Injection Mold Validation Procedure
The Injection Mold Validation Procedure is used to develop and verify a mold-process which is capable of achieving critical part dimensions and tolerances. The procedure provides detailed instruction for tooling development and validation. The procedure also includes example Operational Qualification (OQ) and Performance Qualification (PQ) protocols and control charts.
Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.
Editable Microsoft Word and Excel files, with related forms and control charts, supplied as a digital download.
Mold-process development and OQ/PQ qualification
The injection-mold validation document organizes process development around critical dimensions, material and equipment settings, operating limits and acceptance criteria. It distinguishes challenges of the proposed operating window from performance at routine settings, with sampling, data review, deviations and a final report. Control charts or other monitoring records can support the decision that the process is stable enough for production. The protocol must be completed with the actual mold, device and process data.
For the broader approach to determining validation needs, acceptance criteria and revalidation, see the separately sold Medical Device Process Validation Procedure. This injection-mold document focuses on mold-process development and qualification.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Process Validation: Protocols, Statistics and Mold Processes for workflow guidance, a checklist and common mistakes.
