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Home » LMS » CRE Preparation Course » I. C. Ethics, Safety, and Liability » I. C. 3. System Safety

by Fred Schenkelberg Leave a Comment

I. C. 3. System Safety

I. Reliability Management
C. Ethics, safety, and liability

3. System safety (Analyze)

Identify safety-related issues by analyzing customer feedback, design data, field data, and other information. Use risk management tools (e.g., hazard analysis, FMEA, FTA, risk matrix) to identify and prioritize safety concerns, and identify steps that will minimize the misuse of products and processes.

When a product or system fails it may increase the risk of harm (safety incidents). Likewise as systems age or degrade. The tools reliability engineers use to identify and reduce reliability risks are value to identify and eliminate or mitigate safety risks.

 

  • mp4 I. C. 3. System Safety video Download
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  • mp3 I. C. 3. System Safety audio Download

Additional References

MIL-STD-882E System Safety 11 May 2012 (pdf)

3 Steps NRTL use for product safety (article)

Required Case History for Reliability Engineers (article)

Quick Quiz

1-123. Which of the following is not a system-safety analytical technique?

(A) hazard analyses
(B) design readiness reviews
(C) fault tree analyses
(D) logic diagram analysis

Answer

(B) design readiness reviews

Discussion

While important as part of the design process, readiness reviews do not specifically focus on system safety.


1-124. A sample of a chocolate bar is tested for the presence of peanuts (a potential allergen). Identify the only possible valid statement of the results.

(A) A “positive” result means that, given the state of the technology, no peanuts can be detected.
(B) A “negative” result means that, given the state of the technology, no peanuts can be detected.
(C) Levels above one part per billion are to be rejected.
(D) A gram of peanuts is permissible.

Answer

(B) A “negative” result means that, given the state of the technology, no peanuts can be detected.

Discussion

Testing includes the capability of the measurement system including measurement error. A test that does not find evidence is only valid to the limits of the measurement capability.


1-125. There are numerous reasons to assess human factors in product safety planning. Which is not one of them?

(A) to allocate the proper balance between humans and machine
(B) to address the limitations of human beings
(C) to ascertain the user hardware interaction
(D) to accelerate material property test results

Answer

(D) to accelerate material property test results

Discussion

The testing of materials may provide information concerning product safety, yet is not a human factors element thus not necessary for an assessment of human factors for safety planning.


1-126. Identify which of the following is not a way of eliminating a hazard?

(A) performing a contingency analysis
(B) performing a fault-tree analysis
(C) performing a FMEA
(D) performing a procedure analysis

Answer

(A) performing a contingency analysis

Discussion

The key word here is “contingency” which implies the failure has occurs and the analysis is for a backup or work around process.


1-130. Identify the Incorrect statement concerning preliminary hazard analysis.

(A) Preliminary hazard analysis is best accomplished with actual customer complaint data of the product.
(B) Preliminary hazard analysis is normally conducted at a time when there is little design detail.
(C) Preliminary hazard analysis entails a review of safety problems prior to production.
(D) Preliminary hazard analysis can be used to identify the principal hazards when the product is in the conceptions phase.

Answer

(A) Preliminary hazard analysis is best accomplished with actual customer complaint data of the product.

Discussion

The key word is “preliminary” which implies early or first analysis. Using customer complaint information implies the product is produced and shipped to customer before the analysis occurs. In general the purpose of a hazard analysis is to avoid providing a product to customers that posse a potential hazard.


1-145. Hazard severity categories are used to provide a measure of the seriousness of an event in the area of risk assessment. How would a system failure causing major environmental damage be classified?

(A) catastrophic
(B) critical
(C) marginal
(D) negligible

Answer

(B) critical 

Discussion

Hazard severity categories, originally defined in MIL-STD-1629A Procedures for Performing a Failure Mode, Effects and Criticality Analysis (canceled in 1998) and currently defined in MIl-STD 882D, Standard Practice for System Safety, February 10, 2008, p. 18. define the terms as follows:

Catastrophic — Could result in death, permanent total disability, loss exceeding $1M, or irreversible severe environmental damage that violates law or regulation.

Critical — Could result in permanent partial disability, injuries or occupational illness that may result in hospitalization of at least three personnel, loss exceeding $200K but less then $1M, or reversible environmental damage causing a violation of law or regulation.

Marginal — Could result in injury or occupational illness resulting in one or more lost work days, loss exceeding $10k but less then $200k, or mitigatible environmental damage without violation of law or regulation where restoration activities can be accomplished.

Negligible — Could result in injury or illness not resulting in a lost work day, loss exceeding $2k but less then $10k, or minimal environmental damage not violating law or regulation.

Catastrophic uses the term severe, Critical uses reversible, Marginal uses mitigatible, and Negligible uses minimal. Major is less then severe and has more impact than minimal. Then for me it’s a judgment call if major corresponds with Critical or Marginal. 


1-147. Near the end of the design stage, what should a safety risk assessment be based on?

I.   cost impact
II.  hazard probability
III. hazard severity
IV.  risk impact

(A) I only
(B) I and IV only
(C) II and III only
(D) II, III, and IV only

Answer

(D) II, III, and IV only

Discussion

Risk assessment in general is working to identify hazards that include loss of life, accidents, or injuries; equipment, property or environmental damage. While a program may consider financial risks, it not part of a safety risk assessment.


  1. C. 2

1-149. All companies need to keep formal records in case of product lawsuits. Under what legal rule can company records be subpoenaed?

(A) discovery
(B) due care
(C) negligence
(D) warranty

Answer

(A) discovery

Discussion

discovery:

the entire efforts of a party to a lawsuit and his/her/its attorneys to obtain information before trial through demands for production of documents, depositions of parties and potential witnesses, written interrogatories (questions and answers written under oath), written requests for admissions of fact, examination of the scene and the petitions and motions employed to enforce discovery rights. The theory of broad rights of discovery is that all parties will go to trial with as much knowledge as possible and that neither party should be able to keep secrets from the other (except for constitutional protection against self-incrimination). Often much of the fight between the two sides in a suit takes place during the discovery period. (directly from http://dictionary.law.com/default.aspx?selected=530 on May 31, 2016)

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About Fred Schenkelberg

I am the reliability expert at FMS Reliability, a reliability engineering and management consulting firm I founded in 2004. I left Hewlett Packard (HP)’s Reliability Team, where I helped create a culture of reliability across the corporation, to assist other organizations.

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  • CRE Preparation Course
    • Course Introduction
      • Welcome
      • Introduction
      • Thank You for Your Interest in the Course
      • Exam Day
      • Preparation Approach
      • Discussion Forums Introduction
      • CRE Sample Quiz
      • Terms Glossary
      • Math Quiz
      • Body of Knowledge 2009 version
      • Body of Knowledge 2018 version
    • Reliability Management
      • Reliability Management Introduction
    • I. A. Strategic Management
      • Strategic Management Introduction
      • I. A. 1. Benefits of Reliability Engineering
      • I. A. 2. Interrelationship of Safety, Quality, and Reliability
      • I. A. 3. Role of the Reliability Function
      • I. A. 4. Product and Process Development
      • I. A. 5. Failure Consequences and Liability Management
      • I. A. 6. Warranty Management
      • I. A. 7. Customer Needs Assessment
      • I. A. 8. Supplier Reliability
      • I. A. Strategic Management Quiz
      • I. A. Bonus — Building Influence
    • I. B. Reliability Program Management
      • Reliability Program Management Introduction
      • I. B. 1. Terminology
      • I. B. 2. Elements of a Reliability Program
      • I. B. 3. Types of Risk
      • I. B. 4. Product Lifecycle Engineering
      • I. B. 5. Design Evaluation
      • I. B. 6. Systems Engineering and Integration
      • I. B. Reliability Program Management Quiz
    • I. C. Ethics, Safety, and Liability
      • Ethics, Safety, and Liability Introduction
      • I. C. 1. Ethical Issues
      • I. C. 2. Roles and Responsibilities
      • I. C. 3. System Safety
      • I. C. Ethics, Safety, and Liability Quiz
    • II. Probability and Statistics for Reliability
      • Probability and Statistics for Reliability Introduction
    • II. A. Basic Concepts
      • Basic Concepts Introduction
      • II. A. I. Statistical Terms
        • II. A. I. a. Basic Statistical Terms
        • II. A. I. b. Measures of Central Tendency
        • II. A. I. c. Central Limit Theorem
        • II. A. I. d. Measures of Dispersion
        • II. A. 1. e. COV and a Couple of Laws
      • II. A. 2. Basic Probability Concepts
        • II. A. 2. a. Probability
        • II. A. 2. b. Laws and Counting
        • II. A. 2. c. Expectation
      • II. A. 3. Discrete and Continuous Probability Distributions
        • II. A. 3. a. The Four Functions
        • II. A. 3. b. Continuous Distributions
        • II. A. 3. c. Discrete Distributions
        • II. A. 3. d. Bathtub Curve
      • II. A. 4. Poisson Process Models
        • Poisson Process Models Introduction
        • II. A. 4. a. Homogeneous Poisson Process
        • II. A. 4. b. Repair System Terminology
        • II. A. 4. c. Non-Homogenous Poisson Process
        • II. A. 4. d. Mann Reverse Arrangement Test
        • II. A. 4. e. Laplace’s Trend Test
        • II. A. 4. f. Fisher’s Composite Test
      • II. A. 5. Non-Parametric Statistical Methods
        • II. A. 5. a. The Approach
        • II. A. 5. b. Ranking
        • II. A. 5. c. Reliability and Comparisons
        • Non-Parametric Statistical Methods Introduction
      • II. A. 6. Sample Size Determination
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      • II. A. 7. Statistical Process Control and Process Capability
        • II. A. 7. a. Control Charts Introduction
        • II. A. 7. b. X-bar and R charts
        • II. A. 7. c. Selecting Control Charts
        • II. A. 7. d. Individual and Moving Range Charts
        • II. A. 7. e. Attribute Charts
        • II. A. 7. f. The Analysis
        • II. A. 7. g. Process Capability
        • II. A. 7. h. Standard Normal and z-values
        • II. A. 7. i. Capability and Charts
        • II. A. 7. j. Pre-Control Charts
        • Statistical Process Control and Process Capability Introduction
      • II. A. Basic Concepts Quiz
    • II. B. Statistical Inference
      • Statistical Inference Introduction
      • II. B. 1. Point Estimates of Parameters
      • II. B. 2. a. Statistical Intervals – Point Estimates
      • II. B. 2. b. Statistical Intervals – MTBF Estimates
      • II. B. 3. a. Hypothesis Testing – The Process
      • II. B. 3. b. Hypothesis Testing – Means
      • II. B. 3. c. Hypothesis Testing – Variance
      • II. B. 3. d. Hypothesis Testing – Comparisons
      • II. B. Statistical Inference Quiz
    • III. Reliability in Design and Development
      • Reliability in Design and Development Introduction
    • III. A. Reliability Design Techniques
      • Reliability Design Techniques Introduction
      • III. A. 1. Environmental and Use Factors
      • III. A. 2. Stress-Strength Analysis
      • III. A. 3. FMEA and FMECA
      • III. A. 4. Common Mode Failure Analysis
      • III. A. 5. Fault and Success Tree Analysis
      • III. A. 6. Tolerance and Worst-Case Analysis
    • III. A. 7. Design of Experiments
      • Design of Experiments Introduction
      • III. A. 7. a. How We Experiment
      • III. A. 7. b. Differences and Approaches
      • III. A. 7. c. Language of DOE
      • III. A. 7. d. Only the Right Experiments
      • III. A. 7. e. Steps to Accomplish
      • III. A. 7. f. Dealing with Measurements
      • III. A. 7. g. Interactions and Confounding
      • III. A. 7. h. Adjusting the Design
      • III. A. 7. i. Classical DOE
      • III. A. 7. j. Various Designs
      • III. A. 7. k. A Simple Taguchi Example
      • III. A. 7. l. Robust Design
    • III. A. more Reliability Design Techniques
      • III. A. 8. Fault Tolerance
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      • III. A. 10. Human Factors
      • III. A. 11. Design for X – DFX
      • III. A. 12. Reliability Apportionment or Allocation Techniques
      • III. A. Reliability Design Techniques Quiz
    • III. B. Parts and Systems Management
      • Parts and Systems Management Introduction
      • III. B. 1. a. Selection, Standardization, and Reuse – Parts
      • III. B. 1. b. Selection, Standardization, and Reuse – Software
      • III. B. 2. Derating Methods and Principles
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      • III. B. 4. Establishing Specifications
      • III. B. Parts and Systems Management Quiz
    • IV. Reliability Modeling and Predictions
      • Reliability Modeling and Predictions Introduction
    • IV. A. Reliability Modeling
      • Reliability Modeling Introduction
      • IV. A. 1. Sources and Uses of Reliability Data
      • IV. A. 2. a. Reliability Block Diagrams and Models – Series Systems
      • IV. A. 2. b. Reliability Block Diagrams and Models – Parallel Systems
      • IV. A. 2. c. Reliability Block Diagrams and Models – Redundancy
      • IV. A. 2. d. Reliability Block Diagrams and Models – Complex
      • IV. A. 2. e. Reliability Block Diagrams and Models – Keynote
      • IV. A. 3. Physics of Failure Models
      • IV. A. 4. a. Simulation Techniques – Markov Models
      • IV. A. 4. b. Simulation Techniques – Monte Carlo
      • IV. A. 5. Dynamic Reliability
      • IV. A. Reliability Modeling quiz
    • IV. B. Reliability Predictions
      • Reliability Predictions Introduction
      • IV. B. 1. Parts Count Predictions and Parts Stress Analysis
      • IV. B. 2. a. Reliability Prediction Models – Considerations
      • IV. B. 2. b. Reliability Prediction Models – Uncertainty
      • IV. B. 2. c. Reliability Prediction Models – Tolerance Intervals
      • IV. B. Reliability Predictions quiz
    • V. Reliability Testing
      • Reliability Testing Introduction
    • V. A. Reliability Testing Planning
      • Reliability Testing Planning Introduction
      • V. A. 1. a. Reliability Test Strategies – Types of Testing
      • V. A. 1. b. Reliability Test Strategies – Human Factors Testing
      • V. A. 2. Test Environment
      • V. A. Reliability Test Planning quiz
    • V. B. Testing During Development
      • Testing During Development Introduction
      • V. B. 1. Accelerated Life Tests
      • V. B. Bonus – A Few Models
      • V. B. 2. Discovery Testing
      • V. B. 3. Reliability Growth Testing
      • V. B. 4. Software Testing
      • V. B. Testing During Development quiz
    • V. C. Product Testing
      • Product Testing Introduction
      • V. C. 1. a. Qualification Demonstration Testing – PRST
      • V. C. 1. b. Qualification Demonstration Testing – Success Testing
      • V. C. 2. Product Reliability Acceptance Testing – PRAT
      • V. C. 3. Ongoing Reliability Testing
      • V. C. 4. Stress Screening
      • V. C. 5. Attribute Testing
      • V. C. 6. Degradation Testing
      • V. C. Bonus – Acceleration Factors
      • V. C. Product Testing quiz
    • VI. Maintainability and Availability
      • Maintainability and Availability Introduction
    • VI. A. Management Strategies
      • Management Strategies Introduction
      • VI. A. 1. a. Planning
      • VI. A. 1. b. Planning – System Effectiveness
      • VI. A. 1. c. Planning – Reliability Time
      • VI. A. 2. a. Maintenance Strategies – RCM
      • VI. A. 2. b. Maintenance Strategies – TPM
      • VI. A. 2. c. Maintenance Strategies – Allocation
      • VI. A. 3. Availability Tradeoffs
      • VI. A. Management Strategies quiz
    • VI. B. Maintenance and Testing Analysis
      • Maintenance and Testing Analysis Introduction
      • VI. B. 1. Preventative Maintenance Analysis
      • VI. B. 2. Corrective Maintenance Analysis
      • VI. B. 3. Non-Destructive Evaluation
      • VI. B. 4. Testability
      • VI. B. 5. Spare Parts Analysis
      • VI. B. Maintenance and Testing Analysis quiz
    • VII. Data Collection and Use
      • Data Collection and Use Introduction
    • VII. A. Data Collection
      • Data Collection Introduction
      • VII. A. 1. a. Types of Data
      • VII. A. 1. b. Types of Data – Censored Data
      • VII. A. 2. Collection Methods
      • VII. A. 3. Data Management
      • VII. A. Data Collection quiz
    • VII. B. Data Use
      • Data Use Introduction
      • VII. B. 1. Data Summary and Reporting
      • VII. B. 2. Preventive and Corrective Actions
      • VII. B. 3. Measures of Effectiveness
      • VII. B. Data Use quiz
    • VII. C. Failure Analysis and Correction
      • Failure Analysis and Correction Introduction
      • VII. C. 1. Failure Analysis Methods
      • VII. C. 2. Failure Reporting, Analysis, and Corrective Action System
      • Exam Day Bonus
      • VII. C. Failure Analysis and Correction quiz

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