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A Systematic Approach to Managing Risk Using DFSS and DFMEA. Gary Deniston, CSQE, CRE, DFSS Black Belt Group Leader, Systems Design Quality Assurance / Reliability Engineering Covidien Energy-based Devices gary.deniston@covidien.com 303-530-6212. Speaker Background. Speaker:

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a systematic approach to managing risk using dfss and dfmea

A Systematic Approach to Managing Risk Using DFSS and DFMEA

Gary Deniston, CSQE, CRE, DFSS Black Belt

Group Leader, Systems Design Quality Assurance /

Reliability Engineering

Covidien Energy-based Devices

gary.deniston@covidien.com

303-530-6212

speaker background
Speaker Background
  • Speaker:
  • Gary Deniston is the Group Leader for the Systems Design Quality Assurance Team at Covidien Energy-based Devices. Gary has been involved with many aspects of systems engineering throughout his 20 plus year career, including application systems engineering, embedded systems software development, software quality assurance, reliability engineering and technical leadership in the medical device and industrial controls industries. Gary holds a BS degree in Computer Science from Regis University, and is a Certified Software Quality Engineer and Certified Reliability Engineer through the American Society of Quality. Gary is a DFSS Black Belt and Six Sigma leader within the Covidien organization.
covidien
Covidien

Imaging Products

Contrast media and devices, radiopharmaceuticals

Pharmaceuticals

Branded and generic pharmaceuticals, acetaminophen, bulk narcotics and specialty chemicals

Surgical Devices

Endomechanical instruments and soft tissue repair products

Respiratory and Monitoring Solutions

Pulse oximeters, ventilators and airway management products

Medical Supplies

Nursing care, needles & syringes, monitoring, and operating room products.

Vascular Therapies

Vascular therapy and compression products

Energy-based Devices

Vessel sealing, electrosurgery and ablation products

presentation objectives
Presentation Objectives
  • Managing technical, safety and project risk is an essential element of successful new medical
  • device product development. DFMEA and key DFSS tools can be leveraged systematically to manage these risks. Information obtained from these tools can aid in project decision making and ultimately can lead to reducing time to market and development cost. This approach is applicable and scalable, from the simpler to the more complex development projects. An overview of this approach used to develop new medical devices will be presented, along with practical examples that can be utilized to continuously exceed our customer’s expectations for quality and reliability.
  • Some of the key topics in this presentation include:
  • How to Leverage Risk Management Tools and Techniques (DFMEA, Fault Trees, Hazard Analysis)
  • with other DFSS Tools (DOE, Tolerance Analysis) to Drive Predictable Product Quality and
  • Reliability Outcomes
  • How to Optimize the Utilization of Project Resources by Gathering and Analyzing the Right Data
  • Examples of this Approach in Action to Develop Safe and Effective Products on Time
the big picture levels of thinking
The Big Picture: Levels of Thinking

Create the foundation for a network of pattern thinking that leads to the desired outcome

Risk analysis and risk management system

Structure

Patterns

Anticipate problems and deal with them before they occur.

FMEA

Events

React to problems after they have occurred.

Testing

iso 14971 2007 harmonized standard for risk management
ISO 14971:2007 – Harmonized Standard for Risk Management
  • “… provides manufacturers with a framework within which experience, insight and judgment are applied systematically to manage risks associated with the use of medical devices.”

“… a self-improving process through which the manufacturer must use knowledge gained post-production to improve and refine the safety of the device.”

Compliance with this standard is rapidly becoming a general requirement of regulatory bodies worldwide.

slide7

Safety Risk Analysis: Top Down Approach

List of Harms

…….

…….

…….

Fault Tree

Hazard Analysis

Occurrence

“It is accepted that the concept of risk has two components:

The probability of occurrence of harm;

The consequences of that harm, that is, how severe it might be.”

ISO 14971:2007 Introduction. Page v

Severity

slide8

FMEA Methods: Bottom Up Approach

Prioritized List

of Potential

Failure Modes

…….

…….

…….

Potential

Product

Safety Issues

…….

…….

…….

PFMEA

DFMEA

System

DFMEA

AFMEA

slide9

Risk Management: System Framework

Risk Analysis

Predictable Product Safety,

Quality and Reliability

Outcomes

Develop

Design

Controls

Design

Requirements

……

(IEC 60601-1)

Perform

Design

Verification

FMEA

risk management project decisions
Risk Management: Project Decisions

Information

Risk Management Process

Change Control

Decisions

Manufacturing

Process Validation

Decisions

Field Failure

Root Cause Analysis

Decisions

Concept

Selection Decisions

Material

Selection

Decisions

Verification and

Reliability Test

Strategy

Decisions

DFSS Tool

Deployment

Decisions

Regulatory

Compliance Testing

Strategy Decisions

Resource

Allocation Decisions

Based on Prioritized

List of Potential

Failure Modes

slide11

FMEA Worksheet

11

14

1

2

3

4

5

6

7

8

9

12

13

10

slide12

FMEA Process Steps

6

1

11

ASSIGN SEVERITY

DIVIDE SYSTEM

INTO

LOGICAL PARTITIONS

CALCULATE THE

RISK PRIORITY

NUMBER

RPN

7

2

12

IDENTIFY

ROOT CAUSE

CREATE A

COMPONENT LIST

FOR EACH

PARTITION

SORT FAILURE MODES

IN RPN ORDER

8

3

13

IDENTIFY PRIMARY

AND SECONDARY

FUNCTIONS

ASSIGN OCCURRENCE

RECOMMEND AND

TAKE ACTIONS

ON THE HIGH

RISK ITEMS

DEPLOY DFSS

TOOLS TO REMOVE

ANY UNCERTAINTY

4

9

IDENTIFY CONTROLS

AND MITIGATIONS

IDENTIFY FAILURE

MODES

14

RE-CALCULATE

RPN

10

5

ASSIGN DETECTION

DESCRIBE

THE EFFECTS

slide16

FMEA Process Steps ~ Identify Controls ~ Assign Detection

9

10

  • Detection is the likelihood

of the controls in place detecting the failure mode.

Score = 10:

Control Does Not Exist or Failure Mode is not detectable

Score = 1:

The Design Control will Almost Certainly Detect The Failure Mode

  • Controls are the safeguarding measures in place at the time of review that are intended to do the following:
  • Eliminate the causes of failure
  • Identify or detect failure
  • Reduce impacts/consequences of failure
slide17

ACME Coyote Lifter

11

12

1

2

3

4

9

10

13

5

7

8

14

6

two level three factor doe
Two Level Three Factor DOE
  • This is a two level three factor experiment with four midpoints
  • Each part was tested until failure and the breakaway torque was recorded.
  • The Torque to Failure values are the responses.
pareto analysis
Pareto Analysis
  • Weld current, time, tip force, and the interactions between weld current and time, and weld current and tip force are the most significant factors.
interaction plot graphical analysis
Interaction Plot Graphical Analysis
  • The plot indicates that an increase in weld current and time results in increased weld strength. The plot also indicates that a decrease in tip force results in increased weld strength. There is some interaction between the weld current and time and weld current and tip force.
main effects plot graphical analysis
Main Effects Plot Graphical Analysis
  • By comparing the slopes of the lines on the plots, you can compare the relative magnitude of the factor effects. Again, the plot indicates that an increase weld current and time results in increased weld strength. The plot also indicates that a decrease in tip force results in increased weld strength.
slide23

ACME Coyote Lifter

11

12

9

13

8

10

14

key takeaway
Key Takeaway
  • Shifting our level of thinking from event level to structure level allows us to be more effective
  • Risk Management and DFSS tools can be leveraged systematically to manage risks.
  • Information obtained from these tools can aid in project decision making and ultimately can lead to reduced time to market and development cost.
  • For high RPN failure modes a DOE may be useful to identify the factors and interactions that have the highest impact on critical responses and to determine the optimal design parameters to reduce the likelihood of occurrence of a failure mode.
slide26

FMEA Process Steps ~ Logical Partitioning ~ Create a Component List

1

2

  • Segment the System into Logical Partitions
  • Create a Component List
    • In an Application FMEA each user interaction may be considered a component
    • In the System FMEA each Functional Block may be considered a component
    • In the Design FMEA the structured BOM is an excellent source of a component list
    • In the process FMEA each process step can be considered a component
slide27

FMEA Process Step ~ Identify the Functions

3

  • From the component list develop a list of the component functions
  • A component may have multiple functions
  • Identifying component functions serves two purposes:
    • It sets the baseline for identifying the primary failure modes
    • It identifies components that are likely to have multiple failure modes
slide28

FMEA Process Step ~ Identify the Failure Modes

4

  • A potential failure mode is the manner in which a failure can occur or the ways in which it can fail to perform its intended function
  • Typical potential failure modes include the following:
      • Fail to open/close
      • Brittle
      • Cracked
      • Warped
      • Undersized/ Oversized
      • Open / Short
      • Corrupted
slide29

FMEA Process Step ~ Describe the Effects

5

  • Consider the effect on the end user of the product
  • Potential failure effects may include these examples:
    • System shuts down and becomes nonfunctional
    • Loss of control of system
    • Erratic system operation
slide31

FMEA Process Step ~ Indentify The Root Cause

7

  • Potential failure causes identify the Root Cause of the failure mode and provide an indication of a design weakness that leads to the failure mode.
  • Failure Causes often include these types of problems:
    • Overstressing
    • Incorrect Material Specified
    • Improper Tolerance
    • Stability and Aging
slide33

FMEA Process Steps ~ Identify Controls ~ Assign Detection

9

10

  • Detection is the likelihood

of the controls in place detecting the failure mode.

Score = 10:

Control Does Not Exist or Failure Mode is not detectable

Score = 1:

The Design Control will Almost Certainly Detect The Failure Mode

  • Controls are the safeguarding measures in place at the time of review that are intended to do the following:
  • Eliminate the causes of failure
  • Identify or detect failure
  • Reduce impacts/consequences of failure
slide35

FMEA Process Step ~ Calculate RPN

11

  • An RPN is a measurement of relative risk. It is calculated by multiplying together the severity, occurrence and detection ratings. The RPN is determined before implementing recommended actions and is intended to be used to prioritize the actions.
  • A policy for assigning corrective actions based on the value of the RPN should be agreed upon early in project planning.
slide36

FMEA Process Steps

~ Sort Failure Modes by RPN~ Take Actions on High RPN~ Recalculate the RPN

12

13

14

  • An RPN is a measurement of relative risk. It is calculated by multiplying together the severity, occurrence and detection ratings. The RPN is determined before implementing recommended actions and is intended to be used to prioritize the actions.
  • This process is iterated Continuously throughout a product’s life.
leveraging dfmea with other dfss tools
Leveraging DFMEA with other DFSS Tools
  • The DFMEA recommended actions field may be used to identify opportunities for controls to be developed through the PFMEA.
  • DFSS tools often are useful in determining or validating assumptions made on the occurrence ranking
      • Tolerance Analysis
      • Monte Carlo Simulations or Circuit Simulations
      • Reliability Testing
  • For high RPN failure modes a screening DOE may be useful to identify the factors and interactions that have the highest impact on critical responses.
slide38

Maximize Benefits of Reuse

  • By using a modular approach to DFMEA the benefits of reuse can be maximized. If the design is modularized into logical partitions, the data and information can be managed so that it is easily reused on future projects.
  • The modularity approach will encourage reuse of this information on future designs. These logical partitions or modules can be viewed as building blocks. Building a framework that allows these blocks to easily be linked leads to increased efficiency on each subsequent project that reuses modules from the preceding project.
references
References

McDermott RE, Mikulak RJ,

Beauregard MR. 1996.

Dailey KW. 2004.

Failure Modes and Effects Analysis during Design of Computer Software

0-7803-8215-3/04/$17.00 2004 IEEE

FMEA Is Not Enough

1-4244-2509-9/09/$20.00 IEEE

Using Failure Mode Effect Analysis to Increase Electronic Systems Reliability

1-4244-1218-8/07/$25.00 IEEE