Shipping Qualification

1. Introduction

The purpose of this SOP is to describe the procedure that should be followed during all
shipping Qualification (SQ) activities.

2. Scope

This SOP applies to the qualification of all shipping configurations. This includes, and not
limited to, intermediates, finished goods (full and partial load) and cold chain shipping
configurations.

This SOP will provide guidance on the evaluation and qualification of shipping units in
accordance with a uniform method, using established test methods at levels representative
of those occurring in actual distribution.

The methods used to design a SQ are based on industry standards. These standards are
created by the American Society for Testing Materials (ASTM) and/or International Safe
Transit Association (ISTA). The most common method used is ASTM D 4169: Standard
Practice for Performance Testing of Shipping Containers and Systems. However, ISTA creates
a variety of methods that can be followed for more specific situations.

3. Responsibilities

The packaging engineer, or equivalent, is responsible for managing the SQ which includes
and not limited to writing the SQ protocol, procurement of test materials, coordinating
execution of the test, and writing the SQ report. The packaging engineer will determine the
need for performing the SQ and the type of testing to be performed during the SQ.

The Quality Unit is responsible for the review and approval of the SQ Protocol and SQ
Report.

4. Definitions
 Assurance level as defined in ASTM D 4169 – The level of test intensity based on it’s
probability of occurring in typical distribution. Note: there are three test intensity
levels. Level 1 is a high level with low probability of occurrence. Level 3 is a low level,
but has a correspondingly high probability of occurrence. Level 2 is between the two
extremes.
 ASTM – Acronym for American Society for Testing and Materials. ASTM is an
international organisation that develops and publishes technical standards for
materials, products, systems and services.

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  ISTA – Acronym for international Safe Transit Association. ISTA is an organisation
that develops and publishes a variety of technical tests that are used for the analysis
of package performance during transit.
 LTL – Acronym for less than truckload.
 Shipping Qualification – A shipping qualification is a written plan used to qualify a
specified shipping configuration and packaging components. The qualification
includes testing, sampling, inspection against pre-approved acceptance criteria.
Shipping qualifications are used to demonstrate that the product and packaging will
be able to withstand the rigors of the distribution environment.
 Shipping study – A shipping study is used to gather data. It is not used for
qualification on a shipping system.
 Shipping unit – The smallest complete unit that will be subjected to the distribution
environment. An example of a shipping unit is a shipping container and its contents.
 Test plan – A specific listing of the test sequence to be followed to simulate the
hazards anticipated during the distribution cycle of a shipping unit. This includes the
test intensity and number of sequential tests.
 Test Schedule – In ASTM D 4169, the test schedule refers to the specific procedure
used, including the three assurance level intensities.

5. General Information

A SQ is generally required whenever there is a change to packaging that could affect the
form, fit or function of the product during storage and shipment. A shipping qualification is
necessary whenever designing the packaging for a new product. The testing is performed by
subjecting the shipping units to a test plan consisting of a sequence of anticipated hazard
elements encountered in various distribution cycles.

ASTM and ISTA tests provide a guide for evaluating shipping units using established test
methods at levels representative of those occurring in actual distribution. The test levels are
based on available information on the shipping environment, and current
industry/government practice and experience. The tests should be performed sequentially
on the same containers.

Test deviations that are encountered should be recorded on a protocol deviation form and
included in the final report.

6. Procedure

6.1 Materials of Construction

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Define the shipping unit. Describe it in terms of size, weight and materials of
construction. Describe if the container construction is designed with stress bearing
interior packaging or if the product will support any of the load.

Determine if the shipping unit will be handled manually or mechanically. Manual

handling should be used to test single containers, small parcels or shipping containers
weighing up to 200lbs. Mechanical handling should be used to test unitised loads, large
cases and crates and shipping containers that are handled by mechanical equipment.

6.2 Method of Transportation

Identify whether the shipping unit will be shipped using identical shipping units or using
mixed commodities. Identical shipping units are usually shipped on pallet loads. Mixed
commodities are usually shipped in an LTL or small package delivery environment. This
information will be required for calculating the theoretical load during warehouse
stacking and/or vehicle stacking. Also identify method of shipping (i.e. truck, rail, air or
any combination of these). This information will be necessary for determining vehicle
vibration.

If the shipping units are identical and they will be shipped as a unitised load, it is possible
to perform the SQ using one shipping unit by following ASTM or ISTA test procedures to
simulate a unitised load.

6.3 Conditioning

Different atmospheric and/or climatic conditions are likely to exist between the origin
and destination points of a distribution cycle. This may have an effect on the
performance characteristics for the product and/or packaging. The packaging engineer
should evaluate these conditions and the need for conditioning. If conditioning is
necessary for the SQ, the following procedures can be followed for conditioning:

 Conduct the test at standard conditions and compensate for the effects of any
climatic conditions. Condition the shipping unit(s) to a standard atmosphere of
23 ± 1oC (73.4 ± 2oF) and 50 ± 2% relative humidity. Condition fibreboard
containers in accordance with ASTM D 4332: standard practice for conditioning
containers, packages or packaging components for testing. A conditioning period
of 72 hours, or sufficient time to reach equilibrium of all parts of the package
and product is recommended. Test should be conducted in the conditioned
atmosphere whenever possible. If not possible, conduct the test as soon after
removal from the conditioning atmosphere as practicable. Recondition the
shipping units to the standard atmosphere as necessary during the test plan.
 It may be necessary to conduct some or all of the tests at special climatic
conditions, such as tropical, desert, cold and/or ambient. A conditioning period
of 72 hours, or sufficient time to reach equilibrium of all parts of the package

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 and product is recommended. Tests should be conducted in the conditioned
atmosphere whenever possible. If this is not possible, conduct the tests as soon
after removal from the conditioning atmosphere as practicable. Recondition the
shipping units to the standard atmosphere as necessary during the test plan.

6.4 Altitude

Evaluate if the shipping unit will experience conditions such as low pressure (high
altitude). This is important when packaged products are transported via feeder aircraft
(potentially non-pressurised) or by ground over mountain passes. Test method ASTM
D6653 can be used to perform a low pressure test. If expected altitude levels are
unknown, us 4,267m (14,000 ft.) for a period of 60 minutes.

6.5 Test Specimen

The test specimens that are used during a SQ should be representative samples of the
complete shipping units, including the contents. “Dummy” test loads are acceptable if
testing the actual product might be hazardous and is representative of the load. Ideally,
actual labelling components are used for the SQ; however, this may not always be
possible or practical. In the event actual labelling components are not used, then
labelling test components may be used. All components need to be representative of
the design and materials of construction for actual/expected commercial components.
Avoid unnecessary pre-handling that may damage the components and inspect all
components before testing.

6.6 Test Design

After the information in 6.5 has been defined, determine if the test design will be based
on ASTM D 4169 or an ISTA test method. Design the testing based on the test method
that is chosen.

6.7 Acceptance Criteria

Establish acceptance criteria prior to testing and consider the required condition of the
product and package at receipt. Determine if acceptance criteria will be based on a
sampling plan. Depending on the objective of the SQ different criteria may be used
provided it is justified in the protocol.

6.8 Protocol Generation

After the information in 6.7 has been determined, the packaging engineer should create
a protocol using the following format:

 Cover sheet/approval page – include the document title, document number,

author, approvers name and title, and space for approval signatures.

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  Table of contents – a numbered list of sections in the protocol.
 Purpose – statement as to why the shipping qualification is to be performed and
what it will accomplish.
 Background/introduction – on the product and/or packaging is to be provided.
Define the shipping methods that will be used (i.e. identical shipping units
shipped on pallets or mixed commodities shipped LTL or small package delivery).
 Scope – Statement as to what the scope of the shipping qualification covers.
 Responsibilities – Statement of the responsibilities for all groups involved in
executing the SQ.
 Test plan – An explanation of the testing configuration(s) and samples that will
be used for the SQ. Give a justification for why each testing configuration was
chosen. Describe the test method that will be followed (i.e. ASTM, ISTA) and
justify why that particular test was chosen. Discuss the assurance level that will
be used. Name the testing facility that will be performing the work (if applicable).
 Deviations – Deviations to the protocol are to be documented. Reference and
record on protocol deviation form.
 Materials – A list of packaging components, part numbers, and product (if
applicable) that will be used in the SQ.
 Environmental conditioning (if applicable) – Explanation of the conditions that
will be used for environmental conditioning prior to the distribution testing.
 Procedure – A detailed list of all steps that will be followed throughout the SQ.
Reference the test method that is followed for the SQ.
 Sampling plan – Include a detailed sampling plan as per company SOP on
sampling.
 Acceptance criteria – List the criteria that will be determined whether the test
meets protocol requirements.
 List of testers – A table which includes the name, signature, title and date of
anyone that performed testing and/or collected data while executing the
protocol.
 References – Section to list any documents that are referenced in the protocol.
 Attachments – Includes, but not limited to, any tables, graphs, diagrams, images,
documents, etc used during the execution of the protocol.
 Appendices – Section to list any supplementary documents related to the SQ (i.e.
actual test method).

6.9 Review and Approval

The designated departments are to review and approve the SQ Protocol. When the
protocol is approved, the execution of the SQ protocol can begin.

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6.10 Execution of Protocol

The packaging engineer is to procure the test materials and coordinate the activities
necessary to execute the protocol. Any deviations to the protocol are to be recorded
and included in the report.

6.11 Report Generation

When the testing is complete and all data is collected, the packaging engineer should
analyse and discuss the results in a SQ report. The report is to be written using the
following format:

 Summary – A brief explanation of why the study was performed, the protocol
that was used, and the test configuration that was used. Include a brief
description of the results(s) and further recommendation(s).
 Approval page – Include the document title, document number, author,
approvers name and title, and space for signatures.
 Tablet of contents – A numbered list of sections in the report.
 Introduction – Background on the product/package configuration that was used
and the type of testing that was completed.
 Experimental – An explanation of the testing configuration(s) and samples that
were used. Include a summary of the test plan and test
equipment/instrumentation.
 Results and discussion – A detailed summary of the results from the testing.
Results and data should be reported for each configuration tested. The results
section must include data from the sampling plan and whether the samples
passed/failed the acceptance criteria. If any deviations from the protocol
occurred, an explanation should be provided.
 Deviations – Include a section describing the deviation(s) from the protocol.
Attach the completed form(s) used to record the deviation. If there were no
deviations, state “there were no deviations during the execution of the
protocol”.
 Conclusion – An explanation of what the results represent. A recommendation
should be made based on the results of the testing.
 Attachments – Includes, but is not limited to any tables, graphs, diagrams,
images, documents, etc. that may help display data and/or results.

6.12 Report Approval

The designated departments are to review and approve the SQ Report.

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6.13 Packaging Configuration Approval

Once the SQ Report is approved, a decision could be made based on the

recommendation(s) from the report. If the product/package configuration(s) are
satisfactorily qualified, the proposed changes can be implemented and the necessary
activities to implement the change can begin.