BIOGRAPHY

Mark Allen Durivage

Managing Principal Consultant, Quality Systems Compliance LLC, Lambertville, MI, USA

Mark Allen Durivage has worked as a practitioner, educator, and consultant. He is Managing Principal Consultant at Quality Systems Compliance LLC located in Lambertville, MI. His consulting practice includes a diverse clientele serving clients globally. Durivage has been elected to Fellowships in ASQ and SRE. Durivage holds several professional certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS.

Durivage has written several books available through ASQ Quality Press including Practical Engineering, Process, and Reliability Statistics, Practical Attribute and Variable Measurement Systems Analysis (MSA), and Practical Design of Experiments (DOE) A Guide for Optimizing Designs and Processes, published articles in Quality Progress, is a frequent contributor to Life Science Connect, and other recognized quality-related trade publications.

Areas of subject matter expertise include statistical quality and process control, sampling plans, equipment and facility qualification, process validation, design of experiments (DOE), process optimization, measurement systems analysis (MSA), and risk management.

Durivage primarily works with companies in the FDA regulated industries (medical devices, human tissue, animal tissue, cosmetics, and pharmaceuticals) focusing on quality management system implementation (QMS), integration, updates, training, and auditing (internal, supplier, and compliance). Additionally, he assists companies by providing internal and external audit support as well as FDA 483 and Warning Letter response and remediation services. Additionally, he also assists and supports organizations with ISO 9001, ISO 13485, ISO 14001, ISO 15378, ISO 17025, and ISO 45001 systems with implementation, integration, updates, training, and auditing (internal, supplier, and compliance).


ABSTRACT

Defining QMS Processes to Increase Effectiveness

Defining and measuring quality management system (QMS) processes is an oft overlooked and misunderstood requirement when implementing ISO QMS standards. ISO 9000:2015 Quality management systems - Fundamentals and vocabulary states ‘Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system’.

ISO 9000:2015 further explains a ‘QMS consists of interrelated processes. Understanding how results are produced by this system enables an organization to optimize the system and its performance. Acknowledging that a QMS consists of several interrelated processes, understanding how results are produced by that system of interrelated processes enables an organization to optimize the system and improve its performance.ISO 9001:2015 Quality management systems – Requirements promotes the adoption of the process approach when developing, implementing, and improving the effectiveness of the QMS, to enhance customer satisfaction by meeting customer requirements.

Organizations are required to determine the processes needed for the QMS, determine the required inputs required and the expected outputs, assign the responsibilities and authorities, and address the risks and opportunities associated with the process.

Additionally, organizations are required to determine and establish measurements of process effectiveness and/or efficiency to ensure the successful operation and control of these processes, and evaluate these processes and for changes needed to ensure processes achieve their intended results. The primary means of process monitoring and measurement of process besides the obvious variable and attribute measurements of process outputs includes internal audits and management review.

This presentation will demonstrate a method of defining and categorizing the processes needed for the QMS, documenting the process requirements, and determining the effectiveness and/or efficiency of processes utilizing process approach audits.













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