Glossary Term
Production Part Approval Process (PPAP)
Definition
The Production Part Approval Process (PPAP) is a standardized process used in manufacturing to ensure that suppliers meet the required specifications and quality standards before mass production begins. It is particularly used in industries such as automotive and aerospace, as well as in medical device manufacturing, to verify that production parts are consistent with design requirements and that the manufacturing process can consistently produce high-quality parts. The PPAP involves several documentation and approval stages, including the submission of samples, materials certifications, process flow diagrams, and control plans, among other requirements.
Relevance to the MedTech Industry
PPAP ensures that all production parts meet the customer’s specifications and are manufactured consistently to the required standards. It serves as a formal approval process between the supplier and the manufacturer to confirm that the production process is capable of delivering parts that are both safe and effective for their intended use. PPAP helps prevent quality issues, minimizes the risk of product recalls, and ensures compliance with regulatory requirements.
Additional Information & Related Terms
Important Aspects of the Production Part Approval Process (PPAP)
Design Documentation:
Includes all the design specifications, drawings, and requirements necessary to produce the part, ensuring that the design meets functional, safety, and regulatory standards.
Process Flow Diagrams:
A process flow diagram shows the sequence of operations required to manufacture a part, from raw material input to final inspection. It ensures that the manufacturing process is well-defined and capable of producing parts consistently.
Control Plan:
A control plan outlines how the product will be controlled during production, specifying key characteristics that must be monitored and the methods used to measure them. It ensures that critical quality factors are consistently managed.
Measurement System Analysis (MSA):
MSA evaluates the accuracy and precision of the measurement systems used to assess product quality during production. This ensures that the measurement tools used to verify the parts are capable of producing reliable and consistent results.
Dimensional Results:
This includes data from measurements taken from the first production parts to ensure that they meet the required dimensions and tolerances as defined in the design documentation.
Material Certifications:
This involves documentation confirming that the materials used in manufacturing the parts meet the required specifications, including certifications from material suppliers and testing results.
Initial Sample Inspection Report (ISIR):
The ISIR is a report that summarizes the inspection results of the first production samples to ensure that they meet all design and quality requirements before full-scale production.
Production Part Samples:
Samples of the first production parts are submitted for approval. These samples are tested for functionality, compliance with design specifications, and consistency in quality.
Corrective Action Reports (CARs):
If any issues are identified during the approval process, corrective actions must be taken and documented to address the root cause of the issue. This ensures that the process is continuously improved.
Related Terms
Design Validation: The process of confirming that the product design meets the user’s needs and is capable of performing as expected in real-world conditions.
Supplier Quality Assurance: The set of practices used to ensure that suppliers provide components that meet the required quality standards, including the use of PPAP to verify that manufacturing processes are capable of consistently delivering high-quality products.
Process Capability: A measure of a manufacturing process's ability to produce parts within specified limits, critical to the PPAP process to ensure consistency and quality.
Control Plan: A document outlining the specific steps and measurements needed to maintain the desired quality during the production process.