Guidelines For Failure Mode and Effects Analysis FMEA For Automotive Aerospace and General Manufacturing Industries 1st Edition Dyadem Press
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Guidelines for Failure Mode and
Effects Analysis for Automotive,
Aerospace and General
Manufacturing Industries
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FMEA, Process FMEA, Service FMEA, Application FMEA, Hardware FMEA, Software
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Guidelines for Failure Mode and Effects Analysis for Automotive, Aerospace and
General Manufacturing Industries
Copyright © 2003 by Dyadem Press
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Table of Contents
Glossary x
CHAPTER 1 Introduction 1
CHAPTER 2 General Manufacturing, Automotive and Aerospace Quality 4
System Standards
CHAPTER 3 Industry Specific Standards for Failure Mode & Effects 23
Analysis
CHAPTER 4 Risk Management Planning 30
CHAPTER 5 Risk Analysis Methodologies 33
CHAPTER 6 Overview of FMEA 37
CHAPTER 7 FMEA Procedures 41
CHAPTER 8 FMEA Team 52
CHAPTER 9 Common Tools Used with FMEA 54
CHAPTER Pitfalls with FMEA 59
10
CHAPTER Product Life Cycle & FMEA 61
11
CHAPTER Product/Design FMEA 67
12
CHAPTER Process FMEA 73
13
CHAPTER Machinery FMEA 79
14
CHAPTER Application FMEA 86
15
CHAPTER Service FMEA 92
16
CHAPTER Hardware and Software FMEA 99
17
CHAPTER Analysis of FMEA Results 102
18
CHAPTER Overview of Failure Mode, Effects and Criticality Analysis 104
19 (FMECA)
CHAPTER Post FMEA Study 111
20
CHAPTER FMEA in Advanced Quality Planning/Advanced Product 112
21 Quality Planning
CHAPTER Product Quality Control Plans and Dynamic Control Plans 118
22
References 129
Glossary
Acceptable Quality Level (AQL): For the purposes of sampling inspection, AQL is the
maximum percent defective that can be considered satisfactory as a process average.
Average Outgoing Quality Limit (AOQL): For a given sampling plan, it is the
maximum average quality of outgoing product after 100% screening of rejected lots.
Characteristics: Distinguishing features of a process or its output on which variables or
attributes data can be collected.
Control Plans: A description of the system for controlling parts and processes. It is
written by suppliers to address the important characteristics and engineering
requirements of the product.
Cpk (process capability per thousand): An index that considers both the process spread
and the proximity of the process spread to specifications limits.
Design Defect: An imperfection that causes a product to inadequately protect against
risks of injury, fail to perform intended functions safely, inadequately safeguard
against a specific danger, create unreasonably dangerous side effects, or fail to
minimize avoidable consequences in the event of an accident.
Design for Manufacturability (DFM)/Design for Assembly (DFA): A simultaneous
engineering process designed to optimize the relationship between design function,
manufacturability, and ease of assembly.
Design of Experiment (DOE): An experimental technique used to manipulate process
inputs in order to better understand their effects on process outputs.
Detection: The probability of the failure being detected before the impact of the effect is
realized.
Facilitator: An expert who ideally has no vested interest in the process under
investigation, but who has the knowledge and ability to guide the project leader and
the team through the various process improvement steps. The facilitator will work
with the client to identify the opportunity, develop a structure for the project, and
contract for the boundaries of the project and timing issues. He or she should be aware
of sources for information, expert advice and practical assistance.
Failure Mode: A symptom, condition or fashion in which hardware fails. A failure mode
might be identified as loss of function, premature function (function without demand),
an out-of-tolerance condition, or a simple physical characteristic such as a leak
observed during inspection.
Failure Modes and Effects Analysis (FMEA): A systematic, tabular method for
evaluating and documenting the causes and effects of known types of component
failures.
Failure Modes, Effects and Criticality Analysis (FMECA): A variation of FMEA that
includes a quantitative estimate of the significance of the consequences of a failure
mode.
Fault Tree: A logic model that graphically portrays the combinations of failures that can
lead to specific main failure or accident.
Hazard: Any situation with the potential for causing damage to life, property or the
environment.
Human Error: Any human action (or lack thereof) that exceeds some limit of
acceptability (i.e., an out-of-tolerance action) where the limits of human performance
are defined by the system. Human errors include actions by designers, operators or
managers that may contribute to or result in accidents.
Likelihood: A measure of the expected probability or frequency of an event’s
occurrence.
Manufacturing Defect: An imperfection that causes a product to fail to meet the
manufacturer’s own specifications. Manufacturing defects occur when the raw
materials or components used in making the product contain unacceptable flaws, or
there are assembly mistakes.
Original Equipment Manufacturer (OEM): Entity holding design rights to any
product. The OEM is not necessarily the manufacturer, designer or distributor of the
product.
Occurrence: The probability or frequency of the failure occurring.
Process Capability Index (CpK): A measure of both process dispersion and its
centering about the average.
Quality Function Deployment (QFD): A structured method in which customer
requirements are translated into appropriate technical requirements for each stage of
product, development and production.
Quality System: The organization, structure, responsibilities, procedures, processes and
resources for implementing quality management. It is a method of maintaining
consistent quality for producing products or providing services that consistently meet
or exceed the customer’s implied or stated needs.
Quantitative Risk Analysis: The systematic development of numerical estimates of the
expected frequency and/or consequence of potential accidents associated with a
facility or operation based on engineering evaluation and mathematical techniques.
Repeatability: Variation in measurements obtained with one gage when used several
times by one appraiser while measuring a characteristic on one part.
Reproducibility: Variation in the average of the measurements made by different
appraisers using the same gage when measuring a characteristic on one part.
Residual Risk: Risk remaining after protective measures have been taken.
Risk: A measure of the consequence of a hazard and the frequency with which it is likely
to occur.
Risk Analysis: Systematic use of available information to identify hazards and to
estimate the risk.
Risk Assessment: Overall process of risk analysis and risk evaluation.
Risk Evaluation: Judgment based on the risk analysis to determine whether the risk is
acceptable given the context and the current values of society.
Risk Management: The systematic application of management policies, procedures and
practices to the tasks of analyzing, assessing and controlling risk in order to protect
employees, the general public, the environment and company assets.
Safety: A judgment of the acceptability of risk. An activity is deemed as “safe” if its
risks are judged to be acceptable when compared with other common daily activities.
No activity is totally free from risk. Provided the activity is undertaken, risk can never
be totally eliminated. However, it can usually be reduced to acceptable levels with the
use of adequate safeguarding.
Statistical Process Control (SPC): Use of statistical techniques to analyze a process or
its output in order to take appropriate actions to achieve and maintain a state of
statistical control and to improve the capability of the process.
Value Engineering (VE): A planned, clean sheet approach to problem solving, focusing
on specific product design and process characteristics. Value engineering is employed
to maximize value prior to expenditures of facilities and tooling money.
CHAPTER 1
Introduction
Product quality planning and assessment are critical to assure that a product meets the
requirements of the customer and that it satisfies all safety and regulatory requirements.
One of the key elements to success is to manage and reduce risk effectively throughout
the product’s life cycle. This requires a delicate balance between risk, cost and
performance. Risk management provides the required decision framework centered on
understanding risks and evaluating their acceptability by weighting technical and
economic practicability against risk/benefits. It manages the residue risk, as risk cannot
be completely eliminated.
To reduce risk, it is essential to identify hazards, evaluate the associated potential
consequences and their likelihood, and then estimate the risk. A number of analysis
techniques, including top-down and bottom-up approaches, can be used. These
techniques include Failure Mode and Effects Analysis (FMEA), Hazard and Operability
Analysis (HAZOP) and Fault Tree Analysis (FTA).
These Guidelines focus on FMEA and its application throughout the product’s life
cycle. Other topics include regulatory requirements relating quality system analysis in the
automotive, aerospace and general manufacturing industries, risk management, Failure
Mode, Effects and Criticality Analysis (FMECA), Control Plans and Advanced Product
Quality Planning.
The following list describes the organization of the manual:
Chapter 3—Industry Specific Standards for Failure Mode and Effects Analysis
This chapter reviews the current industry-specific standards and technical specifications
that provide guidelines for performing FMEA.
Guidelines for failure mode and effects analysis 2
Quality system standards and specifications associated with the automotive, aerospace
and general manufacturing industries are reviewed in this chapter for the purpose of
identifying the requirements for Failure Mode and Effects Analysis and Control Plans in
the Product Quality Cycle. This chapter provides only a brief overview of each
document, and anyone who wants to fulfill the regulatory and industrial requirements
should obtain a copy of the respective documents from the International Organization for
Standardization (ISO), Society of Automotive Engineers (SAE) or other publishing
organizations in order to ensure that all documentation required for registration is
completed. As regulations and standards are periodically updated, it is the reader’s
responsibility to ensure the applicability of these documents.
Automotive Industry
▪ Analysis of motion/ergonomics;
▪ Mistake proofing.
Documentation should be established to ensure the effectiveness of facilities,
equipment, tooling and process planning.
▪ Operational procedures;
▪ Quality assurance procedures;
▪ Material specifications.
Engineering Specifications—4.5.2.1 requires the supplier to establish a procedure to
assure timely review (e.g. business “days” not weeks or months), distribution and
implementation of all customer engineering standards/specifications and changes.
The supplier shall maintain a record of the date on which each change is implemented
in production. A change in the engineering specification should require updated
Production Part Approval Process (PPAP) documents i.e. FMEAs, Control Plans, etc.,
when these specifications are referenced on the design record.
4.6 Purchasing
The supplier should establish and maintain documented procedures to ensure that the
purchased product for ongoing production conforms to specified requirements, including
Government, Safety and Environmental regulations (4.6.1.1 & 4.6.1.2).
Requirements for the selection of contractors and subcontractors should be defined
and documented.
The supplier shall perform subcontractor quality system development with the goal of
subcontractor compliance to QS-9000 using Section I of QS-9000 as their fundamental
quality system requirement.
Required product identification information for the purchased products and the
verification methods should be defined and documented.
4.18 Training
Procedures should be established for conducting the training of all personnel. Training
records should be maintained and the effectiveness of the training program should be
reviewed periodically.
4.19 Servicing
When servicing of the product is a requirement, procedures should be established
defining the specifications for servicing and verifying that specified requirements are
met.
Chrysler-Specific Requirements
• Production and part suppliers to Chrysler should be QS-9000 registered;
• Products should be developed based on Product Assurance Planning (PAP) method or
APQP and Control Plan;
• Significant characteristics should be identified and Special Characteristics should be
identified by the symbols specified by Chrysler;
• An annual layout inspection to ensure continuous conformance to all Chrysler
requirements should be conducted;
• Product Verification/Design Validation should be performed based on Chrysler’s
specification;
• Internal Quality Audits should be conducted at least once per year.
The Corrective Action Plan should include the following:
• Description of the nonconformance;
• Definition/root cause;
• Interim action and effective date;
• Permanent action and effective date;
• Verification;
• Control;
• Prevention;
Guidelines for failure mode and effects analysis 14
Ford-Specific Requirements
• Suppliers to Ford are not required to have third party registration, except for Ford
Australia’s unique suppliers, who should have third party registration;
• Control Item parts that have critical characteristics that may affect the safe operation of
the vehicle and/or compliance with government regulations are required to have
Control Plans and FMEAs approved by Ford’s design and quality engineers;
• All product characteristics are required to be measured annually to demonstrate
conformance to specified requirements;
• Setup verification is required for all critical and significant characteristics;
• Lot traceability and Material Analysis for heat-treated and non-heat-treated parts should
be included in the Control Plan for control items. And those who provide heat treating
should comply with Ford’s requirements (W-HTX, WSS-M99A3-A);
• Process changes and design changes for supplier-responsible designs require Ford’s
approval if specified in the design record;
• Corrective action should be taken if engineering specification does not confirm design
intent;
• Ford’s Quality Operating System methodology should be implemented;
• APQP guidelines should be used.
GM-Specific Requirements
QS-9000 applies to all contracted GM suppliers. GM suppliers should refer to the forms
noted in QS-9000 to address the requirements that are applicable to them.
a. Parts or materials, or
b. Heat treating, painting, plating or other finishing services, or
c. Other customer-specified products.
The International Automotive Task Force (IATF) has been working with the ISO
community on updating ISO/TS 16949 to align it with ISO 9001:2000. The expectation is
that, sometime in 2002, the new ISO/TS 16949 will be released for use by automotive
suppliers around the world. How APQP, PPAP and the other AIAG reference manuals
will figure into the new ISO/TS 16949 is still not clear, although Ford has just announced
in its new Q1–2002 program that its suppliers must be registered to either QS-9000 or
ISO/TS 16949 and to ISO 14001 (Environmental management system—specification
with guidance for use)
4.1—Management responsibility:
• A number of additions to this element are clearly intended to focus suppliers’ attention
on continuous quality improvement;
• Suppliers must establish goals, objectives and measurements to develop their quality
policies;
• Continuous improvement in quality, service, cost and technology must be covered in the
quality policy;
• Quality-responsible personnel’s authority to stop production is no longer a “note” or
suggestion, as in QS-9000, but a requirement;
• All production shifts must be staffed with personnel responsible for quality;
• The management review requirement is expanded to include the “performance (of the
QMS) over time as an essential part of the continuous improvement process;”
• Evaluation of the cost of poor quality was a parenthetical note in QS-9000, but is a
specific requirement of ISO/TS 16949;
• Suppliers must develop a process for motivating employees to achieve quality
objectives and providing employees at all levels with “quality awareness;”
• Customer experience with the supplier’s product must be communicated in a timely
manner;
Guidelines for failure mode and effects analysis 16
• Finally, the “due care for product safety” requirement from QS-9000 has been expanded
to minimize risks to employees, customers and the environment.
4.2—Quality system:
• The term “product realization” is introduced to cover the entire process of designing,
planning and delivering products that meet customer requirements;
• A requirement for a project manager and a project team is introduced;
• The modifying phrase “If a project management approach is used” suggests that this
approach is preferred, if not actually required. Continuing to expand the project
management concept, ISO/TS 16949 requires that a method be established for
measuring the product-realization process against appropriate mileposts, with
appropriate analysis and management review;
• The factors to be measured include quality, risks, costs and lead times. Process
capability studies must be conducted on all new processes;
• Results for the capability studies must be used to establish requirements for production
equipment where applicable. Inclusion of all special characteristics on Control Plans,
although always implicit, is now explicitly required;
• ISO/TS 16949 also has a requirement for procedures on developing and verifying the
product-realization process;
• Detailed procedural requirements for process design inputs and outputs have been
added, including a verification of the inputs vs. the outputs;
• The use of the “customer-recognized product approval process” (e.g., production part
approval process [PPAP]) is mandated rather than recommended as in QS-9000,
although General Motors has had a customer-specific requirement for subsupplier
PPAP for some time;
• Additionally, when the customer so requires, special verification methods for new
products must be implemented.
4.3—Contract review:
Suppliers must have a formal process for identifying cost elements and employ this
process in the preparation of price quotations for new products.
4.4—Design control:
• The requirement for skill qualifications of the supplier’s design team is now a “shall”
rather than a “should”;
• Suppliers must have access to research and development to support product innovation.
Analysis of competitive products is identified as one alternative source of input for the
design process;
• For design changes, the impact on the customer’s assembly operations is added to the
factors that the supplier must consider for each change.
General manufacturing, automotive and aerospace quality system standards 17
4.6—Purchasing:
Suppliers must encourage their subsuppliers to comply with ISO/TS 16949. However,
there’s no target date for compliance, nor is there an expectation of third-party
registration for subsuppliers.
4.9—Process control:
• The term “process monitoring and operator instructions” has been replaced with the
simpler “job instructions,” which “shall” rather than “should” be accessible at the job
station without disruption;
• These job instructions shall be derived from “appropriate sources,” including the
Control Plan and the entire product-realization process;
• Significant process events shall be noted on control charts.
4.18—Training:
Additions include requirements for on-the-job training for new or modified jobs affecting
quality and for training on customer-specific requirements.
General manufacturing, automotive and aerospace quality system standards 19
4.19—Servicing:
If the supplier provides post-sale servicing, the effectiveness of service centers’ special
equipment and personnel training must be re-evaluated.
4.20—Statistical techniques:
Appropriate statistical methods shall be determined during the planning process, and
these methods shall be understood throughout the organization.
The sheer number and broad implications of these additions clearly indicate that a
great deal of effort will be required to migrate from a QS-9000-based Quality
Management System (QMS) to one that can be registered to ISO/TS 16949. However,
there’s no need to drop everything for ISO/TS16949 now; it will exist as an alternative to
QS-9000 for a substantial period, perhaps 12 to 24 months. ISO/TS 16949 will be revised
to mesh with the new ISO 9001. At that time, the countdown will begin for the possible
replacement of QS-9000 with ISO/TS 16949. Nevertheless, automotive suppliers will
want to prepare for ISO/TS 16949 with greater urgency than this scenario might suggest:
Early evaluation of ISO/TS 16949 will allow suppliers to develop the most cost-effective
ways to meet these new and revised requirements.
d. VDA 6.1
VDA 6.1 is the German Quality Management System for the automotive industry.
Verband der Automobilindustrie e. V. (VDA) issued the 4th edition in December 1998
and it became mandatory for all German car manufacturers on April 1, 1999. Based on
ISO 9001:1994, it includes all elements of QS-9000, with an additional four requirements
specific to VDA 6.1 as follows:
• Element 06.3 Recognition of product risks—These are the risks of the product fulfilling
its own function and its effect on the whole assembly;
• Element Z1.5 Employee satisfaction—The perception of the employees of the company,
as well as the needs and expectations of the employees that will be met through the
company’s quality approach;
• Element 07.3 Quotation structure—A customer or market is offered products for
purchase or made available to own or to use;
• Element 12.4 Quality history—The system describes the quality history of customer
supplied product and gives an overview of the situation during a particular period.
The VDA standard is broken into two parts, with the first classed as management and the
second focusing on products and processes. Any company that goes through an audit
must achieve at least 90 percent correct on all questions to obtain registration.
Guidelines for failure mode and effects analysis 20
Aerospace Industry
• Supplier (the AS9100 organization) purchasing and subcontractor evaluation, data and
product verification;
• Product identification and traceability;
• Process control documentation and process changes;
• Qualification and control of special processes;
• First article inspection;
• Inclusion of all inspection, measuring and test equipment devices;
• Nonconforming material review authority and disposition;
• Flow down of corrective action to the appropriate subcontractor(s);
• Flow down of requirements from the Quality Manual to work instructions for use on
Internal Quality Audits;
• Where servicing is a requirement, the procedure(s) will address specifics on data,
technical documentation, repair schemes and controls;
• In the event statistical techniques are required, some specific areas and techniques
offered for consideration include the following:
Design verification;
Process control;
Inspection;
Quality management;
Failure Mode and Effects Analysis.
CHAPTER 3
Industry Specific Standards for Failure
Mode & Effects Analysis
Aerospace Industry
Functional FMEA
This type of Failure Mode and Effects Analysis is initiated during the conceptual or
preliminary design phase. Functional FMEA is performed on the conceptual design to
support the architectural definition and verify necessary design compensation and failure
recovery requirements derived by the Functional Requirements Analysis. Functional
FMEA can be performed on control systems, processes, software and complex devices
whose functionality is more readily understood than the details of their operation.
Functional FMEA focuses on the functions that an item, group of items or process
performs rather than on the characteristics of the specific implementation.
Guidelines for failure mode and effects analysis 24
Interface FMEA
This type of FMEA is initiated during the preliminary or detailed design phase. Similar to
Functional FMEA, Interface FMEA is performed to verify compliance to design, safety
and regulatory requirements. Unlike Functional FMEA, Interface FMEA is the process of
determining and recording characteristics of failures in the interconnections between
interfacing system elements. Interface FMEA is done to evaluate interconnections
between hardware elements (i.e. wires, cables, fiber optic lines, etc.) and software
elements. While conducting an Interface FMEA, failure modes specific to the interfaces
are defined and their characteristics (effects and fault signatures) are determined.
Detailed FMEA
This type of analysis is initiated during the detailed design phase, but in some cases the
functional analysis may be updated during the detailed design phase rather than doing a
Detailed FMEA. Detailed FMEA is performed to verify that the design complies with
requirements for failures that can cause loss of end item functions, single point failures,
fault detection and fault isolation. In Hardware Detailed FMEA, the components
comprise the physical system design. In Software Detailed FMEA, the components are
from the source code. The characteristics of the failure of each and every component is
determined and documented in this process. The Detailed FMEA is initiated as the design
of each element matures and the detailed design schematics, part lists, and detailed
software design documents and source code become available.
FMEA Verification
This process is initiated during the design verification and validation phase. Verification
of FMEA ensures that adequate actions are taken to control, prevent and reduce the end
effects of the identified potential failure modes.
Documentation
This document suggests that the documentation set should include the following:
Description of the system or subsystem analyzed;
Worksheets for the types of FMEA conducted;
Summary of the analysis results.
FMEA Applications
Applications of FMEA can be categorized into Product Design Hardware and Software
FMEA, and Process Design FMEA. Functional, Interface and Detailed analysis could be
done for both product design hardware and software FMEA.
The following guidelines are provided in SAE ARP 5580.
Industry specific standards for failure mode & effects analysis 25
requirements to ensure that incorrect software behavior can be detected and that
appropriate system corrective actions are instituted.
requirements
• Requirements for FD/FI
provisions.
Identifies critical
functions for more
detailed analysis.
Interface Supports system level Initiated during Performed when analyzing a
Failure Mode assessment of down- preliminary or system or subsystem or
and Effects stream failure effects (e.g. detailed design when required by the
Analysis cascading faults). phase. system integrator.
Provides a system view to
the response of the FD/FI
provisions.
Provides an assessment of
the
Automotive Industry
Guidelines for the following three types of FMEAs are provided in this document:
• Design FMEA (D-FMEA)—Design FMEA evaluates the initial design for
manufacturing, assembly, service and recycling requirements, including functional
requirements and design alternatives. Design FMEA should be initiated before or at
design concept finalization and be continually updated as changes occur or additional
information is obtained throughout the phases of product development. Design FMEA
should be completed before the production drawings are released for tooling.
Suggested criteria for the evaluation of severity, occurrence and detection for D-
FMEA are provided in Tables 1, 2 and 3 of SAE J1739.
• Process FMEA (P-FMEA)—Process FMEA is utilized to accomplish the following:
• Identify the process functions and requirements;
• Identify potential product- and process-related failure modes;
• Assess the potential customer effects of the failures;
• Identify the potential manufacturing/assembly process causes and identify process
variables on which to focus controls for occurrence reduction or detection of the
failure conditions;
• Identify process variables on which to focus process controls;
• Develop a ranked list of potential failure modes, thus establishing a priority system
for preventive/corrective action considerations;
Industry specific standards for failure mode & effects analysis 29
Process FMEA should be initiated before or at the feasibility stage and prior to tooling
for production. It should take into account all manufacturing operations from individual
components to assemblies.
Suggested criteria for the evaluation of severity, occurrence and detection for P-
FMEA are provided in Tables 4, 5 and 6 of SAE J1739.
• Machinery FMEA (M-FMEA)—The Machinery FMEA supports the design process
in reducing the risk of failures by:
• Aiding in the objective evaluation of equipment functions, design requirements and
design alternatives;
• Increasing the probability that potential failure modes and their effects on the
machinery have been considered in the design and development process;
• Providing additional information to aid in the planning of thorough and efficient
design, validation and development programs;
• Developing a ranked list of potential failure modes ranked according to their effect
on the “customer,” thus establishing a priority system for design improvements,
development and validation testing analysis.
Machinery FMEA should be initiated during design concept development and should
be continually updated as changes occur or additional information is obtained throughout
the phases of machinery development. The analysis should be completed before
engineering release for construction. Suggested criteria for the evaluation of severity,
occurrence and detection for Machinery FMEA are provided in Tables 7, 8 and 9 of SAE
J1739.
CHAPTER 4
Risk Management Planning
Risk Management
The focus of risk management is to identify the hazards associated with functional units
and their accessories, estimate and evaluate the risks, control these risks and monitor the
effectiveness of the control.
The foundation of effective risk management is a clear commitment from corporate
management. There are three key commitments that must be made in order to build the
necessary infrastructure for a cost-effective risk management program:
• Organize and maintain the knowledge and information on the design, development and
manufacturing of the product and ensure this data is up-to-date and accurate. This
process is essential as the quality of the risk management program depends directly on
this information.
• Provide knowledgeable and competent personnel throughout the organization to
manage the risk management process and to participate in risk assessment and other
work activities.
• Create a system that not only documents and maintains risk management files, but also
records management’s response to these studies and enforces an audit system to
ensure that all approved risk reduction actions are implemented in a timely manner.
The risk management process in general includes the following elements:
• Risk Management Plan;
• Risk Assessment—covering both Risk Analysis and Risk Evaluation;
• Risk Control;
• Post-Production Information.
Risk Control
Risk reduction should focus on reducing the hazard severity, the probability of
occurrence, or both. The following are examples of risk control:
• Inherent safety by design;
• Use of consensus standards;
• Protective design measures (e.g. incorporating alarms and interlocks into the design to
mitigate risks that cannot be eliminated);
• Protective manufacturing measures, with improved process or test capabilities;
• Safety information (labeling, instructions for use, training, etc.).
The technical and economic practicality of implementing the options should be evaluated.
Once the risk reduction decisions are made, the associated risk reduction actions should
be implemented and monitored throughout the product’s life cycle.
Post-Production Information
Risk management should start at the early design stage to establish the highest level of
inherent safety. This can significantly offset the cost of implementing risk-mitigating
measures.
CHAPTER 5
Risk Analysis Methodologies
This chapter gives an overview of Hazard and Operability Analysis (HAZOP) and Fault
Tree Analysis (FTA), which are risk analysis techniques commonly used in the industry
as alternatives to Failure Mode and Effects Analysis (FMEA).
This technique was originally developed for use in the chemical process industry for
identifying hazards and operability problems.
HAZOP is a highly structured bottom-up methodology. It uses the combination of
design parameter and guide word to help identify deviation from design intent. The
following are examples of guide words and design parameters:
Guide Words
• More or High or Higher or Greater (words that imply an excess), when compared to
the design intent;
• No, None, Less or Low or Lower or Reduced (words that imply insufficiency), when
compared to the design intent;
• Part of or Not all of or Partially (words that imply incompleteness), when compared
to the design intent.
Design Parameters
Applicable parameters typically include:
• Pressure;
• Temperature;
• Flow;
• Composition;
• Level;
• Reaction Rate;
• Viscosity;
• pH.
Guidelines for failure mode and effects analysis 34
Deviations
For example:
■ When Property=Parameter:
High + Flow = High Flow
Low + Pressure = Low Pressure
More + Reaction = Greater Reactivity
■ When Property=Operation:
No + Transfer = No Transfer
Less + Empty = Residue Remaining
■ When Property=Material:
No + Steam = No Steam
More + Diluent = More Diluent
Fault Tree Analysis is a top-down methodology. The analysis starts with the undesired
consequence or top event and identifies the various combinations of faulty and normal
possible events occurring in the system. This procedure deduces the root cause(s) of the
top event. The events and logical relationships between events are represented
graphically in a tree structure using both logic and event symbols, as shown in Tables 5–1
and 5–2, respectively. An example of a fault tree is shown in Figure 5–1.
FTA can be used to identify multiple failure conditions where two or more events
must occur for the top-level event to occur. If estimates of failure rates are available for
individual events, the probability of the top event can be predicted.
Risk analysis methodologies 35
This chapter is an introduction to Failure Mode and Effects Analysis (FMEA). It outlines
the objectives of FMEA, reasons and benefits of performing FMEA and the limitations of
the technique.
Overview
The need for continuous improvement of product quality, reliability and safety arises
from product recalls (see Table 6–1), government regulatory requirements, agency
recommendations, legal implications and above all a company’s desire to improve its
market position and customer satisfaction. These issues require product manufacturers to
perform risk analyses that identify and minimize part/system failures throughout the
product’s life cycle.
The FMEA methodology is one of the risk analysis techniques recommended by
international standards. It is a systematic process to identify potential failures to fulfill the
intended function, to identify possible failure causes so the causes can be eliminated, and
to locate the failure impacts so the impacts can be reduced. The process of FMEA has
three main focuses:
▪ The recognition and evaluation of potential failures and their effects;
▪ The identification and prioritization of actions that could eliminate the potential failures,
reduce their chances of occurring or reduce their risks;
▪ The documentation of these identification, evaluation and corrective activities so that
product quality improves over time.
FMEA is primarily adapted for material and equipment failures, but in a broad sense,
human error, performance and software errors can also be included.
By applying the FMEA methodology during the various phases of a product’s life
cycle, the methodology provides a systematic and disciplined strategy for examining all
the ways in which a product can fail. The results of FMEA in turn affect the product
design, process development, sourcing and suppliers’ quality, downstream (referring to
downstream of a process or user of the product) application, and field service.
The following are some of the benefits of conducting a FMEA study:
▪ Ensures that the potential failures and their effects on the system have been identified
and evaluated, consequently helping to identify errors and define corrective actions;
▪ Provides a means for reviewing product and process design;
▪ Helps to identify critical characteristics of the products and processes;
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