ISO 9001 requires reviews to be conducted to evaluate the ability of the results of design and development activities to meet requirements. This means that a least one ISO 9001 design review should be completed for each design and development activity or project. Projects that involve any level of complexity will most likely need more than one formal design review.
Design Review Planning
The various reviews to be completed during a project should be defined and documented within the design and development plan. ISO 9001 clause 8.3.2b specifically requires the D&D Plan to include all applicable design and development reviews. This planning should clearly define:
- When each review will occur: Define the review(s) to be completed during each project phase in the plan and/or project schedule and include any dependencies which might exist.
- The type of review to be completed: This might be a project review, technical review, system review, etc. Complex products may even need to have specific sub-system reviews such as electrical systems, mechanical, software, etc. Clearly defining the review type will help determine who should participate and the appropriate timing during the project for the review.
- The appropriate participants: Define the functional areas to be represented along with the leadership and facilitators. While not an ISO 9001 requirement, a good practice is to involve an independent reviewer, especially for technical reviews.
Product & Process Design Reviews
A project of any significant size and complexity should consider completing the following design reviews throughout the design and development project:
- Design Input Requirements: Analysis and review of user, customer, product, process, and/or technical requirements. This review can also be used to review results of any design feasibility activities. Usually completed during project feasibility phase prior to start of actual design and development activities.
- Design & Development: Detailed technical reviews of product design with focus on safety, performance, and ability of product specs to meet defined product requirements, including any prototype and bench testing results. Completed during design and development phase and often includes technical reviews of product sub-systems as applicable.
- Design Outputs: Review of the design output package to ensure completeness, compliance, and adequacy. May also be used to review proposed design verification methods and protocols prior to execution of design verification activities.
- Manufacturing & Design Transfer: Evaluation of manufacturing processes including process validation / capability methods and activities to transfer the product design into the manufacturing environment. Also consider review of product pilot builds required for verification and validation testing activities. These reviews can be completed during product/process design and development through manufacturing implementation, process validation, and design transfer. For projects that involve new, large, or complex manufacturing processes, manufacturing design reviews should mirror product design reviews and be scheduled throughout the entire project timeline.
- Pre-Validation: Review of product verification testing results and product validation plan and protocols. Also review of process validation activities and results, and readiness of manufacturing processes to produce pilot product for validation. Completed following design verification and before start of design validation.
- Post-Validation: Review of product validation results and launch readiness activities. Completed following successful product validation and prior to formal product launch.
- Post-Launch: Review of product and process performance following product launch. Generally completed once meaningful data is available (6-12 months after launch).
Also consider “lessons learned” project review with the results added to Organizational Knowledge.
In addition to the technical reviews discussed above, other ISO 9001 design reviews should be planned and executed concerning the state of the project. The meeting agenda might verify the following:
- All activities and deliverables are complete and meet the letter and spirit of the development process and any applicable regulatory requirements,
- Project documentation is complete and accurate in format and content,
- Technical reports and data accurately represent product and process performance,
- Product and process performance meets or exceeds established criteria and requirements,
- Where product and/or process documentation demonstrates failure to meet criteria, risk is assessed (where applicable), and defendable justifications are provided,
- All requirements and deliverables for the current project management phase have been met and the project is positioned to begin the next phase of work,
- Discuss and mitigate project risks,
- Confirmation that the project and product are still viable for the business,
- Provide visibility to the project and resource requirements for completing the next phase of the project.
Design Review Execution
How you execute design reviews is your choice, but it is recommended that you develop a process that treats the review as formal meeting. The most effective meeting is probably one where participants meet face-to-face which allows for open and meaningful dialog and even constructive conflict if needed. However, this doesn’t need everyone in the same conference room as participation using remote meeting technology is acceptable as long as everyone has access to technical information to be shared and reviewed. With this said, there is no formal requirement that the review be completed as a formal meeting and if the review can be effectively completed using other methods, that is acceptable. A simple review might be completed by sharing a set of technical documents or other design or project artifacts with appropriate personnel individually and allowing them to review the items and provide feedback.
Develop and issue an agenda to the required participants well in advance of the meeting and maintain a strict attendance policy. There is no way to effectively complete a design review without the appropriate people present and prepared. Be sure that the agenda clearly defines the various topics and those responsible for presenting each topic and facilitating the discussion.
The output of the design review is often times major decisions about the product design or project, approved milestones or product artifacts, identified issues or risks, and action items to address these issues. Be sure to capture and document these outputs and ensure that all open actions are appropriately addressed and closed in a timely manner. The EBS Free Library contains an example Design Review Report template that you can download and use to capture your design review activities. Feel free to adapt this document to meet your specific needs.
Based on the nature of the review and topics to be discussed, ensure that the appropriate participants are invited and available. This means that all functions concerned with the review activity should be represented. Consider the need for Marketing, Engineering, Manufacturing, Quality, Purchasing, Supply Chain, Materials Management, Executive Management, etc.
One best practice seen across many different industries is the inclusion of an “independent reviewer” for technical reviews. These are personnel who have knowledge and expertise associated with main topic of the review, but who also do not have direct or immediate involvement with the project. The idea is to get a second independent opinion from someone not involved with the effort who might see issues or concerns not readily apparent to those on the project team. For instance, a review of the mechanical system might include a secondary mechanical engineer to review the design and provide feedback to the team concerning the mechanical aspect of the design. This independent review is completely optional and not required by ISO 9001.
Design reviews are a crucial element of the overall ISO 9001 design and development process. Define the various ISO 9001 design reviews needed early in the project and be sure to document design review requirements within your design and development plan. Remember that reviews should cover and address both technical and project level activities and deliverables. The use of independent reviewers during applicable reviews can help identify problem areas that the project team may miss. Chances are that you are already completing some type of review activities that can be easily modified to meet the ISO 9001 design review requirements. If you need additional guidance and information on this topic, check out the EBS ISO 9001 eCoach Learning and Coaching System.