PUR002

TITLE: Tooling Management Procedure

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Approvals: Date:

Originator: Randall D. Goodnight

Quality Assurance Keith Burton

Sourcing: Don Dison

Accounting: Lisa Hart

Process Engineering: Tim Hamel

REVISION PAGE

Rev. Effective Page/Paragraph Description

Date

- All New Procedure

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1. Purpose
The purpose of this procedure is to clearly define the tooling management requirements and process for suppliers
delivering parts or performing services to Thermo Fisher Scientific (TFS), Asheville, NC. This procedure defines the
supplier’s responsibility for design, fabrication, and handling of TFS owned tooling. It also establishes
requirements for records and reports associated with the maintenance and disposition of TFS tooling.
2. Scope
This procedure applies to all direct material and service suppliers. It applies to all tooling either furnished to,
fabricated or procured by the suppliers under a TFS purchase order or other authorizing document, and includes
tooling located at a supplier’s lower tier supplier.
Expendable tools, shop equipment, and capital tooling are specifically excluded from this procedure.
3. Supplier Compliance
a. All tooling including the designs and specifications that were purchased by TFS and/or provided to the
supplier for the purpose of producing product or performing services for TFS remain the property of TFS.
b. Suppliers are to only use TFS tooling for producing product and performing services for TFS. Any other
use is strictly prohibited and can only be done with the written consent of TFS.
c. TFS has the right to remove all and/or any tooling at the Supplier at any time upon verbal and written
notices which may includes electronic media.
d. Suppliers are responsible for meeting all the requirements defined within this procedure. Failure to do so may
result in the removal of all tooling from the supplier’s premises.
e. The Suppliers are expected to meet all on-time delivery from tooling owned by TFS under normal use.
f. Suppliers are responsible for achieving 100% part conformance to TFS drawings and specifications. For its
achievement, suppliers must ensure that the tooling is inspected to applicable data (engineering data,
engineering drawings, master layouts, tool design, control tool, etc.) as specified in the purchase order
prior to release to production. It is understood that TFS owns all design drawings and specifications. TFS
will be forward a copy of all tooling design drawings per guidelines of this procedure.
g. In the event that the supplier recommends any change to the print / tooling, a TFS, ECR, must be
h. Suppliers are responsible for pursuing continuous improvement activities that will support and ensure
flawless tooling reliability.
i. Failure to meet these requirements may result in the loss of existing or future business with TFS. Any and all
costs associated with the supplier’s failure to comply with this procedure will be the responsibility of the
supplier.
j. TFS will be allowed to visit the supplier for full process and tooling audits at TFS discretion. TFS will notify the
supplier of such audits with three working days from the time of audit.

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4. References
Supplier Quality Manual GS-002-P-B
Addendum Supplier Quality Manual – Asheville
Metal Forming Checksheet Form FPC025
Test Tooling Checksheet Form FPC026
Plastic Molding Checksheet Form FPC027
Supplier’s Acceptance Management Agreement FPC028
Supplier Master Tooling/Fixture List FPC029
Manufacturing Feasibility Analysis form FPC030
Part Deviation Request FPC022
Supplier Part Approval Request FPC023

5. Definitions
5.1 Tooling/Tools - All test equipment, test fixtures, measuring devices, molds, jigs, dies, patterns, taps,
gages, templates and other manufacturing aids made for and limited to the production of particular
detail parts and assemblies for TFS.
5.2 PCBA - Printed Circuit Board Assembly
5.3 Test Equipment - A single or multipurpose test unit designed, developed, fabricated, modified, or
procured to TFS specifications. Also a single or multipurpose test unit used to develop, produce, test,
service, or measure parts. It may consist of a single item or an assembly, including standard or general
purpose items or components that are interconnected and inter-dependent, so as to become new
functional entity.
5.4 Expendable Tooling - These tools consist of catalogue items readily available on the open market, which,
because of their size and nature are considered expendable. Drills, reamers, snap gauges, electrodes and
all types of cutting tools are considered expendable tools, even though they are altered for production
purposes and may be special in nature.
5.5 Shop Equipment and Capital Tools - These tools include supplier owned plant equipment such as:
machines, motors, cranes, etc. Suppliers shall utilize any/all supplier owned shop equipment, which is
not to be included in tooling quotations for support of production.
5.6 ECR - Engineering Change Order
5.7 DC - Document Control

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6. Manufacturing Feasibility Considerations

6.1 TFS has considered control questions, although not intended to be all-inclusive, for suppliers to perform
a feasibility evaluation. The drawings and/or specifications provided to the supplier must be used as a
basis for analyzing its ability to meet all specified requirements from TFS.

6.2 The Manufacturing Feasibility Analysis Form FPC030 is required to be completed by the supplier to help
TFS understand the extent of its process capability and feasibility to meet the drawings and/or specifications.
The areas of the feasibility evaluation will include, but not limited to the following areas:
1) Engineering
2) Manufacturing
3) Quality / Inspection
4) Capacity Planning
5) Cost Analysis
6) Statistical
6.2 The Manufacturing Feasibility Analysis Form shall be published and sent to TFS Sourcing when new
business, new tooling, tooling relocation or tooling transfer is confirmed and prior to commencement of
production.
7. Tooling Packaging and Shipping
7.1 TFS and the supplier will agree upon the packaging specifications for the tooling during the tool
development phase. The agreed upon specification will be detailed on the tooling purchase order.
7.2 It is the supplier’s responsibility to provide adequate packaging to protect TFS tooling during shipping.
 The basic requirements for packaging and shipment will include:
1) Packaging shall be sufficiently robust to protect the tooling. The packaging must be robust
enough to prevent damage or contamination during tooling shipment.
2) TFS may require an independent evaluation of the tooling after shipment for validation
purposes when damage is suspected or found after shipment from the supplier’s premises.
3) All packaging must be labeled as specified for all tooling delivered.
4) There shall be only one part number for each tool and only one part number on each
shipping container unless otherwise agreed upon with TFS.
5) Suppliers are responsible for providing all shipping and release documents in a timely
manner as required. Any failure to do so may result in fees and expedited freight cost

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incurred on the part of the supplier.

7.3 In the event that any of these parameters are not met the tooling may be rejected upon delivery and
shipping cost will be the responsibility of the supplier at the discretion of TFS.
8. Tooling Storage:
8.1 Suppliers are responsible for the safe storage of the fixtures, tooling, and test equipment. This
responsibility extends to damage and risk of loss from the time it is delivered to supplier until it is
returned to TFS.

8.2 All tooling components and parts supplied by TFS to its suppliers for purposes of manufacturing
products for TFS shall be stored in a manner that maintains the integrity of those materials and their
adherence to their specifications. Suppliers are expected to store them in such a manner as to keep
them safe from damage or loss.
9. New Tooling
9.1 TFS highly recommends that the production supplier be integrated into the design process for new
tooling. TFS requires the production supplier to manage new tooling projects. This would include
the development of prototype tooling and prototype components. This involvement allows for a
smoother introduction of production tooling at the supplier. It will also help enable suppliers to
consistently produce high quality parts while meeting the desired process capabilities. This project
management requirement includes the development of a formal project plan.
9.2 All parts produced from new production tooling must go through the required qualification process,
including PPAP as directed by the TFS Supplier Engineering Department. Modifications to the tool
design that occur during or after the qualification process may require parts to go through a portion or all
of the qualification process a second time. Suppliers are encouraged to raise the issue of potential
different requirements (i.e. cosmetic) for TFS parts and accessories during this initial qualification
process.
9.3 These project plans are expected to be updated and delivered to the designated representatives at TFS
Sourcing on a regular basis, which will be predetermined by TFS. TFS Engineering, Quality, and Sourcing
Departments must be notified immediately of any major changes to the original project plan that may
impact the quality or timing of the new tool.
10. Tooling Identification and Traceability
10.1 Tooling identification and traceability are essential requirements for proper management of TFS tooling.
The tooling shall be identified to include the part number, serial number, detachable components, and
ownership.
10.2 If the tool requires modification as a result of purchase order change, then the tool identification must reflect

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revision A, B, etc., as applicable a TFS Sourcing will be notified prior to replacement.

10.3 The tooling must be properly named and properly tagged with a TFS identification number supplied by
TFS. Whenever practical, tools shall be identified by means of a metal tool identification tag to be affixed upon
the tool.
10.4 If tool tags are impractical because of the design and/or material, tooling identification shall be
accomplished as described below.
10.4.1 Metal tools shall be identified by acid etching, electro-engraving, vibropeening, steel stamping,
laser etching or any other method that will permanently identify, but not damage the tools.

10.4.2 Wood and plastic tools shall be identified by impressing, stenciling, or stamping. Tools too small
for any of the above methods shall be boxed and/or chained/affixed to a tool tag to ensure their
proper identity.

10.4.3 Regardless of identification method applied, suppliers must ensure that the identification
number is maintained in good condition at all times, and will not be removed or altered in
anyway once affixed to the tooling. Should the identification number become damaged or
ineligible in any respect, the supplier agrees to immediately notifying TFS and replacing the
damaged tag with a new one from TFS.

10.4.4 The name, identification number, a photo of each tool together with the part it produces must
be taken and included for all tools that are documented on the Supplier Tooling/Fixture Master
List, FPC029 and sent to Sourcing by June 30, of each calendar year.

10.4.5 The production tooling payment on any new sourcing awards is contingent upon that all
tooling is tag in accordance with this procedure. Once the supplier submits the digital
pictures of the tooling with clear permanent identification that states that this tooling is
’Property of TFS’ and shows our tooling order number…only then payment is released to
the supplier for the tooling cost
11. Tool Maintenance and Reporting
11.1 Suppliers are responsible for performing all maintenance work, repairs and component replacements as
necessary to ensure tooling remains in good working condition and suitable for its intended use.
11.2 Any maintenance required that exceeds what is considered to be normal wear and tear of the
tooling, any component replacements, and repair work must be documented and reported to TFS
Sourcing immediately upon discovery. Such work shall have prior approval from TFS before
performed.

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11.3 Suppliers must have effective systems in place for completing proper maintenance on TFS tooling at
periodic intervals so that optimal tooling performance and conditioning are ensured as set forth prior
to approval by TFS.
11.4 When the tooling is not in use or is taken out for service, TFS requires that it be stored in a manner that
maintains its integrity, and does not put it at risk for possible loss or damage.
11.5 Suppliers shall report to TFS Sourcing on an annual basis regarding the condition of the tooling, its
remaining life expectancy and should be used in the quality production of TFS production parts. The
appropriate and required forms for tracking the current condition of the tooling are an integrate part of
this procedure and are listed in this section below. Although these forms are self explanatory for data
entry purposes, the TFS Supplier Quality Department is available for guidance in completing the form(s)
as needed.
There are three forms that are available and each form is representative of the different types of
tooling that can apply. The forms are as follows:
1) Metal Forming Checksheet Form, FPC025
2) Test Tooling Checksheet Form, FPC026
3) Plastic Molding Checksheet Form, FPC027
11.6 When a supplier is notified by TFS of a part problem that may relate to the tooling, a team must be
assembled by the supplier to determine root cause and corrective action. TFS recommends suppliers use
the industry standard Global 8-D problem solving methodology and submit results to TFS upon completion.

12. Tooling Calibration (Test Equipment & Measuring Devices)

12.1 TFS requires calibration to be performed on test equipment and measuring devices in accordance
with the specification provided from TFS or the original equipment manufacturer.
12.2 All calibration results will be documented on the supplier’s internal calibration document(s) and
forwarded to the designated TFS Sourcing representative at the predetermined calibration interval
established by TFS Sourcing for the equipment.
12.3 Calibration reports should include at the minimum the following data:
1) Manufacturer
2) Tool Name
3) Serial Number
4) Tool ID Number
5) Calibration Cycle
6) Last Calibration Date

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7) Calibration Due Date

8) Initial of Person Performing the Calibration
13. Tooling Changes
13.1 Any change to the tooling, the process where the tooling is used, or the physical location of the tooling
MUST have prior approval by TFS before implementation of the change. Furthermore, TFS shall be
notified immediately and in advance once the supplier has made firm plans to make such changes. All
proposed changes must be documented on an Form FPC022 ( Supplier Part Deviation Request) and
Form FPC023 (Supplier Part Approval Request) for TFS, review prior to any changes or temporary
changes that may affect any drawing, tooling or any documentation that may pertinent to the tooling
production concerning TFS. Both these forms will be provided by TFS upon request.
13.2 Failure to notify TFS in advance or failure to obtain prior approval can result in immediate containment
of parts produced and 100% inspection of such at the supplier’s expense. Further consequences may
include “New Business Hold” and/or the immediate loss of the existing business.
14. Tooling Transfers
14.1 Any tooling that is being transferred should be done so by ensuring the following:
All tooling shall be identified as specified in the Tooling Identification and Traceability section of
this procedure.
The transfer of all related documentation and software available including drawings,
specifications, recent run records, and maintenance records, etc.
The transfer of all TFS owned measuring tools, gauges, electronic measuring devices, spare parts,
paint chip coupons, etc.
14.2 In cases where the tooling is transferred from one supplier to another supplier, the transferee must
complete the Manufacturing Feasibility Analysis form FPC030 as described in section Manufacturing
Feasibility Considerations of this procedure.
15. Tooling Not In Service
15.1 When the tooling is not in use or is taken out of service, TFS requires that it be stored in a manner that
maintains its integrity, and does not put it at risk for possible loss or damage.
15.2 TFS considers it’s tooling to be obsolete when:
15.2a The tooling is no longer capable of producing parts that consistently meet the required quality
standards within acceptable process parameters or
15.2b The product it is producing is considered obsolete.
15.3 All potential repair options must be exhausted before the production tool can be deemed unusable
or obsolete. TFS only considers a product to be obsolete if there is no potential for future demand,
including service requirements, for that particular product.

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15.4 Once a tool has been determined obsolete, the supplier must contact the appropriate TFS Sourcing
representative for further direction regarding the disposition of the tool. The supplier must also notify
TFS if there are any components that can be salvaged from the tool. TFS will then determine whether to
destroy, store, or return the tooling to TFS.
16. Tooling and Product Verification
16.1 TFS Sourcing representative shall be afforded the right to verify at the supplier’s premises that the TFS
tooling conforms to requirements specified by TFS. Such verification shall not be used by the supplier as
evidence of effective quality control. Under normal operating conditions of the tooling, the control of quality
for the parts produced from the tooling is the sole responsibility of the supplier.
16.2 Verification by TFS shall not absolve the supplier of the responsibility to provide acceptable product, nor
shall it preclude subsequent rejection by the customer. Upon request, the supplier is required to provide
verification that product from the tooling being produced meets all print specifications and requirements.
17. Records
17.1 Suppliers shall maintain adequate records for all TFS tooling in accordance with the supplier’s Quality
Management System. It is necessary for the records to reflect the following:
Ownership and contract (purchase order number) under which the tools are fabricated
Part number and serial number
Nomenclature and description
Location of tools
Rework and/or TFS disposition authority for tools no longer in the supplier’s possession
17.2 Suppliers shall maintain current tool designs, schematic drawings, sketches and photographs used in the
fabrication, testing or calibration of tooling for future references and/or revisions.
17.3 Tool manufacturing tolerances will be shown on the tool design. Disposition of this data will be made at
the same time the disposition of the related tool is provided.
17.4 TFS – Asheville will maintain the following records:

Record Retention Location Index Method

Metal Forming Checksheet FPC025 7 yrs DC Electronic

Test Tooling Checksheet FPC026 7 yrs DC Electronic

Plastic Molding Checksheet FPC027 7 yrs DC Electronic

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Record Retention Location Index Method

Manufacturing Feasibility Analysis FPC030 7 yrs DC Electronic

Part Deviation Request FPC022 7 yrs DC Electronic

Supplier Part Approval Request FPC023 7 yrs DC Electronic

18. SUPPLIER ACCEPTANCE AND AGREEMENT

18.1 This procedure shall govern the possession and use of all TFS owned tooling. For the tooling that is now
in the possession by the supplier or that may be placed in the possession of the supplier is subject to the
requirement set forth in this procedure. All TFS tooling must be listed by the supplier on the Supplier
Tooling/Fixture Master List FPC029, and signed by authorized personnel.
18.2 Also, the Supplier’s Acceptance and Management Agreement Form FPC028 will accompany Form
FPC029, and will serve as the supplier’s agreement to and acceptance of this procedure.

End of Document

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