In the highly regulated, patient-critical medical device industry, consistent quality, safety, and performance of components and finished products is essential. Even minor variations in materials, dimensions, or manufacturing processes can compromise product integrity, put patient safety at risk, and result in costly recalls or regulatory delays.
That’s where the Production Part Approval Process (PPAP) comes in.
What Is PPAP and Why Does It Matter in MedTech?
Originally developed for the automotive sector, PPAP has become a powerful quality assurance tool in the medical device industry. Its structured, standardized approach verifies that a supplier’s production process consistently produces parts that meet all defined specifications.
In medical device manufacturing—where tolerances are tight and compliance is critical—PPAP helps ensure:
- Full alignment between supplier capabilities and customer expectations
- Traceable, documented validation of each component or process
- Reduced risk of late-stage product failures and recalls
- Increased confidence in both regulatory compliance and product performance
PPAP also aligns with global quality standards and regulatory expectations such as FDA requirements, ISO 13485, and guidelines from other health authorities.
SQA’s PPAP Managed Program: A Smarter Approach
SQA Services is a recognized leader in delivering PPAP support to global supply chains in regulated industries. Our PPAP Managed Program is designed to help medical device manufacturers and their suppliers implement, execute, and continuously improve PPAP efforts, especially when internal resources or expertise are limited.
We break our support into three key phases:
- PPAP Readiness Assessment: A one-day on-site evaluation to determine whether a supplier has the infrastructure, documentation, and training needed to properly execute PPAP. If gaps are found, SQA provides tailored support to build readiness.
- Initial PPAP Execution: Hands-on guidance at the supplier site, where SQA’s quality experts train, monitor, and assist in completing the supplier’s first PPAP submission. This ensures a compliant and complete process from the start.
- Ongoing Review and Remediation: As the supplier gains experience, SQA shifts to reviewing submitted PPAPs, identifying gaps, and recommending or implementing corrective actions to ensure compliance and consistency.
Why Medical Device Companies Choose SQA
Implementing PPAP effectively doesn’t just reduce regulatory risk—it can save time and money across the supply chain. With SQA’s help, clients benefit from:
- Fewer delays and rework
- Lower scrap and recall rates
- Improved supplier accountability and transparency
- Reduced quality control costs through upfront process control
- Stronger alignment between suppliers and internal quality teams
By working directly with your suppliers, SQA enables your supply chain to consistently meet specifications and deliver quality from start to finish.
Interested in learning more? Reach out via the contact us form on our website or email us at [email protected].
