Quality & Industrial Performance

CONTAMINATION CONTROL

“Going From Reactive to Proactive”

This presentation was developed by General Motors Corporation Global Purchasing & Supply Chain and PSA Supplier Development.
All rights reserved. No part of this material may be reproduced in any form, or by any method,
for any purpose, without written permission of General Motors Global Purchasing & Supply Chain or PSA Supplier Development.
Reference Doc-Info: 01601_13_00124

Confidential - PSA GM Purchasing & Logistic Committee 1

 CONTAMINATION CONTROL
Introduction
PURPOSE: SCOPE:
• Improve part cleanliness over time via • Manufacturing Operations
measurement, control and process /
• Assembly Area
handling improvements.
• Shipping / Receiving
• Utilize a standardized systematic and
a structured approach to monitor and • All In-plant operations
control contamination sources such as
sediment, extra parts in assemblies,
paint and painted parts RESPONSIBILITY:
contamination. • Ownership
 Process / Manufacturing
• Apply a disciplined approach when
Engineering
responding to issues.
• Evaluation of Performance
 Operations Manager
 Quality Manager
 Contingency reaction plan for all
failures.

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 CONTAMINATION CONTROL

Benefits

• Provides a systematic approach for Contamination Control and

communication of Contamination issues.
• Provides elements of an effective control system.
• Assigns responsibility for contamination reduction.
• Supports and establishes defined areas of continual improvement.
• Prevents repetitive mistakes and reduces waste of resources.
• Transfers knowledge to all stakeholders in an organization.
• Improves Quality metrics: reduces PPM and warranty costs.

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 CONTAMINATION CONTROL

Keeping parts and processes clean and free of debris

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 CONTAMINATION CONTROL
Contamination Philosophy
• This section will focus on Five distinct areas of contamination and the necessary
controls to minimize its effect on product appearance and / or function.
1. Sediment
2. Sediment reduction strategies
3. Clean rooms
4. Dirt in paint
5. Extra parts
• Suppliers shall have procedures and work instructions for Contamination Control
where appropriate.
• Procedures / Work instructions may require:
Note: All contamination
• Process monitoring
failure modes shall be
• SPC or data collection included in PFMEA and
• Routine maintenance Control Plans under
“Process Controls”
• Preventative or predictive maintenance

Confidential - PSA GM Purchasing & Logistic Committee 5

 CONTAMINATION CONTROL
Control of sediment, what are we searching for?

Criteria of Requirement
1 – page 7
2 – page 8
3 – page 9
4 – page 9
Auditor hints – page 10

Next Requirement

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 CONTAMINATION CONTROL
Sediment
Definition: Sediment – small particles of material that will adversely affect the
function of the product.
• Particulate examples include contaminants like lint, dirt, sand, plastic,
machined chips, etc.
• Examples of products that are adversely affected are:
– Engines
– Transmissions
– Brakes
– Steering Gears
– Fuel Modules
– Compressors
• Organization shall:
• Identify all areas / operations that could be affected by contamination ;
• Identify the failure modes related to contamination and consider them in
PFMEA;
• Establish appropriate process and controls
• Where applicable, put in place work instructions and routine maintenance

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 CONTAMINATION CONTROL
Monitoring and measuring Sediment
Sediment Lab:

Test Method To Quantify Foreign Material GMN6752

FILTER
(EXAMPLE)
Apparatus

RINSE

BALANCE

FILTER
VACUUM

This method involves removal of sediment from production components by rinsing,

collecting the sediment using a suitable filtering apparatus, weighing and reporting
the total weight and composition of solids found.

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 CONTAMINATION CONTROL
Monitoring and measuring Sediment (continued)
• Establish an acceptable initial level of part/process cleanliness
• Establish appropriate processes and controls
• Require a procedure to measure part cleanliness at a specified frequency
• Require recording/plotting of these measures
• Require control limits be utilized to trigger reaction plans
• Require corrective action to prevent nonconforming products

Note: monitoring of the process shall be included in Layered Process Audits and non-
conformances included as candidates for Fast Response.

• Debris weight/size limits may be utilized to establish process upper control

limits or targets values in a component’s Statements of Requirements (SOR)
without formally being applied to an engineering drawing.

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 CONTAMINATION CONTROL
Auditor hints

- Verify if the organization had mapped all areas/operations that could be affected by
contamination and identify the type of contamination in each area. Also, if these
information were used during the PFMEA and Process Control Plan development.
- Check if the cleanliness controls are being done according to frequency established
at PCP. Frequencies are reasonable.
- Check sediment measurement in lab (instruction and process).
- Application using statistical method to monitor and control (Include individual
parts, sub-assemblies, full assemblies).
- Verify if there is a documented reaction plan for cases where the limit control or
unstable condition is reached.
- Ask to team member and/or inspector what they should do when an out of control
condition is reached.

Confidential - PSA GM Purchasing & Logistic Committee 10

 CONTAMINATION CONTROL
Sediment Reduction Strategy, what are we searching for?

Criteria of Requirement
1 – page 12-20
Auditor hints – page 21

Prev. Requirement Next Requirement

Confidential - PSA GM Purchasing & Logistic Committee 11

 CONTAMINATION CONTROL
Sediment Reduction Strategy
Process Controls:
• Each manufacturing site shall define procedures for the method and frequency of
checks required to ensure proper functionality of equipment and processes
designed to remove/prevent sediment contamination:
• Parts Washers
• De-burr operations
• Metal working fluid controls
• Fluid / air probe flush station controls
• Dunnage and part storage systems
• Includes Purchased parts and materials and Finished Goods
• Work Station Cleanliness

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Parts Washer:
• Local procedures need to be developed to define and maintain washer systems
that will ensure their effectiveness.
• Minimum requirements shall include but are not limited to:
• Daily verification that nozzles are functioning (e.g. not plugged, broken,
misdirected, etc.)
Examples of verification include:
– Crisco tests
– Physical verification of nozzles
• Daily verification to ensure washer fluids are at the correct concentration
levels, correct temperature if applicable and do not exceed contamination/dirt
requirements.
• Documented PM program for washers are required.

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
De-Burring Operation:
• Types of deburring include water, mechanical, flame, etc.
• Local procedures need to be developed to define and maintain deburring systems
that will ensure their effectiveness.
• Minimum requirements shall include but are not limited to:
• Daily verification of functionality.
Examples include:
– Paint/Bluing of parts to ensure deburring equipment is functioning.
– Physical verification of product to ensure burrs have been adequately
removed.
• Daily verification of process parameters/settings need to be established.
• Documented PM program for deburring operations are required.

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Metal Working Fluid Controls:
• Local procedures need to be developed to define and maintain the method and
frequency of checks required to ensure metal working fluid quality and cleanliness.
• Minimum requirements shall include but are not limited to:
• Metal working fluid properties (e.g. concentration ratio, bacteria, tramp oil,
etc.)
• Cleanliness/Particulate (e.g. dirt, chips, etc.) suspended in fluid
• Documented Preventive Maintenance Program which includes
filtration methods, pumps, separators, etc.

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Fluid / Air Probe Flush Station Controls:
• Local procedures need to be developed to define and maintain the method and
frequency of checks required to ensure functionality of fluid/air probe flush
stations.
• Minimum requirements shall include but are not limited to:
• Probes/Flush nozzles are not plugged
• Fluid Is flowing at desired flow rate, pressure, and direction
• Preventive maintenance as required

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Work Station Cleanliness Controls:
• Local procedures need to be developed to define and maintain work station
cleanliness (specifically areas of the work station that physically touch the part like
nests, hangars, storage surfaces)
• Minimum requirements shall include but are not limited to:
• Daily verification of an established cleanliness standard
(Note: Tape test is an effective method to monitor cleanliness)
See example next page.
• Standardized work describing cleaning methods, equipment, and
frequency are required.

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Example of Tape-Lift Testing
Tape lift method:
• Define area to be checked.
• Apply transparent tape to surface to be verified
• Transfer tape to a white piece of paper
• Any dirt/debris will be visible against the white
paper
• Compare these results to a cleanliness
acceptance standard

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Dunnage and Parts Storage Systems:
• Local procedures need to be developed to define and maintain the methods used
to verify materials and processes involved in part storage and transport to minimize
and/eliminate sediment on components.
• Minimum requirements shall include but are not limited to:
• A dunnage cleaning process to include frequency and method
(Note: Includes W.I.P. and Finished Goods dunnage)
• Monitoring material storage areas for cleanliness (e.g. Finished goods are
safely protected from contamination being introduced during transport and
storage)
• Storage environment controls to maintain the integrity of the product (e.g.
Temperature, humidity, dirt, dust, pests, etc.)
• The use of cardboard should be limited

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 CONTAMINATION CONTROL
Sediment Reduction Strategy (continued)
Purchased Parts and Materials:
• Local procedures need to be developed to define which purchased components
require sediment monitoring and/or cleaning prior to use.
• Minimum requirements shall include but are not limited to:
• If purchase parts are cleaned/washed in-house then local procedures shall
define requirements
• Method and frequency to check purchased parts
• Acceptable limits need to be established

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 CONTAMINATION CONTROL
Auditor hints

- Check work stations cleanliness, daily verification to be established (Layered Audit,

Tape test etc.).
- Dunnage cleaning process defined and kept.
- Parts are covered / properly protected.
- Parts on the assembly lines handled with lint free gloves / towels.
- All wash/debur machine parameters captured and monitored/ documented.
- Wash solution and process parameters monitored and analyzed on an on-going
basis.

Confidential - PSA GM Purchasing & Logistic Committee 21

 CONTAMINATION CONTROL
Clean room/area, what are we searching for?

Criteria of Requirement
1 – page 23
2 – page 23
3 – page 23
4 – page 23
5 – page 23
Auditor hints – page 24

Prev. Requirement Next Requirement

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 CONTAMINATION CONTROL
Clean Rooms
• If clean rooms are required as part of the manufacturing process, the following set
of requirements should be considered as best practices:
• Limited access to clean rooms by employees to limit exposure to contaminants
• Clean room protective clothing defined and enforced (e.g. hair nets, shoe
covers, lint free lab coats, rags, gloves, etc.)
• Positive pressure to stop outside air/contaminants from being drawn into the
clean room.
• Air locks to enter/exit clean rooms
• Sticky mats to remove contaminants from footwear
• Atmospheric air quality monitoring per standard
• Anti-static devices (ESD) and verification to compliance prior to
entrance to the area as applicable. (e.g. ground straps, wrist bands)
• Control of Chemicals detrimental to the process (e.g. windex, lotions, fragrances,
aerosol sprays, etc.)

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 CONTAMINATION CONTROL
Auditor hints

- Check if protective cloths are worn (e.g. hair nets, shoe covers, lint free lab coats,
rags, gloves, etc.)
- Check how access control to clean room is kept.
- See if air quality and pressure are monitored.
- Verify if filters are changed according to planning.
- Check if controls of restrictions (e.g.: no fibrous material, no aerosol sprays, no
food, etc.) are in place.
- See if LPA is in place (if out of condition is identified there’s a reaction plan in place).

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 CONTAMINATION CONTROL
Prevent dirt in paint and foreign material contamination, what are we
searching for?

Criteria of Requirement
1 – page 26-27
2 - page 26
3 – page 28-32
4 – page 33
5 – page 33-34
6 – page 34
Auditor hints – page 35

Prev. Requirement Next Requirement

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 CONTAMINATION CONTROL
Extra Parts
Definition: Parts or materials which fall into or stick to products which are not
intended as part of the finished product.
• The manufacturing site shall include process controls to eliminate or reduce extra
parts:
• Utilize Rollovers and Dump Stations (Monitor findings)
• Parts assembled at prescribed location / rework station
• Magnetic wrench functionality
• Correct use of masks where the potential exists for parts to fall into
assemblies
• Rework operations to use same tools as primary operation
• Layered Process Audit to verify proper part storage
• Monitor findings of extra parts / Use data management / Corrective Actions

Note: All potential contamination

failure modes caused by extra parts
shall be included in PFMEA and Control
Plans under “Process Controls”

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 CONTAMINATION CONTROL
Dirt in paint
Definition and Philosophy:
• Dirt is an undesired foreign inclusion in the paint film caused by
disturbances in the paint process or operation.
• Dirt contamination as a group represents the greatest group of paint defects.
• Sources should be minimized in all areas.
• Dirt control shall be continuous and ongoing to be effective.

Note: All potential

contamination failure
modes caused by dirt shall
be included in PFMEA and
Control Plans under
“Process Controls”

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 CONTAMINATION CONTROL
Dirt in paint (continued)

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 CONTAMINATION CONTROL
Dirt in paint (continued)
Key issues in the People area:
• “Dirt Awareness” training
• Self inspection/clean up on all operations
• Entire paint shop considered a “clean area”
• Communicate expectations
– Approved attire only
– Understand and follow personal product restrictions such as use of
deodorants, silicone wrist bands and aerosol sprays which contain
silicone and cause craters.
– No Food/Drink/Smoking
– No fibrous materials in the paint shop
– Newspapers, paper towels, cardboard, etc.

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 CONTAMINATION CONTROL
Dirt in paint (continued)
Key issues in the Process area:
• Dirt Sources - Prevention
– Paint Spatter, chips, overspray
– Hair, Clothing, towels, Cardboard
– Conveyor lubricants
– Rust, minerals from Condensation
• Communicate expectations
• Ensure PM Schedule is Adhered to
• Monitor the Process
• Audit to Requirements

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 CONTAMINATION CONTROL
Dirt in paint (continued)
Key issues in the Facilities area:
• Facility maintenance relating to dirt sources in all ovens and booths.
- Cleaning
- Filter changes
- Balance requirements
• General Housekeeping requirements.
• Racks clean and in proper repair
• Entire Paint Shop closed and sealed.
• Positive ventilation 24 hours per day.
• No traffic access.

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 CONTAMINATION CONTROL
Dirt in paint (continued)
Key issues in the Material area:
• Entire Paint Shop clean room wear.
- Proper laundry
- Proper wear methods/procedures
• Proper consumable controls.
– No eating, drinking or smoking.
– Approved personal products only.
• Correct paint materials, mix instructions and work methods.
• Proper storage area identification and reject area controls.

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 CONTAMINATION CONTROL
Dirt in paint (continued)
• Suppliers with painted product shall ensure that the paint operation standards and
maintenance schedules are adhered to. Whether the process is internal or through
Supply Chain Management. This includes:
• Process Monitoring such as
• Dirt count (SPC, U-Charts)
• Dirt identification (Pareto)
• Process analysis and investigative techniques
• Establish and maintain a Dirt Reference Handbook
• Layered Process Audits and Communication of results
• Maintenance routine in equipment and process designed to remove/prevent
dirt in paint or part

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 CONTAMINATION CONTROL
Dirt in paint (continued)
Elements of an Effective Contamination Control System:
• Make controls visible.
- Maintain a list of acceptable/unacceptable products in easily
accessed areas.
- Make the list easy to update.
- Make information clear & concise.
- Personal product lists displayed on posters in locker rooms and employee
areas.
• Clearly define those products that need to be totally eliminated from the paint
shop.
• Clearly define those products that can be used in the paint shop, but should be
kept away from product surfaces.
• Behavior Instructions are defined and respected

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 CONTAMINATION CONTROL
Auditor hints

- Check if foreign material/extra part (screw, pin, washer, any small components, etc.)
effect (like noise, function issue, etc.) are considered in the PFMEA.
- Verify that dunnage, fixtures, conveyors, washers and pre-assemblies are protected
to prevent falling material.
- Check possibility to assemble part without masking.
- Verify if all stations in the Paint area are clean up and operators do a self inspection
of the area.
- Ask to team member to explain what are the main sources of dirt - key issues in the
people, process, facility and material area and how he works to avoid them.
- See if the sources related to Process (paint spatter, overspray, towels, etc.) are
checked by PM and there's a reaction plan established.
- Check if general housekeeping process is established for facility and it is followed.

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 CONTAMINATION CONTROL
Effectiveness, what are we searching for?

Criteria of Requirement
1 – page 37
2 - page 38
3 – page 39
4 – page 39
Auditor hints – page 40

Prev. Requirement What goes wrong

Confidential - PSA GM Purchasing & Logistic Committee 36

 CONTAMINATION CONTROL
Sediment Results and Reduction Plan

Results of reduction
Problem definition plan

Problem analysis and

Reduction plan

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 CONTAMINATION CONTROL
Process Specific Audits / Layered Process Results

G Y R

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 CONTAMINATION CONTROL
Internal or Customer issues related with cleanliness.

Pareto of defects for key sensible process (painting, metallization,...).

Confidential - PSA GM Purchasing & Logistic Committee 39

 CONTAMINATION CONTROL
Auditor hints

- Review sediment results and verify sediment reduction activities.

- Evidence of site leadership reviews.
- Audits performed focusing contamination control.

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 CONTAMINATION CONTROL
What goes wrong?

• Lack of Contamination Map which will indicate the critical process (affected by
contamination) and their controls
• Effects/Potential Causes related to contamination not addressed to PMEA
• Lack of Contamination Controls addressed in the Process Control Plan
• Issues related to contamination not escalated in a proper way
• No strategy to reduce the sediments
• Lack of special rules for clean room
• No results revision and /or countermeasures established by leadership

Prev. Requirement

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