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Guidelines for Failure Mode and Effects
Analysis for Medical Devices
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Guidelines for Failure Mode and Effects Analysis for Medical Devices
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About Dyadem Engineering Corporation
Dyadem Engineering Corporation focuses on controlling the risks associated with major hazards in the automotive,
aerospace, process, medical device and general manufacturing industries, delivering a wide spectrum of services in the fields
of process design, risk management, incident investigation and risk study facilitation.
We offer professional training services for Failure Mode and Effects Analysis, Process Hazards Analysis, Job Safety
Analysis and Ergonomics. Dyadem has also become a respected publisher of engineering manuals. Our successful Guidelines
series also includes Guidelines for Failure Mode and Effects Analysis for Automotive and General Manufacturing Industries
and the popular Guidelines for Process Hazards Analysis, Hazards Identification & Risk Analysis.
Table of Contents
Glossary xi
CHAPTER 1 Introduction 1
CHAPTER 2 Regulations & Standards Governing Medical Device Manufacturing 3
Background. 3
United States Regulations 3
European Union Regulations 4
International Standards 5
EU/EC EN (European Norm) Standards 7
CHAPTER 3 Risk Management of Medical Devices 8
Risk Management 8
CHAPTER 4 Risk Analysis Methodologies 12
Hazard And Operability Analysis (HAZOP) 12
Fault Tree Analysis (FTA) 13
CHAPTER 5 Overview of FMEA 15
Overview 15
Limitations of FMEA 17
CHAPTER 6 FMEA Procedures 18
Introduction 18
FMEA Terminology 18
FMEA Steps 21
Preliminary Consideration of FMEA 23
Preparation Before FMEA Sessions 23
Conducting FMEA Sessions 25
Follow-Up of FMEA 26
CHAPTER 7 FMEA Team 27
Introduction 27
Team Size 27
Team Membership 27
Team Leader (Facilitator) 27
CHAPTER 8 Pitfalls with FMEA 28
CHAPTER 9 Common Tools Used with FMEA 30
ix
Process Mapping/Process Flowcharts 30

Block Diagrams/Functional Flow Diagrams 30
Pareto Charts 31
CHAPTER 10 Product Life Cycle & FMEA 34
Introduction 34
Different Types of FMEAs 34
Integration of FMEA and Control Plan to Product Cycle 36
CHAPTER 11 Product/Design FMEA 39
Objectives 39
Recommended Team Members 39
Recommended Information in the Product/Design FMEA Worksheet 39
Suggested Risk Guidelines for Product/Design FMEA (D-FMEA) 41
CHAPTER 12 Process FMEA 44
Objectives 44
Recommended Information in the Process FMEA Worksheet 44
Suggested Risk Guidelines for Process FMEA (P-FMEA) 47
CHAPTER 13 Application FMEA 50
Objectives 50
Recommended Information in the Application FMEA Worksheet 50
Suggested Risk Guidelines for Application FMEA (A-FMEA) 52
CHAPTER 14 Service FMEA 55
Objectives 55
Recommended Information in the Service FMEA Worksheet 55
Suggested Risk Guidelines for Service FMEA (S-FMEA) 58
CHAPTER 15 Post FMEA Study 61
CHAPTER 16 Control Plans 62
Introduction 62
Benefits of Developing and Implementing Control Plans 62
Information Used to Develop Control Plans 62
Control Plan Terminology and Recommended Information to Include 62
CHAPTER 17 Overview of Failure Mode, Effects, and Criticality Analysis (FMECA) 66
Overview of Criticality Analysis 66
Criticality Analysis Terminology 66
Criticality Worksheet/Report Format 68
x
References 73
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.
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.
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.
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 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.
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.
CHAPTER 1
Introduction
Medical device manufacturers face tremendous challenges today, including stringent regulations, vigorous competition,
consumer advocate groups, product liability lawsuits and their implications. In order to face such challenges, manufacturers must
create safe, reliable and cost-effective products. One of the key elements to success is to manage and reduce risk effectively
throughout the product’s life cycle. This requires 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).
As suggested by its title, these Guidelines focus on FMEA and its application throughout the medical device’s life cycle.
Other topics include regulatory requirements relating to manufacturing of medical devices, risk management, Failure Mode,
Effects and Criticality Analysis (FMECA) and Control Plans.
The following list describes the organization of the manual:
Chapter 2—Regulations & Standards Governing Medical Device Manufacturing

This chapter outlines the major standards and regulations in the United States (U.S.) and the European Union (E.U.)
relating to medical device manufacturing. The intent of this chapter is to provide the readers with a general overview of the
regulatory requirements and standards related to risk management of medical devices in these two regions.
Chapter 3—Risk Management of Medical Devices

This chapter describes the essence of risk management of medical devices, as outlined in ISO 14971. For more details,
refer to the international standard.
Chapter 4—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 medical device industry as alternatives to Failure Mode and Effects Analysis.
Chapter 5—Overview of FMEA

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.
Chapter 6—FMEA Procedures

This chapter describes the basic terminology and process used in FMEA. In addition, the procedures for setting up,
conducting and following up FMEA are described.
Chapter 7—FMEA Team

This chapter describes the responsibilities of FMEA team members and the facilitator/team leader.
Chapter 8—Pitfalls with FMEA

This chapter describes some major pitfalls during the conduction of FMEA studies.
Chapter 9—Common Tools Used with FMEA

2 INTRODUCTION
This chapter gives an overview of tools commonly used with FMEA, including process flowcharts, block diagrams and
Pareto charts.
Chapter 10—Product’s Life Cycle & FMEA

This chapter outlines the application of FMEA at various stages in a product’s life cycle. It also introduces the use of
Control Plans as a tool to document the design and process characteristics for manufacturing the device.
Chapter 11—Product/Design FMEA

This chapter describes the objectives of Product/Design FMEA (D-FMEA), recommended team members and
recommended information to be included in the FMEA worksheet. It also provides rating guidelines for severity, occurrence
and detection.
Chapter 12—Process FMEA

This chapter describes the objectives of Process FMEA (P-FMEA), recommended team members and recommended
information to be included in the FMEA worksheet. It also provides rating guidelines for severity, occurrence and detection.
Chapter 13—Application FMEA

This chapter describes the objectives of Application FMEA (A-FMEA), recommended team members and recommended
Chapter 14—Service FMEA

This chapter describes the objectives of Service FMEA (S-FMEA), recommended team members and recommended
Chapter 15—Post FMEA Study

This chapter describes the required steps to be taken after the completion of the FMEA.
Chapter 16—Control Plans

This chapter outlines the benefits of creating a Control Plan and what information should be included in it.
Chapter 17—Overview of Failure Mode, Effects and Criticality Analysis (FMECA)

This chapter provides an overview of Failure Mode, Effects and Criticality Analysis (FMECA), including the terminology
and the worksheets used in the analysis for both quantitative and qualitative approaches. The final chapter also recommends
the information to be included in the worksheets.
CHAPTER 2
Regulations & Standards Governing Medical Device Manufacturing
This chapter outlines the major standards and regulations in the United States (U.S.) and the European Union (E.U.) relating
to medical device manufacturing. The intent of this chapter is to provide the readers with a general overview of the regulatory
requirements and standards related to risk management of medical devices in these two regions. This is not an attempt to
exhaust the topic, nor to offer legal advice.
Background
In the U.S. and E.U., there are regulatory requirements applied to manufacturers of medical devices intended for commercial
distribution. The major objectives of the regulations are to ensure that a medical device company produces a safe product and
that it is able to provide quality assurance that it can manufacture this safe product consistently. These objectives are tied into
the quality management system.
In the U.S., the quality management system requirements are covered under the Quality System (QS) regulation (Current
Good Manufacturing Practice for Medical Devices, 21 CFR Parts 808, 812, and 820). For the E.U., they are covered by
Directive 93/42/EEC— Medical Device Directive. In both regions, manufacturers are required to provide technique
documentation for regulation conformity assessment. Risk analysis is part of the required documentation. These regulatory
requirements are supported by the well-known international standards of quality system, ISO 9000 series together with ISO
13485/88 and EN 46001/2/3, which are the international and European standards, respectively, for medical devices quality
system. Risk analysis related standards include ISO 14971, EN 1441. The following sections give brief descriptions of related
regulations and standards.
United States Regulations

Products meeting the definition of a device under section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C Act)
are regulated by the Food and Drug Administration (FDA). The FDA has developed regulations to fulfill provisions of the
Act. For most devices, the regulations are published in Title 21 Code of Federal Regulations (CFR) Parts 800 to 1299.
The FDA has established three regulatory classes based on the level of control necessary to assure the safety and
effectiveness of the device. The three classes and the requirements that apply to them are as follows:
CLASS REGULATORY CONTROLS EXAMPLES

Class I General Controls Elastic bandages, examination gloves, and hand-held surgical instruments
Class II General Controls and Special Controls Powered wheelchairs, infusion pumps, and surgical drapes
Class III General Controls and Premarket Approval Implantable pacemaker pulse generators, vascular grafts less than 6mm in length,
and endosseous implants
The general controls are the baseline requirements of the FD&C Act that apply to all medical devices, Class I, II and III.
The requirements of general controls include submitting a premarket notification 510(k) to the FDA and designing and
producing devices under good manufacturing practices (GMP).
510 (k)/Premarket Notification

A premarket notification 510(k) is a marketing application submitted to the FDA to demonstrate that the medical device you
wish to market is as safe and as effective as—or substantially equivalent to—a legally marketed device that was or is
currently on the U.S. market and that does not require premarket approval. Premarket approval is a process by the FDA to
4 REGULATIONS & STANDARDS GOVERNING MEDICAL DEVICE MANUFACTURING
evaluate the safety and effectiveness of Class III devices that are not exempted by regulations. The FDA defines a device as
substantially equivalent if, in comparison to a legally marketed device, it:
■ has the same intended use as a predicate; and

■ has the same technological characteristics as the predicate devices;
or
■ has the same intended use as a predicate; and

■ has different technological characteristics, and the information submitted to the FDA:
○ does not raise new questions of safety and effectiveness, and

○ demonstrates that the device is as safe and as effective as the legally marketed device.
US FDA 21 CFR Parts 808, 812, and 820—Current Good Manufacturing Practice (CGMP) Final
Rule; Quality System (QS) Regulation
Current Good Manufacturing Practices (CGMPs) refer to the quality systems for FDA-regulated products (food, drugs, biologics
and devices). The CGMP specifically for medical devices is known as the Quality System (QS) regulation. It is in Part 820 of
Title 21 of the Code of Federal Regulations (CFR). They require that domestic or foreign manufacturers have a quality system
for the design and production of medical devices intended for commercial distribution in the United States.
The QS regulation is harmonized with ISO 13485:1996 Quality Systems—Medical Devices—Particular Requirements for
the Application of ISO 9001, which is based on ISO 9001:1994. It includes requirements related to the methods used in, and
the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing medical
devices intended for human use.
Risk analysis is one of the quality system requirements. The FDA has recommended Failure Mode and Effects Analysis
(FMEA), Fault Tree Analysis (FTA) and Hazard and Operability Analysis (HAZOP) as tools for conducting risk analysis. For
guidance on risk analysis, the FDA makes references to EN 1441 Medical devices—Risk management and ISO 14971
Medical devices—Application of risk management to medical devices.
Due to the newly published ISO 9001:2000, ISO 13485 is under the process of revision and QS regulation is not aligned
with ISO 9001:2000. The FDA is currently working closely with the revisions to ISO 13485. These revisions are expected to
be completed by late 2002 or early 2003. For further information, consult the FDA Web site at www.fda.gov.
European Union Regulations

All regulated products exported to the European Union must comply with E.U. regulations, also known as directives.
Directive 93/42/EEC—Medical Device Directive (MDD) governs all medical devices (as defined in MDD Article 1),
excluding active implantable medical devices and in vitro diagnostic. Other directives may come into play (for example,
Electromedical Equipment Directive 84/549/EEC, E.U. Good Manufacturing Practice, Human Medical Products and Risk
Assessment directives.)
Directive 93/42/EEC—Medical Device Directive

MDD intends to harmonize standards that benefit manufacturers, users and patients and to define the requirements for the clinical
testing, design, manufacture, testing/inspection, marketing, installation and service of medical devices sold within the E.U.
The directive consists of 23 articles, 12 annexes and 18 classification rules. Twenty-three articles summarize the requirements,
including definitions, defines the rules and routes for compliance, describe the classification of medical devices, and direct the
reader to the 12 annexes that provide the detail. Annex IX contains the classification criteria.
Medical devices are divided into four classes of increasing risk to the patient according to their properties, function and
intended purpose.
CLASS RISK LEVEL TO PATIENT EXAMPLES

Class I Low Tubing used for intravenous drips, cups and spoons used to
administer medication
REGULATIONS & STANDARDS GOVERNING MEDICAL DEVICE MANUFACTURING 5
CLASS RISK LEVEL TO PATIENT EXAMPLES

Class IIa Medium (generally refer to devices that are invasive through Infusion pump tubing, anesthesia breathing circuits
natural body orifices and therapeutic devices used in
diagnosis or in wound management)
Class IIb Medium (generally refer to devices that are partially or totally implantable Hemodialyzers, Blood cell separation systems
within human body and may modify the biological or chemical composition
of body fluids)
Class III High (generally refer to devices affecting the functioning of vital organs and/ Cardiovascular catheters
or life support systems)
Manufacturers of all classes of medical devices must provide technical documentation that demonstrates their products’
conformity with MDD requirements. Class I (Sterile and Measuring), Class IIa, IIb and III require the intervention of a
Notified Body that will be responsible for auditing the manufacturer’s quality system in accordance with the ISO 9001, EN
46000 and ISO 13485 standards. The Notified Body will also determine whether or not the product conforms to the
requirements of the MDD.
One of the essential requirements of the MDD is that the manufacturer is obliged to conduct a risk assessment. The
principles that can be used to evaluate risks can be found in EN 1441 Medical Devices—Risk Analysis, which is one of the
Harmonized Standards that support European legislation.
International Standards
ISO 9000:1994 and ISO 9000:2000 Series—Quality Management and Guidelines

The 9000 Series from the International Organization for Standardization is a set of individual but related international
standards on quality management and quality assurance. They are generic and not specific to any particular products. These
standards are used by manufacturing, design and service industries alike.
The ISO 9000 Series standards do not specify the technology to be used for implementing quality system elements, but
these standards enable industries to improve the quality of systems.
There are two versions of the series. The older version was published in 1994 and the latest revised version, which replaces
the 1994 edition, was published at the end of 2000. The 1994 version will remain viable until December 2003.
The 1994 version of ISO 9000 Series encompasses the following standards:
■ ISO 9000 contains guidelines for selection and use of suitable models;
■ ISO 9001 covers design, manufacturing, installation and servicing systems;
■ ISO 9002 covers production and installation (excluding design and development);
■ ISO 9003 covers only final product inspection and testing;
■ ISO 9004 provides guidelines for internal use by a producer developing its own quality system to meet business
requirements.
The 2000 version integrates ISO 9001, ISO 9002 and ISO 9003 into a new standard called ISO 9001:2000. This new standard
specifies the requirements for a quality management system for any organization that strives to consistently provide products
that meet customer satisfaction and regulatory requirements. ISO 9004:2000 contains guidelines for implementing a quality
management system to effectively meet business goals.
The latest version of ISO 9000 Series standard includes these standards:
■ ISO 9000:2000 describes fundamentals of quality management systems and specifies the terminology for quality
management systems;
■ ISO 9001:2000 specifies requirements for a quality management system where an organization needs to demonstrate its
ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer
satisfaction;
■ ISO 9004:2000 provides guidelines that consider both the effectiveness and efficiency of the quality management system.
The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other
interested parties.
6 REGULATIONS & STANDARDS GOVERNING MEDICAL DEVICE MANUFACTURING
The ISO 9000 Series includes the following key issues relating to medical devices:
■ Risks;
■ Problems analysis;
■ Health and safety;
■ Complaints;
■ Problems prevention;
■ Corrective actions;
■ Incorporation of new technologies;
■ Unintended use and misuse;
■ Regulatory requirements;
■ Documentation;
■ Record keeping;
■ Reporting.
ISO 13485:1996—Quality Systems—Medical Devices— Particular Requirements for the Application

of ISO 9001
ISO 13485:1996 carries over all requirements on design/development, production and, when relevant, the installation and
servicing systems from ISO 9001:1994, with additional requirements that are relevant to all medical devices or to some classes
of medical devices.
Due to the newly published ISO 9001:2000, ISO 13485 is under the process of revision. There are plans to release the
revised version by late 2002.
ISO 13488:1996—Quality Systems—Medical Devices— Particular Requirements for the Application

of ISO 9002
ISO 13488:1996 is the medical device equivalent of ISO 9002:1994, which outlines quality system requirements for
production and installation of medical devices, excluding design and development. Despite the fact that ISO 9002:1994 will
be eliminated, as a number of medical device regulatory schemes in Europe and North America relay on the existence of
separate standards, there are still plans to revise ISO 13488.
ISO 14969:1999—Quality Systems—Medical Devices— Guidance on the Application of ISO 13485

and ISO 13488
ISO 14969:1999 is a standard that provides guidance on the application of ISO 13485:1996 and ISO 13488:1996. It is
applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes
concepts and methods that can be considered by suppliers who are establishing and maintaining quality systems. The
objective is implementation of a quality system targeted at meeting customer requirements. This guidance can also be useful
as background information for those representing quality system assessors, notified bodies and regulatory agencies.
Similar to ISO 13485 and ISO 13488, the revised version of ISO 14969 will be made available in the near future.
ISO 14971:2000—Medical Devices—Risk Management— Application of Risk Management to

Medical Devices
In ISO 13485, risk management is recognized as an element of quality system for design and development, and it makes
reference to ISO 14971. This international standard specifies a procedure for the manufacturer of a medical device to identify
hazards associated with the device and its accessories, including in vitro diagnostic devices, to estimate and evaluate the risks
associated with those hazards, to control those risks and to monitor the effectiveness of that control. To meet the requirements
of this standard, Failure Mode and Effects Analysis, Fault Tree Analysis, and Hazard and Operability Analysis are
recommended for the risk analysis of medical devices.
REGULATIONS & STANDARDS GOVERNING MEDICAL DEVICE MANUFACTURING 7
EU/EC EN (European Norm) Standards
EN 46001:1996—Quality Systems—Medical Devices— Particular requirements for the application of

EN ISO 9001
This European Standard specifies, in conjunction with EN ISO 9001:1994 (identical to ISO 9001:1994), the quality system
requirements for the design/development, production and, where relevant, installation and servicing of medical devices. The
standard is superseded by EN ISO 13485:2000, which is identical to ISO 13485:1996 and as mentioned earlier is under
revision to align with ISO 9001:2000. This European Standard is scheduled to be withdrawn in 2003.

EN ISO 9002
This European Standard specifies, in conjunction with EN ISO 9002 (identical to ISO 9002:1994), the quality system
requirements for the production and, where relevant, installation of medical devices. The standard is superseded by EN ISO
13488:2000, which is identical to ISO 13488:1996 and as mentioned earlier is under revision. This European Standard is
scheduled to be withdrawn in 2003.

EN ISO 9003
This European Standard specifies, in conjunction with ISO 9003:1994 (identical to ISO 9003:1994), the quality system
requirements for the final inspection and testing of medical devices, excluding in vitro diagnostic medical devices and active
implantable medical devices, and is applicable when a medical device supplier’s quality system is assessed in accordance with
regulatory requirements.
EN 1441:1997—Medical Devices—Risk Analysis

This European standard has now been replaced by EN ISO 14971:2000. The current version of the European standard is still
made available until ISO 14971:2000 is fully adopted by the medical device industry.
CHAPTER 3
Risk Management of Medical Devices
This chapter describes the essence of risk management of medical devices, as outlined in ISO 14971. For more details, refer to
the international standard.
Risk Management
The focus of risk management is to identify the hazards associated with medical devices 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 medical
device 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 adapted from ISO 14971 includes the following elements:
• Risk Management Plan;

• Risk Assessment—covering both Risk Analysis and Risk Evaluation;
• Risk Control;
• Post-Production Information.
Risk Management Plan

Management must clearly define the objectives and scope of the project, which are dependent on a number of factors:
• The part of the product/process/system to be focused on;

• At what phase of the product’s life cycle the project is in;
• The amount of information available.
Responsibility and resources should be allocated to ensure that no responsibility is omitted.

Decisions concerning risk acceptability may be based on operational, technical, financial, legal, social, humanitarian, or
other criteria. The decisions can be justified by doing the following:
• Using product-specific standards. If standards are properly implemented and the product is tested, it should result in an
acceptable level of risk.
• Comparing with levels of risk evident from other similar devices on the market. It should consider similarities and
differences in:
○ Intended use;
○ Hazards;
RISK MANAGEMENT OF MEDICAL DEVICES 9
○ Risk;
○ Safety features;
○ Historical data.
• Following appropriate guidance. For example, the single-fault philosophy detailed in IEC 60513 implies that medical
electrical equipment has two means of defense against any one hazard, so that a single fault cannot result in the hazard.
Risk Assessment (Risk Analysis & Risk Evaluation)

Risk analysis addresses three specific questions:
• What can go wrong?

• How likely is it?
• What are the impacts?
In order to answer the above questions, it is essential to understand the intended use or purpose, including any foreseeable
misuse, of the medical device and to identify the device characteristics that could impact on safety. Table 3-1 at the end of this
chapter provides a list of questions adopted from ISO 14971, which although not exhaustive, can be used to identify such
characteristics.
The next step is to identify hazards associated with the device and determine the related causes and consequences, and
ultimately estimate the risk.
Some potential hazards (if applicable) that should be evaluated include these factors:
• Toxicity, flammability and reactivity of raw materials and wastes;

• Sensitivity to environmental factors such as temperature and humidity;
• Mechanical or electronic hazards;
• Human factors associated with the operator-device interface;
• Patent-device interface. Hazards can result from unsafe or ineffective delivery of energy, administration of drugs or control
of life-sustaining functions. Also, incorrect information could lead to misdiagnosis or wrong treatment or the wrong
therapy being ordered.
The risk analysis is not only restricted to the design of the product, it should also be done for the manufacturing process (e.g.
assembly process, packaging) and the process of delivering the device to its intended location. For devices that involve
materials that are sensitive to the environment (e.g., heat, humidity, cold or light), storage and transportation methods need to
be reviewed. If problems are identified, appropriate changes should be made in packaging or warnings on storage or
packaging containers.
The software used to control or monitor a medical device also needs to be reviewed. The consequences of software errors
can be unpredictable, particularly those that involve data corruption or false alarms. In such cases, the device should have a
means of detecting software errors or the consequences. For example, consider installing separate redundant alarms or
interlocks on critical aspects of the device.
Depending on the complexity of the device, one or a combination of risk analysis techniques can be used to identify
hazards. Some common techniques include Failure Mode and Effects Analysis (FMEA), Hazard and Operability Analysis
(HAZOP) and Fault Tree Analysis (FTA). The FMEA methodology and its application through the entire lifecycle of the
device are addressed later in this manual. The other two techniques are described in the next chapter.
Once the risk estimation for all hazards is completed, the acceptability of risk is determined based on the company’s risk-
acceptability criteria (based on what was established in the risk management plan) and, if it is too high, the risk needs to be
mitigated.
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;
10 RISK MANAGEMENT OF MEDICAL DEVICES
• 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
Throughout the device’s lifetime, new information obtained during postmarketing vigilance regarding a new
hazard or risk must be assessed and recorded in the risk management file. Hence, risk analysis and management is
an ongoing process throughout a device’s lifetime and it is the continuous responsibility of the manufacturer to
ensure the device safety.
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.
Table 3-1: Suggested questions for identifying medical device characteristics that can impact safety
1. What is the intended use/purpose and how is the medical device to be used?
2. Is the medical device intended to be in contact with patients or other persons?
3. What materials and/or components are incorporated in, or are in contact with, the medical device?
4. Is energy delivered to and/or extracted from the patient?
5. Are biological materials processed by the medical device for subsequent re-use?
6. Is the medical device supplied in a sterile condition, or is it intended to be sterilized by the user, or are other microbiological
controls applicable?
7. Is the medical device intended to be routinely cleaned and disinfected by the user?
8. Is the medical device intended to modify the patient environment?
9. Are measurements taken with the device?
10. Is the medical device interpretative?
11. Is the medical device intended to control or to interact with other devices or drugs?
12. Are there unwanted outputs of energy or substances?
13. Is the medical device susceptible to environmental influences?
14. Does the medical device influence the environment?
15. Are there essential consumables or accessories associated with the medical device?
16. Is maintenance and/or calibration necessary?
17. Does the medical device contain software?
18. Does the medical device have a restricted shelf life?
19. Are delayed and/or long-term effects of use possible?
20. To what mechanical forces will the medical device be subjected?
21. What determines the lifetime of the medical device?
22. Is the medical device intended for single use or multiple uses?
23. Is safe decommissioning or disposal of the medical device necessary?
24. Does installation of the medical device require special training?
25. Will new manufacturing processes need to be established or introduced?
26. Is successful application of the medical device critically dependent on human factors, such as the user interface?
27. Does the medical device have connecting parts or accessories?
28. Does the medical device have a control interface?
29. Does the medical device display information?
30. Is the medical device controlled by a menu?
31. Is the device intended to be mobile or portable?
RISK MANAGEMENT OF MEDICAL DEVICES 11
CHAPTER 4
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 medical device industry as alternatives to Failure Mode and Effects Analysis
(FMEA).
Hazard And Operability Analysis (HAZOP)
This technique was originally developed for use in the chemical process industry for identifying hazards and
operability problems. It can also be applied to the operation of medical devices, e.g. the processes used for the
diagnosis or treatment of disease, or the processes used to manufacture the device.
HAZOP is a highly structured bottom-up methodology. It uses the combination of design parameter and
guideword to help identify deviation from design intent. The following are examples of guidewords and design
parameters:
Guidewords
• 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.
Applicable operations typically include:
• Filling;
• Transferring;
• Purging;
• Emptying;
• Draining;
• Venting;
• Maintenance;
• Start-up;
• Shut-down.
RISK ANALYSIS METHODOLOGIES 13
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 (FTA)

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 4-1 and 4-2, respectively. An example of a fault tree is shown in
Figure 4-1.
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.
Table 4-1: Logic Gate Symbols

Gate Symbol Gate Name Causal Relation
AND Output event occurs if all input events occur simultaneously
OR Output event occurs if any one of the input events occurs
Table 4-2: Event Symbols

Event Symbol Event Name Meaning
CIRCLE Basic event with sufficient data
DIAMOND Undeveloped event
RECTANGLE Event represented by a gate

TRIANGLE Transfer symbol
14 RISK ANALYSIS METHODOLOGIES
Figure 4-1: Fault Tree Analysis Example

CHAPTER 5
Overview of FMEA
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 5-1),
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 lifecycle.
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 lifecycle, 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;
■ Improves productivity, quality, safety and cost efficiency;
■ Helps to determine the need for selecting alternative materials, parts, devices, components and tasks;
■ Assists in documenting the reasons for changes;
■ Provides a means of communication between different departments;
■ Helps increase customer satisfaction;
■ Improves a company’s image and competitiveness.
Table 5-1: List of Product Recalls

Model/Type of Product Quantity Recalled Problem Failure Effect
Automotive
2001 Nissan Sentra 130,000 passenger cars One or more of the attachment Unusual noise or vibration felt
bolts for the front-suspension, through the steering wheel when
lower control arms may break. hitting bumps.
16 OVERVIEW OF FMEA

2000 and 2001 Chrysler Neon 515,000 from USA, Canada, Brake booster vacuum hose may Harder for drivers to stop the
Mexico and foreign markets loosen. vehicle. Greater pedal pressure
may be required to stop the
vehicle.
1997–2000 Chevrolet Venture, 54,700 minivans Passenger side power sliding Door could open while the car is
Pontiac Trans Sport/Montana doors may close but not latch. in motion.
and Oldsmobile Silhouette
Pontiac Grand Am, Buick 778,000 cars High current flows and heat in Fires could occur in the steering
Skylark and Oldsmobile the ignition switch when key system. Reports of three injuries
Achieva held in the start position for an from electrical fires.
extended period of time.
GM light trucks and sports 1.38 million vehicles Brake pedal will be lower than Crash could occur when
utilities normal and stopping distances stopping distance is smaller.
will be longer.

Home Products
Take 2, Travel Solutions, Pioneer, 650,000 strollers Strollers can unexpectedly collapse Infants can suffer serious injuries.
Travelite, Pro Sport 4-in-1 strollers or the car seat/carrier adapter can 681 incidents including 250
unexpectedly detach. injuries reported.
Star Cruiser and Rock Rider 190,000 sets Screws that hold the swing 291 incidents of seats separating
swings (backyard gym sets) together can fall out, causing the and 19 injuries reported.
seat to fall to the ground.
Ariens Scotts and Husqvarna walk- 40,000 lawnmowers Piece attaching the blade to the Possible injury to the operator or
behind lawnmowers mower can crack and break off. bystander.
Zep commercial cleaner 1.4 million 32 oz. bottles Leaking occurs through the cap Cleaner causes irritation and burns
when bottles are turned on their to the skin and eyes. 10 bottle
side. leaks and three injuries reported.
AquaStar natural gas water heaters 320 units Produces dangerous levels of Serious injuries and death
carbon monoxide in exhaust gas. possible.

Children’s Toys and Consumer Goods
Princess Ariel costumes 54,000 costumes Fabric ignites easily. A burn injury to a four-year-old
girl and one case of ignition
reported.
Accessory to a video game — 140,000 baseball video games to Bats can separate during A split lip, facial lacerations, a
baseball bats replace the bats swinging. bump on the head and bruising
reported.
Nike Trunner LX and Jordan 225,000 pairs Thin metal strip on the outside Forms a sharp edge that can cut.
Trunner 2000 cross trainers of the heel can protrude from the 16 reports of cuts to the lower
shoe. legs. Some stitches to close.
Scuba buoyancy compensator 10,000 units Overpressure valve can stick in Risk of drowning to divers.
devices (BCDs) by Sheico PKS the open position.
Inc.
Medical Devices and Pharmaceuticals
Inter-Op shells by Sulzer Approximately 17,500 patients Lubricant residue may cause the 129 cases of loosening reported.
Orthopedics worldwide have received the shells to come loose and may All presented symptoms of
recalled Inter-Op shells. prevent implant from bonding aseptic loosening within six
with the bone, causing the shells months of implantation.
to loosen.
Migraine drug Sandomigran DS 941 large bottles sent out to Muscle relaxant tablets were These foreign tablets could lead
(pizotifen, double strength) by pharmacists still need to be found in some bottles. to drops in blood pressure.
Novartis Pharmaceuticals located
Canada
OVERVIEW OF FMEA 17

Consumer Electronics
Electric drills 58,000 units Switches on these power tools can Drills can continue to operate after
stick. the trigger is released. Risk of injury
to user.
Nightlights by Dura Kleen Inc. 459,000 nightlights Electrical connections are loose; Poses shock and fire hazards to
made of flammable plastic, and consumers.
power switch does not work.
Black & Decker miter saws 118,400 units Bolts can loosen. Risk of lacerations to the user.
Batteries in Dell Inspiron 5000 and 284,000 batteries Can overcharge and become very Possible smoke and fire.
5000e notebook computers hot.
Limitations of FMEA
Using Failure Mode and Effects Analysis can potentially be disadvantageous for the following reasons:
■ Analysis of complex systems that have multiple functions consisting of a number of components can be tedious and difficult;
■ Compound failure effects cannot be analyzed;
■ Incorporating all possible factors influencing the product/process, such as human errors and environmental impacts, can
make the analysis lengthy and require a thorough knowledge of the characteristics and performance of the different
components of the system;
■ Successful completion requires expertise, experience and good team skills;
■ Dealing with data redundancies can be difficult;
■ Can be costly and time consuming.
CHAPTER 6
FMEA Procedures
This chapter describes the basic terminology and process used in FMEA. In addition, the procedures for setting up,
conducting and following up FMEA are described.
Introduction
Similar to a HAZOP, the FMEA is a bottom-up approach starting with components and using a single-point failure approach
to progressively work up to the top level. During the FMEA study, risk is estimated by rating the severity of failure effects,
the likelihood of causes, and the likelihood of detecting the cause of a failure or the failure mode. Table 6-1 shows a sample
FMEA worksheet for documenting the result of the analysis. The terminology used on the worksheet and the FMEA
procedures are described below.
FMEA Terminology
Item Function
Item function specifies the function of the part or item under review.
Potential Failure Mode

A potential failure mode is the manner in which a failure can occur i.e. the ways in which the reviewed item can fail to
perform its intended design function, or perform the function but fail to meet the objective. The potential failure mode may
also be the cause of another potential failure mode in a higher-level subsystem or system, or be the effect of one in a lower-
level component.
Typical potential failure modes include the following:
■ Fail to open/close;
■ Brittle;
■ Cracked;
■ Warped;
■ Underfilled;
■ Undersized/Oversized.
Potential Failure Causes

Potential failure causes identify the root cause of the potential failure mode, not symptom, and provide an indication of a
design weakness that leads to the failure mode. The prompt identification of the root cause is important for the
implementation of preventive or corrective measures. Failure causes often include these types of problems:
■ Overstressing;
■ Incorrect material specified;
■ Improper wall thickness;
■ Improper tolerance.
FMEA PROCEDURES 19
Potential Failure Effects

Potential failure effects refer to the potential outcome of the failure on the system, design, process or service. The potential
failure effects need to be analyzed based on the local and global impacts. A local effect is an outcome with only an isolated
impact that does not affect other functions. A global effect, on the other hand, affects other functions/components and has a
domino effect on the system.
For a design, three types of potential failure effects need to be considered:
■ The effect on the end user of the product (end effect);

■ The effect on the local/reviewed area (local effect);
■ The effect on aspects situated between the above two (next high level effect).
For a manufacturing process, two types of potential failure effects need to be considered:
■ The effect on the product;

■ The effect on local and downstream processes.
The severity of a particular failure is determined based on the failure effect. The more serious the effect is, the higher the
severity.
Potential failure effects might include these examples:
■ Erratic operation;
■ Failure to operate;
■ Noise;
■ Loss of life.
Current Controls
Current controls are the safeguarding measures in place at the time of review that are intended to do the following:
■ Eliminate causes of failure;

■ Identify or detect failure;
■ Reduce impacts/consequences of failure.
This list includes common examples of current controls:
■ Statistical Process Control (SPC) analysis;

■ Product capability studies;
■ Function tests;
■ Gauge repeatability and reproducibility (R&R) studies;
■ Durability tests;
■ Design reviews and design guidelines;
■ Operator training.
Severity
Severity is the seriousness of the effects of the failure. Severity is an assessment of the failure effects on the end user, local
area and in-between (next higher) areas. The severity rating applies only to the effects.
The severity can be reduced only through a change in the design. If such a design change is attainable, the failure can
possibly be eliminated.
Occurrence
Occurrence is the frequency of the failure—that is, how often the failure can be expected to take place.
20 FMEA PROCEDURES
Detection
Detection is the ability to identify the failure before it reaches the end user/customer.
Risk Priority Number (RPN)

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 corrective actions, and it is used to prioritize the actions.
The value, by itself, does not have any other significance.
Recommended Corrective Action

The recommended corrective action is intended to reduce the RPN by reducing either the severity, occurrence or detection
ranking, or all three together.
Corrective Actions Taken

It is a brief description of the actual actions taken, after identifying recommended corrective actions.
Resulting Severity
After a corrective action has been chosen/identified, “estimate” and record the resulting severity rating.
Resulting Occurrence
After a corrective action has been chosen/identified, “estimate” and record the resulting occurrence rating.
Resulting Detection
After a corrective action has been chosen/identified, “estimate” and record the resulting detection rating.
Resulting RPN
The resulting RPN is determined based on the resulting severity, occurrence and detection.
Critical Characteristics
Critical Characteristics are characteristics that can affect compliance with government regulations or product safety. Critical
Characteristics are defined by:
■ The courts—through product liability;

■ Regulatory agencies—through formal laws and/or regulations;
■ Industrial standards—through generally accepted practices in the industry;
■ Customer requisitions—through their wants, needs and expectations;
■ Internal engineering requirements—through historical data, or leading edge technology, or experiences with products or
services.
Such characteristics require specific producer, assembly, shipping or monitoring actions and inclusion on Control Plans.
Examples of critical characteristics include part or process requirements, such as dimensions, specifications, tests, processes,
assembly sequences, tooling, torque, welds, attachments and component usages.
FMEA PROCEDURES 21
Significant Characteristics
Significant characteristics are characteristics of products, processes and tests where a reduction in variation within a specified
tolerance around a proper target will improve customer satisfaction. Significant characteristics must be supported with
Control Plans.
Control Items
Control items are parts that can affect either compliance with government regulations or safe product/process operation, and
are identified by the customer’s product engineering on drawings and specifications with a specific and unique symbol.
FMEA Steps
During an FMEA study, the product/process/service/system being reviewed is broken down into smaller items/subsystems.
For each item, the following steps are performed:
1. Define the item being analyzed.

2. Define the functions of the item being analyzed.
3. Identify all potential failure modes for the item.
4. Determine the causes of each potential failure mode.
5. Identify the effects of each potential failure mode without consideration of current control.
6. Identify and list the current controls for each potential failure mode.
7. Determine the most appropriate corrective/preventive actions and recommendations based on the analysis of risk.
After going through all the items for each failure, assign a rating (from 1 to 10, low to high) for severity, occurrence and detection.
Determine the RPN and use it to prioritize the recommendations. The severity rating should be based on the worst effect of
the potential failure mode.
When the severity is very high (8 to 10), special attention must be given to ensure that the risk is addressed through existing
design controls or corrective/preventive actions, regardless of the RPN.
If there are no recommended actions for a specific potential failure mode, failure cause or existing control, enter “None”.
If this is a follow-up of an existing FMEA, note any action taken to eliminate or reduce the risk of failure modes.
Determine the resulting RPN as the risk of the potential failure modes are reduced or eliminated.
Once corrective action has been taken, the resulting RPN is determined by reevaluating the severity, occurrence and
detection ratings. Improvement and corrective action must continue until the resulting RPN is at an acceptable level for all
potential failure modes.
22 FMEA PROCEDURES
Table 6-1: Sample FMEA worksheet

FMEA PROCEDURES 23
Preliminary Consideration of FMEA

It is important that the scope of the FMEA study is clearly defined. This allows the FMEA team to suggest and implement
improvements freely within the defined boundaries. The following is a list of questions that help to define the boundaries of
the study:
■ What aspects of the FMEA is the team responsible for? e.g. FMEA analysis, recommendations for improvement,
implementation of improvements.
■ What is the budget for the FMEA?
■ Does the project have a deadline?
■ What is the scope of the FMEA?
When it comes to planning the meeting, the following is a suggested list of considerations:
■ People—People involved in all meetings may differ in values, attitudes, experiences, gender, age and education. All these
differences must be accounted for in the planning of the meeting.
■ Purpose—As mentioned before, the scope of the study—the purpose, objective and the goal, must be understood by all, both
management and participants.
■ Atmosphere or climate—The atmosphere contributes to the effectiveness of the meeting. It is imperative that whoever
plans the meeting takes into consideration the climate and atmosphere.
■ Place and space—All meetings are held in a space and a place. Therefore, planners must consider the following:
○ Access to the space, available parking;

○ Size of the space;
○ Acoustics, lighting, temperature control;
○ Cost;
○ Equipment requirements.
■ Costs—The FMEA budget should take into consideration the required preparation time, as it can be lengthy. The required
preparation work is discussed further in the next section. As the system, design, process or service personnel assigned to do
the FMEA may be in different places, one should consider the travel expenses of participants.
■ Time dimensions—When estimating the time required for conducting the FMEA, one should consider the conditions,
objectives and complexity of the project. The time constraints should be fully evaluated. If the meeting is going to be
prolonged, the agenda items and objects should be adjusted accordingly.
■ Prework and “after the official meeting work”—The quality of the FMEA study depends on good preparation work, which
is discussed further in the next section.
■ Plans, program and agenda—All meetings have an agenda. Without an agenda there cannot be a meeting. A detailed
planned program or agenda, which can be shared (no surprises) by all participants, is a valuable addition to a meeting.
When planning the agenda, make sure all the objectives of the meeting are covered.
■ Follow-up—After the meetings have ended, there is a need for some follow-up in these areas:
○ Implementing action items;

○ Communicating information to all appropriate personnel;
○ Publishing the documented study and writing the report.
Preparation Before FMEA Sessions

Before conducting a FMEA, preparation work should be done to ensure the FMEA study is carried out smoothly. The
following are the recommended procedures for doing so:
24 FMEA PROCEDURES
1.
Define scope
After considering the questions outlined in the previous section, the study scope should be defined and documented. This would
help prevent the FMEA team from focusing on the wrong aspect of the product, process or service during the FMEA. It would
also assist the process of data collection (next step).
2.
Collect data
On the basis of the scope defined in step 1, assemble as much information as possible. The following are some examples:
■ Product prototype;
■ Design specification;
■ Design drawings;
■ Process flow diagram;
■ Operating manual;
■ Maintenance log.
3.
Break the system down
During the process of breaking down the product/process/service into smaller items, consider the following:
■ If items are too small, you can lose your sense of analysis and incur excessive repetition;
■ If items are too large, they can become confusing and hard to handle. The best way to size an item is based on item
function.
4.
Prepare list of potential failure modes
The list of potential failure modes prepared at this stage acts as a starting point for the FMEA section. It is not intended to
replace the effort of identifying the potential failure modes during the FMEA section. The list can be established based on this
information:
■ Failure history of products with similar design;

■ Product recalls;
■ Failure records of the product/process/system;
■ Review of product/process/system.
5.
Assemble FMEA team
A FMEA study requires efforts of experts from different areas. It cannot be done on an individual basis. Hence, the team should
be cross-functional and multi-disciplined. It is important to ensure that the appropriate individuals are going to participate.
6.
Choose the right tool for transcribing FMEA
Choosing the right tool for transcribing the FMEA ensures efficiency of conducting the analysis. There are three different
methods (non-computer and computer based):
■ Manual transcription;
■ Spreadsheet—type software;
■ Risk analysis software (Windows based).
FMEA PROCEDURES 25
Table 6-2 compares the features of the above methods. Each feature is ranked from 10 to 1 with 10 being the best
performance. It is concluded that using risk analysis software is the best and most efficient method.
Table 6-2: Comparison of features of different methods of transcribing risk analysis

Feature Manual Transcription Spreadsheets Risk analysis software
(Windows based)
Learning Curve Required None Little Some
(10) (7) (4)
User Friendliness Maximum Good Fair
(10) (7) (7)
Productivity Poor Fair Very Good
(1) (4) (10)
Customization Features Very Good Good Very Good
(10) (7) (10)
Copying Capabilities None Some Very Good
(1) (4) (10)
Team Participation No Some Very Good
(1) (4) (10)
Quality Assurance None Little Very Good
(1) (4) (10)
Assists Auditing of FMEA No Little Very Good
(1) (4) (10)
Good Documentation No Fair Very Good
(1) (4) (10)
“Power” Features None Some Very Good
(1) (4) (10)
Overall Assessment Poor Fair Very Good
(37) (49) (91)
Conducting FMEA Sessions

The FMEA team is led by the team leader or the facilitator. The team leader/facilitator provides assistance and guidance to the
team to ensure the FMEA session is conducted effectively on a timely basis. A typical FMEA session would follow the steps
outlined below:
1.
Facilitator or team leader explains
The facilitator or one of the team members explains the purpose and scope of the FMEA and sets the rules for the study.
2.
Review the system being studied
The system is reviewed to ensure everyone on the FMEA team has the same understanding of the system.
3.
Perform the analysis
The FMEA process described earlier is applied to the product/process/system. When FMEA is performed on commodity
items, it would be efficient to perform group FMEAs on similar or identical items and then address the out-of-the-ordinary
conditions as separate items.
26 FMEA PROCEDURES
4.
Review FMEA
At the end of the FMEA, the team should ensure that the function, purpose and objective have been met. Some helpful hints
include the following questions:
• Is the problem identification specific?

• Was a root cause, effect or symptom identified?
• Is the corrective action measurable?
• Is the corrective action proactive?
• Is the use of terminology current and consistent?
Follow-Up of FMEA
■ The facilitator/team leader would issue a preliminary FMEA report including the following:
○ Attendance;
○ Study Outline;
○ Detail Report;
○ Action Register.
■ The FMEA is a living document and should always reflect the latest level of the system being analyzed, as well as the latest
relevant actions, including those occurring after the start of production.
■ The distribution is a controlled document and should be treated as such.
■ Each recommendation must be assigned to the appropriate personnel to ensure it has been implemented or adequately
addressed.
■ A person should be assigned to oversee the progress of implementing all recommendations and to ensure all actions are
carried out properly.
CHAPTER 7
FMEA Team
This chapter describes the responsibilities of FMEA team members and the facilitator/ team leader.
Introduction
Failure Mode and Effects Analysis (FMEA) is a team function and cannot be done on an individual basis. The makeup of the
FMEA team is cross-functional and multi-disciplined for each study. The knowledge that is required for a specific problem is
often unique to that problem and may require personnel from other specialized departments as well.
Team Size
■ The best size for the team is usually 4 to 6 people.

■ The minimum number of people can be dictated by the number of areas that are affected by the FMEA.
■ When appropriate, consider offering team membership to the customer, whether internal or external to the organization.
Team Membership
The responsibilities of team members are as follows:
■ Participate;
■ Contribute your knowledge and experience;
■ Be open-minded for discussion, negotiation and compromise;
■ Share adequate information with your colleagues.
Team Leader (Facilitator)

The team leader is responsible for coordinating the FMEA process:
■ Setting up and facilitating meetings;

■ Ensuring the team has the necessary resources available;
■ Making sure the team is progressing toward the completion of the FMEA.
The team leader should not dominate the team and does not normally have the final word on team decisions. The team
leader’s role is more like that of a facilitator than a decision-maker.
Arrangements should be made for a scribe to be responsible for documenting the study during the FMEA session. The
scribe’s role is often rotated among all team members, except the team leader. This spreads the burden equally among all
participants.
CHAPTER 8
Pitfalls with FMEA
This chapter describes some major pitfalls during the conduction of FMEA studies.
Prepare FMEA Team

Inadequate preparation may:
■ Slow the team down;

■ Result in excessive study times.
Do Not Assume Everyone Understands FMEA

Prepare the team. This objective can be achieved through the services of risk management consultants.
Choose Team Members Carefully

The wrong team players can negatively impact the FMEA. See Chapters 11 to 14 for a suggested list of team members for
different types of FMEA.
Avoid Getting Sidetracked
■ Avoid getting off topic;

■ Avoid “hobby horses”;
■ Avoid redesigning during the FMEA. Identify Action Items for further study.
Do Not Run Excessively Long Sessions

FMEA sessions should not exceed 6 to 7 hours since the team will become very exhausted and will be ineffective.
Use the Right Type of FMEA Methodology

Selecting the right type of FMEA methodology depends on which stage the product cycle is at. For example, during the
preliminary design stage, Product/Design FMEA should be used to review the design of the product, while Process FMEA
should be used in the process planning stage.
Address Group Participation
■ Avoid team sessions being dominated totally by one or two people;

■ Ensure everyone is encouraged to input by using “round table” techniques and sharing the responsibility of the FMEA.
List Action Items Effectively
■ Record the Action Item so that it can be acted upon by the responsible person designated to execute it. Avoid indecisive
instructions such as “Consider studying…”
COMMON TOOLS USED WITH FMEA 29
■ Do not propose Actions that are just “wish lists.” Excessive numbers of Actions tend to devalue their worth. Be critical,
but not over or under zealous.
CHAPTER 9
Common Tools Used with FMEA
This chapter gives an overview of tools commonly used with FMEA, including process flowcharts, block diagrams and Pareto
charts.
Process Mapping/Process Flowcharts

The concept of process mapping is to capture knowledge and sequence of flow of operations about processes and then
represent that knowledge using boxes and arrows. Process mapping provides a clear picture of the process and allows easy
identification of the main sequence of activities, and it clarifies critical connections across individual operations and
departments. Table 9-1 shows some commonly used symbols in process mapping. An example process map is given in
Figure 9-1.
Table 9-1: Common Symbols Used in Process Mapping

Symbol Meaning Examples
Decision • Is the part to customer spec?
• Is the supplier the correct one?
Control/Inspection • Inspect part.
• Is it the correct quality/quantity?
Operation • An action or process.
• Is it manual or automatic?
Movement/Transfer • Material handling.
• Movement of people.
• Data transfer.
Symbol Meaning Examples

Delay • Down time or setup time.
• Items in queue.
• Waiting for additional information.
Storage/Inventory • Inventory materials, finished products.
Reject • Items rejected.
• What happens to rejected part and subsequent parts?
Here are just a few of the typical symbols used in process mapping. By using symbols and words, a picture of a company’s manufacturing
process can be drawn.
Block Diagrams/Functional Flow Diagrams

Block diagrams illustrate the operation, interrelationships and interdependencies of the functions of a system, which are
required to show the sequence and the series dependence or independence of functions and operations. Block diagrams may
be constructed in conjunction with, or after, defining the system and shall present the system breakdown of its major
functions. More than one block diagram is sometimes required to represent alternative modes of operation, depending upon the
definition established for the system.
Two types of block diagrams are used in FMEA:
Figure 9-1: Sample Process Map for Order Entry

■ Functional block diagrams—Functional block diagrams illustrate the operation and interrelationships between functional
entities of a system as defined in engineering data and schematics. An example is given in Figure 9-2.
■ Reliability block diagrams—This type is useful for identifying the series dependence or independence of major
components, subsystems or detail parts in achieving required functions. An example is given in Figure 9-3.
Pareto Charts
The Pareto Chart combines a bar graph with a cumulative line graph. The bars are placed from left to right in descending
order. The cumulative line graph shows the percent contribution of all preceding bars. The Pareto Chart shows where effort
can be focused for maximum benefit. It may take two or more Pareto Charts to focus the problem to a level that can be
successfully analyzed.
In FMEA, Pareto Charts are usually used for the following:
■ Comparison of RPNs between different failure modes of the item analyzed and identification of high RPN failure modes.
32 COMMON TOOLS USED WITH FMEA
Figure 9-2: Functional Block Diagram

■ Comparison of total RPNs between items and identification of high RPN items. The total RPN of each item is the
summation of RPNs of all failure modes of the item.
In either case, the team must set a cut-off RPN, where any failure modes or items with an RPN above that point require
further attention. An example Pareto Chart for comparison of RPNs between different failure modes is given in Figure 9-4.
Figure 9-3: Reliability Block Diagram
Figure 9-4: Pareto Chart for comparison of RPNs between different failure modes
CHAPTER 10
Product Life Cycle & FMEA
This chapter outlines the application of FMEA at various stages in a product’s life cycle. It also introduces the use of Control
Plans as a tool to document the design and process characteristics for manufacturing the device.
Introduction
During the process of design, development and manufacture, the following issues affect the reliability (safety, durability,
robustness) of medical devices:
• Design of process and product;

• Verification of product design;
• Quality of parts purchased from suppliers;
• Validation of processes for production;
• Amount of process variation;
• Clarity of the device instruction.
Applying FMEA at different stages in the product’s life cycle helps in the identification of not only design and manufacturing
defects but also the product and process characteristics that need to be controlled, monitored and tested. Such information,
together with the methods of monitoring and testing, are documented in the Control Plan.
A Control Plan is a written summary of the producer’s quality planning actions for a specific process, product and/or
service. The Control Plan lists all process parameters and design characteristics considered important to customer satisfaction
and which require specific quality planning actions. It also describes the actions and reactions required to ensure that the
process is maintained in a state of statistical control, as agreed upon between the design team, customer and supplier. It
supports verification and validation of the product and the process. It also helps minimize process variation.
Figure 10-1 is an illustration of how various types of FMEAs and Control Plans can be integrated into the product’s life
cycle. The various types of FMEAs in Figure 10-1, their application in the product’s life cycle and the use of Control Plans
are described in the following sections. The various FMEA methodologies are discussed in Chapters 11 to 14.
Different Types of FMEAs

Table 10-1 summaries the focuses of the various types of FMEAs. Each type of FMEA is briefly described below:
Product/Design FMEA (D-FMEA)

The primary focus of D-FMEA is on the product. This includes the components/parts, raw materials used and the features/
characteristics of the product. The D-FMEA is important in a product’s life cycle as approximately 76 percent of all
engineering changes are due to the correction of bad designs, and the rest are the result of other improvements. Therefore,
identifying all potential failures in the design stage is crucial.
Process FMEA (P-FMEA)

Process FMEA focuses on the manufacturing process, including the process steps, process equipment, process conditions,
tooling/fixtures, operator errors, materials quality and so on. This methodology identifies potential or known failure modes
and provides follow-up and corrective actions before the first or subsequent production runs.
PRODUCT LIFE CYCLE & FMEA 35
Figure 10-1: Relationship between FMEA, Control Plan and product cycle.
36 PRODUCT LIFE CYCLE & FMEA
Application FMEA (A-FMEA)

Application FMEA focuses on the design application. There are two types of A-FMEA: Supplier side A-FMEA and
downstream customer side A-FMEA. The purpose of the supplier side A-FMEA is to detect any potential failures of the
product relating to the application, design and manufacturing processes of parts and materials acquired from an outside
supplier. The downstream customer side A-FMEA investigates the effects of the customer’s application of the product on the
product itself and on the customer. It is used to eliminate confusion and customer complaints.
Service FMEA (S-FMEA)

Service FMEA focuses on field service after sales—for example, serviceability, spare parts availability and service manpower
availability. The objectives of the FMEA are to define, demonstrate and maximize solutions in response to quality, reliability,
maintainability, cost and productivity as defined by the design specifications and the customer. These goals are achieved
through the active participation of personnel in the departments of customer service, product development, research, quality
assurance, marketing and operations. Thus, the focus of the Service FMEA is to minimize failure effects on the service,
regardless of what level of FMEA is performed, and to maximize customer satisfaction.
Table 10-1: Focuses of various types of FMEAs

Type of FMEA Product/Design Process FMEA Application FMEA/ Application FMEA/ Service FMEA
FMEA Supplier Side Downstream
Customer Side
Review Item Design of the product Process Your product & the Your product and Product
(manufacturing and application process customer’s
assembly processes) application process
Focus Determine what Concentrate on Focus on failures of Focus on failures of Minimize service
could go wrong with potential failures your product relating your product, which failures on the total
the product in both during manufacturing to parts and affect downstream organization
manufacturing and in service components from customer’s process
operations and in resulting from non- outside suppliers
services as a result of compliance to
weaknesses in the specification and/or
design design intent
Failure Modes On product, e.g. On manufacturing & On the product On the product On the product/
components, process, e.g. service
subsystems, sub- equipment, machines,
assemblies tooling, process steps
Causes From engineering From manufacturing From the supplier, From the customer, From the service
efforts, e.g. and process, e.g. e.g. e.g. provider, e.g.
• Improper tolerance • Missing parts • Ambiguous • Wrong • Human error
• Incorrect stress • Adjustment error instruction interpretation of • Failure to enforce
calculations • Equipment not set • Insufficient instruction process and quality
• Wrong assumptions up properly information in user controls
• Hardware failure manual • Improper selection
of component parts
Effects • Impacts to the item • Impacts on the • Impacts on the • Impacts on the • Impacts on the
being reviewed operation itself significant significant product/service
(Local effect) (Local process characteristics of the characteristics of the (Local effects)
• Impacts on the end effects) product (Local product (Local • Impacts on the end
user (End effect) • Impacts to effects) effects) user (End effects)
• Impacts between downstream • Impacts on the end • Impacts on the end
local and end user operations user (End effects) user (End effects)
(Next higher level (Downstream process
effects) effects)
• The end user of the
produced product
(End Product Effects)
Integration of FMEA and Control Plan to Product Cycle

Based on Figure 10-1, the following discusses the integration of the FMEAs and Control Plan to the product’s life cycle.
PRODUCT LIFE CYCLE & FMEA 37
Feasibility Phase
At this stage, financial and technological feasibility studies are established. The feasibility phase is concluded with the product
design target specifications.
Product Design and Development Phase

At the beginning of the design phase, several candidate concepts are usually developed based on the product design target
specifications established in the feasibility phase. Design FMEA (D-FMEA) can be used in the selection of the most
promising concept by providing a means of locating respective weaknesses. Although there is often little information made
available at this stage, the failure modes can either be established through design analysis or recalls of products with similar
design. Similarly, when evaluating the hazard likelihood, comparisons may be made with similar devices and their histories in
the medical device reports. The causes of failure modes would be mainly engineering related.
Once a design is selected, the associated critical characteristics identified in D-FMEA are recorded in the Control Plan. The
primary purpose of the Control Plan at this stage is to document and communicate the initial plan for process control. At the
end of the design phase, preliminary design and mechanical drawings are available, and the basic process operations
(manufacturing and assembly) have been defined.
During the development phase, before building the prototype, a more detailed D-FMEA can be performed to minimize
design defects, eliminate all high-severity hazards and reduce as many medium- and low-severity hazards as possible. As
there is considerable flexibility at this early design stage, the cost of major changes to make the device inherently safer would
be minimal. The critical design characteristics identified in the FMEA are recorded in the Control Plan (prototype Control
Plan).
Process Design and Development Phase

Based on the product criteria, features and mission requirements, conceptual process designs are established. A preliminary
Process FMEA (P-FMEA) can be used in the selection of the most promising concept by providing a means of locating
respective weaknesses. The preliminary P-FMEA is also used to solidify product design characteristics and manufacturing
processes. When the process design is selected, the P-FMEA is expanded by incorporating product characteristics that are
identified in the Control Plan. The failure modes in the D-FMEA identify their own causes in the system. These failure modes,
which affect the production processes, will also be used for the P-FMEA.
At the end of the development phase, the P-FMEA reflects the final design of both the product and process and provides
risk control/mitigation activities for personnel in production, product support and quality control. The critical process
characteristics identified in the FMEA are recorded in the Control Plan (pre-launch Control Plan).
Purchasing Phase
At this stage, production and tooling planning take place with the P-FMEA focusing on the key characteristics of the
processes in production.
A-FMEA (supplier side) can be used to evaluate the potential process failures resulting from application of parts,
components and materials from outside suppliers. The causes are due to suppliers’ manufacturing processes or designs, but
the effects would be on the respective product manufacturing process. The failure modes in the A-FMEA identify their own
causes in the system. These failure modes, which affect the manufacturing process, will also be used for the P-FMEA. The
key characteristics identified in the FMEA would be recorded in the Control Plan (production Control Plan).
Production Phase
The production Control Plan is executed in the production phase. Prior to post-production activities (e.g. product verification,
packaging, distribution and servicing), A-FMEA (customer side) can be used for evaluating the application of the product by
the customer (if the product is involved in the customer’s downstream manufacturing process) or the end user (if it is the end
product, e.g. reviewing the user instruction manual).
In the S-FMEA, the end product is the focus. It is very difficult to evaluate the entire service, especially in the early stage
or initiation of the services. In most cases, the service evaluation develops over time and as such the S-FMEA becomes a
living document to reflect the changes of the services. The failure causes in the D-FMEA and P-FMEA, if not corrected,
would have an effect on the end product, which in turn would result in failure modes in the Service FMEA and would lead to
product recalls.
38 PRODUCT LIFE CYCLE & FMEA
Table 10-2 shows how each type of FMEA interacts with the Control Plan at various stages of the product cycle.
Table 10-2: Relationship between FMEA, product cycle and Control Plan
Stages in Product Cycle Function Type of FMEA FMEA Focuses Control Plan Status
Product Design Engineering Product FMEA Balanced Design Started
Process Planning Processing Process FMEA Process Seq. & Flow Study Continued
Sourcing & Suppliers, Quality Purchasing Supplier Side Application Key Characteristics of Parts Continued
Planning FMEA Identified
Production, Tooling Planning Manufacturing Process FMEA Key Characteristics of Process Executed
Identified
Product Usage & Application Services Customer Side Application Key Characteristics of Product Monitored
FMEA & Service FMEA Identified
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Die beiden Wächter
Zween Wächter, die schon manche Nacht

Die liebe Stadt getreu bewacht,
Verfolgten sich aus aller Macht
Auf allen Bier- und Branntweinbänken
Und ruhten nicht, mit pöbelhaften Ränken
Einander bis aufs Blut zu kränken;
Denn keiner brannte von dem Span,
Woran der andre sich den Tabak angezündet,
Aus Haß den seinen jemals an.
Kurz, jeden Schimpf, den nur die Rach’ erfindet,
Den Feinde noch den Feinden angetan,
Den taten sie einander an,
Und jeder wollte bloß den andern überleben,
Um noch im Sarg ihm einen Stoß zu geben.
Man riet und wußte lange nicht,
Warum sie solche Feinde waren;
Doch endlich kam die Sache vor Gericht,
Da mußte sichs denn offenbaren,
Warum sie seit so vielen Jahren
So heidnisch unversöhnlich waren.
Was war der Grund? Der Brotneid? War er’s nicht?
Nein. Dieser sang: »Verwahrt das Feuer und das Licht!«
Allein so sang der andre nicht;
Er sang: »Bewahrt das Feuer und das Licht!«
Aus dieser so verschiednen Art,
An die sich beid’ im Singen zänkisch banden,
Aus dem verwahrt und dem bewahrt
War Spott, Verachtung, Haß und Rach’ und Wut entstanden.
»Die Wächter,« hör ich viele schrein,
»Verfolgten sich um Kleinigkeiten?
Das mußten große Narren sein.«
Ihr Herren! Stellt die Reden ein,
Ihr könntet sonst unglücklich sein;
Wißt ihr denn nichts von so viel großen Leuten,
Die in gelehrten Streitigkeiten
Um Silben, die gleichviel bedeuten,
Sich mit der größten Wut entzweiten?
Fürchtegott Gellert
Sturmnacht
Im Hinterhaus im Fliesensaal
Über Urgroßmutters Tisch’ und Bänke,
Über die alten Schatullen und Schränke
Wandelt der zitternde Mondenstrahl.
Vom Wald kommt der Wind
Und fährt an die Scheiben;
Und geschwind, geschwind
Schwatzt er ein Wort,
Und dann wieder fort
Zum Wald über Föhren und Eiben.
Da wird auch das alte verzauberte Holz

Da drinnen lebendig;
Wie sonst im Walde will es stolz
Die Kronen schütteln unbändig,
Mit den Ästen greifen hinaus in die Nacht,
Mit dem Sturm sich schaukeln in brausender Jagd,
Mit den Blättern in Übermut rauschen,
Beim Tanz im Flug
Durch Wolkenzug
Mit dem Mondlicht silberne Blicke tauschen.
Da müht sich der Lehnstuhl, die Arme zu recken,
Den Rokokofuß will das Kanapee strecken,
In der Kommode die Schubfächer drängen
Und wollen die rostigen Schlösser sprengen;
Der Eichschrank unter dem kleinen Troß
Steht da, ein finsterer Koloß.
Traumhaft regt er die Klauen an,
Ihm zuckt’s in der verlornen Krone;
Doch bricht er nicht den schweren Bann.
Und draußen pfeift ihm der Wind zum Hohne,
Und fährt an die Läden und rüttelt mit Macht,
Bläst durch die Ritzen, grunzt und lacht,
Schmeißt die Fledermäuse, die kleinen Gespenster,
Klitschend gegen die rasselnden Fenster.
Die glupen dumm neugierig hinein –
Da drinn steht voll der Mondenschein.
Aber droben im Haus
Im behaglichen Zimmer
Beim Sturmgebraus
Saßen und schwatzten die Alten noch immer,
Nicht hörend, wie drunten die Saaltür sprang,
Wie ein Klang war erwacht
Aus der einsamen Nacht,
Der schollernd drang
Über Trepp’ und Gang,
Daß dran in der Kammer die Kinder mit Schrecken
Auffuhren und schlüpften unter die Decken.
Theodor Storm
Was bei den Sternen war
Selbst der Naturforscher gibt es diesmal zu, was der Poet
behauptet, daß nämlich im Waldlande die Sterne heller leuchten als
sonstwo. Das macht die reine feuchte Luft, sagt der eine; der andere
hingegen meint, der kindliche Glaube der Einschichtbewohner sei
Ursache, daß der Sternenhimmel so hell und hold niederfunkle auf
den weiten, stillen Wald.
Hat doch mein Vater zu mir gesagt, als wir noch beisammen auf
dem Holzbänklein unter der Tanne gesessen:
»Du bist mein liebes Kind. Und jetzt schau zum Himmel hinauf, die
Augen Gottes blicken auf uns herab.«
Ei freilich, ich konnte mir’s wohl denken, einer, der auf des
Menschen Haupt die Haare zählt, muß hunderttausend Augen
haben. Nun war es aber schön zu sehen, wie mir der liebe Gott mit
seinen Augen zublinzelte, als wollte er mir was zu verstehen geben;
– ja, und ich konnte es doch um alles nicht erraten, was er meinte. –
Ich nahm mir wohl vor, recht brav und folgsam zu sein, besonders
bei Nacht, wenn Gott da oben seine hunderttausend Augen auftut
und die guten Kinder zählt und die bösen sucht und recht scharf
anschaut, auf daß er sie kennt am Jüngsten Tage …
Ein andermal saß ich auf demselben Holzbänkchen unter der
Tanne, an Seite meiner Mutter. Es war bereits späte Abendstunde,
und die Mutter sagte zu mir:
»Du bist ein kleiner Mensch, und die kleinen Leute müssen jetzt
schon ins Bett gehen, schau, es ist ja die finstere Nacht, und die
Engel zünden schon die Lichter an, oben in unseres Herrgotts
Haus.«
Mit solchen Worten ein Kind zur Ruhe bringen? Das war übel
geplant.
»In unseres Herrgotts Haus die Lichter?« fragte ich, sofort
durchaus für den Gegenstand eingenommen.
»Freilich,« entgegnete die Mutter, »jetzt gehen alle Heiligen von
der Kirche heim, und im Hause ist eine große Tafel, und da setzen
sie sich zusammen und essen und trinken was, und die Englein
fliegen geschwind herum und zünden alle Lichter an und den großen
Kronleuchter auch, der mitten hängt, und nachher laufen sie zu den
Pfeifen und Geigen und machen Musik.«
»Musik?« entgegnete ich, in die Anschauung des Bildes
versunken. »Und der Wollzupfer-Michel, ist der auch dabei?«
Der Wollzupfer-Michel war ein alter, blinder Mann gewesen, der
bei uns Waldbauern das Gnadenbrot genossen und dafür zuweilen
Schafwolle gezupft und gekraut hatte. Wenige Wochen vor diesem
Abendgespräche war er gestorben.
»Ja du,« versetzte die Mutter auf meine Frage, »der Wollzupfer-
Michel, der sitzt ganz vorn bei unserem lieben Herrgott selber, und
er ist hoch in Ehren gehalten von allen Heiligen, weil er auf der Welt
so arm gewesen ist und so verachtet und im Elend hat leben
müssen, und weil er doch alles so geduldig ertragen hat.«
»Wer gibt ihm denn beim Essen auf den Teller hinaus?« war
meine weitere Frage.
»Nu wer denn?« meinte die Mutter, »das wird schon sein heiliger
Schutzengel tun.« Sogleich aber setzte sie bei: »Du Närrisch, der
Michel braucht jetzt gar keine Behelfer mehr, im Himmel ist er ja
nimmer blind; im Himmel sieht er seinen Vater und seine Mutter, die
er auf der Welt niemalen hat gesehen. Und er sieht den lieben
Herrgott selber und unsere liebe Frauen und alle, und zu uns sieht er
auch herab. Ja freilich, mit dem Michel hat’s gar eine glückselige
Wendung genommen, und hell singen und tanzen wird er bei der
himmlischen Musik, weil der heilige David Harfen spielen tut.«
»Tanzen?« wiederholte ich und suchte mit meinen Augen das
Firmament ab.
»Und jetzt, Bübel, geh schlafen!« mahnte die Mutter. Wohl machte
ich die Einwendung, daß sie im Himmel erst die Lichter angezündet
hätten und also gewißlich auch noch nicht schlafen gingen; aber die
Mutter versetzte mit entschiedenem Tone, im Himmel könnten sie
machen, was sie wollten, und wenn ich fein brav wäre und einmal in
den Himmel käme, so könnte ich auch machen, was ich wollte.
Ging zu Bette und hörte in selbiger Nacht die lieben Englein
singen. –
Wieder ein andermal saß ich mit der Ahne auf der hölzernen Bank
unter den Tannen.
»Guck, mein Bübel,« sagte sie, gegen das funkelnde Firmament
weisend, »dort über das Hausdach hin, das ist dein Stern.« Ein
helles, flimmerndes Sternchen stand oft und auch heute wieder über
dem Giebel des Hauses; aber daß selbes mein Eigentum wäre, hörte
ich nun von der Ahne das erstemal.
»Freilich,« belehrte sie weiter, »jeder Mensch hat am Himmel
seinen Stern, das ist sein Glücksstern oder sein Unglücksstern. Und
wenn ein Mensch stirbt, so fällt sein Stern vom Himmel.«
Todeserschrocken war ich, als gerade in diesem Augenblicke vor
unseren Augen eine Sternschnuppe sank.
»Wer ist jetzt gestorben?« fragte ich, während ich sogleich
schaute, ob mein Sternchen wohl noch über dem Dachgiebel stehe.
»Kind,« sagte die alte Ahne, »die Welt ist weit, und hätten wir nur
Ohren dazu, wir täten Tag und Nacht nichts hören als
Totenglockenklingen.«
Focht mich dieweilen nicht an.
»Ahndl,« fragte ich; denn Kinder, die in ihrem Haupte so viel Raum
für Vorstellungen und Eindrücke haben, sind unermüdlich im Fragen.
»Ahndl, wo hast denn du deinen Stern?«
»Mein Kind,« antwortete sie, »der ist schon völlig im Auslöschen,
den sieht man nimmer.«
»Und ist das ein Glücksstern gewesen?«
Da schloß sie mich an ihre Brust und hauchte: »Wird wohl so sein,
du herzlieber Enkel, wird wohl so sein!«
Ein alter Schuhmacher kam zuweilen in unser Haus, der redete
wie ein Heide. Wir Menschen, meinte der alte Schuhmacher, kämen
nach dem Tode weder in den Himmel, noch in die Hölle, sondern auf
einen Stern, wo wir so wie auf dieser Welt wiedergeboren würden
und je nach Umständen weiterlebten.
Das Närrischste aber sagte schon der Schulmeistersohn aus

Grabenbach, der als Student einmal zu uns kam. Der schwätzte von
Bären und Hunden und Wasserschlangen, die da oben am Himmel
herumliefen, und ein Widder und ein Walfisch sei auch dabei; und
gar eine Jungfrau wollte er durch seine Augengläser gesehen haben.
Dieser Schulmeistersohn war schuld daran, daß mich mein Vater
nicht studieren lassen wollte.
»Wenn sie solche Narrheiten lernen in der Stadt,« sagte mein
Vater, »daß sie auf unseres Herrgotts goldnem Firmament lauter
wilde Tiere sehen, nachher hab ich genug. Mein Bub, der bleibt
daheim.«
Eine junge Magd hatten wir im Hause; die war gescheit, die hat
einmal was gesagt, was mir heute das Herz noch warm macht. Sie
hatte es sicherlich von ihrem alten Ziehvater, der so ein Waldgrübler
gewesen war. Der Mann hat etwas Wundersames in seinem Kopfe
gehabt; er wäre gern Priester geworden; aber blutarm, wie er war,
sind ihm alle Wege dazu verlegt gewesen. Da wurde er
Kohlenbrenner. Ich habe den Alten oft heimlich belauscht, wenn er
auf seinem Kohlenmeiler stand und Messe las oder wenn er den
Vögeln des Waldes vorbetete, wie voreinst der heilige Franziskus in
der Wüste. Von diesem Manne mag unsere junge Magd das seltsame
Wort gehört haben.
»Der Sternenhimmel da oben,« sagte sie einmal, »das ist ein
großmächtiger Liebesbrief mit goldenen und silbernen Buchstaben.
Fürs erste hat ihn der liebe Herrgott den Menschen geschrieben, daß
sie doch nicht ganz auf ihn vergessen sollten. Fürs zweite schreiben
ihn die Menschen für einander. Das ist so: wenn zwei Leut, die sich
rechtschaffen liebhaben, weit auseinander müssen, so merken sie
sich vorher einen hellen Stern, den sie beide von aller Fremde aus
sehen können und auf dem ihre Augen zusammenkommen. –
Dasselbig funkelnde Ding dort,« setzte die Magd leise und ein wenig
zögernd bei, indem sie auf ein glühend Sternlein deutete, das hoch
über dem Waldlande lag, »dasselbe Ding, das schaut zu dieser
jetzigen Stund auch der Hans an, der weit drin in Welschland ist bei
den Soldaten. Ich weiß wohl, er wird nicht darauf vergessen, es
glänzt wie der kein Stern so hell am ganzen Firmament.«
Eines Tages mußte ich am Waldrande spät abends noch die Rinder
weiden, die tagsüber im Joche gegangen waren. Sonst war in
solchen Stunden lieb Ahne bei mir, aber die war nun schon seit
länger unwohl und mußte zu Hause bleiben. Jedoch hatte sie mir
versprochen, oftmals vor das Haus herauszutreten und den
Hühnerpfiff zu tun, damit mir in der einschichtigen stillen Nacht nicht
zu grauen beginne.
Ich stand zagend neben meinen zwei Rindern, die auf der
taunassen Wiese eifrig grasten, aber ich hörte heute keinen jener
lustigen Pfiffe, welche meine Ahne mittelst zweier Finger, die sie in
den Mund legte, so vortrefflich zu machen verstand, gewöhnlich zu
dem Zwecke, um die Hühner damit zusammenzulocken.
Das Haus lag still und traurig oben auf dem Berge. Von der tiefen
Schlucht herauf hörte ich das Rieseln des Wässerleins, das ich sonst
hier noch nie vernommen hatte. Hingegen schwiegen heute die
Grillen ganz und gar. Ein Uhu krähte im Walde und erschreckte mich
dermaßen, daß ich die Hörner des Rindes erhaschte und dieselben
gar nicht mehr loslassen wollte.
Der Sternenhimmel hatte heute einen so heiligen Ernst; mir war,
als hörte ich durch die große Stille das Saitenspiel des heiligen
Sängers David klingen. – Siehe, da löste sich plötzlich ein Stern und
fiel in einem scharfen Silberfaden, der gerade über unser Haus
niederging, vom Himmel herab. – –
Mir zuckte es heiß durchs Herz, mir blieb der Atem stehen. »Jetzt
ist die Ahne gestorben!« sagte ich endlich laut, »das ist ihr Stern
gewesen.« Ich hub an zu schluchzen. Da hörte ich vom Hause her
bereits des Vaters Stimme, ich sollte eilends heimzutreiben.
Bald jagte ich in den Hof ein. Das Haus war in allen Fenstern
beleuchtet; ein Geräusch und Gepolter war, und Leute eilten hin und
her nach allen Ecken und Winkeln.
»Geschwind, Peterle, geh her!« rief es mir von der Tür aus zu,
und das war die Stimme der Ahne. Ich lief in das Haus – was hab ich
gehört? Klein Kindesgeschrei.
»Ein Brüderlein hast kriegt,« rief die Ahne, »das hat ein Engel vom
Himmel gebracht!«
So war es. Mutter lag schon im Bette, und sie hielt das winzige
Büblein an der Brust.
Ein Engel vom Himmel! Ja, ich habe ihn fliegen gesehen. »Ahndl,«
sagte ich, »es ist nicht wahr, daß Sterne fallen, lauter Engel sind es,
die mit kleinen Kindlein niederfliegen vom Himmel!«
Ich verharre bei diesem Glauben noch heute, da ich vor einer
Wiege stehe, in die mir selbst ein liebes himmlisches Wunder
gegeben ist.
Peter Rosegger
Um Mitternacht
Gelassen stieg die Nacht ans Land,

Lehnt träumend an der Berge Wand,
Ihr Auge sieht die goldne Wage nun
Der Zeit in gleichen Schalen stille ruhn;
Und kecker rauschen die Quellen hervor;
Sie singen der Mutter, der Nacht, ins Ohr
Vom Tage,
Vom heute gewesenen Tage.
Das uralt alte Schlummerlied,

Sie achtet’s nicht, sie ist es müd;
Ihr klingt des Himmels Bläue süßer noch,
Der flücht’gen Stunden gleichgeschwungnes Joch.
Doch immer behalten die Quellen das Wort,
Es singen die Wasser im Schlafe noch fort
Vom Tage,
Vom heute gewesenen Tage.
Eduard Mörike
Sternentrost
Es gäb noch mehr der Zähren

In dieser trüben Welt,
Wenn nicht die Sterne wären
Dort an dem Himmelszelt;
Wenn sie nicht niederschauten
In jeder klaren Nacht
Und uns dabei vertrauten,
Daß Einer droben wacht.
Martin Greif
Der Sternseher
Die Jahre gehn vorüber,

Auch ich geh bald zur Ruh,
Da schau ich immer lieber
Dem Lauf der Sterne zu.
Ich kann mich oft noch freuen

Recht wie ein großes Kind,
Wenn abends die Getreuen
Auf ihren Wegen sind.
Mich dünkt, sie stehn so stille,

Sie schaun und ruhn zumeist,
Da doch ein ew’ger Wille
Sie zur Vollendung reißt.
So staun ich wohl in Fernen

Und sinn und blick empor.
Da spricht mir aus den Sternen
Mein Herz ein Gleichnis vor:
Du füllst den Tag mit Hasten,

Und bleibt doch leeres Spiel.
Hier glaubst du still zu rasten
Und näherst dich dem Ziel.
Carl Busse
In Harmesnächten
Die Rechte streckt’ ich schmerzlich oft

In Harmesnächten
Und fühlt’ gedrückt sie unverhofft
Von einer Rechten –
Was Gott ist, wird in Ewigkeit
Kein Mensch ergründen;
Doch will er treu sich allezeit
Mit uns verbünden.
C. F. Meyer
Ansage
Ein Käuzlein rief vergangne Nacht

Vom Berg ins Dorf hinein: »Komm mit!«
Lang horcht ich hin, als ich erwacht,
Und immer rief es noch: »Komm mit!«
Wie dann vom Turm die Zwölfe schlug,

Ins Läuten kam die Glock’: »Komm mit!«
Als käm’s zum letzten Atemzug
Von einem bald, so rief’s: »Komm mit!«
Martin Greif
Mondspuk
Der Vollmond leuchtet hoch am bläulichen Himmel; sein Glanz hat
das letzte, weiße Wölkchen verzehrt; sogar die Sterne sind in seiner
Lichtflut ertrunken, und nur die großen Himmelsbilder glänzen noch
neben ihm. Von unten herauf funkelt die Wintererde festlich im
Schnee; Berge recken dort ihre Silberköpfe empor, und mitten in den
Bergen drin, am Fuß eines Hügels, liegt das Dorf lautlos im
Mondschein.
Leer und hell sind alle Gassen des Dorfs. Riesig ragt die Kirche aus
den niedrigen Häuschen hervor, ein mächtiges, steinernes Ungetüm;
wie ein hoher Zaubererhut glitzert der spitze Kirchturm darüber. Zwei
Lukenaugen schauen finster aufgerissen unter dem Hut. Auf einmal
fängts an, im Innern des steinernen Tiers zu rumoren; es rasselt, es
stöhnt, es zieht schwerfällig Atem: ’s will Mitternacht schlagen. Aber
seltsam: es stöhnt und rasselt, es wird wieder still, und kein
Glockenschlag hat geschallt. Statt dessen in den dunklen
Lukenaugen droben glüht’s auf, und eine schnarrende Stimme
schreit hinaus ins Land:
»Eins, zwei, drei … zwölf!«
Da tut’s einen Rumpler unten im Dorf. Das ist im Haus vom
Wegmacher-Jackl gewesen. Der selber ist aus dem Bett hart auf die
Füße gefahren und wandelt quer durch die Stube. Aber ganz
abwesend schaut er drein. Er geht ans Fenster; ’s ist dicht mit Efeu
zugewachsen; und sitzt nieder. Der Mond scheint durch den Efeu,
malt helle Flecke aufs wetterbraune Runzelgesicht und blickt grad
hinein in die Augen …
Ganz stad ist’s draußen, und grausam hell, und alle Haustüren
stehn weit offen.
»Was ist denn des?« denkt der Jackl: »is doch nachtschlafende
Zeit!«
Aber die Haustüren stehen offen, und jetzt sieht er’s: eine ganz
leise, leuchtende Schafherde wimmelt die Gasse hinab; schneeweiß,
wollig, flockig wimmelt’s, wuselt’s durcheinander. Ein mondheller
Wolfshund rennt an ihr hin, umkreist sie; Funken tanzen aus seinem
Borstenfell, flüssiges Silber trieft ihm aus dem Maul. Und hinter der
Herde drein wankt der Hirt, in blauem Mantel, ein alter Mann. Tief
sitzt ihm der große Glanzhut im Gesicht, daß nur der welke Mund
und das bleiche Kinn hervorschauen; an langem Stecken wankt er
hin und bewegt die Lippen. Er singt.
»In Gottes Namen

Die Mondschaf treib ich. Amen!«
klingt’s kaum hörbar in die Stube, während er vorbeischwankt. Und

Hirt und Hund und Herde sind verschwunden.
Lange Eiszapfen funkeln an den Dachrinnen. Der Schnee strahlt
von tausend feurigen Sternlein. Mit schlafschwerem Blick schaut der
Jackl hinaus in die weiße Pracht, die so stumm ist und so kalt.
»Wie einsam, daß is, ha, wie einsam!«
Auf einmal träppelt’s daher durch die Mondnacht – ein Hündlein
träppelt über den glitzernden Schnee. Ganz allein. Graufarben ist’s,
ein Krummbein, ein Dackeltier ist’s. Kerzengerade hat’s seinen
Schwanz aufgestellt und wedelt leis mit der Spitze, und seine langen
Ohrwatscheln zittern, wie es dahinläuft. –
»Ah, Narr! Is denn das nit der Woidl! Ja bist denn nit tot? Was bist
denn so grau, Woidl?«
Aber Jackl’s Stimme hat gar keine Kraft. Der Waldl hört ihn nicht,
schon ist er weg – und die Gasse hinab kommt eine junge Dirn
gezogen, wie im Schlaf, mit geschlossnen Augen. Sie hat ein volles
Gesicht; doch ist es so weiß wie das Licht, das draufscheint. Einen
Augenblick bleibt sie stehen und wendet den Kopf mit den
geschlossenen Augen in der Luft, als suchte sie etwas. Dann geht sie
grad aufs Haus vom Maurer Franz zu. Die Eckenlisl ist’s, die so
schnell hat sterben müssen, ein Jahr ist’s her! Sie tritt ans Fenster.
Mit den Fingerspitzen der rechten Hand schlägt sie leicht ans Glas,
daß es klingt. Dann setzt sie sich aufs Bänklein darunter, legt die
Hände in den Schoß und lächelt still vor sich hin.
Aber da rauscht es auf in der Ferne; rauscht wie ein
Menschenflüstern, zieht näher; die Lisl verblaßt, zergeht; jetzt
schwillt’s ins Dorf und schau! durch die Gasse stäubt’s heran, eine
blasse Schar, Männer und Weiber. Eben grad sichtbar blinken sie im
Mondlicht durcheinander. Bekannte, Unbekannte wechseln, wogen
hin, verdrängen einander, und alle steigen sie dort hinten bei der
Kirche ins Mondlicht hinein und verschwinden einer um den andern.
Der Jackl will sie anrufen, den, jenen, zurückhalten will er sie – zu
rasch treibt alles dahin. Wie er sich aber noch anstrengt, sie zu
erkennen, da knarrt’s ihm zu Häupten, knarrt und rasselt, als täte
sich die Decke auseinander, als schütte der Kalk herab, und die
schnarrende Stimme schreit durch die offene Decke: »Eins!«
Der Jackl steht auf – sein Bewußtsein ist ausgelöscht, die Augen
haben sich geschlossen – und marschiert zurück in sein Bett.
Reingefegt ist die Gasse von allem Spuk, nirgends regt es sich
mehr. Die Haustüren sind zu. In den Lukenaugen des Kirchturms ist
das heimliche Glühen ausgegangen. Der Mond scheint aufs weiße
Zifferblatt, und unten biegt der bärtige Nachtwächter ums Eck beim
Krämer und singt in die Gasse hinein:
»Hört, ihr Herren, und laßt euch sagen:

Die Glocke hat eins geschlagen.
B’hüt euch Gott und Maria!«
Leopold Weber
Alter Spruch
So dunkel ist doch keine Nacht,

Daß Gottes Aug nicht drüber wacht.
Volksmund
Stimme im Dunkeln
Es klagt im Dunkeln irgendwo.

Ich möchte wissen, was es ist.
Der Wind klagt wohl die Nacht an.
Der Wind klagt aber nicht so nah.

Der Wind klagt immer in der Nacht.
In meinen Ohren klagt mein Blut,
Mein Blut wohl.
Mein Blut klagt aber nicht so fremd.

Mein Blut ist ruhig wie die Nacht.
Ich glaub, ein Herz klagt irgendwo.
Richard Dehmel
Alp
Ich stellte den Stuhl nicht an die Wand

Und wandte die Schuh am Bett nur halb
Und nahm den Daumen nicht in die Hand,
Da kam des Nachts der böse Alp.
Er bohrte durch ein Wandloch sacht;
Ich dacht und nahm es genau in acht:
»Sollst dich auf mir nicht wiegen,
Wart, wart, ich will dich kriegen!«
Und als er zur Wand hereingeschlüpft

Und auf den Zehen leise ging,
Da war ich zum Loch an der Wand gehüpft
Und stopft es zu, da schrie das Ding
Mit feiner Stimm’: »O Pein, o Pein,
Nun muß ich hier gefangen sein!
O weh, wie werden weinen
Zu Hause meine Kleinen!«
»O Menschlein,« wimmert er bitterlich,

»Hab sieben Kinderchen zu Haus,
Die müssen verhungern fürchterlich,
O Menschenkind, laß mich hinaus!«
Da sprach ich: »Komm nicht wieder herein.«
Da sprach er: »Nein, gewiß nicht, nein.«
Kaum, daß ich mich aufmachte …
Husch, war er hinaus und lachte. –
Und wie er so lachte, ging ich nach,

Und als ich vor die Haustür kam,
War er schon unten an dem Bach;
Ich sah, wie er ein Ruder nahm,
Und lief hinab und hielt den Kahn:
Da winselt er von neuem dort
Und sah zuletzt mich drohend an.
Ich ließ den Kahn – da glitt er fort! –
Mich überkam ein Grauen
Vor seinen Augenbrauen!
August Kopisch
Närrische Träume
Heute Nacht träumte mir, ich hielt

Den Mond in der Hand,
Wie eine große, gelbe Kegelkugel,
Und schob ihn ins Land,
Als gält es alle neune.
Er warf einen Wald um, eine alte Scheune,
Zwei Kirchen mitsamt den Küstern, o weh,
Und rollte in die See.
Heute Nacht träumte mir, ich warf

Den Mond ins Meer.
Die Fische all erschraken, und die Wellen
Spritzten umher
Und löschten alle Sterne.
Und eine Stimme, ganz aus der Ferne,
Schalt: »Wer pustet mir mein Licht aus?
Jetzt ist’s dunkel im Haus.«
Heute Nacht träumte mir, es war

Rabenfinster rings.
Da kam was leise auf mich zugegangen,
Wie auf Zehen ging’s.
Da wollt ich mich verstecken,
Stolperte über den Wald, über die Scheune vor Schrecken.
Über die Kirchen, mitsamt den Küstern, o weh,
Und fiel in die See.
Heute Nacht träumte mir, ich sei

Der Mond im Meer.
Die Fische alle glotzten und standen
Im Kreis umher.
So lag ich seit Jahren,
Sah über mir hoch die Schiffe fahren,
Und dacht, wenn jetzt wer über Bord sich biegt,
Und sieht, wer hier liegt,
Zwischen Schollen und Flundern,
Wie wird der sich wundern!
Gustav Falke
Der Traum
Es war ein niedlich Zeiselein,

Das träumte nachts im Mondenschein:
Es säh am Himmel Stern bei Stern,
Davon wär jeder ein Hirsekern,
Und als es geflogen himmelauf,
Da pickte das Zeislein die Sterne auf.
Piep –
Wie war das im Traume so lieb!
Und als die Sonne beschien den Baum,

Erwachte das Zeislein von seinem Traum.
Es wetzte das Schnäbelchen her und hin
Und sprach verwundert in seinem Sinn:
»Nun hab ich gepickt die ganze Nacht,
Und bin doch so hungrig aufgewacht!
Ping –
Das ist mir ein närrisches Ding!«
Victor Blüthgen
Ein Traum
Heut Nacht hatt ich ’nen tollen Traum,

Der hat mich zum Kamel gemacht,
Im Maule fühlt ich scharfen Zaum
Und auf dem Buckel schwere Fracht.
Und Wüste hier und Wüste dort,

Rückwärts und vorwärts, links und rechts,
Und durch die Glut ging’s langsam fort,
Im Sand tief watend mit Geächz.
Zum Knuspern fand sich da kein Strauch,

Kein Wind zur Kühlung fern und nah,
Zum Saufen war gefüllt kein Schlauch,
Kein Platz zum Niederstrecken da.
Da plötzlich – fern am Himmelssaum

Sieh! Palmen nicken, Quellenglanz!
Dorthin! – Da schwindet’s wie ein Traum,
Es war ein leerer Dünstetanz.
Und immerfort sich aufgerafft,

Und immer fort mit Ach und Uff!
Der Treiber braucht die letzte Kraft,
Mich anzufeuern durch ’nen Knuff.
Geäfft, gebrochen im Genick,

Schon war ich dem Verschmachten nah,
Als ich ganz nah der Quelle Blick
Durch grüne Schatten prachten sah.
Da hat das Glück mich so erschreckt,
Daß ich mit eins zusammenfuhr,
Da hat der Schreck mich aufgeweckt,
Und ach! ein Traum war alles nur.
O hätt’ ich ewig fortgeträumt!

Dann läg’ ich an der Quelle jetzt,
Weich hingestreckt und abgezäumt,
Vom frischen Schattentrunk geletzt.
So aber zieh ich fort und fort,

Auch wachend, als Kamel einher.
Dicht vor mir winkt der kühle Ort,
Doch ich erreich ihn nimmermehr.
Friedrich von Sallet

Traumland
Wo gibt’s diese Welt wie im Traume?

So seltsame Luft, so milchig-kalt,
Solch Haus von Holze so silbrig-alt,
Solch seltsame Blätter am Baume –
Und Menschen gehen und kommen

Mit fremden Gesichtern, doch seltsam bekannt,
Die reden – ich weiß nicht, warum ich verstand,
Was ich von ihnen vernommen …
Drauf hab ich das Städtlein verlassen:

Da schwamm ein seltsam bleierner Fluß,
Der wälzte tiefab mit schweigendem Schuß
Die ungeheuren Massen …
Ich stieg auf den Berg, den vertrauten:

Da sah ich ein Land, das ich nie gesehn,
Erdfremde beleuchtet, so selig-schön! –
Meine Augen vor Wonne tauten …
Nun, wo ich am Tag so gehe,

Verfolgt mich die Sehnsucht überall
Nach dem seltsamen Fluß mit dem Wasserfall
Und dem Lande hinter der Höhe.
Victor Blüthgen

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Guidelines for Failure Modes and Effects Analysis

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Handbook of Materials for Medical Devices Asm

Practical Design Control Implementation for Medical

Medical device materials proceedings from the Materials

Guidelines for the Avoidance of Vibration Induced

Radiation Effects in Semiconductors Devices Circuits

ISTFA 2010 conference proceedings from the 36th

Candidacy for Implantable Hearing Devices Candidacy for

Nonparametric Regression Methods for Longitudinal Data

ISBN 0-203-49011-8 Master e-book ISBN

ISBN 0-203-58884-3 (Adobe eReader Format)

Process Mapping/Process Flowcharts 30

Chapter 2—Regulations & Standards Governing Medical Device Manufacturing

Chapter 3—Risk Management of Medical Devices

Chapter 4—Risk Analysis Methodologies

Chapter 5—Overview of FMEA

Chapter 6—FMEA Procedures

Chapter 7—FMEA Team

Chapter 8—Pitfalls with FMEA

Chapter 9—Common Tools Used with FMEA

Chapter 10—Product’s Life Cycle & FMEA

Chapter 11—Product/Design FMEA

Chapter 12—Process FMEA

Chapter 13—Application FMEA

Chapter 14—Service FMEA

Chapter 15—Post FMEA Study

Chapter 16—Control Plans

Chapter 17—Overview of Failure Mode, Effects and Criticality Analysis (FMECA)

United States Regulations

CLASS REGULATORY CONTROLS EXAMPLES

510 (k)/Premarket Notification

■ has the same intended use as a predicate; and

■ has the same intended use as a predicate; and

○ does not raise new questions of safety and effectiveness, and

European Union Regulations

Directive 93/42/EEC—Medical Device Directive

CLASS RISK LEVEL TO PATIENT EXAMPLES

CLASS RISK LEVEL TO PATIENT EXAMPLES

ISO 9000:1994 and ISO 9000:2000 Series—Quality Management and Guidelines

ISO 13485:1996—Quality Systems—Medical Devices— Particular Requirements for the Application

ISO 13488:1996—Quality Systems—Medical Devices— Particular Requirements for the Application

ISO 14969:1999—Quality Systems—Medical Devices— Guidance on the Application of ISO 13485

ISO 14971:2000—Medical Devices—Risk Management— Application of Risk Management to

EU/EC EN (European Norm) Standards

EN 46001:1996—Quality Systems—Medical Devices— Particular requirements for the application of

EN 46002:1996—Quality Systems—Medical Devices— Particular requirements for the application of

EN 46003:1999—Quality Systems—Medical Devices— Particular requirements for the application of

EN 1441:1997—Medical Devices—Risk Analysis

• Risk Management Plan;

Risk Management Plan

• The part of the product/process/system to be focused on;

Responsibility and resources should be allocated to ensure that no responsibility is omitted.

Risk Assessment (Risk Analysis & Risk Evaluation)

• What can go wrong?

• Toxicity, flammability and reactivity of raw materials and wastes;

• Inherent safety by design;

Hazard And Operability Analysis (HAZOP)