Posted on January 26, 2012. Filed under: Uncategorized |

§ 820.30(d) Design output.
  • Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.
  • Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
  • Design output shall be documented, reviewed, and approved before release.
  • The approval, including the date and signature of the individual(s) approving the output, shall be documented.
Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.5 Design output.
§ 820.3(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
§ 820.3(y) Specification means any requirement with which a product, process, service, or other activity must conform.
The quality system requirements for design output can be separated into two elements: Design output should be expressed in terms that allow adequate assessment of conformance to design input requirements and should identify the characteristics of the design that are crucial to the safety and proper functioning of the device. This raises two fundamental issues for developers:
  • What constitutes design output?
  • Are the form and content of the design output suitable?
The first issue is important because the typical development project produces voluminous records, some of which may not be categorized as design output. On the other hand, design output must be reasonably comprehensive to be effective. As a general rule, an item is design output if it is a work product, or deliverable item, of a design task listed in the design and development plan, and the item defines, describes, or elaborates an element of the design implementation. Examples include block diagrams, flow charts, software high-level code, and system or subsystem design specifications. The design output in one stage is often part of the design input in subsequent stages.
Design output includes production specifications as well as descriptive materials which define and characterize the design.
PRODUCTION SPECIFICATIONS. Production specifications include drawings and documents used to procure components, fabricate, test, inspect, install, maintain, and service the device, such as the following:
  • assembly drawings
  • component and material specifications
  • production and process specifications
  • software machine code (e.g., diskette or master EPROM)
  • work instructions
  • quality assurance specifications and procedures
  • installation and servicing procedures
  • packaging and labeling specifications, including methods and processes used
In addition, as discussed in Section H (Design Transfer), production specifications may take on other forms. For example, some manufacturers produce assembly instructions on videotapes rather than written instructions. Similarly, a program diskette, used by a computer-aided milling machine to fabricate a part, would be considered a production specification. The videotape and the software on the program diskette are part of the device master record.
OTHER DESCRIPTIVE MATERIALS. Other design output items might be produced which are necessary to establish conformance to design input requirements, but are not used in its production. For example, for each part which is fabricated by computer-aided machine, there should be an assembly drawing which specifies the dimensions and characteristics of the part. It is a part of the design output because it establishes the basis for the machine tool program used to fabricate the part. Other examples of design output include the following:
  • the results of risk analysis
  • software source code
  • results of verification activities
  • biocompatibility test results
  • bioburden test results
FORM AND CONTENT. Manufacturers must take steps to assure that the design output characterizes all important aspects of the design and is expressed in terms which allow adequate verification and validation. Two basic mechanisms are available to manufacturers to accomplish these objectives.
  • First, the manufacturer proactively can specify the form and content of design output at the planning stage. For some types of design output, form and content may be codified in a consensus standard which can be referenced. In other cases, a manufacturer could specify the desired characteristics, or even simply specify that the form and content of an existing document be followed.
  • Second, form and content can be reviewed retroactively as a part of the design verification process. For example, the verification of design output could include assessing whether specified documentation standards have been adhered to.
As these examples illustrate, conformance with the quality system requirements concerning design output generally requires no “extra” effort on the part of the manufacturer, but simply the application of some common sense procedures during the planning, execution, and review of design tasks.

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