17 May 2021
(and some handy tables of activities involved in each)
Note: When developing products, companies use a variety of gate review frameworks. The reviews can be called Stage-Gate®, Tollgate, Phase Gate, Decision Gate, or a variety of other names. The names and scopes of gates may vary, but the overall concept is similar. Below are a few examples of gate reviews.
Stage Gate® Processes with Gate Reviews at the end of each stage:
Ideation > The Business Case > Development > Testing and Validation> Launch
Concept > Feasibility > Develop > Qualify > Launch > Deliver
Ideation > Feasibility > Development > Verification > Launch
Design for Six Sigma (DfSS) Processes with Tollgate Reviews at the end of each phase:
Define > Assess > Develop > Validate > Launch > Sustain
Define > Measure > Analyze> Valiate > Launch > Control
Define > Measure > Analyze > Design > Verify
This post refers to Tollgate Reviews which is are used in the Design for Six Sigma process. However, the concepts in Tollgate Reviews can also apply to the wide variety of Gate Review processes.
Tollgate Reviews and Design Reviews are both vital elements of product development, but many companies confuse the two. They often happen in parallel with each other, but they serve two distinct functions. In the broadest sense, Tollgate Reviews are checkpoints to ensure that no important business and product requirements are skipped, while Design Reviews are checkpoints to ensure that all regulatory requirements are met. Tollgate Reviews are not Design Reviews, and Design Reviews are not Tollgate Reviews.
The Design for Six Sigma (DfSS) process uses Tollgate Reviews. DfSS is a business process that includes not only product development but also business metrics and requirements like market trends, competitor analysis, pricing, profit margins, intellectual property, patents and business risks. Tollgate Reviews include these metrics. Tollgate Reviews have a go/no go decision on whether to stop or continue with the development process and launch the new product. The reviews continue through post-launch and project closure.
Design Controls are a sub-set of the DfSS process. Design Reviews are specific to ensuring the quality and regulatory requirements for each of the design control sub-systems are met per ISO13485:2016 and 21 CFR Part 820. Design Reviews are a systematic review of the design to ensure all regulatory requirements have been met during each stage of the design and development process. The purpose of these reviews is to identify potential design problems and implement actions to address those issues. Design Reviews can be iterative till final approvals are obtained. Design Reviews end at Design Transfer. A final Design Transfer review ensures all requirements for full-scale production have been met.
The tables below detail the elements that are typically considered in Tollgate Reviews and in Design Reviews.