Quality Digest

(STR-R: Stroudsburg, PA) -- STR-Registrar (STR-R), a leading provider of management system registration services, recently became the first certification body to receive accreditation from ACLASS for its good manufacturing practices (GMP) factory-assessment program for over-the-counter (OTC) drugs, medical device, and dietary supplement manufacturers. Accreditation for cosmetics and nonregulated products is expected by the end of the month.

(ISO: Geneva) -- The International Organization for Standardization (ISO) and Danish Standards (DS, the ISO member for Denmark) have jointly published a handbook on geometrical product specifications (GPS) for which nearly 120 ISO standards provide a globally harmonized base for technical drawing, with benefits for manufacturing and trade.

Two weeks ago, the White House issued a memorandum recognizing the role of the National Institute of Standards and Technology (NIST) in helping agencies implement best practices for standards development activities to address national priorities. The memo clarifies how federal agencies should work with the private sector in standards development, and it stresses the importance of public-private partnerships to the U.S. standards system and promoting innovation.

(ANSI: New York) -- The U.S. National Committee (USNC) to the International Electrotechnical Commission (IEC) is seeking nominations for young professionals at the start of their electrotechnology careers to participate in the Young Professionals 2012 Workshop, to be held in conjunction with the 76th IEC General Meeting (GM) in Oslo, Norway, during Oct. 1–5, 2012.

(ISO: Geneva) -- Safer food farming is the principal benefit targeted by a new ISO technical specification, latest in the ISO 22000 series of standards for food safety management systems.

(ISO: Geneva) -- As vehicles become more complex, with new features like driver assistance systems or electronic-based functions, it is more important than ever to identify potential risks of software and hardware failures whose consequences could be fatal. For this purpose, the International Organization for Standardization (ISO) has published a new standard to ensure the functional safety of electrical and electronic systems in road vehicles.

(TÜV SÜD: Peabody, MA) -- TÜV SÜD America has added Certified Professional for Requirements Engineering (CPRE) examinations to its personal certification services in the Americas region through TÜV SÜD Examination Institute.

(ANSI: New York) -- The American National Standards Institute (ANSI) announces the availability of two key documents:
• 2012 edition, ANSI Essential Requirements: Due process requirements for American National Standards (ANSI Essential Requirements)

(ANSI: Washington, D.C.) -- The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, and the Interstate Renewable Energy Council (IREC) invite certificate-awarding entities that develop and administer energy efficiency and renewable energy programs to apply for participation in a pilot accreditation program. Successful participants will be awarded accreditation under a program designed to provide quality assurance to the programs.

(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA or FMECA… good tools? Yes. They are very good tools that can be utilized. Are they in and of themselves a risk management system? Absolutely not. I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA—that is not a risk management system.