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Technical Library - Articles that can be downloaded

Acceptance Sampling

Articles:

Confidence Statements Associated With Sampling Plans (12/97 - 1 page)

Selecting Statistically Valid Sampling Plans (10/97 - 6 pages)

Alternative Sample Sizes for Verification Dose Experiments and Dose Audits (5/97 - 12 pages)

Acceptance Sampling Update (10/95 - 8 pages)

Selecting Representative Samples (2/95 - 2 pages)

The Importance of Trending Attribute Data (11/94 - 1 page)

The Effect of Lot Size (9/94 - 1 page)

Statistically Valid Sampling Plans (3/94 - 1 page)

Classifying Defects and Selecting AQLs (11/93 - 1 page)

Other Sources of Information

List of Standards

Change-Point Analysis

Change-Point Analysis: A Powerful New Tool For Detecting Changes - Detailed explanation of how a change-point analysis works. 19 pages. To download in pdf format, click here: (0.1 MB).

A Pattern Test for Distinguishing Between Autoregressive and Mean-Shift Data - Very technical. 14 pages. To download in pdf format, click here: (0.1 MB).

ASA 2002 Presentation - Change-Point Analysis - To download slides in pdf format, click here: (0.1 MB). To download paper in pdf format, click here: (0.1 MB).

Validation

Methods and Tools for Process Validation (5/98 - 4 pages) Written for Global Harmonization Task Force (GHTF) Study Group #3 Quality Management Systems - Process Validation Guidance – Edition 2. Appears as Annex A in document.

DEVICES

Code of Federal Regulation: Title 21, Subsection H, Part 820, Section 820.75.

Federal Register - Preamble Vol. 61, No. 195, October 7, 1996.

Global Harmonization Task Force (GHTF): “Quality Management Systems - Process Validation Guidance – Edition 2,” January 22, 2004.

Global Harmonization Task Force (GHTF): “Quality Management Systems - Process Validation Guidance – Edition 1,” January 22, 2004. (OBSOLETE)

Food & Drug Administration (FDA): “Design Control Guidance for Medical Device Manufacturers,” March 1997.

   DRUGS

Food & Drug Administration (FDA): “Process Validation: General Principles and Practices ,” January 2011.

Process Validation A Lifecycle Approach, Grace E. McNally, FDA, May 6 2011.

Food & Drug Administration (FDA): “Guideline on General Principles of Process Validation,” May 1987. (OBSOLETE)

Robust Design and Tolerance Analysis

Process Tolerancing: A Solution to the Dilemma of Worst-Case Versus Statistical Tolerancing (9/97 - 15 pages)

Reducing Variation During Design (2/96 - 6 pages)

Comparing Three Approaches to Robust Design: Taguchi Versus Dual Response versus Tolerance Analysis (10/96 - 10 pages - pdf)

Measurement Error

Articles:

Measurement Error Due To Rounding (10/97 - 1 page)

Describing Compounder Accuracy (12/04 - 1 page)