2017 - The Dynamic Control Plan

Key Take Away
Failure mode effects analysis (FMEA) is the key input source for development of a control plan in advanced quality planning (AQP). The dynamic control plan is the very logical extension of an FMEA to include the control plan, thus connecting control points directly to failure modes and ensuring that they are updated in response to evolution of the FMEA.
Overview
Quality Function Deployment (QFD), design FMEA, process FMEA, and the control plan are all interrelated activities in advanced quality planning. The control plan, in turn, identifies gages and instruments that must be covered by the calibration program and, where applicable, measurement systems analysis (MSA). This webinar will describe all of these activities and their synergistic roles in AQP.
The FMEA training course will however focus on FMEA, including some caveats that are not covered in traditional references. These include the fact that a failure mode's risk depends not only on its individual chance of occurrence as reflected by the occurrence rating in FMEA, but also on the frequency of exposure to the risk. The Risk Priority Number (RPN) also has limitations noting that it is actually the product of three ordinal numbers: the severity, occurrence, and detection risks.
The FMEA is presented in a columnar format, and the dynamic control plan simply adds additional columns for aspects of the control plan. This relates aspects of the control plan directly to failure modes, and ensures that the control plan is updated in response to changes in the FMEA portion of the dynamic control plan.
Why Should You Attend
FMEA and control plans are key aspects of advanced quality planning, and their combination into a dynamic control plan delivers significant planning advantages. FMEAs are, or should be, living documents that drive continual improvement as opposed to once and done activities, and these improvements should be reflected in the control plans for the processes involved.
In addition, the traditional approach to FMEA overlooks the consideration that risk is not the individual chance of occurrence (as reflected by the Occurrence rating on a 1 to 10 scale), but this chance multiplied by the frequency of exposure. As an example, if the individual chance of occurrence is 1 in 2 million, this will be reflected as an occurrence rating of 1 (best possible). If however the product consists of 50 million tire valve stems, nonconformance’s that affect product safety (9 to 10 severity) become near certainties. The Army's Risk Management Process, in contrast, recognizes frequency of exposure as an issue. RPN, meanwhile, has the drawback of being the multiplicative product of three ordinal numbers, so judgment must be applied to prioritize activities to reduce risks associated with each failure mode.
Areas Covered In This Webinar
1. Roles of QFD, FMEA, and the control plan in AQP (APQP in automotive)
2. Definition of critical and significant characteristics; those which affect product safety and customer satisfaction respectively. These are also known as critical to quality (CTQ) characteristics that must be assured by the control plan.
3. Procedure for FMEA preparation, including definitions of failure mechanisms and modes, along with severity, occurrence, and detection ratings. The product of these ratings is the Risk Priority Number (RPN).
4. Limitations of the RPN, and the need to address failure modes with catastrophic severities regardless of their RPNs. Frequency of exposure to the risk in question also must be considered, as is done in the Army's Risk Management Process but not by traditional FMEA.
o A key take away from the latter consideration is the need to make mistakes and failures physically impossible for jobs that are repeated multiple times. If it is possible to do the job wrong, it will eventually be done wrong regardless of the skill and diligence of the workers. The need for engineering controls (Army terminology), poke-yoke (error proofing), or Henry Ford's "Can't rather than don't" principle has been underscored repeatedly in Shigeo Shingo's case studies.
5. Control factors are aspects of the process that can affect CTQ characteristics. Process controls are required in the forms of, for example, statistical process control, error proofing, or automatic process controls of the kinds often found in chemical plants.
6. Extension of the FMEA's columns to include the control plan results in the dynamic control plan.
Learning Objectives
Attendees will learn:
• The roles of FMEA and control plans in advanced quality planning
• Basics of FMEA preparation, and practical considerations that go beyond the textbook aspects.
• Control plan considerations
• Creation of a dynamic control plan
Who Will Benefit
• 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
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