Quality standards ensure that customers’ parts and products will function as expected, are safe, and comply with regulations.
Our standard production process provides design for manufacturability (DFM) analysis, a first step to ensuring a quality molded part. Plus, we measure up to four plane-to-plane and outside diameter dimensions based on your CAD model (X, Y, Z) to quoted tolerances. Our company also is ISO 9001:2015 certified and ITAR registered.
At Protolabs, we use digital manufacturing and scientific molding processes, combined with quality assurance and control methods, to produce parts rapidly and consistently. One of the more critical quality controls for industries with high requirements, Production Part Approval Process (PPAP) is a popular inspection report for molded parts.
What is the Production Part Approval Process?
PPAP emerged out of the automotive industry, where engineers had developed a precise, standardized procedure that ensured a supplier’s production process or capabilities consistently produced parts that would meet customer requirements.
PPAP became the automotive industry standard, according to the Automotive Industry Action Group, which helped develop, create, and then formally adopt the quality standard. It defines the production part approval process for that sector and demonstrates that engineering design records and specification requirements are achieved by the supplier's manufacturing process.
Notably, in 2008 and 2009, during the financial crisis that eventually became known as the Great Recession, the automotive industry was hit especially hard. Many engineers who had left automotive OEMs at that time, brought PPAP with them to their new jobs, adopting the inspection standard for their new industries. Aerospace was an early adopter of PPAP as was the medical industry, which uses injection molding for medical devices and other medtech parts and products.
What is the Process for Conducting PPAP Inspections?
Here is what to expect when you request a PPAP inspection at Protolabs.
At time of quote, you can request our standard PPAP by checking a box along with your requested inspection. This will start our standard PPAP using our automated inspection process. If you have more specific needs, you can indicate a PPAP through our additional services selector, which will initiate a discussion to gather requirements.
Our standard offer PPAP is comparable to a traditional level 3 PPAP. For this, we use the information you supply to us. The form includes basic information about the part and process used at time of quote and order. The PPAP includes results of the customer-chosen inspection options, identifying the dimensional requirements of your part. Check out this sample of our PPAP package.
Our PPAP contains several of the traditional 19 elements that will show the repeatability and reliability of processes used to produce your part. Standard PPAP-included items are process flow charts, PFMEA, control plans, inspection plans, dimensional results, certificates of conformance, and part submission warrants. We retain batch records for sample production parts, and master samples with your mold. Part-specific analysis containing DFM with associated risks is provided with every quote. Our standard PPAP has minimal impact on your quoted lead times.
If you have additional needs, selecting a custom PPAP through our additional services selector will initiate a review process by our team where we can use an external certified inspection provider. Our team will work with you to gather specific requirements. Note that custom PPAPs require additional lead time. This additional lead time will be quoted at the time of the part order, and is typically 11-plus business days, depending on the PPAP level.
Industry Adoption of PPAP
These days, most industries use some level of PPAP as an option, in addition to other quality inspection methods they might choose. Companies in sectors such as automotive, aerospace, medical, consumer electronics, industrial heavy equipment, and others opt for PPAP.
The automotive industry, which pioneered PPAP, actually requires it, considering the process a standardized system throughout automotive manufacturing.
The aerospace industry, with so many high-risk factors that are a part of a diverse range of commercial, industrial, and military/defense applications, requires it, both for new product development and existing product changes within aerospace and defense segments.
In the medical industry, PPAP is required when launching a new product or changing the design or manufacturing process. Though PPAP is not mandatory for existing parts, industry sources say that it can help medtech and medical device companies meet regulatory requirements and, overall, can help ensure quality, safety, and compliance.
What are the Benefits to Using PPAP?
Essentially, PPAP verifies that a production process can reliably and consistently produce a quality part. But maybe that’s too general. Let’s give the last word to the Automotive Industry Action Group, which created the quality standard in the first place. That group states that PPAP:
- Provides consistent part approval process
- Assures parts conform to customer requirements
- Offers evidence of process stability
- Controls product and process change process, providing an approval outlet for all changes to ensure conformance to the next level assembly/process
Additional Inspection Options
In addition to our standard process, we offer a broad range of quality measurement, inspection, and documentation options, working with you to ensure that we achieve our rigorous standard for delivering high-quality injection-molded parts.
In addition to PPAP, other inspection report options include measurement methods such as various points of First Article of Inspection (FAI), Critical-to-Quality Inspection (CTQ), and Digital Inspection Reports (DIRs), available at time of purchase.
As always, you can consult with one of our injection molding experts to decide which inspection options are best suited for your project needs. If you have more questions about PPAP, or any other quality inspection methods that we offer at Protolabs, contact one of our applications engineers at customerservice@protolabs.com or 877-479-3680.
Special thanks to Protolabs colleagues Ben Wilson, Injection Molding Product Leader, and Perry Haislet, Quality Manager, for their contributions to this article.
