an introduction to the requirements of the iso/ts 16949 ... · an introduction to the requirements...

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An introduction to the requirements of the ISO/TS 16949:2009

Quality Management System for the Automotive Industry

Course Objectives

1. Understand the requirements of the ISO/TS

16949:2009 (“TS”) quality management system• Disposition of the standard to use the “Process” theory of

manufacturing

• The intent of the standard

– International automotive industry requirements


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– International automotive industry requirements

• The minimal requirements to insure compliance

2. Discuss the requirements of TS within the

context of your organization• Your organizations formal method

• Informal methods used

Course Objectives

3. Minimum document requirements (4.2.3):• Relaxed documentation requirements

• 7 required documented procedures

• Additional inference to documentation

4. Minimum record requirements (4.2.4):


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4. Minimum record requirements (4.2.4):• ISO 9001:1994 version referred to 4.16 for records

• ISO 9001:2000 & 2008 version refers to 4.2.4

• 26 records required as a minimum (20 ISO + 6 TS)

• Follows similar requirements for tracking of storage,

identification, retention time, etc.

QS-9000

• Specific to the North American

automotive industry

• Focus on documentation to

control processes

• Emphasis on formalizing &

QS 9000 vs. TS 16949

TS 16949

• Accepted & recognized world-

wide

• Focus on satisfying customer

needs & perception

• Emphasis on creating &


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improving processes through

documentation

• Little direct management

responsibility or specific

requirements.

• Continuous improvement

monitoring relevant goals &

objectives at all levels

• Accountability from all levels of

the organization (including

management)

• Continual improvement

What is TS 16949?

• ISO is the International Organization for Standardization

• Webster's definition: iso- 1: equal : homogeneous : uniform

– isos-ce-les: having two equal sides (i.e. isosceles triangle)

– iso-met-ric: equality of measure

– iso-gen-ec: essentially identical genes (i.e. identical twins)

• Based on need to provide quality products to customer in 1920's - 1940's

via quality control typically through end-of-production inspection and


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via quality control typically through end-of-production inspection and

segregation; US Department of Defense adopted in-process controls in

1940's to improve on "after the fact" quality via quality assurance

• Standardization based on quality necessary during battle; benefits also in

manufacturing costs (< scrap costs), free trade & common language

• Standard methods of operation written, approved and published by

International Organization for Standardization in Geneva, Switzerland

(9000) plus automotive requirements from IATF and JAMA (16949).

ISO 9000 series of Quality Standards• Major overhaul of the standard in 2000 revision

– Less focused on documentation requirements

– Increased focus on customer satisfaction & achieving desired quality outputs

– Introduces quality management concepts developed over


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– Introduces quality management concepts developed over last 20 years

• Minor updates to 2008 revision

– Clarification of existing requirements

– Further explanation of intentions of Notes

– Better alignment with ISO 14001

What is TS 16949?

Terms & Definitions:

Shall is used to define standard requirements that must be fulfilled. 136

"shall" (requirements) in ISO 9001 + 154 additional automotive = 290 total

“The organization shall ensure that product which does not conform to product requirements is

identified and controlled to prevent its unintended use or delivery." (8.3 Control of

nonconforming product)

Top Management – the highest level of the organization responsible for


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Top Management – the highest level of the organization responsible for

direction & control of business activities

Suitability – the appropriateness to a given purpose

Effectiveness – having an expected or intended effect

Monitoring and Measurement – Inspection and testing activities used to

determine conformity of product or process

Monitoring and Measurement Device – Instrument used to conduct a specific

monitoring and measurement activity

What is TS 16949?

Requirement - need or expectation that is stated, generally implied or obligatory

Conformity - fulfillment of a requirement

Nonconformity - non-fulfillment of a requirement

Defect - non-fulfillment of a requirement related to an intended or specified use

Correction - action to eliminate a detected nonconformity



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Correction - action to eliminate a detected nonconformity

Corrective action - action to eliminate the cause of a detected nonconformity or

other undesirable situation

Corrective action impact – action applied to other similar processes and products

as a part of eliminating the cause of a nonconformity.

Preventive action - action to eliminate the cause of a potential nonconformity or

other undesirable potential situation

What is TS 16949?

Quality Plan - the "recipe" used to assure the product or service conforms to

expected standards throughout all stages of product realization.

Quality Planning - the "recipe" used to establish quality objectives and the

plan to achieve these objectives. Also includes a plan to react to outputs below

expectations.



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Objective Evidence - factual data used to verify the condition or performance

of a product or process output.

Preventive maintenance - planned action to eliminate causes of equipment

failure and unscheduled interruptions to production, as an output of the

manufacturing process design

Predictive maintenance - activities based on process data aimed at avoidance

of maintenance problems by prediction of likely failure modes

http://www.ebaumsworld.com/flash/burgerking.html

What is TS 16949?

Control plan - Documented description of the systems and processes required

for controlling product

Design responsible organization - Organization with authority to establish

new, or change an existing product specification

Error-proofing - Product and manufacturing process design and development

to prevent manufacture of nonconforming product



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to prevent manufacture of nonconforming product

Laboratory - Facility for inspection, testing or calibration that may include, but

is not limited to, chemical, metallurgical, dimensional, physical, electrical or

reliability testing

Laboratory scope - Controlled document containing:

• specific test, evaluations and calibration laboratory is qualified to perform

• list of equipment which is used to perform qualified test

• list of methods and standards to which it performs the qualified test

What is TS 16949?

Premium freight - Extra cost or charges incurred additional to contracted

delivery (can be caused by method, quantity, unscheduled, late deliveries, etc.)

Remote location - Location that supports sites and at which non-production

occurs

Site - Location at which value-added manufacturing occurs

Special Characteristics - Product characteristics or manufacturing process



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Special Characteristics - Product characteristics or manufacturing process

parameter which can affect safety or compliance with regulations, fit, function,

performance or subsequent processing of product

• Based on evolving ISO 9000 & QS 9000 family of documents:

– 1st US companies certified under 1987 version of ISO 9001 (Auto industry

suppliers had to comply with individual customer-specific standards)

– 2nd release of ISO 9000 in 1994 + auto-sector requirements = QS 9000:1994

– Current version of QS 9000 (1998) based on obsolete ISO 9001 standard

• Major overhaul in switching from QS to TS

– Less focus on documentation

What is TS 16949?


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– Less focus on documentation

– Increased focus on customer satisfaction & achieving desired results

– Integrating “quality system” into the “business management system”

• Benefits include:

– organizational growth with control & predictability

– reduction in multiple 3rd-party audits (QS 9000 – North America, VDA 6.1 -

Germany, SMMT – UK, ANFIA – Italy, etc.)

– increases confidence in global customer & supplier relationships throughout the

international automotive sector

Why this standard?

• International ownership/mergers of major automotive OEMs

• Customer-requirement for QS-9000 registered companies (Ford,

GM & DCX suppliers)

– Expiration of QS-9000 on December 14th, 2006

– DCX suppliers by July 1st, 2004

– Suppliers to Tier I required to have ISO 9001:2000 or customer approval


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– Suppliers to Tier I required to have ISO 9001:2000 or customer approval

– Global standard for automotive in global pool of manufacturers and

suppliers

– Automotive company acquisitions & mergers complicate supplier

management process

• More emphasis on PDCA methodology (Plan, Do, Check & Act)

• Pushing back growth & “lessons learned” to the Planning or

Design functions

How I manage my business…

• 5-clause structure similar to business process model

• New requirement to add quality objectives to business plan

• Quality risks/responsibility rest with top management

– Clause 5.0 directed specifically at top management (6/23 sections)

– Top management shall… in 5.1 and 5.6 sub-clauses

• ISO 9001:2000 + auto-specifics provide model for business to


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• ISO 9001:2000 + auto-specifics provide model for business to

grow with:

– control

– predictability

– self-discipline

– awareness

– goals & objectives

How I manage my business…

Non-sector or Industry Specific

ISO 9001:2008 Requirements

Automotive Industry Specific

ISO/TS 16949:2009 Requirements


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Company Policies & Procedures

Customer Specific Requirements

ISO 9001:2008 Requirements

Eight Management Principles

1. Customer Focus

2. Leadership

3. Involvement of

People

6. Continual

Improvement

7. Factual approach

to decision

making


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People

4. Process Approach

5. System Approach

to Management

making

8. Mutually

beneficial Supplier

Relationships


1. Customer Focus– The organization is responsible for determining the needs and

expectations of the customers

• Interfaces between different parts of the organization and the

corresponding customer functions

– Sales


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– Sales

– Quality

– Engineering

– Design & Development

• Develop a system that allows for the analysis of obtained data

• Short and long term planning with a focus on improving

customer satisfaction as well as forecasting future expectations


2. Leadership– Top management must exhibit leadership to ensure

• Understanding of organizational objectives & direction

• Relate customer-specific needs to the organization

• Communication to all levels of the organization

• Methods to monitor performance


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• Provide resources needed to achieve goals

• Ensure employees are competent to perform according to plan

• Roles & responsibilities are understood at all levels

– Quality objectives are consistent with quality policy

– Requirements of the International Standard are met

– QMS is reviewed at planned intervals to ensure suitability, adequacy & effectiveness


3. Involvement of people

– All levels of organization must be involved, as

appropriate, in pursuit of the organization goals and

objectives


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1. “What are we doing?”

2. “How do you do it?”

3. “What is the company quality policy and

objectives?”

4. “What role do I play in achieving these objectives?”


4. Process Approach– Recognize the interactions between different organizational

functions (inputs & outputs)

• All aspects of the organization are a part of the overall output -

Customer Satisfaction!

• A change or nonconformance in one area has an impact on


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• A change or nonconformance in one area has an impact on

another area of the organization

– Based on recognizing that the process consist of defined system

inputs and expected system outputs

– Changes focus from "Say what you do. Do what you say.

Document it." to a focus on desired results necessary for customer

satisfaction and continual improvement.


5. Systematic approach to management– Based on recognizing the process approach and determining the

system’s inputs and outputs

– Management of organization on data and facts

• Method used to define the “effectiveness” of a process

– Increases predictability & control


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– Increases predictability & control

– Promotes teamwork & awareness of interrelationships

– Provides sense of involvement at all levels of organization

• Provides system ownership at all levels of organization


6. Continual improvement– Allows a shift in resources to concentrate on those outputs that are

below expectation as well as those that are most important

– Avoids wasting resources on non-priority objectives

– Establishing a system to continuously measure key outputs in order

to ensure desired results with current resources


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to ensure desired results with current resources

– "Bigger fish to fry" approach


7. Factual Approach to Decision Making– Speak with data!

– Disciplined approach to problem resolution

• Using PDCA methodology, Fishbone Diagram, Fault tree

analysis, 8D, etc.

– Removal of personal basis and feeling from problem resolution


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– Removal of personal basis and feeling from problem resolution

– Increases confidence in management decisions and direction


8. Mutually Beneficial Supplier Relationship– The idea that the supplier is an integral part of achieving objectives

and customer satisfaction

– Moves past the “Buy on price” concept

– Requires a system that monitors data pertaining to supplier performance

• On time delivery (+ premium freight incidents)


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• On time delivery (+ premium freight incidents)

• Quality of product delivered

– PPM, % of product rejected/returned

– Working with the suppliers to reduce cost of non-quality, improve communication, problem solving, sharing of improvement proposals

Live it vs. Look it

• Does ISO/TS 16949 registration ensure world-class quality?

– Of course not - nor is it meant to. The quality system requirements of

the ISO/TS 16949 document is only the beginning.

• Common occurrences of ISO/TS 16949 registration "Makeovers".

– “We’re almost done with TS 16949.”

– "But it says QUALITY management system! Isn't that something that the

Quality Department should be doing?"


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Quality Department should be doing?"

– “Make sure that coffee vendor is on the Critical Supplier List!”

– “We have to review these 500 work instructions by Friday for the audit on

Monday!”

– "Keep the auditor in the conference room as much as possible."

– "We need the Internal Auditing Team to hurry up & do a quick audit.“

– “I simply did what you TOLD me to do!” (without focusing on a desired

output)

Your "Business System”

How are we supposed to work if we're not sure what we're working for?

• Similar to a sports team or orchestra (knowing your role in the team)

• Process are interrelated and share stake in the fulfillment of outputs

• Who has a role in the process?

• Who is the primary process owner?

• Roles must be defined


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• Roles must be defined

• Direction understood at all levels effecting quality

• Coaching and review amongst coaches must take place

• Constant feedback and comparison must be given

• If we pick option “B”, what are the potential effects? Risks?

• What are the consequences if I don't follow the correct process?

Organization of ISO 9001:2008

ISO 9001:2008 is organized into four parts

1. Scope

2. Normative reference

3. Terms and Definition

Supplier Organization Customer

Removed in 2008 version


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Supplier Organization Customer

4.-8. Quality Management System Requirements

Note: Terminology change in #3

…wherever the text “product” occurs, it can also mean “service”.

Added in 2008 version

Organization of ISO/TS 16949:2009

ISO/TS 16949:2009 is organized into five separate

clauses or “processes”:

4.0 - Quality Management System

5.0 - Management Responsibility


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6.0 - Resource Management

7.0 - Product Realization

8.0 - Measurement, Analysis and Improvement

Note: New reference to "Clauses" as opposed to "Elements"

General Interaction of Processes Model


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Process Flow & Interaction

Project Development

•APQPFrom accepted customer order…

To PPAP approval and project review

Customer Focus

•Sales

•Engineering

• Quoting From initial customer inquiry…

To accepted customer order

Core Processes

Communication with Customer

as inputs to internally (orders)

Communication with Customer

on quality outputs (satisfaction)

Customer Requirements Customer Feedback

Continual ImprovementInternal AuditsBusiness Planning &Management Review

Management Processes

Material Management

Purchasing

•Supplier Development

•Outsourced Processes

From supplied parts needed…

To receipt of supplied goods

Resources

•Capital Needs

From request for capital goods…

To delivery to user

Value-added Manufacturing

•Stamping

•Joining & Assembly

•Painting

From order received from scheduling…

To finished product

Support Processes

Shipping

From transport of finished product…

To delivery to carrier

Quality Assurance InfrastructureResource

Management

ApprovedSuppliers

Invoice CustomerReceiving

From receiving & storage of supplied goods…

To delivery to production

Order Entry & Scheduling

From order received

To scheduling parts


The five processes are further broken down into 23 sub-clauses

4.0 Quality Management System

4.1 General Requirements

4.2 Documentation requirements

5.0 Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

7.0 Product Realization

7.1 Planning of Product Realization

7.2 Customer-related Processes

7.3 Design and Development

7.4 Purchasing

7.5 Product and Service Provision


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5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, Authority & Communication

5.6 Management Review

6.0 Resource Management

6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment

7.5 Product and Service Provision

7.6 Control of monitoring and measuring

devices

8.0 Measurement, Analysis & Improvement

8.1 General

8.2 Monitoring and Measurement

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5 Improvement


“Notes” are used further define requirements

– Notes are not requirements therefore nonconformance statements can not be made due to a non-compliance to a note.

– Notes give additional detail to requirements located above them.

– Notes are suggestions

Supporting documents

– ISO 9000:2005 QMS Fundamentals & Vocabulary


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– ISO 9000:2005 QMS Fundamentals & Vocabulary

– ISO 9004 QMS Guidance

– ISO 19011:2000 QMS/EMS Auditing Guidance

– IATF Guidance to ISO/TS 16949:2009 (recommended automotive industry practices, examples, illustrations, etc.)

Items listed in green are new to the ISO 9001:2008 standard


4.1 General Requirements

– Overview of the requirements necessary to establish a quality management system

• Defined in 4.1.a-f.

• Requires that a system be establish, documented and continually improved


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continually improved

• Addresses the requirements in the Quality Manual, references related quality management procedures for process element 4.2, Documentation Requirements

• Section also used to define interaction of processes within the organization


4.1 the requirements of the standard state:

a) Identify the processes needed to establish a quality

management system, and their application throughout

the organization

b) Determine the sequence and interaction of the processes


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b) Determine the sequence and interaction of the processes

identified

c) Define the system measurements and criteria needed to

ensure the operation and control of the identified

processes


d) Define the resources needed to support the system, and

the related data to determine the system’s effectiveness

e) Monitor, measure (where applicable), and analyse these

processes, and

f) f) implement actions necessary to achieve planned


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f) f) implement actions necessary to achieve planned

results and continual improvement of these processes.

– Use corrective actions, or other means to achieve the

planned results and to continuously improve the

processes related to the quality management system


Where an organization chooses to outsource any process that

affects product conformity to requirements, the organization

shall ensure control over such processes. The type and extent of

control to be applied to these outsourced processes shall be

defined within the quality management system.


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NOTE 1 Processes needed for the quality management system

referred to above include processes for management activities,

provision of resources, product realization and measurement,

analysis and improvement.


NOTE 2 An outsourced process is identified as one being needed for the

organization’s quality management system but chosen to be performed by a party

external to the organization.

NOTE 3 The type and nature of control to be applied to the outsourced process may

be influenced by factors such as:

a) the potential impact of the outsourced process on the organization’s capability to


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a) the potential impact of the outsourced process on the organization’s capability to

provide product that conforms to requirements;

b) the extent to which the control for the process is shared;

c) the capability of achieving the necessary control through the application of clause

7.4.

Ensuring control over outsourced processes does not absolve the organization of the

responsibility of conformity to all customer, statutory and regulatory requirements.

TS Add-On

4.1.1 General Requirements – Supplemental

– When your organization out sources a process, it still

remains responsible for conformity to all customer

requirements


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Discussion: “It’s your fault!”

Customer satisfaction data

New accounts/sales growth

Operating costs & processing errors

Internal/external audit results

Status of CPA

Working environments

Preventive Maintenance

HR Policies

Job descriptions

Training methods

Development techniques

Employee evaluation & incentive programs

Resource ProvisionResource Provision

#4 Infrastructure Provision and Maintenance

#3 Training & Employee

Development

Resource

Needs

EXTERNAL CUSTOMERS

#1 Business Planning

Management Management ResponsibilityResponsibility

#12 Management Review

Policies, directives, & objectives

#2 Document Control

Measurement Analysis & Measurement Analysis & ImprovementImprovement

#9 Control of Non-conforming Product

#10 Corrective & Preventive Action & Continuous Improvement

#11 Internal Auditing

Customer concerns

Returned goods

Undesirable trends

Training effectiveness data

Equipment effectiveness data

EXTERNAL CUSTOMERS

EXTERNAL CUSTOMERS

Product & Service RealizationProduct & Service Realization

#8 Inspection and Test

#5 Quoting & Quality Planning

#6 Order Processing

Materials and service suppliers

#7 Purchasing

Sales functions Requests for quotes

Market research

Product conformance data

Process conformance data

Supplier performance data

Repeat orders

Schedule requirements

Work instructions

Incoming inspection

WIP

Finished goods

New product testing

Process flow and controls

P.O. Issued

Parts Received Shipping Ticket

Invoicing

1. Customer satisfaction survey results

2. Quarterly review schedule compliance

3. Diversification (of customer base)

4. Total expense as a % of sales (all overhead and other)

5. Sales $$ per total hour

6. Ratio of current sales capacity vs. monthly demand

Company Profit

#1 Business Planning

Projected vs. actual plan

#3 Training, & Employee Development

Employee turnover

#4 Infrastructure Provision & Maintenance

Machine/asset uptime

#2 Document Control

Audit results

#10 Corrective &

Preventive Action + Continual

#11 Auditing

Schedule compliance

#12 Management Review

Schedule compliance

• Inner ring measured quarterly

• Middle ring measured monthly

• Outer ring measured weekly (if practical and beneficial); monthly otherwise 1. Cross-training %

2. Outstanding evaluations

3. % of terminated employees > 90 days

4. Recordable accident rate

5. # of total accidents

6. # of lost time accidents

7. Total # employees

8. Temp. employees as % of total

9. # of open positions

1. # of open work orders

2. Lead-time to close work orders

3. Utility expense as a % of sales

4. OSHA inspection results

5. Floor space utilization

6. Safety and housekeeping audit scores (including PM compliance)

1. Hit rate (# of new PO’s vs. # of RFQ’s)

NA

1. Open-time of CARs/PARs

1. Audit per schedule

2. Trained Auditors

1. % of Participation

2. # of minutes

3. % of completed action items

4. # of Improvement Projects approved & submitted to Business Planning process

Process Measures ChartProcess Measures Chart

Profit#5 Quoting & Quality

Planning

Sales

#6 Order processing

On-time and complete

#7 Purchasing

Total inventory $$ as a % of sales

#8 Inspection & Test

# of NCMR’s and (product related) CAR’s

#9 Control of NCP

Audit results

Preventive Action + Continual Improvement

CAR’s w/ same root cause

1. Hit rate (# of new PO’s vs. # of RFQ’s)

2. # of new RFQ’s

3. Quoting accuracy (via ECR’s)

4. Fixture jobs completed

5. Open fixture jobs

1. # of ECR’s to correct processing errors

2. 0 nonconformities

3. Efficiency (actual time/quoted time)

4. DL as a % of sales

5. IDL as a % of sales

6. IDL/DL ratio

7. Transaction accuracy (log on/off)

8. Overtime $$ as a % of sales

9. Sales dollars/DL hour1. Inventory turns

2. Supplier performance

3. RM inventory $$ as a % of sales

4. Purchased components as a % of sales

5. Shop supplies (MRO) as a % of sales

6. Off-site inventory as a % of sales

7. Steel cost/pound

8. Jobs not completed or delayed due to material shortages

1. Internal PPM (%)

2. External PPM (%)

3. Inspection audit results

4. Gage audit results

5. Gage capability

6. Rework $$ as a % of sales

2. # of CARs vs. PARs

3. Types of CAR’s (pareto)

4. # of Improvement Projects

1. Storage time of NC product


4.2 Document Requirements

4.2.1 General

– The organization is required to establish a documentation system that addresses:

a) A documented statement of the organization’s Quality Policy and quality objectives


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and quality objectives

– Established by Top Management

b) A Quality Manual

c) Documented procedures and records as required

d) Documents, including records, (i.e. work instructions, forms, prints, technical standards) necessary to ensure effective planning, operations and control of processes

e) Records required by the standard



4.2.1 General

– Note 1: “Documented procedure” = procedure is

established, documented, implemented and


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established, documented, implemented and

maintained. A single document may address one

or more procedures. A requirement for

documented procedure may be covered by one or

more documents.



4.2.1 General

– Note 2: Extent of Documentation

•Size


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Documentation =

•Size

•Type of activities

•Complexity of processes

•Process interactions

•Competence of personnel


4.2.2 Quality Manual

– The organization is responsible for maintaining a Quality Manual that addresses each of the requirement of ISO 9001:2008

• Either reference a related Quality Management System Procedure (QMSP, QSP, SOP, etc.) or define the methods used in the manual itself


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manual itself

– Defines the scope of the organization's quality management system, including any details of any system exclusions

• Justify the exclusion of product design responsibility (7.3) or to provide any post production service requirements

– A description of the interaction between the processes of the quality management system


4.2.3 Control of Documents

– Documents referenced in the quality management system are required to be controlled. These documents include the Quality Manual and the related or referenced procedures including associated documents (i.e. forms, work instructions, etc.)

– Seven mandatory documented procedures:

• 4.2.3 Control of documents


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• 4.2.3 Control of documents

• 4.2.4 Control of records

• 6.2.2.2 Training (*not required by ISO 9001)

• 8.2.2 Internal audit

• 8.3 Control of nonconforming product

• 8.5.2 Corrective action

• 8.5.3 Preventive action


4.2.3 Control of Documents, cont.– This control includes:

• Documents are approved prior to issue

• Review, update and revise as necessary. Revised documents require re-approval prior to reissue

– Only the current documents are available for use


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• Ensure that document changes and the current status is identified for each document

– Use a single system, date, letter, number, but not multiple methods

• Ensure that the necessary documents are available at the point of use

• Documents are legible and readily identifiable


4.2.3 Control of Documents (continued)– identify any documents of external origins necessary for the planning

and operation of the quality management system and ensure that their

distribution throughout the organization is controlled (i.e. standards,

customer-specific manuals, etc.)

– Prevent the unintended use of obsolete, superceded or revised


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documents

• Provide suitable identification of any obsolete, revised or

superceded documents retained for any purpose

• Legal or knowledge preservation

TS Add-On

4.2.3.1 Engineering specifications

– Your organization is required to establish a process to

assure timely review, distribution and implementation of all

customer engineering standards/specifications and changes

related to customer-required schedules

• Reviews are conducted as soon as possible


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• Reviews are conducted as soon as possible

– Within two working weeks (10 working days)

– Maintain a record of date when each change is

implemented in your system

– Implementation includes revision of relevant

documentation

TS Add-On

4.2.3.1 Note (Engineering specifications)

– A change in these specifications/standards requires an

updated record of the customer’s production part approval

(PPAP) when these specifications are referenced on the

design record or if they affect the documents related to the

production parts approval process, such as Control Plans,


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production parts approval process, such as Control Plans,

Flow Charts and FMEAs


4.2.4 Control of Records– Records, a specific type of documents, are retained to provide evidence of

compliance and the effective operation of the organization with the

requirements of the standard and your organization's stated methods and

practices to achieve compliance with the requirements shall be controlled

– Records required :

• Remain legible


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• Remain legible

• Readily identifiable

• A documented procedure shall be established to define the controls

needed for:

– Storage

– Protection

– Retrieval

– Retention times

– Disposition of records after the retention time has expired

Record Identification

Minimum required

4.2.3.1 Engineering specification changes

5.6.1 Management review records

6.2.2 (e) Education, training, skills & experience

7.1 (d) Product & realization processes evidence (plan vs. actual)

7.2.2 Product requirements review (feasibility)

7.3.2 Design & development input

7.3.4 Design & development review

7.3.5 Design & development verification

7.3.6 Design & development validation

7.3.7 Design & development changes

7.4.1 Supplier evaluations & actions

7.5.2 Validation records

7.5.3 Product identification & traceabilityMinimum required

records (26)

7.5.3 Product identification & traceability

7.5.4 Lost, damaged or unusable customer property

7.6 Basis for calibration (in case of no standard method)

7.6 Calibration & verification records

7.6.2 Calibration & verification records

8.2.2 Internal audit records

8.2.3.1 Significant process events

8.2.3.1 Records of effective dates of process changes

8.2.4 Product conformity & person(s) releasing records

8.3 Nonconforming material (nature, actions, concessions)

8.3.4 Expiration date or quantity authorized under concession

8.5.2 Results of corrective actions

8.5.2.4 Records of rejected product test/analyses

8.5.3 Results of preventive actions

TS Add-On

4.2.4 Control of records

Note 1: “Disposition” of records includes disposal

Note 2: Records also include those records that are customer-

specified


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4.2.4.1 Records retention

– Record control is required to satisfy all statutory, regulatory

and customer requirements

Discussion: Customer requirements for record keeping can

not “trump” regulatory requirements


5.1 Management commitment :

– Top Management must provide evidence of its commitment to the quality management system and its continual improvement by:

a. Communicating the needs of the customer and the marketplace


53


marketplace

– Including regulatory and statutory requirements

b. Establishing the company quality policy

c. Establishing quality management system objectives

d. Conducting reviews of the quality management system

e. Ensuring availability of resources

TS Add-On

• 5.1.1 Process efficiency

– Must review product realization and support processes to

assure:

•Effectiveness

•Efficiency


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Discussion: How does your company define and monitor

“effectiveness” and “efficiency”?

5.0 Management Responsibility.

5.2 Customer Focus:

– Top management must ensure that customer

requirements are understood & met

• Alignment with market-place

• Feedback loop to management (i.e. Sales &


55


• Feedback loop to management (i.e. Sales &

Marketing)

• Communication to employees on achieving needs

• Internal alignment of processes to satisfy customer


5.3 Quality Policy– Top management must ensure:

a. Quality policy is appropriate to the purpose of the organization

b. Commits the organization to complying with customer requirements

– Continually improve the quality management system


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c. Provides a “Framework for establishing and reviewing quality objectives”

d. Is communicated by management throughout the organization

e. Is understood by all in the organization

– Is periodically reviewed for continuing suitability

You can SAY the Quality Policy, but show me how you

EXECUTE the Quality Policy.


5.4 Planning

5.4.1 Quality Objectives:

• Top management must ensure that the relevant quality

objectives are established at the appropriate functions

and levels within the organization


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and levels within the organization

– including customer requirements

• Quality objectives are required to be

– Measurable

– Consistence with the quality policy

TS Add-On

• 5.4.1.1 Quality objectives – Supplemental

– Quality objectives must be included in the business plan

– Quality objectives must be used to deploy the quality policy


58


Discussion: This is the first time we see the connection

between the QMS and the Business Planning functions


5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

• Top Management must ensure that the responsibilities

& authority for the organization

– Defined and communicated throughout


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– Defined and communicated throughout

TS Add-On

• 5.5.1.1 Responsibility for quality

– Managers with responsibility/authority must be promptly

informed of nonconformities (product & process)

– Personnel responsible for quality must have the authority to

stop production to correct quality problems

– All shifts must be staffed with personnel responsible for


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– All shifts must be staffed with personnel responsible for

product quality

Discussion: Who has your organization defined as “personnel

responsible for quality”? Are these employees empowered

to stop production? On all shifts?


5.5 Responsibility, authority and communication

5.5.2 Management Representative

• Top management is required to appoint a member of

the organization’s management, regardless of other

assigned duties, is responsible for ensuring the process


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assigned duties, is responsible for ensuring the process

needed for the quality management system are

established, implemented and maintained

• Reporting to management the current status of the

quality management system achieved performance &

improvements needed

• Promotes awareness of customer requirements

TS Add-On

• 5.5.2.1 Customer representative

– Top management must designate personnel (1 or more)

with responsibility/authority to ensure customer

requirements are met, including:

• Selection of special characteristics (as applicable)

• Setting quality objectives & related training


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• Setting quality objectives & related training

• Liaisons for necessary actions taken (corrective &

preventive)

• Product design & development


5.5.3 Internal Communication

• Top Management is required to ensure communication

process are established

• Communication takes place regarding the effectiveness

of the quality management system


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of the quality management system


5.6 Management Review

5.6.1 General

– Top Management shall review the quality management system

• At planned intervals


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• Ensuring the continuing suitability, adequacy and effectiveness

• Review opportunities for improvements and changes to the quality management system

– Including the quality policy and objectives

• Management Reviews requires a record (see 4.2.4)

TS Add-On

• 5.6.1.1 QMS performance

– Must monitor all QMS requirements & processes (i.e. not

just OTD, PPM, % scrap, etc.)

– Monitoring of quality objectives

– Reporting & evaluation of cost of poor quality


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– Minimum records required to provide evidence of:

• achieving objectives as specified in the Business Plan

• satisfying customer requirements with product shipped


5.6 Management Review (continued)

5.6.2 Management Review Inputs

Inputs required:

• Audit results,

– internal, customer, 3rd party

TS Add-Ons:

5.1.1 Process efficiency

5.6.1.1 Quality objectives

including cost of poor quality

5.6.2.1 Actual/potential field

failures

7.3.4.1 Monitoring results of


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– internal, customer, 3 party

• Customer feedback

• Product and process performance results

• Status of corrective and preventive actions

• Follow-ups from previous reviews

• Business changes that might affect the quality management system

• Possible quality management system improvements

7.3.4.1 Monitoring results of

stages of Design &

Development (APQP)

TS Add-On

• 5.6.2.1 Review input – supplemental

– Management Review input (agenda items) must include:

• Analysis of actual field-failures

• Analysis of potential field-failures

• Field failure impact on


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• Field failure impact on

– Quality

– Safety

– Environment


5.6 Management Review (continued)

5.6.3 Review Outputs

• Decisions and actions related to the management

review requiring output

– Determined improvements of the quality


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– Determined improvements of the quality

management system and its related processes

– Product improvements related to customer

requirements

– Needed resources


6.1 Provision of Resources– Your organization is responsible for determining and providing the resources

needed:

• To implement and maintain the ISO 9001:2008 quality management system and continually improve the effectiveness of the established quality management system

• Enhancing customer satisfaction by meeting the customer’s requirements


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6.2 Human Resources6.2.1 General

Personnel performing work affecting quality are required to be competent based on the appropriate education, training, skills and experience

Competency = Education + Training + Skills + Experience

NOTE Conformity to product requirements may be affected directly or indirectly

by personnel performing any task within the quality management system.


6.2 Human Resources6.2.2 Competence, Awareness and Training

• The organization is responsible for determining the competence for performing work affecting conformity to product qualityqualityquality requirements

– Initial training identification

– Ongoing identification of training needs

• Where applicable, provide the necessary training or take other actions to achieve the necessary competence

• Evaluate the training provided to determine its effectiveness


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• Evaluate the training provided to determine its effectiveness

• The organization is responsible for ensuring that personnel are aware of the importance of their contribution; how it impacts the organization's ability to meet established quality goals & objectives

• The organization is responsible for maintaining training records

– Education

– Training

– Skills

– Experience

TS Add-On

• 6.2.2.1 Product design skills

– Must ensure personnel with product design responsibility

are competent:

• To achieve design requirements

• Are skilled in applicable tool & techniques


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– Applicable tools & techniques must be identified

Discussion: Do you have pre-requisites for hiring those

involved in the design function? Are competency

requirements identified for design skills needed for

processing data such as GD&T, CAD, Modeling, etc.?

TS Add-On

• 6.2.2.2 Training

– Must have documented procedure for identifying training needs & achieving competency

– Specific assigned tasks must be qualified with particular attention to satisfaction of customer specific requirements (product deliverables)


72


(product deliverables)

Note 1: Applies to all employees (contract, temporary, interns, etc.) at all levels

Note 2: Example of customer specific requirements is the application of “digitized mathematically-based data” (i.e. CAD, SPC, GR&R, process capability, etc.)

TS Add-On

• 6.2.2.3 On-the-job Training (OJT)

– Must provide OJT for any new or modified job affecting product quality (includes contract & temps)

– Personnel whose work affects quality must be informed of consequences to customer

• 6.2.2.4 Employee motivation & empowerment


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• 6.2.2.4 Employee motivation & empowerment

– Must have a measurable process to motivate employees to:

• achieve quality objectives

• make continual improvements

• create an environment to promote innovation

• Promotes quality & technological awareness


6.3 Infrastructure– The organization is responsible for determining, providing the

necessary infrastructure to ensure product conformity, as appropriate, including

• Buildings, work spaces and associated utilities

• The necessary equipment to produce the product, including

– Machines


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– Machines

– Tools

– Dies

– Jigs

– Measurement and monitoring instruments

– Computers

– Associated software


6.3 Infrastructure cont.

– Support services

• Transportation

• Communication

– Phone


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– Phone

– Computer/internet

• Information systems

TS Add-On

• 6.3.1 Plant, facility & equipment planning

– Must use “multidisciplinary approach” for plant, facility &

equipment planning

– Plant layout (material flow & space requirements) to

facilitate synchronous material flow (JIT, one-piece flow,

balanced lines, 5S principles, Hoshin, etc.)


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balanced lines, 5S principles, Hoshin, etc.)

Note: Focus on lean manufacturing principles and link to

QMS success

TS Add-On

• 6.3.2 Contingency plans

– Must prepare contingency plans to satisfy customer

requirements in event of emergency

• Utility interruptions

• Labor shortages


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• Key equipment failure

• Field returns (recall plan)

Discussion: What about key supplier relationships and/or

material?


6.4 Work Environment

– The organization is responsible for determining the

appropriate work environment needed to achieve product

conformity

• Macro level,


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– building and facilities

• Micro level

– Immediate operator work environment

NOTE The term "work environment" relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).

TS Add-On

• 6.4.1 Personnel safety to achieve product quality

– Product safety & means to minimize injury risks to

employees must be addressed

– Preference is build into design & development processes as

well as in manufacturing process activities (i.e. design out

sharp edges, design in work-cell rotation, etc.)


79


sharp edges, design in work-cell rotation, etc.)

• 6.4.2 Cleanliness of premises

– Must maintain premises in state of order, cleanliness and

repair necessary to achieve objectives


7.1 Planning of Product Realization– Organization is required to plan and develop the processes needed to

develop the product or service from concept to deliverable ("product

realization")

– Planning requirements are required to be consistence with other

processes of the quality management system


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– The organization’s product planning determines:

• Quality objectives & product requirements

• Necessary processes, documentation & resources

• Quality assurance activities & criteria for product acceptance

• Record providing evidence that product/process requirements were

met according to "product realization plan" (4.2.4)

TS Add-On

7.1 Planning of product realization

Note: Some customers reference “Project Management” or

“APQP” as the means to achieve product realization. The

APQP approach uses the concepts of error preventive and

continual improvement using a multi-disciplinary approach to

planning .


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planning .

TS Add-On

• 7.1.1 Planning of Product Realization

– Product planning efforts includes customer requirements and reference to customers technical specifications

• Component of Quality Plan

• 7.1.2 Acceptance Criteria:

– Defined by your organization


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– Defined by your organization

• Approved by the customer as required

• C= 0 sampling plans for attribute data

• 7.1.3 Confidentiality:

– Ensure that the customer-contracted designs, projects and products confidentiality is maintained

TS Add-On

• 7.1.4 Change Control:

– Must have a process to control & react to changes that impact the production process

• Change effect, including those caused by the supply base, are required to be assessed.

– Change verification and validation activities are defined to ensure compliance with customer requirements

– Validated prior to implementation


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– Validated prior to implementation

– For proprietary designs, impact on form, fit & function must be reviewed with customer so all effects of the design change can be evaluated

– When required additional verification/identification requirements, such as those required for new product introduction, are required to be met

Note 1: Any product realization changes affecting customer requirements must include customer notification & agreement

Note 2: These requirements apply to product and manufacturing changes


7.2 Customer related processes

7.2.1 Determination of requirements related to product

– Organization determines

• Customer specified requirements

– Including delivery and post delivery activities

• Customer requirements unstated by customer, but


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• Customer requirements unstated by customer, but necessary for intended use

– Only where known

• Statutory and regulatory requirements

• Other requirements determined by organization

NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

TS Add-On

7.2.1 Determination of requirements related to the product

• Note 1: Post-delivery activities = any after-sales product

service as part of the original agreement

• Note 2: Process for determining customer requirements must

consider recycling, environmental impact, other characteristics

associated with your organization’s expertise


85


associated with your organization’s expertise

• Note 3: Statutory/Regulatory requirements include all

applicable government, safety and environmental regulations

associated with acquisition, storage, handling, recycling,

elimination or disposal of materials

TS Add-On

7.2.1.1 Customer designated special characteristics

– Your organization is responsible for demonstrating

conformity to customer requirements of special

characteristics, including:

• Designation

• Documentation


86


• Documentation

• Control (i.e. SPC, process capability, etc.)


7.2.2 Review of requirements related to product

– Prior to accepting an order, the organization is required

• Review requirements

• Prior to order acceptance

• Review requires


87


• Review requires

– Product requirements are defined and understood

– Any differences between the offer and tender are

resolved prior to the order’s acceptance by the

organization

– Organization can meet the stated requirements


7.2.2 Review of requirements related to product cont.

– Records of customer orders must be maintained (see 4.2.4)

– When no written order is received, customer requirements are to be confirmed prior to acceptance

– When orders are changed, the organization is required to

• Amendments made to original order


88


• Amendments made to original order

• Relevant personnel are notified of changes

TS Add-On

7.2.2.1 Review of requirements related to the product:

– Waving the requirements of 7.2.2 for a formal review

requires customer authorization

7.2.2.2 Organization manufacturing feasibility:


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– Must investigate, confirm and document the manufacturing

feasibility of proposed products in the course of contract

review including risk analysis

Discussion: Keep in mind feasibility must be done prior to

making the commitment to customers


7.2.3 Customer communication

– The organization is required to determine and implement

arrangements for communicating with customers,

specifically

a. Product information


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a. Product information

b. Enquiries, including contracts, orders and

amendments

c. Customer feedback, including the handling of

customer complaints

TS Add-On

7.2.3.1 Customer Communication:

– Your organization is responsible for communicating the

necessary information, including data, in a customer

specified language and format

• Examples:

– CAD data


91


– CAD data

– EDI data

– Multiple languages

– Subscriptions to 3rd party web services


7.3.1 Design and development planning

– Organization is required to plan and control the design and development of product

– In design/development plan, the organization determines

TS Add-On: Requirements of 7.3 include product and manufacturing process design & development, & a focus on error prevention rather than detection.


92


– In design/development plan, the organization determines

a. The necessary design and development stages

b. Design reviews,

• Verification

• Validation, as appropriate

c. The responsibilities and authority for the design and development activities


7.3.1 Design and development planning (continued)

– The organization is required to manage the interface

between involved design groups, ensuring effective

communication and clear assignment of responsibility

– Planning output is required to be updated as the

design/developments progresses and is changed


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design/developments progresses and is changed

TS Add-On

7.3.1.1 Multidisciplinary approach:

– Must use a multidisciplinary approach to the design process, including

• Development, finalization and monitoring of special characteristics

• Development of FMEAs


94


• Development of FMEAs

– Including actions taken to reduce potential risk

• Development and review of Control Plans

Notes: Multidisciplinary approach includes design, manufacturing, quality, engineering, production and others as appropriate (i.e. purchasing, maintenance, IT, etc.)


7.3.2 Design and development inputs

– Design and development inputs are recorded when

determined (see 4.2.4)

• Design and development inputs are required to include

a. Product function and performance requirements


95


b. Statutory and regulatory requirements, as applicable

c. Information and data derived from previous, similar designs

d. Other essential design/development requirements

– Inputs are reviewed for adequacy

– Requirements are complete, unambiguous and not in

conflict with each other

TS Add-On

7.3.2.1 Product design input

– Must identify, document and review product design input requirements, including:

• Customer requirements such as Special Characteristics, identification and traceability requirements

• Use of information for current and future


96


• Use of information for current and future

– Process to deploy data from previous designs, Competitor analysis, supplier feedback, field feedback, internal input other relevant sources of information

• Targets for product quality, life, reliability, maintainability, timing and cost

TS Add-On

7.3.2.2 Manufacturing process design input:

– Your organization is required to identify, document and review the manufacturing process design inputs, including:

• Product design output data

• Targets for productivity, process capability and cost

• Specific customer requirements


97


• Specific customer requirements

• Experience from previous design projects

Note: Manufacturing process design includes error-proofing methods to a degree appropriate to the magnitude of potential problems & commensurate with the potential risk

TS Add-On

7.3.2.3 Special Characteristics:

– Must identify applicable special characteristics

• Including all special characteristics in Control Plan

• Comply with customer-specified definitions & symbols

• Identify process control documents with the customer’s


98


• Identify process control documents with the customer’s

special characteristics symbol, or your equivalent,

including (i.e. FMEAs, control plans, drawings &

operator instructions)

Note: Special Characteristics can include product

characteristics or process parameters


7.3.3 Design and development outputs

– Design/development output is required to be expressed

in a form that enables verification against

design/development inputs.

– Design/development outputs require approval prior to

design release


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design release

– Design/development outputs require

a. Design output meets the design input criteria

b. Provides information for purchasing, production and servicing

provisions as appropriate

c. Contain, or reference the acceptance criteria

d. Specify any characteristics or design feature that are essential for safe

and proper functioning

TS Add-On

7.3.3.1 Product design output

– Product design is required to be expressed in terms that can

be verified and validated against design inputs. Design

outputs include:

• Design FMEAs

• Product Special Characteristics


100


• Product Special Characteristics

• Product error-proofing, as appropriate

• Product definition – either as a drawing or related

mathematically based data

• Product design review results

• Diagnostic guidelines where applicable

TS Add-On

7.3.3.2 Manufacturing process design output:

– Manufacturing design output is required to be expressed in terms that can be verified against manufacturing design inputs, including:

• Specifications and drawings

• Manufacturing flowcharts/layouts

• Manufacturing FMEAs

• Control Plans


101


• Control Plans

• Work Instructions

• Process Approval acceptance criteria

• Data for quality, reliability, maintainability and measurability

• Error-proofing results, as appropriate

• Methods for rapid detection and feedback of manufacturing process nonconformities


7.3.4 Design and Development Review

• Design and development reviews are required as planned (7.2.1)

a. Evaluate the ability of the design result to meet the design requirements

b. Identify any related problems, and propose any


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b. Identify any related problems, and propose any necessary action items

• Design review participants include representative of the design functions concerned with design/development stages being reviewed.

• Design/development review records are required to be maintained (see 4.2.4)

- Including any assigned action items

TS Add-On

Notes: Design reviews are coordinated with the appropriate design phases, and include manufacturing process design and development.

7.3.4.1 Monitoring

– Measurements at specified stages of design and


103


– Measurements at specified stages of design and development are defined, analyzed and reported with the summary results being used as input to the management review process

Note: Monitoring measurements includes quality risk, cost, lead-times, critical paths and others as appropriate


7.3.5 Design and development verification

– Design verification is performed in accordance with the

design plan (7.3.1) to ensure that the design inputs

requirements are met by the design outputs.

– Records of design/development verifications are recorded


104


– Records of design/development verifications are recorded

(see 4.2.4), including any necessary actions arising from

the verification results


7.3.6 Design and Development validation

– Design validation is required to be performed according to

the planned arrangements (7.3.1)

– Ensures that the product meets the specified requirements

for the product’s intended application or use


105


for the product’s intended application or use

– When practical, validation is required to be completed prior

to delivery or use of the product.

– Records of design validation are required to be maintained

(see 4.2.4),

• Including any necessary action items

TS Add-On

• 7.3.6 Design & development validation

Note 1: Validation process normally includes an analysis of

field reports for similar products

Note 2: The requirements for 7.3.5 (Verification) and 7.3.6

(Validation) apply to both product and processes


106


(Validation) apply to both product and processes

TS Add-On

7.3.6.1 Design and development validation

– Design and development validation is performed in accordance with

customer requirements and design program timing

7.3.6.2 Prototype program

– When required, must provide a prototype program and related Control


107


Plan. Whenever possible, your must utilize the same suppliers, tooling

and manufacturing processes

– All performance-testing must be monitored for compliance and timely

completion

– If prototype services are outsourced, your organization is responsible

for the services provided, including technical leadership

TS Add-On

7.3.6.3 Product approval process (PPAP):

– Must conform to customer-specified product and

manufacturing approval process (PPAP)

Notes : Product approval should be subsequent to

verification of the manufacturing process

– Whatever product approval process is used, the same


108


– Whatever product approval process is used, the same

product approval process is applied to your supplier base


7.3.7 Control of design and development changes

– The organization is required to identify any

design/development changes

• Records must be maintained (see 4.2.4)

– Design changes are reviewed, verified, validated and


109


– Design changes are reviewed, verified, validated and

approved prior to design change implementation

– Design review considers evaluation of effect of changes on

the design’s constituent parts, and product in the field

– Records and any necessary actions items are maintained

(see 4.2.4)

TS Add-On

7.3.7 Control of design and development changes

– Note: Design & development changes include all changes

during the life of the program


110



7.4.1 Purchasing Process

– Purchasing process ensures that product purchased for

incorporation in the product realization process meets the

specified requirements

• Minimally applies only to product used to make final


111


• Minimally applies only to product used to make final

product

– Control exercised over the supplier is based on

• Effect purchased product has on organization’s final

product


7.4.1 Purchasing Process (continued)

– Organization is required to select and evaluate suppliers

based on

• Supplier’s abilities to meet the organization's requirements

– Criteria for supplier’s selection


112


• Established - documented

– Criteria for supplier’s evaluation

• Established

• Periodic re-evaluation defined

– Records of supplier performance maintained

• Including any necessary actions arising from the selection and

evaluation process

TS Add-On

7.4.1 Purchasing Process

• Note 1: Purchased product includes all product and services

that affect customer requirements, including sub-assembly,

sequencing, sorting, rework and calibration services

• Note 2: When mergers occur, your organization is required to

verify the supplier’s quality management system continuity


113


verify the supplier’s quality management system continuity

and effectiveness

TS Add-On

7.4.1.1 Regulatory conformity

– All purchased product or materials are required to conform with the applicable regulatory requirements

7.4.1.2 Supplier QMS development

– Must develop your supply base with the goal of supplier conformance with TS 16949:2009. ISO 9001:2008 is the


114


conformance with TS 16949:2009. ISO 9001:2008 is the first step in achieving this goal

Note: Prioritization of supplier development is dependent upon the supplier’s performance and impact of their product on your organization’s final product

– Unless otherwise specified, third party registration to ISO 9001:2008 is required of your suppliers

TS Add-On

7.4.1.3 Customer approved sources

– Must use customer designated suppliers when contractually

stipulated

– The use of customer-designated supplier does not relieve

your organization from ensuring purchased product

conformity (includes tool and gage suppliers)


115


conformity (includes tool and gage suppliers)

Discussion: “Many times… you’re screwed. So what

happens when your customer mandates Cousin Earl’s

Plating Services, but Cousin Earl is your worst supplier?”


7.4.2 Purchasing information

– The organization’s purchasing information provided to the supplier is required to include, as appropriate

a. The requirements for approval of the purchased product

• Specified procedures


116


• Specified procedures

• Specified processes and equipment

b. Personnel qualification requirements

c. Quality management system requirements

– Organization approves purchasing information prior to release to supplier


7.4.3 Verification of purchased product

– Organization is required to establish and implement the

inspection necessary to verify that the product’s specified

requirements are met

– When verification takes place at the supplier's location, the


117


– When verification takes place at the supplier's location, the

method of inspection and product release is stipulated in

the purchasing information

TS Add-On

7.4.3.1 Incoming product quality

– Must use a process that assures the quality of received

product, utilizing one or more of the following:

• Receipt and evaluation of statistical data

• Receiving inspection/testing


118


– Sampling based on performance

• Second or third party assessments or audit of supplier

sites + records of acceptable delivery product quality

• Evaluation by designated laboratory

• Methods agreed to by customer

TS Add-On

7.4.3.2 Supplier monitoring

– Must monitor supplier performance using the following indicators:

• Delivered product quality

• Customer disruptions, including field returns

• Delivery performance


119


• Delivery performance

– Including tracking of premium freight

• “Special status” customer notification related to delivery and quality issues

– Must promote your supplier’s monitoring of their manufacturing processes


7.5.1 Control of Production and Service Provision:

– Organization is required to plan production

– Production is required to be carried out under controlled condition, these controlled conditions must include:

a) Documents that describe the product characteristics

b) Work instructions, as necessary


120


b) Work instructions, as necessary

c) Use of suitable production equipment and processes

d) Availability of monitoring devicesdevicesdevices equipment

– Availability of IMTE

e) Implementing the identified monitoring and IMTE devices

f) Implementation of product release

– Delivery

– Post delivery activities

TS Add-On

7.5.1.1 Control Plans

– Must develop control plans at the system, subsystem, component and/or material level for the product supplier

• Includes those processes producing bulk materials

– Required for production and pre-launch, and accounts for design and manufacturing FMEA outputs

– Control Plans include:


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– Control Plans include:

• Controls used to control manufacturing processes

• Monitoring methods used to exercise control over special characteristics

– Internal and external special characteristics

• Includes any customer-specified information (as applicable)

• Initiation of a reaction plan (8.2.3.1) when the process becomes unstable, including lack of statistical capability

TS Add-On

7.5.1.1 Control Plans cont.

– Control plans are required to be:

• Updated and revised when changes occur, including:

– Product changes

– Manufacturing process changes

– Measurement changes, either methods or instrumentation


122


– Measurement changes, either methods or instrumentation

– Logistical changes

– Supplier changes

– FMEA changes

Note: Customer approval may be require prior to making Control Plan

changes

TS Add-On

7.5.1.2 Work Instructions

– Work instruction for personnel having responsibility for

operation of processes that affect quality are required.

– These work instructions are required to be accessible for

use at the work station

– Work instruction are derived using appropriate sources,


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– Work instruction are derived using appropriate sources,

including:

• Quality Plan

• Control Plans

• FMEAs

• Product manufacturing process

TS Add-On

7.5.1.3 Verification of job set-up

– Verification of set up is required

• Initial run of production

• Material changes

• Job changes


124


• Job changes

– Work instruction for job set-up is required and the use of

statistical methods of set-up verification, as applicable

Note: Last-off part comparisons are recommended (not

required)

TS Add-On

7.5.1.4 Preventive and predicative maintenance

– Must identify key process equipment and ensure resources for

equipment maintenance

– Develop an effective planned total preventive system

– Minimally this system includes:

• Planned maintenance activities


125


• Planned maintenance activities

• Methods used to package, preserve tooling, equipment and gauging

• Availability of replacement parts for key equipment

• Documenting, evaluating and improving maintenance objectives

– Use predictive methods to continually improve the effectiveness and

efficiency of production equipment

TS Add-On

7.5.1.5 Management of production tooling

– Must provide resources for tool and gauging design, fabrication and

verification activities. A production management system is required,

including:

• Maintenance and repair facilities and personnel

• Tooling/gauging storage and recovery


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• Setup

• Tool-changing programs for perishable tooling

• Tool modification and revision

• Tool identification, including:

– Status of tool (i.e. production, repair or disposal)

– System must also account for outsourced tooling activities

Note: Also applies for tools used for service production parts

TS Add-On

7.5.1.6 Production scheduling

– Production must be scheduled to meet customer requirements such as JIT supported by a system that permits access to data at key stages of the production process that is order driven


127


7.5.1.7 Feedback of information from service

– Your organization is required to provide information on service concerns to manufacturing, design and engineering functions within your organization

Note: Ensure a feedback loop is established and maintained enabling awareness of external non-conformances

TS Add-On

7.5.1.8 Service agreement with customer

– Where there is a service (post-delivery) agreement with the

customer, you must verify the effectiveness of:

• Any service center within the organization

• Any special-purpose tools or measurement equipment


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• Training of service personnel

Discussion: Can you give me an example of a personal

service agreement (outside of work)? What special

training is required for your service provider?


7.5.2 Validation of Processes for Production and Service

Provision– Shall validate any processes for production and service provision where

the resulting output cannot be verified by subsequent monitoring or

measurement and as a consequence, deficiencies become apparent only

after the product is in use or the service has been delivered.


129


– This process requires:

a) Defined criteria for process review and process approval

b) Approval of process equipment

– Qualification of process personnel

c) Use of specific methods and procedures

d) Records required to indicate compliance

e) Revalidation

TS Add-On

• 7.5.2.1 Validation of processes for production & service

provision – Supplemental

– The requirements of 7.5.2 apply to all process for

production & service provision


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7.5.3 Identification and Traceability

– The organization is required to identify product by suitable means from it’s receipt and through the product’s realization

– The organization is required to identify the product’s status with respect to the monitoring and measurement


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with respect to the monitoring and measurement requirements

– When traceability is a requirement, the organization is required to control the product’s traceability

• Record of traceability is required to be maintained

TS Add-On

7.5.3.1 Identification and Traceability

– The ISO language used in 7.5.3, “where appropriate” does

not apply to ISO/TS 16949 clients. All product is required

to be identified throughout the production process


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Note:

• Inspection and test status is not indicated by location in

the production flow, unless inherently obvious.

• Alternatives are permitted, if status is clearly identified,

documented and achieves the designate purpose.


7.5.4 Customer Property– Your organization is required to exercise care with customer property

when in and use/control

– Organization is required to:

• Identify customer property

• Verify customer property

• Protect and safeguard customer property used in product


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• Protect and safeguard customer property used in product realization

– If customer property is lost, damaged or otherwise unsuitable for use, then your organization is required to

• Report this to the customer

• Records of lost, damaged or otherwise unusable customer product are required to be maintained

– NOTE Customer property can include intellectual property and personal data.

TS Add-On

Note: Customer-owned returnable packaging included.

7.5.4.1 Customer-owned production tooling

– The following customer-owned equipment must be

permanently mark so that ownership is visible and can be

determined:


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determined:

• Manufacturing tooling

• Testing tools & equipment

• Inspection tools & equipment


7.5.5 Preservation of Product• The organization shall preserve the product during internal processing

and delivery to the intended destination in order to maintain conformity to requirements.

• Preservation includes:

• Product identification

• Product handling


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• Product handling

• Product packaging

– Packing

– Labeling

• Storage

• Protection

– Preservation of product also applies to final product’s constituent parts

TS Add-On

7.5.5.1 Storage and inventory

– Must assess inventory at planned intervals

• Detect deteriorated stock (i.e. paints, samples, etc.)

– Use an inventory management system for stock rotation

and reduction of WIP inventory costs (FIFO)


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– Obsolete products are controlled in similar manners to non-

conforming product (8.3)


7.6 Control of Monitoring and Measurement Equipment

– The organization is required to determine the product or

process monitoring and measurement to be undertaken

– Identify the monitoring and measurement devices needed to

provide evidence of conformance to determined

requirements


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requirements

– Organization is required to establish processes which ensure

that monitoring and measurements can be carried out

• Identified monitoring and measurements are executed in

a manner that is consistence with the stated monitoring

and measurement requirements


7.6 Control of Monitoring and Measurement Devices- Where necessary to ensure valid inspection results, measuring equipment is required to:

a) Be calibrated and/or verified, or both•Calibrated against national or international recognized standards

•Where no such standards exist, the methods are required to be documented

b) Be adjusted or re-adjusted as necessary


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b) Be adjusted or re-adjusted as necessary

c) Identify measurement devices to enable the calibration status to be determined

d) Safeguard measurement devices from unintended adjustments

e) Measurement devices are protected from damage during handling, maintenance and storage

NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.


7.6 Control of Monitoring and Measurement Devices

– Organization is required to assess and record the validity of

previous measurement results when the measurement

device is found to be out of calibration

• take appropriate actions to affected equipment and related product

– The organization is required to maintain records of


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– The organization is required to maintain records of

calibration (see 4.2.4)

– When used in measurement and monitoring, test software is

verified of its ability to satisfy it’s intended application

• Prior to use

• Reconfirmed as necessary

TS Add-On

7.6.1 Measurement system analysis (MSA)

– The use of statistical tools to analyze the variation in the

measuring and test equipment is required

• For all measuring and test equipment and

instrumentation referenced in the Control Plan


140


• Methods and acceptance criteria used to analyze

equipment is required to conform to customer specified

reference manuals on MSA

– If other methods are used they must be approved by

the customer

TS Add-On

7.6.2 Calibration/verification records

– Records of calibration are required to provide evidence of the ability to

determine conformance of requirements

• Including all customer and employee owned gauging

• Calibration records include:

– Equipment identification, including the measurement standard


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– Equipment identification, including the measurement standard

used to calibrate

– Revision following engineering changes

– Any out-of –spec reading as received

– An assessment of the impact of the out-of-specification

condition

– Customer notification when suspect product has been shipped

TS Add-On

7.6.3.1 Internal laboratory requirements

– Lab must have a defined scope, including:

• Capability to perform required inspections, test or cal services offered

• The laboratory’s scope is included in the quality management system documentation.

• Technical techniques are required to be determined and specified for the laboratory, including:


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for the laboratory, including:

– Adequacy of laboratory procedures

– Adequacy of laboratory personnel

– Testing/calibration of product

– Capability to perform test and calibration correctly, traceable to relevant standards

– Review of calibration records

• Accreditation to ISO/IEC 17025 may be used to indicate compliance, but is not required

TS Add-On

7.6.3.2 External laboratory requirements

– Your organization may use outside lab to conduct

necessary inspection and testing activities. The external

laboratory is required to have a defined scope including the

capability for the testing contracted.

– The evidence of customer approval is required for external


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– The evidence of customer approval is required for external

laboratories, or

– Accreditation to ISO/IEC 17025 or national equivalent

TS Add-On

7.6 Laboratory Requirements

Note 1: Evidence of laboratory conformance may include

– Demonstrated customer assessment and approval

– Customer approved second part assessment to intent

of ISO/IEC 17025


144


Note 2: When a qualified laboratory is not available, the

original equipment may be used, if the conditions of 7.6.3.1

(internal lab requirements) are met


8.1 General

– The organization is required to plan and implement the

monitoring, measurement, analysis and improvement

processes needed

a) To demonstrate conformity of product requirements


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b) To ensure conformity of the quality management system

c) Continually improve the effectiveness of the quality

management system

– Including the determination of applicable methods,

including statistical techniques, and the extent of their

use

TS Add-On

8.1.1 Identification of statistical tools

– Appropriate statistical tools are identified in the course of APQP activities

• Included on the developed Control Plan

8.1.2 Knowledge of basic statistical concepts

– Basic statistical concepts are required to be understood and


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– Basic statistical concepts are required to be understood and utilized throughout your organization, including:

• Variation

• Control/stability

• Process capability

• Over-adjustment


8.2.1 Customer Satisfaction

• As a component of the measurement of performance of

the quality management system, the organization is

required to monitor information related to customer



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required to monitor information related to customer

perception as to whether the organization has met the

customer's requirements

• The methods used to obtaining customer satisfaction

information is determined by the organization

• How customer satisfaction information obtained is used

is determined by the organization


Note: Monitoring customer perception can include obtaining

input from sources such as

– customer satisfaction surveys

– customer data on delivered product quality



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– customer data on delivered product quality

– user opinion survey

– lost business analysis

– compliments

– warranty claims

– dealer reports

TS Add-On

8.2.1.1 Customer satisfaction

– Your organization is required to monitor customer satisfaction through the continual evaluation of performance of realization processes.

– Performance indicators are objective data including, but not limited to:


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limited to:

• Delivered part performance

• Customer disruptions, including field returns

• Deliver schedule performance

– Don’t forget including premium freight

• Customer notification related to quality and delivery issues

TS Add-On

8.2.1.1 Customer satisfaction (continued)

– Must monitor the performance of the manufacturing

processes to demonstrate compliance with customer

requirements for product quality and efficiency of the

process


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8.2.2 Internal Audits

– The organization is required to conduct internal audits at planned intervals to determine whether the quality system

a) Conforms to planned arrangements (see 7.1), to the requirements of the international standards, and to the quality management system requirements established



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quality management system requirements established by the organizations

b) Is effectively implemented and maintained

– An audit program planned

• Considers the status and importance of the process and areas to be audited, as well as previous audit results

• Audit scope,criteria, frequency and methods are required to be defined

8.2.2 Internal Audits (continued)

– An audit program planned

• Selection of auditors and conduct of the audit must ensure impartiality of the audit process

• Auditors can not audit their own WORK (different than ISO 9001:1994)

– Documented procedure required to define responsibility &



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– Documented procedure required to define responsibility & requirements for

• planning audits

• conducting audits

• establishing records

• reporting results

– Records of audits and results shall be maintained

8.2.2 Internal Audits

– Area management required to ensure any

necessary corrections and corrective actions are

taken without undue delay to eliminate detected

nonconformities and their causes



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nonconformities and their causes

– Follow-up activities shall include verification of

actions taken and reporting of verification results

(see 8.5)

NOTE See ISO 19011 for guidance.

TS Add-On

8.2.2.1 Quality management system audit

– Must conduct internal audits of the quality management system to

ISO/TS 16949 and any additional QMS requirements

8.2.2.2 Manufacturing process audit

– Must conduct audits of each manufacturing process to determine

effectiveness (i.e. Layered Process Audits)


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8.2.2.3 Product audit

– Must audit product (at defined frequencies) at appropriate stages of

production and delivery to verify conformance with specified

requirements, such as:

• Product dimensions

• Functionally

• Packaging, packing and labeling

TS Add-On

8.2.2.4 Audit plans

– Internal audit plans are required to cover all facets of the quality

management system

• All processes and related activities

• All shifts

– Use an annual audit plan


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– Increase audit frequencies, as appropriate, when internal/external non-

conformances or customer complaints occur

8.2.2.5 Internal auditor qualification

– Must use internal auditors that are “qualified” to audit the requirements

of ISO/TS 16949:2002

• Using 6.2.2.2 as a guideline

Discussion: ISO 19011 is also recommended as a guideline

8.2.3 Monitoring and Measurement of Processes

– The organization is required to apply suitable methods of monitoring the quality management system process

• Measurement where applicable

– The monitoring and measuring methods are used to demonstrate the ability of the quality management system



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demonstrate the ability of the quality management system processes to achieved planned results

• When these results are not achieved, corrective action is required to ensure conformity of the product

NOTE When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

TS Add-On

8.2.3.1 Monitoring and measurement of the manufacturing process

– Must perform process studies on all new processes to verify process

capability and provide input for process control

– Process studies must be documented with specification, as applicable

for production methods, measurements, test and maintenance

instructions

– Process study documents are required to include:


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– Process study documents are required to include:

• Objectives for manufacturing

• Process capabilities

• Reliability

• Maintainability and availability

• Acceptance criteria

TS Add-On

8.2.3.1 Monitoring and measurement of the manufacturing

process (continue)

– Must maintain process capability per customer specified

part approval process requirements

– The developed control plan and process flow diagram are

required to be implemented, including adherence to


158


required to be implemented, including adherence to

specified:

• Measuring techniques

• Sampling plans

• Acceptance criteria

• Reaction plans when the acceptance criteria is not met

TS Add-On


process (continued)

– Significant process events, such as tooling changes or

machine repairs are required to be recorded

– Must initiate a reaction plan from the Control Plan when

statistical process capability is not achieved, or the process


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statistical process capability is not achieved, or the process

becomes unstable.

– Reaction plans are required to include product containment

and 100% inspection, as appropriate

TS Add-On


process (continued)

– A corrective action plan is required including timing and

responsibility assignments, to assure the process returns to

statistical capability and stability

– Corrective action plan are required to be reviewed with the


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– Corrective action plan are required to be reviewed with the

customer when required

– Must maintain records of effective dates of process changes

8.2.4 Monitoring and Measurement of Product– The organization is required to monitor and measure the characteristics

of product to verify product requirements are met

• Carried out according to the arrangement made in product

realization (see 7.1)

– Evidence (records) of conformance with the acceptance criteria are

required



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required

• Records require indication of persons authorizing product release

(see 4.2.4)

– Release of product and delivery of service are prohibited until planned

measurement and monitoring arrangements have been satisfactorily

completed

• Unless prior release authorization is obtained from customer

(customer deviation)

TS Add-On

8.2.4 Monitoring & measurement of product

Notes: When your organization selects product parameters to

monitor compliance to requirements, either external or

internal, you must determine the measurable product

characteristics, including:

– The types of measurements made


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– The types of measurements made

– Suitable measurement means

– The necessary skill and capability required of the

personnel performing monitoring and measurement

activities

TS Add-On

8.2.4.1 Layout inspection and functional testing

– Layout inspection and any functional testing to

customer engineering material and performance

standards is required to be performed for each

product at the frequency specified by the Control


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product at the frequency specified by the Control

Plan

– Results are required to be made available to the

customer

Note: Layout inspection is a complete measurement of all

product dimensions shown on the design record.

TS Add-On

8.2.4.2 Appearance items

– When your organization manufactures product designated by your

customer “appearance items”, your organization provides:

• Appropriate resources for evaluation

– Including lighting

• Masters, as appropriate


164


– Color

– Grain

– Gloss

– Metallic brilliance

– Texture

– Distinctness of image

TS Add-On

8.2.4.2 Appearance items (continued)

– Maintenance and control of appearance masters and

evaluation equipment

– Verification that personnel making appearance evaluations

are competent and qualified to do so


165


8.3 Control of Nonconforming Product– Organization is required to control and identify nonconforming

product to prevent its unintended use

– Controls and related responsibility dealing with nonconforming products are required to be documented in a procedure

– Where practicable, must resolve nonconforming product as follows

a) taking action to eliminate detected nonconformity



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a) taking action to eliminate detected nonconformity

b) by authorizing use, release or acceptance under concession

• Relevant authority

• Customer

c) taking actions to preclude unintended use or application

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

8.3 Control of Nonconforming Product

– Records of the nature of nonconforming products and any subsequent actions taken are required to be maintained (see 4.2.4)

• Including any concessions obtained

– When nonconforming product is corrected (repaired or



167


– When nonconforming product is corrected (repaired or reworked) it is required to be re-verified to demonstrate conformance to requirements

– When product nonconformity is detected after product’s delivery, or the product is in use, the organization is required to take action appropriate to the effects, or potential effects, of the product nonconformity

TS Add-On

8.3.1 Control of nonconforming product

– Suspect or unidentified product’s status is required to be

classified as nonconforming

8.3.2 Control of rework product

– Rework instruction, including re-inspection requirements,

are required to be accessible and used by the appropriate


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are required to be accessible and used by the appropriate

personnel

8.3.3 Customer information

– Your organization is required to inform your customer

promptly if you ship nonconforming product to their

location

TS Add-On

8.3.4 Customer waiver

– Required to obtain customer concessions or deviation to permit further

processing when the product differs from that which is currently

approved

– Required to maintain records of customer deviations and concessions.

– Required to ensure compliance with the original or superseding


169


specification and requirements when the deviation expires

– Each shipping container shipped on authorization must be identified

– This requirement applies equally to purchased product. Must agree

with your supplier before submitting a deviation to your customer


– The organization is required to determine, collect and

analyze data to demonstrate the suitability and

effectiveness of the quality management system

– Evaluate where continual improvement of the quality

management system can be made



170


management system can be made

– This analysis is required to include data gathered as a

result of monitoring and measurement (see 8.2) and other

relevant sources (see 8.2.1)


– The analysis of data is required to provide information

related to

a) Customer satisfaction (see 8.2.1)

b) Conformity to product requirements (see 7.2.1)



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b) Conformity to product requirements (see 7.2.1)

c) Characteristics and trends of processes and products,

including opportunities for preventive actions

d) Suppliers

TS Add-On

8.4.1 Analysis and use of data

– Must compare trends in quality and operational performance with

progress towards stated goals and objectives driving action in order to:

• Develop priorities for prompt solution to customer-related problems

• Determine key customer related trends and correlation for status

reviews, decision-making and longer term planning


172


• An information system for the timely reporting on product

information relating to product usage

Note: Data should be compared to those of competitors and/or

appropriate benchmarks

8.5 Improvement

8.5.1 Continual Improvement

• The organization is required to continually improve the

effectiveness of the quality management system through

– Use of the quality policy



173


– Use of the quality policy

– Quality objectives

– Internal audits

– Analysis of data

– Corrective and preventive action

– Management reviews

TS Add-On

• 8.5.1.1 Continual improvement of the organization

– Must define a process for continual improvement

(examples in ISO 9004, Annex B)

• 8.5.1.2 Manufacturing process improvement


174


– Must continually focus on control and reduction in

variation (product & process)

Note 1: Controlled characteristics are listed on the control plan

Note 2: Continual improvement only after stability & control or

predictability and meet customer requirements

8.5.2 Corrective actions

– The organization is required to take actions to eliminate

the cause of nonconformities in order to prevent recurrence

– Corrective actions are appropriate to the effects of the

nonconformities encountered



175


8.5.2 Corrective actions

– A documented procedure is required to establish the

defined requirements for

a)Reviewing nonconformities, including customer

complaints



176


b)Determining the cause of nonconformities

c)Evaluate the need for action to ensure that

nonconformances do not recur

d)Determining and implementing actions needed

e)Record results of actions taken (see 4.2.4)

f)Review of corrective actions taken

TS Add-On

8.5.2.1 Problem Solving

– Required to employ a defined process for problem solving

leading to root cause identification and elimination

• Fishbone Diagram

• PDCA


177


• Six sigma

– Must use a customer prescribed problem solving format, if

applicable

8.5.2.2 Error-proofing

– Required to utilize error-proofing methods in your

corrective action process

TS Add-On

8.5.2.3 Corrective action impact

– Required to implement corrective actions and associated

controls to eliminate the causes of nonconformities with

similar products & processes (This is NOT preventive

action)

8.5.2.4 Rejected product test/analysis


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8.5.2.4 Rejected product test/analysis

– Must analyze parts rejected from the customer, including:

• Manufacturing facilities

• Engineering facilities

• Dealerships

– Minimize the cycle time for the rejected parts analysis

TS Add-On

8.5.2.4 Rejected product test/analysis (continued)

– Required to maintain records of rejected parts

analysis & make them available upon request

– The results of this analysis is to identify and

implement appropriate corrective action to prevent


179


implement appropriate corrective action to prevent

recurrenceNote: Cycle time for product analysis should be consistence with the

determination of the problem’s root cause, corrective action and monitoring

the effectiveness of the corrective action’s implementation

Difficult problem = more difficult and/or longer problem solving cycle

8.5.3 Preventive Action

– The organization is required to determine actions to

eliminate the cause of potential nonconformities in order

to prevent their occurrence

– Preventive actions are required to be appropriate to the

effects of the potential problems



180


effects of the potential problems

a) Determining potential nonconformities and their causes

b) Evaluating the need for action to prevent occurrence of

nonconformities

c) Determining and implementing actions needed

d) Records of results of actions taken (see 4.2.4)

e) Reviewing preventive action taken

TS Add-On

A.1 Phases of the Control Plan

– Your organization’s Control Plan covers three distinct

phases of production:

a)Prototype

b)Pre-launch


181


c)Production

– Each part is required to have a Control Plan; however

“family” Control Plans for similar products and processes

are acceptable.

– The output of quality planning is a Control Plan

TS Add-On

Prototype Control Plan

– A description of the dimensional measurements, material

and performance test that occurs during the building of the

prototype

– Required if specified by customer

Pre-launch Control Plan


182


Pre-launch Control Plan

– The required measurements, material and performance test

that occur after prototyping and prior to full production

– Considered a phase of production realization which may be

required after prototyping

TS Add-On

A.2 Elements of the Control Plan

– The Control Plans developed for your organization are

required to minimally include elements of:

• General data

• Product control


183


• Process control

• Methods

• Reaction plan & corrective actions

*created after March 2002 unless otherwise specified by customer

Customer-specific requirements

• Do you know your customer-specific requirements? Do you have a list or

general storage location of ALL customer-specific requirements?

• Many organization miss this point. (What was the first principle in the 8

Management Principles?)

• Customer-specific requirements may include items such as:

Don't forget the customer-specific requirements!


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• Customer-specific requirements may include items such as:

– Supplier Quality Manuals

– Control Plans (process steps required to produce a desired output in a specific manner)

– Purchase Orders or Sales Orders

– Engineering Specification or Standards

– Packaging or Shipping Configurations

– Special customer identification requirements (on product, packaging, etc.)

– Other forms, templates or special requests

Effectiveness

Effectiveness – having an expected or intended effect

• Appears in standard numerous times (35)

• Can not simply “go through the motions”

• Must demonstrate implementation of an “effective” system or process

• Documentation does not equal effectiveness

• Must evaluate processes/systems for compliance and effectiveness, for


185


• Must evaluate processes/systems for compliance and effectiveness, for

example

– Internal auditing process

– Management review of entire QMS

– Corrective action

– Preventive action

– Management commitment

TS Rules Changes (2009)

• Certificate transfers

– 1 transfer per 3 years max

– Existing certificate must be valid

– All open registrar NCRs must be closed

– No IATF OEM special status allowed

– No suspended, cancelled or withdraw status

– Copy of last audit report and findings submitted to new registrar


186


– Copy of last audit report and findings submitted to new registrar

• Certificate suspension – Enterprise certification

– If one plant in enterprise scheme fails recertification, only that affected plant loses certification; not whole enterprise

• Auditor rotation

– One consistent auditor from initial certification must be in surveillance

– For subsequent 3-year cycles, different auditors must be used

Congratulations!!!


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You've made it through the entire standard!