Design Control Guidance - Food and Drug Administration

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• The environment in which the product is intended to be used should be properlycharacterized. For example, manufacturers frequently make the mistake ofspecifying “laboratory” conditions for devices which are intended for use in thehome. Yet, even within a single country, relative humidity in a home may rangefrom 20 percent to 100 percent (condensing) due to climactic and seasonalvariations. Household temperatures in many climates routinely exceed 40 °Cduring the hot season. Altitudes may exceed 3,000 m, and the resultant lowatmospheric pressure may adversely affect some kinds of medical equipment. Ifenvironmental conditions are fully specified, a qualified reviewer can make adetermination of whether the specified conditions are representative of theintended use.• When industry standards are cited, the citations should be reviewed forcompleteness and relevance. For example, one medical device manufacturerclaimed compliance with an industry standard covering mechanical shock andvibration. However, when the referenced standard was examined by a reviewer, itwas found to prescribe only the method of testing, omitting any mention ofpass/fail criteria. It was incumbent on the manufacturer in this case to specifyappropriate performance limits for the device being tested, as well as the testmethod.EVOLUTION OF THE DESIGN INPUT REQUIREMENTS. Large developmentprojects often are implemented in stages. When this occurs, the design input requirementsat each stage should be developed and reviewed following the principles set forth in thissection. Fortunately, the initial set of requirements, covering the overall product, is by farthe most difficult to develop. As the design proceeds, the output from the early stagesforms the basis for the subsequent stages, and the information available to designers isinherently more extensive and detailed.It is almost inevitable that verification activities will uncover discrepancies which result inchanges to the design input requirements. There are two points to be made about this.One is that the change control process for design input requirements must be carefullymanaged. Often, a design change to correct one problem may create a new problemwhich must be addressed. Throughout the development process, it is important that anychanges are documented and communicated to developers so that the total impact of thechange can be determined. The change control process is crucial to device quality.The second point is that extensive rework of the design input requirements suggests thatthe design input requirements may not be elaborated to a suitable level of detail, orinsufficient resources are being devoted to defining and reviewing the requirements.Managers can use this insight to improve the design control process. From a designcontrol perspective, the number of requirements changes made is less important than thethoroughness of the change control process.Section C. Design Input 3/11/97 Page 18
SECTION D. DESIGN OUTPUTI. REQUIREMENTS§ 820.30(d) Design output.• Each manufacturer shall establish and maintain procedures for defining anddocumenting design output in terms that allow an adequate evaluation ofconformance to design input requirements.• Design output procedures shall contain or make reference to acceptance criteriaand shall ensure that those design outputs that are essential for the properfunctioning 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 theoutput, shall be documented.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.5 Design output.II. DEFINITIONS§ 820.3(g) Design output means the results of a design effort at each design phase and atthe end of the total design effort. The finished design output is the basis for the devicemaster record. The total finished design output consists of the device, its packaging andlabeling, and the device master record.§ 820.3(y) Specification means any requirement with which a product, process, service,or other activity must conform.III. DISCUSSION AND POINTS TO CONSIDERThe quality system requirements for design output can be separated into two elements:Design output should be expressed in terms that allow adequate assessment ofconformance to design input requirements and should identify the characteristics of thedesign that are crucial to the safety and proper functioning of the device. This raises twofundamental 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 voluminousrecords, 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, anitem is design output if it is a work product, or deliverable item, of a design task listed inSection D. Design Output 3/11/97 Page 19
Page 1: Center for Devices and Radiological
Page 5 and 6: PREFACEEffective implementation of
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Page 10 and 11: are described in comments received
Page 12 and 13: The importance of the design input
Page 14 and 15: patient. Because the problem was no
Page 16 and 17: III. DISCUSSION AND POINTS TO CONSI
Page 18 and 19: design and development team, and pr
Page 20 and 21: more likely to be made with appropr
Page 22 and 23: Unfortunately, there are a number o
Page 24 and 25: SCOPE AND LEVEL OF DETAIL. Design i
Page 28 and 29: the design and development plan, an
Page 30 and 31: Section D. Design Output 3/11/97 Pa
Page 32 and 33: capabilities. The external focus is
Page 34 and 35: Qualifications. Formal design revie
Page 36 and 37: action. In other cases, the reviewe
Page 38 and 39: manufacturers are encouraged to use
Page 40 and 41: Another self-documenting verificati
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Page 46 and 47: Historically, shortcomings in the p
Page 48 and 49: DOCUMENT CONTROL. The features of a
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Page 52 and 53: software in each machine. The contr

Design Control Guidance - Food and Drug Administration

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