (RMC)

13

Comparison of Types2007 -2011

SUR REC INT

SUR=SurveillanceREC = RecertificationINT = Initial

65% of data

SUR REC INT2007 0.66 0.17 0.172008 0.67 0.15 0.182009 0.63 0.21 0.152010 0.68 0.20 0.122011 0.66 0.25 0.09

Registration Management Committee (RMC)

14

Standards Entered Into Database

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0

1000

2000

3000

4000

5000

# O

bser

vatio

ns

Group

Pareto Chart of Audit Activity

byStandard

1071 AS9100C as of 12/1/2011

Group Count % of TotalAS9100:B 3852 71.9%AS9100:C 1071 20.0%AS9120 224 4.2%AS9110 79 1.5%AS9120:A 73 1.4%NBR15100:2004 42 0.8%AS9110:A 14 0.3%EN9100:2003/S1 3 0.1%NBR15100:2009 2 0.0%

Registration Management Committee (RMC)

15

CRB Comments - 2011• Ratio of Surveillance to Recertification to

Initial consistent – potential decrease in initial for the second year in a row

• Slow start in AS9100C, perhaps due to timing

Going to Rolling Format

Company Confidential 16

Registration Management Committee (RMC)

Nonconformities

San Diego, CA 2012

Registration Management Committee (RMC)

17

Pareto of Total Nonconformities

Average per audit = 2.68 nonconformities, this may be leading to a reduction of nonconformities

Count 93 71 2221586 862 769 635 407 309 209 155Percent 1.7 1.3 4.229.8 16.2 14.5 11.9 7.7 5.8 3.9 2.9Cum % 94.5 95.8 100.029.8 46.0 60.5 72.4 80.1 85.9 89.8 92.7

Total Other9876543210

6000

5000

4000

3000

2000

1000

0

100

80

60

40

20

0

Coun

t

Perc

ent

Pareto Chart of Total Totals

2011 – 14,276

2010 – 20,009

2009 -20,980

2008 -18,803

2007 – 14,957

Registration Management Committee (RMC)

18

Total

484032241680

Median

Mean

2.82.62.42.22.0

1st Quartile 0.0000Median 2.00003rd Quartile 4.0000Maximum 52.0000

2.5931 2.7758

2.0000 2.0000

3.3353 3.4646

A-Squared 318.30P-Value < 0.005Mean 2.6845StDev 3.3987Variance 11.5514Skewness 3.2005Kurtosis 22.1998N 5318Minimum 0.0000

Anderson-Darling Normality Test

95% Confidence I nterval for Mean

95% Confidence I nterval for Median

95% Confidence I nterval for StDev95% Confidence I ntervals

Summary for Total

Not Bell Shaped

Registration Management Committee (RMC)

19

Ratio Majors/Entries

On average, one Major is written every fourth audit Range 0 to 19

Totals

2011 - 12712010 – 1387

2009 -1135

2008 – 976

2007 - 870Count 4680 369 129 182

Percent 87.3 6.9 2.4 3.4Cum % 87.3 94.2 96.6 100.0

RESP_TOTAL_MA Other210

6000

5000

4000

3000

2000

1000

0

100

80

60

40

20

0

Coun

t

Perc

ent

Pareto Chart of RESP_TOTAL_MA

Registration Management Committee (RMC)

20

Ratio Minors/Entries

On average, 2.4 Minors are written every auditRANGE: 0 - 52

Count 72 2661645 911 790 635 416 288 188 142Percent 1.3 5.030.7 17.0 14.8 11.9 7.8 5.4 3.5 2.7Cum % 95.0 100.030.7 47.7 62.5 74.4 82.1 87.5 91.0 93.7

RESP_TOTAL_MI Other876543210

6000

5000

4000

3000

2000

1000

0

100

80

60

40

20

0

Coun

t

Perc

ent

Pareto Chart of RESP_TOTAL_MITotals

2011 – 12,8932010 – 18,627

2009 -19,414

2008 -17,393

2007 –14,087

Registration Management Committee (RMC)

21

Top 80% of Nonconformities

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0

500

1000

1500

2000

2500

3000

# O

bser

vatio

ns

Group

Nonconformities Majors + Minors

First time in 3 years the order slightly changed

Group Count % of Total CumProduction and Service Provision 2544 17.9% 17.9%Documentation Requirements 1853 13.0% 30.9%Purchasing 1823 12.8% 43.7%Customer Satisfaction 1587 11.1% 54.8%Improvement 1195 8.4% 63.2%Control of Monitoring and Measurement Equipment 1033 7.3% 70.5%Control of Nonconforming Product 685 4.8% 75.3%Human Resources 644 4.5% 79.8%

Registration Management Committee (RMC)

22

The Remaining 20%Group Count % of Total Cum

Management Review 510 3.6% 83.4%Customer Related Processes 500 3.5% 86.9%QMS General Requirements 489 3.4% 90.3%Planning of Product Realization 341 2.4% 92.7%Design and Development 219 1.5% 94.3%Planning 173 1.2% 95.5%Infrastructure 157 1.1% 96.6%Analysis of Data 116 0.8% 97.4%Configuration Management 76 0.5% 97.9%Responsibility Authority and Communication 72 0.5% 98.4%Work Environment 66 0.5% 98.9%Quality Policy 45 0.3% 99.2%Customer Focus 39 0.3% 99.5%Management Commitment 28 0.2% 99.7%Measurment. Analysis and Improvement - General 23 0.2% 99.9%Provision of Resources 21 0.1% 100.0%

Registration Management Committee (RMC)

23

Feedback Analysis

2011Average to close of “CLOSED” Feedback – 18.54 days

Average of those still “OPEN” – 46.7 days

2007 2008 2009 2010 20110

200400600800

100012001400

Registration Management Committee (RMC)

24

AB Report Card

Slight increase in Minors from previous years, Audits and Majors relatively flat:

0 Complaints, 0 Suspensions

Registration Management Committee (RMC)

25

Questions

Company Confidential

Boston, MA July 19-20, 2011

26

Registration Management Committee (RMC)

Back Up