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Dynamic Control Plans Drive Continual Improvement (MFG361I)

Presented by: William A. Levinson, P.E.
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Pre Recorded Webinar
60 minutes
  •  Wed, March 2, 2016
Event Description
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Know How the Dynamic Control Plan Fits Into the Quality Management System to Support AQP

The control plan is an important part of advanced quality planning (AQP). It describes how, in terms of measurement procedures and equipment, the process is to measure and control critical to quality (CTQ) product characteristics. The control plan is in turn the result of the deliverables from the Failure Mode and Effects Analysis (FMEA), which is another element of AQP.

The FMEA and the control plan can also both be shown in context with quality function deployment (QFD) or the house of quality. The voice of the customer as reflected in QFD is an input that defines critical and significant product characteristics for the design FMEA. The design FMEA provides inputs to the process FMEA, whose outputs dictate the nature of the control plan.

The tabular format of the FMEA includes a row for each part (or process step), its potential failure mode (how it can fail) and effect (the consequences if it does), calculation of its risk priority number (RPN), existing controls, and action plans to reduce the RPN. The dynamic control plan is a logical extension of the FMEA with additional columns for control plan elements such as the measurement method (gage, sample size, and sample frequency), gage capability, process capability, and out of control action plan. This makes the FMEA and control plan into a single entity.

The result is a living document that addresses the risks (in terms of severity, likelihood of occurrence, and likelihood of non-detection) of non-conformance of CTQ characteristics. "Living document" means it is updated to reflect changes and improvements in the product and the process. The dynamic control plan also supports ISO 9001:2015's provisions for actions to address risks and opportunities, and also knowledge retention.

Join expert speaker William A. Levinson to learn how the dynamic control plan fits into the quality management system to support AQP, and also supports ISO 9001:2015's provisions for activities to address risks and opportunities, and knowledge retention. Know how to calculate the risk priority number (RPN), but also recognize that some RPNs are more equal than others. That is, a RPN of 100 with 10 severity, 2 occurrence, and 5 detection requires far more attention than an RPN of 200 with 2 severity, 10 occurrence, and 10 detection. Go beyond textbook FMEA by recognizing that risk involves not only the individual occurrence rating but also the number of parts or transactions involved; that is, the number of times we are exposed to the risk. Know how to combine the FMEA and control plan to get a living document, i.e. one that is updated in response to changes in the process, product, or customer needs, that focuses priorities on critical to quality features and ensures closed-loop actions to reduce risks and improve quality.

Session Highlights:

  • Learn the role of the FMEA and the control plan in advanced quality planning (AQP)
  • Recognize critical characteristics (those that can impact safety or regulatory compliance) and significant characteristics (those that can impact conformance to customer requirements). These must be addressed by the control plan in terms of:
    • Measurement/inspection process including frequency and sample size
    • Measurement equipment (gages), which is in turn subject to calibration and measurement systems analysis (MSA) requirements.
  • Know the numerical rating systems for severity (S), likelihood of occurrence (O), and likelihood of detection (D), and how to multiply them to get a risk priority number (RPN).
    • Also recognize, however, that a severity of 9 or 10 puts the failure mode into the 'legal zone' regardless of RPN.
    • Recognize Army Techniques Publication (ATP) 5-19, "Risk Management," as a simpler alternative to FMEA when it is difficult to quantify the exact probability of occurrence and/or non-detection.
    • ATP 5-19 also recognizes that risk involves not only the individual chance of occurrence (p, nonconforming fraction as reflected by the FMEA occurrence rating), but also the number of exposures to it (n, the number of items exposed to the risk). It therefore offers a perspective that FMEA does not. Suppose for example that the probability that a nurse will connect an enteric feeding tube to an intravenous line is 1 in 1.5 million. This low probability would result in an FMEA occurrence rating of 1 (best possible), which would imply little need for action despite the maximum severity rating. When we recognize that nurses perform this task millions of times per year, however, multiple fatalities become almost certain. The same principle that risk is really np rather than just p applies to safety-related automobile components and many other products.
  • Know how to combine the FMEA and control plan into a dynamic control plan that addresses directly and explicitly the CTQ characteristics and their associated risks.

Who Should Attend

  • Quality management professionals
  • Engineers and technicians with quality management system responsibilities
  • Design engineers
  • People with responsibilities for ISO 9001:2015 or ISO/TS 16949 compliant systems
  • VP Engineering
  • Office Managers & Admin
About Our Speaker(s)

William A. Levinson | Quality and Productivity Management SpeakerWilliam A. Levinson P.E.
William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He is also the author of several books on quality, productivity, and management, of which the most recent ... More info

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