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Failure Mode and Effects Analysis Failure Mode and Effects Analysis

Failure Mode and Effects Analysis Fully User customisable for Design; Machine; System, Equipment and Failure Mode and Effects Analysis Fully User customisable for Design; Machine; System, Equipment and Process FMEA’s and many other non-standard variants. The FMEA Innovator provides an intelligent solution for quick methodical assessment and quantification of risks associated with most business situations. With automatic (optional) interaction with Control Plan activities and linked generation of graphs, charts and databases, the FMEA Innovator provides accurate analysis of risk reduction opportunities. Direct interaction with Risk Reduction activities promotes constant improvement in a realistic manner. Available as a Stand Alone or Integrated version

Control Plans Control Plans

Control Plans Available as a stand alone or integrated version. The Stand Alone version Control Plans Available as a stand alone or integrated version. The Stand Alone version provides a quick and easy method for developing and documenting Control Plans. The Integrated Version combines FMEA Analysis & Control Plans with Risk Reduction activities and ensures accurate replication of appropriate Data from FMEA to Control Plan thereby saving up to 50% of the time utilised in traditional approaches.

Risk Reduction Activities Risk Reduction Activities

Risk Reduction Activities Risk Reduction is an essential ingredient in any FMEA or Control Risk Reduction Activities Risk Reduction is an essential ingredient in any FMEA or Control Plan activity. The Integrated FMEA Innovator provides the ability to analyse the full picture and quickly make informed decisions on which activities should be prioritised for improvement, and then to schedule and monitor those improvements. The Integrated FMEA Innovator enables improvement approval, target date setting, recording of actions taken as well as accurate FMEA updating and review. Archive Facility enables quick and easy access previous Risk Reduction History.

 Starting Point Ensure a Method is in place. Starting Point: Knowing WHERE to Starting Point Ensure a Method is in place. Starting Point: Knowing WHERE to start an FMEA is often a stumbling block to starting AT ALL. Define the System to be analyzed Obtain or develop Process Flow Diagram Establish Process Steps for Process Flow Describe Functions from Process Steps. It is important to have a Method in place to. -ensure that ALL ASPECTS are covered -provide easy trace-ability -monitor progress -schedule & monitor improvements - ensure continued validity. next

 Starting Point Define System to be Analyzed next Define the System to be Starting Point Define System to be Analyzed next Define the System to be analyzed Obtain or develop Process Flow Diagram Establish Process Steps for Process Flow Describe Functions from Process Steps. Starting Point Body shell Dashboard Roof Fit Seat Pan Fit Seat Belts Vehicle Seating Cockpit … Fit Seat Cushions Test Adjusting Mechanism … Example: Definition of System (Vehicle System Structure (partial)

 Starting Point Develop Process Flow Diagram next Define the System to be analyzed Starting Point Develop Process Flow Diagram next Define the System to be analyzed Starting Point Micro level. People trying to improve the way a job is done need a detailed depiction of process steps. The micro-level, or ground-level, view provides a very detailed picture of a specific portion of the process by documenting every action and decision. It is commonly used to chart how a particular task is performed. Obtain or develop Process Flow Diagram Establish Process Steps for Process Flow Describe Functions from Process Steps. Mini level. The term "mini" or "midi" is used for a Flowchart that falls between the big picture of the macro level and the fine detail of the micro level. Typically, it focuses on only a part of the macrolevel Flowchart. Using the airplane analogy, you see the level of detail as if looking at the ground from 10, 000 feet. Macro level. The top leadership may not need the amount of detail required by the workers in a process. A "big picture, " or macro-level, view of the process may be enough for their purposes. Generally, a macro-level Flowchart has fewer than six steps. Think of it as a view of the ground from an airplane flying at 30, 000 feet. Generic Example: Process Flow Diagrams

 Starting Point MACRO Start Draft WI Type WI Distribute End Generic Example: Process Starting Point MACRO Start Draft WI Type WI Distribute End Generic Example: Process Flow Diagram -Develop a Work Instruction Develop Process Flow Diagram next Define the System to be analyzed Obtain or develop Process Flow Diagram Establish Process Steps for Process Flow Describe Functions from Process Steps.

 Starting Point next Define the System to be analyzed Obtain or develop Process Starting Point next Define the System to be analyzed Obtain or develop Process Flow Diagram Process Step Reflects the sequence of the process Establish Process Steps for Process (i. e. operation number) and is Flow Describe Functions from Process directly linked to the Function. Example: Process Step = 20 Steps. Function The name given to the Process Step being analyzed. Example: Process Step = 20: Function = Attach Seat Cushion to Track

 Demonstration Example next Example: In our example we are going to limit the Demonstration Example next Example: In our example we are going to limit the System to a single Function : “Fitting a Seat Pan to an Automobile” This will be an Assembly Process FMEA and should be carried at during the Design of the Assembly Process. It could however also be used in Re-Engineering the Seat Assembly Process, a Problem Solving Exercise or in a routine Improvement Risk Reduction Exercise.

Process Step & Function Directly linked to the Function (sometimes described as the Purpose) Process Step & Function Directly linked to the Function (sometimes described as the Purpose) (1) The Process Step is selected from the Drop Down List. See: Function Database Administration (2) The Function Is automatically copied from the Function Database next

Function– Inserting Function Breaks Each Function should be separated by inserting a Function break Function– Inserting Function Breaks Each Function should be separated by inserting a Function break below the Function Note: The first (top) Function Break is pre-inserted next Function breaks assist correct allocation of RPN Values Tip: Select Field (Row) BELOW where Function Break is required.

Product & Process Requirements are directly linked to the Function. Requirements Typically there may Product & Process Requirements are directly linked to the Function. Requirements Typically there may be more than one Requirement attached to a Function. Requirements can be Product related or. . Requirements can be Process related Requirement example. Function = Bake Cake – Product Requirement =Soft and Fluffy Function = Bake Cake – Process Requirement = 250 deg TIP next The Product & Process Requirements have historically been an aspect of the Control Plan and referred to as Product Characteristics. Information here is valuable in understanding the Function and enhances the capability to accurately assess Risks. . Rows should be inserted to accommodate multiple Requirements

Product & Process Requirements are directly linked to the Function. Requirements next The Process Product & Process Requirements are directly linked to the Function. Requirements next The Process Requirements can be Product related or. . Requirements can be Process related The Product Requirements The example shows Attach Seat Pan to Track (Function) – ensuring – (Product Requirements) – ensuring – (Process Requirement) Screws are to Specification Four Screws are used Screws are Torqued Screws are fully seated the Correct Assembly Sequence generally reflect the Operating Conditions that is required for effective Process Control. generally reflect the Specifications that must be achieved.

Requirements next Each Requirement should be separated by inserting a Requirements break It is Requirements next Each Requirement should be separated by inserting a Requirements break It is not practice to repeat Function for each Requirement. This is the purpose of the Function break. If the Requirement is not adequately specified, the resulting potential “Failure Mode ” may be overlooked. TIP

Potential Failure Modes are directly linked to the Function Requirements next The Potential Failure Potential Failure Modes are directly linked to the Function Requirements next The Potential Failure Typically there may be more than one Failure Mode attached to a Requirement. Mode is defined as the manner in which the process could potentially fail to meet the Product or Process Requirements and/or design intent as described in Requirements . Failure Modes can be selected from the Database. Failure Mode example Function = Bake Cake Product Requirement = Soft and Fluffy Failure Mode = Too Hard and Too Soft TIP Failure Modes can also be added to Database direct from the FMEA.

Potential Failure Mode next Because the Detection of the Failure Mode will be analyzed Potential Failure Mode next Because the Detection of the Failure Mode will be analyzed later, multiple Failure Modes are separated with a Failure Mode Break Line. Failure Mode example Function = Bake Cake Process requirement = 250 deg Failure Mode Too Hot and Too Cold TIP The Failure Mode Database can be reviewed periodically by the FMEA Administrator. New entries from the FMEA are automatically entered after last review date and can be accepted / rejected by the Administrator

Potential Failure Effects are directly linked to the Potential Failure Mode next The Potential Potential Failure Effects are directly linked to the Potential Failure Mode next The Potential Failure Effect is defined as the consequences incurred in the event of an actual Failure. If the requirements are not met what will be the Effect? Typically there may be more than one Failure Effect attached to a Failure Mode The descriptions of the Potential Failure Effect is often a confusing issue. The Effect depends on who we determine is the Customer. TIP The Failure Effect Database can be reviewed periodically by the FMEA Administrator.

Potential Failure Effect next Because the Severity of the Failure Mode will be analyzed Potential Failure Effect next Because the Severity of the Failure Mode will be analyzed later, multiple Failure Effects are separated with a Failure Effect break Line. The Effect can be applicable to either the Supplier or the Customer . This will be identified in the Customer / Supplier Severity columns. Function: Wrap two layers of foam around the product. Potential failure mode : Foam is not entirely wrapped around the product. Effect of failure : Chipped paint on product, dissatisfied customer TIP The Failure Mode is not chipped paint. Chipped paint is the Effect of the Failure Mode.

Severity Ratings are directly linked to the Potential Failure Effect next The Severity of Severity Ratings are directly linked to the Potential Failure Effect next The Severity of the Effect utilizes a numerical scale (usually 1 -10) to quantify how “Severe the Effect” would be if the Failure Mode materialized. Note: the Supplier can refer to the Manufacturer of the Product or the Provider of the Service. It is necessary to assign who the Effect is applicable to. In our example: Rework due to seat loose – has no obvious Effect on the Customer. Seat loosens in service- - has no immediate Effect on the Supplier. (it will of course have a long term Effect on Warranty and reputation). TIP The FMEA Innovator allows the user to allocate and segregate either Customer or Supplier Severity.

Severity Rating next Severity Scales can be customized by the User and are available Severity Rating next Severity Scales can be customized by the User and are available as Pop Up aids. Screw breaks in service – -would result in -Seat loosens in service, . The latter however is obvious, Screw breaks in service , may be more useful Seat loosens in service – -has an obvious Effect on the Customer -caution should be exercised in rating the Effect, as the Supplier must not second guess the rating given by the Customer (design team) during their Design FMEA activity. TIP Users can pre-define multiple Severity Scales and assign as applicable to individual FMEA’s

Severity Rating next Charts assist with the analysis of the distribution of Severity Ratings Severity Rating next Charts assist with the analysis of the distribution of Severity Ratings throughout the Process Flow. Severity Customer 6 5 4 3 2 This Chart shows the dispersion of the Severity Risk throughout the Process Flow The Process Steps should be completed before analyzing Charts 1 0 20 20. 1 21 22 22. 1 23

Severity Rating next Charts assist with the analysis of the frequency of Severity Ratings Severity Rating next Charts assist with the analysis of the frequency of Severity Ratings throughout the Risk Analysis. This Chart shows the frequency of Severity Risks in the overall Process 5 4 3 2 1 0 1 The Frequency of each Rating (1 -10) indicates if the Team has been realistic during the FMEA activity. If all low they was the FMEA necessary and if all High we lower Severities ignored? Comparison of Supplier & Customer Severities indicate the extent that both Risks have been considered. TIP 2 3 4 Severity Supplier 5 6 7 8 9 10 Severity Customer

Potential Failure Causes are directly linked to the Potential Failure Mode next The Potential Potential Failure Causes are directly linked to the Potential Failure Mode next The Potential Failure Cause relates to defects in design, process, quality, or part application, which are the underlying cause of the failure or which initiate a process which leads to failure. Insert Rows l to accommodate Multiple Failure Causes relating to One Function Mode A Failure Cause can be defined as a Product or Process Design Weakness that may result in a failure TIP Because row s have been entered after Severity allocation some maintenance is required by duplicating the Severity in the new rows below.

Potential Failure Cause next Because the Occurrence of the Failure Cause will be analyzed Potential Failure Cause next Because the Occurrence of the Failure Cause will be analyzed later, Multiple Failure Causes should be separated with a Failure Cause Break Line In order for the Occurrence to be included in the RPN equation the Failure Causes must be repeated Against each Effect Insert two additional rows and a Failure Cause break

Potential Failure Cause next Because there are two Effects for the one Failure Mode. Potential Failure Cause next Because there are two Effects for the one Failure Mode. . and each Effect could have a different Severity Rating Some maintenance is required by copying Severity Ratings into the newly generated fields Tip Because row s have been entered after Severity allocation some maintenance is required by duplicating the Severity in the new rows below.

 Prevention Controls are directly linked to the Potential Failure Cause/s next Prevention Controls Prevention Controls are directly linked to the Potential Failure Cause/s next Prevention Controls PREVENT the Cause of the Failure Mode from happening or reduce its Occurrence. DETECT the Cause of the Failure Mode (and hence prevent from happening) with such Detection having a pre-determined Reaction Plan Prevention Controls prevent or reduce the likelihood of occurrence of the failure cause. These controls will affect the occurrence rating and must be considered when evaluating frequency of occurrence. TIP DETECT the Failure Mode (and Prevent it from being processed further)with such Detection having a predetermined Reaction Plan

 Prevention Controls next The Prevention Controls are specific actions taken to prevent the Prevention Controls next The Prevention Controls are specific actions taken to prevent the Potential Failure Causes from happening or reduce its occurrence. Prevention Controls can be ascertained either from History of this Failure Mode, similar Failure Modes or in the absence of History, the Teams opinion must suffice. In design, examples of prevention controls are use of design standards, use of existing components with established performance history, use of design features to eliminate or reduce likelihood of a given failure mode, etc. TIP In process, examples of prevention controls include error proofing, process capability and performance analysis prior to production, design of experiments (DOE), preventive maintenance, etc. TIP

 Occurrence is directly linked to the Potential Failure Cause/s next The Occurrence of Occurrence is directly linked to the Potential Failure Cause/s next The Occurrence of the Failure Cause utilizes a numerical scale (usually 1 -10) to quantify how often the Failure Cause would be expected to happen. The Occurrence Ranking Number has a relative meaning rather than an absolute value. Preventing or controlling the Failure Cause is the only way to reduce the Occurrence Ranking. The Ranking Number can be selected or typed. Values outside of 1 -10 are excluded.

 Occurrence Scales can be customized by the User and are available as Pop Occurrence Scales can be customized by the User and are available as Pop Up aids. next Users can pre-define multiple Occurrence Scales and assign as applicable to individual FMEA’s The FMEA Innovator allows the user to develop and customize 3 Scales and to select the correct scale for the specific Process.

 Occurrence next 4. 5 4 3. 5 3 2. 5 2 1. 5 Occurrence next 4. 5 4 3. 5 3 2. 5 2 1. 5 1 0. 5 0 Occurrence 20 20. 1 21 22 22. 1 22. 2 This Occurrence Chart identifies the Occurrence Rating though the Process Operations. i. e. @ Process Ref. 20 the Occurrence rating is 2 @ Process Ref. 22 the Occurrence Rating is 4 6 Occurrence 5 4 3 2 This Occurrence Chart also identifies the frequency of each Occurrence Rating i. e. Occurrence ratings of 2&3 occur X times Occurrence rating I of 4 & 5 occur X times 1 0 1 2 3 4 5 6 7 8 9 10

 Detection Controls are directly linked to the Failure Mode In some exceptional cases Detection Controls are directly linked to the Failure Mode In some exceptional cases Detection Control can relate to the ability to detect the Failure Cause, (if we detect the Failure Cause then the Failure Mode wont happen) but this is not generally recommended. In other instances an organisation may regard the whole operation as a single entity, under such criteria everyone will evaluate the “detection” on the basis that the eventual CUSTOMER is the one “who counts”. TIP next The Detection Controls are specific actions taken to detect the Failure Mode if it happens It is acceptable practise for a section, to analyse their processes and set themselves the objective of detecting any faults before reaching their ASSEMBLY AREA. So, they could regard the next operation as their “Customer”. TIP

 Detection Responsibility Identifying the Responsibility will assist in determining the correct allocation in Detection Responsibility Identifying the Responsibility will assist in determining the correct allocation in the Detection Scale. i. e. an Inspector may be more likely to Detect a Failure Mode than an Operator. Responsibility is not traditionally part of an FMEA however it is often used in Control Plans. TIP Detection Responsibility is directly linked to the Detection Controls Where multiple People (Responsibilities) carry out some Detection activity all people should be entered into the same field. This can be done within the FMEA by using the Alt & Enter keys to force a second row or alternatively it can be set up in the Responsibility Database. Inserting Multiple Responsibilities next

The Detection Rating is directly linked to the Detection Controls Detection Rating Detection Scales The Detection Rating is directly linked to the Detection Controls Detection Rating Detection Scales can be customized by the User and are available as Pop Up aids. The Detection of the Failure Mode utilizes a numerical Scale (usually 1 -10) to quantify how reliable the Detection Controls are in finding the Failure Mode if it happened. Do not automatically presume that the Detection Ranking is low because the Occurrence is low. The Cause may happen and may not result in a Failure Mode happening. TIP The Detection Ranking allocated, is associated with the combination of Detection Controls. Detection is a relative ranking. TIP next

Detection Rating Other Factors identified in the Control Plan will also have an effect Detection Rating Other Factors identified in the Control Plan will also have an effect on the Detection Scale. e. g. Responsibility Sample Size Sample Frequency next Detection generally refers to the ability to detect the Failure Mode. Because the Severity of the Effect and the Failure Occurrence may have different values it is necessary to “copy” the Detection Rankings to the corresponding Rows will all effect the ability to Detect the Failure Mode. The Detection Ranking allocated, is associated with the combination of Detection Controls. Detection is a relative ranking TIP Detection Controls, and Responsibility may also be “copied” down, however it is necessary to do this only if confusion is probable.

Detection Rating 9 8 7 6 5 4 3 2 1 0 Detection next Detection Rating 9 8 7 6 5 4 3 2 1 0 Detection next 4 Detection 3. 5 3 2. 5 2 20 20. 1 21 22 22. 1 22. 2 1. 5 1 0. 5 0 1 2 3 4 5 6 7 8 9 10 Charts assist with the analysis of the frequency & distribution of Detection Ratings throughout the Risk Analysis.

Risk Priority Number ( SOD) (RPN SOD) is directly linked to the combined Severity, Risk Priority Number ( SOD) (RPN SOD) is directly linked to the combined Severity, Occurrence & Detection ratings The Risk Priority Number (RPN) is a mathematical result of Severity, Occurrence and Detection rankings. (Severity) the seriousness of the Effect caused on the Supplier or the Customer if the Failure Mode happens. (Occurrence ) the known or anticipated frequency of the Cause, considering history, experience and the Prevention Controls in place. (Detection ) the ability to Detect (or Control) the Failure Mode before it leaves the process or gets to the Customer (internal or external). In equation form, RPN = S x O x D This number is used to help identify the most serious risks, leading to corrective action. next

Risk Priority Number The FMEA Innovator permits other formulae to be analysed when for Risk Priority Number The FMEA Innovator permits other formulae to be analysed when for assessing Risk Remember FMEA is NOT a Science TIP next Inspection of the equation reveals that the RPN method for assessing risk can be an oversimplification. Severity, Occurrence, and Detection are not equally weighted with respect to one another in terms of risk.

Risk Priority Number. SOD) ( RPN SOD 120 next RPN SOD 120 100 80 Risk Priority Number. SOD) ( RPN SOD 120 next RPN SOD 120 100 80 80 60 60 40 20 40 0 22 20 0 20 20. 1 21 22 22. 1 Charts assist with the analysis of the of SOD RPN ratings throughout the Process. 22. 1 23 Pareto Analysis 22. 2 20

Risk Priority Number. SOD) ( Customer next Supplier The Customer and the Supplier SOD Risk Priority Number. SOD) ( Customer next Supplier The Customer and the Supplier SOD Charts make it is visually apparent that this Process is Detection dominant. (green portion).

Risk Priority Number. SOD) ( The Customer and the Supplier SOD Charts make it Risk Priority Number. SOD) ( The Customer and the Supplier SOD Charts make it is visually apparent that this Process is Detection dominant. (green portion). next

(RPN SO) is directly linked to the combined Severity & Occurrence ratings Risk Priority (RPN SO) is directly linked to the combined Severity & Occurrence ratings Risk Priority Number ( SO) 18 RPN SO 16 next The Risk Priority Number (RPN SO) is a mathematical product of the Risk of a group of Process Functions. 14 12 (Severity) the seriousness of the Effect caused on the Supplier or the Customer if the Failure Mode happens. 10 8 6 4 2 0 20 20. 1 21 22 22. 3 (Occurrence ) the known or anticipated frequency of the Failure Cause, considering history, experience and the Prevention Controls. In equation form, RPN = S x O. This number is used to help identify the biggest Risk which may benefit from corrective action.

(RPN SO) is directly linked to the combined Severity & Occurrence ratings Risk Priority (RPN SO) is directly linked to the combined Severity & Occurrence ratings Risk Priority Number ( SO) RPN SO 18 16 Pareto Analysis next The Risk Priority Number (RPN SO) is a mathematical product of the Risk of a group of Process Functions. 14 12 (Severity) the seriousness of the Effect caused on the Supplier or the Customer if the Failure Mode happens. 10 8 6 4 2 0 22 22. 1 21 23 20 22 20. 1 22. 2 22. 3 (Occurrence ) the known or anticipated frequency of the Failure Cause, considering history, experience and the Prevention Controls. In equation form, RPN = S x O. This number is used to help identify the biggest Risk which may benefit from corrective action.

Risk Priority Number ( OD+SD) next The Risk Priority Number (RPN SO) is a Risk Priority Number ( OD+SD) next The Risk Priority Number (RPN SO) is a mathematical (RPN OD) is a product of the Risk of a mathematical product of group of Process Functions. the Risk of a group of Process Functions. (Severity) the seriousness of the Effect caused on the (Occurrence ) the known or Supplier or the Customer if anticipated frequency of the Failure Cause, considering the Failure Mode happens. The Risk Priority Number (RPN SD) is a mathematical product of the Risk of a group of Process Functions. anticipated frequency of the (Detection ) an ability to detect the Failure Mode before it leaves the process or gets to the Customer history, experience and the Prevention Controls in place. (Occurrence ) the known or (Detection) an ability to detect Failure Cause, considering the Failure Mode before it history, experience and the leaves the process or gets to the Customer (internal or Prevention Controls. external). RPN OD and RPN SD (Severity) the seriousness of the Failure Effect caused on the Supplier or on the Customer if the Failure Mode happens. are not commonly used, however both are useful to analyze the extent the Process relies on Detection to reduce overall Risk.

FMEA Complete next FMEA Complete next

Control Plan This Information is directly linked from the FMEA As this data effects Control Plan This Information is directly linked from the FMEA As this data effects the FMEA and subsequent Risk Analysis; changes in theses columns should be made in the FMEA and consequences reviewed before final change approved next

Equipment, Machine, Device, Jig Equipment, . Machine, Device, Jigs are in-directly linked to the Equipment, Machine, Device, Jig Equipment, . Machine, Device, Jigs are in-directly linked to the Function. The Equipment Column has historically been an aspect of the Control Plan. Information here can however be a valuable aid to understanding the Failure Mode and this will enhance the capability to accurately assess Risks. . TS 16949 Annex A A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents c) Process control machines, jigs, fixtures, tools for manufacturing Information entered here is automatically copied forward from the FMEA. next

Characteristics Number The Characteristics Number is directly linked next to the Product Requirements The Characteristics Number The Characteristics Number is directly linked next to the Product Requirements The Characteristics Number is an optional feature. Customers often require an Initial sample inspection report (ISIR). ISIR reports carry a Characteristics Number A marked up drawing often carries a reference No. for each dimension or Characteristic. The Part Submission Approval Process (PPAP) or the Part Submission Warrant PSW could also use a Characteristics Number

Special Characteristics are directly linked to the Significant & Critical Characteristics A distinguishing feature, Special Characteristics are directly linked to the Significant & Critical Characteristics A distinguishing feature, dimension or property of a process or its output (product) on which variable or attribute data can be collected. (Source: AIAG APQP Reference Manual Special Characteristics are Product Characteristics or Manufacturing Process Parameters which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product. Refer to Customer-Specific Requirements. Source: AIAG PPAP Reference Manual, Fourth Edition, Robust Characteristic A characteristic is called Robust if the customer is insensitive to the characteristic’s expected variation. Source: AIAG SPC Reference Manual, next

Special Characteristics can be divided into two categories: next Special Product Characteristics and Special Special Characteristics can be divided into two categories: next Special Product Characteristics and Special Process Characteristics Special Product Characteristics Special Process Characteristics A Special Product Characteristic (e. g. , critical, key, major significant) A Special Process Characteristic (e. g. , critical, key, major significant) is a Product Characteristic for which reasonably anticipated variation – is a Process Characteristic for which variation must be controlled to some target value -- could significantly affect product safety or compliance with governmental standards or regulations -- to ensure that variation in a Process or in a Special Product Characteristic or is likely to significantly affect customer satisfaction with a product. is maintained to its target value during manufacturing and assembly. TS 16949 Annex A A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents b) Product control c) Process control product-related special characteristics, process-related special characteristics,

Special Characteristics can be divided into two categories: next Significant Characteristics and Critical Characteristics Special Characteristics can be divided into two categories: next Significant Characteristics and Critical Characteristics can be defined by: can be any characteristic with a Severity of 9 or 10 and which requires a special Detection Control. The courts = through product liability Regulatory agencies = through formal laws and or regulations Industrial standards = through industry accepted practices Customer requisition = through their wants, needs, & expectations Internal engineering = through historical data or experience state of the art technology, or experience with product or service. Critical Characteristics examples of Customer Product Requirements could include. . dimensions, specifications, tests, assembly sequences, tooling, joints, torques, welds, attachments, and component usages. Supplier Process Requirements could include. . machine / process operating safety issues occupational health & safety Issues environmental Issues

Special Characteristics next Significant Characteristics Special Characteristics and can be divided into two categories: Special Characteristics next Significant Characteristics Special Characteristics and can be divided into two categories: Critical Characteristics Significant Characteristics can be any Quality feature of a process or product or service on which data should be collected. Significant Characteristics should have a Control Method. Significant Characteristics are identified by the consensus of the customer and supplier as well as the FMEA team. Special Processes may result in components whose quality, reliability and durability may be compromised by potential variation in the process. . and the resulting defect is not feasibly detected prior to use. The output of Special Processes cannot be readily verified (without destroying the Product) …. . therefore the Control of the Process becomes more important.

The Classification (Class) is directly linked to the Function and its Requirements. Classification (CLASS) The Classification (Class) is directly linked to the Function and its Requirements. Classification (CLASS) 10 Classification (Y) should be used to define potential Critical Characteristics and potential Significant Characteristics. Critical characteristics ( YC) (Characteristics with a Severity of 9 or 10) and are reliant on DETECTION should have associated Recommended Actions. Significant characteristics ( YS) next Y C = Potential Critical Characteristics: 9 8 S e v e r i t y Y S = Potential Significant Characteristics: 7 6 5 4 3 2 1 1 2 3 4 5 6 7 Occurrence (Severity of 5 -8 & Occurrence of 4 – 10) should have associated recommended actions Y P = Top 20% RPN values 8 9 10 Top 20% of Failure Modes by RPN R P N Failure Modes

Specification The Specification is directly linked to the Product / Process Requirements next The Specification The Specification is directly linked to the Product / Process Requirements next The Specification refers to the Tolerance of the Product or Process Requirements and effects the Detection Method (Controls) In some cases it may be logical to refer to a Inspection Method or some other data sheet where the Requirements are more detailed. i. e. the testing of a metal or substance may refer to a Laboratory Test in which all the chemical / physical values (and their corresponding tolerances) are specified. Care must be taken not to be too generic in cross referring to a separate Data Sheet. The Detection Controls will be dependent on the Tolerance. i. e. a linear tolerance of +/- 0. 2 may require a Digital Caliper, whereas a tolerance of +/- 0. 02 may require a Micrometer. TS 16949 Annex A A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents b) Product control c) Process control specification/tolerance. process parameters,

Detection Controls Typical Detection Controls = The Type of Measurement Variable Measurement Vernier Micrometer Detection Controls Typical Detection Controls = The Type of Measurement Variable Measurement Vernier Micrometer Scale Attribute Measurement Go- No Go Gauge Comparison Gauge Subjective Measurement Visual Identification Sensual – Feel Taste Smell Poka Yoke 100% Automated Inspection 100% prevention of defect being processed further 100 Prevention of Defect production Documentation Procedures Check Sheets Layered Audit The Detection Controls are directly linked to the Responsibility Detection Controls (sometimes confused with the Control Method), Indicates HOW the Product or Process Requirements are controlled. The Tolerance must always be considered when deciding on Detection Controls. TS 16949 Annex A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents d) Methods evaluation measurement technique, error-proofing, sample size and frequency, control method. next

Detection Responsibility The Responsibility is directly linked to the Detection Controls Responsibility is traditionally Detection Responsibility The Responsibility is directly linked to the Detection Controls Responsibility is traditionally part of the Control Plan however as it assists in determining the Detection Rating it is controlled in the FMEA. Identifying the Responsibility will assist in determining the correct allocation in the Detection Scale. i. e. an Inspector may be more likely to Detect a Failure Mode than an Operator. Examples Operator Inspection Patrol Inspection, Product Audit, First Off inspection , Last Off inspection, Laboratory Batch Inspection next Other Factors identified in the Control Plan will also have an effect on the Detection Scale. e. g. Sample Size / Sample Frequency will effect the ability to Detect the Failure Mode.

Sample Size/ Frequency The Sample Size refers to the number of consecutive samples taken Sample Size/ Frequency The Sample Size refers to the number of consecutive samples taken from the process Sample Sizes i. e. at the same point in time. Operator Inspection Patrol Inspection, Product Audit, First Off inspection , Last Off inspection, Laboratory Batch Inspection Sample Size & Frequency are directly linked to the Detection Controls The Sample Frequency refers to “how often” the sample is taken. i. e. Once an Hour Every 50 products Once per shift etc, All inspections have sample sizes and frequencies and the will differ dependent on the type of inspection. . As the Risk is dependent on the accumulation of inspection they should be recorded separately. Sample Sizes and sample frequency must take into account the: “Risk” of allowing non conforming parts to go undetected. “Risk” must be a known factor and is normally calculated statistically or using pre-defined tables. TS 16949 Annex A A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents d) Methods evaluation measurement technique, error-proofing, sample size and frequency, control method. next

Control Method The Control Method is directly linked to the Detection Controls The Control Control Method The Control Method is directly linked to the Detection Controls The Control Method provides a brief description of how the operation will be controlled. This should not be confused with Detection Controls. Effective analysis of the process Control Methods are determined by the combination of the type of Process, Detection Controls and Responsibility. In order to analyze: it is necessary to RECORD. Therefore the Control Method refers to the method used to RECORD the results of the Detection Method. EXAMPLES Inspection Reports, Check Sheets, Exception Reports, SPC Charts, Audit Sheets are examples of Control Methods. First Off Reports, Poke Yoka verification records. TS 16949 Annex A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents d) Methods evaluation measurement technique, error-proofing, sample size and frequency, control method. next

Reaction Plan The Reaction Plan is directly linked to the Detection Controls “When a Reaction Plan The Reaction Plan is directly linked to the Detection Controls “When a characteristic fails the evaluation what is done about it? ” This decision should not be left until the event happens but should be planned for in advance. Actions should ensure that suspect material, manufactured since the last evaluation is considered. i. e. Quarantine & Sort, Recall & Sort Actions such as “call Supervisor” should be avoided. When the Supervisor is called “what will they do about it”. ? TS 16949 Annex A A. 2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents e) Reaction plan and corrective actions reaction plan (include or reference), corrective action. next

Control Plan Complete next Control Plan Complete next

Recommended Risk Reduction Actions Risk Classification should prompt prioritisation of Risk Reduction actions. Critical Recommended Risk Reduction Actions Risk Classification should prompt prioritisation of Risk Reduction actions. Critical characteristics ( YC) (Characteristics with a Severity of 9 or 10) that are Detection dependent Significant characteristics ( YS) (Severity of 5 -8 & Occurrence of 4 – 10) Thereafter Risk Reduction should be directed at high severity, high RPN and other items designated by the team. The intent of any Risk Reduction should be specifically targeted to reduce rankings in : Severity, Occurrence and Detection.

Recommended Risk Reduction Actions such as the following . . should be considered: • Recommended Risk Reduction Actions such as the following . . should be considered: • Reduce the Occurrence of the Cause by Process Improvement. • Reduce the Severity of the Effect by Re-design. by Product or Process • Improve Detection of the Failure Mode with the use of error/ mistake proofing methods.

New Severity The New Severity is a prediction of the reduced Risks. Occurrence of New Severity The New Severity is a prediction of the reduced Risks. Occurrence of the Cause Severity of the Effect Detection of the Failure Mode The new severity says IF we take these actions our risk will reduce from X to Y.

Authority& Target Date The FMEA Team will be responsible for identifying Risk Reduction opportunities Authority& Target Date The FMEA Team will be responsible for identifying Risk Reduction opportunities and for quantifying the potential Risk Reduction. Often a higher authority will approve that Risk Reduction Action, set Target Dates and assigning Responsibility for implementing the required actions.

Actions Taken A brief action result description, and the date when the action(s) was/were Actions Taken A brief action result description, and the date when the action(s) was/were taken. FMEA Update Recalculate RPN, after action has been taken • Occurrence • Detection Note: • Severity will likely stay the same unless failure mode is eliminated.

FMEA Updated By entering an X in the update column and hitting the update FMEA Updated By entering an X in the update column and hitting the update button. . a permanent record of the Change, including all associated Data in the FMEA & Control Plan, is copied to the Update Change Revision Record.

FMEA Updated After Updating ; the User can safely make the changes to the FMEA Updated After Updating ; the User can safely make the changes to the current FMEA. i. e. in this example change the Detection rating and insert new Detection Controls