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Process Validation Program

Lockheed Martin Aeronautics Company

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The New Defense Environment Lockheed Martin Aeronautics Company

Traditional Defense Contracting

• Receiving Inspection – Sorting Good From Bad

• Source Inspection – Final Inspection at the Source

• Surveillance and Audits – Moving into a Process Mode

Commercialization
• Single Process Initiatives – Provides Contractors Flexibility

• International Standards – Less Prescriptive Requirements

• Commercialization – Opportunities for Change

• Performance Based Specifications – New Contracting Methodology

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What Is Process Validation? Lockheed Martin Aeronautics Company

• A planned approach that focuses on process capability

• Key or critical processes are identified and performance

capability measures are established and tracked

• By measuring key and critical processes, we develop

confidence the process is capable of produce conforming
product

• Measurement of key or critical process capability trends

can identify opportunities for improvement

Product acceptance via the tracking and verification of

process capability data
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Process Validation vs Source Inspection Lockheed Martin Aeronautics Company

Why do we inspect?

Because we lack confidence in the

processes so we have to verify the output
(end item)

Inspection is nothing more than the sorting

of good from bad

Inspection is not value added – if you inspect

and find no non-conformances, then in reality
you’ve just wasted your time!!
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Process Validation vs Source Inspection Lockheed Martin Aeronautics Company

Why Validate the Process? – The Big Picture

We monitor and measure processes to provide

information to management for fact based
decision-making
By establishing realistic parameters for
processes, we can gather data that provides
useable process health indicators
This data should be analyzed and used to
determine when corrections or improvements
are needed
Process validation can aid in capacity and capital
decisions by identifying performance issues that
may be driving capacity issues
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Process Validation vs Source Inspection Lockheed Martin Aeronautics Company

Why Validate the Process? – The Detail

Capturing of performance data can indicate

whether product is good or bad

Process validation can identify performance

movements or shifts that can potentially lead
to non-conforming product (preventive action
can be taken)

Process validation can provide data to establish

process control limits for the purpose of
reducing variability
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Process Validation Program

Lockheed Martin Aeronautics Company

SUPPLIER PROCESS

Capability
Assess Scrap MRB
REJECT
and / or &
or
Initial
Q.Sys. RTV C/A Fix REJECT

Audit
ACCEPT

Design, INPUT Supplier To Stock

OUTPUT
Change Review, Production Inspect Inspect Or
Planning Process Customer

....to There ACCEPT

From here...

Process Validation is a continuous evaluation of a company’s

procurement and manufacturing processes, procedures, and
controls for product fabrication and assembly
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Why Process Validation? Lockheed Martin Aeronautics Company

Quality, Cost, and Schedule Improvements!

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What Is The Goal of PVP? Lockheed Martin Aeronautics Company

Delegation of
Source Inspection???

9Capable, stable, predictable processes!!

Delegation is a By-product of the PVP Process
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PVP Is Not Complicated Lockheed Martin Aeronautics Company

Eight Easy Steps

1. Identify (map) your manufacturing process flow including
contract review and procurement related activities
2. Categorize the map to identify the critical processes within
the flow
3. Capture current data for the processes
4. Establish measurement criteria for the critical processes
5. Put the critical processes into the LM PVP template and
gain approval of LM PQAR and PQAE
6. Continuously capture, track, and analyze the data
7. Make data and analysis available to the LM PQAR and PQAE
8. Strive and action yourself to continually improve the
processes based on the data analysis
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Eight Easy Steps Lockheed Martin Aeronautics Company

1. Identify (map) your manufacturing process flow including

contract review and procurement related activities
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

2. Categorize the map to identify the critical processes

within the flow (using these definitions and color codes)

• Critical - Those processes that if performed incorrectly would have a high

probability of a negative impact on unit or product installation or on the performance
of the product or unit; e.g. acceptance test procedure (ATP) - if a unit fails ATP there is
a high probability the unit will cause the failure of the aircraft system checkout (SCO).

• Significant - Those processes that if performed incorrectly may have a

negative impact on installation but the probability of a negative impact on product
performance is low; e.g. oversized mount holes in component creating need to install
oversized fasteners during installation.

• Noteworthy - Those processes where an undetected nonconforming

condition leads to a low probability of causing installation issues and product failure is
unlikely; e.g. insufficient deburr
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

3. Capture Current Data for the Processes

Production
Control

MRP

Storage Machine Inspect Storage Transport Assemble Storage

MCT: 5 min. C/T: 35 min.

Set-up: 180 min. Document any Set-up: 60 min.
Q/T: 180 min. Q/T: 30min. Q/T: 14400 min. Q/T: 28800 min.
Damage
WIP: 60. Batch size: 15 WIP: 45. WIP: 105 Batch size: 15 WIP: 150.
Occurring
Yield % Yield: 88% During Yield %
Scrap: 4.5% Transport Scrap: 1.5%
Rework: 2.3% Rework: % Rework: 8.3%
Scrap: % Statistical
Statistical
Tracking (Y/N)
Tracking (Y/N)

3 hrs 5 mins. 30 mins. 10 days 3 mins. 35 mins. 20 days

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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

4. Establish measurement criteria for the critical processes

• Statistical Process Control

• Yield Data

• Established Periodic Measurements (e.g. heat treat

logs, chemical tank analysis, paint tests, etc)

• Running results and corrective actions of audits (e.g.

sub-contract flow down)

• Other methods…..???
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

5. Put the critical processes into the LM PVP template and

gain approval of LM PQAR and PQAE
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

6. Continuously capture, track, and analyze the data

• Capture the Data – per the method agreed to in the

PVP template

• Track the data - statistically where appropriate - to

show trends , spikes, other indicators of
performance or process degradation or improvement

• Analyze the data to determine:

• Root cause of trends, spikes, other indicators
• If the process capability limits can be narrowed
(reduce the process variability)
• Necessity to continue tracking
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

7. Make data and analysis available to the LM PQAR and

PQAE
• LM Aero PQAR and PQAE will monitor the data
as a part of their normal job function.

• When the PQAR and PQAE jointly agree that

performance is such that final acceptance
delegation can be granted they will make the
recommendation to PQA Management
• 70% of PVP points verified – historical data is OK
• 98% or greater quality rating

• If recommendation is approved, you (supplier)

will receive a letter of delegation from LM Aero
asking you to identify those in your company
authorized to accept product on LM Aero’s behalf
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Eight Easy Steps (cont’d) Lockheed Martin Aeronautics Company

8. Strive and action yourself to continually improve the

processes based on the data analysis

LM Aero has resources that can help you:

• Kaizen events
• DOE’s
• Data Analysis
• Project Planning
• Lean and Six Sigma assistance
• Sub-tier issues (Procurement)
• Bottleneck elimination
• Assessments
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We’re in This Together Lockheed Martin Aeronautics Company

PQA Will Facilitate a 2 Day PVP Mapping Event at Your Facility

Mapping Event Agenda

Identify and Form the Team
Map the Process
Collect the Appropriate Data
Define the Criticality Level for Each Process Step
Identify Performance Risk Areas (Quality and Schedule)
Create Plan With Initial Verification Dates and Frequency
Create Action Plan for Items Necessary for Implementation
Sign Plan As Indication of Move Forward Agreement
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A Visual Map Lockheed Martin Aeronautics Company

• A Visual Representation of
Every Process in the Flow
of Manufacturing and
Support Operations
• A Visual Means of
Understanding the Current
Process and It’s Capability
• A Method of Capturing
Performance Data in a
Teaming Environment
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Criticality Example Lockheed Martin Aeronautics Company

Categorize Steps - Example

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The Plan Template Lockheed Martin Aeronautics Company

Initiated/Revised
Process
PVP Key or Critical Associated Process Validation
Selection Validation Method Date By
No. Process Procedures Location Frequency
Rationale

Flow diagram Key process Measure location

Machining before 21-Mar-
01 PAP-258.0 step M3; Dept. for locating distance using CMM; Each part J. Smith
heat treat 00
21; Bldg A diameters plot on control chart
Flow diagram
Critical NDT 21-Mar-
02 NDI NDT-876 step I2 & I5; Monitor NDI results Each part J. Smith
points 00
NDI dept.
(1) HT Temp.; (2) Soak
Time; (3) Out Time;
Flow diagram (1) - (6)
Critical to part (4) Quench Temp; (5) 21-Mar-
03 Heat Treat SP-900 step P6; Dept. Each lot; J. Smith
performance Age Temp; (6) Soak 00
10 (7) each part
Time; (7) Hardness &
Conductivity
Flow diagram History of Dimension
Machining after 18-May- B.
04 PAP-258.0 step M4; Dept. customer measurement of Each part
Heat Treat 00 Jones
21; Bldg. A problems 2.000" diameter
(1) chemical (1) Each lot;
Flow diagram
Key for wear properties of bath; (2) (2) Each lot; 21-Mar-
05 Chrome Plate SP-833 step P9; Dept. J. Smith
properties Time in/out; (3) plating (3) Each 00
10
thickness part
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Identify Actions Necessary For Implementation Lockheed Martin Aeronautics Company

• Virtually Walk the Map, Identifying Data Deficiencies

• Brainstorm Process Enhancements

• Identify Areas for Potential LM Aero Assistance

(Supplier Lean Deployment, PQA, Procurement. Etc)
“As Is Process”

• Capture Inhibitors to Implementation

• Capture on an Action Plan

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Action/Milestone Event Schedule Lockheed Martin Aeronautics Company

Create an Action/Milestone Chart - Example

2003

Feb Mar Apr May

Process Validation Mapping

Process Owner – Michael Jackson

Develop SPC Charting for

Processes 1,5,6,11
Process Owner – Willie Nelson
Capture Yield Data at Drilling
Process Owner – Bill Clinton

Set-up Reduction – Forming Cell

Process Owner – Lynyrd Skynyrd

Mistake Proofing - Assembly

Process Owner – Jeb Bush
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PVP Map Summary Lockheed Martin Aeronautics Company

• Build the Map

• Capture Accurate Data
• Apply to Template
• Define Verification Frequencies
• “As Is Process”
Define Verification Begin Date
• Identify Actions Necessary to Enable Implementation
• Create, Agree, and Publish Action Plan
• Get Going!!