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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
Terms & Definitions:
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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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.
Terms & Definitions:
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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
Terms & Definitions:
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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
Terms & Definitions:
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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
• 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
People
4. Process Approach
5. System Approach
to Management
making
8. Mutually
beneficial Supplier
Relationships
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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
Eight Management Principles
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
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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?”
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
• 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.
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
to ensure desired results with current resources
– "Bigger fish to fry" approach
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– Removal of personal basis and feeling from problem resolution
– Increases confidence in management decisions and direction
Eight Management Principles
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
• 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
• 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
Organization of ISO/TS 16949:2009
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
Organization of ISO/TS 16949:2009
“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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
– 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
4.0 Quality Management System
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
4.0 Quality Management System
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
4.0 Quality Management System
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
4.0 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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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.
4.0 Quality Management System
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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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con·cen·tric (kn-sntrk) adj. Having a common center.Management System Consulting, Training & Registration Project Implementation
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
4.0 Quality Management System
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
4.0 Quality Management System
4.2 Document Requirements
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.
4.0 Quality Management System
4.2 Document Requirements
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
4.0 Quality Management System
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
4.0 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
4.0 Quality Management System
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
4.0 Quality Management System
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
4.0 Quality Management System
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
5.0 Management Responsibility
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
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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 &
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• Feedback loop to management (i.e. Sales &
Marketing)
• Communication to employees on achieving needs
• Internal alignment of processes to satisfy customer
5.0 Management Responsibility
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.
5.0 Management Responsibility
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
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Discussion: This is the first time we see the connection
between the QMS and the Business Planning functions
5.0 Management Responsibility
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?
5.0 Management Responsibility
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
5.0 Management Responsibility
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
5.0 Management Responsibility
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
5.0 Management Responsibility
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
5.0 Management Responsibility
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
6.0 Resource Management
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.
6.0 Resource Management
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)
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(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
6.0 Resource Management
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
6.0 Resource Management
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?
6.0 Resource Management
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.)
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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
7.0 Product Realization
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
7.0 Product Realization
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
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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
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• Documentation
• Control (i.e. SPC, process capability, etc.)
7.0 Product Realization
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
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• 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
7.0 Product Realization
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
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• 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
7.0 Product Realization
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
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– CAD data
– EDI data
– Multiple languages
– Subscriptions to 3rd party web services
7.0 Product Realization
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.
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– 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
7.0 Product Realization
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
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• 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.)
7.0 Product Realization
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
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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
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• 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
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• 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
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• 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
7.0 Product Realization
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
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• 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
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• 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
7.0 Product Realization
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
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– 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
7.0 Product Realization
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
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– Records of design/development verifications are recorded
(see 4.2.4), including any necessary actions arising from
the verification results
7.0 Product Realization
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
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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
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(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
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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
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– Whatever product approval process is used, the same
product approval process is applied to your supplier base
7.0 Product Realization
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
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– 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
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7.0 Product Realization
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
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• 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
7.0 Product Realization
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
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• 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
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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
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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)
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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?”
7.0 Product Realization
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
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• Specified procedures
• Specified processes and equipment
b. Personnel qualification requirements
c. Quality management system requirements
– Organization approves purchasing information prior to release to supplier
7.0 Product Realization
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
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– 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
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– 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
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• 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
7.0 Product Realization
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
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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
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– 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
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• 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
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• 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
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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?
7.0 Product Realization
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.
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– 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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7.0 Product Realization
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.
7.0 Product Realization
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
7.0 Product Realization
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)
7.0 Product Realization
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
7.0 Product Realization
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.
7.0 Product Realization
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
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• 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
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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
8.0 Measurement, Analysis & Improvement
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 Monitoring and Measurement
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
8.0 Measurement, Analysis & Improvement
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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
8.2 Monitoring and Measurement
Note: Monitoring customer perception can include obtaining
input from sources such as
– customer satisfaction surveys
– customer data on delivered product quality
8.0 Measurement, Analysis & Improvement
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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
8.0 Measurement, Analysis & Improvement
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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 &
8.0 Measurement, Analysis & Improvement
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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
8.0 Measurement, Analysis & Improvement
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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
8.0 Measurement, Analysis & Improvement
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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
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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
8.2.3.1 Monitoring and measurement of the manufacturing
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
8.2.3.1 Monitoring and measurement of the manufacturing
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
8.0 Measurement, Analysis & Improvement
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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
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– 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
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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
8.0 Measurement, Analysis & Improvement
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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
8.0 Measurement, Analysis & Improvement
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– 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
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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
8.4 Analysis of Data
– 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
8.0 Measurement, Analysis & Improvement
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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)
8.4 Analysis of Data
– 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)
8.0 Measurement, Analysis & Improvement
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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
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• 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
8.0 Measurement, Analysis & Improvement
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– 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
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– 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
8.0 Measurement, Analysis & Improvement
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8.5.2 Corrective actions
– A documented procedure is required to establish the
defined requirements for
a)Reviewing nonconformities, including customer
complaints
8.0 Measurement, Analysis & Improvement
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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
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• 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
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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
8.0 Measurement, Analysis & Improvement
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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
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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
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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
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• 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
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• 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
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– 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!
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