Context of the Organization and ITAR Compliance

Context of the organization

Utilizing the context of the organization clause of an ISO 9001:2015 Quality Management System (QMS) can allow for a more resilient ITAR compliance program.    This can be accomplished by integrating export compliance into an existing management system s that includes all the tasks required to ensure that business is conducted in accordance to federal regulations.  These task include top management involvement, risk assessment, training, and auditing.

What is Context of the Organization?

The context of the organization and ITAR Compliance requirement in ISO 9001:2015 uses the internal and external issues that impact its strategic objectives as  inputs for establishing the QMS framework .   This means that you need to define influences of various elements on the organization and how they reflect on the QMS, the company’s culture, objectives and goals, complexity of products, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to detect risks and opportunities regarding the business context.

Assuredly, export compliance is an external factor that effects objectives, goals, and processes.  It also presents a risk to the organization because of the possible penalties that may be faced in the event of violation of any number of federal export violations.

Context of the organization

What is Export Compliance?

The two major set of U.S. export regulations are the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations  (EAR).   Both are in place to give the government a tool to ensure that restricted technologies do not get into the hands of nation states or parties that threaten U.S. security or impede U.S. foreign policy interests and obligations.

The ITAR was written to control the export of goods and services developed specifically for defense related applications.  These goods are categorized in the United States Munitions List (USML).  The EAR controls items which fall under a dual-use classification under the Commerce Control List (CCL).  An export license may be required for both ITAR and EAR controlled items if the parties involved are non-US citizens or involve non-US charted corporations.

Failure to comply with all parts of these regulations can result in significant fines and even imprisonment.  Additionally, a business can be banned from any future export activities.

Context of the Organization and Export Compliance

If your company manufactures or provides services that are classified as restricted under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR), consideration for compliance must be included.  Registrars are becoming more aware in the past few years of how U.S. Government Regulatory compliance impacts companies and their operations and they are starting to issue derogatory findings for companies that explicitly ignore the ITAR or EAR in their QMS, when they clearly are providing products or services that should be controlled.

Context of the Organization is all about the external and internal factors that will guide the company and its pursuit of risk mitigation through its commitment to continuous improvement.  The Context of the Organization and ITAR Compliance is the lens that companies need to view their commitment to ITAR and EAR Compliance.  It allows companies to formalize policies, processes, and procedures to ensure compliance and enact procedures to promptly respond to incidents where violations may have occurred.

Consultants can help you with understanding how to implement this.  We do recommend that your work with a consultant who is fluent in the ITAR and EAR and is experienced in Quality Management Systems such as ISO 9001:2015, ISO 13485:2016 and AS9100D

CVG Strategy Can Help

CVG Strategy consultants are experts in quality management systems and export compliance.  Our team members are Exemplar Global Certified Lead Auditors in these areas as well as certified through ECTI as Export Compliance Professionals.  We have helped business of all sizes in a variety of sectors integrate their export compliance program into their quality management systems.

 

 

Military Product Testing – Verifying Reliability

military product testing

Military product testing is performed at various stages of a products development and service initiation.  The earliest phase of this testing is known as Developmental Test and Evaluation.  This phase is conducted by the product developer and includes a detailed regime of climatic, dynamic, EMI/EMC, and electrical compatibility test procedures.

The United States Department of Defense (DoD) has consistently had issues with the quality of testing provided by its vendors.  Defense systems that fail to meet their required level of reliability are less capable of fulfilling their intended missions and endanger the lives of personnel operating and depending on them.  Additionally these reliability issues can delay project implementation, involve costly redesign, and result in higher costs of operation.

As stated in Reliability Growth – Enhancing Defense System Reliability, issues exist with the quality of both operational and developmental test and evaluation currently being performed.  By adequately engaging in the preparation, execution, and analysis of developmental test and evaluation, designers of defense materiel can achieve higher levels of reliability, avoid redesign issues, and learn important lessons for future product design specifications.

military product testing

Elements of a Viable Product Test Program

Knowledge of Applicable Standards

For defense product developers a wide range of defense test standards are applicable.  These military standards include:

  • MIL-STD-810
  • MIL-STD-461
  • MIL-STD-1275
  • MIL-STD-1399-300
  • MIL-STD-704
  • MIL-STD-202
  • MIL-DTL-901

The test program manager should have a good working knowledge of these standards and understand their interrelation in terms of product development.  This knowledge should then be applied to the development of a test program that addresses perceived component vulnerabilities and prioritizes design verification testing of those concerns.  Ultimately, a test program must be created that addresses all requirements and returns important data for analysis.

Life Cycle Analysis

For environmental testing (climatic and dynamic) MIL-STD-810 “Environmental Engineering Considerations and Laboratory Tests” requires a thorough examination of the stresses likely to be encountered by the product during its service life, including logistical transit, tactical transit, maintenance, and operation.  This is accomplished by conducting a Life Cycle Environmental Profile (LCEP).  The LCEP along with customer requirements and any measured data provide data for the Environmental Issues/Criteria List.

From these documents a tailored list or Test and Evaluation Master Plan (TEMP) of required test methods with appropriate levels of stress can be created that will establish a basis for required testing.

Test Plan Preparation

Test plans must be developed that inform all personnel involved in testing, including the testing laboratory, of exactly how the test is to be performed, and what data is to be captured.  As most testing should be performed with the test item in an operational mode representative of expected service, the plan must include information as how these modes should be executed, monitored and recorded.  Additionally procedures for verifying the test items functionality before, during and post testing should be included.

Management of Complex Programs

Military product testing for military equipment involves a large number of mil-std tests.  Often these tests will be run concurrently.  Some tests can be performed in a few hours, others may require months for completion.  Staying abreast of test program activities, addressing failures, troubleshooting and providing root failure analysis are but a few of the responsibilities of a test program manager.

The manager must also coordinate all activities with product development engineers, laboratories, and shipping services.  Additionally interim and final reporting of the test program must be created.

CVG Strategy Product Test Consultants

CVG Strategy Test Management experts have extensive experience in military product testing as well as, commercial, aerospace, defense, and automotive product test and evaluation.  They have worked with numerous standards that apply to environmental and EMI/EMC testing.  They are adept at coordinating with product development teams to provide value added test programs that provide confidence in a products capabilities and reliability.

We can tailor a statement of work to include any number of tasks that might be required.  This can include:

  • Test Standards Technical Support for proposals and customer inquiries
  • Defining Test Requirements
  • Design of Simulation and Monitoring Equipment
  • Development of Required Test Fixtures
  • Development of Required Documentation
  • Test Scheduling
  • Onsite support
  • Laboratory Test Witnessing
  • Company representative and advocate at Test Lab
  • Subject Matter Expertise