Using reliability engineering to ensure high-quality products

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The quality-reliability connection When defining a high-quality product, the question of whether the product will work when and how it is neededfor as long as it is neededis usually the first consideration for most people. This is, in fact, the very definition of product reliability: a measure of the probability that an item will perform its anticipated function for a specified period of time.

What is reliability engineering? Reliability engineering is the field dedicated to the study of product reliability more specifically, to predicting, analyzing, and preventing or mitigating product failures. In commercial industries, product reliability is critical to meeting consumer demands for quality products at competitive prices. In regulated industries, like medical device manufacturing and aerospace & defense, product reliability is crucial to meeting government standards for product safety.

The aerospace & defense industry initially developed and continues to rigorously maintain many of the exacting standards and methodologies applied today throughout the field of reliability engineering. This is largely a result of the extremely demanding conditions, high cost, and sensitive nature of A&D products, as well as the large number of human lives that rely on the quality and performance of those products.

In the medical device industry, strict FDA and ISO standards govern the release of products to consumers, requiring rigorous pre- and post-production risk and reliability management activities.

In commercial and industrial fields, reliability engineering enables companies to offer products with competitive performance, reliability, safety, and quality to support customer satisfaction and minimize the results of poor quality, such as warranty claims, repairs, returns, and market share erosion.

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How does reliability engineering impact product quality? Reliability analysis techniques are many and varied, but together they help engineers answer three main questions: How do we reduce the rate of system failures? How do we eliminate or mitigate the sources of system failures? How can we improve products by analyzing their performance in the field?

Reliability analysis techniques are many and varied, but together these three functions create a holistic approach to improving product quality throughout its lifecycle.

Reliability Block Diagrams Reliability Prediction

Maintainability Prediction Life Cycle Cost Analysis

Reduce system failures rates

FRACAS Weibull Analysis Accelerated Life Testing

Gather and analyze test and field failures

FMEA

Reliability Engineering

Eliminate or control system risks

Fault Tree Analysis

life testing Accelerated analysis Weibull FRACAS

test and field failures Gather and analyze

Engineering Reliability

system risks Eliminate or control

analysis Fault tree FMEA

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Together, these three functions create a holistic approach to improving a products quality throughout its life cycle, supporting:

Quality Governance
Audit Management & Execution

Quality Planning
Requirements Management Risk Management (FMEA, Fault Tree) Reliability/Maintainability Prediction Robust Design (DOE, Taguchi, VSA) Test, Control, and Service Planning Design Validation tracking (DVP&R)

Quality governance, by providing input to the governance techniques that oversee this entire process, as well as visibility to high-level management into each of these activities.

Management Review Master Quality Records Quality Reporting/Dashboards Supplier Management Training Management Product Labeling Change Control

Quality planning, by helping to develop more reliable products during early-stage design and system modeling.

Quality
Quality Execution
Quality execution, by influencing product testing and manufacturing procedures to help prevent quality problems in products before they are released to production and use.
Document Control Configuration Management Production Inspection (SPC) Non-Conformance (deviation and waiver) Complaints (field non-conformance) Problem Reports (software, hardware) Supplier Part Inspection & PPAP

Quality Improvement
Failure Reporting (FRACAS) CAPA (DMAIC, PDCA, 8D) RCA (Root Cause Analysis) Continuous Improvement Statistical Trends Analysis

Quality improvement, by communicating real-world quality issues back to earlier lifecycle stages to equip next-generation product design with important metrics and lessons learned from fielded use.

Reliability engineering techniques contribute vital product design and performance information to each of these four quality management activities.

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Understanding reliability engineering techniques Lets examine each of the three areas of reliability engineering in greater detail. Reducing the rate of system failures Reliability engineering analysis begins early in the system design process, before a prototype system is even built. A technique known as Reliability Prediction is used to analyze and predict the failure rate of a system over time and under various operating conditions.

It uses extensive industry sources, known as reliability prediction standards, to calculate the failure rate of a system from the failure rates of its component parts.

Reliability engineering analysis begins early in the system design process, before a prototype system is even built.

Other analyses are used along with reliability prediction to analyze and reduce failure rates:

Reliability Block Diagrams (RBDs) help calculate reliability for complex systems by modeling these systems with complex mathematical algorithms, enabling the analyses of parallel systems, system redundancy, hot/cold/warm standby states, and other complex system configurations. RBD techniques compute reliability and availability metrics for complex systems while accounting for maintenance policies, spare parts, and repair resources.

Maintainability Prediction helps predict a products maintenance and repair metrics based on globally accepted standards and calculations. By analyzing the repair metrics of systems, maintainability predictions help predict repair times, minimize downtime, and increase system availability. Maintainability prediction enables the analyst to predict and define repair tasks and associated resources at any assigned level: from extremely detailed repairs to higherlevel, functional repairs.

Life Cycle Cost Analysis (LCC) uses reliability information to calculate a products cost of ownership. It combines industry-standard or user-defined cost and work breakdown structures to compare costs across alternate designs, helping the analyst reach the most cost-effective and reliable system design. It can include many different types of costs, including design, production, warranty, repair, and disposal.

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Eliminating the sources of system failures Determining how not just how often a system will fail is also central to reliability. Beginning early in system design and extending throughout the vital testing and manufacturing phases, product risks must be managed. Risk analysis techniques consider the sources of system failures and work to eliminate or mitigate these risks in order to safeguard system functioning, system users or others nearby, and the environment in which the system operates. Determining the criticality of each risk relies on identifying first and foremost the requirements of the system what its essential functions are and translating these into critical-to-quality product characteristics. Defining product requirements helps provide a baseline for considering product risks that is, events that could pose a threat to

those essential system characteristics and to the systems ability to carry out its critical functions. Other effects of product risks to users, other people, the environment, and other equipment or functions can also be considered part of a risk analysis.

FMEA, or Failure Mode and Effects Analysis, is a bottom-up method used to

analyze and mitigate product risks. By breaking down a system into its component parts and identifying all the ways those parts could fail, FMEA evaluates the effect of these risks or failure modes on the entire system.

Fault Tree Analysis a top-down methodology examines a single, negative

end-effect and systematically identifies all of its possible contributing factors, working from the system and subsystem level down to the component parts level.

Overheated Battery

Power Supply Conditioner Defective PS-1

Q:3.73597E-5

Q:0.039213

Battery Defective BAT-2 Q:0.005

Temperature Sensor Failure TS-1 Q:0.007472

Power Bus Short BUS-1 Q:0.039211

Power Conditioner Circuit Faliure PS-2 Q:2.9955E-6

Anode Cathode Short BAT-3 Q:0.005

BAT56A04 BAT-4 Q:0

Capacitator Shorted CAP-1 Q:0.002996

Fault Detection Failure FD-1 Q:0.001

The Design FMEA begins with the part and extends to an analysis of its related functions, failure modes, failure rates, causes of failure, and effects (both next- and higher-level effects). It also enables users to connect manufacturing control plans (shown here), test specifications, and maintenance activities directly to the risk analysis, associate these three elements with the part, and communicate them to the responsible parties throughout the organization.

Fault Tree Analysis is a top-down methodology to analyze risk by logically connecting all possible contributing factors to a single, negative end event.

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Risk management using FMEA and Fault Tree Analysis extends not only to the planning and design stages of product development, but also to the testing, manufacture, service, and use stages. It involves identifying tests that need to be performed to verify predicted system risks and discover new ones, establishing manufacturing controls that can mitigate or eliminate risks and formulating best practices for service and use that can help safeguard fielded products from these identified risks. In contrast to FMEA, which is a bottom-up analysis, a Fault Tree Analysis is a top-down methodology beginning with the negative end-event, such as the overheated battery shown below. A Fault Tree Analysis traces this event down through all the possible contributing factors using gate logic (AND, OR, etc.) to represent groups of events that must take place to contribute to the overall negative end-event.

It is easy to see how these two techniques may be used together, so that a part with its associated failure modes and effects identified in the FMEA could be a contributing factor in a Fault Tree Analysis while a negative end-effect in a Fault Tree Analysis could be an associated failure mode or effect of a part identified in an FMEA.

Risk management using FMEA and Fault Tree Analysis can mitigate or eliminate risks and help safeguard fielded products from risks.
Hazardous system-level failure

FMEA:

Part-level failure

Assembly level failure

Fault Tree:

Hazardous system-level failure

Assembly level failure

Part-level failure failure Part-level

level failure Assembly

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Analyzing test or field failures When a product fails during testing or field use, reliability engineering offers techniques to capture failure data such as the source of product failure, the age at which the product failed, and how frequently products failed from the same cause and uses this information to improve future products. A FRACAS or Failure Reporting, Analysis, and Corrective Action System is used to record product failures observed during testing or field use, identify the root cause of the error, implement corrective or preventive actions to address the error in future products, and verify the effectiveness of these actions. A FRACAS can be combined with sophisticated statistical methodologies to further analyze test and field failure information. One such technique, Life Data Analysis or Weibull Analysis, is used to calculate the real-world failure rate of parts and systems from actual failure data collected during testing or field use. A similar technique to Weibull Analysis, Accelerated Life Testing or ALT is used during product testing to extrapolate actual product behavior from the behavior of a small sample exposed to extreme or accelerated conditions.

FRACAS implements a closed loop corrective action process to ensure that every quality issue reported is addressed with root cause analysis, corrective action, and review.

Reliability engineering offers techniques to capture failure data and uses this information to improve future products.
Weibull Analysis is used to calculate the real-world failure behavior of systems from a sampling of parts or equipment

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Integrating reliability analyses to close the quality loop While each of these reliability engineering techniques can be used independently of the others to improve product performance and reduce product risks, it is easy to see how, together, they can have an even bigger impact on product quality. Failure rates calculated during Reliability Prediction and other early system design methods can inform risk analyses like Fault Tree Analysis and FMEA to help calculate how critical a risk is based on how frequently the associated parts are likely to fail. In turn, key risk analyses performed in Fault Tree Analysis and FMEA can be used to reduce product failure rates by informing the system design process of the need for more statistically reliable parts or designs. Product failure data gathered in FRACAS can provide vital information about actual system performance experienced in the field including real-world product failure rates that may be greater or less than those predicted during system design. When designing next-generation products, quantitative field failure information can play a vital role in refining Reliability Prediction data to reflect actual failure rates, in order to help design products whereby predicted performance more closely matches actual performance. Since FRACAS also provides qualitative information related to the source of products failures or the actual risks experienced in the field and the effectiveness of risk controls the data it collects can inform future risk analyses performed on similar or next-generation products, parts, and systems during the design phase. Field data contributes to these analyses actual, experienced sources of risk, effectiveness of novel risk-control measures discovered in the field, and even new information regarding best-practice testing or manufacturing methods devised to correct or prevent such risks.

Observed product failure information (test, field) Observed failure rates Likelihood of failure Predicted reliability, availability, maintainability, cost Recommended risk controls Risk analysis: sources/ effects of failures Observed failure modes

Legend
Reliability Prediction FRACAS Reliability Block Diagram LCC Weibull FMEA Fault Tree ALT Maintainability

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The data FRACAS collects can inform future risk analyses performed on similar or next-generation products, parts, and systems during the design phase.
Analyze Reliability
Reliability Prediction Reliability Block Diagram FMEA Fault Tree FRACAS Maintainability LCC Weibull ALT

Conclusion By connecting product quality gaps experienced during real-world use with the planning and design techniques used to prevent them during product development, reliability engineering methods close the quality loop, reduce repeat quality errors, and help significantly improve next-generation products. To learn more about quality, reliability, and risk management,

Analyze Risk

Analyze Cost

Analyze Logistics

Analyze Field Data

-- Read PTCs whitepaper, Quality Lifecycle Management: Managing Quality, Reliability, and Risk throughout the Product Lifecycle -- View the webcast, Reliability and Quality Planning Across the Product Lifecycle: A QLM Framework -- Study the impact of Quality, Reliability, and Risk Management on various industries at the QLM resource center -- Read about PTCs Windchill Quality Solutions

Used in an integrated fashion, these reliability engineering techniques enable multiple product quality, performance, and safety analyses across the product lifecycle

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