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Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 1 of 19
1. Area of application
This company standard applies to all the companies in the Thomas Group. It is to be understood as the top-
level, supplementary document for Technical Cleanliness. This company standard can be used as a basis for
creating user requirement specifications for bought-in parts and for the formulation of quality
characteristics lists of Thomas magnets GmbH.
2. Description
This company standard how to address the topic of Technical Cleanliness and Product Cleanliness. This
organizational instruction defines cleanliness measures for the various products, product groups,
components and assemblies. It also describes behavior with and handling of cleanliness-critical products.
This company standard or extracts taken from it shall be applied to all products and processes of Thomas
magnets GmbH that are applicable to product realization as defined by customer requirements. This
applies both to the suppliers of Thomas magnets GmbH and to the supporting processes.
This company standard instruction was created for application to products of Thomas magnets GmbH. The
provisions and procedures described are binding for general availability as soon as reference is made to this
company standard in drawings, user requirement specifications, component-related QA agreement or in
any other technical specifications using the formats specified here. Deviations from specifications in this
organizational instruction are equivalent to a drawing deviation and must systematically be treated with
targeted decisions, by rework using a cleaning operation for example.
The present company standard shall enter into force on the date of its approval for components,
production facilities and processes for which technical cleanliness specifications have been defined with
reference to this organizational instruction.
2.1 Cited Standards
ISO 16232
VDA 19.1
VDA 19.2
2.2 Terms and Definitions
P-FMEA = Process Failure Mode and Effects Analysis
PCP = Production Control Plan
PFC = Process Flow Chart
PSW = Part Submission Warrant
Cleanliness level = VDA 19.2 classification of various cleanliness levels. These reflect the
necessary measures and specifications to achieve a cleanliness level
Thomas cleanliness class = Thomas cleanliness classes represent cleanliness relevance in the
product. Classification triggers measures and specifications, matched
to the particular cleanliness level.
Component cleanliness code = Reflects the degree of residual soiling, divided into size and number.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 2 of 19
2.3 Concept
2.3.1 General
To be able to effectively implement the requirements imposed here, it is necessary to think and
act across all levels, divisions and processes.
Each individual person, from the buyer to the production employee, must be aware of the
importance of Technical Cleanliness.
Rules, processes and procedures that must be integrated at the earliest possible stage of product
realization will be defined and optimized in the following sections of this document.
2.3.2 Component Cleanliness Code
Indication by Thomas magnets GmbH is strictly based on VDA 19.
Thomas magnets GmbH opts to indicate with reference to a component (CCC=N) by default.
This means that both the formulation of the Component Cleanliness Code internally (cleanliness
analyses, documentation, drawing, etc.) and externally (drawing, specifications, customer and
supplier communication, etc.) refers to a component by default and not to the area.
Consequently, indication uses size classes, supplemented by the recoded number of particles.
Size classes as per VDA 19 and ISO 16232:
The Component Cleanliness Code can refer to various criteria.
/b = Component Cleanliness / analysis value refers to particle width.
/I = Component cleanliness / analysis value refers to particle length.
If a criterion is not indicated explicitly, particle size refers to length.
Example: CCC/b = N (B586/C180/D38/E3/F1)
Indication of Component Cleanliness Code CCC with reference to component N
Example: CCC = N (B7647/C2934/D1016/E174/F19/G6/H5/I1/J-K0)
Reference
N = component
Size class as per Table 1
Number of particles, recoded
5≤x
15µm
15≤x
<25µm
25≤x
<50µm
50≤x
<100µm
100≤x
<150µm
150≤x
<200µm
200≤x
<400µm
400≤x
<600µm
600≤x
>1000µm >1000µm
B C D E F G H I J K
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 3 of 19
In exceptional cases indication of the Component Cleanliness Code CCC may refer to
volume V or area A
Example: CCC = A (B20/C16/D16/E12/F12/G-J8)
Reference
V = volume; A = area
Size class as per Table 1 (Section 2.2)
Concentration class as per Table 2 (Section 2.2)
Combined size classes
Example 2; CCC = A(B18/C-E16/F-I11/J-K2) (per 1000cm²)
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 4 of 19
Table 1 – Size classes for particle counting Table 2 – Definition of the cleanliness level of a component
Größenklasse (Size Class)
Größe X (m) Sauberkeitsklasse (Cleanliness)
Anzahl der Partikel (pro 1000 cm2 oder 100 cm3)
B 5 ≤ x < 15 mehr als bis einschließlich
C 15 ≤ x < 25 24 8 x 106 16 x 106
D 25 ≤ x < 50 23 4 x 106 8 x 106
E 50 ≤ x < 100 22 2 x 106 4 x 106
F 100 ≤ x < 150 21 1 x 106 2 x 106
G 150 ≤ x < 200 20 500 x 10³ 1 x 106
H 200 ≤ x < 400 19 250 x 10³ 500 x 10³
I 400 ≤ x < 600 18 130 x 10³ 250 x 10³
J 600 ≤ x < 1000 17 64 x 10³ 130 x 10³
K 1000 ≤ x 16 32 x 10³ 64 x 10³
15 16 x 10³ 32 x 10³
14 8 x 10³ 16 x 10³
13 4 x 10³ 8 x 10³
12 2 x 10³ 4 x 10³
11 1 x 10³ 2 x 10³
10 500 1 x 10³
9 250 500
8 130 250
7 64 130
6 32 64
5 16 32
4 8 16
3 4 8
2 2 4
1 1 2
0 0 1
00 - 0
Quelle VDA Band19
Note 1 The size of the largest particle (found or allowable) can be expresses individually, Independent of the nominal size classes
specified above (see clause 8)
Note 2 According to individual requirements, size ranges may be combined and left out.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 5 of 19
2.3.3 Thomas Cleanliness Classes
Thomas Cleanliness Classes Degree of cleanliness
A Highest component standard Ultrafine cleanliness
B High component standard Fine cleanliness
C Medium component standard Normal cleanliness
D Standard component standard Coarse cleanliness
E Undefined component standard Undefined particulate cleanliness
Every product must be recorded and assigned to a Cleanliness Class. Thomas cleanliness classes
are used as a basis for specifying
Measuring intervals
Test method and testing equipment
Cleaning specifications for production equipment
Thomas Cleanliness
Classes
Test method at
supplier's Supplier's test intervals
Cleaning specifications
for production
equipment
Packaging
A Highest component
standard
Automatic particle
counting system:
1 x per shipping unit or
per production batch
but at least once a
week.
3 components from
different packing units
in one group analysis
Coordination of
cleaning by external
contractor for all
systems (2 x per year)
No wood or cardboard,
plastic, with cover,
delivery preferably as
positioned parts in
trays,
heat-sealed in plastic
film, in special load
container (adapted to
workpiece geometry,
with plastic film hood)
B High component
standard
Automatic particle
counting system
1 x per shipping unit or
per production batch
but at least once every
two weeks.
3 components from
different packing units
in one group analysis
Coordination of
cleaning by external
contractor for all
systems (2 x per year)
No wood,
plastic, with cover,
delivery in trays; special
load container closed
(e.g. adapted to
workpiece geometry,
with plastic film hood)
C Medium component
standard
Monitoring: Twice a
year
3 components from
different packing units
in one group analysis
Coordination of
cleaning by external
contractor for all
systems (2 x per year)
No wood,
plastic, with cover,
load container closed
(e.g. Schäfer box with
lid, pallet closed on all
sides)
D Standard
component standard
Coordination of
cleaning by external
contractor for all
systems (2 x per year)
E User device
standard for use on
user device drawings
Customer requirements
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 6 of 19
2.3.1 Drawing
Cleanliness requirements must be integrated into the drawings. Here the product cleanliness is
defined by indicating the Thomas Cleanliness Class and the Component Cleanliness Code,
According to the requirements of this company standard, Section 2.3.2, the Component
Cleanliness Code shall refer to the individual component (CCC = N ).
The following formulation shall be used on drawings of articles (bought-in parts). The Component
Cleanliness Code CCC defined here in the formulation is to be understood as an example.
Product cleanliness as delivered:
Technical cleanliness as per Thomas CS 0135
CCC = N(B462/C177D61/E11/F1/G0/H0/I0/J0/K0)
2.4 Preliminary Planning
In line with our concept of integrating Technical Cleanliness into the processes as early as possible,
the issue shall be integrated into the APQP process.
Specifically, this means that in the following documents, procedures and processes the issue of
Technical Cleanliness must be addressed with the supplier.
2.4.1 Customer Specifications
Supplier specifications shall be discussed with regard to cleanliness requirements and be applied
to the list of quality features (performance specification).
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 7 of 19
Thomas magnets GmbH must formulate and communicate specifications with regard to VDA 19
and Section 2.3 of this company standard
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 8 of 19
2.4.2 Contract Review
In line with the APQP process, the supplier shall issue confirmation of manufacturability. This
confirmation of manufacturability must also explicitly refer to the fulfilment of cleanliness
requirements. Contractual items (limits, escalation management and complaints handling, tests,
test location and time) that address the issue of Technical Cleanliness must be agreed with the CTQ
department.
2.4.3 Design FMEA
If the supplier is responsible for design, a design FMEA must be performed. A design FMEA
constitutes an important tool for influencing the cleanliness of the product. In it the influence of
particles on the design must be described and evaluated by a cross-divisional team.
2.4.4 Facilities and Tools
In this context the equipment, means of production and facilities for manufacturing products with
increased standards of Technical Cleanliness must be checked for suitability.
2.4.5 Test and Testing Equipment
A check must be performed to establish whether the test methods and testing equipment are
suitable for analyzing cleanliness. Potential equipment and methods are discussed in Section 2.7.
Any deviations from the test methods and testing equipment must be approved by the CTQ
department at Thomas magnets GmbH.
2.4.6 Technical Approval of A-Article (Design Freeze Drawings / Specifications)
In all necessary documents, but at least on the drawing, the standards of Technical Cleanliness
must be defined by the time of Technical Approval of the A-articles at the latest. They shall be
formulated clearly and unambiguously, based on VDA 19 and Section 2.3.3 – 2.4 of this
organizational instruction.
2.4.7 Process Flow Chart and Production Layout
The specific processes for cleanliness must be indicated on the process flow chart. Since this flow
chart is regarded as a basis of the P-FMEA and the PCP, this step is of fundamental importance.
Thomas magnets GmbH must check the PFC for specific cleanliness processes.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 9 of 19
2.4.8 Process FMEA
All cleanliness-relevant points arising from the Design FMEA and the process flow chart constitute
the basis of detailed analysis in the P-FMEA. Furthermore, the various process steps of product
realization (from goods receiving and logistics to packaging) must be analyzed for potential risks of
soiling and contamination, and measures must be taken to reduce the risk.
The supplier must perform and analyze its P-FMEA with regard to cleanliness.
2.4.9 Process Instructions
In the documents concerning manufacture of the product all the instructions (Operating
Procedures, Process Procedures, Inspection and Test Plans, Maintenance Plans, etc.) must be
extended to include the topic of Technical Cleanliness if necessary.
2.4.10 Logistics Concept / Packaging Materials
The logistics concept is crucial to compliance with cleanliness requirements. The concept must be
developed taking into account the avoidance of contamination, selection of suitable packaging,
primary and secondary packaging, transport routes, method and duration of storage in accordance
with the specifications of Section 2.5.5
2.4.11 PPAP-Documents
Documented Technical Cleanliness must also be specified in the PPAP documents. A record must
be kept of the fact that the cleanliness requirements have been met. A PSW must not be issued
without objective evidence of the fulfilment of the cleanliness requirements.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 10 of 19
2.5 Suppliers
2.5.1 Selection of Suppliers
Suppliers shall be selected according to the rules issued by Thomas magnets GmbH.
However, care must be taken to ensure that the requirements regarding Technical Cleanliness can
be met by subcontractors. This also includes the requirements specified in this standard for
packaging materials, cleanliness, possible analysis and transport.
2.5.2 Integration of Suppliers into the Cleanliness Concept
To ensure seamless, plannable component cleanliness, the subcontractor shall be notified of the
various measures concerning Technical Cleanliness. In an early conceptual phase the various
measures (e.g. cleaning, transport, packaging materials, etc.) must be agreed with the
subcontractor and implemented. The points discussed in the APQP process over which the
subcontractor has an influence should serve as a guide and as a basis for constructive talks. The TS
16949 requirement that all the specifications be passed on to subcontractors applies here too.
2.5.3 Requirements for the Supplier
To define requirements for all suppliers and products is extremely difficult and not expedient. The
specifications should be determined individually for the particular project/product but should at
least meet the requirements derived from the Thomas Cleanliness Classes.
The specifications to be defined shall comprise the following point:
Measuring intervals
Number of samples (number of components)
Cleaning specifications
Production site
Packaging
Testing equipment
2.5.4 Support / Supplier Development
To successfully realize the concept and implement Technical Cleanliness as an important
requirement, Thomas magnets GmbH gives the suppliers an assurance that they will receive
support in the form of:
Cleanliness audits
Know-how transfer
Exchange of experience
Training sessions / audits
Checklists
Recommendations concerning suitable analysis equipment
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 11 of 19
2.5.5 Packaging
2.5.5.1 Determining the Packaging
The definition of packaging is derived from multiple factors:
Thomas Cleanliness Class (Thomas`internal one)
Function of the component
Material
No supplier article may ever be packed directly in a cardboard bos (a protective enclosure is
required, e.g. polythene bag / tray / blister pack). In addition, the large load container must not be
made of wood and must be surrounded by secondary packaging (stretch-wrap film).
The decision whether an article must be delivered as bulk cargo, layered cargo or positioned cargo
shall be based on the following decision-making chart:
2.5.5.2 Use of Packaging
The packaging provided by Thomas magnets GmbH (small load container, tray, etc.) shall only
serve as packaging for products that are delivered to Thomas magnets GmbH. Internal use is
prohibited.
It is enclosed by secondary packaging and must be stored until use in such a way that the
packaging is protected against becoming soiled again.
Component
Components with minimal
surface sensitivity (very light,
round, hardened)
or solely with
inner functional surfaces
Components that must not be
poured as bulk owing to their
mass, size and surface.
Components with moderate
surface sensitivity
or with inner
functional surfaces
Components with sensitive
outer surfaces
Bulk cargo Layered cargo Positioned cargo
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 12 of 19
2.5.5.3 Cleanliness of Pool Packaging
If the packaging was cleaned before delivery to the supplier, the supplier must check the
cleanliness of the packaging. The packaging (e.g. small load container, tray) shall be subjected to
visual inspection before it is filled with Thomas magnets GmbH goods. If the cleanliness of the
packaging is not guaranteed due to soiling (wood shavings, swarf, fluff, etc.), such packaging must
be not be used. At the same time the soiling must be documented and reported to Thomas
magnets GmbH.
2.6 Controlling, Campaigns and Measures
2.6.1 Audits
The scope of audits at suppliers` premises shall include verification of Technical Cleanliness. In the
event of any deviations, measures must be defined and their effectiveness checked.
When conducting Internal Audits the supplier undertakes to extend them to include the issue of
Technical Cleanliness.
2.6.2 Monitoring
As part of the in-process inspections the supplier must check the cleanliness of articles by means
of a residual dirt analysis (see Section 2.7). The results must be documented and sent to Thomas
magnets GmbH along with the relevant deliveries (can also be performed electronically). The test
intervals shall accompany production and be based on the production batch. If the production
batches are too large so that in-process monitoring does not allow any representative conclusion
to be made regarding the soiling of the article, the test interval must be shortened. The analysis
interval should be selected according to the production volume, the aim being to make reliable
statements concerning product cleanliness. The test intervals must be clearly formulated and be
integrated into the manufacturing processes, including documentation. Depending on the product,
test intervals can be based on the following parameters:
Batch
Packing unit
Shipping unit
Working shift
Quantity in units
However, the test must be performed at least once a week.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 13 of 19
2.6.3 Test Methods and Testing Equipment
To perform the test required by para 2.6.2 of this organizational instruction, a suitable item of
testing equipment must be used. This equipment shall be regarded as suitable if the results
confirm the following:
A low error of measurement
Repeatability
Low dependence on personnel and environment factors
Thomas magnets GmbH has compiled a compact, powerful and low-cost system and recommends
this system for cleanliness analyses.
It is a particle counting system based on a scanner.
The device is compact, mobile and easy to operate. It allows automatic counting of particles and
an associated high level of results repeatability.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 14 of 19
Measurement takes place in an area that has been partitioned off.
2.7 Test Methods
2.7.1 Transport/Packaging
The packaging documented on the drawing shall be used. The internal packaging should be such
that the individual parts from Goods Receiving or from Production are protected against damage
and soiling. It is advisable to use clean polyethylene bags that permit prior labelling with “Product,
ID and Batch Number”. The bags shall be disposed of after the sampling procedure.
Cleanliness analysis:
Product-specific test parameters shall be documented in the PCP.
The analysis results of in-process inspections shall be recorded in an electronic/digital form (e.g.
MS Excel).
2.7.2 Control Sample
Determination of the blank sample (blank value) to calculate the gravimetric and determining the
cleanliness of items.
Equipment: Filter membrane Ultrasonic bath
Tweezers Mesh screen
Clamp Rinsing device
Suction flask Filter cascade
Funnel Filter plate
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 15 of 19
2.7.2.1 Procedure
Particle extraction for individual parts:
Specify extraction method:
By client or depending on function and shape of the individual part.
Specify number of samples:
By client or determination using the decay method:
Note, the first sample of the decay curve should be a multiple of the control sample
Specify quantity of liquid:
By client or determination using the decay method.
Note, the last sample of the decay curve should be approximately the same size as the control
sample
Specify cleaning time:
By client or determination using the decay method.
Note, the last sample of the decay curve should be approximately the same size as the control
sample.
Control sample of the analysis equipment
Dry and weigh the filter beforehand
Take control sample with an appropriate quantity for blank value correction
Filter off over suction flask, rinsing device or cabinet
Rinse with 50ml petroleum benzene over suction flask
Dry filter for 1 hour at approx.. 80° C – 100° C and backweigh
Maximum gravimetric weight 0,5 mg -> if exceeded, change liquid
Individual parts
Dry and weigh the filter beforehand
Extract particles of individual parts with defined quantity of cold detergent
Filter off over suction flask, rinsing device or cabinet
Rinse with 50ml petroleum benzene over suction flask
Filter dried for 1 hour at approx.. 80° C – 100° C
Determination of gravimetric weight:
(Filter after filtering off in mg – filter before filtering off in mg) – blank value for analysis equipment
in mg = gravimetric weight in mg
Analysis of the filter membrane:
According to specification by client or according to VDA19
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 16 of 19
2.7.3 Analysis of the Sample
2.7.3.1 Drying
Dry the filter in the drying oven at approx.. 100° C for a least 1 hour.
2.7.3.2 Rinse Down
Rinse down the individual parts with the appropriate volume of HAKU 1025-921 and fine-jet wash
bottle in a glass beaker.
Picture of an Example
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 17 of 19
2.7.3.3 Filtration
Filter off the cleaning medium over suction flask. Assuming empty filter is dry.
Dry filter in the drying oven for at least 1 hour.
Place filter in slide frame,
Label the slide frame and analyze with an automatic particle counting system.
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 18 of 19
2.7.3.4 Analysis with an Automatic Particle Counting System
Examples of inorganic particles:
Sand / metal / salts / glass / iron / grinding residues / brass
Grinding residues Sand
Lathe turnings
Example of organic particles:
Hairs / fibres / dust
Company Standard
Technical Cleanless Articles –Bought-in Parts
(external use) CS 0135 / Revision 02 / Author: COQ-Sku
© Thomas Magnete GmbH. All rights reserved. Strictly confidential. Page 19 of 19
Filtration:
Consists of glass funnel that is mounted on a flask and connected to a vacuum pump.
Drying cabinet:
Dries the wet filter.
Automatic particle counting system:
With this system the accumulation of dirt particles on the filter patch is measured quantitatively.
Aids:
Filter patches (5 µm): for collecting dirt particles.
Beaker:
Container for collecting particles washed out and off in the rinsing medium.
Tweezers:
These are required in order to remove the filter patches from the filtration apparatus.
Cleaning medium:
Haku 1025-921
2.8 What Happens to the Individual Parts / Complete Devices Afterwards
The rinsed samples are generally scrapped in order to prevent contamination by introducing them to
production.
3. Associated Documents
ISO 16232
VDA 19.1
VDA 19.2
4. Advice
The German version is binding!