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Database Committee Report January 2012 (Data from 2011). San Diego, CA January 10-11, 2011 R. Darrell Taylor Raytheon. Executive Summary. Not all 2011 data is in Database (app. 65%) Reviewed a 12 month rolling number. Agenda. CRB Activity OASIS Entries – Audits OASIS Nonconformities - PowerPoint PPT Presentation
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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)
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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)
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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)
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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)
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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)
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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
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5114
5972
6969
7502
4848
Total Entries
Suspect at this point app. 65% of the data is in Database
Registration Management Committee (RMC)
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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)
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Standards Entered Into Database
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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)
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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
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Pareto Chart of Total Totals
2011 – 14,276
2010 – 20,009
2009 -20,980
2008 -18,803
2007 – 14,957
Registration Management Committee (RMC)
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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)
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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
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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
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Pareto Chart of RESP_TOTAL_MITotals
2011 – 12,8932010 – 18,627
2009 -19,414
2008 -17,393
2007 –14,087
Registration Management Committee (RMC)
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Top 80% of Nonconformities
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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)
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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)
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AB Report Card
Slight increase in Minors from previous years, Audits and Majors relatively flat:
0 Complaints, 0 Suspensions
Registration Management Committee (RMC)
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Questions
Company Confidential
Boston, MA July 19-20, 2011
26
Registration Management Committee (RMC)
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