ISO/TS 16949: 2002 3 Days Internal Auditor Certification Course Instructor / Lecturer:
Mohamed Ghorab March 2008
Audience Acquaintance / Ice Breaker: Introduce yourself What Company do you work for? Any previous Quality Management or auditing experience? Define a process in your company which has a direct impact on the customer (External)
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Basics Switch mobile phones to the silent mode. Toilets. Break. Material provided. A written open book final exam
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Is THE Global Group Established in 1878 - Head Office in Geneva, Switzerland. 42’000 employees -1000 Offices and 320 Laboratories in more than 120 Countries. SGS is recognized as the global benchmark for the highest standards of expertise, quality and integrity.
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We provide leading & innovative services to all industries Certification Inspection & Verification Outsourcing In the areas of: Risk Management Technical Consulting Testing & Analysis
Trainings ®: ISO/TS 16949: 2002 3 Days Internal Auditor Certification Course 5
Course Objectives: Understand and apply the automotive process approach to auditing. Understand the structure and content of ISO/TS 16949: 2002, the support documents and the automotive core tools.
Who should attend? A person who has the competence to conduct an audit. Demonstrated personnel attributes and demonstrated ability to apply knowledge and skills.
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Goal of ISO/TS 16949: 2002 The goal of this Technical 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.
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Course Outline: Session 1
Background & Development of ISO/TS & Automotive Process Approach
Session 2
Internal Auditor Qualification
Day 1
& Customer Specific requirements Session 3
APQP & Control Plan
Session 4
Statistical Process Control (SPC)
Session 5
Failure Mode & Effect Analysis (FMEA)
Session 6
Measurement System Analysis (MSA)
Session 7
Rules For Achieving IATF Recognition
Day 2
Day 3
Written Exam (Open Book)
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Session 1: Background & Development of ISO/TS 16949: 2002 & Automotive Process Approach
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History of Quality Standards
1979 BS 5750 1987 ISO 9000 series 1994 ISO 9000 revision / QS 9000 issued
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Automotive migration to International Standards EAQF France AVSQ Italy VDA 6 Germany QS 9000 USA
ISO/TS 1st edition
ISO/TS 2002 edition
ISO 9001: 1994 Based document
ISO 9001: 2000 Based document
Automotive sector Quality requirements (With registration variation)
1994
1997
1998
1999
2000
2002
The plan is to have no change before 2008 at the earliest due to alignment with ISO 9001: 2000 update.
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IATF Representatives Car Makers
France
Germany Italy
USA
PSA
VW
Chrysler
Renault
BMW
Ford
Daimler
GM
Opel
VW of USA
Liaison
Fiat
(Europe / US) FIEV National Super Organization
VDA
ANFIA
AIAG / IAOB
UK
Japan
SMMT
JAMA Nissan Toyota Honda
Suppliers
Faurecia
Bosch
Magneti Marelli
Bosch USA
GKN
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Scope of ISO/TS 16949: 2002
This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured. This technical specification can be applied throughout the automotive supply chain. Also applicable to vehicle manufacturers.
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Business Planning Business Plan
Policy
Imp act
Objectives
In
e c n e flu
Planning Employee Motivation & Empowerment 14
Terminology ISO 9001: 1994
ISO/TS 16949: 2002 Process Customer Procedure
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8 Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach to management Continual Improvement Factual Approach to decision making Mutually beneficial supplier relationship Please find a requirement in ISO/TS which relates to each of the above principles.
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Process Approach
5
6
4
8
7
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Process
Any Activity or set of activities that uses resources to transform inputs to outputs
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A process
A process has a start and an end defined by two limits. OUTPUT Customer who has a need met
INPUT Customer who has a need
And a chain of activities between these two limits Input
Step 1
Step 2
Step “N”
Output 19
Identification of processes
ISO/TS 16949: 2002 requires: The organization shall identify processes needed for the quality management system and their application throughout the organization. Determine the sequence and interaction of these processes. Measure, monitor and improve these processes.
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Audit Tool: Turtle Diagram With Who? Competence criteria (6.2.1) Induction/ training records (6.2.2) Agency/ Contract labour (6.2.2.3) Job responsibilities/ authorities (5.5) Training effectiveness (6.2.2) SPC awareness (8.1.2) Personnel safety (6.4.1) Awareness of policy/ objectives (6.2.2.4)
With What? Plant and machinery (6.3) Process equipment (6.3) Measuring equipment (7.6) Tooling (7.5.1.5) Maintenance (7.5.1.4) Packaging/labeling (7.5.5) Customer property (7.5.4) Transportation (6.3) Inputs Customer schedule (7.5.1.6) Raw materials (7.4)
How? Control plans (7.5.1.1) Work instructions (7.5.1.2) Preventive maintenance (7.5.1.4) SPC (8.1.1) Nonconforming product procedure (8.3) Dispatch process (7.5.1.7) Contingency plan (6.3.2) Document control/ records (4.2.3/4)
Process:
Manufacturing Process (7.5)
(Support Processes) IT Human resource Logistics Sales Quality Preventive maintenance
Outputs Conforming product delivered to customer schedule (8.2.1.1)
What Results? Analysis of data (8.4.1) Customer satisfaction (8.2.1) Other Organizational objectives (5.4.1) Maintenance objectives (7.5.1.4) Cost of poor quality (5.6.1.1) Process capability (8.2.3.1) Management review (5.6.1) Continual improvement results (8.5) Audit records (8.2.2)
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Turtle Diagram Workshop
In your groups analyze the process allocated by the trainer and create a turtle diagram. 22
Process Improvement (Shewart Cycle) Plan • What and why? Act
Plan
Check
Do
Do • How, when, and how much?
Check • How will you know it worked?
Act • How do you plan to fully adopt? 23
The Dilbert Cycle
Blame someone else for catastrophe
Make wild guess at what is wrong
ACT
Adopt unproven process or technology 24
Plan-Do-Check-Act diagram
Requirement Requirement
Yes
Plan Plan
Do
Check
Conforms?
Product / Service
No
Corrective Action
Feedback Loop
Continual Improvement
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The > Cycle and the audit
A
P C Approach >
PDCA feedback system
D 26
The > Cycle and the audit – Cont. The audit plan must take into account the way the processes should be managed, looking at such items as: 1. Deployment of objectives. 2. Organization. 3. Resources assigned. 4. Worst case operations. 5. Indicators, information feedback. 6. Management of improvement plans (the dinamism) 27
The > Cycle: Follow through the business strategy Responsibilities shared, responsibilities assigned and responsibilities defined!
Top Management
P
Process Owners
Management from the top management at every level! Strategy Policy Objectives Resources
Strategic thinking Decisions Use information
Risk analysis
C
Planning the activities
Participants
D
A
Top Management
Reporting Improvement actions Collect and analyze Operational information
Process Owners
Participants
Operations & recording
The organization must identify and allocate necessary resources but also ensure continual improvement 28
The CAPDo Logic
C
Start with a questions about performance, what is expected, what are the indicators and objectives, What is the actual performance?
A
How is performance being improved?
P
How was the process planned, does the process design allow performance objectives to be met? Previous Performance results?
Do
Is the process being carried out as designed? Are the Methods being applied in the field? On the shop floor, At the work station? 29
Understand the process to audit With Who? Competence criteria (6.2.1) Induction/ training records (6.2.2) Agency/ Contract labour (6.2.2.3) Job responsibilities/ authorities (5.5) Training effectiveness (6.2.2) SPC awareness (8.1.2) Personnel safety (6.4.1) Awareness of policy/ objectives (6.2.2.4)
With What? Plant and machinery (6.3) Process equipment (6.3) Measuring equipment (7.6) Tooling (7.5.1.5) Maintenance (7.5.1.4) Packaging/labeling (7.5.5) Customer property (7.5.4) Transportation (6.3) Inputs Customer schedule (7.5.1.6) Raw materials (7.4)
How? Control plans (7.5.1.1) Work instructions (7.5.1.2) Preventive maintenance (7.5.1.4) SPC (8.1.1) Nonconforming product procedure (8.3) Dispatch process (7.5.1.7) Contingency plan (6.3.2) Document control/ records (4.2.3/4)
Process: Outputs
Manufacturing Process (7.5)
(Support Processes) IT Human resource Logistics Sales Quality Preventive maintenance
Conforming product delivered to customer schedule (8.2.1.1)
What Results? Analysis of data (8.4.1) Customer satisfaction (8.2.1) Other Organizational objectives (5.4.1) Maintenance objectives (7.5.1.4) Cost of poor quality (5.6.1.1) Process capability (8.2.3.1) Management review (5.6.1) Continual improvement results (8.5) Audit records (8.2.2)
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Effectiveness of system Customer measures: • Delivered part quality performance • Customer disruptions including field returns • Delivery schedule performance (including incidents of premium freight) • Customer notification related to quality or delivery issues
Organization measures: • Establishing, reporting and reviewing performance against quality objectives & evaluation of the cost of poor quality
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SMART
The more the goals reflects the customers needs and expectations, the more successful the project will be. An effective quality planning goal has five characteristics (SMART): • Specific. • Measurable. • Agreed upon/Achievable. • Realistic • Time-phased. 32
Audits parties’ levels Accreditation Body
4th p
Certification Body S U P P L I E R
3rd p
3rd p
1st p
O R G A N I Z A T I O N
3rd p
1st p
C U S T U M E R
1st p
2nd p 2nd p
2nd p
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Why conduct Internal Audits?
To comply with quality management system standards! To help facilitate continuous improvement of the quality management system Help in sharing best practices between departments Provides management information about the state of the business Helps focus attention on need for system compliance. 34
Phases of an audit
Audit planning and scope Preparation • Documentation • Checklist
Executing the audit • Opening meeting • Collecting evidence • Closing meeting
Audit report preparation / distribution Corrective action follow up / Close out. 35
Audit Planning The audit program shall be planned taking into consideration: • Status and importance of the processes and areas to be audited. • Results of previous audits. • When internal / external non conformities or customer complaints occur, the audit frequency shall be appropriately increased. • Cover all processes, activities and shifts in accordance with an annual plan. Prepare an audit plan to satisfy the system and process audit requirements in ISO/TS 16949: 2002 36
The audit approach
Quality management system audit: Verify compliance with ISO/TS 16949 + any additional quality management system requirements. Manufacturing process audit: Audit of each manufacturing process to determine its effectiveness Product Audit: Audit of product at appropriate stages of production and delivery to verify conformance to all specified requirements. 37
Manufacturing Process Audit
ISO/TS requirement 8.2.2.2: The organization shall audit each manufacturing process to determine its effectiveness.
Can be extended to apply to any company business processes. ISO 9001; 2000 requires a process approach 38
Product Audits
Known in QS-9000 as final product audit (Applied to final packaged product only) ISO/TS requirement 8.2.2.3 Audit product at appropriate stages of production and delivery to verify conformance to all specified requirements such as product dimensions, functionality, packaging, labeling, at a defined frequency. 39
Product Audits
A product audit is the planning, performance, evaluation and documentation of examinations of - Quantitative and qualitative characteristics. on
- material products
after
- completion of a production stage
by
- comparison with reference values
by
- an independent auditor 40
Product audit planning
Link to production process audits or run as an independent audit program? Base frequency on results! Immediate action required if problems found Refer to VDA6.5 for guidance 41
Session 2: Internal Auditor Qualification & Customer Specific Requirement
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Internal Auditor Qualification ISO 19011 Auditor: a person who has the competence to conduct an audit.
Competence: Demonstrated personal attributes and demonstrated ability to apply knowledge and skills.
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Auditor Competence defined in ISO 19011
Quality system knowledge
Education
Work Experience
Generic Knowledge
Environment System knowledge
Auditor training
Audit Experience
Personnel attributes
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Current techniques
What is your organizations current process for qualifying internal auditors? How is competence maintained?
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Internal Auditor Qualification
Auditor Qualification: “The organization shall have internal auditors who are qualified to audit the requirements of this technical specification” (See 6.2.2.2 Training) Ensure that your understand your Customer specific requirements for auditor qualification • E.g. Ford / GM / Peugeot 46
Examples of Customer Specific qualification requirements Ford (requirement 4.39) • Trained in ISO/TS 16949: 2002, core tools, customer specific requirements and the automotive process approach. • Participate in practice sessions equivalent to one day. • Training delivered by a trainer qualified under the above criteria Or • Conduct at least 5 internal audits in 24 months, under supervision of an auditor trained as above 47
Examples of Customer Specific qualification requirements General Motors (Requirement 4.1.10) • Qualified as recommended in ISO 19011 sections 7.17.5 • Understand the process approach • Understand core tools (PPAP, APQP, MSA, SPC, FMEA) • Understand GM customer specific requirements
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Internal Auditor Qualification
What do you think an organization should take into account when selecting and qualifying internal auditors? Define what you think a “Competency profile” should be?
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Personnel Attributes Ethical: Fair, truthful, sincere, honest, discreet Open minded: Willing to consider other points of view Diplomatic: Tactful in dealing with people Observant: Actively aware of physical surroundings and activities Perceptive: Instinctively aware of and able to understand situations Versatile: Adjusts readily to different situations Tenacious: Persistent, focused on achieving objectives Decisive: Reaches timely conclusions based upon logical reasoning and analysis Self – reliant: Acts and functions independently while interacting effectively with others 50
Auditor Qualification Criteria
Education Training in ISO/TS 16949: 2002 Work Experience Quality management experience Demonstrated ability to apply knowledge and skills
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Customer Specific Requirements
Overview of Ford Motor Company: • 4.4 Control of records: – PPAP, tooling records, purchase orders, and amendments maintained for the length of time for the part plus one year – Production inspection and test results retained for one year after the year when they are created – Internal audit and management review records retained for three years
• 4.6 Customer representative: – Inform Ford within 10 days of any change to senior management responsible for quality
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Process Approach to auditing methodology What are the objective(s) for the process? How do they link to business objective? What activities are carried out in the process? What are the applicable support processes? How is achievement measured? What results are actually being achieved? What actions are planned to ensure achievement of defined objectives? What improvement efforts are being made? 53
Preparing to audit a process
Ensured scope of audit is clearly defined (i.e. where to start and finish!) Make logistical arrangements with auditee (timings, agenda, audit scope) Identify any objectives / measures related to the process and documents used to control the process (may be done by discussion with auditee) 54
Preparing to audit a process
Prepare for a process audit by review of key information gathered which may include: • • • • • •
Relevant performance indicators / objectives Management review minutes Previous audit records Continuous improvement plans ISO/TS 16949: 2002 Customer specific requirements
Planning is essential for an effective audit 55
Checklist Preparation
ISO/TS 16949: 2002, 8.2.2.4 note states: “Specific checklists should be used for each audit” Create your own generic checklists or an individual turtle diagram / checklists for each audit Use turtle / checklist as a guide and not the only questions to be asked!
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Undertaking the audit (What, Where, When, How, Why, Who, Show me?)
1. Set the Scene: Opening meeting, Outline the objective of the audit to the auditee. 2. Establish responsibilities: Confirm responsibilities and what happens in the process / area. 3. Analyse the process: Review what actually happens, e.g. follow an audit trail.
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Undertaking the audit (What, Where, When, How, Why, Who, Show me?)
4. Search for objective evidence & records Interview relevant employees (Include management) Look for the evidence of implementation and effectiveness of process, not just procedure compliance! Look for opportunities for Improvement
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Undertaking the audit (What, Where, When, How, Why, Who, Show me?)
4. Search for objective evidence & records • • • •
Follow process flow Do not get distracted Take notes on items to follow up on Manage time effectively Open questions may take minutes Closed questions may take seconds It takes time to study data Allow for the unexpected 59
Undertaking the audit (What, Where, When, How, Why, Who, Show me?)
5. Check back Confirm understanding & link findings (e.g. to ISO/TS 16949: 2002 requirement)
6. Close out Explain audit findings to auditee and agree actions required 60
Reporting Findings
Evidence gathered should be evaluated against requirements defined in ISO/TS 16949: 2002, customer requirements, and organizations management system Confirm decisions, (Conformity, Non conformity or opportunity for improvement) Where found, prepare written nonconformities / opportunity for improvement 61
ISO 9000: 2000 definitions
Conformity: Fulfillment of requirement Nonconformity: Non fulfillment of a requirement
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ISO/TS 16949 Definitions Major Nonconformity: • Absence of or total breakdown of a system to meet an ISO/TS 16949 requirement • Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the product or services for their intended purpose. • A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products 63
ISO/TS 16949 Definitions
Minor Nonconformity: • A failure to comply with ISO/TS 16949 which based on judgement and experience is not likely to result in the failure of the quality system or reduce its ability to assure controlled processes or products.
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Opportunities for Improvement
Auditors should identify opportunities for improvement as these become evident.
e.g. Where the situation is compliant but could be undertaken more efficiently.
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Preparing nonconformities
Typical reporting structure • • • • • • • • •
Report number Date Auditor / audit team name and auditee Process / area audited ISO/TS requirement / related procedure Failure observed Evidence found Nonconformity grade (Where applicable) Agreement / signature of auditee 66
Audit reporting
Report content: • Scope & objectives of audit • Details of auditors / auditees • Reference documents against which audit was conducted • Nonconformities and opportunities for improvement • The systems ability to achieve defined quality objectives • Distribution list
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Corrective action follow up
Auditee is responsible for determining root cause, and initiating corrective and preventive action needed to address nonconformities Auditors responsibility is to verify corrective and preventive action is effectively implemented within the agreed timescale
68
Audit situation “Work shop”
Following submission of the nonconformity report to the manufacturing manager, the following response was received by the auditor, within the agreed timescale: Report no. IBW1 “Temporary employee trained and leak test now being undertaken at the required frequency”
Is this acceptable to close the nonconformance? 69
Nonconformity report Report #: IBW1
Date raised: May 2004
Auditor: I.B. Wright Process / support: Manufacturing / HR Management ISO/TS req.: 8.2.3.1, 6.2.2.3 Nonconformity: The leak test, specified on the control plan for product A1246, was not being undertaken at the defined frequency & failures were found at customer. No evidence was available to demonstrate the temporary employee operating the process was competent to undertake the leak test. Evidence of competency was not seen for other temporary staff. Grade: Major Signed: Auditor: I.B. Wright
Auditee: U.B. Nhad 70
The End of Day 1
Mohamed Ghorab
[email protected] 71
Session 3: Advanced Product Quality Planning (APQP) & Control Plan
72
Product Quality Planning Timing Chart
73
1. Plan & Define Program Outputs: Design goals. Reliability & Quality goals. Preliminary bill of Material. Preliminary process flow chart. Preliminary listing of special product & process characteristics. Product Assurance plan. Management Support. 74
2. Product design & development
Outputs: New equipment, tooling & facilities requirements. Special product & process characteristics. Prototype Control Plan. Gages / Testing equipment requirements. Team feasibility commitment and management support. 75
3. Process Design & Development Outputs: Packaging Standard. Product / process quality system review. Process flow chart. Floor plan layout. Characteristics matrix. PFMEA. Pre-launch Control Plan. Process instructions. Measurement systems analysis plan. Preliminary process capability study plan. Packaging specifications. Management support. 76
4. Product & Process Validation Outputs: Production Trial run. Measurement system evaluation. Preliminary process capability study. Production part approval. Production validation testing. Packaging evaluation. Production control plan. Quality planning sign off & management support. 77
5. Feedback, Assessment & Corrective Action
Outputs: Reduced variation.
Customer satisfaction.
Delivery & Service. 78
Process analysis
79
Control plan methodology What: is a formal document that provides a written summary description of the systems, methods and documents used in controlling parts and processes in order to minimize process and product variations Why: to aid in the manufacture of quality products according to customer requirements How: by providing a structured approach for the design, selection and implementation of value added control methods for the whole product manufacturing processes Where: all actions required at each phase of processes including receiving, in-process ,outgoing , and periodic requirements to assure that all process outputs will be in a state of control 80
CP – Important notes The control plan does not replace the information contained in detailed operator instructions but may make reference to. The control plan should provide the processes monitoring and control methods that will be used to control both product characteristics and process parameters The control plan represents an integral part of an overall quality system and should be used in conjunction with other related documents The control plan should be utilized as a living document that responds to continual updating and improvements of processes Organization should use the control plan format that is most suitable to its type, size and complexity of its manufacturing processes . A single control plan may apply to a group or family of products that are produced by the same processes at same source. 81
While establishing control plans
use a cross functional (multidisciplinary) team that comprises engineering, design, manufacturing, customer services, quality functions and others as appropriate. Utilize all the available information to gain a better understanding of the process, such as: • • • • • •
Process flow diagram PFMEA Special product characteristics Lessons learned from similar parts Team knowledge of the process and experience Design reviews 82
Benefits of developing and implementing control plans includes It’s an aid to reduce waste and improve the quality of the products during design, manufacturing and assembly . It’s a structured discipline that provides a thorough evaluation of the product and process It helps to identify source of variations (input variables) that cause variation in product characteristics (output variables) It focus resources on processes and products related to characteristics that are important to the customer , this will help to reduce costs without sacrificing quality ,ultimately enhancing customer satisfaction As a living document , it identifies and communicates changes in product/process characteristics, control methods and corrective actions.
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Types of control plans
Prototype CP: it is a description of dimensional measurements and material and performance tests that will occur during prototype build Pre launch CP: it is a description of dimensional measurements and material and performance tests that will occur after prototype and before full production Production CP: it is a description of dimensional measurements and material and performance tests that will occur during mass production 84
Control Plan Table: 1
2
Serial
Operation #
3
10 Size
Material
Sample Frequency
Operation Description
11 Respo nsible
4
5 Characteristics
12
Reaction Plan
6 Measurement Technique
7 Clas s
8 Machines / Device / Equipments / Tools
13 Documents
9 Spec./Tolerance
14 Records
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Session 4: Statistical Process Control (SPC)
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Objectives
Understand the purpose of statistical process control (SPC) and link to ISO/TS 16949: 2002 Understand variable and attribute data and the types of charts used for each Understand methods of constructing control charts, calculating control limits and interpreting data Understand the term process capability
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Link to ISO/TS 16949: 2002
7.5.1.1:
Control Plan
7.5.1.3:
Verification of Job setup
7.6.1:
Measurement system analysis
8.1.1:
Identification of statistical tools
8.1.2:
Knowledge of basic statistical concepts
8.2.3.1:
Monitoring and measuring of manufacturing processes
8.5.1.2:
Manufacturing process improvement 88
What is Statistical Process Control
The use of statistical techniques such as Control Charts to analyze 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”
89
Quality Loss Function; Distribution of Products produced
90
Types of Statistical Quality Control
91
Quality Characteristics
92
Statistical Process Control
Statistical technique used to ensure process is making product to standard. All process are subject to variability: • Natural causes: random variations. • Assignable causes: correctable problems. – Machine wear, unskilled workers, poor material.
Objective: Identify assignable causes. Uses process control charts. 93
Process Control: Three Types of Process Outputs
94
Process Chart Shows sequence of events in process. Depicts activity relation ships. Has many uses: • • • •
Identify data collection points. Find problem sources. Identify places for improvement. Identify where travel distances can be reduced. 95
Statistical Process Control (SPC)
Uses statistics & control charts to tell when to adjust process. Developed by Shewhart in 1920’s. Involves: • Creating standards (Upper & Lower limits). • Measuring sample output (e.g. mean wgt.). • Taking Corrective actions (if necessary).
Done while product is being produced. 96
Statistical Process Control Steps
97
Process Control Chart
98
Patterns to look for in Control Charts
99
Process Capability Cpk
100
Meaning of Cpk Measures
101
Capability Indices
If the process data have a normal (bell shape) distribution the following can be used as a guide to interpret Cpk:
Cpk
Approx, % out of Spec
1.00
66,000 / 1,000,000
1.33
6,000 / 1,000,000
1.67
233 / 1,000,000
2.00
3.4 / 1,000,000
Customer will often specify minimum Cpk 102
Session 5: Failure Mode & Effect Analysis
103
Requirement for FMEA in ISO/TS 16949
0.5:
Goal
4.2.3.1:
Engineering specifications
7.3.1.1:
Multidisciplinary approach
7.3.2.3:
Special Characteristics
7.3.3.1:
Product Design Output
7.3.3.2:
Manufacturing process design outputs
7.5.1.1:
Control Plan 104
Definition of FMEA
A systematic group of activities intended to:
Recognize and evaluate the potential failure of a product / process and the effects of failure Identify actions that could eliminate or reduce the chance of the potential failure occuring Document the entire process
105
Vehicle Manufacturing View
Evidence from vehicle campaigns / recalls have shown a fully implemented FMEA could have prevented many cases
Act “before the event” (Prevention) not after (Detection)
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Interaction with ISO/TS 16949: 2002
Product Realization
Design Control
Design & Process FMEA
Process Control
Continual Improvement
Competence / Training
Corrective / Preventive Action
107
Severity
Severity is the rank associated with the most serious effect for a given failure mode Severity can only be reduced by design change Team should establish criteria and ranking system 108
Occurrence
Occurrence is the likelihood that a specific cause / mechanism of failure will occur Rank from 1 to 10 The ranking number has a relative meaning rather absolute value 109
Detection
Detection is the rank associated with the best detection control listed in the process control column
110
Risk Priority Number – RPN
RPN is the product of severity, Occurrence and detection ranking
S X O X D = RPN This value can be between 1 and 1000 Customers may define trigger points for action (e.g. RPN > 100 Severity > 8) 111
FMEA Flow Chart Assign a label to each process or system component List the function of each component List potential failure modes Describe effects of the failures Determine failure severity Determine probability of failure Determine detection rate of failure Assign RPN Take action to reduce the highest risk
112
FMEA Worksheet FailureModeandEffectsAnalysis Product or ProcessName: Component:
ItemFunctionor Purpose
Potential Potential FailureMode Effect of Failure
Model Number: DesignResponsibility: CompletionDate: FMEANumber: PreparedBy: S C Potential O Current e l Causeof c Controls v a Failure c s u s r r
ActionResults D R Recom- Responsibility Actions e P mended &Completion Taken t N Action Date
S O D R e c e P v c t N
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Recommended Actions
Actions should be targeted toward high RPN / high severity
Intent is to reduce ranking by actions Actions taken should be tracked, recorded and closed
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Documentation Linkages within the FMEA process DFMEA
PFMEA & Flow Chart
Control Plan Work Instruction & Standard Operations 125
The End of Day 2
Mohamed Ghorab
[email protected] 126
Session 6: Measurement System Analysis (MSA)
127
Requirement for MSA in ISO/TS 16949; 2002
7.6.1: Measurement System Analysis “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 system analysis. Other analytical methods of acceptance criteria may be used if approved by the customer”
128
MSA (Definition)
A collection of instruments or gages, standards, operations, methods, fixtures, software, personnel, environment & assumptions used to quantify a unit of measure or fix assessment to the feature characteristic being measured. The complete process used to obtain measurements.
129
Calibration
A set of operations that establish, under specified operating conditions, the relation ship between a measuring device and a traceable standard of a known reference and uncertainty.
130
Calibration Linkages
National Standard
Reference Standard
Working Standard Production /gauge
131
Measurement System Analysis
Material
Input need to measure
Man
Method
MEASUREMENT SYSTEM
Machine
(Time)
Output Data
Environment
132
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”.
This will allow us to quantify and communicate the limitations of specific measurement systems.
133
Quality of Measurement Data
Reference value: “A reference for comparison, normally determined under laboratory conditions or using a more accurate instrument”. Accuracy: How close measurements are to the reference value
134
Measurement System Properties
Discrimination: The smallest detectable unit of a measurement device. Should be 1/10 of the tolerance to be measured. Resolution: Capability of measurement system to detect & faithfully indicate even small changes.
135
Measurement system variation
Location (Mean) Linearity Reference Value
Reference Value Smaller Bias
Bias
Reference Value
Larger Bias
Stability
Time 2
Time 1 136
Measurement system variation
Spread (Mean) Repeatability
Reproducibility Operator B
Operator C
Operator A
Repeatability (EV): Common cause random variables resulting from successive trials under defined conditions of measure. Reproducibility (AV): When 2 or more people measure the same parts or items using the same measuring technique. 137
Gauge R & R Studies
There are 3 principle methods: Range Method. Average & Range Method. ANOVA (Analysis Of Variance) Method.
138
Gauge R & R Studies Range Method Quick Approximation of overall measurement variability. This has a defined confidence level, e.g. 80% with sample of 5. Typically uses 2 appraisers & 5 parts for study.
% Gauge R&R = (
Gauge R&R
)
X 100%
(Process Standard Deviation) 139
Gauge R & R Studies Average & Range Method Summarizes the data gathered in a measurement study, to provide information on the total variation and its components of: • • • •
Equipment, Appraiser, Equipment / appraiser combined & Part variation.
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Gauge R & R Studies Average & Range Method – Cont. Select appraisers, should be the same people using the instrument. Select measurement tool, has the gauge the required discrimination?, if the characteristic variation is 0.01 mm the gauge should be able to read 0.001mm. Select parts, from the process that represent entire operating range, from several days production, number each part.
141
Gauge R & R Studies Average & Range Method – Cont. Somebody should facilitate the study. Ensure each appraiser uses the same procedure. Measurements should be made in a random order. Readings should estimate the nearest number to that which can be obtained.
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Gauge R & R Studies Average & Range Method – Cont. Numerical analysis of the study; Gauge repeatability and reproducibility data sheet or specific software, e.g. “Minitab”. The study estimates; the variation and percent of process variation for the measurement system and its components. • Repeatability. • Reproducibility. • Part to Part variation. 143
Guidelines for Acceptance of Gauge Repeatability & Reproducibility
Under 10%
10% - 30%
Over 30%
Generally considered to be acceptable.
May be acceptable based on importance of application, cost of repairs, etc. Not acceptable. Every effort should be made to improve. 144
R & R – Analysis of results
EV > AV reasons: • • • •
Gauge need maintenance. Gauge need redesigning. Gauge fixture need to improve. Excessive within part variation.
AV > EV reasons: • Training appraiser. • Gauge dial / indicator is difficult to read (Parallex). 145
Gauge Discrimination (NDC)
5
Accepted
146
Example:
See next attached work sheets. 147
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Session 7: The registration Process Rules for Achieving IATF recognition, 2nd edition
150
Scope of ISO/TS 16949: 2002
“This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured” “This technical specification can be applied throughout the automotive supply chain” Site: Where value added manufacturing processes occur
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Definitions (FAQ 1)
Automotive shall be understood as including the following: Cars, Trucks (Light, Medium and Heavy), Buses, Motorcycles Automotive shall be understood to exclude the following: Industrial, Agriculture, Off-highway (Mining, Forestry, Construction, etc…) See www.iaob.org for latest FAQ’s and sanctioned interpretations. 152
Scope
Scope of registration must include all products / services provided to subscribing customers. Scope of registration may also include at the decision of the organization, manufacturing meeting the applicability to ISO/TS supplied to customers non subscribing. Support functions onsite or remote must be included (design, purchasing, sales) 153
Registration Process
Audit days for ISO/TS 16949: 2002 defined in Annex 3 of Scheme rules ISO 9001: 2000
Audit days of recert. Audit
QS9000 / VDA 6.1 & ISO 9001: 2000 QS9000
Max 50% reduction Max 30% reduction 154
Registration Process Select an IATF recognized Certification Body Contract with Certification Body Optional pre-audit / assessment Stage 1 Readiness Review Audit Planning for Stage 2 Stage 2 site audit (Within 90 days of stage 1) Nonconformance closure (90 days max) Certification decision / certificate issue Surveillance audits (years 1 and 2) Recertification (year 3) 155
Stage 1 Readiness Review
Scheme rules require the following documents are submitted for review: • Description of processes showing sequence and interaction, including key indicators of performance trends for the previous 12 months, minimum • Evidence that all the requirements of ISO/TS 16949: 2002 are addressed by the organization’s processes • Quality Manual (for each site to be audited)
156
Stage 1 Readiness Review • Internal audit and management review planning and results from previous 12 months • List of Qualified internal auditors • List of customer specific requirements • Customer satisfaction & complaints status, including customer reports and score cards
157
Stage 2 Site Audit
Audit will start with “Top Management” Auditors will look for evidence of implementation and effectiveness of processes Audit will cover all shifts Evidence must include the results of at least one complete internal audit and management review cycle.
158
Stage 2 Audit Findings
Certificate cannot be issued with any open nonconformances Any nonconformance must be 100% resolved within 90 days of the end of stage 2 site audit Any nonconformity identified at registration assessment will require re-audit Any nonconformity identified on surveillance will result in suspension process being instigated 159
The End of Day 3 & the Course
Mohamed Ghorab
[email protected] 160
