ts16949 standard presentation

An Introduction to ISO/TS 16949:2009

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

FMEA Control Plans

Considering the next steps

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 productionIn the standard document ISO 9001:2000 text is shown

in boxes

Prepared by International Automotive Task Force (IATF) + Japan Automobile Manufacturers Assoc. (JAMA)

ISO 9000series

QS 9000

VDA 6.1

AVSQ

EAQF

ISO 9001:1994 ISO 9001:2000

Automotive

1994 1999 2000 2002

ISO/TS16949:1999

ISO/TS16949:2000

ISO 9001:2008

ISO/TS16949:2009

2008

All major automotive OEMs US, European + Japanese supplier

organizations Some Tier 1 suppliersUSA UK France Germany Italy Japan

OEMs FordGMChrysler

PSARenault

VWBMWDaimler

Fiat Nissan Toyota Honda

National Supplier Org’ns

SMMT FIEV VDA ANFIA JAMA

Suppliers Bosch USA 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.”

Top management involvement including; implementing a business plan linked to defined

measurable quality objectives

• Clear definition of responsibilities including;– Authority to stop production to correct quality

problems

• Top management review of the performance of the quality system including;– reporting and evaluation of the cost of poor quality

Focus on Human Resource management including ( processes for defining competence requirements, providing training (including on the job training for employed,

temporary and agency personnel), verifying effectiveness of actions taken

A process to motivate employees 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)

Controlling production processes by use of control plans work instructions

Ensuring effective control of internal & external laboratories.

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

organisation’s 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.”

For each processes, we have to consider: 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 Orientated Processes – examples Management Responsibility Customer Focus Internal Audit Control of Non-Conformity products. Customer Complaints Corrective, Preventive and Improvement

Actions. .....

Examples of ‘Production Orientated Processes’ Sales and Product Specification (Order/Request) Engineering, Design and Development processes (DDP,

Project mananagement.....) Production and delivery.

Examples of ‘Resource Orientated Processes’ Purchasing Change control Process HR...

Customer measures of process effectiveness Delivered part quality performance Customer disruptions including field returns Delivery schedule performance (including instances

of premium freight) Customer notification of quality or delivery issues

Organisation measures of process effectiveness Reports & reviews of performance against objectives Evaluation of the cost of poor quality

Customer specific requirements are included in an audit for ISO/TS 16949 “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”

Which of our process need to include customer specific KPI requirements?

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]

Bold = from ISO 9001:2000

“The goal of this Technical Specification is the development of a quality management system that provides for;- continual improvement- emphasising defect prevention and- the reduction of variation and waste in the

supply chain.”

Process approach of ISO 9001:2000 complements ISO/TS 16949 – many common requirements (less paper?)

•ISO/TS 16949 is currently supported by:BMW, DaimlerChrysler, Fiat, Ford, GM (incl Opel-Vauxhall), PSA Peugeot-Citroën, 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 ISO/TS 16949 or ? Customer Specific Requirements

Audi/Volkswagen ISO/TS 16949 or VDA 6 [ Quality Cap. Suppliers 4th Ed ]

BMW Contact customer [ Supplied Parts Quality Mgmt ]

Daimler Chrysler ISO/TS 16949 [ Daimler Chrysler Customer specific Requirements for use with ISO/TS 16949: 2000 ]

Ford Motor Co. ISO/TS 16949 (QS 9000 / Q1) Contact customer

General Motors ISO/TS 16949 [ ISO/TS 16949 Customer Specific Requirements ]

Honda Contact customer [ Honda Supplier Quality Manual ]

Isuzu Contact customer [ Supplier Quality Manual ]

Mazda Contact customer Contact customer

Mitsubishi Contact customer [ SMITQA-003 ]

Nissan Contact customer [ Supplier Quality Manual / Alliance Supplier Guide ]

PSA Peugeot-Citroën

ISO/TS 16949 Contact customer

Renault ISO/TS 16949 Contact customer

Rover Contact customer [ RG2000 Supplier Management System ]

Saab Contact customer Contact customer

Subaru Contact customer [ Subaru Supplier Manual ]

Toyota Contact customer [ Supplier Quality Assurance Manual ]

Comparing ISO/TS 16949 with ISO 9001

Additional Requirements of ISO/TS 16949 vs ISO 9001:2000

Applying to Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement


Quality Management System Retain responsibility for all outsourced

processes [4.1.1] Review customer engineering specifications &

changes within 2 weeks [4.2.3.1] Control records of regulatory and customer

requirements [4.2.4.1]

Additional Requirements of ISO/TS 16949 vs ISO 9001:2000Management Responsibility

Top management shall review product realisation and support processes [5.1.1]

Top management shall define quality objectives in the business plan and their use to deploy quality policy [5.4.1(.1)]

Managers responsible for corrective action shall be promptly informed of products or processes that do

not conform to requirements. appoint ‘quality representatives’ with authority to stop

production (all shifts) to correct quality problems [5.5.1.1]


Management Responsibility (cont’d) Top management shall appoint ‘customer

representatives’ with specific responsibility to ensure compliance with customer requirements, including selection of special characteristics, corrective/preventative actions and design/development. [5.5.2.1]

Management reviews shall include; monitoring of performance trends, the cost of poor

quality, the achievement of quality objectives, [5.6.1.1] review of actual and potential field failures. [5.6.2.1]


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]


Resource Management (cont’d) Ensure all skilled staff in the factory are involved in deciding plant

layout and handling methods; include lean manufacture using minimum work in progress & minimum movement of parts [6.3.1]

Have contingency plans for emergency situations that could affect customer requirements, including power failure, communication failure, raw material or parts supply failure, equipment failure, labour shortage and handling returned product. [6.3.2]

Ensure that the plant layout and working methods are designed with safety to employees in mind. [6.4.1]

Ensure that workplaces are tidy and appropriately clean. [6.4.2]


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]

Additional Requirements of ISO/TS 16949 vs ISO 9001:2000Product Realisation (cont’d)

Obtain customer approval for any waiving of a review of requirements related to the product [7.2.2.1]

Review manufacturing feasibility within contract review [7.2.2.2]

Communicate necessary information in a customer specified language and format [7.2.3.1]

Document and include the following in ‘product design input’ customer requirements including performance and

special characteristics experience from previous products targets for product quality, life, reliability, durability,

maintainability, timescales and cost. [7.3.2.1]


Product Realisation (cont’d)

Document and include the following in ‘manufacturing design input’ product design outputs that have to be met by

manufacturing experience from previous products targets for productivity, process capability and

cost. [7.3.2.2] Identify special characteristics [7.3.2.3]



Document and include the following in ‘product design output’ in ways that demonstrate that all design inputs have been met design FMEAs including diagnostic guidelines to predict

failure modes reliability results special characteristics an analysis of error proofing product drawings, specifications and calculations product design reviews [7.3.3.1]



Document and include the following in ‘manufacturing design output’ in ways that demonstrate all design inputs have been met design FMEAs including diagnostic guidelines to predict

failure modes a control plan, specifications, drawings, instructions and

flowcharts plant & workstation layouts an analysis of error proofing manufacturing process validity and approval method

including acceptance criteria [7.3.3.2]



Report measurements of design & development at management review [7.3.4.1]

Perform validation in accordance with customer requirements [7.3.6(.1)]

Prototype programme required using manufacturing processes [7.3.6.2]

Approval procedure required as recognised by the customer [7.3.6.3]

All purchased products shall conform to regulatory requirements [7.4.1.1]


Product Realisation (cont’d) Work in partnership with suppliers to develop the supplier

quality management system. Conformity to ISO 9001:2000 is required. [7.4.1.2]

As specified in the contract, use approved sources for purchased material [7.4.1.3]

Monitor the quality of purchased product by one or more of the following; evaluation of the statistical data received from the supplier receiving inspection 2nd or 3rd part audits with records of acceptable delivered

performance part evaluation by a designated laboratory [7.4.3.1]


Product Realisation (cont’d) Monitor supplier performance by;

delivered product quality performance customer disruptions that have occurred returns or other feedback from end users delivered schedule performance [7.4.3.2]

Use Control Plans to the format specified in Appendix A [7.5.1.1]

Work instructions for operations that impact on quality are required [7.5.1.2]

Verify job set ups [7.5.1.3]


Product Realisation (cont’d) Use predictive and preventative maintenance for key

processes [7.5.1.4] Resources for tool and gauge design, fabrication and

verification are required [7.5.1.5] Schedule production to meet customer requirements e.g.

just-in-time [7.5.1.6] Establish a process for communication of information on

service concerns [7.5.1.7] Verify the effectiveness of any customer service agreements

[7.5.1.8]


Product Realisation (cont’d) Validate all processes for product and service provision to

demonstrate the ability of these processes to achieve planned results – where applicable through; defined criteria for review and approval of the process approval of equipment and qualification of personnel use of specific methods & procedures requirements for records revalidation [7.5.2(.1)]


Product Realisation (cont’d) In all cases;

identify the product throughout product realisation identify the product status with respect to monitoring &

measurement requirements where traceability required, control and record unique

product identification [7.5.3(.1)] Permanently mark customer owned tooling Assess the condition of stock. Assure stock rotation (FIFO).

Control obsolete stock as nonconforming. [7.5.5.1] Perform statistical studies on measuring equipment to

analyse variation [7.6.1]


Product Realisation (cont’d) Maintain calibration records including

Equipment identification The standard against which the equipment is calibrated Revisions following changes to equipment Assessments of the impact of out-of-specification equipment Notifications to customer of any product that may have been

affected by out-of-specification measuring equipment A positive statement of the acceptance of the calibration for

the intended purpose [7.6.2]


Product Realisation (cont’d) Define the scope of any internal laboratory to include its

ability to perform the required duties and be managed by a documented management system either within or separate from the main system [7.6.3.1]

Use only external laboratories that have a suitable scope are accredited to ISO 17025 or acceptable to the

customer [7.6.3.2]


Measurement, Analysis and Improvement Identify appropriate statistical tools for each process

[8.1.1] Understand statistical concepts [8.1.2] Monitor customer satisfaction and produce performance

indicators [8.2.1(.1)] Audit the quality management system to verify

compliance with the standard [8.2.2.1] Audit each manufacturing process [8.2.2.2] Include in internal audits all quality management related

processes, activities and shifts [8.2.2.4]


Measurement, Analysis and Improvement (cont’d)

Internal auditors shall be suitable qualified [8.2.2.5]

Perform process capability studies and include the conclusions in the quality or control plan. Studies shall include the; stability of the process capability of the inspection and test process capability of the reaction plans to contain the effect of

any nonconformity [8.2.3]



Conduct product audits [8.2.2.3] and ‘layout inspections’ i.e. checking every measurement and parameter shown on the approved design drawings. [8.2.4.1]

Conduct appearance inspections on items for which customer specifies this i.e. checking every aspect of the appearance of the finished product as perceived by the end user. Maintain master samples and means of making comparisons. [8.2.4.2]

Class product with unidentified status as nonconforming. Make instructions for rework available. [8.3(.1), 8.3.2]

Inform customers promptly if nonconforming product is shipped [8.3.3]



Obtain a customer concession before proceeding with any further processing if any part or material is not fully in accordance with approved requirements. This shall apply to product or material still being processes by a supplier. [8.3.4]

Analyse trends in quality & operational performance; use data to: manage progress towards overall objectives identify priorities provide a factual basis for decision making anticipate and predict problems arising from the end users.Establish benchmarks to measure performance against

competitors or other appropriate recognised criteria.[8.4.1]



Define a programme for continual improvement [8.5.1.1] Focus manufacturing improvement on reducing variation

[8.5.1.2] Define a process for problem solving [8.5.2.1] Use error proofing methods in the corrective action process

[8.5.2.2] Apply corrective action to other similar processes and

products [8.5.2.3] Minimise the time for corrective action [8.5.2.4]

Assessing where we are now

Statistical Analysis

- Statistical Process Control (SPC)- Measurement Systems Analysis (MSA)

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.” Detects variation in process measures to enable;

reduction of variation, and, prevention of defects / waste.

Applied to all processes whose output measures offer Variable data e.g. part dimensions Attribute data – conforming; yes/no - that can be counted

e.g. parts received on-time

ISO/TS 16949 requirement for Statistical Analysis 8.0 Measurement, analysis and improvement

8.1.1 Identification of statistical tools 8.1.2 Knowledge of basic statistical concepts 8.2.3.1 Monitoring and measurement of manufacturing

process 8.5.1.2 Manufacturing process improvement

Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in Location Spread Shape …or any combination of these.

• If the shape of variable data is ‘normal’ (typical);– location is measured by the mean [ X ]– spread is measured by the range [R] or standard

deviation [sd]– SPC can be applied to see if variation is unacceptable

Variation in variable data can come from Common causes – natural random events – which

affect all values of process output Special causes – intermittent, often unpredictable

causes making the process output unstable

Control charts help identify special causes by showing Values beyond control limits Non–random patterns or trends e.g. 7 points

increasing/decreasing, 7 points one side of the average

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 requirementCpk Approx parts per million out of

specification

1.00 66,000

1.33 6,000

1.67 233

2.00 4.6 (Six sigma)

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

parts c chart for the number of nonconformities

Benefits of Statistical Process Control (SPC)

Show how successfully a process is adjusted & controlled to achieve consistent and therefore predictable outputs e.g. conforming products

Flag any special causes of variation which need to be identified and eliminated by local action

Quantify the effects of improvements in quality, leading to reductions in waste (poor quality costs)

Statistical Analysis

- Statistical Process Control (SPC)- Measurement Systems Analysis

(MSA)

Why Measurement System Analysis?“The purpose of any analysis of a measurement system should be to better understand the sources of variation that can influence the results produced by the system.”

To quantify and communicate the limitations of specific measurement systems.

ISO/TS 16949 requirement for Measurement Systems Analysis (MSA) [7.6.1]

“ Statistical studies shall be conducted to analyze the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods of acceptance criteria may be used if approved by the customer.”

Terminology Measurement system:

the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement.Material Man Method

Machine (Time) Environment

MEASUREMENT SYSTEM

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.

Quality of measurement data If measurements are close to the reference value the quality

of the data is high

Measurement systems Must be in statistical control Must have small variability compared with specified tolerance

or manufacturing process variability*Descrimination: the amount of change from the reference

value that an instrument can detect and faithfully indicate. Typically the smallest graduation on the scale of the

instrument *Descrimination should be one tenth of the tolerance

range, however recently the descrimination target is one tenth of the process variation – significantly less.

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

Spread Errors (Gauge R & R) Repeatability: variation in measurements obtained

with one measurement instrument, when used several times by one appraiser while measuring the identical characteristic on the same part. (‘Equipment Variation’) Under 10% considered acceptable To improve, instruments may need maintenance or redesign

Reproducibility: variation in measurements obtained with one measurement instrument, when used by different appraisers while measuring the identical characteristic on the same part. Under 10% considered acceptable To improve, appraiser(s) may need training, or more ease of

use

Measurement System Study Select appraisers – people already using the instrument Select measurement instrument – has it the required

discrimination Select parts from the process that represent entire operating

range e.g. several days production and number each part.

Measurement System Analysis – when? “As processes change and improve, a measurement system

must be re-evaluated for its intended purpose”For example, when there is a new product, capability

improvement, skill level change, process change e.g. new equipment, change in work environment, change in test method/procedure.

Failure Modes & Effects Analysis

Failure Mode and Effects Analysis (FMEA) A systematic group of activities to:

Recognize and evaluate potential failures of a product or process and the effects of failure

Identify actions that could eliminate or reduce the chance of the potential failure occurring

Document the above process Evidence from vehicle recalls has shown a fully

implemented FMEA could have prevented many causes Enables action before the event (Prevention),

not after (Detection)

ISO/TS 16949 requirement for FMEA

4.2.3.1 Engineering specifications 7.3.1.1 Multidisciplinary approach 7.3.2.3 Special Characteristics 7.3.3.1 Product design outputs 7.3.3.2 Manufacturing process design

outputs 7.5.1.1 Control Plan

Item Responsibility &

Function Requirements

Target Completion Date

Actions Taken Sev

Occ

Det

RPN

RPN

Recommended Action(s)

Action Results

Potential Failure Mode

Potential Effect(s) of

Failure

Sev

Class

Potential Cause(s)/

Mechanisms of Failure

Occur

Current Controls

(Prevention / Detection)

Detec

What are the customer related functions or requirements?

What can go wrong?

-No function

-Partial/over/ degraded function

-Intermittent function

-Unintended function

What are the effects?

How bad is it?

What are the causes?

How often does it happen?

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?

Design FMEA Focuses on designing out Potential Failures in Product

Design causing detrimental effects on functional performance

Applies when products’ design is created or revised Uses test, production, quality, supplier & customer

experience Assumes manufacturing process would achieve

specification

Process FMEA Focuses on preventing Potential Failures in manufacturing

Process causing detrimental effects on functional performance

Applies when manufacturing process is applied to new product or changed

Uses test, design, quality, supplier & customer experience Assumes if design made to spec., it would otherwise

succeed

TEAM EFFORT

TEAM EFFORT

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

RPN = Severity rating x Occurrence rating x Detection rating

Process FMEA used to address potential risks in the manufacturing process achieving functional performance, by: Identifying potential process failures, their causes & effects Rating the;

Severity of effects; 1 to 10 (10 = most severe), Occurrence of effects; 1 to 10 (10 = most likely), Detection/prevention of effects by current controls eg. test; 1 to 10

(10=unlikely to be detected/prevented),

using guidance available in PFMEA manuals. Using the Risk Priority Number (RPN)

…to prioritise action – focussing on preventing failure• Customers may define triggers for action e.g. RPN >100, Severity

> 8

RPN = Severity rating x Occurrence rating x Detection rating

FMEA is successful as a process & living document, if: All links to external (& internal) customer

requirements from Design and Process elements are understood and systematically reviewed for risk of potential failure

Informed team approach leads to multidisciplinary experience being shared to evaluate risk consistently

Actions are planned at an early stage – before changes are considered too costly

Actions are taken as planned and the resulting effect on the risk is evaluated and documented

FMEA appears ‘difficult’, if: Team does not have

common understanding of the FMEA process

agreement/guidance on ratings

multidisciplinary experience – particularly a history of customer concerns or internal failures to consider in evaluating a new item

time to work through sufficient detail and agree actions

Relationship between Design and Process elements and external (& internal) customer requirements is not understood

Actions are not

Planned early enough

Followed through to achieve reward in better satisfying customer

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.

ISO/TS 16949 requirement for Control Plans [7.5.1.1]“The organization shall- develop control plans (see Annex A)… for the product

supplied…- have a control plan for pre-launch & production that

takes into account the design FMEA and manufacturing process FMEA outputs.Control plans shall be reviewed and updated when any change occurs…

NOTE Customer approval may be required…”

ISO/TS 16949 requirement for Control Plan content [7.5.1.1]

“The control plan shall- list the controls used for the manufacturing

process control,- include the methods for monitoring of control

exercised over special characteristics…- include the customer required information, if

any, and,- initiate the specified reaction plan when the

process becomes unstable or not statistically capable.”

ISO/TS 16949 requirement for Control Plan content [Annex A]

a) General Data; part no. & name, process step descriptions, etc

b) Product Control; characteristics for control; spec. tolerance

c) Process Control; process parameters, manufacturing tools

d) Methods; evaluation of measurement technique, sample size & freq.

e) Reaction Plan & corrective actions

Control Plan Example format minimum elements required by ISO/TS 16949 Annex

ACONTROL PLAN

Prototype Pre-launch Production Key Contact/Phone Date (orig.) Date (Rev.) Control Plan Number Part Number / Latest Change Level Core Team Customer Engineering Approval/Date (if Req'd)

Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (if Req'd)

Supplier/Plant Supplier Code Other Approval/Date (if Req'd) Other Approval/Date (if Req'd)

Part/ Process Number

Process Name / Operation

Description

Machine, Device, Jig,

Tools for Manuf.No. Product

Process parameters

Special Char. Class

Product/Process Specification/Tolerance

Evaluation Measurement

Technique

Sample Size

Sample Frequency

Control Method

Reaction Plan / Corrective

Action

Characteristics Methods

Control Plan Checklist/Review process. Have customer requirements been adopted in Control Plan format and

preparation?

Have all known customer concerns been identified to facilitate the selection of special product/process characteristics?

Are all special product/process characteristics included in the control plan?

Are material specifications requiring inspection identified?

Does the control plan address incoming material/components through processing/assembly including packaging?

Are engineering performance testing requirements identified

Are gauges and test equipment available as required by the control plan?

If required, has the customer approved the control plan?

Are gauge methods compatible between supplier & customer?

Benefits of Control Plans Improved quality of products during design,

manufacturing and assembly, by identifying sources of variation

Resources focussed on process and product characteristics important for customer satisfaction

Communication of changes in product/process characteristics and

their control & measurement prepared responses to nonconformities (Reaction

Plan)

Next Steps??

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