Design review processes and their impact on product development.
Development organizations typically have a predefined set of formal design reviews that are held throughout the development process. A design review usually includes assessing design input requirements for adequacy, assessing the adequacy of a design to fulfill design input requirements, and verification/validation-related reviews. When done correctly, design reviews are an important part of a robust product development process because they help identify design issues early when they cost less to fix. When not done correctly, design reviews can be detrimental to the success of a development organization. So what are the top signs that design reviews are hurting your business and not helping you develop better products on time and within budget?
- Not planning design reviews appropriately.
- Performing design reviews that are not effective or efficient.
- Not following up on review action items.
RELATED POST: Five Key Design Control Practices that Improve Compliance and Help Develop Better Products
Not planning appropriately for design reviews involves not performing design reviews at the correct time and not sending out review material with sufficient time that reviewers can adequately prepare for the review. Often, formal reviews involve reviewing deliverables associated with a milestone or a certain phase of the development process. Because these reviews are required by procedure, they are generally performed but often end up as a status marker of where the project is at, instead of a design review intended to identify issues. Additionally, design reviews can be performed at any time in the development process, when a review of some element of the design is beneficial in identifying potential issues. These technical reviews can be invaluable in identifying design issues early in development and should be performed on an as necessary basis. Development organizations are sometimes hesitant to hold additional reviews, other than the required formal reviews, because of the time required to prepare, perform, and document the review, thus passing up opportunities to improve the design while it is still less expensive to make changes.
Unfortunately, oftentimes, design reviews are just performed to meet the regulatory requirement, but not with the goal of identifying issues. The check-the-box mentality, prioritizes project schedule over product quality, as it passes upon opportunities to significantly impact and improve on the quality of the design before the design is frozen. In order for design reviews to be efficient and effective:
- Reviewers should be provided sufficient time to review the material prior to the review meetings.
- An independent reviewer, a person with no responsibility for the design being reviewed, should be invited to the review.
- All participants should come prepared for the review, having reviewed the material beforehand.
- An experienced facilitator/moderator shall be utilized, the role of the facilitator is to keep the meeting on track, ensure the agenda is followed.
- Utilize a scribe to record the meeting minutes, this will free the design owner to fully focus and participate in the review. It will also allow the meeting to progress more efficiently.
- Ideally, utilize a requirements tool, like Jama Software, to automate and centralize the above activities.
RELATED POST: A Guide to Requirements Elicitation for Product Teams
Gathering metrics on the number of issues found during reviews, the types of issues found, and the amount of time spent in reviews can help determine the effectiveness of your design review process.
When a review is performed appropriate documentation should be generated. First, a design review agenda should be prepared to detail the date and time of the review, the location of the review, the review objective, the review participants and their roles along with the materials to be reviewed. During the review, the list of attendees should be documented, along with items discussed, decisions agreed to, conclusions reached and any action items generated, along with the person responsible and due date of the action items. Review minutes should be published containing all this information.
When action items are generated as a result of a design review, a requirements tool, like Jama Software, should be used to track review action items to completion. Ideally, action items should be completed prior to the next project milestone or major review. Not following through on review action items is not only a regulatory liability but can give the impression to reviewers that the time spent in reviews is wasteful, causing them to treat design reviews as a check-the-box activity.
In summary, design reviews can be a very helpful tool in identifying design issues early, when they are less costly to fix. However, in order for design reviews to be helpful, they need to be planned and held at the appropriate times during the development process, following guidelines for effective design reviews, documenting design reviews appropriately, and following up and tracking design review action items to completion. If you are going to spend the time in design review, let the time be well spent, let reviews serve their purpose, and gain the benefits from the time and resource investment in this activity.
- Top Signs Your Design Review Process Is Hurting Your Business - December 9, 2021
- Five Key Design Control Practices that Improve Compliance and Help Develop Better Products - October 7, 2021
- Software as a Medical Device (SaMD): Four Key Development Best Practices - August 17, 2021