Technology Services – National Institute of Standards and Technology

Conformity Assessment

Body Armor Technical WorkshopOctober 2005

Gordon GillermanConformity Assessment Advisor

Homeland SecurityNational Institute of Standards and Technology

gordon.gillerman@nist.gov

Technology Services – National Institute of Standards and Technology

Factors in CA System Design?•The risks associated with non-compliance should be proportional to the rigor and independence of the CA system.

•System over-design will add too much cost.

•System under-design will result in too little confidence of compliance.

•Penalties associated with non-compliance may reduce the needed rigor and independence of the conformity assessment system.

•Timely mechanisms that effectively remove non-compliant products from the market may also reduce the needed rigor and independence of the system.

Technology Services – National Institute of Standards and Technology

Risk and Conformity AssessmentP

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Ris

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Independence and Rigor of Conformity Assessment

1st party conformity assessment

3rd party conformity assessment

Type Testing

Surveillance

Technology Services – National Institute of Standards and Technology

Conformity Assessment Model for Body ArmorIncludes:

• Type testing by accredited laboratory to performance requirements

• Evaluation of test data from accredited lab and required characteristics of body armor

• Compliance decision based on the evaluation

• Attestation of conformity

• Surveillance to enhance the confidence that fielded armor will meet the same performance requirements

• Program managed by conformity assessment body

Technology Services – National Institute of Standards and Technology

Type Testing

• Used when the critical characteristics can be evaluated via measurement or performance against technical criteria under specified conditions.

• Type test is a test carried out on samples that represent production for the purpose of determining conformity.

Technology Services – National Institute of Standards and Technology

Elements of Surveillance for Body Armor

• Used to ensure/enhance ongoing conformity

• Assessment (paper evaluation) of quality management system focused on maintaining ballistic performance of produced armor

• Quality management system to include materials benchmarking tests to ensure that materials and components perform at least as well as type test samples

• Initial factory audit/inspection to ensure mfg. is capable of producing compliant armor and mfg. has implemented QM system

• Unannounced regular inspection of armor production combined with audits of the implementation of to enhance confidence that certified armor continues to meet requirements

Technology Services – National Institute of Standards and Technology

Potential Candidate Component/Material Quality Benchmark Tests

• Infrared spectroscopy (IR):

– detection of chemical degradation

– small amount of sample needed

– commonly used in forensic analysis laboratories

• Tensile strength and elongation before break testing:

– straightforward methods of assessing physical and mechanical degradation

– tensile strength correlates with ballistic performance

– can be carried out with small amounts of sample

Technology Services – National Institute of Standards and Technology

Laboratory Accreditation

• Used to assess and ensure/enhance ongoing compliance of laboratory with management, process and technical competence requirements

• Standard – ISO/IEC 17025 plus test specific technical requirements

• Can cover issues such as independence, calibration, personnel competence, test environment…

Technology Services – National Institute of Standards and Technology

Laboratory Accreditation

• Conformity assessment process very similar to ISO 9000 quality management registration process

• Desktop review of laboratory quality and procedure manual

• Findings presented to laboratory

• Corrective action and resolution if needed

• On site audit to determine if quality and procedure manual is well implemented and if equipment and facilities are adequate

• Periodic assessments and audits to demonstrate continued compliance with ISO/IEC 17025 and programmatic requirements