Guidance to API Specification Q2 (API 18TR2)

Scope of Guidance Document
This document provides guidance on the intent and use of API Specification Q2 (API Q2). This document is not intended to provide training on the development and implementation of a quality management system.  This document will not provide guidance to each section of the API Q2.

What is there in Guidance Document ?

This guidance document provides basic clarity on the following sections of API Spec Q2

  • Risk Assessment and Management ( API Spec Q2 Clause 5.3)
  • Contingency Planning   ( API Spec Q2 Clause 5.5)
  • Purchasing Controls and Purchasing Information ( ( API Spec Q2 Clause 5.6.1 and 5.6.2)
  • Service Quality Plan( ( API Spec Q2 Clause 5.7.2)
  • Identification and traceability ( API Spec Q2 Clause 5.7.3)
  • Customer Property  ( API Spec Q2 Clause 5.7.5)
  • Validation of Service Related Products ( API Spec Q2 Clause 5.7.7)
  • Preventive Maintenance and Inspection Test Program (API Spec Q2 Clause 5.7.8)
  • Control of Testing, Measuring, Monitoring and Detection Equipment ( API Spec Q2 Clause 5.8)
  • Nonconforming Service Execution and SRP ( API Spec Q2 Clause 5.10.2)
  • Management of change implementation ( API Spec Q2 Clause 5.11.2)
  • MOC Notification and Control  ( API Spec Q2 Clause 5.11.3)
  • Internal Audit  ( API Spec Q2 Clause 6.2.2)
  • Analysis of Data  ( API Spec Q2 Clause 6.3)
  • Preventive action  ( API Spec Q2 Clause 6.4.3)
  • Management Review – General (API Spec Q2 Clause 6.5.1)
  • Management Review Inputs – (API Spec Q2 Clause 6.5.2)

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