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Human Factors
 

Human Factors

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human factors as substitutes for operator error in FMEA and Root Cause Analysis

human factors as substitutes for operator error in FMEA and Root Cause Analysis

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    Human Factors Human Factors Presentation Transcript

    • Technical Risk Methodology Cameco Fuel Systems Proposal
    • Methodology • Technical Risk Assessment and subsequent counter measures or containment is not about FMEA or FTA. • Risk Mitigation Methodology proposed by QAI Inc. utilizes several levels of analysis and increasing levels of detail as risk is determined to exist.
    • Methodology • Technical Risk Assessment and subsequent counter measures or containment is not about FMEA or FTA. • Risk Mitigation Methodology proposed by QAI Inc. utilizes several levels of analysis and increasing levels of detail as risk is determined to exist.
    • Process Risk Factors • When working with various causes of Failure Modes in a process or assembly, there are several categories to consider. – Methods – Machines – Materials – Measurement – Mother Earth (Engineering Noise Factors) – Man
    • Causal Considerations • The primary items are typically part of : – Aristotle’s Theory of Causality – Ishakawa’s Cause and Effects Diagram (Fishbone) • Most are self explanatory. • Mother Earth and Man require additional explanation.
    • Noise Factors • Mother Earth refers to the Noise factors which when present can affect proper function. • A Parameter or P Diagram is a common Input/output tool used to capture the noises. • There are five noises which are investigated. – Environment – Process/Design Interfaces – Degradation – Customer/Processor/User/Duty Cycles – Unit to Unit or Batch to Batch variation
    • P-Diagram Noise Factors Product or Process Input Outputs Response Control Error Factors States
    • FMEA Working Model Per AIAG FMEA Handbook, pg 3 What Severity 9 & 10 What can be done? How bad are the • Design Changes is it? Effect(s)? • Process Changes What are the Functions, Severity < 9 and 9/10 inclusive • Special Controls Features, or Requirements? • Changes to Pot. Standards, What How often are the does it KPCs Procedures, or Guides Cause(s)? happen? What can go wrong? • No Function • Partial/Over Function/Degraded How can Over Time the cause be All items • Intermittent prevented requiring Function and test detected? How good • Unintended planning is this Function method at detecting it?
    • The Completed Characteristics Matrix Characteristics Ranked in Order of Importance Process Operations from Process Flow Potential Significant and Critical Characteristics from DFMEA High / Medium Interactions become Causes / Failure Modes in PFMEA Prioritized Ranking of Process Steps Relative to Risk
    • Level III Process Operations QFD Level IV QFD Level III Process Characteristics High Priority Process Parameters / Matrix Operations Variables Level IV Characteristics Matrix KPC’s Failure Causes on Process related Modes on PFMEA KPC’s Key Control from all DFMEA’s PFMEA Characteristics Process FMEA Inputs •Failure Data •Process Flow Control Plan •Process •Line Layout Capability •MFMEA KCC Development
    • Selective on Processes • Perform FMEA as required – New processes or technology – Process or design changes affecting KPC’s & KCC’s – Poor performance in the past • Focus only on exceptions to the Legacy of “what we know we know” – Drives mistake proofing – Process capability and variation control – Kaizen and Lean events
    • Example of Significant / Critical Threshold 10 CRITICAL CHARACTERISTICS S 9 Safety / Regulatory E 8 SIGNIFICANT V 7 CHARACTERISTICS E 6 Customer Dissatisfaction R 5 I 4 ANNOYANCE T 3 ZONE Y 2 ALL OTHER CHARACTERISTICS Appropriate actions / 1 controls already in place 1 2 3 4 5 6 7 8 9 10 OCCURRENCE
    • Actions • Derived from focused effort and are timely • Can be based on Kaizen and area improvement activities • Actions should be tracked outside of the FMEA for efficiency – Concerns database at York • Actions drive control activities when mistake proofing cannot be deployed
    • FMEA Control Plan PFMEA Recommended Actions KPC’s & KCCs Current Controls Pre - Launch Control Plan
    • Legacy Matrix Example Detective controls related to the Failure Mode Issues Occurrence color-coded values from by risk PFMEA Worst Preventive severity controls values from related to PFMEA the process parameters / causes
    • Fault Tree Analysis • FTA Example: Spindle Failure Bearing Motor Inadequate Failure Failure PM 1 Improperly Incorrect Supplier Scheduled Recommendations 2
    • Human Factors Operator Dependant Operations
    • Human Factors • Man or Manpower is often thought of as operator error. • Operator Error is possible but not actionable therefore the study of Operator impacts on process and product is required. • Human Factor analysis and design is the technical approach used to quantify the human impact on product or process.
    • Human Factors Operator Error Level 1 Cause Why? Level 2 Causes Why? Level 3 Causes Level…n Cause Why? When operator dependant operations are the main cause of a Failure Mode: Operator Error must be translated to an Operator Error is not an actionable state. acceptable response! 3. The Level 2 Cause must be selected. 4. If Risk (Severity or/and Occurrence) is unacceptable therefore level 3…n is required.
    • Human Factors Level 1 Operator Error 1.0 Work Station Layout Level 2 2.0 Ergonomics 3.0 Documentation and Training 4.0 Assist/tool Design 5.0 Attention/Concentration Level 3 See following pages for Level 3 Causes 1.1….n Level …n (multiple why) to root cause level 1.1.1…n
    • Human Factors • Man or Manpower is often thought of as operator error. • Operator Error is possible but not actionable therefore the study of Operator impacts on process and product is required. • Human Factor analysis and design is the technical approach used to quantify the human impact on product or process.
    • Example of Significant / Critical Threshold 10 CRITICAL CHARACTERISTICS S 9 Safety / Regulatory E 8 SIGNIFICANT V 7 CHARACTERISTICS E 6 Customer Dissatisfaction R 5 I 4 ANNOYANCE T 3 ZONE Y 2 ALL OTHER CHARACTERISTICS Appropriate actions / 1 controls already in place 1 2 3 4 5 6 7 8 9 10 OCCURRENCE
    • Human Factors Operator Error Level 1 Cause Why? Level 2 Causes Why? Level 3 Causes Level…n Cause Why? When operator dependant operations are the main cause of a Failure Mode: Operator Error must be translated to an Operator Error is not an actionable state. acceptable response! 3. The Level 2 Cause must be selected. 4. If Risk (Severity or/and Occurrence) is unacceptable therefore level 3…n is required.
    • Human Factors Level 1 Operator Error 1.0 Work Station Layout Level 2 2.0 Ergonomics 3.0 Documentation and Training 4.0 Assist/tool Design 5.0 Cognitive/Attention/Concentration Level 3 See following pages for Level 3 Causes 1.1….n Level …n (multiple why) to root cause level 1.1.1…n
    • Level 2 Causes Work Station Design • Level 3 Causes – Bench/Table Height – Organization of work tools (5S) • # of tools and placement – Component Positions • Quantity • Similarity – Extended Reach (occasional) – Lighting – Comfort Features • foot rests/seat position • Standing work bench position
    • Level 2 Causes Ergonomics • Level 3 causes • Height and Reach – Work type • Weight – Lifting • Motion – #of steps – Degrees of freedom • Work station interface – Blind operation • Posture • Insertion force • Static insertions – Plastic deformation of end source • Tool – vibration – Tool design
    • Level 2 Causes Documentation and Training • Level 3 Causes • Illustrations on Process Documentation • “A4” One page • No Documentation • Validation of Work Practice – Testing – Demonstration – Frequency of validation • Training definition • Complexity of documentation • Labeling • Legibility of work instructions – # of pages – Understandability (5 second rule) – Fonts size and type
    • Level 2 Causes Assists and Tool Design • Level 3 Causes • Error proofing features • Tool calibration – Pallet compliance • Correct tool • Life of tool • Fixture control • Clamp pressure • Cycle completion/interruption • Locator/proximity life • Measurement instrument
    • Level 2 Causes Cognitive/Perception • Level 3 Causes • Audible Noise • Environment – Temperature – Humidity • Sensitivity to Interruption • Repetition – Motion • Trance/Zone Inducement – Sound Quality – Harmonics – Vibration/cyclical noise