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  2. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.

  3. Quality by design - Wikipedia

    en.wikipedia.org/wiki/Quality_by_design

    Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]

  4. Configuration management - Wikipedia

    en.wikipedia.org/wiki/Configuration_management

    Configuration Control: includes the evaluation of all change-requests and change-proposals, and their subsequent approval or disapproval. It covers the process of controlling modifications to the system's design, hardware, firmware, software, and documentation.

  5. Quality control - Wikipedia

    en.wikipedia.org/wiki/Quality_control

    Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]

  6. Quality management - Wikipedia

    en.wikipedia.org/wiki/Quality_management

    Quality management ensures that an organization, product, or service consistently functions as intended. It has four main components: quality planning, quality assurance, quality control, and quality improvement. [1] Customers recognize that quality is an important attribute when choosing and purchasing products and services.

  7. Advanced product quality planning - Wikipedia

    en.wikipedia.org/wiki/Advanced_product_quality...

    Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation but has similarities to Design for Six Sigma (DFSS).

  8. Production part approval process - Wikipedia

    en.wikipedia.org/wiki/Production_part_approval...

    Control Plan A copy of the Control Plan, reviewed and signed off by supplier and customer. The Control Plan follows the PFMEA steps, and provides more details on how the "potential issues" are checked in the incoming quality, assembly process or during inspections of finished products. Measurement System Analysis Studies

  9. Software quality control - Wikipedia

    en.wikipedia.org/wiki/Software_quality_control

    Software quality control is the set of procedures used by organizations [1] to ensure that a software product will meet its quality goals at the best value to the customer, [2] and to continually improve the organization’s ability to produce software products in the future. [1]