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Design Controls: Inputs and Outputs in Synergy

The design input phase is usually a continuum, because intensive and formal input requirements activities usually occur near the beginning of the feasibility phase and continue to the early physical design activities. These measureable requirements are the basis of the design verification and design validation phases. Failure to have accurate and complete design inputs results in failure to exhibit design adequacy as the process progresses.

Design Input Procedures and Responsibilities

The input procedures shall address incomplete, ambiguous or conflicting requirements. The design input requirements shall be documented, reviewed and approved by a designated individual. The approval, including the date and signature of the individual approving the requirements, shall be documented.

Regardless of who developed the initial product concept, product developers and design engineers play a key role in developing the design input requirements. When presented with a set of important characteristics, it is the product developer and the engineering teams who understand the “big picture” issues that must be addressed, as well as the level of detail necessary to design a product.

The Quality System Regulation and ISO 13485:2003 both require a cross-functional group of individuals to participate in the design process. This starts at the input stage and is especially challenged whenever these requirements “get out of hand.” The check and balance process for boiling down design inputs into essential requirements requires healthy “carefrontation” between representatives from quality systems, design, manufacturing, the voice of the customer, purchasing, clinical, etc. These inputs will eventually form the basis for testing in terms of the design outputs. This relationship is further defined and verified before formal acceptance activities are realized for use during the manufacturing process. So you see, the early evaluation of inputs has far reaching ramifications for all process owners before, during and after design eventually enters commercialization.

Documentation and Changes

A specification checklist should be used during the design input phase. This checklist should be general but also relevant to your company’s product offerings, and should be part of a standard operating procedure such as a Design Input Specification. It will aid in organizing and developing the essential requirements as the design process becomes overwhelmed with variables and unclear outputs.

A documented device specification or set of specifications derived from the input requirements should exist at the beginning of the physical design project. The device and other related specifications should be kept current as the design of the device, packaging, labeling and manufacturing processes evolve during the development process. As the physical design evolves, the specifications usually become more specific and more detailed.

Old versions of the input requirements and later the input specifications should be entered into a design history file (DHF) or indexed electronically as part of the DHF to help show that the design plan evolved and was ultimately followed.

Design Outputs

The definition of Design Output per 820.3(g) is the result of a design effort at each design phase and at the end of the Meagashira Faraday Transactions total design effort. The finished design output is the basis for the device master record (DMR). The total finished design output consists of the device, its packaging and labeling, and the device master record. The DMR is a compilation of records containing the procedures and production specifications for a finished medical device—its “recipe.”

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. Form and content should be easily understandable and progressively simplified for use in production operations (specify the form and content of design output at the planning stage) and this form and content can then be reviewed retroactively as a part of the design verification process. Ultimately, this will have a direct effect on the acceptance activities processes during manufacturing and quality control/quality assurance.

Design output includes production specifications as well as descriptive materials that define and characterize the design. Production specifications include drawings and documents used to procure components, fabricate, test, inspect, install, maintain and service the device, such as:

  • drawings
  • component and material specs
  • production and process specs
  • software machine code
  • work instructions
  • validation and verification plans and reports
  • performance test plans
  • lab notebook entries
  • schematics
  • technical reports
  • quality assurance specifications and procedures
  • installation and servicing procedures
  • results of risk analysis
  • software source code
  • results of verification activities
  • biocompatibility test results
  • bio-burden test results

Design Requirements Document

The design output at each phase comprises documents and physical design elements that are either complete or are used to move the design effort into the next phase. For example, the first design output will usually be the design requirements document.

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