Process Validation Kit: Master Validation Plan, IQ / OQ / PQ Protocol & Report Templates, Sample Size Calculator

Not eligible for NQT documentation review.

Process Validation Kit: Master Validation Plan, IQ / OQ / PQ Protocol & Report Templates, Sample Size Calculator

Master validation plan, IQ/OQ/PQ protocol and report templates, and a calculator for success-run sample size, binomial sample size with allowed failures, and Ppk acceptance.

What's inside:

- 00_Start_Here_README.pdf

- 01_Master_Validation_Plan.docx

- 02_IQ_Protocol_and_Report.docx

- 03_OQ_Protocol_and_Report.docx

- 04_PQ_Protocol_and_Report.docx

- 05_Sampling_Rationale_Calculator.xlsx

Sample-size math checked: 95/95 gives 59, 95/99 gives 299, 90/90 gives 22 (zero failures).

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice.

Not affiliated with or endorsed by SpaceX or any other current or former employer of the author.

Norman Quality Tools is not affiliated with or endorsed by any standards body, certification body, government agency or company named in this description.

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