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To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used.
This guidance is intended to assist manufacturers in understanding the intent of the regulation. The Center publishes the results of its work in scientific journals and in its own technical reports.
Effective implementation of design controls requires that the regulation and its intent be well understood. Those persons in medical device companies charged with responsibility for developing, implementing, or applying design controls come from a wide variety of technical and non-technical backgrounds--engineering, business administration, life sciences, computer science, and the arts.
The response of medical device manufacturers and other interested parties to the March, 1996 draft version of this guidance has significantly influenced this latest version. It is noteworthy that many comments offered suggestions for improving the guidance, and that the authors of the comments often acknowledged the value of design controls and the potential benefit of good guidance to the medical device industry, the public, and the FDA. Finally, there are several people within CDRH that deserve recognition for their contributions to the development of this guidance. FDA would also like to acknowledge the significant contributions made by the Global Harmonization Task Force (GHTF) Study Group 3. FDA wishes to acknowledge the contributions of the Global Harmonization Task Force (GHTF) Study Group 3 to the development of this guidance. Among other efforts, the GHTF Study Group 3 started developing guidance on the application of design controls to medical devices in the spring of 1995. This guidance is intended to assist manufacturers in understanding quality system requirements concerning design controls. In practice, design controls provide managers and designers with improved visibility of the design process.
The medical device industry encompasses a wide range of technologies and applications, ranging from simple hand tools to complex computer-controlled surgical machines, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment.
When using this guidance, there could be a tendency to focus only on the time and effort required in developing and incorporating the controls into the design process. The guidance applies to the design of medical devices as well as the design of the associated manufacturing processes. Design controls are a component of a comprehensive quality system that covers the life of a device. The importance of the design input and verification of design outputs is illustrated by this example. As the figure illustrates, design validation encompasses verification and extends the assessment to address whether devices produced in accordance with the design actually satisfy user needs and intended uses. In a traditional waterfall development scenario, the engineering department completes the product design and formally transfers the design to production.
One benefit of concurrent engineering is the involvement of production and service personnel throughout the design process, assuring the mutual optimization of the characteristics of a device and its related processes.
Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a) (2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
The essential quality aspects and the regulatory requirements, such as safety, performance, and dependability of a product (whether hardware, software, services, or processed materials) are established during the design and development phase. The context within which product design is to be carried out should be set by the manufacturer's senior management. The quality system requirements do not dictate the types of design process that a manufacturer must use.
It is important to note that the design function may apply to various facets of the operation having differing styles and time scales. It is for senior management to ensure that adequate resources are available to carry out the design in the required time. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.
Design and development planning is needed to ensure that the design process is appropriately controlled and that device quality objectives are met. Planning enables management to exercise greater control over the design and development process by clearly communicating policies, procedures, and goals to members of the design and development team, and providing a basis for measuring conformance to quality system objectives. Design activities should be specified at the level of detail necessary for carrying out the design process. In summary, the form and organization of the planning documents are less important than their content. Tasks for all significant design activities, including verification and validation tasks, should be included in the design and development plan. For complex projects, rough estimates may be provided initially, with the details left for the responsible organizations to develop.
The relationships between tasks should be presented in such a way that they are easily understood.
The design and development plan may include a schedule showing starting and completion dates for each major task, project milestone, or key decision points. Unless a manufacturer has experience with the same type of device, the plan will initially be limited in scope and detail. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented. Many medical device manufacturers have experience with the adverse effects that incomplete requirements can have on the design process. By comparison, the experience of companies that have designed devices using clear-cut, comprehensive sets of requirements is that rework and redesign are significantly reduced and product quality is improved.
Unfortunately, there are a number of common misconceptions regarding the meaning and practical application of the quality system requirements for design input.
CONCEPT DOCUMENTS VERSUS DESIGN INPUT In some cases, the marketing staff, who maintain close contact with customers and users, determine a need for a new product, or enhancements to an existing product.
Some members of the medical device community view these marketing memoranda, or the equivalent, as the design input.
There are occasions when it may be appropriate to specify part of the design solution in the design input requirements. Functional requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs. Performance requirements specify how much or how well the device must perform, addressing issues such as speed, strength, response times, accuracy, limits of operation, etc.
Interface requirements specify characteristics of the device which are critical to compatibility with external systems; specifically, those characteristics which are mandated by external systems and outside the control of the developers. What is the scope of the design input requirements development process and how much detail must be provided? There are many cases when it is impractical to establish every functional and performance characteristic at the design input stage. For complex designs, it is not uncommon for the design input stage to consume as much as thirty percent of the total project time. The environment in which the product is intended to be used should be properly characterized.
When industry standards are cited, the citations should be reviewed for completeness and relevance. It is almost inevitable that verification activities will uncover discrepancies which result in changes to the design input requirements. The second point is that extensive rework of the design input requirements suggests that the design input requirements may not be elaborated to a suitable level of detail, or insufficient resources are being devoted to defining and reviewing the requirements.
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. The approval, including the date and signature of the individual(s) approving the output, shall be documented. 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. The first issue is important because the typical development project produces voluminous records, some of which may not be categorized as design output. Design output includes production specifications as well as descriptive materials which define and characterize the design. In addition, as discussed in Section H (Design Transfer), production specifications may take on other forms.
First, the manufacturer proactively can specify the form and content of design output at the planning stage.
Second, form and content can be reviewed retroactively as a part of the design verification process.
Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF). Each design document which constitutes the formal output, or deliverable, of a design task is normally subject to evaluation activities, sometimes referred to as informal peer review, supervisory review, or technical assessment. Developers may conduct routine or ad hoc meetings to discuss an issue, coordinate activities, or assess development progress.
Control of the design review process is achieved by developing and implementing a formal design review program consistent with quality system requirements. As discussed in Section C (Design Input), it is beneficial in almost every case to conduct a formal review of the design input requirements early in the development process. For a simple design, or a minor upgrade to an existing product, it might be appropriate to conduct a single review at the conclusion of the design process. For a product involving multiple subsystems, an early design task is to allocate the design input requirements among the various subsystems.
There are a number of approaches to conducting formal design reviews at the end of the design process. In some instances, components having long lead times may enter production prior to completion of the overall device design. A manufacturer will often employ one or more specialists to conduct certain types of specialized assessments which are beyond the capabilities of the designers. These difficulties can be avoided by stating the goals and ground rules for conducting the formal design review clearly at the outset.
In most cases, verification activities are completed prior to the design review, and the verification results are submitted to the reviewers along with the other design output to be reviewed.
Similarly, validation typically involves a variety of activities, including a determination that the appropriate verifications and reviews have been completed. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the Design History File.
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Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. We appreciate the many comments, suggestions for improvement, and encouragement we received from industry, interested parties, and the Global Harmonization Task Force (GHTF) Study Group 3. Through these reports, CDRH also provides assistance to industry and to the medical and healthcare professional communities in complying with the laws and regulations mandated by Congress. The Office of Compliance within CDRH is using several methods to assist manufacturers in developing this understanding. Therefore, it is important that a tool be provided that conveys the intent of the regulation using practical terminology and examples. Some comments even included examples of past experiences with the implementation of controls.
Al Taylor and Bill Midgette of the Office of Science and Technology led the development effort and served as co­chairs of the CDRH Design Control Guidance Team that reviewed the comments received last spring. The Study Group reviewed and revised this guidance at multiple stages during its development. As has been stated in the past, FDA is firmly committed to the international harmonization of standards and regulations governing medical devices. Study Group 3 has recognized FDA's need to publish timely guidance on this topic in conjunction with promulgation of its new Quality System Regulation.
Assistance is provided by interpreting the language of the quality systems requirements and explaining the underlying concepts in practical terms. With improved visibility, managers are empowered to more effectively direct the design process-that is, to recognize problems earlier, make corrections, and adjust resource allocations.
These devices are manufactured by companies varying in size and structure, methods of design and development, and methods of management. The guidance is applicable to new designs as well as modifications or improvements to existing device designs. The assurance process is a total systems approach that extends from the development of device requirements through design, production, distribution, use, maintenance, and eventually, obsolescence.
Design control applies to all changes to the device or manufacturing process design, including those occurring long after a device has been introduced to the market.
Although aspects of their utility are sometimes described, they are included in the guidance for illustrative purposes only.
The simple example shown in Figure 1 illustrates the influence of design controls on a design process. When the design input has been reviewed and the design input requirements are determined to be acceptable, an iterative process of translating those requirements into a device design begins.
Although the waterfall model is a useful tool for introducing design controls, its usefulness in practice is limited. Subsequently, other departments or organizations develop processes to manufacture and service the product.
While the primary motivations of concurrent engineering are shorter development time and reduced production cost, the practical result is often improved product quality. From a design control standpoint, it is sufficient to note that concurrent engineering may blur the line between development and production.
Risk management is the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk. In addition to procedures and work instructions necessary for the implementation of design controls, policies and procedures may also be needed for other determinants of device quality that should be considered during the design process. It is their responsibility to establish a design and development plan which sets the targets to be met.


Such facets are related to products, including services and software, as well as to their manufacturing processes.
The extent of design and development planning is dependent on the size of the developing organization and the size and complexity of the product to be developed. The management responsibility section of the quality system requirements requires management to establish a quality policy and implement an organizational structure to ensure quality. For example, if clinical trials are anticipated, there may be tasks associated with appropriate regulatory requirements. As development proceeds, the plan should evolve to incorporate more and better information. It should be clear which tasks depend on others, and which tasks need to be performed concurrently. The method chosen and the detail will vary depending on the complexity of the project and the level of risk associated with the device. At all times, the plan should be specified at a level of detail enabling management to make informed decisions, and provide confidence in meeting overall schedule and performance objectives.
There is inherent conflict between the desire to maximize performance and the need to meet business objectives, including development deadlines.
The requirements which form the design input establish a basis for performing subsequent design tasks and validating the design. They know that the development of requirements for a medical device of even moderate complexity is a formidable, time-consuming task.
Many seem to arise from interpreting the requirements as a literal prescription, rather than a set of principles to be followed. Alternatively, the idea for a new product may evolve out of a research or clinical activity.
Some manufacturers have difficulty in determining where research ends and development begins. Regardless of who developed the initial product concept, product developers play a key role in developing the design input requirements.
Effective development of design input requirements encompasses input from both the product developer as well as those representing the needs of the user, such as marketing. Product developers make incorrect assumptions about user needs, and marketing personnel make incorrect assumptions about the needs of the product designers. A basic principle is that design input requirements should specify what the design is intended to do while carefully avoiding specific design solutions at this stage. For example, a manufacturer may want to share components or manufacturing processes across a family of products in order to realize economies of scale, or simply to help establish a corporate identity. This includes a quantitative characterization of the use environment, including, for example, temperature, humidity, shock, vibration, and electromagnetic compatibility.
The scope is dependent upon the complexity of a device and the risk associated with its use.
But in most cases, the form of the requirement can be determined, and the requirement can be stated with a to-be-determined (TBD) numerical value or a range of possible values. Unfortunately, some managers and developers have been trained to measure design progress in terms of hardware built, or lines of software code written. For example, many new devices are simply replacement parts for a product, or are kits of commodity items. As discussed in Section E (Design Review), it is important for the review team to be multidisciplinary and to have the appropriate authority.
That is, each requirement should be able to be verified by an objective method of analysis, inspection, or testing. It is not unusual for requirements to conflict with one another or with a referenced industry standard due to a simple oversight. For example, one medical device manufacturer claimed compliance with an industry standard covering mechanical shock and vibration.
For example, some manufacturers produce assembly instructions on videotapes rather than written instructions.
Other design output items might be produced which are necessary to establish conformance to design input requirements, but are not used in its production.
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. For some types of design output, form and content may be codified in a consensus standard which can be referenced.
For example, the verification of design output could include assessing whether specified documentation standards have been adhered to.
These activities, while they may be called reviews, are often better described as verification activities, because they are not intended to be comprehensive, definitive, and multidisciplinary in their scope. Decisions from such meetings may not require formal documentation; however, if a significant issue is resolved, this should be documented.
The following issues should be addressed and documented in the design and development plan(s).
It is a well-accepted fact that the cost to correct design errors increases as the design nears completion, and the flexibility to implement an optimal solution decreases.
For example, in a microprocessor-based system, designers must decide which functions will be performed by hardware and which by software. For example, engineering sketches may be developed for prototyping purposes prior to development of production drawings.
In some organizations, engineering essentially completes the design, tests an engineering prototype, and conducts a formal design review prior to turning the design over to manufacturing. What is important is that the manufacturer establish a reasonable rationale for the number and type of reviews, based on sound judgment. In determining who should participate in a formal design review, planners should consider the qualifications of reviewers, the types of expertise required to make an adequate assessment, and the independence of the reviewers.
Formal design reviews should be conducted by person(s) having technical competence and experience at least comparable to the developers. For example, a mechanical engineer may be retained to perform a structural analysis of a design, and perhaps conduct vibration testing to verify its performance under stress.
Many medical device designs involve a number of technologies, such as electronics, mechanics, software, materials science, or pneumatics. The formal design review should include at least one individual who does not have direct responsibility for the design stage under review. In simple cases, the technical assessor and reviewer may be the same person, often a project manager or engineering supervisor, and the review meeting is a simple affair in the manager's office. The reputation of the designers tends to be linked to the number of discrepancies found, causing the designers to become defensive, while the reviewers score points by finding weaknesses in the design. While the designers are in the best position to explain the best features of the design, they are also most likely to be aware of the design's weaknesses. For extremely simple designs or design changes, it may be appropriate to specify a procedure in which review materials are distributed or circulated among the reviewers for independent assessment and approval. The reviewers consider concerns raised during the evaluation portion of the formal design review and decide on an appropriate disposition for each one. Therefore, review procedures should include a process for resolving differences, and provide reviewers with enough leeway to make practical decisions while protecting the integrity of the process. In practice, design review, verification, and validation overlap one another, and the relationship among them may be confusing.
Alternatively, some verification activities may be treated as components of the design review, particularly if the verification activity is complex and requires multidisciplinary review. Thus, at the conclusion of the validation effort, a review is usually warranted to assure that the validation is complete and adequate.
Despite the fact, there are still many farmers in Central Visayas aspired to grow cacao trees. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.
This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples. The comments were systematically reviewed, and revisions made in response to those comments and suggestions are incorporated in this version. These reports are sold by the Government Printing Office (GPO) and by the National Technical Information Service (NTIS).
Methods include the use of presentations, teleconferences, practice audits, and written guidance. Therefore, it has been rewritten to be more pragmatic, focusing on principles rather than specific practices. Team members included Ashley Boulware, Bob Cangelosi, Andrew Lowrey, Deborah Lumbardo, Jack McCracken, Greg O'Connell, and Walter Scott. It is hoped that this cooperative effort will lead to this guidance being accepted as an internationally recognized guidance document through the GHTF later this year.
The Study Group has therefore devoted considerable time and effort to combine its draft document with the FDA's efforts as well as to review and comment on FDA's subsequent revisions. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process. Designers benefit both by enhanced understanding of the degree of conformance of a design to user and patient needs, and by improved communications and coordination among all participants in the process.
It is a well-established fact that the cost to correct design errors is lower when errors are detected early in the design and development process. Design control begins with development and approval of design inputs, and includes the design of a device and the associated manufacturing processes. This includes evolutionary changes such as performance enhancements as well as revolutionary changes such as corrective actions resulting from the analysis of failed product. Basically, requirements are developed, and a device is designed to meet those requirements.
In this manner, the design input requirements are translated into a device design conforming to those requirements. For example, a review is conducted to assure that the design input requirements are adequate before they are converted into the design specifications. This requirement might be expressed as the number of miles-per-gallon of a particular grade of gasoline for a specified set of driving conditions. Historically, there has frequently been a divergence between the intent of the designer and the reality of the factory floor, resulting in such undesirable outcomes as low manufacturing yields, rework or redesign of the product, or unexpectedly high cost to service the product.
On the one hand, the concurrent engineering model properly emphasizes that the development of production processes is a design rather than a manufacturing activity.
It is intended to be a framework within which experience, insight, and judgment are applied to successfully manage risk. To systematically identify and, when necessary, reduce these risks, the risk management process is integrated into the design process.
Late in the development process, risk analysis of the system uncovered several failure modes that could result in overexposure to the patient. The need for policies and procedures for these factors is dependent upon the types of devices manufactured by a company and the risks associated with their use.
However, whatever the processes may be, it is important that the design controls are applied in an appropriate manner.
Some manufacturers may have documented policies and procedures which apply to all design and development activities.
Planning should reflect the degree of perceived development risk; for example, tasks involving new technology or processes should be spelled out in greater detail, and perhaps be subjected to more reviews and checks, than tasks which are perceived as routine or straightforward.
For small projects, the plan may consist of only a simple flow diagram or computer spreadsheet.
Lack of experience in planning often leads to optimistic schedules, but slippage may also occur for reasons beyond the control of planners, for example, personnel turnover, materiel shortage, or unexpected problems with a design element or process.
This is important because scheduling pressures have historically been a contributing factor in many design defects which caused injury.
Therefore, development of a solid foundation of requirements is the single most important design control activity. They accept the investment in time and resources required to develop the requirements because they know the advantages to be gained in the long run. In this guidance document, the focus is on explaining the principles and providing examples of how they may be applied in typical situations. In any case, the result is a concept document specifying some of the desired characteristics of the new product.
Research activities may be undertaken in an effort to determine new business opportunities or basic characteristics for a new product.
When presented with a set of important characteristics, it is the product developers who understand the auxiliary issues that must be addressed, as well as the level of detail necessary to design a product. Incorrect assumptions can have serious consequences that may not be detected until late in the development process. For example, a concept document might dictate that the product be housed in a machined aluminum case.
Failure to understand the abuse to which a portable instrument would be subjected might result in the selection of housing materials inadequate for the intended use of the product. In the case of a product upgrade, there may be clear consensus regarding the features to be retained. This may be quite difficult for manufacturers who are implementing a system of design controls for the first time. For most medical devices, numerous requirements encompassing functions, performance, safety, and regulatory concerns are implied by the application.
This makes it possible for reviewers to assess whether the requirements completely characterize the intended use of the device, judge the impact of omissions, and track incomplete requirements to ensure resolution. They fail to realize that building a solid foundation saves time during the implementation. Typically, only the packaging and labeling distinguishes these products from existing products. For example, it is insufficient to state that a catheter must be able to withstand repeated flexing. Yet, even within a single country, relative humidity in a home may range from 20 percent to 100 percent (condensing) due to climactic and seasonal variations. When this occurs, the design input requirements at each stage should be developed and reviewed following the principles set forth in this section.
One is that the change control process for design input requirements must be carefully managed.
From a design control perspective, the number of requirements changes made is less important than the thoroughness of the change control process.
The total finished design output consists of the device, its packaging and labeling, and the device master record.
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. Similarly, a program diskette, used by a computer-aided milling machine to fabricate a part, would be considered a production specification. 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. 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.
The internal focus is on the feasibility of the design and the produceability of the design with respect to manufacturing and support capabilities.
Next, the main function of the reviews may be to evaluate or confirm the choice of solutions being offered by the design team. The following exceptions may help to clarify the distinguishing characteristics of design reviews.
If the outcome results in change to an approved design document, then applicable change control procedures should be followed, as discussed in Section I (Design Changes).
When an error is discovered at the end of the development cycle, difficult decisions have to be made regarding an acceptable corrective action. In another case, tolerance buildup from several components may combine to create a clearance problem.
In such cases, an additional review will be needed after the design has been validated using production devices. The manufacturer runs the business risk that the design review at the end of the design process will uncover a defect that must be corrected in production devices before any devices are distributed.


For a small manufacturer, this may require that an outside consultant be retained to participate in the evaluation of the design. At this meeting, the designer(s) may make presentations to explain the design implementation, and persons responsible for verification activities may present their findings to the reviewers.
For more elaborate reviews, detailed written procedures are desirable to ensure that all pertinent topics are discussed, conclusions accurately recorded, and action items documented and tracked. If the designers and reviewers are encouraged to work together to systematically explore problems and find solutions, the resultant design will be improved and all parties will benefit from the process. However, such a procedure negates the benefits of synergy and teamwork, and should be considered only in cases where the design issues are limited in scope and well defined. As experience is gained with the guidance, FDA will consider the need for additional revisions within the next six to eighteen months. As the lead person within CDRH with responsibility for implementing the Quality System Regulation, Kim Trautman reviewed the guidance and coordinated its development with the many other concurrent and related activities. FDA, for its part, delayed final release of its guidance pending final review by the Study Group.
Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.
Given this diversity, this guidance does not suggest particular methods of implementation, and therefore, must not be used to assess compliance with the quality system requirements. Large and small companies that have achieved quality systems certification under ISO 9001 cite improvements in productivity, product quality, customer satisfaction, and company competitiveness. There may be alternative ways that are better suited to a particular manufacturer and design activity. Another is used to assure that the device design is adequate before prototypes are produced for simulated use testing and clinical evaluation.
As the design of the car proceeds, the requirements, including the one for fuel efficiency, are converted into the many layers of system and subsystem specifications needed for design. However, for more complex devices, a concurrent engineering model is more representative of the design processes in use in the industry.
On the other hand, various components of a design may enter production before the design as a whole has been approved. In this way, unacceptable risks can be identified and managed earlier in the design process when changes are easier to make and less costly.
Because the problem was not identified until the design was near completion, an expensive, independent, back-up timer had to be added to monitor exposure times. Management with executive responsibility has the responsibility for determining what is needed. This guidance document contains examples of how this might be achieved in a variety of situations. For each specific development program, such manufacturers may also prepare a plan which spells out the project-dependent elements in detail, and incorporates the general policies and procedures by reference. In some cases, however, the design and development plan, rather than the quality manual, is the best vehicle for describing organizational responsibilities relative to design and development activities. For larger projects, there are a number of project management tools that are used to develop plans.
Sometimes the schedule can be compressed by using additional resources, such as diverting staff or equipment from another project, hiring a contractor, or leasing equipment.
To the extent that good planning can prevent schedule pressures, the potential for design errors is reduced.
Rather, the intent of the quality system requirements is that the product conceptual description be elaborated, expanded, and transformed into a complete set of design input requirements which are written to an engineering level of detail. It may be reasonable to develop a rapid prototype to explore the feasibility of an idea or design approach, for example, prior to developing design input requirements. Therefore, both product developers and those representing the user must take responsibility for critically examining proposed requirements, exploring stated and implied assumptions, and uncovering problems. It would be prudent for product developers to explore why this type of housing was specified. However, it is important to realize that every such design constraint reduces implementation flexibility and should therefore be documented and identified as a possible conflicting requirement for subsequent resolution. These implied requirements should be explicitly stated, in engineering terms, in the design input requirements. The operator and service manuals may contain more detailed specifications and performance limits, but these also fall short of being comprehensive. Part of the solution is to structure the requirements documents and reviews such that tangible measures of progress are provided.
In such cases, there is no need to recreate the detailed design input requirements of the item.
All future changes will be subject to the change control procedures, as discussed in Section I (Design Changes). A better requirement would state that the catheter should be formed into a 50 mm diameter coil and straightened out for a total of fifty times with no evidence of cracking or deformity. It was incumbent on the manufacturer in this case to specify appropriate performance limits for the device being tested, as well as the test method.
Fortunately, the initial set of requirements, covering the overall product, is by far the most difficult to develop. Often, a design change to correct one problem may create a new problem which must be addressed.
Examples include block diagrams, flow charts, software high-level code, and system or subsystem design specifications.
The videotape and the software on the program diskette are part of the device master record.
It is a part of the design output because it establishes the basis for the machine tool program used to fabricate the part. The external focus is on the user requirements; that is, the device design is viewed from the perspective of the user. Then, issues such as the choice of materials and the methods of manufacture become more important.
Verification activities affect and add to the design output, and are themselves subject to subsequent design review.
When that corrective action is implemented in haste, the result is often an unintended consequence leading to a new problem.
System designers must establish tolerance specifications for each component to meet the overall dimensional specification. Similarly, software development commonly includes a high-level design phase, during which requirements are elaborated to a greater level of detail and algorithms are developed to implement key functions. Alternatively, they may be assigned to make an independent assessment and submit observations and recommendations to the reviewers.
Manufacturers should carefully consider which interests should be represented at formal design reviews.
Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Reviewers may ask for clarification or additional information on any topic, and add their concerns to any raised by the presenters.
An added complication is the presence of invited guests, often clinicians, who are expected to provide the user perspective.
Participants must be encouraged to ask questions, avoid making assumptions, and think critically. In some cases, the reviewers play an advisory role to the engineering manager or other company official, who directs the formal design review and ultimately selects a course of action. In most cases, however, resolution involves a design change, a requirements change, or a combination of the two. As a result, it is hoped that this document, with some minor editorial revisions to make the guidance global to several regulatory schemes, will be recognized through the GHTF as an international guidance document. Rather, the intent is to expand upon the distilled language of the quality system requirements with practical explanations and examples of design control principles.
In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development.
Upon verification that the high-level specifications conform to the design input requirements, they become the design input for the next step in the design process, and so on. As these various systems and subsystems are designed, design verification methods are used to establish conformance of each design to its own specifications. Thus, concurrent engineering and other more complex models of development usually require a comprehensive matrix of reviews and approvals to ensure that each component and process design is validated prior to entering production, and the product as a whole is validated prior to design release.
Other manufacturers may develop a comprehensive design and development plan which is specifically tailored to each individual project. The importance of defining responsibilities with clarity and without ambiguity should be recognized. Three of the most commonly used are the Program Evaluation and Review Technique (PERT), the Critical Path Method (CPM), and the Gantt chart. With awareness, decisions are more likely to be made with appropriate oversight and consideration of all relevant factors. But manufacturers should avoid falling into the trap of equating the prototype design with a finished product design.
While this is primarily an engineering function, the support or full participation of production and service personnel, key suppliers, etc., may be required to assure that the design input requirements are complete. Medical terminology is appropriate in requirements when the developers and reviewers are familiar with the language, but it is often preferable to translate the concepts into engineering terms at the requirements stage to minimize miscommunication with the development staff. Perhaps there is a valid reason-superior electrical shielding, mechanical strength, or reduced time to market as compared to a cast housing. Some insight as to what is necessary is provided by examining the requirements for a very common external interface. It is acceptable to simply cite the predecessor product documentation, add any new product information, and establish the unique packaging and labeling requirements. A qualified reviewer could then make a judgment whether this specified test method is representative of the conditions of use. Altitudes may exceed 3,000 m, and the resultant low atmospheric pressure may adversely affect some kinds of medical equipment.
As the design proceeds, the output from the early stages forms the basis for the subsequent stages, and the information available to designers is inherently more extensive and detailed. Throughout the development process, it is important that any changes are documented and communicated to developers so that the total impact of the change can be determined. During the final stages, issues related to the verification, validation, and production may predominate.
In cases like these, a formal design review is a prudent step to ensure that all such system-level requirements have been allocated satisfactorily prior to engaging in detailed design of each subsystem. A formal design review would typically be conducted to review this work prior to beginning detailed coding. Thus, reviewers will often be from the same organization as the developers, but they should not have been significantly involved in the activities under review. These reviewers are often very reluctant to ask probing questions, especially if they sense that they may become involved in a conflict where all the rules and relationships are not evident. In other cases, the reviewers are given limited or broad authority to make decisions and commit resources to resolve problems. If the solution is evident, the reviewers may specify the appropriate corrective action; otherwise, an action item will be assigned to study the problem further.
Armed with this basic knowledge, manufacturers can and should seek out technology-specific guidance on applying design controls to their particular situation. Such topics as project management, design review, process capability, and many others referred to in this guidance are available in textbooks, periodicals, and journals.
However, this detail has been omitted from the figure to make the influence of the design controls on the design process more distinct. Generally, they are used to provide assurance that an activity or phase has been completed in an acceptable manner, and that the next activity or phase can begin. Because several specifications directly affect fuel efficiency, many of the verification activities help to provide confirmation that the overall design will meet the fuel efficiency requirement. When input to the design is from a variety of sources, their interrelationships and interfaces (as well as the pertinent responsibilities and authorities) should be defined, documented, coordinated, and controlled.
Thus, a concept document may be the starting point for development, but it is not the design input requirement.
Prototypes at this stage lack safety features and ancillary functions necessary for a finished product, and are developed under conditions which preclude adequate consideration of product variability due to manufacturing. Or perhaps machined aluminum was specified because a competitor's product is made that way, or simply because the user didn't think plastic would be strong enough. For the power requirements for AC-powered equipment, it is not sufficient to simply say that a unit shall be AC-powered.
If environmental conditions are fully specified, a qualified reviewer can make a determination of whether the specified conditions are representative of the intended use. A corollary is that planners should presume that problems will be detected, and allocate a reasonable amount of time to implement corrective actions. For example, the marketing department of a small manufacturer shared a new design with several surgeons on their advisory board. As discussed in the following section, the formal design review procedures play a large role in assuring independent and objective reviews.
In any case, action items and corrective actions are normally tracked under the manufacturer's change control procedures. As a manufacturer applies design controls to a particular task, the appropriate tools and techniques used by competent personnel should be applied to meet the needs of the unique product or process for that manufacturer. This might be the case, for example, if a multidisciplinary product development team is assembled for a specific project, or if the team includes suppliers, contract manufacturers, users, outside consultants, or independent auditors. When selecting these tools, be careful to choose one that best fits the needs of the project. This is a key principle-the design input requirements are the result of the first stage of the design control process. It is better to say that the unit shall be operable from AC power in North America, Europe, and Japan, but that is still insufficient detail to implement or validate the design. Typically, formal reviews are conducted at the end of each phase and at important milestones in the design process.
I am into the preparation of self study guide for PP module for the freshers in my company. This is establishing by objective evidence that the design output conforms to the fuel efficiency requirement. If one considers the situation just in North America, where the line voltage is typically 120 volts, many systems are specified to operate over the range of 108 to 132 volts. Subsequently, the manufacturer invited two experienced operating room nurses to participate in the final design review. However, to account for the possibility of brownout, critical devices may be specified to operate from 95 to 132 volts or even wider ranges.
During the course of the review, it became apparent that while surgeons may be the customers, nurses are the primary users of the device, and no one up to that point had consulted with any nurses. The design may be validated when a representative sample of users have driven production vehicles under a specified range of driving conditions and judged the fuel efficiency to be adequate. Based on the intended use of the device, the manufacturer must choose appropriate performance limits. Thank You Emil says: November 15, 2012 at 11:28 am Where I can get good training in SAP PP module in India ?
This is providing objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. After some further market survey, the manufacturer decided to make changes to the design to accommodate these concerns. It was unfortunate (and expensive) in this case that the user requirements were not considered until late in the development cycle, but the design review was ultimately very successful.



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