An Introduction to ISO/TS 16949:2002

An Introduction to ISO/TS 16949:2002
* 07/16/96 An Introduction to ISO/TS 16949:2002 15/11/61 *

Learning objectives Appreciating key aspects of ISO/TS market drivers Comparing ISO/TS 16949:2002 with ISO 9001:2002 Approaches to assessing where you are now Appreciating the techniques to support ISO/TS 16949; Statistical Analysis Statistical Process Control Measurement Systems Analysis FMEA Control Plans Considering the next steps 15/11/61

What is ISO/TS 16949:2002? TS is a Technical Standard expressing “particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations” …which means... ISO 9001:2000 requirements plus additional requirements specific to automotive production In the standard document ISO 9001:2000 text is shown in boxes 15/11/61

Where did ISO/TS 16949:2002 come from?
Prepared by International Automotive Task Force (IATF) + Japan Automobile Manufacturers Assoc. (JAMA) ISO 9000 series QS 9000 VDA 6.1 AVSQ EAQF ISO 9001:1994 ISO 9001:2000 Automotive 1994 1999 2000 2002 ISO/TS 16949:1999 16949:2002 15/11/61

Who contributed - through IATF/JAMA?
All major automotive OEMs US, European + Japanese supplier organizations Some Tier 1 suppliers USA UK France Germany Italy Japan OEMs Ford GM Chrysler PSA Renault VW BMW Daimler Fiat Nissan Toyota Honda National Supplier Org’ns SMMT FIEV VDA ANFIA JAMA Suppliers Bosch USA GKN Faurecia Bosch Magneti Marelli 15/11/61

Key Aspects – Scope & goal
SCOPE: “This technical specification is applicable to sites of the organization where production and/or service parts specified by the customer are manufactured… …throughout the supply chain.” GOAL: “The goal of this specification is the development of a quality management system that provides for; continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.” 15/11/61

Key Aspects – Overview Top management involvement including;
implementing a business plan linked to defined measurable quality objectives Clear definition of responsibilities including; Authority to stop production to correct quality problems Top management review of the performance of the quality system including; reporting and evaluation of the cost of poor quality 15/11/61

Key Aspects – Overview Focus on Human Resource management including
processes for defining competence requirements, providing training (including on the job training for employed, temporary and agency personnel), verifying effectiveness of actions taken A process to motivate employees to achieve quality objectives, make continual improvement, and create an environment to promote innovation. A process to measure the extent to which personnel are aware of the relevance & importance of their activities - how they contribute to achieving the quality objectives 15/11/61

Key Aspects – Overview Focus on product & process design to meet requirements Use of automotive core tools Statistical Process Control (SPC), Measurement System Analysis (MSA) Failure Mode Effect Analysis (FMEA) Controlling production processes by use of control plans work instructions Ensuring effective control of internal & external laboratories 15/11/61

Key Aspects – Overview Focus on process for measurement of customer perception and satisfaction All processes need to take into account any customer specific requirements Development of suppliers using ISO/TS16949: 2002 Focus on continual improvement Undertaking effective system, process & product audits Effective analysis of data to drive improvement Evidence of continual improvement throughout the organisation’s processes, not just manufacturing 15/11/61

Key Aspects – 8 QM principles
Process Approach [ 4.1, ] Customer focus [ 5.1, 5.2, , 8.2.1, ] Leadership [ 5.3, ] Involvement of people [ 5.5.3, ] System approach [ 4.1, 5.1.1, 5.4.1, ] to management Continual improvement [ 5.1, 5.3, ] Factual approach [ 5.6.1, 8.2.2, 8.4 ] to decision making Mutually beneficial [ ] supplier relationship 15/11/61

Key Aspects – Process focus
Process – “any activity or set of activities that uses resources to transform inputs into outputs.” [4.1] “The organisation shall identify processes needed for the quality management system and their application throughout the organisation determine the sequence and interaction of these processes measure, monitor and improve these processes.” 15/11/61

Examples of ‘customer orientated processes’ Bid/Tender, Order/Request Production Product/Production verification For your own operations, consider such processes - inputs outputs possible indicators of process effectiveness from the customer and/or organisations (internal customer) perspective what management/support processes are needed for this process to work effectively 15/11/61

Management & support processes – examples Management Review & Business Planning Internal Audit Production Engineering Quality Purchasing Finance Maintenance Human Resources 15/11/61

Customer measures of process effectiveness Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (including instances of premium freight) Customer notification of quality or delivery issues Organisation measures of process effectiveness Reports & reviews of performance against objectives Evaluation of the cost of poor quality 15/11/61

Key Aspects – Customer focus
Customer specific requirements are included in an audit for ISO/TS 16949 “Customer specific quality management system requirements supplemental to ISO/TS shall be included in the audit in order to obtain customer recognition of such certification” What is your process for identifying and using customer specific quality management system requirements? 15/11/61

Key aspects – required documents
Quality policy & objectives [4.2.1] + Quality manual [4.2.2] Procedures & documents to ensure effective planning, operation and control of processes + records [4.2.1] Procedure for document control [4.2.3] Procedure for identifying training needs and achieving competence of all personnel performing activities affecting product quality [ ] Procedure for internal audits, reporting results & keeping records [8.2.2] Procedure for control of nonconforming product + responsibilities [8.3] Procedure for reviewing nonconformities, determining causes with action to prevent recurrence [8.5.2] Procedure for determining potential nonconformities & causes, action to prevent occurrence [8.5.3] Bold = from ISO 9001:2000 15/11/61

Market Drivers – the goal
“The goal of this Technical Specification is the development of a quality management system that provides for; continual improvement emphasising defect prevention and the reduction of variation and waste in the supply chain.” Process approach of ISO 9001:2000 complements ISO/TS 16949:2000 – many common requirements (less paper?) 15/11/61

Market Drivers – OEM & Tier1 requirements
ISO/TS is currently supported by the following: BMW, DaimlerChrysler, Fiat, Ford, GM (incl Opel-Vauxhall), PSA Peugeot-Citroën, Renault SA, VW. OEM’s deadlines for (Tier 1) suppliers achieving ISO/TS 16949:2002 Renault 1 July 2004 Daimler Chrysler 1 July 2004 PSA Peugeot-Citroën 15 Dec 2004 Ford & GM 14 Dec 2006 The following UK-based manufacturers have indicated their support: BMW Group; Ford Motor Company; Honda UK; Jaguar Cars; Nissan Motor Manufacturing UK; Peugeot Motor Company; Rolls-Royce Motor Cars & Bentley Motor Cars; GKN; Mobil Oil. 15/11/61

Market Drivers – OEM requirements
ISO/TS 16949:2002 or ? Customer Specific Requirements Audi/Volkswagen ISO/TS 16949:2002 or VDA 6 [ Quality Cap. Suppliers 4th Ed ] BMW Contact customer [ Supplied Parts Quality Mgmt ] Daimler Chrysler ISO/TS 16949:2002 [ Daimler Chrysler Customer specific Requirements for use with ISO/TS 16949: 2000 ] Ford Motor Co. ISO/TS 16949:2002 (QS 9000 / Q1) General Motors [ ISO/TS 16949:2002 Customer Specific Requirements ] Honda [ Honda Supplier Quality Manual ] Isuzu [ Supplier Quality Manual ] Mazda Mitsubishi [ SMITQA-003 ] Nissan [ Supplier Quality Manual / Alliance Supplier Guide ] PSA Peugeot-Citroën Renault Rover [ RG2000 Supplier Management System ] Saab Subaru [ Subaru Supplier Manual ] Toyota [ Supplier Quality Assurance Manual ] 15/11/61

Market Drivers – Tier 1 requirements
ISO/TS 16949:2002 or ? Customer Specific Requirements Dana Corporation Contact customer Delphi [ Supplier Standards ] Johnson Controls [ Global Supplier Standards Manual ] Navistar (International) [ Navistar Quality Requirements ] Visteon QS-9000, Section II [ + Your customers? 15/11/61

Comparing ISO/TS 16949 with ISO 9001
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Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Applying to Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement [ also shows comparison to QS9000 ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Quality Management System Retain responsibility for all outsourced processes [4.1.1] Review customer engineering specifications & changes within 2 weeks [ ] Control records of regulatory and customer requirements [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Management Responsibility Top management shall review product realisation and support processes [5.1.1] Top management shall define quality objectives in the business plan and their use to deploy quality policy [5.4.1(.1)] Managers responsible for corrective action shall be promptly informed of products or processes that do not conform to requirements. appoint ‘quality representatives’ with authority to stop production (all shifts) to correct quality problems [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Management Responsibility (cont’d) Top management shall appoint ‘customer representatives’ with specific responsibility to ensure compliance with customer requirements, including selection of special characteristics, corrective/preventative actions and design/development. [ ] Management reviews shall include; monitoring of performance trends, the cost of poor quality, the achievement of quality objectives, [ ] review of actual and potential field failures. [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Resource Management Personnel with product design responsibility shall be competent to achieve design requirements and skilled in applicable tools and techniques. [ ] Document procedures for identifying training needs and achieving competence of personnel [ ] Provide on-the-job training, including the consequences to the customer of nonconformities [ ] Have a process to motivate employees to; achieve quality objectives, make continual improvements & create an innovative environment. [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Resource Management (cont’d) Ensure all skilled staff in the factory are involved in deciding plant layout and handling methods; include lean manufacture using minimum work in progress & minimum movement of parts [6.3.1] Have contingency plans for emergency situations that could affect customer requirements, including power failure, communication failure, raw material or parts supply failure, equipment failure, labour shortage and handling returned product. [6.3.2] Ensure that the plant layout and working methods are designed with safety to employees in mind. [6.4.1] Ensure that workplaces are tidy and appropriately clean. [6.4.2] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation Include customer requirements and reference to spec.s in the planning of product realisation [7.1(.1)] Define and approve acceptance criteria with the customer [7.1.2] Ensure confidentiality of customer contracted products and product information during design & development and production. [7.1.3] Have change control process that; prevents any change to product, materials or processes without customer approval, includes testing the validation or effectiveness of the change before implementation. For a proprietary design, review impact on form fit and function with the customer. [7.1.4] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Obtain customer approval for any waiving of a review of requirements related to the product [ ] Review manufacturing feasibility within contract review [ ] Communicate necessary information in a customer specified language and format [ ] Document and include the following in ‘product design input’ customer requirements including performance and special characteristics experience from previous products targets for product quality, life, reliability, durability, maintainability, timescales and cost. [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Document and include the following in ‘manufacturing design input’ product design outputs that have to be met by manufacturing experience from previous products targets for productivity, process capability and cost. [ ] Identify special characteristics [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Document and include the following in ‘product design output’ in ways that demonstrate that all design inputs have been met design FMEAs including diagnostic guidelines to predict failure modes reliability results special characteristics an analysis of error proofing product drawings, specifications and calculations product design reviews [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Document and include the following in ‘manufacturing design output’ in ways that demonstrate all design inputs have been met design FMEAs including diagnostic guidelines to predict failure modes a control plan, specifications, drawings, instructions and flowcharts plant & workstation layouts an analysis of error proofing manufacturing process validity and approval method including acceptance criteria [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Report measurements of design & development at management review [ ] Perform validation in accordance with customer requirements [7.3.6(.1)] Prototype programme required using manufacturing processes [ ] Approval procedure required as recognised by the customer [ ] All purchased products shall conform to regulatory requirements [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Work in partnership with suppliers to develop the supplier quality management system. Conformity to ISO 9001:2000 is required. [ ] As specified in the contract, use approved sources for purchased material [ ] Monitor the quality of purchased product by one or more of the following; evaluation of the statistical data received from the supplier receiving inspection 2nd or 3rd part audits with records of acceptable delivered performance part evaluation by a designated laboratory [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Monitor supplier performance by; delivered product quality performance customer disruptions that have occurred returns or other feedback from end users delivered schedule performance [ ] Use Control Plans to the format specified in Appendix A [ ] Work instructions for operations that impact on quality are required [ ] Verify job set ups [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Use predictive and preventative maintenance for key processes [ ] Resources for tool and gauge design, fabrication and verification are required [ ] Schedule production to meet customer requirements e.g. just-in-time [ ] Establish a process for communication of information on service concerns [ ] Verify the effectiveness of any customer service agreements [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Validate all processes for product and service provision to demonstrate the ability of these processes to achieve planned results – where applicable through; defined criteria for review and approval of the process approval of equipment and qualification of personnel use of specific methods & procedures requirements for records revalidation [7.5.2(.1)] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) In all cases; identify the product throughout product realisation identify the product status with respect to monitoring & measurement requirements where traceability required, control and record unique product identification [7.5.3(.1)] Permanently mark customer owned tooling Assess the condition of stock. Assure stock rotation (FIFO). Control obsolete stock as nonconforming. [ ] Perform statistical studies on measuring equipment to analyse variation [7.6.1] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Maintain calibration records including Equipment identification The standard against which the equipment is calibrated Revisions following changes to equipment Assessments of the impact of out-of-specification equipment Notifications to customer of any product that may have been affected by out-of-specification measuring equiment A positive statement of the acceptance of the calibration for the intended purpose [7.6.2] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Product Realisation (cont’d) Define the scope of any internal laboratory to include its ability to perform the required duties and be managed by a documented management system either within or separate from the main system [ ] Use only external laboratories that have a suitable scope are accredited to ISO or acceptable to the customer [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Measurement, Analysis and Improvement Identify appropriate statistical tools for each process [8.1.1] Understand statistical concepts [8.1.2] Monitor customer satisfaction and produce performance indicators [8.2.1(.1)] Audit the quality management system to verify compliance with the standard [ ] Audit each manufacturing process [ ] Include in internal audits all quality management related processes, activities and shifts [ ] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Measurement, Analysis and Improvement (cont’d) Internal auditors shall be suitable qualified [ ] Perform process capability studies and include the conclusions in the quality or control plan. Studies shall include the; stability of the process capability of the inspection and test process capability of the reaction plans to contain the effect of any nonconformity [8.2.3] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Measurement, Analysis and Improvement (cont’d) Conduct product audits [ ] and ‘layout inspections’ i.e. checking every measurement and parameter shown on the approved design drawings. [ ] Conduct appearance inspections on items for which customer specifies this i.e. checking every aspect of the appearance of the finished product as perceived by the end user. Maintain master samples and means of making comparisons. [ ] Class product with unidentified status as nonconforming. Make instructions for rework available. [8.3(.1), 8.3.2] Inform customers promptly if nonconforming product is shipped [8.3.3] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Measurement, Analysis and Improvement (cont’d) Obtain a customer concession before proceeding with any further processing if any part or material is not fully in accordance with approved requirements. This shall apply to product or material still being processes by a supplier. [8.3.4] Analyse trends in quality & operational performance; use data to: manage progress towards overall objectives identify priorities provide a factual basis for decision making anticipate and predict problems arising from the end users. Establish benchmarks to measure performance against competitors or other appropriate recognised criteria.[8.4.1] 15/11/61

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000 Measurement, Analysis and Improvement (cont’d) Define a programme for continual improvement [ ] Focus manufacturing improvement on reducing variation [ ] Define a process for problem solving [ ] Use error proofing methods in the corrective action process [ ] Apply corrective action to other similar processes and products [ ] Minimise the time for corrective action [ ] 15/11/61

Assessing where you are now
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Techniques to support ISO/TS 16949
Statistical Analysis Statistical Process Control (SPC) Measurement Systems Analysis (MSA) 15/11/61

Statistical Analysis - SPC
Statistical Process Control (SPC) “ The use of statistical techniques such as control charts to analyse a process or its outputs so as to take appropriate actions to achieve and maintain a state of statistical control and to improve process capability.” Detects variation in process measures to enable; reduction of variation, and, prevention of defects / waste. Applied to all processes whose output measures offer Variable data e.g. part dimensions Attribute data – conforming; yes/no - that can be counted e.g. parts received on-time 15/11/61

Statistical Analysis ISO/TS 16949:2002 requirement for Statistical Analysis 8.0 Measurement, analysis and improvement 8.1.1 Identification of statistical tools 8.1.2 Knowledge of basic statistical concepts Monitoring and measurement of manufacturing process Manufacturing process improvement 15/11/61

Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in Location Spread Shape …or any combination of these. If the shape of variable data is ‘normal’ (typical); location is measured by the mean [ X ] spread is measured by the range [R] or standard deviation [sd] SPC can be applied to see if variation is unacceptable 15/11/61

Variation in variable data can come from Common causes – natural random events – which affect all values of process output Special causes – intermittent, often unpredictable causes making the process output unstable Control charts help identify special causes by showing Values beyond control limits Non–random patterns or trends e.g. 7 points increasing/decreasing, 7 points one side of the average 15/11/61

Before assessing process capability, special causes must be removed Process Capability then measures How variable the process is [ Pp, Cp ] How process variation fits within the specified limits [Ppk, Cpk] - how well it meets a customer requirement Cpk Approx parts per million out of specification 1.00 66,000 1.33 6,000 1.67 233 2.00 (Six sigma) 15/11/61

Attribute data can be analysis using p chart for proportion of nonconforming parts u chart for nonconformities per unit np chart for the number of nonconforming parts c chart for the number of nonconformities 15/11/61

Statistical Analysis – SPC
Benefits of Statistical Process Control (SPC) Show how successfully a process is adjusted & controlled to achieve consistent and therefore predictable outputs e.g. conforming products Flag any special causes of variation which need to be identified and eliminated by local action Quantify the effects of improvements in quality, leading to reductions in waste (poor quality costs) 15/11/61

Statistical Analysis Statistical Process Control (SPC) Measurement Systems Analysis (MSA) 15/11/61

Statistical Analysis - MSA
Why Measurement System Analysis? “The purpose of any analysis of a measurement system should be to better understand the sources of variation that can influence the results produced by the system.” To quantify and communicate the limitations of specific measurement systems. 15/11/61

ISO/TS 16949:2002 requirement for Measurement Systems Analysis (MSA) [7.6.1] “ Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods of acceptance criteria may be used if approved by the customer.” 15/11/61

Terminology Measurement system: the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement. Material Man Method Machine (Time) Environment MEASUREMENT SYSTEM 15/11/61

Terminology Gauge: any device used to obtain measurements, frequently used to refer specifically to the devices used on the shop floor. Calibration: a set of operations that establish under specific operating conditions, the relationship between a measuring device and a traceable standard of a known reference and uncertainty. Reference Value: a reference for comparison, normally determined under laboratory conditions or using a more accurate instrument. 15/11/61

Quality of measurement data If measurements are close to the reference value the quality of the data is high Measurement systems Must be in statistical control Must have small variability compared with specified tolerance or manufacturing process variability* Descrimination: the amount of change from the reference value that an instrument can detect and faithfully indicate. Typically the smallest graduation on the scale of the instrument *Descrimination should be one tenth of the tolerance range, however recently the descrimination target is one tenth of the process variation – significantly less. 15/11/61

Variability characterised by Location - bias, linearity, stability Width or spread – repeatability, reproducibility Location Errors Bias: the difference between the mean measurement and the reference value. Linearity: the difference in bias through the operating range Stability: the total variation in the measurements obtained from a single characteristic over time (change in bias over time) Check change in characteristic, such as values from Electrical Test Equipment, between calibration intervals Plot data and take action if bias outside a specified value 15/11/61

Spread Errors (Gauge R & R) Repeatability: variation in measurements obtained with one measurement instrument, when used several times by one appraiser while measuring the identical characteristic on the same part. (‘Equipment Variation’) Under 10% considered acceptable To improve, instruments may need maintenance or redesign Reproducibility: variation in measurements obtained with one measurement instrument, when used by different appraisers while measuring the identical characteristic on the same part. To improve, appraiser(s) may need training, or more ease of use 15/11/61

Measurement System Study Select appraisers – people already using the instrument Select measurement instrument – has it the required discrimination Select parts from the process that represent entire operating range e.g. several days production and number each part. Measurement System Analysis – when? “As processes change and improve, a measurement system must be re-evaluated for its intended purpose” For example, when there is a new product, capability improvement, skill level change, process change e.g. new equipment, change in work environment, change in test method/procedure. 15/11/61

Failure Modes & Effects Analysis 15/11/61

Failure Mode and Effects Analysis
Failure Mode and Effects Analysis (FMEA) A systematic group of activities to: Recognize and evaluate potential failures of a product or process and the effects of failure Identify actions that could eliminate or reduce the chance of the potential failure occurring Document the above process Evidence from vehicle recalls has shown a fully implemented FMEA could have prevented many causes Enables action before the event (Prevention), not after (Detection) 15/11/61

ISO/TS 16949:2002 requirement for FMEA Engineering specifications Multidisciplinary approach Special Characteristics Product design outputs Manufacturing process design outputs Control Plan 15/11/61

What are the customer related functions or requirements? How can cause or effect be prevented & detected? What should be done, by whom & when? design/ process change special controls, changes in procedures/ guides What are the effects? How bad is it? What can go wrong? No function Partial/over/ degraded function Intermittent function Unintended function How good is this method at detecting / preventing? What are the causes? What has been done? What risks are highest priority? Is there still a priority risk? How often does it happen? 15/11/61

Design FMEA Focuses on designing out Potential Failures in Product Design causing detrimental effects on functional performance Applies when products’ design is created or revised Uses test, production, quality, supplier & customer experience Assumes manufacturing process would achieve specification Process FMEA Focuses on preventing Potential Failures in manufacturing Process causing detrimental effects on functional performance Applies when manufacturing process is applied to new product or changed Uses test, design, quality, supplier & customer experience Assumes if design made to spec., it would otherwise succeed TEAM EFFORT TEAM EFFORT 15/11/61

Design FMEA used to address potential risks in the design achieving functional performance, by: Identifying potential design failures, their causes & effects Rating the; Severity of effects; 1 to 10 (10 = most severe), Occurrence of effects; 1 to 10 (10 = most likely), Detection/prevention of effects by current controls eg. analysis, test; 1 to 10 (10 = not likely to be detected/prevented), using guidance available in DFMEA manuals. Using the Risk Priority Number (RPN) …to prioritise action – focussing on designing out failure Customers may define triggers for action e.g. RPN >100, Severity > 8 RPN = Severity rating x Occurrence rating x Detection rating 15/11/61

Process FMEA used to address potential risks in the manufacturing process achieving functional performance, by: Identifying potential process failures, their causes & effects Rating the; Severity of effects; 1 to 10 (10 = most severe), Occurrence of effects; 1 to 10 (10 = most likely), Detection/prevention of effects by current controls eg. test; 1 to 10 (10=unlikely to be detected/prevented), using guidance available in PFMEA manuals. Using the Risk Priority Number (RPN) …to prioritise action – focussing on preventing failure Customers may define triggers for action e.g. RPN >100, Severity > 8 RPN = Severity rating x Occurrence rating x Detection rating 15/11/61

FMEA is successful as a process & living document, if: All links to external (& internal) customer requirements from Design and Process elements are understood and systematically reviewed for risk of potential failure Informed team approach leads to multidisciplinary experience being shared to evaluate risk consistently Actions are planned at an early stage – before changes are considered too costly Actions are taken as planned and the resulting effect on the risk is evaluated and documented 15/11/61

FMEA appears ‘difficult’, if: Team does not have common understanding of the FMEA process agreement/guidance on ratings multidisciplinary experience – particularly a history of customer concerns or internal failures to consider in evaluating a new item time to work through sufficient detail and agree actions Relationship between Design and Process elements and external (& internal) customer requirements is not understood Actions are not Planned early enough Followed through to achieve reward in better satisfying customer 15/11/61

Control Plans 15/11/61

Control Plans - Overview
summarize the systems used to minimize process and product variation, guiding manufacturing on how to control the process and ensure product quality structure the approach to design, selection and implementation of value-added control methods describe the actions required at each phase of the process to ensure all process outputs will be in control are living documents - updated as measurement systems and control methods are evaluated and improved. 15/11/61

Control Plans - Requirement
ISO/TS 16949:2002 requirement for Control Plans [ ] “The organization shall develop control plans (see Annex A)… for the product supplied… have a control plan for pre-launch & production that takes into account the design FMEA and manufacturing process FMEA outputs. Control plans shall be reviewed and updated when any change occurs… NOTE Customer approval may be required…” 15/11/61

Control Plans - Content
ISO/TS 16949:2002 requirement for Control Plan content [ ] “The control plan shall list the controls used for the manufacturing process control, include the methods for monitoring of control exercised over special characteristics… include the customer required information, if any, and, initiate the specified reaction plan when the process becomes unstable or not statistically capable.” 15/11/61

Control Plans - Content
ISO/TS 16949:2002 requirement for Control Plan content [Annex A] General Data; part no. & name, process step descriptions, etc Product Control; characteristics for control; specif’n tolerance Process Control; process parameters, manuf’g m/cs & tools Methods; evaluation of meas’t technique, sample size & freq. Reaction Plan & corrective actions 15/11/61

Control Plans - Example
Control Plan Example format minimum elements required by ISO/TS 16949:2002 Annex A 15/11/61

Control Plans Control Plan Checklist Have customer requirements been adopted in Control Plan format and preparation? Have all known customer concerns been identified to facilitate the selection of special product/process characteristics? Are all special product/process characteristics included in the control plan? Are material specifications requiring inspection identified? Does the control plan address incoming material/components through processing/assembly including packaging? Are engineering performance testing requirements identified Are gauges and test equipment available as required by the control plan? If required, has the customer approved the control plan? Are gauge methods compatible between supplier & customer? 15/11/61

Control Plans - Benefits
Benefits of Control Plans Improved quality of products during design, manufacturing and assembly, by identifying sources of variation Resources focussed on process and product characteristics important for customer satisfaction Communication of changes in product/process characteristics and their control & measurement prepared responses to nonconformities (Reaction Plan) 15/11/61

Next Steps 15/11/61

An Introduction to ISO/TS 16949:2002

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