Quality Control Out-of-Specification Investigation Form

Streamline OOS Investigations with Paperform

When a quality control test returns out-of-specification results, manufacturers need a structured, traceable investigation process that meets regulatory requirements while keeping production moving. This Quality Control Out-of-Specification Investigation Form provides a complete framework for documenting OOS events, conducting root cause analysis, and making defensible disposition decisions.

Built for quality assurance teams, laboratory managers, and production supervisors in pharmaceutical, food and beverage, chemical, and regulated manufacturing environments, this template helps you maintain compliance with FDA, ISO 9001, and GMP standards while reducing paperwork overhead.

What this template covers

The form guides investigators through every phase of the OOS process: initial detection and documentation, preliminary laboratory investigation (Phase I), extended investigation when needed (Phase II), root cause determination, retest authorization protocols, and final material disposition. Custom conditional logic ensures teams only complete relevant sections based on investigation findings, while calculation fields track timelines and escalation requirements automatically.

How Paperform enhances quality processes

Unlike static PDFs or spreadsheet-based systems, Paperform makes OOS investigations more efficient and reliable. The form adapts in real-time based on responses—if a laboratory error is identified, additional assessment fields appear automatically. When investigations require management approval, you can route submissions through Stepper to notify the right stakeholders, update your quality management system, and track resolution status without manual follow-up.

The built-in eSignature capability via Papersign lets QA managers, laboratory supervisors, and production leads approve investigations digitally, creating a complete audit trail that's always linked to the original investigation record. No more chasing down wet signatures or managing separate approval documents.

Built for manufacturing workflows

This template is designed for regulated industries where documentation integrity and traceability are non-negotiable. Use it to replace cumbersome paper-based OOS procedures, ensure consistent investigation practices across shifts and facilities, and make audit preparation straightforward. All submission data can flow directly into your QMS, ERP, or LIMS through Paperform's integrations, keeping quality records synchronized across your entire operation.

Whether you're managing a single production line or coordinating quality across multiple manufacturing sites, this OOS investigation form gives your team the structure and flexibility they need to resolve specification failures efficiently while maintaining the rigorous documentation that regulators expect.