Quality Systems - Aerospace - Model for Quality Assurance in Design, Development, Production, Installation and Servicing

IntroductionAccess to quality-assured medicines is an essential prerequisite for universal health coverage, and pharmaceutical distributors play an important role to assure the quality of medicines along the supply chain.MethodsWe retrospectively assessed the compliance with WHO quality standards, that is, the Model Quality Assurance System for Procurement Agencies (MQAS) or the good distribution practices (GDP), of a convenience sample of 75 public, private-for-profit and non-for-profit distributors, audited by QUAMED in 14 low-income and middle-income countries (LMICs) between 2017 and 2019. We calculated the compliance per quality assurance activity, and we defined the percentage of compliant distributors, that is, the percentage (%) of distributors with MQAS or GDP levels of >2 for each activity.ResultsThe distributors in our sample were mainly private for-profit (66/75). Only one MQAS-audited distributor out of 11 was found compliant with all MQAS-activities, while none out of 64 GDP-assessed distributors were found compliant with all GDP activities. The GDP-assessed distributors were generally less compliant with WHO standards than MQAS-audited distributors. Common weaknesses and strengths were observed. The activities with lowest compliance were quality control, and physical storage conditions, while those with highest compliance were warehouse organisation and stock control.ConclusionsThe quality systems of pharmaceutical distributors in LMICs remain weak. For preventing harm caused by poor-quality medicines, a comprehensive and stringent regulatory oversight should be urgently implemented; the WHO MQAS-standards and GDP-standards should be incorporated in national regulations; and reliable information on the quality systems of distributors (and manufacturers from which they buy) should be publicly available.

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Research and Design of Software Quality Control System Based on the CMMI System

Applied Mechanics and Materials ◽

10.4028/www.scientific.net/amm.241-244.2837 ◽

2012 ◽

Vol 241-244 ◽

pp. 2837-2840

Author(s):

Ying Lan Fang ◽

Bing Han ◽

Wei Fu Zhou

Keyword(s):

Quality Assurance ◽

Software Development ◽

Software Quality ◽

Process Management ◽

Design Development ◽

Information Industry ◽

New Ideas ◽

Development Methods ◽

Research And Design ◽

Correct Implementation

In recent years, the "software crisis" in the information industry which reflected the traditional software development methods had no longer met the current software quality assurance. In order to solve the outstanding problems, this paper continuous explores and in-depth studies CMMI system. It makes engineering idea apply to complex software development process management and quality assurance, uses new ideas and methods to achieve efficient control with multi-dimensional and multi-level heterogeneous characteristics model system for software engineering quality to ensure the correct implementation in the process throughout the organization. It provides reasonable technical support so as to achieve the improvement of software development efficiency and quality. Contrast to the popular defect management software, this system innovatively achieves multi-dimensional systematic management from requirements, design, development, defects, testing, evaluation and dissemination with a certain degree of practicality, feasibility and promotion.

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