Production Part Approval Process

The Production Part Approval Process, or PPAP, is a key procedure in several industries to ensure that manufactured parts meet quality and industry requirements and minimize the risk of potential challenges in the future. PPAP lays out clear guidelines for suppliers like MedFab so that we know what our customers expect of us with each part.

The Elements of Production Part Approval Process

PPAP contains 16 elements, though which of these elements matters depends on the customer requirements and the complexity of the individual part. MedFab applies each element as needed to ensure that components meet customer specifications and are ready for production.

Design Documentation: This element ensures that everything in the planned production process aligns with all TDS documentation and the purchase order.
Engineering Change Notice: If requests are made to amend an existing part design, this element will be part of the PPAP.
Customer Approval: Always included, this refers to any evidence of approval from the customer’s engineering department.
Process Flow Diagram: The PPAP’s process flow diagram lays out every step in creating the part.
PFMEA: The Process Failure Mode and Effects Analysis (PFMEA) examines all possible failures that could occur within the actual manufacturing process.
Control Plan: The control plan offers preventative measures that mitigate any possibilities outlined in the PFMEA.
Measurement System Analysis: The Measurement System Analysis records every specification and detail of the equipment being used for production.
Dimensional Layout Results: This element involves a validation check to ensure that any measurements included on the drawing are correct in relation to the end result.
Statistical Process Control: This type of documentation details all the processes that will take place and the components that make up the product–a little like the process flow diagram, but more involved in what’s in the final product rather than the process itself.
Qualified Laboratory Documentation: As the name suggests, this element of PPAP covers any certifications from any lab testing done on the parts.
Appearance Removal Inspection: Better known as ARI, this verification ensures that the customer approves the product’s appearance.
Sample Production Parts: The supplier sends a sample part to the customer for their approval.
Master Sample: The master sample part offers an example of the final version of the product and requires sign-off from the customer.
Checking Aids: This element contains a list of all required checks during production, such as tool calibration.
Customer Specific Requirements: This part of the PPAP documents any specific requests made by the customer.
Part Submission Warrant Form: This form summarizes everything done within the Production Part Approval Process and includes any relevant declaration signatures.

Quality that You Can Count On

MedFab provides high-quality, end-to-end manufacturing solutions, from prototyping to production and beyond.