Professional Documents
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Appreciating key aspects of ISO/TS 16949 + market drivers Comparing ISO/TS 16949:2009 with ISO 9001 Approaches to assessing where we are now Appreciating the techniques to support ISO/TS 16949;
Statistical Analysis
Statistical Process Control Measurement Systems Analysis
TS 16949 is a Technical Standard expressing particular requirements for the application of ISO 9001:2009 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
Prepared by International Automotive Task Force (IATF) + Japan Automobile Manufacturers Assoc. (JAMA)
EAQF AVSQ Automotive VDA 6.1 QS 9000 ISO 9000 series ISO/TS 16949:1999 ISO/TS 16949:2000 ISO/TS 16949:2009
OEMs
FIEV
ANFIA
GKN
Faurecia
Bosch
Magneti Marelli
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.
processes for defining competence requirements, providing training (including on the job training for employed, temporary and agency personnel), verifying effectiveness of actions taken
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 .
This will be cover in the annual review performance new format, however a training plan is advisable to be created. And some metrics for HR department.
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)
Focus on process and process measurement and pursue the improvement. (include measurement of customer perception and satisfaction) All processes need to take into account any customer specific requirements Development a network of suppliers using ISO/TS16949 Focus on continual improvement
Undertaking effective system, process & product audits Effective analysis of data to drive improvement Measurable KPI
deployment.
Evidence of continual improvement throughout all organisations processes, not just manufacturing or Quality.
Process Approach [ 4.1, 5.1.1 ] Customer focus [ 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 ] System approach [ 4.1, 5.1.1, 5.4.1, 5.6.1 ] to management Continual improvement [ 5.1, 5.3, 8.5.1 ] Factual approach [ 5.6.1, 8.2.2, 8.4 ] to decision making Mutually beneficial [ 7.4.1.2 ] supplier relationship
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.
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 Inputs and outputs
Management Responsibility Customer Focus Internal Audit Control of Non-Conformity products. Customer Complaints Corrective, Preventive and Improvement Actions. .....
Sales and Product Specification (Order/Request) Engineering, Design and Development processes (DDP, Project mananagement.....) Production and delivery. Purchasing Change control Process HR...
Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (including instances of premium freight) Customer notification of quality or delivery issues
Reports & reviews of performance against objectives Evaluation of the cost of poor quality
Customer specific quality management system requirements supplemental to ISO/TS 16949 shall be included in the audit in order to obtain customer recognition of such certification
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 [6.2.2.2] 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]
The goal of this Technical Specification is the development of a quality management system that provides for;
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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 many common requirements (less paper?)
ISO/TS
BMW, DaimlerChrysler, Fiat, Ford, GM (incl Opel-Vauxhall), PSA Peugeot-Citron, Renault SA, VW.
UK-based
manufacturers:
BMW Group; Ford Motor Company; Honda UK; Jaguar Land Rover; Nissan Motor Manufacturing UK; Peugeot Motor Company; Rolls-Royce Motor Cars & Bentley Motor Cars; GKN; Mobil Oil.
OEM
Audi/Volkswagen BMW Daimler Chrysler Ford Motor Co. General Motors Honda Isuzu Mazda Mitsubishi Nissan PSA Peugeot-Citron Renault Rover Saab Subaru Toyota
Customer Specific Requirements [ Qality Cap. Sppliers 4t Ed ] [ Spplied Parts Qality Mgmt ] [ Daimler Crysler Cst mer specific Reqiremets f r se it ISO/TS 6 4 : ] /Q ) C tact cst mer
tact cst
ISO/TS 6 4
tact cst mer tact cst mer tact cst mer tact cst mer tact cst mer
[H
C C
[ SMITQA- 3 ] [ Spplier Qality Maal / Alliace Spplier Gide ] C C tact cst mer tact cst mer Spplier Maagemet System ]
ISO/TS 6 4 ISO/TS 6 4 C C
tact cst mer tact cst mer tact cst mer tact cst mer
[ RG C
C C
Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement
Resource Management
Personnel with product design responsibility shall be competent to achieve design requirements and skilled in applicable tools and techniques. [6.2.2.1] Document procedures for identifying training needs and achieving competence of personnel [6.2.2.2] Provide on-the-job training, including the consequences to the customer of nonconformities [6.2.2.3] Have a process to motivate employees to; achieve quality objectives, make continual improvements & create an innovative environment. [6.2.2.4]
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]
Statistical Analysis
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Statistical Process Control (SPC) The use of statistical techniques such as control charts to analyze a process or its outputs and take appropriate actions to achieve and maintain a state of statistical control and to improve process capability.
Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in
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
Common causes natural random events which affect all values of process output Special causes intermittent, often unpredictable causes making the process output unstable
Values beyond control limits Nonrandom patterns or trends e.g. 7 points increasing/decreasing, 7 points one side of the average
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 Approx Cpk requirement parts per million out of specification
. .33 .67 . 66, 6, 33 4.6 (Si sigma)
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)
Statistical Analysis
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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.
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
MEASUREMENT SYSTEM
Machine (Time) Environment
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.
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.
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
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.
Under 10% considered acceptable To improve, appraiser(s) may need training, or more ease of use
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.
Evidence from vehicle recalls has shown a fully implemented FMEA could have prevented many causes Enables action before the event (Prevention), not after (Detection)
Engineering specifications Multidisciplinary approach Special Characteristics Product design outputs Manufacturing process design outputs Control Plan
Item
How can cause or effect be prevented & detected? How good is this method at detecting / preventing? What risks are highest priority?
What should be done, by whom & when? -design/ process change -special controls, changes in procedures/ guides What has been done? Is there still a priority risk?
What can go wrong? -No function -Partial/over/ degraded function -Intermittent function - nintended function
S e
C l a s s
O c c u r
D e t e c
Action Results S e O c c D e t R P N
Design FMEA
TEAM EFFORT
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 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
Process FMEA
TEAM EFFORT
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 FMEA workbook. 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
Detecti
rati g
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
Detecti
rati g
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
Control Plans
Control Plans
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.
General Data; part no. & name, process step descriptions, etc Product Control; characteristics for control; spec. tolerance Process Control; process parameters, manufacturing tools Methods; evaluation of measurement technique, sample size & freq. Reaction Plan & corrective actions
Protot pe Contro P an Number Part Number / Late t Change Level Part Name/Description Supplier/Plant
Customer Qualit Approval/Date (if Req'd) Other Approval/Date (if Req'd) Methods Reaction Plan / Corrective Control Method Action
Process Name / Part/ Machine, Operation Process Device, Jig, Description Number Tools for Manuf.
No.
Special Evaluation Process Product/Process Sample Sample Char. Measurement Product parameters Specification/Tolerance Size Frequenc Class Technique
Date (orig.)
Date (Rev.)
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)
Next Steps??