Process Validation Capabilities

Source: PTI Engineered Plastics, Inc.

PTI is experienced in advanced precision inspection and testing abilities that tackle a number of dimensional and functional product requirements and specifications. These validation processes support a wide range of comprehensive inspection actions including receiving final audits, first article layouts, and full AIAG PPAP and IQ, OQ, PQ Process Validation Submissions.

It is important to go through validation in order to ensure that the design, process, and products are manufactured to the safest measures, and to ensure that the part meets the application requirements, specifications, and regulatory obligations.

The PTI Validation Process includes:

  • A multi-functional hands-on team that will collaborate throughout the validation process
  • Defining the requirements and plan the approach
  • Identifying product outputs and acceptance criteria for form and function
  • Identifying and describing the necessary processes and equipment
  • Creating a validation master plan – otherwise known as an MVP, CVP, or master protocol
  • Developing the validation protocols and any other necessary documentation
  • Performing the validation protocols
  • Maintaining and validating the validated state during the production process
  • Revalidating — required when equipment changes, a process deviation occurs, and on a periodic basis (such as annual equipment and software revalidations)

Visit the PTI webpage for more on the benefits of using PTI in your validation process.