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7.3 Design & Development Planning
7.3.1 D & D Planning - Continued
Key Explanation Points and Tips:
ÞA multi-disciplinary approach applies collective and relevant knowledge and skills of these different functions to carry out or review d & d activities
ÞThe d & d project plan serves as both a document and a record as it is updated for completion for various activities.
ÞWhere some or all of clause 7.3 d & d activities are done offsite, then you must show the linkages and interaction of these offsite activities with your on-site QMS processes (see clause 4.1).
ÞClause 7.3 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities (see clause 4.2.1d).
These documents may include - contracts; technical drawings and specifications; a documented plan for d & d; work instructions; a documented procedure; etc., combined with unwritten practices, procedures and methods.
ÞLook at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes). Many organizations use various software tools to document their product or process d & d plans.
ÞIf the nature of your business does not require you to design and develop product (e.g. you manufacture strictly from customer provided engineering drawings and specifications), then you must clearly state this exclusion to your QMS scope, in your quality manual.
ÞPerformance indicators (to measure the effectiveness of design and development processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving these processes and related use of resources. Indicators may include reduction in - design cycle time; development cycle time; specification errors, omissions; changes; d & d costs; etc., as well as measurable improvements in products developed.
7.3.2 D & D Inputs
Determine inputs to product requirements that include:
a)functional and performance requirements
b)applicable statutory and regulatory requirements
c)applicable information from previous similar designs
d)Other requirements essential for d & d
ÞReview the inputs for adequacy
ÞRequirements must be complete, unambiguous, and not in conflict with each other
Key Explanation Points and Tips:
ÞYou must identify, document and review design inputs requirements for function, performance, safety, regulatory, quality, reliability, durability, life, timing, maintainability, cost, identification, traceability, packaging, special or safety characteristics (from the customer or regulatory body), and other requirements essential to the product.
ÞYou must have a process (should be part of your d & d plan) to deploy (identify, document, review and use) design input information (documents) coming from various sources such as - customer contracts, drawings and specifications; your own organization’s database of previous d & d projects; competitor analysis; industry standards; feedback from suppliers; field data.
ÞD & D usually requires the input and involvement of many other functions and processes (e.g. contract review; product realization; purchasing, top management; etc.) within the organization and your process must manage this interaction by defining responsibilities and means of communications. Inclusion of these controls in your d & d plan is one of many effective ways to achieve this. Such a multi-disciplinary approach has the benefit of applying the collective and relevant knowledge and skills of these different functions to carry out or review d & d activities.
ÞYou must identify and include any special and safety characteristics in your process control documents such as - quality plans; product drawings; operator instructions and other documents used to make or verify product. Note that special requirements can also include process parameters such as temperature, timing, concentrations, etc.
ÞYou must review all input requirements; review d & d progress; verify product design and validate developed product at various stages of your d & d process. The nature, frequency and scope of these controls must be defined in your d & d plan or other document. You must carry out these controls according to your plan and keep appropriate records (see record requirements in clauses 7.3.4; 7.3.5; 7.3.6 and 7.3.7).
