Regulatory Compliance & Safety Standards Flashcards
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Read the first 7 Regulatory Compliance & Safety Standards flashcards as text
Which federal law authorizes states to enforce weights and measures regulations and receive federal funding assistance through NIST?
Answer: The Fair Packaging and Labeling Act (FPLA)
The FPLA, administered jointly by NIST and FDA, provides authority over labeling accuracy and is linked to state enforcement of net quantity declarations.
During inspection, a technician finds that a price-computing scale's display flickers and occasionally shows erroneous readings. Before condemning the device, what is the correct first step?
Answer: Perform repeatability and discrimination tests per NIST HB 44 testing procedures
Standard inspection protocol requires documented repeatability and discrimination testing to objectively confirm performance failures before rejection.
An automatic bulk weighing system fills bags of grain sold by weight. Which NIST HB 44 section and key accuracy consideration applies?
Answer: Section 2.22 – Automatic Weighing Systems; batch accuracy over multiple consecutive weighments
Automatic bulk weighing systems are covered under NIST HB 44 Section 2.22, which specifies accuracy requirements evaluated across multiple consecutive automatic weighments.
What is the significance of the 'OIML R 76' standard in the context of US scale regulation?
Answer: It is an international standard that NIST HB 44 is harmonized with, facilitating mutual recognition of type approvals
OIML R 76 is the international non-automatic weighing instrument standard; NIST HB 44 is substantially harmonized with it to enable international mutual recognition of NTEP type approvals.
A scale technician identifies a software-related vulnerability where the device's calibration constants could be altered via an unsecured service port. Under NIST HB 44 General Code, this is a violation of which requirement category?
Answer: Design requirements – specifically security seal and event logger provisions
NIST HB 44 design requirements include provisions for software security, audit trails, and event loggers to prevent unauthorized changes to metrological parameters.
When a state weights and measures official uses 'undercover buys' to test retail scales, what is being evaluated?
Answer: The accuracy of the scale in a real commercial transaction as experienced by a customer
Undercover purchases allow officials to evaluate scale accuracy and transaction integrity in actual commercial conditions, simulating a real consumer experience.
A scale's indicator board bears CE marking and an 'M' conformity marking with a two-digit year. What does the 'M' marking signify in a US commercial context?
Answer: The device meets EU Measuring Instruments Directive (MID) requirements, relevant when NTEP mutual recognition applies
The EU 'M' conformity marking indicates compliance with the Measuring Instruments Directive (MID/2014/32/EU); under OIML mutual recognition agreements, this may facilitate acceptance in NTEP evaluations.