Articles by Mark Durivage
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An Introduction To qFMEA – A Tool For QMS Risk Management
5/8/2017
The real issue in developing a QMS failure mode effects analysis (qFMEA) for the quality management system is how to develop the scales traditionally used to calculate the risk priority number.
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Integrating Risk Management In The Quality Management System — A Primer
4/7/2017
This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.
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How To Establish The Number Of Runs Required For Process Validation
3/3/2017
FDA regulations, ISO standards, and GHTF guidance documents do not prescribe the number of runs required for process validation activities. Industry has typically used three batches during the process performance qualification phase to demonstrate that a process is capable of consistently delivering quality product, but the so-called "rule of three" is no longer appropriate for process validation activities.
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How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing Is Required
1/30/2017
This article will discuss how to establish sample sizes for process validation when the testing required is expensive or destructive. Of all the approaches discussed in this series, this one is probably the most difficult to address and statistically justify.
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How To Establish Sample Sizes For Process Validation Using LTPD Sampling
12/27/2016
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.
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How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans
11/28/2016
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.
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How To Establish Sample Sizes For Process Validation Using Statistical Tolerance Intervals
10/27/2016
This article demonstrates how to use statistical tolerance limits, which use the confidence level (how sure we are) and reliability value (population value) to determine appropriate statistically valid sample sizes for process validation.
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How To Establish Sample Sizes For Process Validation Using C=0 Sampling Plans
9/7/2016
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of C=0 sampling plans to establish sample sizes for process validation.
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How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
7/19/2016
This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.
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Risk-Based Approaches To Establishing Sample Sizes For Process Validation
6/14/2016
Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.