ARTICLES BY MARK DURIVAGE

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

  • Using Risk-Based Thinking To Manage Nonconformances And Deviations

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking.

  • Contingency Plans: An Essential Quality Management System Risk Tool

    This article will present the concept of contingency planning and introduce some considerations that can be utilized to develop an effective contingency plan.

  • Using Trending As A Tool For Risk-Based Thinking

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. This article will present definitions and requirements pertaining to process and performance trending and introduce some trending tools that can be utilized throughout the QMS.

  • Using Risk-Based Thinking To Manage Suppliers

    This article will first present the definitions and requirements regarding risk pertaining to the control of suppliers and then introduce some tools to incorporate and integrate risk management techniques within the QMS specifically applied to supplier management/purchasing controls.

  • An Introduction To qFMEA – A Tool For QMS Risk Management

    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.

  • Integrating Risk Management In The Quality Management System — A Primer

    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.

  • How To Establish The Number Of Runs Required For Process Validation

    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.

  • How To Establish Sample Sizes For Process Validation When Destructive Or Expensive Testing Is Required

    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.

  • How To Establish Sample Sizes For Process Validation Using LTPD Sampling

    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.

More Articles by Mark Durivage
Mark Durivage

Mark Durivage

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Mark Allen Durivage is the managing principal consultant at Quality Systems Compliance LLC and an author of several quality-related books. He earned a B.A.S in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. Durivage is an ASQ Fellow and holds several ASQ certifications including CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, and CSSBB. He also is a Certified Tissue Bank Specialist (CTBS) and holds a Global Regulatory Affairs Certification (RAC). Durivage resides in Lambertville, MI.