ISO 9001-Clause 7.3 Design and development
ISO 9001-Clause 7.3.1 Design and development planning
ISO 9001 Requirement
The organization shall plan and control the design and development of product.
During the design and development planning, the organization shall determine
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be updated, as appropriate, as the design and development progresses.
NOTE Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization.
You must include product design and development in your QMS scope if you contract or convey the perception that you design product, regardless whether you buy, outsource or actually do design and development. The scope of your design and development activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage and protection during internal processing and delivery to the customer. Product design and development sometimes results in new manufacturing processes or changes to existing manufacturing processes. This clause is equally applicable for designing and developing manufacturing processes. Product design and development planning must focus on error prevention rather than detection in product quality as well as product realization processes.
You must have an overall plan for your design project. Your plan must specify the design and development stages, activities and tasks, responsibilities, timeline and resources, specific tests, validations, and reviews, and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. The degree and details of planning may vary according to size and length of contract or project, complexity, risk, product life, customer and regulatory requirements, past experience with similar product, etc. You have flexibility in determining the scope of the stages, review, verification and validation required for your product design and development projects.
Your plan must be dynamic and updated as requirements and circumstances change. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses. Your design and development plan must include methods to communicate information, responsibilities, results, discussions, reviews and resources. You must take a multi-disciplinary approach that includes as needed, other functions (besides design) such as quality, engineering, purchasing, sales, tooling, production, etc. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress.
A multi-disciplinary approach applies collective and relevant knowledge and skills of these different functions to carry out or review design and development activities. The design and development project plan serves as both a document and a record as it is updated for completion for various activities. Where some or all of clause 7.3 design and development activities are done offsite, then you must show the linkages and interaction of these offsite activities with your on-site QMS processes.
You must identify and document all processes addressing this clause as part of your. For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities These documents may include contracts, technical drawings and specifications, a documented plan for design and development, work instructions, a documented procedure etc., combined with unwritten practices, procedures and methods. Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have . Many organizations use various software tools to document their product or process design and development plans. If 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. Performance 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, design and development costs etc., as well as measurable improvements in products developed.
ISO 9001-Clause 7.3.2 Design and development inputs
ISO 9001 Requirement
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,and
d) other requirements essential for design and development.
The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
You 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. You must have a process that should be part of your design and development plan to identify, document, review , deploy and use design input information such as documents coming from various sources such as customer contracts, drawings and specifications, your own organization’s database of previous design and development projects, competitor analysis, industry standards, feedback from suppliers, field data.
Design and Development usually requires the input and involvement of many other functions and processes such as 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 design and development 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 design and development activities.
You 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. You must review all input requirements, review design and development progress, verify product design and validate developed product at various stages of your design and development process. The nature, frequency and scope of these controls must be defined in your design and development plan or other document. You must carry out these controls according to your plan and keep appropriate records .
ISO 9001-Clause 7.3.3 Design and development outputs
ISO 9001 Requirement
The outputs of design and development shall be in a form suitable for verification against the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
NOTE Information for production and service provision can include details for the preservation of product.
Design and development output may be product or documentation or both. Product may be prototype or finished product and documentation could be a computerized or hardcopy drawing or specification. Check design and development output against the input requirements specified in 7.3.2, before you use it any further. Provide appropriate design and development output information to:
- Purchasing material or service specifications
- Production output such as product specifications, special characteristics, drawings, diagnostics, etc.
- Service output such as product specifications; performance reliability and maintenance criteria.
Initially, this information may be used for trials and validation, before being firmed up. Many documents are created from the design and development output stage such as drawings, quality plans, work instructions, etc. These documents must be controlled as per clause 4.2.3 such as approval, revision control, distribution, etc.
Where any sophisticated design and development tools such as AutoCAD are used requiring specific competency or training, ensure you provide and keep appropriate records of competency and training of personnel performing design and development activities and use of these tools.
ISO 9001-Clause 7.3.4 Design and development review
ISO 9001 Requirement
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
Do design reviews at one or more milestones of the design and development project, depending on customer requirements, the size, complexity and risks involved. The purpose of these reviews is to evaluate results to requirements, check project progress and costs to plan and take actions on any problems encountered. You must take a multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed, actions to be taken, responsibilities and timeline for completion. All design and development reviews must be included in your design and development plan.
ISO 9001-Clause 7.3.5 Design and development verification
ISO 9001 Requirement
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
Product design Verification includes design reviews, comparing the new design to a similar proven design if available, performing alternate calculations, performing tests and simulations, reviewing the design documents before release, etc. Verification is checking product or process to input requirements, whereas validation is checking product or process is suitable for its intended use does it perform/function in the way intended by your customer or your organization. Manufacturing process design verification include design review , process capability studies, testing various process parameters, performing tests and trials, reviewing the manufacturing process design documents before release, etc.If you outsource any part of your design and development activity, then you must exercise the same controls required by clause 7.3 on the outsourced work and the organization doing the work, had it been done internally.You must keep records for verification.
ISO 9001-Clause 7.3.6 Design and development validation
ISO 9001 Requirement
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
Product and manufacturing process validation includes – design reviews, comparison between customer requirements and internal development plans, design and development validation against customer requirements and design and development input requirements, corrective action and lessons learned from documented process failures and product nonconformities. If you outsource any part of your design and development activity, then you must exercise the same controls required by clause 7.3 on the outsourced work and the organization doing the work, had it been done internally. You must keep records for validation activities.
ISO 9001-Clause 7.3.7 Control of design and development changes
ISO 9001 Requirement
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be
Make sure your process for design and development changes follow appropriate steps of clause 7.3 ie define plan, have inputs and outputs, verify and validate to the extent necessary to meet customer requirements and control product, quality and business risks. Changes may come from internal, customer or regulatory sources. Get all requests for product or manufacturing process design changes in writing from your customer.
Impact of the change must be evaluated on materials used, design process, manufacturing process, characteristics and use of developed product, regulatory compliance, cost etc.
An audit checklist should cover these areas:
For Clause 7.3.1:
- How are the stages of design planned?
- Is Planning output updated, as appropriate, as the design and development progresses?
- How are the design and development stages determined?
- How is design and development review, verification and validation activities determined?
- How is responsibilities & authority for design and/or development activities determined?
- Are the interfaces between different groups managed to ensure effective communication & clarity of responsibilities?
- Are planning output kept up-to-date?
For Clause 7.3.2:
- How are input requirements identified and documented?
- Do the design and development input includes functional & performance requirements, applicable statutory & regulatory requirements, applicable information derived from similar design and Any other essential requirements?
For Clause 7.3.3:
- Where do design outputs approved before issue?
- Where do design outputs meet the design/development input requirements?
- Where do design outputs provide appropriate information for production & service operations?
- Where do design outputs contain or reference product acceptance criteria?
- Where do design outputs define the characteristics of the product that are essential to its safe and proper use?
For Clause 7.3.4:
- How often are design and development reviews done? How are all input requirements checked?
- At suitable stages, are systematic reviews of design and development conducted to evaluate ability to fulfill requirements and to identify problems & propose follow-up actions?
- Are results of the review and any necessary action of the review recorded?
- Do representatives of the functions concerned with the design and development participate in design & development review?
For Clause 7.3.5:
- How is the design verified? When is it verified? Is it Documented?
- Is design & development verification performed to ensure that the design and development outputs meets its inputs?
- Are the results of the verification and resulting follow-up actions recorded?
For Clause 7.3.6:
- How is the design validated? When is it validated? Is it Documented?
- Is design & development validation performed to confirm that the resulting product is capable of meeting the requirements for intended use?
- Wherever applicable, is validation completed before delivery or implementation of the product?
- Are results of validation & subsequent follow-up actions recorded?
For Clause 7.3.7:
- How are design changes reviewed? How is impact evaluated? Are Record kept?
- Are these identified, documented, reviewed, verified and validated, as appropriate before implementation?
- Are there evaluation of the effect of changes on constituent parts and products already delivered?
|Example of format for Design input record|
For Clause 7.3.3:Not applicable
For Clause 7.3.4:Record of D & D review for e.g Design Review Records,D&D Minutes of meeting
|Example of format for Design output and review record|
For Clause 7.3.5: D & D verification for e.g Adequacy report, D&D plan, test plan
|Example of format for Design verification report|
For Clause 7.3.6:D& D Validation for e.g Feasibility report, User acceptance test plan,acceptance record
|Example of format for Design validation|
For Clause 7.3.7: D& D change For e.g Design change record, D&D review MOM
|Example of format for Design change record|
Evidence/Implementation document ( Not mandatory but helps in fulfillment of requirement):
- Procedure for design and development
- Checklist for Design Input Adequacy
- Design and Development input
- List of Design output
- Documents are needed for effective planning, operation and control of production activities:- contracts, technical drawings and specifications, a documented plan for design and development, work instructions, a documented procedure, etc., combined with unwritten practices, procedures and methods.
- Performance indicators: – include reduction in – design cycle time, development cycle time, specification errors, omissions, changes, design and development costs, etc., as well as measurable improvements in products developed.
- Design input information (documents):customer contracts, drawings and specifications, your own organization’s database of previous design and development projects, competitor analysis, industry standards, feedback from suppliers, field data. contract review, product realization, purchasing, top management- quality plans, product drawings, operator instructions and other documents used to make or verify product
|Example of Procedure for design and development|
|Example of format for Design planning|
|Example of format for Development Enquiry Register|
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