Hello All So, What is the difference between Quality Assurance and Quality Control??? In this article I…

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8.3.3 Design and Development Inputs

Design inputs serve as the basis for product development. The inputs for design and development processes and activities must be determined in order to ensure their availability to those processes and activities.

Determine the Essential Requirements for Design and Development

The inputs serve as essential requirements necessary for the progress of design and development. Those requirements must all be defined as corresponding to the purposeof the product or service. The inputs should be determined according to the planned activities of the design and development processes and the intended use of the product. The main concept of defining one’s design and development inputs is simple: the inputs must relate to the product’s intended use, functional performance, and quality and regulatory requirements. Within the design and development of inputs requirements, the organization must refer to the issues that will be discussed in this chapter. The inputs may be derived from

• Development of prototypes
• Need to modify earlier developments
• Request for changes
• Problems or failures with earlier versions
• Failure to comply with the acceptability criteria
• New customer requirements
• An iterative development

Inputs Relevant to the Intended Use and Performance

The organization shall determine product requirements for performance, functionality,and intended use in order to allow the identification of all necessary design and development inputs. The objective here is to ensure that the product will acquire all its expected features and functionalities. The intended use of the product or service refers to its purpose, operation, and utilization and relates to user expectations. Intended use refers to information and outputs derived from market surveys or research, risk-based thinking outputs, customer requirements, and a review of requirements related to the product. The definition shall refer to situations where it is inadvisable to use the product or provide the service. Let us review some aspects of the functional and performance requirements:

• Physical characteristics of the product such as plans, sizes, dimensions, diagrams, drawings, samples, and prototypes. The definition shall refer to tolerances and limits.
• Requirements for handling and behavior with the product and specifications of aspects such as packaging, storage, labeling, operation, handling, and maintenance requirements; anything that might affect the quality of the product or its intended use must be reviewed during the development stages.
• Definition regarding the operating environment of the product or the environment in which the service shall be provided. If the product is to operate under a controlled temperature, the design and development activities must take that into consideration. This requirement is also valid when a software must be installed and there are technical specifications for installation.
• Interface with other products where the product is to be combined or installed with other products or pieces of equipment and/or accessories; this shall be referred to as inputs to design and development.
• Service requirement shall be taken into account. When it is already known that the product will require service activities in the long run, it will be reviewed in the design and development activities so that certain characteristics of the product may be planned appropriately.
• Compatibility of the product’s components shall be considered when the product is constructed or assembled from various components and materials; it is necessary to examine the materials used in order to ensure that the different components compete or match one another and the risk of contamination, error, or failure is prevented.
• The organization will specify any safety requirements that are needed to serve as inputs for the development and which may affect the design of the product and its characteristics and intended use.
• Appropriate considerations to the integration of environmental protection aspects shall be delivered as inputs to design and development as and when they are applicable.

8.3.5 Design and Development Outputs

The outputs of design and development shall demonstrate that the activities were carried out in accordance with the plan through a traceability to the design and development inputs. In other words, the outputs will allow adequate evaluation of conformance to design input requirements. Design and development outputs shall be documented, reviewed, and approved before release.

Definition of Design and Development Outputs

Design and development outputs are the results of design and development activities, and they represent the specifications for the product or the service:

• Characteristics of the product or service
• Specifications for the realization (manufacturing of a product or provision of a service)
• Monitoring and measuring activities to ensure conformity to the product or service
• Acceptance criteria for expected outputs of the realization activities

It must be clear to the design and development team which outputs are required, in which form and format, and what are the expected details. This definition of the outputs  shall assist in controlling all the expected outputs that were accepted after each design and development activity and will allow traceability to the inputs. In the next paragraphs, I will go into details.

Acceptance Criteria

One output of the design and development activities shall be the acceptance criteria for the product. The acceptance criteria are used as a basis for comparison or as a reference point against which the product can be compared, evaluated, and then released or rejected. A good example is the determination of quality specifications or characteristics of a product. These characteristics are to demonstrate the features of a product or a service such as measurements of the product, performance or functionality, and tolerances and limits. These acceptance criteria shall be used during the realization of the product in order to determine the quality of the product and eventually enable the release of the product. The acceptance criteria shall demonstrate traceability to the design and development inputs. For example, one of the inputs is customer expectations of the product— a specific feature. The acceptance criteria shall include an examination that this feature exists and answers the expectations.

Activities Necessary for the Realization of the Product or Service

One of the main purposes of the design and development outputs is to prescribe the necessary requirements and activities necessary for the realization of the product:

• To demonstrate how the organization’s QMS applies to the realization of the product
• To demonstrate how realization activities may meet customer specifications
• To demonstrate how realization activities may meet regulatory specifications
• To describe how resources shall be used during the realization processes including reference to responsibilities and authorities
• To describe the controls that shall be applied on the realization processes
• To describe how risks shall be addressed during the realization processes
• To describe which documented information shall be maintained during the realization processes: used documentation and expected records

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ISO 9001 – Design and Development Review

The ISO 9001 requires a method for reviewing the design and the development. The goal is to create a reporting method regarding the progress of the development according to the organization’s requirements, goals or schedules. The design and development review must deal with the next points:

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8.2.1 Customer Communication Communication with customers is considered to be one of the most common…

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