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Supplier Quality Manual
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Table of Contents
1
2
3
4
GENERAL REQUIREMENTS ................................................................................................... 4
1.1 Quality Management Systems (QMS) & Audits .............................................................. 4
1.2 Waiver / Deviation of Requirements ................................................................................ 4
1.3 Special Process Suppliers ............................................................................................... 5
1.4 Sub-Tier Supplier Requirements ..................................................................................... 5
1.5 Restricted, Controlled, and Reportable Substances ....................................................... 5
1.6 Contingency Planning ...................................................................................................... 6
QUALITY REQUIREMENTS ..................................................................................................... 6
2.1 Lot Coding (Serialization) ................................................................................................ 6
2.2 Identification & Traceability .............................................................................................. 6
2.3 Shipment Related Documents ......................................................................................... 7
2.3.1 Product/Process Certificate of Conformance ............................................................ 8
2.3.2 Raw Material Certificate of Conformance ................................................................... 8
2.4 Change Notification ......................................................................................................... 8
2.5 First Article Sample Requirements (FAS) / Production Approval .................................... 9
2.6 Process Capability/Risk Assessment .............................................................................. 9
2.7 Inspections & Sample Plans ............................................................................................ 9
2.8 Symmetry Medical Inc. Supplied Material ..................................................................... 10
2.9 Control of Inspection, Measuring and Testing Equipment............................................. 10
Cleaning (categorized as a special process) .......................................................................... 10
3.1 Marking – Screen Printing ............................................................................................. 10
3.2 Welding (Excluding Casting and Forging operations per specific specifications) ......... 10
3.3 Documentation Accuracy and Legibility......................................................................... 11
3.4 Records/ Archiving......................................................................................................... 11
3.5 Commercial or Subcontracted Storage Facility Requirements……………………………11
3.6 International Traffic in Arms Regulations (ITAR) and Export Administration Regulations
(EAR)…………………………………………………………………………………………12
3.7 Foreign Object Detection (FOD)
Policy………………………………………………………...…………………………………12
3.8 Calibration and Laboratory Testing
Suppliers……………………………………………………………….………………………12
SUPPLIER PERFORMANCE & EVALUTION ........................................................................ 13
4.1 Nonconforming Material ................................................................................................ 13
4.2 Supplier Corrective/Preventive Actions ......................................................................... 13
4.3 Supplier Performance .................................................................................................... 14
5
Requirements for Change Notification .................................................................................... 14
6
Receipt and Acceptance of this Agreement ............................................................................ 16
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INTRODUCTION
We at Symmetry Medical Inc. are dedicated to continuously striving to meet our
customer’s goals by expecting the best from our suppliers. We ask you, our supplier, to
join us in providing the best products to our customers with respect to Quality, Delivery
and Price. This manual is designed in conjunction with the requirements of ISO 9001,
ISO 13485, CDMDCAS, PAL, AS 9100, NADCAP, and the FDA Quality System
Regulations/Good Manufacturing practices to help you understand all the expectations
that Symmetry Medical Inc. requires for supplied goods and product/process related
services.
COMPANY OVERVIEW & PROFILE
Symmetry Medical Inc. is the leading provider of implants, instruments and cases to the
global orthopedic industry by specializing in precision forging and machining, as well as
providing specialized products and services to the aerospace market.
The Company designs, develops and produces these products for companies in other
segments of the medical device market, including dental, osteobiologic and endoscopy
sectors, and provides specialized products and services to non-healthcare markets.
SYMMETRY MISSION
Symmetry Medical Inc. is dedicated to providing quality products and services for all our
customers; both internal and external. We are committed to the statutory and regulatory
requirements and maintaining the effectiveness of our quality management system. The
foundation of our success is the people. It is through our commitment to employee
development and continuous improvement that we are able to achieve our quality
objectives and meet our customers’ expectations.
OBJECTIVES OF THIS MANUAL
The purpose of this Manual, in conjunction with the purchase order general terms and
conditions and long term agreement (if applicable), is to establish the quality assurance
and purchasing requirements for our suppliers when providing a product or service.
Where conflicts exist, the long term agreement / purchase order requirements take
precedence over the requirement(s) in this manual. Facility purchasing/quality will
determine on a case by case basis as to which suppliers are excluded from the
requirements of this manual.
Please review the content of this manual and document any exceptions or areas that do
not apply to the products or services you provide or those areas where further
clarification is required on the acceptance page at the end of this document. Contact
Symmetry supplier quality to discuss these areas prior to signing the agreement. Once in
agreement, please sign the receipt and acceptance of this agreement.
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1 GENERAL REQUIREMENTS
1.1
Quality Management Systems (QMS) & Audits
A supplier may be required to maintain a QMS. If it is deemed necessary,
those suppliers may be required to participate in supplier QMS audit to ISO /
AS / NADCAP / FDA / CDMDCAS / PAL as determined by Symmetry Medical
Inc. This determination will be derived from the evaluation of the following, but
not limited to: risk association, products or services being rendered, frequency
of purchase, special requirements (e.g. customer dictated), etc. The audit is
designed to give the supplier feedback on how well their processes and system
align with specified standard(s) and Symmetry Medical requirements. Right of
Entry: Symmetry Medical as well as its Customers and Regulatory Agencies
reserve the right to audit all process steps taken to ensure the quality of its
products and to verify the conformance to the requirements defined in this
document and other purchasing agreements.
NOTE: Where suppliers systems are not in compliance with all applicable
ISO/AS/NADCAP/ FDA/CDMDCAS/PAL standards/regulations, Symmetry
Medical Inc. will confirm the supplier’s systems revolving around identification
and traceability, document and material control, training, process control, nonconforming product control, corrective action activities, maintenance/preventive
maintenance, and calibration systems to assure compliance to the regulations,
subsequently mitigating any associated risks, relative to quality or product
integrity.
1.2
Waiver / Deviation of Requirements
Symmetry Medical Inc. Quality/Purchasing may waive any portion of these
requirements as deemed necessary. Federal and State laws and regulations
cannot be waived. This waiver shall be communicated to the supplier in writing;
verbal waivers are not permitted.
Suppliers providing services in accordance with applicable Current Good
Manufacturing Practice (cGMP) and / or Good Laboratory Practice (GLP)
regulations may be allowed exemptions from appropriate paragraphs of this
manual.
A Supplier may seek a deviation request or waiver request on product
manufactured for Symmetry Medical Inc. that is nonconforming. Deviation
Request form may be obtained from Symmetry Purchasing department or
supplier may submit request on an internal form. Adequate time must be
allowed to process request without affecting original due date. When seeking
any deviation, product shall NOT be shipped to Symmetry Medical Inc. or their
designee prior to the written notification of acceptance. Deviations are
approved by Symmetry Purchasing/Quality.
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Special Process Suppliers
All suppliers performing the special processes, listed below, must have a
documented quality system in place to validate products, processes, and
inspection and test systems. This requirement applies to all Symmetry
suppliers as well as their sub-contractors and/or other suppliers.
Special Process definition: Where the results of a process cannot be fully
verified by subsequent inspection and test, the process shall be validated with
a high degree of assurance and approved according to established procedures.
All special process suppliers must be approved by Symmetry Medical in
advance. For a list of current approved special process providers, contact the
appropriate Symmetry Medical purchasing agent. Special process services
procured by Symmetry Medical Inc. are, but not limited to:
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Non-Destructive Testing (NDT)
Heat Treating
Chemical Processing
Material Testing Lab
Aerospace Suppliers: All suppliers of special processes must be NADCAP
accredited for the process/service being procured. NADCAP accreditation may
be waived only by Symmetry Medical Inc. Quality/Purchasing representatives.
1.4
Sub-Tier Supplier Requirements
All suppliers are responsible for ensuring continued compliance to all
requirements of sub-contractors (including any dictated suppliers). All suppliers
shall request written authorization from Symmetry Medical Inc. prior to
outsourcing any processes needed to complete PO requirements. In the event
the supplier is permitted to utilize sub-tier suppliers, the supplier is responsible
for communicating (flow down) all applicable terms and conditions and any
other purchase order requirements.
1.5
Restricted, Controlled, and Reportable Substances
All materials delivered under the Purchase Order shall satisfy current
governmental and safety constraints or restricted toxic and hazardous
materials; as well as environmental, electrical and electromagnetic
considerations applicable to the country of manufacture and sale.
Seller certifies that all goods, which qualify as chemical substances under the
Toxic Substance Control Act (TSCA), have been registered on the official
inventory of chemical substances maintained by the United States Protection
Agency (EPA). Seller will provide immediate notice to buyer of any use
restrictions, reporting requirements, or other obligations that the EPA imposes
with respect to such goods.
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All suppliers are required to maintain Material Safety Data Sheet (MSDS) on all
manufacturing materials. Suppliers shall include with the first shipment and
each revision of the product a copy of the Material Safety Data Sheet (MSDS)
for such product. Suppliers performing service on a medical device component
must comply with PROP65 list.
All suppliers are required to comply with the obligations under the Dodd-Frank
Wall Street Reform and Consumer Protection Act section 1502 requiring the
supplier to disclose the purchase and/or use of conflict minerals including Gold,
Tin, Tungsten and Tantalum that originated in the Democratic Republic of the
Congo (DRC) and adjacent countries.
All suppliers are required to notify Symmetry if any supplied product and/or
material contain latex. Symmetry recommends that powder free non-latex
gloves be used by suppliers.
All suppliers that provide or perform a service on a medical device or implant
are required to notify Symmetry if any animal tissue-derived materials are used
in the manufacturing process or in any agent that will contact the device or
implant. Some common sources of animal tissue-derived materials are
polishing compounds (beef tallow), lubricants (fatty acids and fatty amines),
and liquid soaps, lubricants, solvents (glycerol). Upon notification, Symmetry
will work with the supplier to collect data, in accordance with FDA guidelines,
and complete a risk assessment.
1.6
Contingency Planning
Supplier shall have a documented contingency plan. The plan shall include, at
a minimum, catastrophic key equipment failure, natural disasters common for
the geographical region, and long term power loss.
2 QUALITY REQUIREMENTS
2.1
Lot Coding (Serialization)
Materials procured by Symmetry Medical Inc. shall be consecutively lot coded.
Individual lot codes or number series, for the deliverable material shall be
marked on the Certificate of Conformance from the manufacturer or supplier.
Where applicable the lot information would be provided by Symmetry Medical
Inc.
2.2 Identification & Traceability
The supplier is required to establish a documented system for the identification
and traceability of all materials. The inspection and test status of all materials
should be easily identifiable by the system, and documentation should include
a description of any applicable containment areas and/or devices.
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The following guidelines must be adhered to for both medical and aerospace
product:
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The lot must be traceable from the moment the parts or materials enter
the plant through the time of shipment. This information must be kept on
file so that in case of failure it can be retrieved.
Lot integrity cannot be broken. Parts are to remain with the lot that they
arrived in and cannot be mixed with another lot. In the case of raw
material, Symmetry Medical Purchasing must be notified before using
material with a different Heat Code than the original heat issued to the
work order so a new work order can be issued.
Parts or products removed from the normal process flow must be
segregated and clearly identified as nonconforming parts to prevent mixups.
All prints and purchase orders must be adhered to 100% unless approved
in writing by the appropriate personnel at Symmetry Medical.
The supplier shall be able to provide a list of all manufacturing materials
upon request.
NOTE: per FDA 820.70 Regulation requirement: Where a manufacturing
material could reasonably be expected to have an adverse effect on product
quality, the manufacturer shall establish and maintain procedures for the use
and removal of such manufacturing material to ensure that it is removed or
limited to an amount that does not adversely affect the device’s quality. The
removal or reduction of such manufacturing material shall be documented.
2.3
Shipment Related Documents
When shipping an order to Symmetry Medical, the supplier shall furnish the
following:

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Completed inspection forms (reference First Article Inspection). First
Article ONLY
Certificate of Conformance, including any sub-tier suppliers, as required
per the PO.
Test reports, including any sub-tier suppliers, as required per the
purchase order.
All prints and process instruction sheets. (Site specific requirement,
reference PO)
When applicable any excess material and all nonconforming parts.
Any gages, fixtures, special tools, etc., as required per the purchase
order.
Packing list.
Special Process and Material certifications.
Country of Origin (COO) & Melting Source
All packing lists and invoices must have the following information:
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Part number.
Vendor Batch/Lot number/Heat number
Purchase order number.
Quantity good and scrap.
Shelf Life Expiration Date (where product has a limited useable
life)
Product/Process Certificate of Conformance
A certificate of conformance is required stating the product conforms to
all purchase order requirements. This certificate must contain the
following at a minimum:

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

2.3.2
A signature by an authorized agent of the Supplier including the
agent’s title and date
PO number, Part name/description, drawing number and revision
level
Unique identification number such as a lot/serial number (if
applicable)
Quantity shipped
Any other Supplier specific information as required per PO
Special process and material certifications.
Raw Material Certificate of Conformance
All raw material stock, purchased directly or indirectly for Symmetry
Medical, shall be certified to conform to its applicable Symmetry Medical
Inc. specification and/or applicable standard/specification denoted on
the Purchase Order/Print. All raw material (acquired or provided by a
supplier) certifications must state the country of origin and the original
melt source defining the chemical, mechanical properties and must
accompany each shipment.
Raw materials from China – Except for Titanium which require sourcing
from specific Symmetry approved mills, it is permissible to use raw
materials procured from China providing the Chinese sources are
directly affiliated with U.S.A based companies. Notification to Symmetry
Medical purchasing/quality is required prior to procuring non-titanium
material(s) from sources in China. All material certifications must be in
English or include English translation.
2.4 Change Notification
Section 5.0 identifies changes requiring Symmetry Medical notification and
approval. Suppliers shall notify Symmetry Medical Inc. in writing prior to
change to allow evaluation of the effect of the change upon the end product or
service being rendered. No changes shall proceed without written
authorization to do so from Symmetry Medical Inc. Request must be received
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by Symmetry to allow adequate time for review and disposition without
affecting original delivery date.
NOTE: per FDA 820.50 regulation requirement: Suppliers agree to notify
Symmetry of any changes in their product, processes, or service so that we
may determine whether the change may affect the quality of a finished device.
2.5
First Article Sample Requirements (FAS) / Production Approval
When required by the PO, the Supplier shall perform a 100% inspection of all
drawing characteristics and notes; the quantity of samples needed shall also be
noted on the PO and any PO specific inspection requirements. An inspection
report shall be submitted identifying each characteristic noted on the
engineering drawing. The inspector shall record each characteristic and
drawing note indicating acceptance status. A certification statement
referencing the PO number, part number and revision level, unique
identification number such as a lot/serial number (if applicable), and quantity
inspected shall accompany the FAS/Production Approval. The signature and
date of an authorized agent of the supplier performing the FAS/Production
Approval including the agent’s title must appear on the certification.
2.6
Process Capability/Risk Assessment
Where required by PO Process capability/risk needs to be quantified for all
critical to quality features (CTQ’s), e.g. fit, form, function, labeling, marking and
the corresponding sampling plan(s) need to be aligned with the
recognized/demonstrated capability/risk, i.e.



2.7
greater than 1.33 Cp/Cpk, Pp/Ppk - 1.0 Sampling plan;
less than 1.33 Cp/Cpk, Pp/Ppk - 100% inspection;
or in lieu of statistical analysis, always 100% insp. CTQ’s
Inspections & Sample Plans
An inspection report, identifying the characteristics produced on the purchased
part(s) with the applicable inspection results, is required with the shipment. This
report is to be signed, dated, and traceable to the person performing the
inspection. When the engineering drawing specifications or PO require 100%
inspection or test, statistical sampling shall NOT be applied. Sampling
procedure ANSI/ASQ Z1.4, current revision, shall be used. If sampling
inspection is utilized, the plan shall not allow the acceptance of known defects
in a lot, and 100% inspection shall be completed for any characteristic if it is
found to be out of tolerance during sample method inspection. Sampling plan
acceptance criteria is C=0.
NOTE: In addition to quantified visual standards, the appropriate gage must be
used to match the precision level of the print tolerance (e.g., 10:1 ratio between
tolerance range being measured and gages ability to repeat and discriminate).
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Symmetry Medical Inc. Supplied Material
The supplier shall choose one of two options when nonconforming product is
generated from Symmetry Medical Inc. Supplied Material:
1. Return the product fully identified as scrap or nonconforming and
segregated from conforming product. OR
2. Complete a deviation request to request that Symmetry Medical Inc.
accept product as is.
Refer to Purchase order general terms and conditions for additional
requirements.
2.9
Control of Inspection, Measuring and Testing Equipment
The supplier must have documented procedures to control, calibrate, and
maintain inspection, measuring and test equipment used to demonstrate
product conformance to required specifications. All inspection, measuring and
testing equipment must be in compliance to the requirements of ISO17025
and/or traceable to the National Institute of Standards and Technology or
equivalent international specification(s).
3 Cleaning (categorized as a special process)
If cleaning is required all parts must be degreased and cleaned, preferably in a hot
alkaline wash. Ultrasound cleaning is strongly recommended, notably for parts with
significant surface roughness (parts subject to sandblasting, knurling, etc.).

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
The use of products containing chlorine is prohibited.
Tapped and blind holes must receive particular attention.
Mounted units shall be cleaned both before and after assembly.
Careful rinsing and drying shall follow all cleaning operations.
3.1 Marking – Screen Printing
If marking is required, it must be in compliance with the supplied part drawing
or instructions, and be biocompatible, indelible and fade-resistant, relative to
handling, autoclave sterilization and alkaline wash products, etc.
3.2
Welding (Excluding Casting and Forging operations per specific
specifications)
All employees welding production hardware must be certified, per AWS
D17.1:2001 “Qualification of Aircraft, Missile, and Aerospace Fusion Welders.”
All Certified employees must be re-certified every 2 years. Welds must be
machined and polished without destroying the weld bead and must not contain
holes, cracks or porosity.
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Documentation Accuracy and Legibility
The accuracy and legibility of the paperwork can be as critical as the
dimensional accuracy of the product being manufactured. Examples of
paperwork are Certificates of Conformance (Finished product and raw
materials), Inspection paperwork (including first article and production
inspection) and paperwork from subcontracted sources for work/processes
done. All entries and sign-offs must be in blue or black ink
3.4 Records/ Archiving
All product records related to the development, manufacturing, inspection,
labeling, and packaging of implants and finished devices are to be kept
available for 30 years. At the end of that time period, the supplier shall confer
with Symmetry on how to proceed with these records. In case of termination of
collaboration the supplier agrees to provide records to Symmetry in a timely
manner. Alternatively, the supplier may commit to hand over all product records
to Symmetry for archiving. In case of objection with regard to proprietary
information, the supplier may choose to forward all records to a trustee. The
use of a trustee shall be agreed with Symmetry in writing declaring the trustee
concerned. These records shall be and shall remain legible, readily identifiable
and retrievable. These records must be stored in safe conditions (i.e. in a room
protected from fire, flooding, rodents, ultraviolet radiation and theft). All entries
and sign offs must be in blue or black ink. Examples of product records are:
inspection records, testing reports, NDT records, corrective action reports,
personnel qualifications, C of C’s.
3.5
Commercial or Subcontracted Storage Facility Requirements
The following requirements apply to commercial or subcontracted storage
facilities used by Symmetry Medical and Symmetry Medical suppliers to store
documents/records.
All commercial or subcontracted storage facilities shall have a documented
procedure for:
Identification: Facility shall not cover, remove, duplicate, or make unreadable
any marking/identification present on box/container at time of receipt.
Supplier’s internal identification method may not obstruct customer
marking/identification.
Storage: Facility shall store documents in safe conditions to protect the
integrity of container/documents. Storage area must be protected from fire,
flooding, wild life, ultraviolet radiation, and theft or vandalism.
Protection: Facility will document access to customer documents. Facility will
ensure that documents are stored in an access controlled environment. Facility
will limit access to Symmetry records to authorized personnel only. Authorized
personnel will be defined in writing by storage facility and customer. Any
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person requesting access to Symmetry documents will be checked against this
list prior to authorizing access. Facility shall have a documented process for
the identification, control, and customer notification for any damaged or opened
boxes/containers.
Retrieval: Documents shall be stored in such a way to allow prompt retrieval.
Retention: facility shall store documents in accordance with stated
requirements until such time as customer authorizes disposition, in writing.
Facility shall ensure that requests for disposition are checked against the
authorized personnel list prior to document disposition.
Disposition: facility shall ensure disposition of records are performed in
accordance with customer approved procedure.
Facility shall notify customer prior to moving documents outside of the
approved storage area. Facility shall notify customer when there have been
any major changes in company management, facility, or financial conditions.
Facility shall notify customer of any capacity issues and prior to reaching full
capacity.
3.6
International Traffic in Arms Regulations (ITAR) and Export
Administration Regulations (EAR)
EAR and/or ITAR may be flowed down to suppliers in purchase orders,
contracts, requisitions, or other written communications for certain aerospace
product. If EAR or ITAR is flowed down to the supplier the supplier becomes
subject to the federal laws governing EAR/ITAR. Suppliers should consult with
the US State Department for any questions as Symmetry cannot offer legal
advice. If your scope of work is limited to medical product then this section
does not apply.
3.7
Foreign Object Detection (FOD) Policy
Finished goods, special process, and suppliers performing any outside service
on Symmetry product are required to have a documented FOD policy. This
policy, at a minimum, must require preventing or detecting and removing any
foreign debris that your process could have exposed the product to. Common
examples of Foreign Object Debris are: Food, beverages, burrs, dirt, blast
media, lubes, coolant, and metal/plastic shavings.
3.8
Calibration and Laboratory Testing Suppliers
All supplier of calibration services are required to comply with the current
version of ISO-17025, General Requirements for the Competence of Testing
and Calibration Laboratories. In addition to complying with ISO-17025,
Calibration and Laboratory Testing Suppliers shall;
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a. Maintain any validated equipment in accordance with the documented
validation plan and notify Symmetry of any changes to the validated state.
b. Receive written approval from Symmetry for any deviation to ISO-17025
requirements.
c. Provide calibration and laboratory test reports that comply with ISO-17025,
Symmetry purchase order, and Symmetry Supplier Quality Manual
requirements, unless otherwise agreed upon in writing.
d. Provide reports free from blank spaces, errors, or invalid changes. If a hand
written change is required to a report then a single line should be drawn
through the error and the person performing the correction should record
their initials or signature, the date of change, and the corrected text
immediately next to where the error occurred. If a field on a report is not
needed then “N/A” or similar verbiage must be recorded.
e. Perform calibrations traceable to NIST standards. If no NIST standard is
available then the standard used for calibration must be approved by
Symmetry in writing.
f.
Seek written approval where methods used are not covered by Standard
methods.
g. Notify Symmetry if equipment used to perform testing or calibration for
Symmetry is later found to be nonconforming or out of calibration.
h. Notify Symmetry in any change in accreditation (ISO-17025, A2LA,
NADCAP, etc.).
i.
Notify Symmetry of any change to sub-suppliers used to complete testing
and/or calibration.
j.
Comply with all Company, state, and federal laws and regulations while on
Symmetry property. This includes ITAR/EAR and all safety policies.
4 SUPPLIER PERFORMANCE & EVALUTION
4.1
Nonconforming Material
If nonconforming material is discovered at Symmetry Medical Inc., or their
designee, the supplier will be notified. If nonconforming material is discovered
at the supplier, the supplier is required to immediately notify Symmetry Medical.
4.2
Supplier Corrective/Preventive Actions
If a problem were to arise, Symmetry Medical may request the responsible
supplier to perform a root cause and corrective action investigation. A detailed
containment plan is due within 48 hours of discrepancy notification and is to
include inventory levels at supplier, sub contractor(s), and any product in
transit. Any containment plan should encompass any like product currently in
process. The corrective/preventive action plan due date will be communicated
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Supplier Quality Manual
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Number:
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Revision:
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Owner:
Joe Coscia
to supplier. Verification of the effectiveness of the corrective/preventive action
is the responsibility of the supplier on the next production run. Verification is to
be provided to Symmetry.
4.3
Supplier Performance
Symmetry Medical Inc. monitors Supplier Quality and Delivery performance.
Feedback will be provided to suppliers as appropriate. Each Symmetry facility
will communicate the minimum expectations for delivery and quality. Suppliers
failing to meet expectations may be required to submit correction action plan
and/or be placed on new business hold.
5 Requirements for Change Notification
The table below provides change notification requirements.
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Location(s):
Title:
Document
Number:
SMA : SWI1; SMA : SNI; SMA : SLP; SMA :
SEN; SMA : SAM; SMA : SRC; SMA : SMM
Supplier Quality Manual
QMS-004
Revision:
Owner:
E
Joe Coscia
Requirements for Change Notification
Type of change or activity
Production facility
Special /
Validated
Processes*
Implants
NonImplants
X
X
X
Raw Matl
Suppliers
Examples (provided as an aid - not all inclusive)
External supplier to in-house
X3
Equipment
Type of equipment
X
X
Specific equipment
X
Movement of equipment w/in a facility
X
Reduced frequency or method of PM
X
Fixturing materials
X
X
Subcontractor change
X
X
X1
Inspection requirements
X2
X2
X2
Production method that affects the
composition and / or properties of the
material
X
X
Manufacturing materials that come in
contact with the product
X
X
Manufacturing process flow
X
X
CNC Mill to CNC Lathe, CNC Mill to Manual
Mill, Cutoff Mill to Saw, etc.
X
Bar sealer A to bar sealer B
Acid change frequency
Titanium jaws to aluminum jaws
X
Change from supplier A to supplier B, testing
facilities for a product or service
X4
Measurement methods, frequency reduction,
changes to inspection criteria
Heat treating, electropolish, forming, chemical
processing, ingot processing, conversion
processing, extrusion processing.
Coolant, machine lubricants, polishing
compounds, cleaning solutions, tumbling media,
release agents
X
Re-sequencing, additions/deletions, rework
X
Rework not following original process
Process parameters
X
Management / Company Ownership
X
X
X
X
Top Management only
Quality system registration changes
X
X
X
X
Includes revocation, suspension
Packaging, cleaning, and sterilization
operations
X
X
X
Machine tooling design / Program
X
Design changes on non-customer
designed finished devices
X
X
X
Time, temperature, pressure
Changes in packaging materials, dose type and
magnitude are reportable changes, Rinse
cycles, cycle times, chemicals
X1 – A subcontractor approved for supply of specific raw materials (ie 17-4 bar stock) may be used for any supplied non-implant using that
material without requiring notifying Symmetry.
X2 – Inspection changes that increase frequencies or change equipment to an instrument with higher accuracy and precision may be
implemented before notifying Symmetry. However, the changes shall be communicated to Symmetry in a timely fashion.
X3 – Addition of new melting methodology and/or new conversion equipment and/or extrusion equipment beyond current capabilities.
Note: Adding additional equipment to increase capacity to an existing process does not require customer notification – qualify internally.
X4 – Addition of a melting, conversion, and/or extrusion methodology not previously used.
* Unless changes are specifically allowed within the Symmetry approved validation.
Note: Multiple subcontractors, equipment, etc. that have historically been used on a given product, may continue to be used interchangeably
without requiring notification.
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Location(s):
Title:
SMA : SWI1; SMA : SNI; SMA : SLP; SMA :
SEN; SMA : SAM; SMA : SRC; SMA : SMM
Supplier Quality Manual
Document
Number:
QMS-004
Revision:
E
Owner:
Joe Coscia
6 Receipt and Acceptance of this Agreement
Supplier acknowledges receipt of Symmetry Medical’s Supplier Quality
Manual and understands Symmetry Medical’s requirements. Supplier
agrees to maintain a quality system in compliance with these requirements.
Supplier Company Name:
Supplier Company Address:
Supplier Representative Name:
Supplier Representative Signature/Date:
Identify sections which do not apply to your company or exceptions to the
requirements listed:
Symmetry purchasing acceptance to excluded sections and/or exceptions:
_____________________________________________________________________________
Print Name
Signature
Date
_____________________________________________________________________________
Print Name
Signature
Date
Page 16 of 16
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Effective Date: Sep 25, 2014
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