Document Information - Diagnostics · Supplier ShippingGuidelines 1.0 Overview Additional Information For additional information on this topic, see GSC-QAP-0001: Supplier Shipping

Document Information:

Document Author: sheedybBusiness Area / Unit: Logistics & All SitesConfidentiality: ConfidentialDocument Class: Quality System RecordDocument Type: Quality System Record with ReviewDocument Creator: Weatherford, Mick {DQCA~Indianapolis}Document Lifecycle Status: EffectiveValid From: 21-Feb-2020 05:05:35 (UTC)Valid To: Document Title: RDCP-081Document Number: 0000000000001009425000012Document Version: 24Template: No

Global Group: Quality Management SystemGlobal SubGroup: Standard Operating Proced. SOPLanguage: EnglishSite: IndianapolisDocument Description: Supplier Shipping GuidelinesLegacy Document Number: RDCP-081Description of change: Leadership requested that a new document be created for

supplier shipping standards. All of that content was removed from this document, so the content remaining focuses on transportation and routing guidelines. There were also some minor updates to the content.

Justification for change: A new document was created to address supplier shipping standards ( GSC-QAP-0001 ). As a result of that update, RDCP-081 was updated to just reflect Transportation and Routing requirements for carriers.

Electronic Signatures: Signed By: balascid (Dan Balascio {DOSN})Role: ReviewerSignature Differentiation: Supply ChainSigned Date: 28-Jan-2020 12:59:55 (UTC)

Signed By: wilsoj26 (Jeffrey Wilson {DQCA})Role: ReviewerSignature Differentiation: Quality SystemsSigned Date: 22-Jan-2020 16:23:29 (UTC)

Signed By: fernant7 (Thiago Scantamburlo {DOSN})Role: ReviewerSignature Differentiation: Supply ChainSigned Date: 24-Jan-2020 21:20:49 (UTC)

This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use.Diese Kopie wird nicht aktualisiert. Überprüfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE

Ansprechpartner.Esta copia no va a ser actualizada. Verifique el “status” de esta versión en DiaDoc o contacte a su representante de ROCHE antes de

utilizarla.

Confidentiality: Confidential

Title: RDCP-081 Document Number: 0000000000001009425000012

Print Comment:Print Date:

Version: 24 Status: Effective Valid from: 21-Feb-2020 05:05:35 (UTC)

Cover Page 1 (2)

Signed By: weatherm (Mick Weatherford {DQCAB})Role: ApproverSigned Date: 30-Jan-2020 15:53:00 (UTC)

This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use.Diese Kopie wird nicht aktualisiert. Überprüfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE

Ansprechpartner.Esta copia no va a ser actualizada. Verifique el “status” de esta versión en DiaDoc o contacte a su representante de ROCHE antes de

utilizarla.


Title: RDCP-081 Document Number: 0000000000001009425000012

Print Comment:Print Date:

Version: 24 Status: Effective Valid from: 21-Feb-2020 05:05:35 (UTC)

Cover Page 2 (2)

Supplier Shipping Guidelines

1.0 Overview

Additional Information

For additional information on this topic, see GSC-QAP-0001: Supplier Shipping Requirements

Purpose The purpose of this document is to establish shipping guidelines for shipments to Roche Diagnostics, Indianapolis (RD) and shipments on behalf of RD, Indianapolis.

Scope All Supplier shipments to RD, IndianapolisAll Supplier shipments to other Roche sites on behalf of RD, IndianapolisAll Supplier to Supplier shipments on behalf of RD, Indianapolis

Exception – any Supplier currently enrolled in the FedEx Supply Chain Inbound (FXSC) Program for RD, Indianapolis must follow the routing and freight payment instructions provided by FXSC. All other provisions of this document apply.

Table of contents

Contents Page1.0 Overview 1 - 22.0 Shipping Documentation 3 - 43.0 Transportation / Routing 5 - 84.0 Record 8

References INDFMEA_Supply Chain (internal RD link) Supply Chain FMEA INDFMEA_Supplier Management (internal RD link) Process FMEA -

Supplier Management GSC-QAP-0001: Supplier Shipping Requirements

Definitions Supplier: any 3rd party manufacturer / distributor, contract manufacturer or Roche Diagnostics manufacturing site.

Continued on next page


Title: RDCP-081 Document Number: 0000000000001009425000012Print Comment:Print Date:

Version: 24 Status: Effective Valid from: 21-Feb-2020 05:05:35 (UTC)Content Page 1 (8)

http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000400681|000|01|007&filetype=PrintPDF&current=1http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000286026|000|01|007&filetype=PrintPDF&current=1http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000287504|000|01|007&filetype=PrintPDF&current=1http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000400681|000|01|007&filetype=PrintPDF&current=1

1.0 Overview, Continued

RocheResponsibilities

The RD Forwarding Department is responsible for maintaining the contents of this document.

The RD Procurement Department is responsible for maintaining a current version of this document on the RD Supplier Portal on the RD, Indianapolis internet site.

The web address of the Supplier Portal can be found on the RD Purchase Order.

Forwarding or Procurement may also provide a hard copy of the Supplier Shipping Guidelines by request. However, the Supplier is responsible for retaining the most current version of the document.

Supplier Responsibilities

Comply with RDCP-081 (Supplier Shipping Requirements).

Comply with GSC-QAP-0001 (Supplier Shipping Requirements).

Comply with regulations noted in 21 CFR 820.80 Receiving and 21 CFR 820.140 Handling.

Comply with all DOT, IATA, and CTPAT regulations as appropriate

Ensure all packaging/pallet components comply with The International Standard for Phytosanitary Measures, publication number 15 (ISPM 15) latest edition.




https://ispm15.com/https://ispm15.com/http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001200000400681|000|01|007&filetype=PrintPDF&current=1

2.0 Shipping Documentation

Shipment Documentation

It is the responsibility of the Supplier to provide the following documentation with each shipment:

Packing List/Delivery Note Supplier Name, Address, Contact Information Roche PO Number Roche Receiver, incl. building number Roche part # and Description Lot/Batch Number or Serial Number as applicable Expiration Date by Lot/Batch Number Date of Manufacture by Lot/Batch Number Product Quantity shipped by Part Number and Lot/Batch Temperature storage condition by Part # Number of shipping units (pallets and / or cartons) by Part Number and

Lot/Batch Total load weight

For those products ordered through the RDI Drop Shipment process, the above Packing List requirements are superseded by those defined in the Global Sourcing OEM Work Instructions or Technical Delivery Terms and Conditions (TDC) provided to the supplier.

Digital Documentation Required for Receiving Roche can / may require the supplier to provide digital shipping notifications with or without handling unit data prior to the physical arrival of goods by use of Electronic Data Interchange standards commercially available (Advanced Shipping Notification).





2.0 Shipping Documentation, Continued

Shipment Documentation, Continued

Bill of Lading (Truck)

Ship From: Name of Shipper and complete street address Ship To: Name of Consignee, complete street address and attention line Carrier Name Ship Date Roche PO #(s) (If credit card purchases: complete name of purchaser) Freight payment terms Trailer and Seal number (if applicable) # of cartons / pallets NMFC class and description Weight Hazardous Material information per CFR 49 including emergency contact

(if applicable) Temperature Condition, i.e. +2C to +8C (if applicable) Temperature Set Point, i.e. +5C (if applicable) Special delivery instructions

Commercial Invoice (International shipments only)

Written in English Shipper name/address Bill to name/address Consignee name/address PO number Invoice number Date Incoterms Part number Detailed description of items Quantity Unit of measure Unit value and currency Total value and currency Country of Origin




3.0 Transportation / Routing

Scope These instructions apply to all Collect or 3rd Party shipments when RD, Indianapolis is responsible for the freight charges including: All shipments to our Distribution Center in Indianapolis, Indiana. Shipments between Suppliers made on RD’s behalf. Drop shipments to RD customers made on RD’s behalf.

Exception: Supplier is currently enrolled in the FedEx Supply Chain Inbound Program for RD, Indianapolis must follow the routing and freight payment instructions provided by FXSC.

Routing for US Domestic Shipments

Shipment type Shipment

Wt. /

Cube /

Volume

States Carrier Assignment

Ground -

Parcel

1 – 300

lbs.All FedEx Ground Collect

LTL

301 –

5999 lbs.

and < 10

pallets

All See LTL Matrix below

Truckload

> 6000

lbs. or

≥ 10

Pallets

AllCall (317)521-2664

(317)521-4676 or email:[email protected]

Air – Parcel

(Overnight)

1 – 300

lbs.All

Call (317)521-2664

(317)521-4676 or email: [email protected]

Air –

Heavyweight

(Overnight)

301 –

5999 lbs.

and < 10

pallets

AllCall (317)521-2664


Temperatur

e Controlled

Trucks

All AllCall (317)521-2664






3.0 Transportation / Routing, Continued

LTL Matrix

If shipment is shipping from or to HI or AK, call or email Roche Forwarding @ (317)521-2664 or (317)521-4676 Or email: [email protected]

For ALL other ship from states, follow this LTL Matrix:Ship From State

Carrier-ContactShip From State

Carrier-Contact

AZ FedEx FreightPriority LTL Service

Call (800)GOFEDEX (463-3339)

Or visit: https://www.fedex.com/en-us/shipping/schedule-manage-pickups.html

AL R & L CarriersStandard Service

Call (800)543-5589

Or visithttps://www.rlcarriers.com/freight/shipping/pickup-request

CA AR

CO CT

FL DE

ID GA

IA IL

KS IN

ME KY

MN LA

MT MD

NE MA

NV MI

NH MS

NJ MO

NM NY

ND NC

OK OH

OR PA

RI SC

SD TN

TX VA

UT WV

VT

WA

WI

WY




mailto:[email protected]


Freight Terms(Incoterms)

Standard RD freight terms are collect (domestic) and FCA (international). Any deviation from these terms must be approved in advance by the RD Procurement Department.

Freight Billing -Parcel

FedEx Ground: Select COLLECT as the billing option. Suppliers do not need an RD FedEx account # to ship via FedEx Ground Collect. Process the shipment under supplier’s account number and FedEx will capture the RD account# at time of delivery.

Fedex Express: Select 3rd party billing option.RD will supply a Fedex Express Account # for use.Supplier is responsible for any costs associated with unauthorized or miss use of RD account #.

Freight Billing – All Others

Bill of lading or airway bill should be marked “Freight Collect – 3rd Party Billing”The Third Party Billing address should be shown as:Roche Diagnostics c/o Software Solutions9595 SW Gemini DriveBeaverton, OR, 97008






When contacting RD

When contacting RD, Indianapolis for routing instructions please provide the following information: Origin Address Destination Address PO Number / Attention # of cartons or pallets Weight Dangerous Goods UN#’s if applicable Temperature requirements if applicable Dimensions of handling units (international shipments only) Service required (name of Roche person authorizing expedited service)

Receiving Hours: Indianapolis

Monday through Friday: 6:00 am - 2:00 pm.After hours, Roche Diagnostics Logistics Operations must authorize receipts in advance.

Dock Appointment

An appointment is required for shipments with 10 pallet loads or more. To schedule an appointment email all required info to: [email protected] or call:317-521-7522 or 317-521-2664

4.0 Records

Records All documentation will be stored and maintained in accordance with CORE-RDCP-0087, US Diagnostics Records Retention Schedule.




http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001009425000091|000|05|007&filetype=PrintPDF&current=1http://diadoc.roche.com/_layouts/15/Roche.DiaDoc/Portal/Download.aspx?DocId=0000000000001009425000091|000|05|007&filetype=PrintPDF&current=1

Additional InformationPurposeScopeTable of contentsReferencesDefinitionsRocheResponsibilitiesSupplier ResponsibilitiesShipment DocumentationDigital Documentation Required for ReceivingShipment Documentation, ContinuedScopeRouting for US Domestic ShipmentsLTL MatrixFreight Terms(Incoterms)Freight Billing - ParcelFreight Billing – All OthersWhen contacting RDReceiving Hours:IndianapolisDock AppointmentRecords

PrintDate: PrintComment:

Documents

Document Information - Diagnostics · Supplier ShippingGuidelines 1.0 Overview Additional Information For additional information on this topic, see GSC-QAP-0001: Supplier Shipping