Download - TS Auditor Course
ISO/TS 16949: 2002
3 Days Internal Auditor
Certification CourseInstructor / Lecturer:
Mohamed GhorabJuly 2009
2
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)
3
Basics
Switch mobile phones to the silent mode.
Toilets.
Break.
Material provided.
A written open book final exam
4
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.
5
We provide leading & innovative services to all industries
Certification
Inspection & Verification
Outsourcing
Risk Management
Technical Consulting
Testing & Analysis
Trainings ®:
In the areas of:
ISO/TS 16949: 20023 Days Internal Auditor
Certification Course
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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:
Background & Development of ISO/TS
& Automotive Process Approach
Internal Auditor Qualification
& Customer Specific requirements
APQP & Control Plan
Statistical Process Control (SPC)
Failure Mode & Effect Analysis (FMEA)
Measurement System Analysis (MSA)
Rules For Achieving IATF Recognition
Written Exam (Open Book)
Day 1
Day 2
Day 3
Session 1
Session 3
Session 4
Session 5
Session 6
Session 2
Session 7
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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
11
EAQF
Automotive migration to International Standards
The plan is to have no change before 2008 at the earliest due to alignment with ISO 9001: 2000 update.
1994 200019991997 1998 2002
ISO/TS1st edition
ISO 9001: 1994Based document
ISO/TS2002 edition
ISO 9001: 2000Based document
AVSQ
Automotive sector Quality requirements(With registration variation)
USA
Germany
Italy
France
VDA 6QS 9000
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IATF Representatives
France Germany Italy USA UK Japan
Car Makers PSA
Renault
VW
BMW
Daimler
Fiat Chrysler
Ford
GM
Liaison
(Europe / US)
Opel VW of USA
National Super Organization
FIEV VDA ANFIA AIAG / IAOB
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.
14
Business Planning
Business Plan
Policy
Objectives
Planning
Employee Motivation
& Empowerment
Impact
Influence
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Terminology
Process
Customer
Procedure
ISO/TS 16949: 2002 ISO 9001: 1994
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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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8 Quality Management Principles
Customer Focus (1, 5.1, 5.2, 5.6.1.1, 8.2.1, 8.3.3)
Leadership (5.3, 5.4.1)
Involvement of People (5.5.3, 6.2.2.4)
Process Approach (4.1, 5.1.1)
System Approach to management (4.1, 5.1.1, 5.4.1, 5.6.1)
Continual Improvement (Goal, 1, 5.1, 5.3, 8.5.1, 8.5.1.1, 8.5.1.2)
Factual Approach to decision making (5.6.1, 8.2.2, 8.4)
Mutually beneficial supplier relationship (7.4.1.2)
Please find a requirement in ISO/TS which relates to each of the above principles.
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Process Approach
4 8
7
6
5
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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.
And a chain of activities between these two limits
INPUTCustomer who
has a need
OUTPUTCustomer who has a need met
InputStep
1Step
2Step“N”
Output
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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
Outputs
Conforming product delivered to customer schedule (8.2.1.1)
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)
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)
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)
(Support Processes)ITHuman resourceLogisticsSalesQualityPreventive maintenance
Process:
Manufacturing Manufacturing Process (7.5)Process (7.5)
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Turtle Diagram Workshop
In your groups analyze the process allocated by the trainer and create a turtle diagram.
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Process Improvement(Shewart Cycle)
Plan What and why?
Do How, when, and how much?
Check How will you know it worked?
Act How do you plan to fully adopt?
Act Plan
Check Do
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The Dilbert Cycle
Blame someone else for catastrophe
Adopt unproven process or technology
Make wild guess at what is wrong
ACT
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Plan-Do-Check-Act diagram
Requirement
Plan
CorrectiveAction
Do Check Conforms?Product /Service
Feedback Loop
Yes
No
Continual Improvement
Requirement
Plan
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The << V >> Cycle and the audit
P
D
C
A
Approach << Top Down >>
PDCA feedbacksystem
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The << V >> 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)
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The << V >> Cycle:Follow through the business strategy
Responsibilities shared, responsibilities
assigned and responsibilities defined!
Management from the top management at every level!P
DC
ATop Management
Process Owners
Participants Participants
Process Owners
Top Management
StrategyPolicy
ObjectivesResources
Risk analysis
Planning the activities
Operations &recording
ReportingImprovement actionsCollect and analyze
Operational information
Strategic thinkingDecisions
Use information
The organization must identify and allocate necessary resources but also ensure continual improvement
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The CAPDo Logic
Start with a questions about performance, what is expected, what are the indicators and objectives, What is the actual performance?
How is performance being improved?
How was the process planned, does the process design allow performance objectives to be met? Previous Performance results?
Is the process being carried out as designed? Are theMethods being applied in the field? On the shop floor,At the work station?
C
A
P
Do
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Understand the process to audit
Outputs
Conforming product delivered to customer schedule (8.2.1.1)
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)
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)
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)
(Support Processes)ITHuman resourceLogisticsSalesQualityPreventive maintenance
Process:
Manufacturing Manufacturing Process (7.5)Process (7.5)
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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.
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Audits parties’ levels
Accreditation Body
Certification Body
ORGANIZATION
CUSTUMER
SUPPLIER
3rd p 3rd p3rd p
1st p1st p1st p
2nd p2nd p
4th 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.
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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.
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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
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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.
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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
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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.
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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
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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
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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
Personnel attributes
EnvironmentSystem
knowledge
GenericKnowledge
Education Work Experience Auditor training Audit Experience
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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 (8.2.2.5):
“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
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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
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Examples of Customer Specific qualification requirements
General Motors (Requirement 4.1.10) Qualified as recommended in ISO 19011 sections 7.1-
7.5 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
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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?
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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)
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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
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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
60
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
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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
62
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
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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
65
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.
67
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
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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
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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?
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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
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Session 3:
Advanced Product Quality Planning (APQP) & Control Plan
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Product Quality Planning Timing Chart
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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.
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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.
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3. Process Design & DevelopmentOutputs:
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.
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4. Product & Process ValidationOutputs:
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.
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5. Feedback, Assessment & Corrective Action
Outputs:
Reduced variation. Customer satisfaction. Delivery & Service.
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Process analysis
81
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
82
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.
83
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
84
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.
85
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
86
Control Plan Table:
SampleRespon
sibleReaction Plan Documents Records
Size Frequency
SerialOperation #
Material
Operation Description
CharacteristicsMeasurement
TechniqueClas
s
Machines / Device /
Equipments / Tools
Spec./Tolerance
1 2 3 4 5 6 78
9
10 1112 1413
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Session 4:
Statistical Process Control(SPC)
88
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
89
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
90
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”
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Quality Loss Function; Distribution of Products produced
92
Types of Statistical Quality Control
93
Quality Characteristics
94
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.
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Process Control: Three Types of Process Outputs
96
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.
97
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.
98
Statistical Process Control Steps
99
Process Control Chart
100
Patterns to look for in Control Charts
101
Process Capability Cpk
102
Meaning of Cpk Measures
103
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
104
Session 5:
Failure Mode & Effect Analysis
105
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
106
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
107
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)
108
Interaction with ISO/TS 16949: 2002
Product Realization
Design & Process FMEA
Design Control
Process Control
Competence / Training
Corrective / Preventive
Action
Continual Improvement
109
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
110
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
111
Detection
Detection is the rank associated with the best detection control listed in the process control column
112
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)
113
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
114
FMEA Worksheet
115
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
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FORD Q1 – 2002 requirements
Annual Review: To prioritize improvement activity to achieve lower RPN figures.
Pareto analysis:To prioritize actions to drive improvements by the following analysis breakdown: Severity Severity X Occurrence
Identify High RPN – (Top 10) focus on actions to reduce.
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Session 6:
Measurement System Analysis(MSA)
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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”
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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.
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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.
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Calibration Linkages
National Standard
Reference Standard
Working Standard
Production /gauge
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Measurement System Analysis
MEASUREMENT SYSTEM
Material Man Method
Machine (Time) Environment
Input need to measure
Output Data
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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.
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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
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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.
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Measurement system variationLocation (Mean)
Reference Value
Reference Value
Reference Value
Time 1
Time 2
Bias
Linearity
Stability
Larger BiasSmaller Bias
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Measurement system variationSpread (Mean)
Operator A
Operator C
Reproducibility
Operator B
Repeatability
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.
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Gauge R & R Studies
There are 3 principle methods:
Range Method.
Average & Range Method.
ANOVA (Analysis Of Variance) Method.
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Gauge R & R StudiesRange 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)
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Gauge R & R StudiesAverage & 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 StudiesAverage & 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.
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Gauge R & R StudiesAverage & 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 StudiesAverage & 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.
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Guidelines for Acceptance of Gauge Repeatability & Reproducibility
Under 10%
Generally considered to be acceptable.
10% - 30%
May be acceptable based on importance of application, cost of repairs, etc.
Over 30%
Not acceptable.
Every effort should be made to improve.
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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).
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Gauge Discrimination (NDC)
< 2 Not Accepted
NDC = 1.41 * (PV / GRR)
> 5 Accepted
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Example:
See next attached work sheets.
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Session 7:
The registration Process Rules for Achieving IATF recognition,
2nd edition
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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”
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.
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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)
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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 Max 50% reduction
QS9000 (is not existing) Max 30% reduction
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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)
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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)
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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
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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.
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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
