Quality Management in the Automobile Industryv5design.eu/wp/wp-content/uploads/VDA-Volume-4... ·...

Dokument wurde bereitgestellt vom

VDA-QMC Internetportal am 01.04.2015 um 11:07

Nur zur internen Verwendung für Faurecia Autositze GmbH bestimmt.

Quality Managementin the Automobile Industry

– General, risk analyses, methods, process models –

4Quality Assurance in theProcess Landscape

risk analyses




Quality Management in the Automobile Industry

Quality Assurance in the Process Landscape - General, risk analyses, methods, process models -

Fault Tree Analysis ( FTA) 4th editorially revised edition 2003

Verband der AutomobilindustrieVerband der Automobilindustrie

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VDA-Volume 4: Product- and Process-FMEA 0 0


4 Quality Management in the Automotive Industry

Quality Assurance in the Process Landscape

- General, risk analyses, methods, procedere models -

Product- and Process-FMEA

2nd

revised edition 2006, updated in June 2012




Volume 4: Product- and Process-FMEA





Notes:

Updates June 2012

The FMEA has been purely formally revised.

- Graphics have been standardized

- Graphics have been unified and regardless of specific software programs to editing an FMEA shown

- The colour in the graphs has been explained

- A suggestion of labelling of unreacted measures has been described. The following updates / corrections were made in 2009: Pages 1 - 8 / wording and pagination of contents

P. 12 / Title of VDA Volume 1

P 85 / completely replaced




2 VDA-Volume 4: Product- and Process-FMEA





Preface

The Failure Modes and Effects Analysis (FMEA) is a development and planning accompanying system and risk analysis. It is integrated in the spe-cialist departments and includes the system optimization as well as the risk reduction.

As an important methodical instrument, the FMEA allows possible failures to be identified at an early stage, in order to prevent their occurrence be-forehand. This is important in new concepts and developments, as well as for the further development of products and processes. Their maturity is al-ready methodically scrutinized and evaluated during the development and planning phases. In all critical places, the FMEA points out suitable actions with whose conduction risks have already been reduced or are still to be minimized.

By means of a consequent structuring of the systems and processes with their respective multilevel cause and effect relationships, the FMEA aids the flow of communication in the team and project work, as well as the neces-sary knowledge transfer in the company. The project workflow depicts how the FMEA, as a method of prevention, is integrated into the product devel-opment and production process development.

Through the documentation of the FMEA, the company gains a recorded knowledge basis with which current and future development projects are and will be efficiently supported.

Preface to the update 2012 The present description of FMEA was formally revised. In particular, the graphics have been unified and regardless of specific software programs to editing an FMEA shown. Specifically, the colour has been explained in the graphs and a suggestion of labelling of unreacted measures has been described. It is pointed out that no special software program was preferred by these representations.





We would like to thank all the companies and collaborators who have contributed in this workgroup:

Audi AG

Robert Bosch GmbH

BMW AG

BP AG,ILS Division

Context Management Consulting GmbH

DaimlerChrysler AG

Siemens VDO Automotive

Thyssen Krupp Stahl AG

Volkswagen AG

ZF Friedrichshafen

ZF Sachs AG

Thanks are also due to all who have provided suggestions for improvement as well as those organizations represented in the editorial circle.

Frankfurt/Main, December 2006

Oberursel, March 2009 (update) Berlin, June 2012 (update)

Verband der Automobilindustrie e.V (VDA)




VDA-Volume 4: Product- and Process-FMEA 5

Contents Page

Preface 3

0 Introduction 10 0.1 Development History of the FMEA 10 0.2 FMEA Objectives 12 0.3 Integration of the FMEA in the Company 14 0.4 FMEA for Products and Processes 15 0.4.1 Product FMEA 15 0.4.2 Process FMEA 15 0.5 Chronological Process of the FMEA Execution 16 0.6 DAMIC, Flow Chart For the Workflow of the FMEA 16 0.7 Handling of the Guideline 17

1 Definition D 19 1.1 Objective of the definition phase 19 1.1.1 Define the Need for Action for the Execution of an FMEA 19 1.1.2 Objective of the FMEA 20 1.2 Time Frame 20 1.3 Input 20 1.3.1 Agreements 20 1.3.2 Procurement of Work Documents 21 1.4 Work Scope 22 1.4.1 Task Assignment in the Definition Phase 22 1.4.2 FMEA Team Building 23 1.4.2.1 Criteria for the FMEA Moderator 23 1.4.2.2 Criteria for the Other Team Members 23 1.4.2.3 The Formation of the FMEA Team 23 1.5 Tools and Supplies 23 1.6 Methods 23 1.7 Measurement Variables 26 1.8 Substeps 26 1.9 Result 27 1.10 Risks 28 1.11 Communication 28





Page

2 Analysis A 29 2.1 Objective of the Analysis Phase 29 2.2 Time Frame 29 2.3 Input 29 2.4 Work Scope 30 2.5 Tools and Supplies 31 2.6 Methods 32 2.7 Measurement Variables 32 2.8 Substeps 32 2.8.1 Preparation of the Product FMEA 34 2.8.1.1 Product FMEA (Step 1) Structure Analysis 34 2.8.1.2 Product FMEA (Step 2) Function Analysis 37 2.8.1.3 Product FMEA (Step 3) Failure Analysis 39 2.8.1.4 Product FMEA (Step 3) Actions Analysis 41 2.8.1.5 Product FMEA (Step 5) Optimization 46 2.8.2 Preparation of the Process FMEA 49 2.8.2.1 Process FMEA (Step 1) Structure Analysis 49 2.8.2.2 Process FMEA (Step 2) Function Analysis 52 2.8.2.3 Process FMEA (Step 3) Failure Analysis 54 2.8.2.4 Process FMEA (Step 4) Actions Analysis 56 2.8.2.5 Process FMEA (Step 5) Optimization 61 2.8.3 Risk Evaluation 64 2.9 Result 67 2.10 Risks 68 2.11 Communication 68

3 Measures Decision M 69 3.1 Objective of the Actions Decision Phase 69 3.2 Time Frame 69 3.3 Input 69 3.4 Work Scope 69 3.5 Tools and Supplies 70 3.6 Methods 70 2.7 Measurement Variables 70 2.8 Substeps 70 3.9 Result 70 3.10 Risks 71 3.11 Communication 71





Page

4 Implementation I 72 4.1 Objective of the Implementation Phase 72 4.2 Time Frame 72 4.3 Input 72 4.4 Work Scope 72 4.5 Tools and Supplies 73 4.6 Methods 73 4.7 Measurement Variables 73 4.8 Substeps 73 4.8.1 Action Tracing 73 4.8.2 Re-Evaluation of the Remaining Risk 74 4.8.3 Summary of the FMEA Results 74 4.9 Result 74 4.10 Risks 74 4.11 Communication 75

5 Communication C 76 5.1 Objective of the Communication Phase 76 5.2 Time Frame 76 5.3 Input 76 5.4 Work Scope 77 5.5 Tools and Supplies 78 5.6 Methods 78 5.7 Measurement Variables 78 5.8 Substeps 78 5.8.1 Communicate Knowledge 78 5.8.2 Using Knowledge 79 5.8.3 Information and Communication 80 5.8.4 Information Systems 81 5.9 Result 82 5.10 Risks 82





Page

Annex 83

A1 Additions 83 A1.1 Execution of the FMEA 83 A1.1.1 Implementation of the FMEA in the company 83 A1.1.2 Distribution of Tasks When Preparing The FMEA 83 A1.1.3 Know-How Protection of the Product FMEA/Process FMEA 84 A1.1.4 Reuse of the FMEA 84 A1.1.5 IT Application When Preparing an FMEA 84 A1.2 Relationships Between Different FMEAs 85 A1.2.1 Levels Within A System 85 A1.2.2 Methodical Interrelationships Between Different FMEAs 86 A1.3 Special Characteristics 87 A1.4 Relation to Other Methods 88 A1.5 Documentation 90 A1.5.1 Final Documentation After Completion of all Phases 90 A1.5.2 FMEA Form 90

A2 Further Application Fields 94 A2.1 FMEA for Mechatronical Systems 94 A2.1.1 Structure and Function Analysis 94 A2.1.2 Failure Analysis 98 A2.1.2.1 “Dormant Failure” 100 A2.1.3 Actions Analysis and Optimization 100 A2.1.4 Evaluation of the Risk 107 A2.2 FMEA for Software Scopes 107 A2.2.1 General 108 A2.2.1.1 Objective of the Software Scopes Inspection 108 A2.2.1.2 FMEA in the Software Development Process 108 A2.2.1.3 Connections to other Methods/Measures of Software Engineering 109 A2.3 Depiction of Error Propagation 110 A2.4 FMEA for Machine and Facility Manufacturers 110





Page

A3 Evaluation of an FMEA 111 A4 Examples of Evaluation Tables 117 A4.1 Product FMEA Example Table: Product General Severity Criteria S 117 A4.2 Product FMEA Example Table: Occurrence Potential O for the Product Design 118 A4.3 Produkt FMEA Example Table: Detection Potential D for the Validation of the Product Design 119 A4.4 Process FMEA Example Table: General Process Severity Criteria S 120 A4.5 Process FMEA Sample Table: Occurrence Potential O for the Process Design 121 A4.6 Process FMEA Sample Table: Detection Potential D for the Validation of the Process Design 122 A4.7 Product FMEA Example Table: Product Occurrence Potential O with Assignment of Failure Rates 123 A4.8 Product FMEA Example Table: Detection Potential D in Customer Operation 124 A4.9 Process FMEA Example Table: Occurrence Potential O with Assignment of Failure Rates 125





0 Introduction

0.1 Development History of the FMEA

The FMEA was developed by the US military as the MIL-P-1629 military di-rective and dates from 9th November 1949. It was used as an evaluation technique for reliability, in order to depict the effects of system and equip-ment failures. The failures were classified according to the influence on the success, the people, and the equipment safety.

In 1963, NASA developed the “Failure Mode and Effects Analysis” (FMEA) for the Apollo project. In 1965, the aero-space engineering adopted this meth-od. Around 1975 this method was de-ployed, among other things, in nuclear power engineering.

The FMEA was first deployed in the automotive industry by the Ford Motor Co. (USA) in 1977 for preventive quality assurance. In Germany, in DIN 25448 the Failure Effect Analysis with the subtitle FMEA was standardized in 1980. In the Verband der Automobilindustrie (VDA) this method was de-veloped further specifically for automobiles. The first method description was published in 1986 in VDA volume 4, Quality Assurance Prior to Serial Application. This method has been increasingly used in the automotive in-dustry.

The application of the FMEA in the different areas of medicine and tele-communications engineering took place in the 90s.

The FMEA is also used in non-technological areas, such as in Facility Man-agement for example, due to the broadening of the term “quality” to include the service industry.

In the beginning of 1990, the method for the System FMEA Product and System FMEA Process for the Automotive Industry was developed further based on the FMEA published in VDA volume 4 in 1986. In 1996, VDA volume 4, part 2, Quality Assurance Prior to Serial Application with the subtitle System FMEA, was published. The knowledge of the automotive manufacturers and their suppliers was written down there, and the execu-tion of the FMEA was defined. This results in a uniform procedure for the





FMEA that is universally accepted. The automotive manufacturers, their suppliers and their subcontractors equally approve this procedure.

At the end of the 90s, the Deutsche Gesellschaft für Qualität e.V. (German Registered Association for Quality - DGQ) founded a workgroup in order to describe the application of the FMEA for additional fields, for example, Ser-vice Industry and Project Management. The DGQ volume 13-11 was pub-lished in November 2001.

A further representation of the FMEA in the United States took place in the SAE paper J1739 from June 2000. This SAE paper served for the revision of the FMEA 3

rd Edition as reference handbook for QS-9000.





0.2 FMEA Objectives

The objectives of the FMEA are derived from the changed influence factors on the company. They are influenced by increased quality demands of the cus-tomer and the necessary cost optimi-zation of the products and processes, as well as the product liability of the manufacturer required by the legislation.

The achievement of the business objectives listed below is supported by, among other things, the FMEA:

Increase of the functional safety and reliability of products and pro-cesses,

Reduction of guarantee and goodwill costs due to the extension of the legal warranty period,

Proof of exoneration in the case of product liability,

Shorter development times,

Low-fault starts of production,

Adherence to schedules,

Profitable production and assembly,

Customer-oriented services,

Targeted communication in internal and external customer and supplier relationships,

Build-up of a knowledge base in the company,

Proof of safety in the registration approval of the vehicles. The FMEA as a method for system analysis and preventive failure avoid-ance is already employed at a very early stage of the product development process, see VDA volume 4, part 3, Project Planning. It examines the de-velopment or planning stages valid at that time for possible failures, in order to initiate actions to avoid these failures.

“Avoidance and detection action costs are not FMEA costs.”





The FMEA is to be carried out according to the project plan and to be eval-uated at the project milestones according to the state of the analysis.

An FMEA already makes sense in an early concept phase, since the FMEA supports the compilation of requirements. The further the development ad-vances, the more detailed the FMEA can become.

The FMEA is a team-oriented method for risk minimization of the develop-ment and planning processes and facilitates the interdisciplinary coopera-tion of the departments involved. Furthermore, it provides a documentation of expertise in the company.





0.3 Integration of the FMEA in the Company

Today, the FMEA is anchored as a requirement in the individual manage-ment systems of the automotive industry (see VDA 6.1, VDA 6.4, ISO/TS 16949).

In further VDA volumes and standards, the FMEA is referred to and/or an FMEA is required in, for example:

VDA 1 Documentation and Archiving VDA 2 Quality Assurance of Supplies VDA 4 Quality Assurance in the Process Landscape VDA 4.3 Project Planning VDA 6.1 QM System Audit VDA 6.3 Process Audit ISO 9001:2000 ISO/TS 16949:2002 In addition to these general requirements in the management systems, the customer orientation plays an important role.

Management carries the responsibility for the application and the implementa-tion of the FMEA and has to fully sup-port the implementation of FMEAs, in order to guarantee the company ob-jectives.

Due to these factors, the integration of the FMEA in the company processes is a necessary prerequisite and therefore an integral part of the communication in the management process.





0.4 FMEA for Products and Processes

There are two approaches to FMEA: the inspection according to functions or according to processes. The FMEA is also universally applicable for non-technical systems and processes.

With the product and process FMEA, all concepts of the FMEA are covered. These could have scopes of inspections such as e.g. system, software functions, interfaces, design, components, production sequences, assembly sequences, logistics, transport and machines.

0.4.1 Product FMEA

The Product FMEA inspects the required functions of products and systems, except for the layout of the attributes and characteristics.

In the process, the possible non-conformities are inspected and the actions to guarantee the require-ments are defined.

0.4.2 Process FMEA

The Process FMEA inspects all processes for the manufacture of products and systems up to the re-quirements for the process influ-ence coefficients.

In the process, the possible non-conformities are inspected and the actions to guarantee the processes and the product characteristics are defined.





0.5 Chronological Process of the FMEA Execution

The preparation of an FMEA should take place as early as possible.

The chronological process must be co-ordinated with the project schedule, see VDA 4.3 Project Planning, Annex. At this point, the customers and sup-pliers are to be involved.

0.6 DAMIC, Flow Chart For the Workflow of the FMEA

Objective and inspection scope: an approach for the execution of the FMEA consists in achieving a prioritization of the items to be covered. This inspec-tion with a model leads to an efficient processing of the FMEA.

The following process model serves as a guideline for the implementation of the method in the company. Irrespective of this, each company can use its own process model.

DAMIC Model with the following structure:

Definition: Preparation and system definition

Analysis: Establish requirements and risks systemati-

cally

Measures decision: Identify actions and procedure

Implementation: Implementation and evaluation through veri-

fication, validation and monitoring

Communication: Present and communicate





0.7 Handling of the Guideline

The depiction of the method tracks the process-oriented approach as it is also tracked in DIN EN ISO 9000 ff. and ISO/TS 16949.

The flow chart shows that one can switch back to the definition phase after the communication phase. An element of every phase is the necessary communication. Each phase includes the process-oriented approach. The efficiency of the phases can be verified by means of the appropriate meas-urement variables.

The characteristics that structure each phase result from the process-oriented approach.

1 Objective: The objective of every phase is to be established.

2 Time frame: The start and time requirement of each phase is to be coordinated with the project plan.

Learning

Training

Use of media

Visualisation

Project

Input

Feedback

Output

Documentation

Communication and

Information chanals

Project ducumentation

and communication(internal, external)

Learning

Training

Use of media

Visualisation

Project

Input

Feedback

Output

Documentation

Communication and

Information chanals







3 Input: Agreements and necessary work documents at the start of the process and, in the further course, the re-sults from the previous phase.

4 Work scope: Tasks and activities of the persons responsible and the contributors named in the individual phases.

5 Tools and supplies: The tools to be employed according to the phase.

6 Methods: Supporting methods and procedures that aid the effi-cient execution of the FMEA in the respective phase.

7 Measurement Indicators and characteristics that refer to a basis variables: that allow an evaluation of the phase with regard to

effectiveness, i.e. the effectiveness for the customer including customer satisfaction and the efficiency, i.e. the performance of the phase.

8 Substeps: The division of the phase into individual substeps.

9 Result: The conversion of the input into results through the sub steps of the individual phases.

10 Risks: Identification of the risks that can result from the ap-plication of the process-oriented approach during the execution and implementation in the phases.

11 Communication: Communicate the results of the individual phases to those responsible, and process and document for further use.

Please note: The analyses for the product FMEA and process FMEA are each described completely in a chapter. As a consequence, redundancies are unavoidable. For the user this has the advantage that he/she can turn directly to the Product and/or Process FMEA without knowing the content of the other chapters and turning back in the text to previous chapters is not necessary.





1 Definition D

1.1 Objective of the definition phase

Defining of boundary conditions and prerequisites for the efficient execution of the FMEA.

1.1.1 Define the Need for Action for the Execution of an FMEA

The clarification of the necessary scopes for the preparation and/or the up-dating of the FMEA takes place by means of criteria. Examples of this are:

New development of products.

Producibility.

Safety relevance.

Complexity.

Use of new facilities, machines or tools.

New site or relocation of the production.

New operating conditions for existing products.

High share of rejects with similar products.

Mountability.

Environmental and operational hazards.

Product change.

Process change.

Changed operational conditions.

Insufficient process capability.

Limited verifiability.

Warranty and goodwill costs.

Operating expenses.

Comfort.

Field experience.

8D report. Hazard Analysis or Quality Function Deployment (QFD), for example, are suitable as further possible decision processes for the need of an FMEA. For this see 1.6 Methods.





The threshold values for the need for action can be regulated by the re-spective company (see 1.6 Methods).

Normally, from the findings of the FMEA, more in-depth methods for subdi-visions are applied, such as Fault Tree Analysis (FTA), Event Tree Analysis (ETA) and simulations.

1.1.2 Objective of the FMEA

The scope of components, functions, processes and/or changes that are to be examined in the FMEA is to be defined by means of the criteria listed above, taking into account the interfaces with other systems.

1.2 Time Frame

The start of the definition phase must take place at the beginning of the development phase according to the project schedule of the product development process.

The conclusion of the definition phase and therefore the start of the analysis phase have to take place at a time when the releases defined in the project schedule, including the implementation of necessary ac-tions, can be met.

The time frame for the individual scopes of the definition phase is to be established and documented in a detailed schedule before the first team meeting of the analysis phase.

The time frame for the individual phases of the total FMEA up to the product and/or process release is to be defined; a rough schedule is to be created and integrated into the project schedule.

The detailed schedules of the subsequent phases are to be created at the beginning of the respective phases.

1.3 Input

The following scopes are necessary as the basis for the definition phase:

1.3.1 Agreements

The specified person in charge of functions and/or the project manager/ customer is responsible for the initiation of the definition phase and/or the FMEA.





The customer’s specifications with regard to FMEA must be coordinated with the parties involved and/or the suppliers on the basis of the tender or the offer documents, and an agreement must be made about the execution, such as for example definition of system boundaries, necessary work doc-uments, analysis methods, and evaluation tables.

The product and process conditions must be clarified with the parties involved.

1.3.2 Procurement of Work Documents

Examples of work documents:

Project schedule, specifications with adequate details, which are for example customer requirements, system description drawings, function descriptions, components, networking, interfaces, interactions with oth-er systems and peripherals, legal and official regulations, customer regulations, customer/supplier agreements, guidelines for prod-uct/process quality objectives, safety concept, diagnosis, usage condi-tions, installation situation, quality regulations, internal regulations and requirements, processes, documented procedures, inspection instruc-tions and/or changes to these scopes.

Part lists, production, assembly and inspection schedules.

Results from the previous analyses (for example hazard analysis, FTA, QFD), use of existent FMEA scopes.

Proof of experience from similar/predecessor products (for example test reports, error lists and field experience).

Legal regulations, procedural requirements, quality regulations, quality-objective definitions, ordinances, safety regulations, standards, classifi-cation documents.

Specific FMEA evaluation tables.

The work documents have to correspond to the current status.





1.4 Work Scope

1.4.1 Task Assignment in the Definition Phase

If necessary, the team members should perform the following:

C: Customer, e.g. project manager

Decision about the execution (need for action of an FMEA and/or other methods).

Define the responsible person for the execution of the definition phase (can also be identical to the person in charge of function and/or cus-tomer/project manager).

Support during information gathering.

Provision of resources. R: Responsible Person for the execution of the definition phase

Procurement of the necessary documents and information.

Coordination and organization of the workflows in the definition phase.

Classification of topics, definition of interfaces, team building.

Responsibility for the result of the definition phase. M: FMEA Moderator

Participation in the team formation.

Participation in the preparation of the rough schedule.

Participation in the invitation to the 1st team meeting for the analysis

phase.

Participation in the preparation of the decision guidelines/criteria. T: Team Members

Participation in the preparation of the FMEA (classification of topics, definition of interfaces, team building).

Contribute experience from similar FMEAs.





1.4.2 FMEA Team Building

1.4.2.1 Criteria for the FMEA Moderator

Method competence (FMEA).

Social skills, able to work in a team.

Competent moderator, ability to convince, organization and presenta-tion skills.

1.4.2.2 Criteria for the Other Team Members

Expertise for the FMEA scopes that are to be considered.

Basics of the FMEA methodology. 1.4.2.3 The Formation of the FMEA Team

Along with the FMEA moderator, the FMEA basis team must contain the additional competent employees necessary for the respective FMEA scope. These employees must come from the specialist de-partments involved (internal and external) from project, development and/or design engineering, production process planning and/or produc-tion planning, testing, prototyping, production execution, production, in-spection planning and quality assurance.

If necessary, additional experts, for example from the laboratory, cus-tomer service, and legal department, or from customers and/or suppli-ers, are to be involved.

1.5 Tools and Supplies

The method of FMEA documentation that includes for example the FMEA tool, flip chart, update, archiving and distribution of information during the FMEA execution and beyond.

1.6 Methods

Examples of supporting methods:

Checklists.

Risk matrixes.

Mind mapping.

Brainstorming.





Please see figure 1.6-1 (Example: Prioritization of the scopes) for an exam-ple of prioritization of the scopes.

This manner of prioritization evaluates the inspection scopes in terms of applicable criteria. The criteria describe known or assumed risk fields within the product development process. For the execution of the prioritization, the inspection scopes and the evaluation criteria are contrasted in a matrix and evaluated according to relevance.

The evaluations are tiered for a clear classification of the risks:

0 Risk does not apply. 1 Risk applies to a minor degree. 3 Risk applies. 9 Risk applies to a high degree. The total of all individual evaluations defines the priority. From this a corre-sponding need for action can be derived.





Fig. 1.6-1 Example of prioritization of the scope





1.7 Measurement Variables

Examples of measurement variables:

Starting time of the analysis phase according to schedule.

Expenditure of workdays for the complete FMEA.

The finish time of the complete FMEA in the project until start of pro-duction (SOP).

Number of queries about the definition phase in the subsequent phas-es.

1.8 Substeps

Clarify and establish scope of the FMEA and/or other methods.

Establish type of FMEA (product/process FMEA).

Appoint the person responsible for the execution of the definition phase.

Appoint the team members and the responsibilities for the definition phase.

Organize invitation to the events of the definition phase.

Coordinate and organize the workflows of the definition phase.

Establish the communication (content and communication channels) for the entire FMEA.

Establish the escalation threshold and channels.

Clarify and establish the objectives of the FMEA, analysis scope (inter-faces and interactions, among other things) of product/process.

Clarify the product and process conditions with the involved parties.

Identify the time frame for the complete FMEA, create the rough schedule and integrate it into the project plan.

Identify the resources/budget demands for the complete FMEA, taking into account the following scopes:

The type of FMEA (product or process FMEA).

The scope of the examination (range of inspection).

The thoroughness of the examination (depth of inspection).

The execution procedure.

The objectives for the FMEA.

The degree of integration achieved.

The quality of the preparation.

The expenditures for the team members.

The quality of the supporting tools and aids.

The complexity of the product or process





Coordinate the results of the resources/budget requirements with the management.

Establish the scopes of the FMEA to be documented, for example, FMEA contents, FMEA accompanying document/cover sheet, FMEA protocol.

Establish the documentation system for the complete FMEA.

Regulate the archiving of the FMEA documentation.

Procure the necessary work documents for the analysis phase.

Classification of topics, definition of interfaces, team building.

Assume responsibility for the result of the definition phase.

Establish the team members and the responsibilities for the 1st team

meeting of the analysis phase.

Organize the invitation to the 1st team meeting for the analysis phase.

Determine the presentation appointments with content/committee.

1.9 Result

The following scopes are determined, documented and coordinated with the customer:

FMEA rough schedule up to the product and/or production process re-lease.

Detailed schedule for step 1 of the FMEA, structure analysis (system structure analysis).

Invitation to the 1st team meeting of the analysis phase.

Service agreement with the people responsible.

Personnel and material resources.

FMEA scopes (FMEA type, content, responsibilities).

System limits with interfaces. The objective of the FMEA for the concrete project, for example

Quality goals for the product and process (measurement variables).

Also cost-optimized repair, among other things (operational costs, cost of ownership).





1.10 Risks

Responsibilities not clearly established.

Incomplete or incorrect specifications.

Communication problems (customer/supplier relationship. development/production).

Deadline difficulties.

Insufficient planning, for example capacity requirements for FMEA scopes.

Inadequate clarification with the customer.

Unavailability of experts.

Qualification deficits of the team members.

1.11 Communication

Regular coordination talks between the parties involved.

Reviews.

Coordination with the project management.

Memos to management.

Dialog with suppliers and customers.





2 Analysis A

2.1 Objective of the Analysis Phase

In the analysis phase, all requirements for plausibility, ability to be verified and validated, and their risks are to be systematically identified. The estab-lished and mature actions and improvement potentials are to be demon-strated for the selected scope.

The analysis phase is followed by the Measures Decision.

2.2 Time Frame

The milestones and phases in the project plan provide the time frame for the analysis phase. For the detailed schedule defined in step 1 - the defini-tion phase - for the system structure, the further schedules for the steps two to five of the FMEA are to be created.

2.3 Input

The results from the definition phase are necessary as input for the analysis phase.

The following scopes are determined, documented and coordinated with the customer:

Objective.

System limits with interfaces.

FMEA scopes.

FMEA rough schedule up to production process release.

Detailed schedule for step 1 of the FMEA, structure analysis.

Invitation to the 1st team meeting of the analysis phase.

Service agreement with responsible parties.

Personnel and material resources.





Clarification and provision of documents, such as

Specifications

In the form of customer requirements, function descriptions, draw-ings, quality regulations, test instructions etc.

For components, functions, processes and/or changes of these scopes etc.

Legal and official regulations.

Customer regulations.

Customer/supplier agreement.

Internal regulations and requirements, such as procedural requirements, test instructions.

Requirements for product/process quality objectives.

Project schedule.

Results from previous analyses, such as risk analysis, FTA, QFD.

Information about comparable products, such as for example experience from predecessor products/processes.

Determination of the necessary documents for the execution of the FMEA.

2.4 Work Scope

FMEA team (core team, FMEA moderator, extended team with experts).

R: Responsible Person

Responsible for the adequate execution of the FMEA against schedule and resources.

Technical responsibility for the FMEA contents.

Preparation of the Measures Decision.

Mitigation of conflicts.





M: FMEA Moderator

Managing execution of structure description, function analysis, failure analysis, risk evaluation and the determination of optimization actions.

If necessary, preparation or wrap-up of FMEA meetings.

Moderation of the FMEA workgroup.

Analysis of FMEA, suggest actions.

Safeguarding of the FMEA documentation.

Processing of decision papers.

Development and maintenance of the evaluation catalog. T: Team Members

Procurement of necessary information about the object of inspection.

Demonstration of the development/planning state in the FMEA team.

Contribution of existing experiences from previous FMEAs already known.

Participation in the execution of the structure description, function ana-lysis, failure analysis, risk evaluation and the determination of optimi-zation actions.

Involvement in the preparation for the Measures Decision. E: Experts

Procurement of additionally necessary information about special topics.

Procurement of necessary information about the object of inspection.

Involvement in the preparation for the Measures Decision.


Flip chart, wall chart, teamwork room, software for the preparation of the FMEA documentation with a computer, video projector, viewing objects, access to internal/external data for FMEA etc.





2.6 Methods

Hierarchical structure, structured brainstorming, logical links, weak-point analysis, risk evaluation etc.


Inspected scope against determined scope.

Actual time frame against target time frame.

All necessary personnel and material resources, such as team mem-bers (external and internal) and FMEA tool, are available and adequate at the planned date.

All established and necessary documents from the definition phase are available and sufficient.

The evaluation of the results is carried out in the team and on schedule.

2.8 Substeps

The FMEA is carried out in five steps.

These five steps communicate the systematic approach in the FMEA and safeguard the coherent documentation.





Fig. 2.8-1 The five steps for the preparation of the FMEA

The steps 1 (Structure Analysis) and 2 (Function Analysis) can be carried out sequentially or simultaneously. Afterwards, the steps 3 to 5 are carried out sequentially.

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2.8.1 Preparation of the Product FMEA

2.8.1.1 Product FMEA (Step 1) Structure Analysis

The objectives of a structure analysis are:

Overview of the inspected product.

Reuse of modules.

Classification and interface description.

Establish responsibilities.

The system consists of individual system elements (SE) that are arranged hierarchically for the description of the structural connections, for example hardware concept.

During the preparation of the system structure, the degree of detailing of an FMEA is dependent and can therefore not be globally established. To what extent a structure must be analyzed in more detail depends on many factors.

The following criteria supports the identification of the inspection depth:

If an unacceptable and/or incalculable risk is found during the analysis (steps 1-5) of an inspection scope, additional detailing is necessary

The detailing is ended if failures in this degree of detailing are suffi-ciently secured by actions.

With known and operationally proven inspection scopes, a lesser de-gree of detailing is necessary than with new scopes.

The lowest level of inspection is the characteristics of the components (the characteristic level).

The clearly structured illustration of the complete system is thereby guaran-teed by the fact that each system element only exists once. The structures arranged under each SE are independent substructures (see figures 2.8.1.1-1 and 2.8.1.1-2).





Due to the structuring, interfaces are also generated on physical connec-tions (that exist in the system) from an SE of a substructure to an SE in other substructures.

All functional connections between the SEs are to be described, including the interfaces of the inspected system structure and beyond.

There is always a structure element present, even if it is only derived from the function and cannot yet be specified more clearly.

Fig. 2.8.1.1-1 Example of system structure up to the component level





Fig. 2.8.1.1-2 Example of system structure up to the characteristics level of the components





2.8.1.2 Product FMEA (Step 2) Function Analysis

The objectives of a function analysis are:

Overview of the functionality of the product.

Overview of the cause-effect relationships.

Verification against the customer require-ments.

Basis for the failure analysis.

The system structure described by SEs provides the basis so that each SE can be analyzed as differentiated as necessary with regard to its functions and failures in the system.

For this, comprehensive knowledge of the system and the ambient condi-tions of the system are necessary, for example heat, cold, dust, splash wa-ter, salt, icing, vibrations, electrical failures etc.

Functions

Each SE has different functions and/or tasks in the system (see figure 2.8.1.2-1). Generally, the functions of other SEs are also necessary for the fulfillment of the individual functions of an SE.

The description of the function must be clear, and it must be possible to ver-ify and validate it.

For better overview functions are shown in green in the graphics.

Function Structures

The interaction of the functions of several SEs must be demonstrated, for example as a function network, function structure, function tree, and flow charts. For the preparation of the function structures of an SE, the functions that are involved must be examined. Subfunctions that in sum describe a function are linked logically with each other in the allotted function structure. This serves the completion of the functional demonstration.

The detailing of a function structure increases from left to right. The right function describes how the previous function is to be fulfilled. For the logical linking of a function structure, the questions “How?” (from left to right) and “Why?” (from right to left) are therefore helpful.





Fig. 2.8.1.2-1 Example of a function structure





2.8.1.3 Product FMEA (Step 3) Failure Analysis

The objectives of a failure analysis are:

Identification of the possible failures, assigned to system structure and to functions.

Links of the failures to the failure structures.

Basis for the illustration of failures in a form anand/or the preparation of the form.

A failure analysis must be carried out for each SE inspected in the system description.

Possible failures are deduced from the functions, for example nonconformi-ties from specified function target states, limited function, unintentional func-tion or exceeding a function.

The description of the failure must be clear. Non-fulfillment, not OK, defec-tive, broken and so on do not suffice to comprehensively assign the failure cause, failure mode and to determine actions. For this, the operating condi-tions of the product are to be considered.

Generally, many failures are associated with a function.

For better overview functions are shown in red in the graphics

Failures Structures

Built up on the known functions, the failures are derived and failure struc-tures (failure trees/failure network/fault tree/fault network) are created for the failure analysis (see figure 2.8.1.3-1). For this, failures are linked ac-cording to cause and effect.

Depending on the focus, a failure can be viewed as a failure cause, failure or a failure mode. The created failure structures are transferred to the cor-responding columns „Potential Failure Modes”, „Potential Failure”, and “Po-tential Failure Causes” of the FMEA form.

Depending on the depth of the failure structure, it is possible to create the analysis on different levels and to illustrate the contents of the failure struc-tures in the three form columns.





Fig. 2.8.1.3-1 Failure structure based on the throttle positioner





2.8.1.4 Product FMEA (Step 4) Actions Analysis

The objectives of the actions analysis are:

Assigning the existing and/or already estab-lished actions to the failures.

Risk evaluation.

There are two different actions groups: the Preventive actions and the de-tection actions.

Preventive Actions (PA)

Preventive actions in the development facilitate the optimal system layout and/or the characteristics layout so that the occurrence potential of the fail-ure possibility is very low.

Preventive actions must be clearly and comprehensively described. If nec-essary, this can be done by reference to an additional document. The indi-cation “proven material” is not enough.

Preventive actions could be:

EMC directives adhered to, directive 89/336/EEC

System design according to simulation, tolerance calculation and VA 17.11

Tolerances taken over from drawing number ZN 1.239.876

Preventive actions in customer operation and in the service are described in Chapter 7, “Additional Fields of Application”

Detection Actions (DA)

By using detection actions in the development, the possible failures are found and/or the effectiveness of the Preventive actions is confirmed.

Detection actions must be clearly and comprehensively described. If neces-sary, this can be done by reference to an additional document. The indica-tion “Test or lab test” is not enough.





Detection actions for the validation of the layout can be:

SV 1645a simulation process

Function check according to test plan PP 136-07

Burst test according to PR 196-00

Climate change test according to test plan 1723

Driving test according to DE44

Endurance test according to PST 1000

Drawing check according to ZN 9.214.543

Lab tests according to PV 5768

Detection actions in customer operation and in the service are described in Chapter 7, “Additional Fields of Application”.

Responsible Person and Deadline

A responsible person (R) and a deadline (DL) are assigned to each action.

The responsible person sees to the decision of the action and, if confirmed, to the implementation.

Deadlines are to be set early enough so that the implementation before the production release is guaranteed. The deadline is to be specified with the date.

If the responsible persons and the deadlines are not entered into the form, these are to be defined in assigned documents.

Status of the Actions:

a) Unprocessed Idea gathering, implementation of the action has not begun yet.

b) Decision pending The action has been defined but not yet decided. A decision paper is being created.

c) Implementation pending The action has been decided and not implemented yet.





d) Completed Completed actions have been implemented and their effectiveness has been demonstrated and documented; a final evaluation has been carried out.

e) Discarded Discarded actions are documented and generally require an optimi-zation, phases A and I (see Step 4, Actions Analysis).

Evaluations

The risk connected to each cause of failure is evaluated. For the evaluation of the risk, avoidance and detection actions recorded in the development and planning stage are consulted.

For this S stands for the severity of the failure mode, O stands for the occurrence potential of the failure cause, and D stands for the detection potential of the occurred failure cause, fail-

ure and/or failure mode. Evaluation numbers from 10 to 1 are used for S, O, and D respectively, in which 10 stands for the highest risk contribution. By means of single examinations and combinations of these three factors, prioritizations can be conducted (see section “Evaluation of the Risk”).

Examples for the preparation of evaluation tables are found in Chapter 9, Samples of Evaluation Tables.

Severity (S)

The evaluation number S is determined by the severity of a failure mode at the highest level of the inspection scope and/or at the interface defined for the superordinated system.

Therefore, “10” or “9” is given, for example, if a failure affects the safety and/or if it violates the compliance to legal regulations, or if it constitutes an existence-endangering risk to the company.

A “1” is given, for example, if the failure mode constitutes a very small im-pairment to the function that is only identifiable by experts.





For a comprehensible evaluation, product group-specific evaluations check-lists are created that, if stated in the contract, are to be coordinated with the customer.

The evaluations of the failure modes have to be mutually agreed upon by the manufacturer and the customer (subpurchaser).

If the failure modes are not known, the severity is to be evaluated at S=10.

Avoidance and Detection Actions

Evaluations for the occurrence and detection potential (D and O) are given according to the effectiveness of the avoidance and detection actions car-ried out for the inspected failure causes.

The more detailed the failure analysis of the FMEA is carried out for the causes, the more differentiated the evaluations O and D can be undertaken.

The O and D evaluation of causes in the FMEA can fall back on empirical values (such as reliability rates of comparable systems). If already evaluat-ed subsystems are integrated into a new system, the evaluations are to be checked, due to the possibly modified boundary conditions of the new sys-tem.

Occurrence Potential (O)

O describes the occurrence potential of the failure cause during the lifecycle of the vehicle, taking into account the associated preventive actions.

The evaluation number is always to be understood as a relative estimation instead of as an absolute measured value according to the current state of knowledge.

In the preventive preparation of the FMEA, the O-value expected according to the current state of knowledge is assessed before the execution of the detection actions.

Expertise, data handbooks, warranty databases or other experiences in the field of comparable products, for example, can be consulted for the analysis of the evaluation numbers.





After the application of the detection action during the development and ver-ification of the effectiveness of the preventive actions, the O-evaluation is either confirmed or corrected according to the result of the detection action.

A “10”, for example, is given in the O-evaluation if the inspected failure cause occurs with high potential, no avoidance action exists and/or its ef-fectiveness is not known.

A “1”, for example, is given when it is improbable that the inspected failure cause occurs.

Detection Potential (D)

The evaluation of the detection potential is carried out taking into account all the detection actions specified for it. Here the DA can be consulted for the failure cause of different levels.

The evaluation number “10”, for example, is given when it is impossible or improbable that the failure will be detected in time or at all, or if no detection actions exist.

The evaluation number “1”, for example, is given when the failure is detect-ed easily and in time.

The evaluation number “1”, for example, is given when an inspected failure cause is discovered easily during the development by the sum of all testing measures.

After decision and implementation of the action and of phases A and I, the effectiveness is to be verified and re-evaluated.





Evaluation at the Time of Inspection

The time of inspection is taken into consideration for the evaluation of O and D actions. In order to depict the current state, the potential of occur-rence and the detection of the failure cause are first evaluated, taking into account the already completed actions.

The actions not yet implemented are additionally included for the evaluation of the expected state. This evaluation is to be labeled. The type of labeling is optional.

The analysis of the evaluation is described in Chapter 2.8.3, Risk Evaluation.

2.8.1.5 Product FMEA (Step 5) Optimization

The objectives of an optimization are:

Identification of the actions necessary for im-provement.

Assessment of the risk.

Checking the effectiveness of the implement-ed actions.

Documenting the implemented actions.

If the result of the evaluation of the status is not satisfactory, new actions are suggested. These actions are processed analogous to step 4. A new actions status is produced. These new actions are evaluated in advance, are provided with responsible persons and deadlines, and are decided on.

After the implementation of the actions, an effectiveness check is to be car-ried out and the evaluation is to be examined. If it becomes apparent that the action has not produced the desired result, the optimization is to be per-formed as often as needed until an acceptable result is reached.

The optimization takes place in the following order:

Concept modification in order to eliminate the failure cause and/or to obtain a failure mode with a low severity





Increase of the reliability of the components in order to minimize the occurrence potential of the failure cause

Effective detection of the failures In the case of concept modifications, all five steps of the FMEA are run through again for the affected sections.

The following figure shows a possible depiction of the information on the form. The evaluation of the expected state is denoted here with round brackets.





Fig. 2.8.1.5-1 Example of an FMEA form for the Product FMEA (Development)





2.8.2 Preparation of the Process FMEA

2.8.2.1 Process FMEA (Step 1) Structure Analysis

The objectives of a structure analysis are:

Overview of the inspected product.

Reuse of modules.

Classification and interface description.

Determine responsibilities.

The process system consists of individual system elements (SE) that are arranged hierarchically in a system structure (for example workflows, tech-nology concepts) for the description of the structural connections in the complete system.

During the preparation of the system structure, the level of detailing of an FMEA is process-dependent and can therefore not be generally deter-mined. To what extent a structure must be analyzed in more detail depends on several factors.

The following criteria support the identification of the examination depth:

If an unacceptable and/or incalculable risk occurs during the analysis (steps 1-5) of an examination scope, additional detailing is necessary

The detailing is ended if failures in this degree of detailing are suffi-ciently secured by actions.

With known and operationally approved examination scopes, a lesser degree of detailing is often necessary than with new scopes.

In the process, the lowest levels of examination are the classic “4M” (Man Machine Method Material).

The clearly structured illustration of the complete system is guaranteed by the fact that each SE exists only once. The structures assigned under each SE are independent substructures (see figure 2.8.2.1-1, Example of System Structure).





In the process FMEA, the so-called 4M are examined in the lowest levels. These serve as reminders in order to illustrate all relevant influencing fac-tors in the process. These can be:

Man stands for fitter, machine operator, production associate, manager etc.

Machine stands for robot, primer, hopper reservoir tank, color mixing unit, heating of the plastifying unit, injection molding form, spiral conveyor etc.

Material stands for intake tread, bearing surface, synthetic granules, col-or batch, plasticized synthetic material etc.

Method stands for ambient conditions such as heat, dust, contamination etc.

Due to the structuring, interfaces occur on connections (that physically exist in the system) of one SE of a substructure to an SE in other substructures.

All functional connections between the SEs are to be described, also be-yond the interfaces of the inspected system structure.

There is always a structure element present, even if it is only derived from the process and cannot be specified more precisely yet.





Fig. 2.8.2.1-1 Example of System Structure





2.8.2.2 Process FMEA (Step 2) Function Analysis

The objectives of a function analysis are:

Overview of the workflows in the process

Overview of the cause-effect relationships

Verification against the process planning

Basis for the failure analysis

The system structure (structure tree) described by the SEs provides the ba-sis so that each SE can be analyzed as differentiated as necessary with re-gard to its function and failures concerning the procedure in the system.

For this, comprehensive knowledge of the system and the ambient condi-tions of the system are necessary, for example the product requirements or characteristics, functions and process requirements and/or costs, time, oc-cupational safety, environmental impact.

Functions/Workflows

Each SE has different workflows, tasks and/or functions in the system, in-dependent of its position in the structure (see figure 2.8.2.2-1). Generally, the functions of other SEs are also necessary for the fulfillment of the indi-vidual functions of an SE.

The description of the function must be clear, verifiable, and it must be pos-sible to validate it.

For better overview functions are shown in green in the graphics.

Function Structures/Workflow Structures

The interaction of the workflows of several SEs must be demonstrated, e.g. as function network, function structure, function tree, or flow charts. For the preparation of the function structures of an SE, the involved functions must be inspected. Subfunctions that in sum describe a function are logically linked with each other in the assigned function structure.

The detailing of a workflow structure increases from left to right. The right workflow describes how the previous workflow is to be detailed. For the log-ical linking of a function structure, the questions “How?” (from left to right) and “Why?” (from right to left) are therefore helpful.





Fig. 2.8.2.2-1 Example of a Function Structure





2.8.2.3 Process FMEA (Step 3) Failure Analysis

The objectives of a failure analysis are:

Identification of the possible failures, assigned to system structure and to functions.

Linking the failures to the failure structures.

Basis for the illustration of the failures on the form and/or preparation of the form.

A failure analysis must be carried out for each SE inspected in the system description.

Possible failures are deduced from the functions/tasks, e.g. nonconformities from specified target state of the facilities, not completely executed tasks, unintentional activity or unnecessary activity.

The description of the failure must be clear. Non-fulfillment, not OK, defec-tive, broken and so one are not sufficient to comprehensively assign the failure cause and mode and to determine actions.

Generally, several failures are associated with a function.

For better overview functions are shown in red in the graphics

Failure Structures

Based on the known functions, the failures are derived and failure struc-tures (failure trees/failure network/fault tree/failure network) are created for the failure analysis (see figure 2.8.2.3-1).

Depending on the focus, a failure can be inspected as a failure cause, fail-ure, or a failure mode. The failure structures that were created are trans-ferred to the corresponding columns “Potential Failure Modes”, “Potential Failure”, and “Potential Failure Cause” of the FMEA form.

Depending on the depth of the failure structure, it is possible to prepare the analysis on different levels and to represent the contents of the failure struc-tures in the three columns of the examples.





Fig. 2.8.2.3-1 Example of Failure Structure Based on the Manu-facture of the Primary Gear





2.8.2.4 Process FMEA (Step 4) Actions Analysis

The objectives of the actions analysis are:

Assigning the failures to the existing and/or al-ready determined actions.

Risk evaluation.

There are two different action groups: the preventive actions and the detec-tion actions. Preventive Actions (PA)

Preventive actions in the development facilitate the optimal process plan-ning so that the occurrence potential of the failure possibility is very low.

Preventive actions must be clearly and comprehensively described. If nec-essary, this can be done by reference to an additional document. The indi-cation “proven process” is not enough.

Preventive actions can be:

Process planning:

Detection of possible layout deficiencies of the production facility, e.g. test runs according to start-up regulation AV 17/3b

Production process:

Detection of defectively produced parts in the production facility, test station 25

Use of A003.7 device

Two-handed operation of machines

Subsequent part can not be attached

Form-dependent position





Detection Actions (DA)

By using detection actions in the process planning, the possible failures are found and/or the effectiveness of the action is confirmed.

Detection actions must be clearly and comprehensively described. If neces-sary, this can be done by reference to an additional document. The indica-tion “Intermediate test, dimensional check, etc” is not enough.

Detection actions for the validation of the layout can be:

Visual inspection according to AA 15.08

Visual inspection with sample checklist MK005.3

Optical test with limit sample GM368

Attributive test with mandrel 46565

Dimensional check with a caliper gauge 159/3

Random inspection 50-0 Responsible Persons and Deadline

A responsible person (R) and a deadline (DL) are assigned to each action.

The responsible person sees to the decision of the action and, if confirmed, to the implementation.

Deadlines are to be set early enough so that the implementation before the production release is guaranteed. The deadline is to be specified with the date.

If the responsible persons and the deadlines are not entered into the form, these are to be established in related documents.

Status of the Actions:

a) Unprocessed Idea gathering, implementation of the action has not yet begun.

b) Decision pending The action has been defined but has not yet decided on. A decision paper is being created.





c) Implementation pending The action has been decided but not yet implemented.

d) Completed Completed actions have been implemented and their effectiveness has been demonstrated and documented, a final evaluation has been done.

e) Discarded Discarded actions are documented and generally require an optimiza-tion, phases A and I (step 4, Actions Analysis).

Evaluations

The risk connected to each failure cause is evaluated. For the evaluation of the risk, avoidance and detection actions recorded in the development and planning stage are consulted.

For this

S stands for the severity of the failure mode, O stands for the occurrence potential of the failure cause, and D stands for the detection potential of the occurring failure cause,

failure and/or failure mode. For S, O, and D, evaluation numbers from 10 to 1 are used respectively, in which 10 stands for the highest risk contribution.

By means of individual inspections and combinations of these three factors, prioritizations can be conducted (see the section “Evaluation of the Risk”).

Examples for the preparation of evaluation tables are found in chapter 9, Examples of Evaluation Tables.

Severity (S)

The evaluation number S is determined by the severity of a failure mode at the highest level of the inspection scope and/or at the interface defined for the superordinated system.

Therefore, the “10” or “9” is given, for example, if a failure affects the safety and/or if it violates the compliance to legal regulations, or if it constitutes an existence-endangering risk to the company.





The “1” is given, for example, if the failure mode constitutes a very small impairment to the function that is only identifiable by experts.

For a comprehensible evaluation, product group-specific evaluation check-lists are created that, if stated in the contract, are to be coordinated with the customer.

The evaluations of the failure modes have to be mutually agreed upon by the manufacturer and the customer (subpurchaser).

If the failure modes are not known, the severity is to be evaluated with S=10.

Avoidance and Detection Actions

Evaluations for the occurrence and detection potential (D and O) are given according to the effectiveness of the avoidance and detection actions car-ried out for the inspected failure causes.

The more detailed the failure analysis of the FMEA is carried out for the causes, the more differentiated the evaluations O and D can be carried out.

The O and D evaluation of causes in the FMEA can fall back on empirical values (e.g. reliability rates of similar systems). If already evaluated subsys-tems are integrated into a new system, the evaluations are to be checked due to the possibly modified boundary conditions of the new system.

Occurrence Potential (O)

O describes the occurrence potential of the failure cause in the process, taking into account the associated preventive actions.

The evaluation number is always to be understood as a relative assess-ment instead of as an absolute measured value according to the current state of knowledge.

In the preventive preparation of the FMEA, the O-value expected according to the current state of knowledge is assessed before the execution of the detection actions.

Expertise or other experiences from comparable processes, for example, can be consulted for the assessment of the evaluation numbers.





After the application of the detection actions in the process and verification of the preventive actions effectiveness, the O-evaluation is either confirmed or corrected according to the result of the detection action.

A “10”, for example, is given in the O-evaluation if the inspected failure cause occurs with high potential, no avoidance action exists and/or its ef-fectiveness is not known.

A “1”, for example, is given when it is improbable that the inspected failure cause will occur.

Detection Potential (D)

The evaluation of the detection potential is carried out taking into account all the detection actions specified for it within the complete production pro-cess. In this connection, the DA can be consulted for the failure cause of different levels.

The evaluation number “10”, for example, is given if it is impossible or im-probable that the failure will be detected in time or at all, or if no detection actions exist.

The evaluation number “1”, for example, is given if the failure is detected easily and in time.

The evaluation number “1”, for example, is given when a production failure in the process is easily detected at the location of the failure cause.

After decision and implementation of the action - phases A and I, the effec-tiveness is to be verified and re-evaluated.

Evaluation at the Time of Inspection

The time of inspection is taken into consideration for the evaluation of O and D actions. In order to demonstrate the current state, the potential of oc-currence and the detection of the failure cause are first evaluated, taking in-to account the already completed actions.

The actions not yet implemented are additionally included for the evaluation of the expected status. This evaluation is to be labeled. The type of labeling is optional.

The analysis of the evaluations is described in chapter 2.8.3, Risk Evalua-tion.





2.8.2.5 Process FMEA (Step 5) Optimization

The objectives of an optimization are:

Identification of the actions necessary for im-provement.

Assessment of risk.

Checking the effectiveness of the imple-mented actions.

Documenting the implemented actions.

If the result of the evaluation of the status is not satisfactory, new actions are suggested. These actions are processed analogous to step 4. A new actions status is generated. These new actions are evaluated in advance, are provided with responsible persons and deadlines, and are decided on.

After the implementation of the actions, an effectiveness check is to be car-ried out and the evaluation is to be validated. If it becomes apparent that the action has not produced the desired result, the optimization is to be per-formed as often as necessary until an acceptable result is reached.

The optimization takes place in the following order:

Process modification in order to eliminate the failure cause and/or to obtain a failure mode with a low severity.

Increase of the stability of the processes, in order to minimize the oc-currence potential of the failure cause.

More effective detection of the failures. In the case of process modifications, all five steps of the FMEA are run through again for the affected subsections.

The following illustration shows a possible depiction of the information in the form. The evaluation of the expected status is denoted here with round-brackets.





Fig. 2.8.2.5-1 Example of FMEA Form for Process FMEA





2.8.3 Risk Evaluation

The evaluations S, O, and D are consulted for the risk evaluation.

Derivatives from the SOD Evaluations

A high S value shows a high potential extent of damage. Conclusion: low occurrence potential and/or reduction of the damage extent is necessary. A high O value demonstrates a (potential) frequent occurrence of the failure cause. The frequency of the failure mode occurrence can often not be concluded from the occurrence of the failure cause. The occurrence of the associated failure mode can be significantly more seldom. If D describes detection actions in the development, a high value for D indi-cates that the detection action is unsuitable to efficiently detect the failure and cannot effectively confirm O.

If D describes detection actions in customer operation, a high value for D indicates that an occurring failure was not detected, or not detected in time to prevent or to minimize the failure mode.

Combinations of Individual Evaluations

Combinations of evaluations from the FMEA can be used in order to demonstrate different risks and to deduce a possible need for action.

The decision whether an action is necessary (actions decision phase) can in certain cases not be made only by inspecting the values S, O and D.

For example, the potential that a failure cause also actually lead to a failure mode is not considered by any parameters; however it plays an essential role in the actions decisions. In cases in which several causes have to come together in order to produce a failure mode, the application of other methods, such as e.g. the fault tree analysis, can make sense for the deci-sion about actions.





Statement about O and D Evaluation

While the O evaluation describes the estimated quantity of faulty products, the D evaluation states how easily the occurring failure can be detected.

Risk Matrix

A further possibility for the classification into risk classes can be carried out by an individually determined tabular classification, with which non-linearities and different weightings of damages can also be considered.

The risk matrix makes the classification of the risk for the determination of the need for action and/or as release requirement possible, among other things.

The risk matrix shown here and the limit values included in it are intended solely for the explanation of the method. The limit values are to be deter-mined as company and/or project-specific.

O

10

9

8

7

6

5

4

3

2

1

1 2 3 4 5 6 7 8 9 10 S

Fig. 2.8.3-1 Example of Risk Matrix





S Severity of the failure mode at higher level (vehicle, driver, environ-ment) taking into consideration the system reactions due to the detec-tion actions (D) in the system and/or the severity of the failure mode for the manufacturer.

O Occurrence potential (O) of the failure cause in the field and/or the oc-currence potential of the failure cause at the manufacturer minus the failures of the process FMEA detected by the detection actions (= slip).

Green zone: there is no need for action.

Yellow zone: there is no imperative need for action, the risk should be reduced by appropriate actions.

Red zone: There is a need for action, the risk must be reduced by appropriate actions.

Prioritization with Individual Limit Values for S, O and D

The following method provides an easy possibility to prioritize:

1. Select all failure causes that lead to an S > limit value for S, e.g. all S > 9, or all S > 8, or all S > etc.

2. Select all failure causes from this group with O > limit value for O, e.g. all O > 1, or O > 2, or O > etc.

3. From this, select all failure causes in which D > limit value for D, e.g. all D > 8, or D > 6, or D > etc.

The groups obtained in this way contain the failure causes with the highest priority. The method can now be run through repeatedly with different limit values, so that several groups with different priorities are formed.





Risk Priority Number (RPN)

The result of the multiplication of the three evaluations numbers S x O x D is referred to as the Risk Priority Number.

In many cases, the inspection of the absolute value of a risk priority number is misleading and not appropriate as the basis for further actions. A relative comparison of the individual risk priority numbers can also be misleading.

It does not make sense to define a “rigid RPN” as the intervention limit (e.g. from RPN > limit), since the evaluation criteria can possibly be different for each FMEA.

The results in the problem that the same RPN values do not necessarily mean the same risk. Based on the RPN = 100, this value can arise through (S x O x D) = (10 x 1 x 10) or also through (S x O x D) = (10 x 10 x 1).

Therefore the RPN has a low significance regarding the quality of products and processes.

Note

The FMEA delivers a predominantly qualitative evaluation. Due to the sub-jective assessment and its uncertainty, it is only conditionally suitable as a method for quantitative evaluation. For this, other appropriate methods are to be applied.

2.9 Result

The documentation for the FMEA is available by the end of the analysis phase:

Detailed schedule for the step 2 to step 5 of the FMEA, function analy-sis until optimization.

The established FMEA scopes are processed according to the objec-tives.

System structure.

Function structure.

Failure structure.





Related and coordinated evaluation checklists.

Evaluations.

Optimization.

Actions checklist with persons responsible/deadlines/status.

The actions decision is prepared. 2.10 Risks

Deficient coordination between product and process or customer and supplier.

No customer requirements for the severity.

FMEA schedule is not in line with project plan.

Processing scopes not completed at the required milestone.


Incomplete or faulty specifications.

Unexpected test and inspection results.

Deficient decision or escalation preparation.

Incorrect actions decision.

Availability problems of the FMEA team members.

Inadequate planning (such as increased capacity requirement for FMEA execution).

2.11 Communication

After the risk evaluation of the individual potential failure causes has taken place, a memo to management about the results of the analysis phase should be prepared.

The contents of the communication are, for example:

Information about the work carried out

Information about necessary actions

Information about further need for optimization

Information whether risks are sufficiently avoided. This data is recorded into the project progress evaluation by the complete project management within the project review (see VDA 4.3).





3 Measures Decision M

3.1 Objective of the Measures Decision Phase

To bring possible actions that have been developed in the team to a deci-sion and to make available the resources necessary for them (implementa-tion planning).

3.2 Time Frame

Actions that have been decided in the team and that do not require man-agement or project management approval are to be incorporated so that they can be implemented and their effectiveness can be evaluated before the corresponding milestone.

Actions that require approval are to be processed and to be decided so that these actions can be implemented and the effectiveness can be evaluated before the corresponding milestone.

3.3 Input

Decide actions that have not been decided yet, taking into account the costs, time, quantities, resources and considering the effect on other sys-tems and components, or send back the actions for analysis.

Ideas for the actions from the team.

3.4 Work Scope


Preparation of the Measures Decision.

Development of the decision paper with costs, deadlines.

Decision on the action.

Release of the resources. T: Team Members

Information about the action to be decided.

Support for the planning of the Measures Decision.






Calculation program for cost calculation, simulation programs, network planning, project planning tool, implementation risks, legal basis such as laws, standards and regulations, presentation methods.

3.6 Methods

Decision matrixes, discussion etc.

3.7 Measurement variables

Efficiency of the decision.

Time frame from the input to the decision.

3.8 Substeps

Cost evaluation and implementation evaluation.

Demonstrate decision premises.

Identify and present alternatives.

Planning of the implementation.

Impact inspection of the actions implementation.

Risk inspection for the actions decision.

Develop decision papers including.

Objectives, costs.

Feasibility.

Implementation time.

Give recommendation.

Make decision.

Documentation of the decision with basic principles. 3.9 Result

Implementation resolution of the actions and documentation of the de-cision and provision of the resources.

Rejection with reasons.

Request for renewed processing.

Detailed schedule for the implementation of the actions decided.

Risk with regard to function safety and producibility, delivery date.





3.10 Risks

Risks that can occur in the Measures Decision process:

Objective not clearly defined.

Inadequate or wrong inputs.

Too late or insufficient result.

Too few resources allocated.

Not all involved parties integrated.

Wrong premises.

Insufficient communication. 3.11 Communication

After the actions decision takes place, a complete overview with person(s) in charge, deadlines and resources for the implementation, and a memo to management should be prepared.

Objective of the communication

Information about actions already decided.

Decision about further need for optimization.

Decision as to whether risks are adequately safeguarded against.





4 Implementation I

4.1 Objective of the Implementation Phase

In the implementation phase, the implementation of the individual actions is traced against the schedule and a re-evaluation is carried out. If the actions have brought the expected success, this action is completed. In the other case, further actions have to be initiated, the schedule has to be traced, and they must be re-evaluated.

4.2 Time Frame

The implementation phase begins after the definition of actions and their responsible persons, and it ends when all actions have been implemented and the results have been accepted.

The determined deadlines must fit the framework of the project plan.

4.3 Input

The actions described and defined in Chapter 3 that have been adopted within the framework of the FMEA, with the corresponding responsible per-sons.

4.4 Work Scope

FMEA team (core team, FMEA moderator and experts).


Monitors the on-schedule implementation of the defined actions.

Summons the FMEA team for the evaluation of the implemented ac-tions.

Produces and distributes the final report.

Gives the appropriate recommendation for releases. M: FMEA Moderator

Chairs the team meetings.

Accounts for the methodical execution.

Documents the meeting.





T: Team Members

Report their experiences for the evaluation of the remaining residual risk.

Along with the experts, are responsible for the correct assessment of the residual risk.

E: Experts

Support the team members in the evaluation of the remaining risk.

Demonstration of the actions conducted. 4.5 Tools and Supplies

Tools for the action tracing and re-evaluation of the remaining risks

Implementation plans.

Schedules.

Work plans. 4.6 Methods

Project management.

Review. 4.7 Measurement Variables

The state of the actions and the processing of the actions are to be demon-strated in a target/actual comparison at established times that are based on customer or project regulations, milestones, releases, or agreed FMEA re-view deadlines, for example.

4.8 Substeps

4.8.1 Action Tracing

When preparing the FMEA, various actions were defined and decided cor-responding to the identified risks. These actions have a deadline for when they must be completed. The deadline is compatible with the project scope deadlines and is monitored in the implementation phase.

The person responsible for the action sees to the on-schedule implementa-tion of the action.





4.8.2 Re-Evaluation of the Remaining Risk

The actions carried out must be re-evaluated with regard to their effective-ness. If the remaining risk is too large, further actions must be defined, if required. If the newly defined actions are not compatible with the project scope (costs/deadlines/quality objectives), the escalation path described in the Actions Decision chapter must be followed. Depending on the result, this iteration loop can be run through repeatedly.

4.8.3 Summary of the FMEA Results

Preparation of a final report with possibly necessary release recommenda-tions.

4.9 Result

All defined actions are completed. The subsequent evaluation of the re-maining risk has been carried out and has been evaluated as acceptable.

The work carried out is summarized in a closing documentation. Among other things, the report includes:

Objective of the FMEA.

Prerequisites, resources, participants, schedule.

Summary of the most important findings.

Remaining risks. 4.10 Risks

Missed deadlines.

Known schedule problems not escalated.

Lack of resources for the FMEA.

Lack of information management and methods.

Organizational risks.





4.11 Communication

After the completion of the implementation phase, or when the schedule and/or the budget have been exceeded, an appropriate memo to manage-ment (final or progress report on the FMEA) must be prepared by the per-son responsible for the FMEA.

Objective of the communication:

Information about the work already carried out.

Decision about necessary actions.

Decision about further need for optimization.

Decision as to whether risks are adequately safeguarded against. In the framework of the project review (see VDA Volume Project Plan-ning/Management), this data will be recorded in the project progress evalu-ation by the general project management.





5 Communication C

5.1 Objective of the Communication Phase

With the help of an effective knowledge management, the existing knowledge of individual employees from the FMEA is consolidated, com-municated and distributed, and made usable for the entire organization and for suppliers and customers, if necessary. In detail, the following objectives are achieved:

Find, record, process, reflect and evaluate information.

Pass on, communicate and distribute knowledge content to others.

Cooperatively exchange and mutually supplement knowledge content with others.

Apply knowledge, implement in action and evaluate.

Present FMEA results.

Knowledge “maintenance” (such as updating, eliminating, structuring).

Create knowledge than can be made further use of and used again.

Final inspection by customer. 5.2 Time Frame

Parallel to the individual phases and after end of project

5.3 Input

Results of all previous phases and their documentation, as well as the re-sults of inquiry calls and database hits.

New findings and/or input (internal or external) with regard to standards, customer requirements etc.





5.4 Work Scope


Establish the communication channels and cycles with the customer (internal and external) and/or suppliers.

Prepare and document information.

Coordination and release of the information contents.

Process, document and present results.

Knowledge maintenance (such as updating, eliminating, structuring).

Determine feedback systematic. M: FMEA Moderator

Support of information gathering.

Participation in the generating of information.

Processing of information with regard to misinterpretation.

Transfer of the information to other FMEA specialists.

Incorporation of information from comparable FMEAs. T: Team Members

Impart, establish and distribute knowledge content to one’s own em-ployees.

Report on positive experiences.

Discuss and present implementation results concerning the own pro-cesses to the person in charge of the process.

Sensitization of the employees, suppliers and customers regarding the risks related to one’s processes.

Safeguarding of the information of the FMEA as well as the knowledge maintenance and processing in one’s own area.

E: Experts

Support of information gathering.

Procurement of additionally or supplementarily necessary information about special topics of the information exchange.

Procurement of necessary information about existing communication and information channels.

Participation in the execution of information workflows and distribution.






Use of media, knowledge management systems, documentation systems, FMEA accompanying documents, intranet, information boards, and meetings.

5.6 Methods

Systematic visualization, presentation techniques, communication techniques.

Determining distribution of the information


Further inquiries regarding results.

Up-to-dateness of the information.

Integration in procedure documents (design guidelines, quality guide-lines, test instructions, process specifications etc).

Amount of Continual Improvement Process projects due to the new FMEA findings.

5.8 Substeps

Processing and storage of the supplied data.

Generation of the presentation documents and presentation (inter-nal/external).

Completion of database with current, possibly version-controlled, find-ings.

Answering further inquiries.

Record and evaluate measurement variables.

Establish the information distribution.

Tracing and projecting the resulting activities. 5.8.1 Communicate Knowledge

The targeted communication of knowledge is a imperative prerequisite to make the isolated existing knowledge of individual employees useable for the entire organization. Without the communication of the findings from the FMEAs and their implementation in the organizational environment of the company, an optimal usage from the FMEA cannot be drawn. The commu-nication of knowledge can take place both as an obligation to provide or to collect.





5.8.2 Using Knowledge

A central factor of the FMEA is the consolidation of expert knowledge for the optimization of the current and also future development expenditure. It is important here to guarantee that others actively use the existing knowledge as an information source, in order to remedy information deficits.

Knowledge is deemed an im-portant element in a tem-porarily and situationally de-pendent process. Therefore, when saving a knowledge ob-ject, the content and chrono-logical contexts are always to be archived with it as project-related metadata. The con-texts in which the knowledge is valid and conclusive are also to be considered when retrieving later. In this way, changed meanings through deviating interpretations and contexts can be avoided.

In order for this knowledge to be used, it must always be kept available, as well as the organized and structured archiving and distribution. Knowledge that is not communicated according to need and which is difficult for em-ployees to access does not, for all intents and purposes, exist.

The communication can be carried out in meetings and project groups, and with the help databases. It is crucial that the information is made available in such a way that it can serve as a source for further knowledge generation for employees that were not involved in the preparation of the FMEA. The knowledge does not only enter into risk inspections but can also be used for:

Product and process information.

Test data and/or test procedures.

Project schedules etc. A structured set-up knowledge communication, especially in large interna-tional projects like those in the automotive industry, has become an indis-pensable resource for the optimization of systems, products and processes.





5.8.3 Information and Communication

Within the scope of an FMEA, information must be constantly exchanged. An electronic data storage is employed as an important basis for the opti-mal execution of information exchange in an FMEA.

Information and communication are dependent on each other, but are clear-ly conceptionally separated. Information is the object of the communication. The communication concept is kept so general that not only the communi-cation between people but also the communication between people and processes as well as only between processes can be included.

For the FMEA, communication is understood to be all organizational regula-tions that determine the information exchange of findings via sending, re-ceiving, storing and processing. The following sub-aspects are necessary for the transmission of information:

A transmitter for the sending of information.

A receiver for the reception of information.

A storage for when the information cannot be immediately made use of.

A conversion, i.e. a processing of the information. In an FMEA, risk evaluations are carried out which span purchasing, devel-opment, production and suppliers. Analogous to this, formally related tasks of decision, planning, inspection and administration of these risks emerge. Since the information is only then valuable for an FMEA when it arrives at the place where the contribution for the task fulfillment must flow in, the communication is a basic prerequisite for the cooperation of all the parties involved in the performance process. The prerequisite for this is created by the sending, receiving, storing and processing of information.

Thus, for an optimal task fulfillment it is on no account enough to only set the locations, departments and instances, but also the rules for the commu-nication must be similarly made in an FMEA. As a result, it must be record-ed that information and communication are of great significance for an FMEA, since without them the highest goal, risk minimizing, cannot be achieved.





5.8.4 Information Systems

The general objective of information systems is to provide the right infor-mation at the right time to the right place in adequate form. For this the data must first be collected, stored, processed to information, and then made available. These steps are carried out with the help of IT supported sys-tems. The relevant elements of an FMEA information system are:

Databases: collection of organized data for certain purposes, e.g. a database for damage management.

Databases of methods: collection of programmed methods that can be employed in the FMEA process, e.g. algorithms and statistical proce-dures.

Databases of models: analysis and decision models, e.g. model for the simulation of a damage scenario.

An appropriate FMEA information system must therefore guarantee a smooth flow of information and communication between all involved func-tions. It collects and processes data, e.g. FMEA actions.

The requirements on the FMEA information system vary corresponding to the individual needs of the project. The identification of the requirements is a central problem when selecting and/or developing an FMEA information system. A few basic requirements can be defined:

Flexible setup with upgrading possibilities.

Availability of an integrated data set via suitable interfaces.

Availability of current data at any time.

Support of different views of the data set.

Provision and compression of data to any compression level.

Fast and flexible simulation possibilities.

Individual layout of reports.

Matured presentation possibilities. Ideally, an FMEA information system should be integrated into the existing IT environment of a company and have adequate interfaces to other com-ponents of the operational information system, e.g. to production planning. The system must also have appropriate communication interfaces, e.g. email, in order to be able to guarantee the flow of information and commu-nication between the functions, departments or companies participating in the FMEA. The FMEA information system should be set up flexibly so that it can be adjusted according to the continuous development and process changes.





5.9 Result

Documentation and processed information.

Sensitization of the employees, suppliers and customers with regard to risks.

Broad understanding of the problems and approaches of other inter-faces.

Knowledge maintenance and distribution.

Presentation of FMEA scopes.

Provided information for the use of synergy effects. 5.10 Risks

The communication of company-internal know-how that is consolidated in an FMEA exhibits varying sets of problems for which the entire FMEA team must be sensitized:

Loss of know-how.

Data security within the framework of product liability.


Communication problems (customer/supplier relationship, development/ production).

Lack of presentation and distribution media.

Deadline problems.

Availability of data.

Incomplete or incorrect information.

Insufficient processing.

Information overload.

Not up-to-date.

“expiration date” for the information is not defined.





Annex

A1 Additions

A1.1 Execution of the FMEA

A1.1.1 Implementation of the FMEA in the company

The FMEA’s integration in the

product development process is

necessary for its successful im-

plementation. Trained modera-

tors are essential for this.

These drive the FMEA process.

The participants in the FMEA meetings must be informed about the basics of the FMEA methods and the process of the FMEA preparation.

In the first FMEA meeting, the method expert gives an overview of the FMEA method. According to past experience, this takes one to two hours during the first FMEA team meeting.

The FMEA moderator ensures the methodically correct procedure during the execution of the FMEA.

An exchange of experiences about the FMEA should take place inside and outside of a company, in order to inform the users and FMEA moderator about the latest state of knowledge of the methods and the application in the company.

A1.1.2 Distribution of Tasks When Preparing The FMEA

Starting with higher system levels, the interfaces to lower system levels are defined. A clear distribution of tasks among several partners is determined for the FMEA. The interface-relevant SEs are jointly developed and/or co-ordinated.

When inspecting interfaces in the FMEA, the customer is completely re-sponsible for this scope. The suppliers account for their shares.

Learning

Training

Use of media

Visualisation

Project

Input

Feedback

Output

Documentation

Communication and

Information chanals



Learning

Training

Use of media

Visualisation

Project

Input

Feedback

Output

Documentation

Communication and

Information chanals







During the FMEA the evaluation numbers for the severity of the failure modes that are established in higher system levels are to be taken into ac-count in lower levels.

The scope and the evaluation tables are to be coordinated between cus-tomers and suppliers.

Results worked out together are available to the parties involved.

A1.1.3 Know-How Protection of the Product FMEA/Process FMEA

For reasons of know-how protection, the product and process FMEAs pre-pared by the suppliers are categorically not given to the customers as long as no other contractual agreement has been reached.

The results are presented when requested. During inspections the custom-er can see that the relevant FMEAs were prepared. Here the procedure is similar to the archived documentations of the quality assurance.

A1.1.4 Reuse of the FMEA

Existing FMEAs for known products and processes are used in new anal-yses. In this way expenditures are reduced. The scopes carried over are to be critically examined with regard to the respective use case, especially the evaluations with the experiences from the application.

A1.1.5 IT Application When Preparing an FMEA

With the application of IT, the FMEA can be carried out more efficiently:

Systematical processing is supported.

User guidance and support are possible.

Execution of necessary preparatory work and analyses is simplified.

Processing is supported, e.g. with pasting, deleting and copying.

Access to already prepared FMEAs by networking single PCs with sys-tematic access protection is possible.

Administer databases of already prepared FMEAs.





A1.2 Relationships Between Different FMEAs

A1.2.1 Levels Within A System

The determination of the interfaces between FMEAs on different system levels is a prerequisite for the continuous processing of complex systems, such as a e-gas-system. With the help of these determinations, a clearly ar-ranged and sensible division of work is achieved for comprehensive FMEAs. This means for the manufacturer of a throttle positioner compo-nent, for example, that its FMEA starts at a defined system scope. Selected system elements of the system description, in this case throttle positioner, servomotor, transmission etc, serve the establishment of system limits. The mutual limits and also the links from FMEAs at different inspection levels are possible with the establishment of system limits (see figure A1.2.1-1 and figure A1.2.1-2).

Fig. A1.2.1-1 Example of levels of different FMEAs (hierarchical, compo-nent and function-oriented)





A1.2.2 Methodical Inter-relationships between different FMEAs

The existing inter-relationships exist between a product and a process FMEA should be used in order to support the co-operation of development and production. Figure A1.2.2.-1 shows this using the example of the failure structure of a product FMEA (the upper section of the illustration) and the corresponding process FMEA (the lower section).

The failure mode "primary gear jams on the primary shaft" is examined for

development errors in the product FMEA 1 and for manufacturing errors in

the process FMEA 2 .

The further consequences of the failure mode are described in the product FMEA and are pursued in the causal links from the process FMEA. In this case the significance is set out in the product FMEA.

Fig. A1.2.2-1 Example of the inter-relationships between FMEAs





A1.3 Special Characteristics

The requirement of ISO/TS with regard to labeling special characteristics is covered by the introduction of the C-column in the form.

Special characteristics are product characteristics or production process pa-rameters that can have an impact on the safety or compliance to official regulations, on the fit, the function, the performance, or on the further pro-cessing of the product.

For special characteristics established by the customer, the organization has to demonstrate the fulfillment of the customer requirements with regard to the determination, documentation and control of special characteristics.

Moreover, special characteristics are to be established by the organization, and further special characteristics can be identified also within the frame-work of the FMEA.

The established special characteristics are

to be incorporated into the production control plan,

and are to be labeled in the documents for the control of the production process - including drawings, FMEA, production control plans and op-erating instructions - with the customer’s symbols for special character-istics or with a corresponding symbol or reference note of the organiza-tion.

In the FMEA the labeling takes place on the form in the classification col-umn. It can be assigned to the cause of failure, the failure modes, the se-verity etc.





If there are no customer-specific symbols or determinations available, the following overview is recommended by the IATF:

§ Product characteristics or process parameters that influence the safety of a product or the compliance to legal regulations.

Product characteristics or process parameters which influence the fit/function of a product, or which have to be controlled and documented for other reasons, such as customer require-ments.

(No Symbol)

No key characteristics, product characteristics or process pa-rameter that do not, even with diligently assessed distribution, affect the product safety, legal regulations, fit or function.

For a continuation see ISO/TS 16949:2002

A1.4 Relation to Other Methods

The various scopes of the FMEA are, among other things, related to the fol-lowing methods:

Quality Function Deployment (QFD).

Function Analysis (German: Funktionsanalyse – FktA 2005).

Fault Tree Analysis (FTA).

Effect Tree Analysis (ETA).

Statistical Process Control (SPC).

Value Analysis (German: Wertanalyse - WA).

Design of Experiments (DoE). The system structure, functions and function structures can already emerge in the course of a QFD and be carried over for the FMEA. Methods of func-tion analysis, such as function trees, support the preparation of the FMEA function structure. Ideally these can be directly carried over to the FMEA. FTA, ETA, SPC, WA and DoE can be built up on this by means of the struc-tured procedure of the failure analysis in the FMEA.





Fig. A1.4-1 Depiction of methods with their interrelationships

Struk-tur Funktio-

nen Funktionsbäume/Netze

Fehlfunktionen

Fehlerbäume/Netze

Vermeidungsmaßnahmen

Entdeckungsmaßnahmen

Bedeutung

Auftretenswahrscheinlichkeit

Entdeckungswahrscheinlichkeit

Verantwortlicher

Termin

Bearbeitungsstand

Auswahl von Schwerpunkten

Prioritäten für Optimierung

QF

D

DO

E

SP

C

Is

hik

aw

a

Pare

to/A

BC

Valu

e

An

aly

sis

W

eib

ull

FT

A

E

TA

Page 1

Structure

Functions

Function Trees/Networks

Failures

Failure Trees/Networks

Avoidance Measures

Detection Measures

Severity

Occurence Probability

Detection Probability

Responsible Person

Deadline

Processing Status

Selection of Focal Points

Priorities for Optimisation

FMEA - Elements

Struk-tur Funktio-

nen/Merkmale Funktionsbäu-

me/Netze Fehlfunktio-

nen Fehlerbäu-

me/Netze Vermeidungsmaß-

nahmen Entdeckungsmaß-

nahmen Bedeu-

tung Occurence Probability

Detection Probability

Verantwortli-cher Ter-

min Bearbeitungs-

stand Selection of Focal Points

Prioritäten für Optimie-rung

PM

(P

roje

ct

Ma

nam

en

t)

Au

dit

s

Pla

nn

ing

Main

ten

an

ce

Pla

n

Dia

gn

osti

cs

PL

P / C

P

QM

- P

lan

-

Pla

n

SIS

(G

&K

)

T

RIZ

Page 2

Structure

Functions/Characteristics

Function Trees/Networks

Failures

Failure Trees/Networks

Avoidance Measures

Detection Measures

Severity

Responsible Person

Deadline

Processing Status

Priorities for Optimisation

Sy

ste

m t

es

t p

lan

FMEA - Elements

Page 2





A1.5 Documentation

For the storage and archive duration see VDA 1, p. 28.

A1.5.1 Final Documentation After Completion of all Phases

The final documentation contains the results of the FMEA.

Examples for the contents of the documentation are

Inspection scope and depth.

Objective of the FMEA.

Prerequisites, resources, participants, schedule.

Summary of the most important findings.

Results of the risk evaluation.

Lessons learned. A1.5.2 FMEA Form

Contents of the FMEA form

1) Master Data The data according to the requirements of the respective products and processes is depicted in the header of the form or on the cover sheet of the FMEA. The inspected system must be identifiable from this data.

2) System Element (SE)/Function/Task Description of the SE with respective inspected function/task.

3) Potential Failure Modes Depiction of the potential failure modes.

4) Evaluation Number for the Severity (S) The evaluation number S is established for the severity of the failure modes for the complete system (see tables in Annex).

5) Potential Failure Depiction of the potential failures (failures) of the inspected system elements from item 2.





6) Classification Here the “special characteristics” are labeled. The C-column can be laid out on the right side of the S-column or on the left side of the “po-tential failure causes” column.

7) Potential Failure Causes Depiction of the potential failure causes.

8) Preventive Actions The preventive actions are shown for each potential failure cause.

9) Evaluation Number for the Occurrence Potential (O) The evaluation number (O) is established for each failure cause tak-ing into account all preventive actions (see tables in Annex).

10) Detection Actions The detection actions are depicted for each potential failure cause.

11) Evaluation Number for the Detection Potential (D) The evaluation number D is established for each failure cause taking into account all detection actions (see tables in Annex).

12) Risk Priority Number The risk priority number is shown here.

13) Action Status for Product and Process

a) Development b) Customer operation c) Service

14) Optimization

Optimization actions are shown here.





15) R/DL/Status Responsible person (R) for the execution and deadline (DL) for the completion of actions.

Status of the actions:

a) unprocessed, b) decision pending, c) implementation pending, d) completed, e) discarded.

16) Risk evaluation of the optimization

according to items 9, 11 and 12





Fig. A1.5.2-1 Content of the FMEA form





A2 Further Application Fields

With the product and process FMEA described, all application fields can be covered.

The procedure is also transferable to suppliers of the automotive industry of other industrial branches. The special features and specific procedures are to be taken into account.

A2.1 FMEA for Mechatronical Systems

In systems that consist of hardware and software, and normally contain sensors, control units and actuators (mechatronical systems), diagnostic and monitoring functions with which the system can diagnose failures are usually implemented. The information about such failures detected during customer operation can be used:

To lessen failure modes (limp home mode),

To inform the driver,

To simplify the search for and elimination of the failure in service.

The inspection scope of the “Diagnostics and Monitoring Functions” in an FMEA is established in consultation between customer and supplier.

A2.1.1 Structure and Function Analysis

Hardware and software elements are shown together in a structure in figure A2.1.1-1.

Functions that serve the detection and treatment of failures during customer operation are analyzed as independent functions.

Functions for the failure detection contain, among other things, monitoring or diagnostic functions such as watchdogs, validations, check sums (CRC), comparison functions and alive counter. Functions for failure treatment can contain the provision of default values, the switching to a limp home mode, the switching off of the corresponding function and/or the display of a warn-ing to the driver, for example.

The functions are modeled for those structure elements that are carriers of these functions. The distinctive feature is that these functions are only nec-essary if a failure has already occurred. In figure A2.1.1-2 the function is shown in normal operation and in figure A2.1.1-3 the function is shown in the case of a failure.





Fig. A2.1.1-1 Example of a structure tree





Fig. A2.1.1-2 Example of function in normal operation (extract)





Fig. A2.1.1-3 Example of function during a failure (extract)





A2.1.2 Failure Analysis

With functions for failure detection and treatment, one can normally distin-guish between two types of failures:

“Pseudo-failure”: a failure was detected by the failure detection and failure responses were initiated although there was actually no failure.

“Failure on demand”: when an initial failure exists, it is not detected or the failure response does not take place as intended.

In order to be able to depict the “failure on demand” in the FMEA, multiple er-rors have to be inspected as an exception to the rule (see Chapter 2.1.2.1 “Dormant Failure”). The following example clarifies the modeling in the failure structure of the FMEA.

Fig. A2.1.2-1 Example of failure structure in customer operation without failure detection and response

Case 1: The failure mode “pedal sensors 1 and 2 actuated too far in propor-tion to adjustment” depicts a failure that cannot be detected by the intended monitoring mechanism in this example, even when the monitoring mecha-nism functions according to specifications.

Case 2: In contrast, the failure cause “value of the pedal sensor 1 (PS1) read-in too high” can be detected by the action depicted in figure A2.1.2-2 so that the appropriate failure response leads to a reduction of the original failure mode. If the functions for the failure detection and treatment are de-fined, a link to the original failure mode can be left out. The original failure mode must then be documented, e.g. in the form, figure A2.8.2.5-1.





Fig. A2.1.2-2 Example of a failure structure in customer operation with failure detection and response (target/actual comparison with cutoff)

Figure A2.1.2-2 depicts the response according to specifications of the fail-ure detection and treatment actions as (moderated) failure mode.

Fig. A2.1.2-3 Example of “pseudo-failure”

Figure A2.1.2-3 shows that, due to a failure cause in the monitoring mecha-nism, a failure response is initiated although no failure exists in the function unit (no demand).

Fig. A2.1.2-4 Example of “failure on demand”

Figure A2.1.2-4 shows that the failure response intended according to spec-ifications fails due to a failure cause in the monitoring mechanism. At the same time it is assumed that the underlying failure cause has occurred. This failure must be documented in the failure cause.





A2.1.2.1 “Dormant Failure”

As a rule, simultaneously occurring failures are not taken into account in the FMEA. The Product and Process FMEA is confined to the analysis of sepa-rately occurring failures. The failure tree analysis also examines the possi-ble simultaneous occurrence of failures and can supplement the FMEA, for example for safety analyses.

As an exception “dormant” failures, i.e. a failure that has no effect on the function in normal operation, can be examined in the FMEA if it occurs alone. This could be functions that are only executed on demand and then are not available when there is a failure. These are especially monitoring functions and warning signals that are necessary only with a failure. In the-se cases, additional failures can be examined.

However, it often makes sense to carry out a combined method approach, such as for example the detection of single failures with the help of the FMEA, or the depiction of combinatorial analysis with the failure tree analysis.

A2.1.3 Actions Analysis and Optimization

When analyzing monitored mechatronical systems in the FMEA, it proves to be advantageous to differentiate between the action groups “Development”, “Customer Operation” and “Service”. The actions and evaluations described in these three groups are explained as a possibility.

The numeration here corresponds to the labeled fields in the form (see fig-ure A2.1.3-1). The sequence of the numeration represents the logical order of the actions analyses. Field 1 “Avoidance During Development”, field 2 “Detection During Development”, field 3 “Detection in Customer Operation”, field 4 “Avoidance in Customer Operation”, field 5 “Detection in Service” and field 6 “Avoidance in Service”. After actions for customer operation and service are labeled, the actions for development should be re-examined and if necessary optimized.

1. In the development actions group, all actions that reduce the occur-rence of the stated failure cause are entered in the “Preventive Actions” column. Here precise information is given which substantiates the relia-bility of the functions and makes the occurrence of the failure cause improbable. These are, for example, specified requirements for compo-nent reliability, use of components with traceable operational maturity,





and actions in the development process. O evaluates here the assess-ment/confirmation of the occurrence potential of the failure cause (FC) during the vehicle lifecycle, taking into account all associated preven-tive actions. If the associated preventive actions are not yet imple-mented, the expected value of O is put into brackets.

In chapter 4.2 “Example Table Product FMEA: Occurrence Potential O for Product Design” and 4.7 “Example Table Product FMEA: Occur-rence Potential O with Assignment of Failure Rates”, examples for cor-responding evaluation tables are shown.

2. In the development action group, all actions that are carried out during product development are entered in the “Detection Actions” column. These include actions with prototypes and experimental vehicles such as tests and trials, as well as virtual actions such as simulations, ana-lyses and reviews.

In this, actions for the confirmation or correction of the occurrence po-tential initially assessed in Field 1 are stated, and actions are described which ensure the effectiveness of the failure detection in customer ope-ration (see Field 3) and the effectiveness of the failure treatment (see Field 4). Additionally, actions can be named that ensure the failure de-tection in the garage (see Field 5) and the repair (Field 6).

D evaluates the overall effectiveness of all actions named for a failure cause during the development (see Chapter “4.3, Example Table, Product FMEA: Detection Potential D for the Validation of the Product Design”). A high value means that further actions are necessary.

This part of the FMEA serves the purpose of checking and, if neces-sary, supplementing existing test and trial plans.

3. In the customer operation action group, all actions that lead to a detec-tion of the failure cause by the system or by the driver are entered into the “Detection Actions” column. Furthermore, actions can also be listed that detect the failure or failure modes that result from the failure cause.





Examples of detection actions in customer operation include monitoring or diagnostic functions such as watchdogs, validations, check sums (CRC), comparison functions etc. A collection of failure detection ac-tions for electrical/electronical systems can be found, e.g., in the DIN 61508-2 standard, tables A2 to A15.

The functions that are consulted as detection actions should also be analyzed within the FMEA as independent functions (see Chapter 2.1.1, “Structure And Function Analysis”). In order to guarantee the clarity and traceability, a cross-reference (hyperlink) to the correspond-ing location within the FMEA should be given.

D evaluates here the potential that the failure cause or a failure result-ing from this, or a failure mode, can be detected early enough so that the failure treatment actions described in field 4 can take effect. In the chapters 4.8 “Example Table, Product FMEA: Detection Potential D in Customer Operation” and 4.9 “Example Table, Process FMEA: Occur-rence Potential O with Assignment of Failure Rates” as examples for corresponding evaluation tables are shown.

4. In the customer operation action group no actions for the avoidance of failure causes are entered in the “Preventive Actions” column. Instead, actions for failure treatment are described which, as a system re-sponse, reduce the failure modes. Such actions can include, for exam-ple, the provision of substitute values, the switching to a limp home mode, the switching off of the corresponding function and/or the re-lease of a warning signal to the driver.

The functions that are consulted as failure treatment actions should al-so be analyzed within the FMEA as independent functions (see Chap-ter 2.1.1 “Structure and Function Analysis”). In order to guarantee the clarity and traceability, a cross-reference (hyperlink) to the correspond-ing location within the FMEA should be given.

In the customer operation action group, O evaluates the potential that the listed actions for the failure treatment are not effective on demand. It is assumed during classification that the original failure described in the failure cause has already occurred. Therefore the question espe-cially arises whether the failure treatment actions are always available completely independent of the original failure. If necessary, an evalua-tion can take place according to an individually determined table in which high evaluations correspond to ineffective failure treatment ac-tions and low evaluations denote effective failure treatment actions.





5. In the service action group, all actions that enable the detection of the failure cause in service garages and that facilitate the diagnostics are entered in the “Detection Actions” column. Here, diagnostic functions in the vehicle that lead to an entry in the failure recorder, as well as func-tions for the test equipment used in the garage are inspected. Actions can also be listed which detect the failure or failure mode resulting from the failure cause, as long as these detections serve an efficient repair.

The functions that are consulted as detection actions in the service can also be analyzed within the scope of the FMEA as independent func-tions. In order to guarantee the clarity and traceability, a cross-reference (hyperlink) to the corresponding location within the FMEA shall be given.

Here, D evaluates the potential that a failure cause, or a failure or a failure mode resulting from it, is detected in sufficient time so that the repair action described in field 5 can take effect. In the Chapters 4.8 “Product FMEA Example Table: Detection Potential D in Customer Op-eration” and 4.9 “Process FMEA Example Table: Occurrence Potential O with Assignment of Failure Rates” examples of corresponding evalua-tion tables are listed.

6. In the service action group, actions for failure repair in the garage are described in the “Preventive Actions” column. An evaluation can be carried out according to an individually established table in which high evaluations correspond to high repair expenditures and low values de-note low repair expenditures.





Fig. A2.1.3-1 Example of actions analysis and optimization for mechatronical systems





A2.1.4 Evaluation of the Risk

Here procedures for different inspections of the risk are presented in order to generate conclusions from the following evaluation parameters.

The references to the fields all refer to figure A2.1.3-1, Example of Actions Analysis and Optimization for Mechatronical Systems.

Severity S of the failure mode described,

Occurrence potential of the failure cause, see field 1,

Effectiveness of the actions, see field 2,

Detection potential in customer operation, see field 3,

Failure potential of the failure response, see field 4

Detection potential in the service, see field 5,

Repair expenditures, see field 6.

A2.2 FMEA for Software Scopes

The functions of a system are realized more and more often by software. A Product FMEA1 examines the functional capability of a system, and there-fore the inspection of software scopes is a part of this. The system and its effect relationships should be inspected as a whole in the analysis of the software scope.

When inspecting software scopes, special problems can occur that are considered in the following chapter.

1 The term “Software FMEA” is misleading, since not the software but the functions that are

realized by the software are to be examined in the system context.





A2.2.1 General

A2.2.1.1 Objective of the Software Scopes Inspection

Analysis of the software requirements:

Demand from the complete system

Checking the basis information/boundary conditions/specifications

Systematical establishment of actions for risk reduction, e.g. con-cept change, avoidance, detection.

Analysis of possible faults in software scopes:

Effect on the complete system

Depiction of the interaction of software modules in the complete system

Assessment of the risk of software modules.

A2.2.1.2 FMEA in the Software Development Process

The FMEA is especially suited for the analysis of requirements and for the validation of the implementation. Therefore its field of application is primarily in the upper part of the model shown, see VDA volume 13 “Requirements on Processes and Products”.

Fig. A2.2.1.2-1 Application of the FMEA in software development process

Development of requirements

Development ot architecture

Design- processing

Implementation Function / module integration

Product integration

System integration

System approval

Vehicle approval test

System test

Product test

Function / module

test

Validation Verification

Field of use

of the FMEA

Field of use

of the FMEA





A2.2.1.3 Connections to other Methods/Measures of Software Enginee-ring

The inspection of software scopes in the FMEA can draw on the findings of other methods/measures of software engineering. The findings from the FMEA can vice-versa be incorporated in other methods/measures.

Fig. A2.2.1.3-1 Methods/measures of software engineering





A2.3 Depiction of Error Propagation

A depiction of the signal flow and its effect connections within different de-tailing levels depends on the objective. If the signal flow is not depicted within the FMEA, the technical documentation from which the signal flows and effect relationships result must be referenced in the FMEA.

If a depiction of the signal flow and its effect connections is necessary with-in the FMEA, there are the following possibilities:

A comment for simple connections.

Depiction as failure mode chain. A2.4 FMEA for Machine and Facility Manufacturers

The Product FMEA of a machine is sometimes referred to as a “Machine FMEA” in the literature.

Starting from a Process FMEA in which a machine was identified as a risk, a Product FMEA can be prepared for the machine.

In the Process FMEA, the requirements on the functions/abilities of the ma-chine are identified in the analysis of the machine.

Separate evaluation tables are to be developed for this FMEA.





A3 Evaluation of an FMEA





A4 Examples of Evaluation Tables

A4.1 Product FMEA Example Table: Product General Severity Criteria S





A 4.2 Product FMEA Sample Table: Occurrence Potential O for the Product Design





A4.3 Produkt FMEA Example Table: Detection Potential D for the Validation of the Product Design





A4.4 Process FMEA Example Table: General Process Severity Criteria S





A4.5 Process FMEA Sample Table: Occurrence Potential O for the Process Design





A4.6 Process FMEA Sample Table: Detection Potential D for the Validation of the Process Design





A4.7 Product FMEA Example Table: Product Occurrence Potential O with Assignment of Failure Rates





A4.8 Product FMEA Example Table: Detection Potential D in Customer Operation





A4.9 Process FMEA Example Table: Occurrence Potential O with Assignment of Failure Rates




Quality Management in the Automobile Industry

Quality Assurance in the Process Landscape - General, risk analyses, methods, process models -

SWOT 1st edition 2008

English version published in 2009


4




VDA-Volume 4: SWOT 1

Preface to First Edition

The present description of the SWOT risk analysis was made available as part of the work of the VDA Working Group 4, " Quality Assurance in the Process Landscape – General, risk analyses, methods, process models “. We are grateful to the participating companies and their employees for their commitment in writing this chapter. The following companies participated in the drafting:

automotive.business.support, Mr. Füller

BMW AG

Robert Bosch GmbH

Daimler AG

Karmann GmbH

Siemens VDO AG

Volkswagen AG

ZF Sachs AG

We also wish to thank everyone who made suggestions for improvements.

Oberursel, September 2008

Verband der Automobilindustrie e. V. (VDA)





Contents Page

Preface to First Edition 1

1 Overview 3

2 Introduction 3

3 SWOT analysis components 4

4 Strengths and weaknesses (SW) 4

4.1 Value chain 5

5 Checklist for a strength-weakness analysis 6

6 Opportunities and threats 10

7 Checklist for an opportunities-threats analysis 11

7.1 Market and competition (branch) 11

7.2 Environment and general framework conditions 12

8 Application example 14

9 Evaluation 15

10 Conclusion 16

11 References 17





SWOT Analysis (Strengths–Weaknesses–Opportunities-Threats)1

1 Overview

SWOT analysis links the internal corporate situation with the competitive situation on the market. SWOT analysis is a relatively easy-to-use proce-dure for presenting a business model (product, services, etc.) through its Strengths, Weaknesses, Opportunities and Threats. The objective of the analysis is to identify possible sources of competitive advantages and in-ternal action requirements based on an (internal) strengths-weaknesses analysis and an (external) opportunities-threats analysis. If the strengths of a company coincide with opportunities or if weaknesses are identified, this results in vital points of departure for corporate strategy.

The internal analysis is intended to empower the company to identify its strengths and weaknesses. They result from competencies, i.e. the skills and resources of a company. During the external analysis, the near (com-petitive environment) and the far (economic environment) of a company are investigated. Only after a comparison with the environment can strengths and weaknesses be correctly weighted.

2 Introduction

A SWOT analysis is one of the most common strategic models. It traces its origins to the strategic "Design" school that reviews the development of strategies as an interlinked and well conceived process. SWOT integrates the main results of an analysis of external factors impacting a company and an analysis of its internal skills. The aim of the analysis is to determine how far the present corporate strategy and its strengths and weaknesses are suited, adequate and relevant to react and act to changes in the corporate environment.

1 Source: http://www.edditrex.de/scripts/consulting/swot_analyse.pdf





3 SWOT analysis components

Internal analyses SWOT

analysis Strengths Weaknesses

Opportunities

S-O strategies Pursue new opportu-nities that fit well with the strengths of the

company.

W-O strategies Eliminate weaknesses to use new opportuni-

ties.

Exte

rnal analy

ses

Threats

S-T strategies Use strengths to avert

threats.

W-T strategies Develop defences to avoid existing weak-nesses from becoming the aim of threats.

4 Strengths and weaknesses (SW)

The SW section deals with internal factors - the strengths and weaknesses of a company. These are skills and resources that the company has at its disposal or under its control. There are many possible variations that result from the circumstances of each individual case. Typically, these may be strengths - or weaknesses - in areas such as

• employee skills • the quality of internal processes • financial capital, financial structure • market position • relations to customer and supplier networks • R&E skills, resources and capacity • corporate culture

etc. What is frequently helpful in the SW analysis is to previously identify the critical / key success factors.

All strengths and weaknesses can be checked against these factors.





Another factor to remember is that all identified strengths and weaknesses are relative. They only gain a genuine value when benchmarked against competitors or industrial standards.

The internal analysis can be structured in various ways, e.g. for individual business units, product groups or according to functional aspects. Here again there are several models available. One of the best known is the Value Chain by Michel E. Porter.

4.1 Value chain

The value chain, or value added chain, is an ideal strategic analysis tool to identify potential competitive advantages in the field of costs or ser-vice/product differentiation. It can be used to show and determine the strat-egy for the entire service/product performance process.

Service/product performance is divided into primary and support activities:

• Primary activities refer to the creation of the product/service and transfer of the product/service to the customer.

• Support activities procure and generate the necessary inputs to per-form the primary activities.

The following is investigated for the main activities:

• Is this activity capable of achieving cost benefits or differentiation? • Does the organisation here have a strength or weakness? • How can strengths be expanded and weaknesses be eliminated?





5 Checklist for a strength-weakness analysis

General corporate characteristics

• Turnover • Success (profitability; profit margin; profit; etc.) • Market shares • Cash flow • Workforce • Locations • Legal form

Potential products and services

• Product quality (service life; durability; etc.) • Product performance • Product design • Product range • Age of product range (product life cycle phases) • Proportion of outsourced products/internal production

Distribution

• Sales organisation • Sales capacity • Sales channels/outlets • Delivery readiness/delivery capacity • Logistics • Location • Warehousing • Transport facilities

Market communication

• Advertising • Presentation at trade fairs • Public relations work • Sales promotion • Online communication • CI/CD standards • Image





Prices and conditions

• Potential price penetration • Price strategy (skimming - penetration) • Rebate system, special conditions • Terms of delivery and payment • Scope of auxiliary services

Function strategy potential/services

• Technical service • Guarantees/warranties • Maintenance • Installation • Training • Financing offers • Technical documentation/documentation/user's manuals

Production/manufacturing/production logistics

• Type of production (one-off, series, mass production) • Production technology/process • Flexibility • Production capacity • Capacity utilisation • Productivity • Manufacturing depth • Degree of vertical integration • Locations

R&E potential

• Size of R&E investment • R&E expertise • Technical equipment • Patents and licenses • Access to external R&E sources/joint ventures • Number of new product launches





Purchasing

• Access to raw materials, semi and finished products • Capability of suppliers • Purchase prices • Delivery period (just in time, etc.) • Quality • Reliability • Number of suppliers/secondary suppliers • Supply security • Integration with production and sales functions • Inventory management and ordering systems (IT) • Warehouse management system • Degree of dependency on suppliers

Finances

• Equity capital • Borrowed capital • Cost of borrowed capital • Access to additional capital • Liquidity • Financial reserves

Personnel

• Qualifications • Experience • Motivation (corporate climate; enthusiasm, etc.) • Wage system • Social benefits • Age structure • Fluctuation • Senior staff





Cost position/structure

• Wages and salaries • Raw materials/primary products • Energy • Depreciation of buildings and equipment • Capital costs • Taxes/charges • Cost accounting and results accounts system • Controlling system

Management and organisation

• Organisational structure (organisation charts, etc.) • Style of leadership • Planning tools • Controlling and steering tools

Information management

• Office communication state • State of computer integrated manufacturing (CIM) • Degree of internal company information networking • Market research • Performability of accounts and controlling





6 Opportunities and threats

The OT section of the SWOT analysis identifies the opportunities and threats that result for the company from trends and changes to its environ-ment. All those factors that have no direct impact themselves on the com-pany are regarded as external factors when related to the SWOT. For ex-ample, high customer loyalty may be regarded as an (internal) strength. However, if this branch is affected by a trend that results in traditional cus-tomer relations losing their significance and customers "migrating" more of-ten, this is an external threat that must be countered.

There is also a number of models available for external analysis. One of the most common is PEST(LE). It analyses the political, economical, socio-cultural, technological, legal and ecological impact factors and trends. What is important here is identifying the main driving forces of change in the cor-porate environment and their possible impacts on the organisation and its environment.

As a result, the company should be able to assess by how far and in what way it is capable of reacting to anticipated external changes with the re-sources at its disposal. However, issues to which SWOT fails to supply an-swers but only provide useful information and food for thought include:

• Is our present strategy suitable and adequate to react to the antici-pated changes?

• In order to utilise opportunities or minimise threats - what strengths must be extended and what weaknesses must we work on?

• Do our previous strengths and core competencies still fit in with the world of tomorrow?

• Can strengths today become weaknesses tomorrow if we do not develop them further?

• How can we best utilise our strengths with regard to opportunities? • How can we react to external changes better than the competition

based on our specific competencies? • What exactly can be done better? • From this, can we derive new core competencies / business activi-

ties / service offers?





7 Checklist for an opportunities-threats analysis

7.1 Market and competition (branch)

Market structures

• Entry barriers • Exit barriers • Structure and strength of buyers • Structure and strength of the competition

Market potential/capacity

• Number of potential buyers • Market growth • Market saturation • Investment behaviour/consumer behaviour • Available investment funds/available income • Demographic trends

Customer structure and customer wishes

• Customer structure (size; branch; etc.) • Buyer power • Customer requirements/key buying facts (KBFs)

Competition/rivals

• Number of competitors • Structure of competitors (size, etc.) • Competitor market share • Competitor strategies/activities • Competitor structure stability • Branch rules





7.2 Environment and general framework conditions

Legal/state framework conditions

• Tax law • Environmental protection law • Competition law • Subsidies/subsidy policies • Award practices for public contracts • Social benefits law • Labour law • Import/export restrictions, trade restrictions • Technical regulations/standards • Economic policies • Political stability

Social framework conditions

• Attitudes/value systems • Mentality • Recreational behaviour

Ecological framework conditions

• Air pollution control • Water pollution control • Soil • Waste disposal and avoidance • Efficient energy utilisation • Efficient use of raw materials

Technological/technical development

• New product technologies/techniques • New production technologies/techniques • New materials • Substitution technologies/products • Complementary technologies/products





Other (economic) framework and environmental conditions

• Economic situation • Inflation • Currency stability • Balance of payments • Employment situation/labour market • Availability of raw materials and energy • Climate





8 Application example

As an example, here is a possible strengths/weaknesses profile of a me-dium-size company (software producer). The profile serves as a general example and therefore demands specific industrial specifications. The data was compared with the industry average.

Criticalre

sourc

es

Perform

ance p

ote

ntial

Weakness

Strength

Opportunitie

sThre

ats

ProductlineX

Customerservice

Marketing concept

Potential production

growth

Distribution

R&E

Leadershipsystems

Senior staffquality

Personnel

Financial situation

Manygood products, specialisation,

buildup corecompetence

Excellentconsultingand customer

support, pricesand rebateswithin

industryaverage

Createmarketingstrategy

High delivery readinessin region, set

upsuperregional distribution

Powerful/innovative IT technicians

Support available

High proportionof newdevelopment

and expansions(innovative)

Short informationroutes, lean

management

High personal commitment, good

identitywithcompany

Highlyqualified, motivated

Increaseequityposition

Missing focalpoint/corecompetence, no

standardproductlineand no matched

productrange

No stringent long-term

strategy, only

short-term

decisions, lack of long-

term

planninghorizon

Limitedcapacitydueto soledirectsales,

no distributionoutsidelocalregion

Employee capacityalmostexhausted

High proportionof newdevelopments

andexpansions(lack of focus)

Lack of accountingforinformation

gatheringformanagement

Relativelylittleexperiencein fieldof

management

At capacitylimits fordailybusiness

Low equityposition, high borrowedcapi-

talwithcorrespondinghigh interestand

paybackamounts





9 Evaluation

In order to use the SWOT analysis to really derive a basis to reply to one or another question, it is of vital importance not to regard this model as a sim-ple listing of internal and external factors. In fact, the actual core is identify-ing and concentrating the main driving forces. Investigating each detail pre-cisely is just as inappropriate as reducing this model to a simple checklist.

The actual strengths are factors that assist the company to win a relatively strong competitive position, whereas the actual weaknesses are points that hinder the company from achieving competitive advantages.

Opportunities that are really significant are only those that can also be used by the company since they fit in well with strategic resources and values. Genuine threats are those which the company must work on without fail - and for which they are not so well equipped.





10 Conclusion

Every company has both strengths and weaknesses - and for each there are opportunities and certain threats. What is decisive for survival is to as-sess the company's situation correctly so as to find the best strategy. Peo-ple often handle strengths and weaknesses intuitively and correctly in their personal environment. When a new product is launched, intuitive proce-dures are insufficient. A critical market analysis needs to be produced. No entrepreneur should forget that customers may award him with a contract mainly because of his strengths but may also prefer his competitor due to his weaknesses.

A SWOT analysis is therefore one of the most important preparations be-fore a product launch and should be conducted carefully. The results from the strengths/weaknesses analysis and the opportunities/threats analysis can be used to verify the product idea on the one hand and also acts as the basis to develop a strategy. It is therefore worthwhile to invest the neces-sary time here.

If information is still missing due to lack of experience, it is recommended to verify the two profiles during the course of the first development year and then amend or revise them if necessary. If a company is sensitised to these issues, it can not only evaluate its situation better, it can act in good time if the circumstances and the framework conditions change for the product.





11 References

• www.denkfabrik.de

• www.uni-hannover.de, University of Hannover

• www.uni-osnabrueck.de, University of Osnabrück

• www.marketing4strom.de, Catholic University of Eichstätt

• www.fh-giessen.de, Technical University of Giessen

• www.thinner.de, German Forum for Thinner Computers

• www.deafin.org, DEAFIN EU project

• www.swot.de, Management-Informationssysteme GmbH, Berlin

• www.b-to-v.com, Brains To Venture AG

• www.noackunternehmensberatung.de, Noack Unternehmens-beratung (management consultants), Berlin

• www.unternehmenstipps.de

• www.themanagement.de

• www.reckliesmp.de, Recklies Management Projekt GmbH

• www.4managers.de

• Gabler, Wirtschaftslexikon (Dictionary of Economics)

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