NPI: PCB & PCBA Manufacturing Part 1
I have found it very difficult to get a comprehensive overview of the NPI process for taking PCBAs from concept to mass production, so I am writing these articles to do just that.
New Product Introduction/Product Development Lifecycle Overview
First thing first, let’s define the steps of NPI/PDL in general:
Research!
Conduct a market and competitive analysis, do patent research
Establish Objectives for the part and/or product
Establish Key Performance Indicators (KPIs) — Financial, customer satisfaction/desires, process efficiency, risk level, error rate, marketing metrics, capacity, and product longevity; a Design for Excellence (DFx) analysis could be helpful here
Determine Feasibility — Budget (BCFM), resources, technical capabilities, scope, schedule, customer desire, service, market competition, review past quality issues and lessons learned
— — — — —If both indicate that moving forward is a good idea: — — — — —
Develop the Design
Identify Design Inputs and Outputs—Conduct QFD analysis if necessary and create a Product Requirements Document (PRD) Note: Life will be a lot easier down the line if you consult the cross-functional engineering group: your PM, manufacturing engineers/operators, human factors, quality, regulatory or compliance, and supplier development engineers during this stage
Design several prototypes and make changes as needed—Start Forming the Bill of Materials (BOM), make models, make technical drawings (GD&T could be useful), address safety concerns, conduct tolerance analyses, begin the FMEA
Preliminary Design Verification — Verify that the design outputs meet the design inputs; do this by having an established test in which results are collected and analysis is performed; should meet the specified requirement in the product requirements document. This can be done through simulations if necessary, but a prototype/concept build is preferable.
Preliminary Design for Manufacturability (DFM) Analysis — Conduct and make changes as needed. This may come further down the line when a supplier is chosen, but a preliminary one does not hurt.
Note: Once you have proof of concept and a functional prototype it is likely a good time to bring in suppliers. If this is a new product for an existing company with already well-established supplier relationships they may already be involved. If your design is only functional on a simulation level or via models they may be able to help you truly verify your design with a physical product (would not recommend it, but can make a case for it). If you have built prototypes with off-the-shelf components they can help you get ready to produce at a mass scale.
This is a time of high-cost and low reward for the supplier. So either a) have an established corporation with large financial assets ready to back you so the supplier will have the incentive to work with you, or b) be ready to hit the ground running to get a product on the market.
— — — — — — — — ——If you have a functional prototype: — — — — — — — — — —
Engage your Suppliers (if parts are not off the shelf)
Find your suppliers — In order to engage your suppliers, you have to decide who your suppliers will be. Typically, you would find multiple options and rank each one in many different categories. You can take a weighted average based on the most and least important criteria.
Common Criteria:
- Price
- Quality System
- Geographical Distance/Geopolitical Considerations
- Management
- Manufacturing Capacity
- Time to Market
- Pricing Transparency
- Service Quality/Capabilities
- Technical/Engineering Expertise
- Safety Adherence
- Environmental Compliance
- Audit Results
- Certifications possessed by the company and their employees
- Company Culture and Reputation
Send them an assembly package — Once you have chosen a supplier, they typically expect you to send them a package that includes, but is not limited to:
- A Product Requirements Document (PRD)
- BOM
- Assembly Criteria and Packaging Criteria if applicable
- R&D Files/Drawings/Schematics/Custom Part Specs
- Sales forecast
- Recommended or Required Vendors they must use for certain parts
- Maybe an APA
- Any additional regulations they will have to comply with when developing the manufacturing line for the process.
— — — — — — — — — — If you have chosen your supplier(s): — — — — — — — — —
Agree to a Master Validation Plan, establish a Quality Contract, and consider payment terms — Establish what quality standards you expect the supplier to perform to and get that in the form of a contract. Establish what the supplier must achieve to receive payment. You should have a proposed schedule ready to share with them.
Conduct a Design for Manufacturability (DFM) and Design for Test (DFT) Analysis with the Supplier
Supplier BOM Analysis
Suppliers should evaluate the BOM to find end-of-life components, parts with long lead times, and what would be good to dual-source to guarantee a supply chain.
This is also a good time to figure out what components are high in price and look for cheaper alternatives.
Complete Engineering Work from the Supplier Side throughout the pre-launch process — Even if you send them your assembly package, suppliers often like to make their own R&D documents, work instructions, etc. Sometimes these require customer approval. The supplier should be adhering to their own quality system as well as yours.
Conduct Engineering Verification Builds — This helps identify design and manufacturing flaws early on so that major changes can be made if needed. The number of samples here should be small.
By the end of this, the design outputs of the prototype should match the requirements listed on the engineering documents. It is proof that the physical product can be created at this manufacturing site and work as intended. It should match closely with prototypes. Any changes that occurred when moving from producing prototypes to producing in a manufacturing environment can be identified.
If a supplier makes multiple parts, for example, something with an electrical and something with a mechanical component, they may do a run of the electrical portion and a run of the mechanical portion before doing an overall prototype verification run.
Note: Engineering verification needs to be passed before moving on to the next step.
— — — — — — —If engineering verification build is passed: — — — — — — —
Refine FMEA/risk control measures, BOM, and MVP
Review Equipment and Fixture Designs, Calibration/Maintenance Schedules, and Prints/Requirements—Usually with working meetings, either in-person or virtual.
Work on Software for Production
Supplier Collaborates with Company for what will be made in-house versus externally — Update BOM if necessary
Order Equipment, Tools, Tooling, or Parts needed to produce — If the supplier has to order things they do not already have you will likely be charged. If the supplier has to validate and install new equipment you will likely be charged for their labor if they have to go outside of their own quality system.
Complete Process Development and Validation
Process Design — First, verify what the actual process of manufacturing this product is going to look like taking input from the builds done thus far. Decide what is most likely to deliver the intended output from each process step. Decide what amount of in-process sampling makes sense. This can be altered based on the results of your validation.
Measurement Systems Analysis/Validate Necessary Measurement Equipment — Not every piece of measurement equipment will need to be evaluated.MSA is necessary anytime measurements are used to assess product quality and quantity. You must ensure that the equipment that is going to be used to measure the outputs of your process is validated. You want to ensure that the equipment is reliably giving the same results. Verify your precision and your accuracy. You will want to do this based on a statistically significant number of samples, operators, and number of repeats/operators. The number that you will need for these is dependent on the type of output.
Types of outputs:
- Attribute: the sample passes or fails the requirements, see examples of analyzing your results and choosing appropriate sample sizes here
- Variable: the sample has a quantifiable output that can be measured; dimensions are often verified through a Gage R&R study
Test the Process Design — DOE studies and risk analysis could be helpful here. The ultimate goal of process validation is to reduce sources of variability in the process. You should be especially concerned with the processes that affect the critical-to-quality elements. Different parameters/variables will lead to different outcomes, and varying your parameters will provide different outcomes. You can adjust as necessary. This is a good time to update drawings, specs, protocols, tooling, work instructions, and supplier quality documents if necessary.
Process Qualification— Defined as the qualification of manufacturing and production processes to confirm they are able to operate at a pre-determined specification during sustained commercial manufacturing. [Source]
- Installation Qualification: or IQ, is a documented verification process that the instrument or piece of equipment has been properly delivered, installed, and configured according to standards set by the manufacturer or by an approved installation checklist. [Source]
- Operational Qualification: Operational qualification is the next step in quality assurance and involves testing the equipment and making sure it performs as specified, within operating ranges as listed by the manufacturer. Sample sizes for the high, low, or nominal ranges can be determined to provide statistical confidence in your process.
- Process Qualification: Verifies that your process and equipment perform as intended under specified conditions. Does it perform as it should under normal production conditions?
Update your in-process sampling if needed — For example, if you struggled during validation, it might make sense to perform 100% sampling on a feature in production
Continued Process Verification — Ensures that the process remains in a state of control during commercial manufacturing
Qualify and Approve Test Systems — Including outside/3rd party testing
Approve Component Qualifications — Tests to see if a component meets its specified criteria, this will be prior to being fully assembled into the device/product
Complete PPAP/Similar Process Documents
—If suppliers have shown the ability to produce parts at mass scale: —
Do any builds that need to happen to show that all qualified parts can be assembled into a functional device/product. This may include Design or Process Verification and Validation builds.
— — — — — — — — — If all steps prior are successful: — — — — — — — — —
Begin sales, order parts, and produce product!
Sources
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