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Standards & Guidelines

This section provides readily accessible reference to both industry standards and guidelines used in many industries today.  All of the standards and guidelines provided are free from usage restrictions.  Most of the references below are provided via public accessible government sources.  Some of the references are obsolete, but listed to allow the reader a historical framework for active standards today.  If you have a standard or guideline that you think would be useful here, then please feel free to send us your comments using the "Feedback" applet found in the footer below.  Thank you for visiting our site, and feel free to tell others about it if find your visit rewarding.

Useful Standards

Corrective Action and Disposition System for Non-Conforming Material, MIL-STD 1520C
This is a US Department of Defense standard for all government contractors that establishes requirements for the corrective action and disposition of non-conforming material.  It formed the basis for the development of similar systems in the automotive and regulated medical device, pharmaceutical, life-sciences, and vaccines industries.  Version C became effective in June 1986.
US Code of Regulations: Title 21, Subchapter H, Para 820, Sec. 75, Medical Device Process Validations
Contains the most recent language supporting the requirements for medical device process validations.
US Federal Register - Preamble to 21CFR Parts 808, 812, and 820 Medical Devices CGMP Practices
This Preamble is provided in Federal Register Vol. 61, No. 195, October 7, 1996. It provides industry and regulator comments supporting the transition of Good Manufacturing Practices into the Quality System Regulation.  It is useful reference for industry quality and compliance professionals.
MIL-STD-105E (1989) - Sampling Procedures and Tables for Inspection by Attributes
Provides procedures developed by the US government that support sampling by attributes. This standard is now obsolete and no longer supported. It was cancelled on 27 Feb 1995. However, it is still useful as it follows its commercial equivalent ANSI/ASQC Z1.4 with the exception that the sampling plans in MIL-STD 105E are indexed on lot size. This indexing was done to improve the marginal quality risk associated with the shipment of small volumes of government military hardware.

Useful Guidelines

Guide for Using MIL-STD 1629: Failure Mode, Effects, and Criticality Analysis
This document prepared by the US Department of Defense Reliability and Analysis Center.  It provides extensive guidance on the use of Failure Mode, Effects, and Criticality Analysis for mission critical systems.
US Department of Energy Root Cause Analysis Guideline DOE-NE-STD-1004-92
The primary support area for this guideline is the Nuclear industry.  It's recommended use is to conduct root-cause safety assessments when issues occur in that industry. It's focus is on human error, as it's believed that is the largest contributor to accidents in the Nuclear industry. This guide is included here to provide the reader with a view how other industries manage root-cause investigations.
Guidance for Drug Manufacturing Industry: Process Validation Principles and Practices, Rev. 1 Jan 2011
Provides the latest guidance by the Center for Drug Evaluation and Research (CDER) on the best practices supporting manufacturing process validation.
Process Validation Lifecycle Approach, Grace E McNally, FDA Sr. Policy Advisor, May 2011
Presentation by G.E. McNally provides the latest thinking on conducting process validations for drug products.  In this presentation McNally covers the fundamental concepts supporting the CGMPs for drug product process validations and presents the latest concepts supporting process validation using a lifecycle approach.
FDA Guidance on Design Control for Medical Devices, March 1997
This guideline establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes..

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