Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

1 Purpose
The purpose of this document is to provide all Ortho Clinical Diagnostics affiliate distribution centers
worldwide receiving deliveries of Ortho finished goods, with instructions on how temperature classified
and ambient shipments are evaluated for package integrity and temperature based on product labeling at
the time of receipt into the destination warehouse. This includes verifying that the total shipping
duration from point of departure from the source distribution center (DC) to the affiliate warehouse is
less than (<) seven (7) days / 168 hours.

2 Scope
This document applies to all temperature classified and ambient finished goods received at Ortho
affiliate distribution centers worldwide that are shipped with or without temperature monitoring devices.
Local warehouse incoming inspection and material transaction procedures shall be used to govern
verification of shipment packing relevant information such as part number, product / pack-out damage,
carton report / packing list, carton size, quantity, lot number, ERP material transactions, etc.
Out of Scope: RhoGAM

3 Frequency
This procedure is performed on receipt of each temperature controlled and ambient finished goods
shipment from Ortho Clinical Diagnostics.

4 Responsibilities
Individuals or functional departments responsible for the information in this document:
Individual/Function
Receiving Affiliate
Warehouse Operator /
Quality Control Inspector /
Quality Control
Supply Chain
Representative
Supply Chain Quality
Representative
Regional Distribution
Quality
Responsibility
Performs inspections of each Ortho temperature controlled and
ambient finished goods shipment and communicates any request
for product disposition via FRM53511 to Ortho Supply Chain
Receives request for product disposition via FRM53511, reviews
the completed FRM53511, initiates the non-conformance record
and attaches all of the applicable supporting information to the
non-conformance that will be needed to process the non-
conformance.
Provides guidance on disposition of finished goods that was
observed to have a temperature excursion or an issue that has the
potential to impact product quality.
Co-ordinates the disposition activities and follows up on potential
corrections and or corrective actions at the local level

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

5 Definitions
Definitions of the terms used in this document:
Term Definition
Air-Con Air Conditioned
AWB Air Waybill
COD Certificate of Destruction
Corrugate / Any evidence of corrugate dents, holes, tears, or heavy stains that
Pack-out Damage compromise the integrity of the shipping container.
DC Distribution Center
SCQ Supply Chain Quality
ERP system Enterprise Resource Planning system.
NC Nonconformance
Ortho Ortho Clinical Diagnostics
Pack-out The system that constitutes the corrugate, thermal insulation, gel
packs, dunnage, and plastic bags that product is shipped in.
Product Finished Goods received from Ortho Clinical Diagnostics
SC Supply Chain
TT TempTale

6 Related Documents
Documents listed below either support the information written in this procedure, or are referenced
within the body of this document for further information:
Object Number Object Name
FRM26019 Certificate of Destruction
FRM53361 Incoming Inspection Record for Ortho Finished Goods
FRM53511 Request for Product Disposition from Ortho
SOP27424 Temperature Monitor Devices
SOP51360 Supply Chain Product Disposition Process

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

7 Safety and Environmental Practices

7.1 Solid Carbon Dioxide (Dry Ice) Safety Procedures:
Each employee working in an area where exposure to Solid Carbon Dioxide (Dry-Ice) is likely to
occur must be informed of the following:
 All employees should be informed at least once a year of the hazards and relevant
symptoms of over-exposure, appropriate emergency procedures and proper procedures
and precautions to minimize exposure. Records of these training sessions should be kept
in the department file to verify the frequency of training.

Note: Refer to the Solid Carbon Dioxide Material Safety data sheet for additional information.
Note: Refer to Appendix A, Notification Label number 10 and 11, indicating package contains
Dry-Ice.

8 Equipment / Materials
 Temperature monitoring device (TempTale or equivalent)
 Digital Camera
 Personal Protective Equipment:
 Gloves
 Tongs for dry ice handling (Refer to local distributor procedures)

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9 Incoming Inspection Instructions

9.1 Initial Receipt
Note: Assessment of all Ortho finished goods shipments should be performed upon receipt.
Note: Refer to Appendix A, for notification labeling used to identify correct package storage
temperature, and identification of internal monitoring device.
 Use FRM53361, Incoming Inspection Record for Ortho Finished Goods, to record
incoming inspection data. Note – final conclusion of product acceptability can be
documented within the electronic warehouse management system / SAP system if
available. Use of FRM53361 is not mandatory for distributors if all elements are captured
within the distributor’s incoming acceptance process.
 Record the date and time of receipt.
Note: Products should be located into their correct storage temperature if receipt inspection
cannot be completed immediately. Product can be moved to appropriate temperature area to
perform the inspection. A refrigerated receiving dock/area is recommended.
Note: For frozen material, in the event of the shipment takes longer than the typical transit time
the carrier has a responsibility to ensure product remains at ≤ -20°C or that the dry ice is
replenished during transit. It is therefore important that affiliate verifies that dry ice is still
present (refer to Flow chart D).
 Complete FRM53361, based product assessment (refer to Master Flowchart A).
Note: If issues are observed during verification of the shipment packing information such as part
number, lot number, carton size, quantity etc. or damage to pack-out and / or product is observed
on receipt place all affected pack-outs in quarantine at the appropriate temperature. These issues
should be managed as per local warehouse incoming inspection procedures and / or
communicated to Ortho Supply chain via FRM53511, Request for Product Disposition from
Ortho.
 Send the completed FRM53511 to the Ortho Supply Chain email distribution list
indicated on FRM53511 along with any objective evidence (e.g. photographs of pack-out
and / or product damage, copies of annotated shipping documentation to highlight
observed discrepancy and etc).
Note: If this information is not made available at time the FRM53511 was originally sent, the
disposition will be delayed until such time as it has been provided.
 Wait for Ortho disposition response

Note: Request for disposition can take up to five (5) business days to complete by Ortho
Personnel.

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

Master Flowchart A

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.2 Product with TempTales (Refer to Flowchart B):

If one or more boxes contain a TempTale, the specific pack-out within the shipment must be
physically moved to the appropriate temperature controlled quarantine storage area, and a
movement transaction must be performed in the ERP system to reflect the updated storage status
of the material until data evaluation is complete.

 When a shipment arrives perform the assessment using the appropriate flowchart for
inspection sequence and instruction in a temperature controlled environment.
 Flowchart B – TempTale / Data-Logger
 Segregate order by pack-out type
 Retrieve TempTale (TT) data to evaluate for temperature excursions
 Analyze each pack-out (TT) separately and if all pass, release.
 If a temperature excursion is observed in one or more pack-outs, place all similar
pack-outs in quarantine at the appropriate temperature.
 Send the completed FRM53511 to the Ortho Supply Chain email distribution list
indicated on FRM53511 along with any objective evidence from the temperature
monitoring devices (e.g. TempTales / Data Logger) and transport carrier and/or
storage chamber temperature data that demonstrates that the finished goods were
transported, handled and stored appropriately during transit
Note: If this information is not made available at time the FRM53511 was originally sent, the
disposition will be delayed until such time as it has been provided.
 Wait for Ortho disposition response

Note: Request for disposition can take up to five (5) business days to complete by Ortho
Personnel.

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.3 Product with TempTales only (see Flowchart B):

 Follow inspection process as described in section 9.2

Flowchart B – Temp- Tale / Data-Logger

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.4 Flowchart C - Left Intentionally Blank

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.5 Product with Dry Ice Only (see Flowchart D):

For frozen material, in the event of the shipment takes longer than the typical transit time the
carrier has a responsibility to ensure product remains at ≤ -20°C or that the dry ice is replenished
during transit.
 If one or more boxes contain Dry Ice, each box must be inspected as high priority.
 If any remaining Dry Ice is observed inside the box, store the products at the appropriate
temperature and release.
 If no Dry Ice is observed inside a box, it MUST be quarantined at the appropriate
temperature as a temperature excursion has occurred during transit.
 Send the complete FRM53511 to Ortho Supply Chain email distribution email list
indicated on FRM53511 along with any objective evidence (e.g. photographs of absence
of Dry Ice, Dry Ice replenishment record from the transport carrier or storage chamber
temperature data) that demonstrates that the finished goods were handled and stored
appropriately during transit.
Note: If this information is not made available at time the FRM53511 was originally sent, the
disposition will be delayed until such time as it has been provided.
 Wait for Ortho disposition response.
Note: Request for disposition can take up to five (5) business days to complete by Ortho
Personnel.

Flowchart D – Dry Ice

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.6 Product without TempTales (see Flowchart E):

Determine the total shipping duration from the point of departure from the source DC to the
affiliate warehouse. If the duration is less than or equal to seven (≤ 7) days, release UNLESS the
product contained within the shipment is listed in Table 1 below (as the maximum allowable
exposure time in temperature interval for each of these products is less than seven (< 7) days).

Table 1: Product with a Maximum Allowable Exposure time (<) than Seven (7) Days
Product Name GEM Code Catalog Number
Calibrator Kit 25 N/A 6801896
Thermal Kit N/A 6802125
Folate Calibrator GEMC355 131 1075
Folate Range Verifier GEMV355 680 0873
CK-MB Calibrator GEMC300 128 6293
Troponin I ES Calibrator GEMC309 680 2302
Troponin I ES Range Verifier GEMV309 680 2303

NOTE: Destination affiliates that are excluded from the 7-day guidelines include:

Brazil, Argentina, China, Mexico, Chile, and Japan (as each of these countries utilize
controlled refrigerated / frozen storage capability in customs).

If the total shipping duration is greater than seven (>7) days (or >168 hours) or any of the
products listed in Table 1 above are contained within the shipment:
 Move the product to the quarantine area at the appropriate temperature.
 Send the completed FRM53511 and send to the Ortho supply chain email distribution list
as indicated on FRM53511 along with any objective evidence (e.g. temperature data from
the transport carrier and / or storage chamber temperature data), that the product has
been handled and stored appropriately during the delay in transit or whilst being held
pending customs release.
Note: If this information is not made available at time the FRM53511 was originally sent, the
disposition will be delayed until such time as it has been provided.
 Wait for Ortho disposition response.

Note: Request for disposition can take up to five (5) business days to complete by Ortho
Personnel.

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

9.7 Use of Certificate of Destruction (FRM26019)

Where the disposition decision outcome is to scrap the affected products, the 3PL and or
distributor must complete FRM26019 or a similar form which exists within their quality system
and covers all the essential elements. This form needs to be completed either when the affected
products are physically scrapped or when the 3PL / distributor confirms that they will physically
scrap the affected product at an agreed timeline. Once complete, this form needs to be returned to
Ortho to enable Ortho to close the event within the Ortho quality system.

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

Flowchart E – More than 7 days

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

Appendix A – Notification Labels

No. Label Description No. Label Description No. Label Description

1 KEEP FROZEN 5 KEEP FROZEN 9 TEMPERATURE

PENGUIN MONITOR
IATA LABEL ENCLOSED
ORTHO LONG
TERM STORAGE
LABEL
2 KEEP FROZEN 6 KEEP FROZEN 10 DRY ICE

IATA LABEL ORTHO LONG

TERM STORAGE
-20˚C or LABEL
below
STORE BELOW
-20˚C
3 +2˚C to +8˚C 7 REFRIGERATE 11 DRY ICE
DO NOT FREEZE
IATA LABEL
ORTHO LONG
TERM STORAGE
LABEL

4 +2˚C to +25˚C 8 DO NOT FREEZE

IATA LABEL ORTHO LONG

TERM STORAGE
LABEL

2˚-25˚C

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Title Incoming Inspection of Ortho Temperature Controlled Finished Goods

Object: SOP52950 Revision: 8 Effective Date: 24-Sep-2019

IATA label is used to indicate the transport temperature for shipments booked as temperature controlled air cargo. This label
does not necessarily reflect the Ortho long term storage requirements of the product.

Ortho Label is used to indicate the long Term Storage temperature requirements of the product being shipped. During
shipment if product is held pending customs release follow guidelines below:

 If a freezer is available in Customs, store containers labelled with Keep Frozen and Dry Ice in the freezer.

 If no freezer available, store containers labelled with Keep Frozen and Dry Ice in 2-8°C

When product arrives at affiliate/distributor warehouse, store at the appropriate Ortho Label Long Term Storage temperature
requirement.

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