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Manufacturing: One to Many
Repeatability, cost control, and the path to production
May 16, 2025
By: Mike Pica
After a few working prototypes, the next challenge is building your product the same way, again and again, at a cost that makes your business work. This post breaks down some of the steps involved in moving from a prototype to a repeatable manufacturing process - including the design package, bill of process development and pilot builds, and deciding where and how to manufacture.
We’ve also developed a template Functional Requirements Document to help guide what’s acceptable to ship.
The Design Package
When you’re ready to build, everything hinges on clear, complete documentation. The design package is your product design blueprint to develop the right manufacturing processes.
It ensures that everyone is working from the same playbook (engineering, manufacturing and product). It also freezes the design and locks in what's acceptable and what's not, so future changes can be handled in a controlled and systematic way.
What’s in a Design Package?
What parts are included
How to put it together
How to know if it's acceptable to ship
A strong design package supports alignment across teams, accelerates the quote process, and reduces the time to bring up a repeatable build process on a manufacturing line.
Design Package Contents
PCBAs
Part numbers
Indented BOM
Gerber package
Fabrication instructions
Test specifications
Conformal coating (as required)
PCBA drawing
Plastics and Metals
Part numbers
Custom part specifications
2D drawings
3D CAD files
Color / Material / Finish (CMF) requirements
Material callouts and finishing requirements (especially for metal parts)
Box Build
Assembly numbers
Indented BOM (PCBA, metals, plastics, off-the-shelf parts)
Top-level assembly and component drawings (2D + 3D)
Test specifications
Assembly instructions
Packaging specifications
Functional Requirements Document (FRD)
The FRD defines what is acceptable to ship.
It outlines what the factory (or your internal team) is responsible for assembling, testing, and shipping. It is an important tool to align expectations with the manufacturing team (and partner), and alignment across teams. Get a copy of a Functional Requirements worksheet here.
The Bill of Process
If the Bill of Materials (BOM) outlines the components and subsystems in your product and the Bill of Process (BOP) outlines how to build it.
The Bill of Process outlines the production process for a specific product, including all steps, tools, machines and equipment needed for manufacturing. This also includes all assembly and test instructions for each step, with pass / fail criteria as applicable.
The Bill of Process is not typically part of the design package, it's developed by the manufacturing team (building inhouse) or codeveloped with a manufacturing partner, all using the design package as a guide. Typically there are questions along the way, which will involve your engineering team.
Why is the Bill of Process Necessary?
The bill of process makes manufacturing more consistent, repeatable, and predictable. Without the bill of process, there may be expensive rework at different stages of the manufacturing line (best case), or issues in the field with customers (worst case).
Consider cooking as an analogy - the Bill of Materials (BOM) is your ingredient list, and the Bill of Process is the recipe.
Pilot Builds
Once your Bill of Process is outlined, and the line has been designed and set up, run pilot builds.
What to track:
Yield at every stage (component, sub-assembly, finished goods)
Time per step and total build time
Defects or issues by step
Notes from operators or engineers
Why track data?
Predict future build effort
Identify root causes of manufacturing issues
Improve line speed and quality
Support field failure investigations
Pilot builds uncover issues, across manufacturability, assembly, and test. Be sure the team has an efficient, closed loop process to identify, document and resolve what’s not working.
Design your line with debugging in mind. A well designed fixture or test equipment will provide visibility into issues early in the assembly process.
In-House Manufacturing vs. Working with a Partner
One of the most critical decisions is how you’ll build. Consider some of the pros / cons in the below image of common manufacturing approaches.
Choosing a Path
Considerations, going from inhouse to an external partner across scalability, quality, and costs:
Cost analysis - inhouse vs external partner (labor, materials, equipment)
Sales pipeline - how confident are you in your sales pipeline, and when will you hit pinch points for inhouse, low volume production?
Intellectual property - what are risks to share with an external partner?
Expertise - where does your staff’s expertise lie? Is managing the process in house possible with your team?
Conclusion
Getting one prototype working is hard, building 10s / 100s / 1000s is a completely different challenge.
To scale efficiently, whether building inhouse or with a partner, you need a system:
Freeze the design, and develop a design package
Create a clear Functional Requirements Document (FRD) to set expectations on what’s acceptable to ship
Develop a bill of process (on your own, or codeveloping if you have a manufacturing partner)
Run pilot builds to uncover and resolve issues before scaling
Start small, update documentation as you go, and build feedback loops into your line. The more issues you expose early, the fewer problems you’ll deal with later as you scale.
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Decide Where and How to Manufacture
Interested in speaking further?