Professional Documents
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Ts 16949
Ts 16949
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Preface
The intent of this document is to provide a clear and in-depth understanding of the intent
and implication of each clause and sub-clause of the TS 16949:2002 standard. While not
intended to serve as an implementation guide, this document should provide sufficient
insight for a quality practitioner to develop and implement an effective TS 16949 based
quality management system (QMS).
This document may be used by:
Beginners - to understand and apply TS 16949 requirements.
QMS managers – to develop a more effective QMS for their organization.
QMS auditors – to conduct more effective QMS audits.
Top management – to gain an understanding of TS 16949 as a business tool.
Consultants – to provide value-added service to their clients.
The specific requirements of the TS 16949:2002 standard is shown in shadedtext Within
this shaded background, the ISO 9001 foundational requirements are shown in regular
print and the TS 19649 additions are shown initalics. The wording of the ISO/TS 16949
requirements are laid out in paraphrased but precise form, following the exact clause by
clause numbering.
Where ISO/TS 16949 has used the word “shall”, it indicates a mandatory requirement. The
word ‘should’ indicates a recommendation and Certification Bodies (Registrars) lean towards
interpreting ‘should’ as a ‘shall’ in most cases. Notes to paragraphs are for guidance in
understanding or clarifying the associated requirement. However, if the note includes the
word ‘should’, then you would be wise to implement the guidance or recommendation in the
note. Wherever possible, I have stated the clauses in the active tense instead of the
sometimes difficult to understand passive tense used in the standard.
Below each section, clause or sub-clause of the standard, I provide key explanation
points and tips to help you better understand the requirement and any underlying intent,
concepts and principles. The key point or phrase in each explanatory paragraph
is bolded for easy reference to the sub-clause being explained. You will find important
explanatory points and tips being repeated or further elaborated in different parts of the
standard. Whenever I make reference to ‘you’ or ‘your’ QMS, I mean your
organization’s quality management system.
In going through the explanatory points and tips, I request that you read each paragraph
carefully and sometimes twice to fully grasp the additional interpretation or insight it may
convey. By doing so, you might be able to save much time, effort and money in
understanding and implementing these requirements or help make your QMS more
effective.
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Introduction
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0.1 General:
The adoption of a QMS should be a strategic decision for your organization. Various factors
influence the design and implementation of your QMS. These include – varying needs;
particular objectives; products provided; processes employed and size and structure of the
organization. The ISO 9001 standard does not require uniformity of QMS structure or
documentation.
The QMS requirements specified in ISO 9001 are complementary to requirements for
product. Information marked “Note” is for guidance in understanding or clarifying the
requirement.
This international standard can be used by internal and external parties, including
certification bodies, to assess an organization’s ability to meet customer, regulatory and the
organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into
consideration in developing this standard.
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Customer requirements may show up in contracts, blueprints, their supplier quality
manuals, or referenced to applicable industry and regulatory standards and codes, etc.
It is important to state here that ISO 9001 certification must not be the ultimate goal of
QMS implementation. Your constant goal must be to continually improve the effectiveness
and efficiency of the organization for the benefit of all its stakeholders. Obtaining
certification must be considered as just a stepping stone in this journey. Organizations that
understand and follow this approach will get the most benefit from QMS development and
implementation.
Organizations implementing an ISO 9001 based QMS must conform to all applicable
requirements that the standard specifies. This provides internal and external parties
(customers, registrars and regulatory bodies), the basis (i.e. a benchmark) against which to
assess the organizations ability to meet customer, regulatory and internal requirements.
It is now a common practice to use ISO 9001 certification as a requirement for making
contractual decisions. The automotive OEM’s (subscribing to the TS 16949 standard) require
their direct (tier 1) suppliers of manufactured product and related services to obtain TS
16949 certification. Tier 1 suppliers in turn are required to flow down conformity to TS
16949 requirements through supplier QMS development.
QMS design and implementation will vary from organization to organization. ISO 9001
allows this flexibility because organizations may have differing - goals and objectives;
business risks; range and complexity of products; processes and resources; organizational
size and structure; workforce competence and stability; etc. This flexibility may relate to
QMS scope; structure; documentation or application of ISO 9001 requirements.
Personnel performing QMS assessments must - have adequate training on the
requirements of the ISO 9001 standard and auditing practices as defined by ISO 19011; be
familiar with your QMS, customer requirements and applicable regulatory requirements.
The guidance documents ISO 9000 and ISO 9004 provide the eight quality management
principles on which this standard is based. These are:
Principle 1 — Customer-Focus
Your organization depends on customers and therefore your organization should understand
current and future customer needs, meet customer requirements and strive to exceed
customer expectations (see clause 5.2; 7.2; and 8.2.1).
Principle 2 — Leadership
Leaders establish unity of purpose and direction of the organization. They should create and
maintain the internal environment in which people can become fully involved in achieving
the organization's objectives (see clause 5)
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Effective decisions are based on the analysis of data and information (see clause 4.1e and
8.4).
These eight management principles form the basis for all QMS standards within the ISO
9000 family which includes TS 16949:2002. All of these principles are included as
requirements in one or more clauses of the TS 16949 standard.
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Major Clauses
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• Supplement or expand on the existing ISO 9001 requirement
• Call for prescriptive ways to address ISO or TS requirements
To help you get the most out this e-Book, you might find it useful to follow key themes that
the TS 16949 standard has emphasized. These include:
• All QMS processes must be planned, implemented, measured and improved.
• TS 16949 requirements focus on controlling QMS processes, not product.
• QMS controls must emphasize prevention of nonconformities rather than detection.
• QMS processes focus on eliminating or reducing variation and waste in processes.
• QMS processes must be customer focused. Process personnel must be aware of and
strive to meet internal and external customer requirements.
• You must continually improve the effectiveness of your QMS.
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Process Approach
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Figure 1 - All work generally involves a process - things go in(inputs); get worked
upon (conversion); and come out differently(output). The value-adding conversion
activity within a process transforms inputs into outputs, e.g. takes raw materials (the input)
and manufactures (the value-adding conversion activity using various resources) a product
(the output).
Process inputs and outputs can be tangible (raw materials or finished product) or
intangible (information – e.g. computerized drawing or specification).
Figure 2 - All process has a supplier and a customer. These suppliers and customers
may be internal processes or external to your organization. Each process must have an
accountable owner, i.e., having defined responsibility and authority to operate, control and
improve their process.
All processes require the use of resources, e.g. – people, equipment, materials,
technology etc. These resources can be used as inputs (raw materials or information such
as a customer specification) as well as for the value-adding conversion activity (e.g. use of
machinery, equipment, computers, technology, people, etc.) to transform raw material
(input) into finished product (output).
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Support Oriented Processes (SOP’s) – These processes provide the necessary
resources to COP’s to facilitate product realization. These processes generally have the
greatest degree of interaction at an operational level with COP’s and to a lesser degree with
other internal QMS processes. SOP’s include - human resources; information technology;
purchasing and receiving; laboratory; maintenance; tooling; facility management; etc,
whether performed onsite or off-site. See clause 6 and 7.
Management Oriented Processes (MOP’s) - These processes provide the
commitment, leadership, resources, review and decision-making by top management (see
clause 5). These processes generally interact with all QMS processes at the QMS planning
and review level. MOP’s include – business planning; management review; quality planning;
resource planning; communication, etc., whether performed offsite or on-site.
Quality Management Processes (QMP’s) to document,measure, analyze and
improve all processes – These processes provide quality management support to and
interact with all QMS processes. QMP’s include - document control; records control;
monitoring and measurement of processes and product; internal audits; control of
nonconforming product; corrective and preventive action; continual improvement; etc
whether performed onsite or off-site. See clause 4 & 8.
Outsourced Processes (OP’s) – These are COP’s or SOP’s that are performed by a
function or organization outside the ownership or managerial control of your facility. They
may be performed onsite or off-site. These processes include - heat treating; painting;
welding, calibration; testing; sort; HR; etc.
Your QMS is made up of a network of value-adding processes that link, combine and
interact with one another to collectively provide product or service (See Figure 2). These
processes are inter-dependent and can be defined by complex interactions. For example,
any of the COP processes, could interact with some or all of the MOP’s, SOP’s; QMP’s. Also
note that resources (SOP’s) and QMP’s may also be applied to all other processes.
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processes.
Interaction between processes may take place at any process stage – as an input,
output, process activity or resources needed for the process.
Probably the root cause of many QMS process nonconformities could be traced to
breakdown in the communication or interaction between processes. For example the sales
function fails to notify the packaging function of a customer’s special packaging specification
and the product is packaged and delivered in the organizations default mode). Therefore
to control the interaction between and within processes, we need to identify and control:
Therefore, in general, in order to plan and implement your QMS using the ‘Process
Approach’, you must:
Identify the processes needed for the QMS (see listing above)
Determine their sequence and interaction (show the sequence and
interaction of your COP’s). There are many ways to document this, e.g., a flowchart or
a process map.
Determine the application of QMS processes throughout the organization
(show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There
are many ways of documenting this. A popular way is through graphical
representation, e.g. process maps.
Determine (plan) the criteria, methods, information, controls and
resources needed for each QMS process. These include:
Identify the internal/external customer-required output.
Describe the process activity that produces the output.
Identify the resources needed for the process activity.
Identify the inputs for the process – information, materials, supplies, etc.
Define the process methods, procedures, forms etc., that may be needed to
produce the output.
Define the controls to prevent or eliminate risk of errors, omissions, or
nonconformities in the process activity. These controls may come from the TS 16949
standard; customer; regulatory and your own organizational requirements (more
details provided in clause 4.1).
Interaction – with sources that provide the inputs (internal process or external
supplier); uses the output (internal process or external customer); or provide the
resources (internal support process) to perform the process activity.
Implement your QMS according to your plan.
Monitor, measure and improve each QMS process and itsinteraction with
other processes. Performance indicators to monitor and measure process performance
may come from the TS 16949 standard; customer; regulatory and your own
organizational requirements. Performance indicators may relate to the process output as
well as the process activity.
Performance indicators for process output must focus on meeting customer and
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regulatory requirements. Performance indicators for process activity should focus on
measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives.
It is useful to point out that while we do need to identify all QMS processes and
describe their interaction, not all identified QMS processes need to be documented or
documented in the detail described above. Review notes on clause 4.1 General
Requirements in conjunction with the above notes on the process approach, for more insight
on process documentation.
For those interested in gaining a deeper insight into understanding and implementing
the process approach, study the ISO guidance document on the concept and use of the
process approach for management systems - Document: ISO/TC 176/SC 2/N544R2(r),
issued 13 May 2004 on the ISO website. Also review the AIAG/IATF guidance on the
automotive approach to QMS processes on the IAOB website.
Keep in mind that the above notes and references are guidance documents and the manner
and detail of application and documentation of the ‘process approach’ will vary from
organization to organization, due to a variety of factors such as size and complexity of the
organization; products, processes; customers; etc. See clause 4.1 for more details on
applying the process approach.
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PDCA
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Plan: Establish the objectives and processes necessary to deliver results in accordance
with customer requirements and the organization’s policies.
Do: Implement the processes
Check: Monitor and check processes and product against policies, objectives and
requirements for the product and report the results
Act: Take actions to continually improve process performance
Preventive and detective controls needed for process activity, input, output and
resources used.
The nature, method, frequency and timing of interaction with other processes and
where this interaction will occur – input, output, use of resources, conversion activity,
etc.
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You must pay a lot of attention to this stage of your QMS development. Planning must
also consider how you will meet customer, applicable regulatory, and your own
organizational requirements, in addition to ISO 9001 requirements. We will look at QMS
planning in more detail when we review clause 4.1 requirements.
(DO) - Deploy and implement your QMS processes and manage and control them
according to your plan as documented above.
(CHECK) – Monitor and measure the effectiveness of your QMS processes against
policies, objectives and performance indicators that you established under PLAN. Monitoring
and measuring activity may focus on any or all of a process’s inputs; outputs; use of
resources for conversion; and interaction with other processes.
(ACT) – Collect and analyze your monitoring and measurement information and use it
to determine the effectiveness of each process as well as your overall QMS in meeting
requirements. Use the information to correct problems and continually improve individual
processes.
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Continual Improvement Model
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Controls for your processes come from the ISO 9001 standard, customer
requirements, your organization or applicable regulatory requirements.. The five clauses of
ISO 9001 provide control requirements for PDCA - planning, implementation; monitoring
and measurement; and for improvement of each QMS process. The applicable requirements
of these five clauses must be applied to each process (inputs; outputs; resources used;
transformation activities; interaction with other processes) for effective control. In clause
4.1 we will discuss this in further detail.
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Compatibility
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NOTE Knowledge and use of the eight quality management principles referred to in ISO
9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the
organization by top management.
The layout, structure and numbering sequence of the requirements in the two
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documents are similar. ISO 9004 includes the requirements of the ISO 9001 standard in
boxed tables and further discusses concepts, principles, issues and ideas for QMS
development and implementation, for each clause.
Keep in mind that ISO 9004 goes far beyond what may be required for initial ISO
9001 certification. Use it to gain knowledge and ideas, butbe careful about trying to
implement all that it covers, as it may be quite overwhelming if you are developing a QMS
for the first time. Use ISO 9004 to continually improve the effectiveness and efficiency of
your organization beyond certification.
All of the automotive examples and explanations in the IATF ISO/TS 16949:2002
guidance document have been included in my key explanation points and tips for each sub-
clause.
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1.1 Scope
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1.1 General
This Standard specifies requirements for your QMS to:
a) demonstrate your ability to consistently provide product that meets customer and
regulatory requirements
b) enhance customer satisfaction by:
c) effective application of your QMS
d) continual improvement of your QMS
e) providing assurance of conformity to customer and applicable regulatory requirements.
Note: The term “Product” applies to product intended for or required by a customer
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prevention based controls; conducting internal/external audits; 3rd party certification of your
QMS; etc.
This standard provides specific requirements to effectively plan, operate, control and
improve your QMS processes. These requirements focus on prevention based controls and
to a lesser extent detection based controls, as well as continual improvement of your QMS.
It is important to note that the ISO 9001 standard does not specify requirements
for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By
effectively controlling and continually improving your QMS processes, there will obviously be
a positive impact on product quality performance.
Don’t overlook regulatory requirements applicable to your organization. These
requirements may come from your customer; the industry you are in; from within your own
organization; or state or federal organizations. You may need to apply regulatory
requirements to your suppliers and outsourced processes (subcontractors).
Your ultimate objective is to enhance customer satisfaction. You achieve this by
planning, operating and improving your QMS to effectively meet customer and regulatory
requirements. As this standard represents specific automotive OEM’s, your QMS must
provide objective evidence that your QMS processes can identify and manage these
requirements and that customer-specific requirements are effectively implemented.
Scope (under this section) refers to the type of automotive supply chain facilities, TS
16949 is applicable to. “Automotive" includes cars, trucks (light, medium and heavy),
buses, motorcycles. It excludes industrial, agricultural, off-highway (mining, forestry,
construction, etc.). It includes all supplier ‘sites’ providing value-added parts, components,
products , sub-assemblies and services up the supply chain to the OEM. TS 16949
requirements may be applied to any site in the supply chain by its customer (see clause
7.4.1.2).
TS 16949 applies to all supply chain facilities or ‘sites’ thatmanufacture production
materials; production and service parts; assemblies; or provide (value-added) finishing
services such as heat treating, welding, painting; etc., for the automotive OEM’s subscribing
to this standard.
This means that all Tier 1 suppliers providing such products or services directly
to subscribing (see last paragraph below for OEM’s subscribing to TS 16949) automotive
OEM’s, must get TS 16949 certification and they in turn may flow TS 16949 conformity or
certification requirements down to Tier 2 suppliers and so on (see clause 7.4.1.2). The flow
down to tier 2 or 3 has now become more the norm than the exception.
TS 16949 cannot be applied to:
Automotive after-market service parts made to original subscribing OEM specifications,
but not procured and released through them.
Manufacturers of tooling; production equipment; jigs; fixtures; molds; etc used by the
auto industry.
Remanufactured automobile parts.
Distribution centers; warehousers; parts packagers; logistics support; and sequencers.
Determine whether your activities or location is a site or support function. Note that
the definition of ‘site’ (under clause 3.1 Terms and definitions) is a location where value-
added manufacturing occurs and asupport function is a value-adding non-
manufacturing process that supports a site. The support function may be on-site or at a
remote location.
The rules for third party Certification Body (Registrar) auditing of sites and remote
locations are specified in an IATF document called “Automotive Certification Scheme for
ISO/TS 16949:2002 – Rules for achieving IATF recognition”. The general rule is
that sites may obtain stand-alone TS 16949 certification, but support functions, cannot
obtain stand-alone certification.
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Support functions may include a variety of non-manufacturing activities such as –
design; purchasing; HR; sales; distribution centers; warehousing; sequencing; logistics;
etc.
All support functions (whether on-site or off-site) that support a site must be included
in that site’s QMS scope. As such they must be audited to all applicable TS 16949
requirements including their interaction with site activities.
Both manufacturing as well as support activities may be outsourced(i.e. performed by
an independently owned organization, on your site or off-site). Organizations performing
outsourced manufacturing activity must be subject to the same TS 16949 requirements that
would apply if the activity were done by your organization. Such organizations can obtain
independent TS 16949 certification if required by their customers.
Organizations performing outsourced support functions (e.g. warehousing or HR
services) may be subject to specific TS 16949 requirements imposed by their customers,
however they cannot obtain independent TS 16949 certification for such support activities.
They may obtain independent ISO 9001 certification. More on outsourcing under clause
4.1.
The organizations subscribing to the TS 16949 standard include: General Motors; Ford;
Daimler Chrysler; Fiat; PSA Peugot-Citreon; Renault SA; FIEV: Opel Vauxhall; Audi; BMW;
VW; Mercedes Benz; etc. The Japanese OEM’s while participating in the development of the
TS 16949 standard, do not formally subscribe to it or require it of their supply chain.
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1.2 Application
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The only permitted exclusions to TS 16949 relate to clause 7.3 where the organization is
not responsible for product design and development.
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must undergo surveillance audits at least once within each consecutive 12 month period.
Consult with your Certification Body (Registrar) for details.
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2 Normative Documents
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Ensure that your internal and external auditors are adequately trained on:
all aspects of your QMS,
your customer requirements and referenced documents
auditing practices as defined by ISO 19011 and IATF guidance documents.
Watch out for those reference documents – make very sure you have the latest
versions and use them as applicable. If there have been any significant changes to them,
make sure you update the training of personnel using these documents.
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3 Terms and Definitions
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documented description of the systems and processes required for controlling product (see
annex A for an example of a Control Plan). (See clause 7.5.1.1 and 7.3.6.2)
NOTE This responsibility includes testing and verification of design performance within the
customer’s specified application.
product and manufacturing process design and development to prevent manufacture of non-
conforming products.(See clause 7.3.3.1 and 7.3.3.2)
3.1.4 Laboratory
facility for inspection, test or calibration that may include, but is not limited to, chemical,
metallurgical, dimensional, physical, electrical or reliability testing.
3.1.6 Manufacturing
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3.1.7 Predictive maintenance
3.1.11 Site
Most of these definitions relate to specific clauses within TS 16949 that call for detailed
requirements to be met and so will be discussed when we cover the requirement.
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4.1 General Requirements
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Note: Your QMS processes should include processes for management activities, provision of
resources, product realization, and measurement as part of QMS
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QMS processes.
A number of different methods can be used to document processes (each with varying
degrees of detail), such as graphical representations, written instructions, spreadsheets,
checklists, flow charts, visual media, or electronic methods, etc. Process flowcharts or block
diagrams can show how policies, objectives, influential factors, job functions, activities,
material, equipment, resources, information, people and decision making interact and/or
interrelate in a logical order.
Procedures may be an acceptable way to document processes provided they describe
details of inputs and outputs, appropriate responsibilities, controls and resources; and
process performance indicators needed to satisfy customer requirements.
Regardless of whether or not you document all of your processes, you must provide
evidence of effective implementation of all your QMS processes. Such evidence does not
necessarily need to be documented and may be demonstrated.
Clause 4.1c requires you to determine criteria for effective process operation and
control. Specific criteria may be needed to control inputs, outputs and resources used.
For example - raw materials as an input to production would have acceptance criteria
that it must meet before it can be used; finished product as an output of the production
process must meet acceptance criteria before it can be shipped to the customer;
the equipment used to transform raw materials into finished product may have set-up and
capability criteria or parameters that it must meet in order to produce conforming product.
These prevention based criteria (controls) must be established for each QMS process. Note
that such controls may also come from the customer, regulatory or industry bodies.
Equally important are the specific methods (clause 4.1c) required for effective
operation and control of each process. These may include job travelers; work instructions;
in process inspection sheet; specifications and drawings; SPC charts; set up checklist;
machine manuals; etc. Note these control methods may apply to any or all of process
inputs, outputs or conversion activities.
Under 4.1d - resources for QMS processes may include – facility, material;
equipment; labor; supplies; utilities; etc. Every QMS process will require a different
combination of resources. Resource details may be identified in specifications; production
schedules; bill of materials; production travelers or routers, work instructions, etc. The
planning of resources will be determined in MOP’s (clause 5) and provision and control of
resources will be determined by SOP’s (clause 6).
Clause 4.1d- information for QMS processes will vary from process to process and
may include – production schedules; bill of materials; product acceptance and process
performance criteria; production traveler or router; work instructions; etc. Use clause 4.2.3
and other relevant clauses to control process information.
Clause 4.1e requires you to monitor and measure your QMS processes. Clause 8
provides requirements to plan and implement these controls for monitoring and measuring
conformity to process performance criteria determined in 4.1c above. Measurement and
monitoring processesmay include – tracking against process parameters, goals and
objectives, using tools and records such as process check-sheets; product acceptance
criteria; SPC records; production records; maintenance records; labor records, etc. More
details on monitoring and measuring controls are covered in clause 8. QMP’s typically
perform this function (see section 0.2 Process Approach of this document).
Clause 4.1e - Analysis of QMS processes may be done through a review of
measurement and monitoring records and performance indicators. These reviews must
identify opportunities to improve QMS processes, use of resources and product quality. See
clauses 8.2.3 and 8.4 for more insight on process monitoring, measurement and analysis.
Under clause 4.1.f, when process nonconformities occur (as shown by process
performance indicators), then corrective action is required to bring the QMS process under
control. Remember, the corrective action process is not just for product related
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nonconformities.
Processes must be continually improved (see clause 4.1f) through setting realistic,
measurable (see clause 5.4.1) objectives- Planning for continual improvement requires a
review of process data, resources and controls to bring about the desired change. More on
this when we look at clause 8.4.
Clause 4.1a – 4.1.f must be applied to all QMS processes. Note also that many TS
16949 clauses (e.g. clause 7.2; 7.4; 7.6; etc.), require specific processes to be identified
and controlled in your QMS. I will highlight all these process as we cover the standard.
Make sure you include all outsourced processes affecting product quality, in the
scope of your QMS. An outsourced process is any value-adding activity related to your
product or service, that is performed by an external organization such as a subcontractor,
sister facility, etc. Note that the external organization may perform the outsourced activity
at their facility or yours. A manufacturing company may outsource welding, heat treatment
or painting of product. A software company may outsource replication and packaging of its
software product. A bank may outsource check clearing services.
You must be able to demonstrate sufficient controls over outsourced processes to
ensure that such processes are performed according to the relevant requirements of TS
16949. The nature and scope of such control will depend on the nature of the outsourced or
subcontracted process and the risk involved.
Outsourced processes may be controlled in any number of ways, e.g., providing the
outsourcer with product specifications; your supplier quality manual that they must meet;
asking for inspection and test results or certificates of compliance; validation of outsourced
process; conducting product and QMS audits of your outsourcer; etc. The expectation here
is that you flow down to your outsourcer, the relevant TS 16949 requirements that you
would have to implement, had you performed the process at your own facility. (also see
notes under clause 1.1 and clause 7.4.1 to better understand control of outsourcing).
One last thing before we leave this all important clause. In systematically applying
clause 4.1 requirements to each QMS process, we are intuitively using the PDCA
approach to development of QMS processes.
PLAN will call upon sub-clauses 4.1.a – 4.1e as well as other applicable TS 16949
clauses as shown above;
DO is required by 4.1.f as well as other applicable TS 16949 clauses
CHECK is controlled by 4.1.e as well as other applicable TS 16949 clauses;
ACT is governed by clause 4.1.e-f as well as clause 8.
Please review clause 4.1 and section 0.2 Process Approach of this
document several times as you go through the rest of this standard.
With a bit of process-mapping practice with the different types of processes, you will
understand better the above explanation points and tips and will be able to develop and
implement an effective QMS. There are also many useful tools available to facilitate this.
The above paragraphs covering control of outsourcing also apply toprototype
programs (see clause 7.3.6.2) and management of production tooling (see clause
7.5.1.5).
Under TS 16949 clause 4.1.1 you cannot delegate technical responsibility for your
product to your outsourcer. You must provide direction, control and monitor all phases of
outsourcers supervise technical work – continuous interaction, reviews, inspections and
approvals.
You must flow down your customers PPAP requirements to those organizations you
outsource to.
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4.2.1 Documentation Requirements
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4.2.1 General
QMS documentation shall include:
a) Statements of a quality policy and quality objectives
b) A quality manual
c) Documented procedures required by the Standard
d) Documents needed by the organization (to ensure effective planning, operation, and
control of QMS processes)
e) Records required by the Standard
Note 1 – Where the term ‘documented procedure’ appears within the standard, this means
that the procedure is established, documented, implemented, and maintained.
Note 2 – The extent of QMS documentation may differ from one organization to another
due to the:
a) size of organization and type of activities
b) complexity of processes and their interaction
c) competence of personnel
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above.
Make a list of all documents required by your QMS, regardless of the media or source
of the document. This list may include documents from customers; suppliers;
subcontractors; outsourcers; from within your organization; industry and regulatory bodies;
registrars; etc. It is this list of documents that is subject to clause 4.2.3 control
requirements.
You must have documented statements of your quality policy and objectives.
These will be discussed later in clause 5. There are many ways to document your Quality
Manual and would be determined by the size, structure and complexity of your organization
(se note 2). Clause 4.2.2 specifies more requirements for the contents of the quality
manual.
Regardless of how you document your QMS, you must demonstrate the effective
implementation of your QMS in terms of conformity to TS 16949, customer, regulatory and
your own organizational requirements.
Under TS 16949, you must have documented procedures for - clause 4.2.3 - Control
of documents; clause 4.2.4 - Control of records; clause 6.2.2.2 - Training; clause; clause
8.2.2 - Internal audit; clause 8.3 - control of nonconforming product; clause
8.5.2 - Corrective action and clause 8.5.3 - Preventive action. Procedures are also
mentioned in other clauses such as 7.3.6.3; 7.6.3.1 and 7.5.2c, but the standard does not
specify that these be ‘documented’ procedures. However, it might add value to some
organizations to document these requirements.
Depending on your organizations size, complexity, competency, etc, (see note 2) you
may decide to have additional procedures or carry over some or all the procedures you had
under previous QMS systems. Note there are several ways to write procedures, other than
the conventional narrative form.
You may choose to include your procedures and lower level documentation in your
quality manual or organize them in some other fashion. The practicality of this would
depend on the size of your organization, complexity of products and processes; competency
of personnel, media used for documentation (hard copy versus computerized); ease of use
and understanding by personnel; maintainability; etc. (see note 2).
In addition to the documents specifically called out in TS 16949, clause 4.2.1d call
for documents deemed necessary for effective management and control of your processes,
e.g. material specifications; competence criteria, product specifications, packaging
specifications, manufacturing specifications, work instructions; forms; schedules; set-up
specifications, etc. See note 2 below.
TS 16949 calls for many records to provide evidence of effective planning, operation
and control of processes. Examples include – management review records; calibration
records, internal audit records; corrective action records, etc. As we go through this
standard, we will highlight these records. Again, your processes may call for additional
records beyond those expected by TS 16949.
Many clauses do not specifically call for documents and records, but there is a strong
implication in the wording of the need to have them. This is where clause 4.2.1d and 4.2.1e
as well as 4.2.4; 7.1b and 7.1d kick in. In defining your processes and controls, you must
indicate what evidence you will have to demonstrate effective planning, operation and
control.
Under Note 1 above it says ‘documented procedures’ must be established,
documented, implemented, and maintained. This is done by following the requirements
under clause 4.2.3 control of documents
Note 2 - provides guidance on the extent of documentation your organization must
have. This will vary from organization to organization according to the criteria indicated.
Other criteria that may also affect the extent of documentation may include – impact on
quality; risk of customer dissatisfaction; customer regulatory, and industry requirements;
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workforce stability and past quality problems and nonconformities. For example, if you have
a highly educated and stable workforce, then the amount of documentation needed may be
significantly less than an organization that has a high turnover of its workforce and lower
educational requirements.
Any combination of media is acceptable for documents and records provided they conform
to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of
records
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4.2.2 Quality Manual
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4.2.3 Control of Documents
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You must review your QMS documentation and determine if anyupdating or
revisions are needed, and if they are changed, they must be re-approved. The frequency
of this review, responsibility and method must be defined in your procedure. This will be
determined by events within your organization and how mature or recent your QMS is.
Auditors will explore this if your documents have not changed in years, while the nature of
your business has changed significantly.
Identify changes made to documents so users know exactly what has changed.
There are many ways of doing this on printed as well as computerized documents. Your
procedure must cover how this done.
Have a method for revision control such as a revision log and masterlist of
documents which identifies the current revision status. Again, there are other ways of doing
this as well. Your procedure must cover how this done.
Not all documents need to be available everywhere within your organization. You must
determine what document is applicable (i.e. needed to assure product or process quality)
to a specific process or activity and make the relevant version of that
document available to that activity, e.g. providing current packaging and shipping work
instructions to the shipping department. Also see clause 7.5.1.2 on accessibility of work
instructions at work stations). Your procedure must cover how this done.
Once you determine that certain documents need to be made available at various
locations, implement some form of distribution control. There are many ways to do this.
One way would be to keep a distribution log. Your procedure must cover your form of
distribution control.
Documents can take a beating in very harsh environments (covered in oil, dust, acid
eaten, weather-beaten, etc.) to the point of being illegible. You must regularly review the
condition of frequently used hardcopy documents to determine whether they need to be
replaced. Your procedure must cover how this done.
Documents must also be readily identifiable as to its purpose and scope. A simple
heading may suffice, (e.g. In-process Inspection Sheet). Computerized documents are
sometimes given file names that don’t identify its contents and this might require numerous
files to be opened before you find the right one. Identification also implies effective filing
for timely retreival, whether manual or computerized. A frequent nonconformity is not being
able to retrieve a document or record because of poor filing procedures.
External documents (such as customer drawings or supplier material/part
specifications) must be identified. There are many ways to do this. One way would be to
keep a manual or computer list of these documents. Determine who needs them and have
some form ofdistribution control to users to ensure they have the current or relevant
versions of external documents. Your procedure must cover how this done. Review specific
requirements for documents at OEM customer or IATF websites.
Don’t overlook supplier, regulatory or industry documents. Apply applicable controls to
these as well (4.2.3f).
Obsolete documents can cause many problems if not controlled. There are many ways
to do this. One way would be to provide computerized documents in read-only mode and
make only the current version accessible at workstation computer screens. Obsolete
hardcopy documents can be removed through distribution control. Your procedure must
cover how this or other methods are used.
Ensure your procedure also covers methods to disallow unauthorized and
unapproved or incorrect documents from being created, used or distributed.
If documents are to be archived make sure that all such documents are
properly identified, indexed and filed, and preferably have controlled or restricted access to
them. Again your procedure must cover how this is done.
Clause 4.2.3.1 - Engineering Specifications – calls for a process.You must
therefore use clause 4.1a-f as guidance for documenting this process and include all the
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controls required by this sub-clause. For all changes to these customer provided documents,
cross reference to PPAP documents such as Control Plans and FMEA’s. These documents
may need to be revised and may require PPAP re-approval. If in doubt, check your PPAP
reference manual or check specific customer requirements.
Your process for engineering change control must also address any impact on
lower level documents such as production work instructions. Develop appropriate linkage
controls or checklist to ensure that such documents are appropriately updated. Also refer to
clause 7.1.4 Change control. We will cover this later when we get to that clause.
Nonconformities against document control are one of the most frequent audit findings.
Develop appropriate performance indicators to demonstrate effective implementation of
your document control process. Examples include – number of obsolete or unauthorized
documents found being used; number of unauthorized changes found; number of instances
documents were not available at points of use; etc. Track trends in these indicators and use
this information to tighten your controls and continually improve your document control
process.
As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve
your document control process. Your procedure should describe this approach.
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4.2.4 Control of Records
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review; calibration; training; etc). Retention times are typically determined by customer,
regulatory, industry or organizational requirements and policies. Check OEM websites for
retention times for specific QMS records.
Records must eventually be disposed off once past their defined retention times.
Disposition could range from destruction of records to storing them in a secure onsite or off-
site archive. The intent here is to remove the risk of inadvertent use for current activities
and unauthorized access. Depending upon the industry, specific records may be kept
indefinitely.
Nonconformities against the process control of records arise frequently. Develop
appropriate performance indicators to demonstrate effective implementation of your
record control process. Examples of indicators could include – number of instances of
inability to retrieve records; amount of time spent looking for records; number of instances
of incomplete records; number of instances of damaged records found; etc. Track trends in
these indicators and use this information to tighten your controls and continually improve
your record control process.
As mentioned in clause 4.1, use the PDCA to plan, implement, measure and improve
your document control process. Your procedure should describe this approach.
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5.1 Management Commitment
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5.1.1 Process Efficiency – Top management shall review the product realization &
support processes to assure their effectiveness and efficiency. Also see 7.5.1.4 & 8.2.1.1)
The above activities are all requirements of clause 5. Each sub-clause of clause 5 starts
with the phrase “top management”. Top management is now clearly accountable and
auditable for their role and responsibilities for the activities listed in the paragraph above.
The phrase “provide evidence” is very important here. Evidence may include
documents and records showing top managements role in planning and implementing the
processes that apply clause 5 requirements.
You must begin with identifying the processes within your organization that perform
these activities. These processes would typically include - business planning; quality
planning; management review; internal communication; organization structure; etc.
Business planning would address 5.1b and 5.1c; management review would address clause
5.6; and so on for the other sub-clauses. Top management would be the process owner of
all these processes.
Clause 5.1a may be viewed in combination with clause 5.2 customer focus, and clause
5.5.3 internal communication. Top management must communicate regularly to the
organization on the importance of meeting customer and regulatory requirements. The
communication process should define what needs to be communicated; to whom; the
methods used; the frequency; and the means for determining communication effectiveness.
(See clause 4.1a- 4.1f for guidance in developing such a process.). Top management may
communicate in any number of ways including - meetings; documented policies; memos;
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directives; email; verbally; etc.
Clause 5.1 does not require a ‘documented’ procedure. However, you must identify and
document (e.g. process map; process flow diagram; etc.) the processes for business
planning; quality planning; management review; internal communication; organization
structure; etc. as part of your QMS (see clause 4.1). You must also identify what
specificdocuments are needed for effective planning, operation and control of these
processes (see clause 4.2.1d). These documents may include – a documented procedure;
business plan; statement of policies and objectives; etc.
Top management at each site must review process efficiency. This may include:
Achievement of continual improvement objectives for identifiedproduct realization and
support processes
Optimization of the interaction of these processes
Verification that these processes operate as an effective and efficient network
Monitoring cost trends and benchmarking of key processes
Note: effectiveness measures the extent to which planned activities (run
rate) and planned results (objectives) are achieved? E.g., say you plan to produce and ship
1000 units a day with zero defects. At the end of the week, the production records showed
we achieved our planned activity of 1000 units per day, but fell short on our planned result,
as we incurred a 2.5% defect rate and only hit a 90% on time delivery rate.
Note: efficiency is the relationship between results achieved and resources used. Can
we produce more units than planned per hour for the set amount of resources? Or can we
use fewer resources than planned to produce the units.? Efficiency can relate to utilization of
any resource – machine, labor, material, facilities, utilities, time, etc.
Let us look at a simple example. Say one operator A can produce 100 good units per
hour with 2% material scrap on a machine. Operator B produces 105 good units with only
1% material scrap per hour on the same machine. Clearly operator B is more efficient in the
use of time as well as material, both of which can be measured. Because there are many
other resources to be considered, the measurement of efficiency can get fairly complex and
requires a multidisciplinary approach involving production, engineering, cost accounting and
other disciplines.
Where some of clause 5 activities are performed off-site (e.g. at head-office), you must
identify these off-site processes in your QMS and ensure that such processes comply with
TS 16949 requirements. Evidence of compliance may include - a copy of their TS 16949
certification; TS 16949 internal audit results (of these processes) for the off-site facility;
auditing these processes at the off-site facility. The expectation is to flow down to the off-
site facility, the relevant TS 16949 requirements that you would have to implement, had
you carried out the process at your own facility.
The specific requirements for clause 5.1b through 5.1d will be discussed in the
upcoming sub-clauses.
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5.2 Costumer Focus
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5.3 Quality Policy
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The wording of the quality policy should preferably specify what requirements are being
complied with (customer, regulatory, TS 16949, etc.). It must also clearly state the
commitment to continually improve the effectiveness of the QMS.
Beyond that, you may state other complementary and important policies (business
growth; product or manufacturing technology; workforce competence; business flexibility,
etc.)
What you state in your quality policy, must lead to establishing quality objectives,
e.g. if you state in your quality policy that you will “meet customer requirements”, then
from this, you might derive customer focused objectives for – product defects; customer
complaints and returns; on time delivery, etc. Similarly, “meet TS 16949 requirements”;
from this you might derive process objectives for effectively and efficiently using TS
requirements to manage, control and improve al of your QMS processes.
Stating that you will “continually improve the effectiveness of your QMS” in your
quality policy - can lead to a number of objectives, as your QMS is comprised of many
processes and you could have one or more objectives to improve each process.
Therefore, each statement in your quality policy may result in one or more quality
objectives. These quality objectives do not need to be stated in your quality policy. Top
management must clearly be involved in providing direction, establishing and reviewing
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these objectives.
Earlier we had covered processes for internal and external communication. Your
internal communication process should cover how the quality policy is
communicated throughout the organization. There are many ways of doing this. Personnel
must understand the importance and impact of the quality policy on the work they do.
If you recall from 4.2.1 your QMS includes documented statements of your quality
policy and quality objectives. Therefore, these documents must be controlled according to
clause 4.2.3 control of documents. Your quality policy and quality objectives may be
documented in your quality manual or as independent documents or both.
If you recall from 4.2.1 your QMS includes the quality policy and quality objectives.
Therefore, these are controlled documents and must be controlled according to clause 4.2.3
control of documents.
The quality policy is not written in stone. It must be reviewed periodically by top
management, for significant changes in your organization, e.g. management, ownership,
relocation, product, shift in customer base, etc. Such changes may result in changes to the
quality policy. The establishment of the quality policy should be part of the business
planning or QMS planning processes. A review of the quality policy for continuing
suitability should be part of your management review process (see clause 5.6).
In clause 8.5.1, we will examine how the quality policy can be used as a tool for
continual improvement.
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5.4.1 Quality Objectives
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5.4 Planning
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process – productivity; reduction of cycle time, errors, omissions and failures; etc.
Examples could include objectives for - set-up time; run rates; process cycle time; scrap
rates; etc. (see clause 7.3.2.2; 7.5.1.4; 7.4.3.1).
Customers - # of complaints; customer satisfaction rating; on time delivery; service;
support, etc, (see clause 8.2).
Suppliers – material defects; on time delivery; # of complaints with supplier.
Resources – (includes facility; equipment; labor; etc.) – objectives could be
established based on availability; capability; maintenance; personnel competency,
absenteeism; production rates; efficiency; safety; etc.
For the QMS – customer satisfaction feedback; internal audit results; # of
improvement opportunities; etc.
Remember the purpose of quality objectives is to determine conformity to
(customer and regulatory) requirements, and effective deployment and improvement of the
QMS
Quality objectives may be set at various functional levels of the organization – top
management; departments; processes; functional groups; work cells; project teams;
individuals; etc. It would be useful to cover all these levels as all should add value and
contribute to customer or organizational objectives.
Quality objectives must be measurable. Measurement can be done quantitatively or
qualitatively. Qualitative measures are generally more objective in determining whether
conformity or effectiveness has been achieved. In some situations, the use of qualitative
measurements may be appropriate. Objectives based on yes/no criteria, (e.g. – develop
new product by March 2006), are also acceptable.
Clause 5.4.1.1 Supplemental - Under TS 16949, you must have abusiness
plan approved by top management that contains quality goals, objectives and
measurements for the organization, including those for quality. You must have
a process for creating, distributing and monitoring the quality objectives defined in the
business plan.
These quality objectives must be deployed and measured (see clause 8) and top
management must conduct an effective review of themeasurement results. These
measurement results must also be used for corrective action and continual improvement.
The quality objectives must be achieved within a defined time periodto ensure
accountability. This could be determined by your customer, your management, your head
office, regulatory bodies, etc. Your business plan must establish these time periods and your
business planning process must include the communication of objectives and timelines to
those responsible for achieving them.
The establishment of quality objectives should be part of the business planning or QMS
planning processes. The output of business planning should be a Business Plan which must
include your quality objectives. A review of the quality objectives should be part of your
management review process (see clause 5.6). As a quality document, your business plan
must be controlled by 4.2.3 control of documents.
You have to be careful not to overwhelm your organization with too many objectives as this
may cause more frustration than positive results. Start with objectives that focus on
meeting customer requirements and then slowly develop meaningful objectives for key
processes and risk prone processes, as initial targets are achieved.
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5.4.2 QMS Planning
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leadership, resources and review of QMS performance.
Performance indicators to demonstrate effective QMS planning could include –
achievement of quality objectives; improved customer satisfaction ratings; reduced number
and seriousness of internal/external audit nonconformities.
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5.5.1 Responsibility & Athority
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leadership, resources and review of QMS performance.
Performance indicators to demonstrate effective QMS planning could include –
achievement of quality objectives; improved customer satisfaction ratings; reduced number
and seriousness of internal/external audit nonconformities.
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5.5.2 Management Representative
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management review meetings or other meetings. The information for the report will come
from the results of the measurement and monitoring requirements specified in clause 8
(e.g. internal audits and customer satisfaction feedback, etc.). The MR must delegate and
facilitate the compilation of this information from all the process owners.
The report must include any recommendation to improve the QMSbased on the
MR’s review of all QMS measurement and monitoring data. It would be appropriate to
discuss and obtain agreement with affected process owners.
As we discussed earlier, TS 16949 focuses heavily on meeting customer and
regulatory requirements and enhancing customer satisfaction. The MR must
likewise promote this focus through all processes that are directly and even indirectly
involved in achieving this. There are many ways of doing this including the use of training;
cross-functional teams; customer focused project teams; project milestone reviews;
designated customer representative; electronic interfaces with the customer; use of PPAP,
FMEA’s, Control Plans, customer specifications, customer product specific work instructions,
etc.
The appointment of the MR and defining his/her responsibilities ands authority should
be part of the business planning process. The MR’s activities must be included in quality
planning; management review and communication processes.
The designated customer representative(s) and their specific responsibilities must
be clearly defined. They must ensure that customer requirements are fully understood and
addressed. A good way to address this, is for the customer representative to participate in
the entire APQP (Advanced Product Quality Planning) process (see reference
manual).Review specific requirements for the customer representative at OEM customer or
IATF websites.
The effective fulfillment of the customer representative’s responsibilities may be
demonstrated by their participation in milestone and decision points related to production
release; engineering release and other related activities linked to customer requirements.
Overall QMS performance indicators may be used to determine how well the MR has
performed the responsibilities defined in clause 5.5.2.
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5.5.3 Internal Communications
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At the operations level, each process owner must identify the methods of
communication (computer; documents; telephone; meetings; directives, visual, etc,) used
and determine whether these methods are appropriate – are they effective for the purpose
intended? - (do they prevent non-conformities from arising due to the reasons mentioned
above?). Process owners should provide feedback on communications effectiveness to the
processes providing and controlling such resources, e.g. IT and top management (business
planning).
The MR must communicate on QMS effectiveness not only to top management (see
clause 5.5.2b, but also to appropriate levels within the organization. If everyone is
responsible for quality, then all process owners as well as their personnel are entitled to
receive periodic feedback on their areas of responsibility.
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provided; signage; computer system; etc.
The performance indicators for the business planning; HR process and QMS processes
may be used to determine the effectiveness of planning and managing the organizational
structure, responsibilities and authorities.
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5.6 Management Review
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5.6.1 General
Top Management shall:
Perform reviews of the QMS
Conduct these reviews at planned intervals
Ensure that the QMS continues to be suitable, adequate and effective
Assess opportunities to improve the QMS
Evaluate the need for any changes to QMS, quality policy and objectives
Maintain records of management reviews
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b) Improvement of product related to customer requirements
c) Resource needs
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also identify what specificdocuments are needed for effective planning, operation and
control of this process (see clause 4.2.1d). These documents may include – a documented
procedure; review schedule; agenda and action forms; etc., combined with unwritten
practices, procedures and methods.
Management review records must include topics discussed; decisions; responsibilities
for corrective or improvement actions and related timelines; provision of resources; and
follow-up actions from previous management reviews.
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6.1 Provision of Resources
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6.2 Human Resources
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6.2.1 General
Personnel performing work affecting product quality shall be competent on basis of
appropriate education, training, skills and experience
6.2.2.2 Training
You shall establish and maintain documented procedures for identifying training needs
and achieving competence of all personnel performing work affecting product quality.
Personnel performing specific assigned tasks shall be qualified and focused on satisfying
customer requirements.
Note 1 This applies to employees at all levels of the organization having an effect on
quality.
Note 2 An example of customer specific requirements is the application of digitized
mathematically based data.
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Create an environment that promotes innovation
Promote quality & technological awareness throughout the whole organization
Measure the extent to which its personnel are aware of the relevance and importance of
their work and their contribution to achieving quality objectives (see 6.2.2.d)
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experience. These records must demonstrate the effective operation of HR process controls
(see first sentence of clause 4.2.4 quality records).
Performance indicators to measure the effectiveness of the HR process in determining
competency and training needs of the workforce, could include – employee turnover;
employee complaints; number of instances unqualified personnel were found performing
QMS activity; number of instances competency criteria were not met; and number of
instances no training or competency records maintained; etc.
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6.3 & 6.4 Infraestructure & Work Environment
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6.3 Infrastructure
Your organization shall determine, provide and maintain the infrastructure needed to
achieve conformity to product requirements. Infrastructure includes, as applicable:
a) Buildings, workspace and associated utilities
b) Process equipment (hardware and software)
c) Supporting services (such as transport or communication)
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address – plant layout; optimization of material travel and value-added use of floor space;
synchronous material flow; waste reduction and lean manufacturing; facility and equipment
maintenance; equipment capability and consistency; control of the work environment;
employee and product safety; facility day to day housekeeping; and contingency
planning. . Review specific requirements for facility planning at OEM customer or IATF
websites.
The productivity and effectiveness of existing operations must be evaluated
through consideration of – ergonomic and human factors; operator and line balance;
storage and buffer inventory levels; use of automation; value added content and use of a
work plan.
You are required to maintain your infrastructure. Your planned preventive maintenance
program should include controls for – schedule and timing; availability and training of
personnel; types and scope of maintenance; maintenance and competency/training records;
tracking to maintenance objectives; use, storage and control of spare parts; control of any
maintenance outsourcing; etc. There are many software programs available to help do this.
Also see notes under clause 7.5.1.4.
You must have contingency plans that includes – availability of alternate remote
production sites for multi-site situations; appointment of a responsible person to operate
emergency procedures; key equipment/machinery list; maintenance operation records; and
outputs of a risk analysis result (similar to a product or process FMEA, but on a more
global – business and infrastructure scope). . Review specific requirements for contingency
planning at OEM customer or IATF websites.
Work environment include controls for ergonomics; personnel safety and facility
conditions that are conducive to achieving product quality. Some of the factors to consider
in determining and managingergonomics include - (worker movement; fatigue; manual
effort and loads, etc); workplace location; social interaction; heat; light; humidity; airflow;
noise; vibration; etc). The applicability and degree to which applicable of these factors will
vary from facility to facility. The focus should be employee safety, welfare and product
conformity. Review specific requirements at OEM customer or IATF websites.
Personnel safety – factors to consider may include – defined responsibility for safety;
error-proofing in DFMEA and PFMEA; knowledge and application of regulations; lessons
learned from internal/external audits and corrective actions; records of accidents; workplace
risk analysis; safety procedures; and use of safety equipment.
Facility conditions include - cleanliness of premises. Factors to consider may
include – defined responsibilities for order and cleanliness; appropriate disposal conditions;
appropriate space and storage conditions; clean intact transport and operating equipment;
organized, clean and well lit workplaces and inspection stations; hygiene standards;
availability of facilities for lockers; lunchroom; cafeteria; washrooms; etc. . Review specific
requirements for cleanliness at OEM customer or IATF websites.
Performance indicators to measure the effectiveness of processes (see first paragraph
above) that determine and control the effective use of infrastructure may include –
equipment maintenance - uptime/downtime; productivity – equipment and workforce;
accident and safety incidents; non-value added use of floor space; excessive handling and
storage; number of instances specific resources were not available or delayed; etc.
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7.1 Planning of Product Realization
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7 PRODUCT REALIZATION
7.1.3 Confidentiality
Keep confidential - customer contracted products and projects under development and
related product information
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Validate changes before implementation.
Review with your customer, any changes to propriety designs, impact on fit, form and
function, to ensure that all effects are evaluated
Perform any additional verification/ identification, when required by the customer, e.g.
new product introduction
Note 1 : Notify & get approval from your customer, for any productrealization change
affecting customer requirements.
Note 2 : This clause for change control applies to changes to product as well as
manufacturing processes.
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where required.
Many customer requirements may come from the sources and reference documents I
listed on page 1 of this document. You must pay careful attention to this listing as they may
be as applicable as customer contracts and product specifications.
Required verification, validation, monitoring, inspection and test activities must apply
to all processes identified for product realization and must be defined in your FMEA’s,
Control Plan, work instructions, and other documents used for product realization.
Access to storage of confidential documents and data (electronic or hard copy) should
be controlled. Be extra careful of confidentiality requirements relating to new projects and
changes. Obtain clarification and approval from your customer when outsourcing production
or needing to disclose technical information when sourcing materials.
Change control is a very important part of the product realization process. It applies
to ANY change in product realization and includes product and manufacturing process
changes. Uncontrolled changes lead to both customer and internal quality problems. The
defined process must include authority for change and consistency of implementation and
communication.
For effective change control, follow the applicable requirements of the APQP
methodology for assessing, verifying and validating product realization changes before
implementing. Comply with any customer requirements for notification and approval of
changes.
Your change control process must include – responsibility; evaluation; verification and
validation; frequency; timing; method; communication; training; documentation; update of
affected activities and documents; implementation; use of multi-disciplinary approach;
checklists; etc., for product realization changes.
Changes may arise from customer complaints; feedback from the field; new
technology; supplier and material changes; internal or customer driven changes; process
improvements; SPC data; etc.
Product realization changes may affect several linked activities and documents. Such
as – clauses (4.2.3.1; 7.3.6.3; 7.3.2.3; 7.3.3.1; 7.3.3.2; 7.3.6.2; 7.5.1.1 and 7.5.1.2).
These cover customer engineering specifications; FMEA’s (design and process); Control
Plans; design record; inspection instructions; machine process parameters; material
specifications; measuring equipment; part approval requirements; technical drawings; and
work instructions.
Where any of the product realization processes are done off-site (e.g. at head-office),
your QMS must include the off-site processes within your QMS and ensure that such
processes comply with TS 16949 requirements. Evidence of the off-site facility’s compliance
may include - a copy of their TS 16949 certification; results of their internal audits to TS
16949; auditing the outsourced facility; etc. The expectation is to flow down to the off-site
facility, the relevant TS 16949 requirements that you would have to implement, had you
carried out the process at your own facility.
Performance indicators, (to measure the effectiveness of product realization in meeting
requirements and achieving quality objectives,) will be specific to each realization process
and focus on reducing variation and waste in realization processes and related use of
resources. Objectives may be used to monitor and improve process – productivity;
reduction of cycle time, errors, omissions and failures; etc.
You must also consider indicators to measure product performance such as - reduction
in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework;
improvement in on time delivery (see clause 7.1a); product returns from customer; etc.
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7.2 Costumer Related Processes
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Note 1: Post delivery activities include after-sales product service, provided as part
of customer contract or order
Note 2 : This requirement includes recycling, environmental impact & characteristics
identified as a result of knowledge of product & manufacturing processes (see clause
7.3.2.3)
Note 3 : Compliance to (c) includes all applicable government, safety & environmental
regulations applied to acquisition storage, handling, recycling, elimination & disposal of
materials
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7.2.2 for a formal review (see Note).
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Make sure you do your due diligence, Feasibility and risk analysis before you commit to
contractual arrangements. I have seen many tier 1 and 11 suppliers get into serious
financial trouble, for taking on programs and product that the OEM transferred from another
supplier, because they did not assess all the risks. Be careful of taking on other suppliers
problems!
Manufacturing feasibility (which includes risk analysis), is an assessment of your
organization’s capacity and capability to effectively and efficiently provide the customer
specified deliverables. The risk analysis should include programming timing; resources;
development costs and investments; potential for, and effects of, possible failures in
processes, including your suppliers. You should also consider financial and profitability risk.
The results of your assessment must be recorded on the applicable APQP form. Review
specific requirements for feasibility at OEM customer or IATF websites.
Sometimes it may take a few months to receive an order or contract from the
customer, after you have sent them your quotation. Your review process must ensure that
you compare the customer’s order or contract with your latest quotation, and resolve any
differences (accept or re-negotiate), before you accept the order or contract.
Your customer relations management process must include a sub-process for change
control and must include – a review of the change (from customer or internal) and its
impact on fit, form, functionality, other processes, financial, delivery, etc. again, use
applicable sections of APQP to address change control.
Obtain customer approval in writing for any waivers of contractual or QMS
requirements.
Customer communications may take many forms including – customer representative
(see clause 5.5.2.1); industry recognized computerized interfaces and software for product
(EDI; CAD); Customer provided software and interfaces for design and development,
logistics, customer satisfaction feedback, etc; multi-disciplinary OEM/Supplier teams for
product programs; etc. You must ensure that personnel at all levels have the competency
and training to use these communications media and tools. Review specific communication
requirements at OEM customer or IATF websites.
Clause 7.2 does not require a ‘documented’ procedure. However, you must identify and
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use a documented procedure or other
combination of practices, procedures and methods that may not necessarily require
documentation. Look at the risks related to your product, processes and resources in
determining the extent of documented controls you need to have (also see clause 4.2.1
notes).
Performance indicators (to measure the effectiveness of customer-related processes in
meeting requirements and achieving quality objectives) should focus on reducing variation
in and improving these processes and related use of resources. Indicators may include
reduction in - quote cycle time; pre and post-award review cycle time; order entry errors
and omissions; etc., and improvement in conversion ratio (i.e. ratio of contracts/orders
awarded to quotes). It might be quite useful to obtain feedback relating to why
jobs/contracts were lost.
For performance indicators for customer communications processes, see clause 5.5.3
first paragraph of key explanation points and tips.
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7.3.1 D&D Planning
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available for planning ranging from a simple checklist to complex software. Use your
customer-specific manuals for APQP as a good starting point.
The degree and details of planning may vary according to size and length of contract or
project, complexity, risk, product life, customer and regulatory requirements, past
experience with similar product, etc. You have flexibility in determining the scope of the
stages, review, verification and validation required for your product d & d projects.
Your plan must be dynamic and updated as requirements and circumstances change.
You must track progress against your plan at regular intervals or project milestones and
update the plan as activity progresses.
You must use a multi-disciplinary approach, that includes as needed, other functions
(besides design) such as quality, engineering, purchasing, sales, tooling, production, etc..
Your plan must clearly identify these other functions and their specific role and
responsibilities regarding the project. Consider including customer and supplier personnel at
appropriate stages to do work and review results or progress. Consideration must also be
given to the methods of communication and interaction. Inclusion of these controls in your d
& d plan is one of many effective ways to achieve this.
A multi-disciplinary approach has the benefit of applying collective and relevant
knowledge and skills of these different functions to carry out or review d & d activities
You must use the multi-disciplinary approach for specific activities such as
determination of special characteristics, conducting FMEA’s, developing control plans, and
plant and facility planning, etc. Review specific requirements for multi-disciplinary approach
at OEM customer or IATF websites.
The d & d project plan serves as both a document and a record as it is updated for
completion for various activities.
Where some or all of the design responsibility is subcontracted or done off-site, then
you must ensure that your organization and the subcontractor or off-site location
collectively address all the requirements of clause 7.3 with particular coverage of the
interfaces between them
You must review all input requirements; review d & d progress; verify product design
and validate developed product at various stages of your d & d process. The nature,
frequency and scope of these controls must be defined in your d & d plan or other
document. You must carry out these controls according to your plan and keep appropriate
records (see record requirements in clauses 7.3.4; 7.3.5; 7.3.6 and 7.3.7).
Clause 7.3 does not require a ‘documented’ procedure. However, you must identify and
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents are needed for effective
planning, operation and control of production activities (see clause 4.2.1d). These
documents may include – contracts; technical drawings and specifications; a documented
plan for d & d; work instructions; a documented procedure; etc., combined with unwritten
practices, procedures and methods.
Look at the risks related to your product, processes and resources in determining the
nature and extent of documented controls you need to have (also see clause 4.2.1 notes).
Many organizations use various software tools to document their product or process d & d
plans.
Performance indicators (to measure the effectiveness of design and development
processes in meeting requirements and achieving quality objectives) should focus on
reducing variation in and improving these processes and related use of resources. Indicators
may include reduction in – design cycle time; development cycle time; specification errors,
omissions; changes; d & d costs; etc., as well as measurableimprovements in products
developed.
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7.3.2 D&D Inputs
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Use your customer specified APQP reference manual as a good tool for d & d planning
and control.
Product d & d is only applicable if you are designated as being design-responsible.
Determine (in writing) from your OEM customer if you are designated as being design
responsible. You must apply all relevant requirements of clause 7.3 for manufacturing
process d & d.
You must identify, document and review design inputs requirements for function,
performance, safety, regulatory, quality, reliability, durability, life, timing, maintainability,
cost, identification, traceability, packaging, special or safety characteristics (from the
customer or regulatory body), and other requirements essential to the product.
You must have a process to deploy (identify, document, review and use) design input
information coming from various sources such as - customer contracts, drawings and
specifications; your own organization’s database of previous d & d projects; competitor
analysis; industry standards; feedback from suppliers; field data.
You must identify, document and review manufacturing process design input that
include – product design output data; targets for productivity; process capability and cost;
customer requirements for manufacturing, if any; and experience from past d & d projects
and manufacturing activities; and the use of error-proofing methods appropriate to the size
of problems and risks experienced.
You must have a process to deploy (identify, document, review and use) manufacturing
process design input information coming from various sources.
You must identify and include all special and safety characteristics (using the
customer’s or your own equivalent symbol or notation) in your process control documents
such as - control plan; FMEA’s drawings; operator instructions and other documents used to
make or verify product. Note that special characteristics can also include process
parameters such as temperature, timing, concentrations, etc. Review specific requirements
for special characteristics at OEM customer or IATF websites.
Not all products or processes necessarily have special characteristics. You may define
them as appropriate and include them in the documents mentioned above. Guidance in
determining special characteristics, comes from customer requirements; regulatory
requirements and analysis of previous concerns
You must review all input requirements for adequacy and completeness. You must
ensure that requirements are complete, clear and consistent with each other.
Clause 7.3.2 is closely associated with clause 7.2.1 and 7.2.2 – determining and
reviewing customer requirements.. Accordingly, you must keep appropriate records of
identification, documentation and review of input data.
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7.3.3 D&D Outputs
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You shall:
Provide d & d outputs in a form that enables verification against d & d inputs
Approve d & d outputs prior to their release
repare design and development output to:
a) meet d & d input requirements
b) provide appropriate information (for purchasing, production, and service)
c) contain or reference product acceptance criteria
d) specify characteristics of the product essential for its safe and proper use
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Key Explanation Points and Tips:
Product d & d output may be product or documentation or both. Product may be
prototype or finished product and documentation could be in computerized or hardcopy
form. A manufacturing d & d output may be a physical manufacturing process as well as
documentation. See examples of both in Clauses 7.3.3.1 and 7.3.3.2 above).
Check product d & d output against the input requirements specified in
7.3.2, before you use it any further. Express product design output in any or all the forms
specified in 7.3.3.1.
Provide appropriate information to purchasing (material or service specifications);
production (product specifications, special characteristics, drawings, FMEA’s, diagnostics,
etc.); service (product specifications; performance reliability and maintenance criteria).
Initially, this information may be used for trials and validation, before being firmed up.
The product design output should result from a process that includes efforts to simplify,
optimize, innovate and reduce waste. The design process should include:
Analysis of cost, performance and business risks and trade-offs
Appropriate use of geometric dimensioning and tolerancing
Design for assembly (DFA); Design for manufacturing (DFM); design of experiments
(DOE); quality function deployment (QFD); Value engineering (VE)
Tolerance studies and appropriate alternatives
Use of Design FMEA’s
Use of feedback from testing, production and the field
Diagnostic guidelines in clause 7.3.3.1 refers to systems software/equipment for field
servicing that requires engineering based data essential to service the vehicle.
Manufacturing process ; Check manufacturing process d & d output against input
requirements specified in 7.3.2.3. Express manufacturing design output in any or all the
forms specified in 7.3.3.2.
The manufacturing process design output should result from a process that includes
efforts to simplify, optimize, innovate and reduce waste such as lean manufacturing tools
that include:
ANDON system (line control system)
Error proofing; level scheduling; pull system inventory control;
Synchronous manufacturing (single-piece flow)
Visual controls
Workplace organization and layout
Many documents are created from the d & d output stage (drawings, FMEA’s, control
plans, etc). These documents must be controlled as per clause 4.2.3 of this standard
(approval; revision control, distribution, etc).
Many sophisticated d & d tools are required to be used as indicated above. You must
provide and keep records of appropriate competence and training for functions performing d
& d activities.
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7.3.4 & 7.3.5 & 7.3.6 D&D Verification, Validation & Control
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Note: These reviews are normally coordinated with the design phases and include
manufacturing process d & d.
7.3.4.1 Monitoring
You shall define, analyze and report (in summary) measurements at specified stages of d &
d, as an input for management review
Note: These measurements include quality risks, lead times, critical paths and others as
appropriate.
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Complete validation before delivery or implementation (wherever practical)
Maintain records of the results of validation and any necessary actions
Note 1 The validation process normally includes an analysis of field reports for similar
products
Note 2 Verification (7.3.5) & validation (7.3.6) apply to both product d & d as well as
manufacturing process d & d.
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7.3.6.2, 7.3.6.3 & 7.3.7 Prototype, PPAP, Changes
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Note: Product approval should follow the verification of the manufacturing process
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Approve the changes before implementation
Evaluate effect of changes on constituent parts and product already delivered
Maintain records of the results of such reviews and any necessary actions
Note: D & D changes include all changes during the product program life (see 7.1.4)
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7.4.1 Purchasing Process
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7.3 Purchasing
Note 1 : Purchased product includes all products & services that affects customer - sub-
assemblies, sequencing, sort, rework & calibration services
Note 2 : Verify the continuity of your supplier’s QMS & its effectiveness if there are
merger, acquisition, affiliations associated with your suppliers.
Note: Prioritize supplier development based on their quality performance & importance
of product supplied.
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maintenance, etc.
Note that clause 7.4 requirements also apply to customer provided property which
might include materials, production equipment; tooling; measuring and test equipment;
facilities; transport vehicles; returnable packaging; intellectual property (drawings,
specifications or proprietary information); product returned for servicing under warranty,
product sent for outsourced work; etc.
You must have specifications/criteria for purchased product. These specifications may
come from your organization, customer, regulatory bodies, supplier or industry. As
documents, these specifications must be controlled as per clause 4.2.4
Many times the customer may require the use of pre-approved purchased products and
suppliers. The onus is still on you to ensure that purchased product from customer-
designated sources meets all requirements.
You must control both, the product that you buy, as well as the supplier you buy from.
Clauses 7.4.3 and 7.4.3.1 and 7.3.6.3 PPAP deal with requirements to control the products
you buy. Your controls must primarily be based on prevention of nonconformities in both
product and supplier performance.
And clauses 7.4.1(second paragraph), 7.4.1.2; 7.4.1.3; 7.4.2c; 7.4.3.2 and 7.3.6.3
PPAP deal with requirements to control the suppliers you buy from.
Determine how important the purchased product is to design, manufacture, assemble
and maintain your end product. Keep in mind clause 7.3.2.1 which requires targets for
product quality, life, reliability, durability, maintainability, timing and cost. You must apply
similar criteria to purchased product going into your end product.
Categorize your purchased products accordingly. Then determine what controls you
need to ensure consistent purchased product quality and consistent supplier performance.
You can apply different controls for different purchased products and suppliers.
Besides product quality, your criteria for supplier selection and evaluation may include
the potential supplier’s - financial capability; technical and manufacturing capability and
capacity; reliability; reputation; flexibility to handle changes; support; service; cost; etc.
The importance of these criteria will vary according to the items materials or services you
purchase, and so you can apply different criteria to different supplies. You can categorize
your suppliers accordingly based on these criteria. It might be useful to maintain a list of all
qualified suppliers.
Not all suppliers of purchased product need to conform to TS 16949. Look at the
importance of the purchased product and their quality performance, to qualify them and
prioritize their QMS development.Supplier - refers to your suppliers manufacturing site
where production and/or service parts are made.
You must promote and encourage your qualified or key suppliers to develop their
QMS - starting with registration by an accredited 3rd party Certification Body (CB) to ISO
9001:2000 (unless, otherwise specified by the customer) and eventually leading to
conformity to the latest TS 16949 standard. Your supplier QMS development process could
include a plan for qualified suppliers to achieve ISO certification and TS conformity within
the 3 year life cycle of your organization’s registration certificate.
If supplier development according to the above plan is not possible, then get
approval in writing from affected customers for an alternate approach to supplier
development, e.g. assessment by a OEM customer approved second party. Very small
supplier organizations may obtain special dispensation from their OEM customers from
obtaining ISO 9001 or TS 16949 certification under certain conditions. Please review specific
requirements for subcontractor development at OEM customer or IATF websites.
Where there are multiple customers for a purchased part or supplier, you must ensure
that your purchased part and supplier meet all specific customer requirements (e.g. PPAP
requirements).
Where OEM customer approved suppliers are used, you must still apply all applicable
TS 16949 control requirements to manage these suppliers. Also review specific
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requirements for customer approved suppliers at OEM customer or IATF websites.
As per clause 4.1, you must identify your purchasing processes whether on site or off
site. For each process, you must document the controls for purchased product and
suppliers. You must also show the linkage and interaction of purchasing processes with
other processes such as design, manufacturing, tooling maintenance, calibration, etc.
Where any of your controlled suppliers have gone through a significant organizational
change (mergers, acquisitions, etc), you must verify (e.g. get a copy of their latest ISO
9001 certification) the continuity and effectiveness of their QMS.
You must keep records of all supplier evaluations (whether initial or periodic), including
any corrective actions placed on them for any nonconformities.
Performance indicators (to measure the effectiveness of purchasing processes in
meeting requirements and achieving quality objectives) should focus on measuring supplier
performance and reducing variation in and improving purchasing p rocesses and related
use of resources.
Indicators for supplier performance may include – reduction of defects in supplied
product; scrap; waste and rework; improvement in on-time delivery, service, cost, etc.
Indicators for purchasing process may include reduction in supplier – quote review cycle
time; contract award cycle time; purchase order-entry errors and omissions; receiving
errors & omissions; etc.
For performance indicators on supplier communications processes, see clause 5.5.3
first paragraph of key explanation points and tips.
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7.4.2 & 7.4.3 Purchasing Information & Verification Purchased
Product
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2nd or 3rd party audits of supplier sites when combined with records of acceptable
delivered quality performance
Part evaluation by a designated laboratory
Any other method agreed to by your customer
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whether caused by you or your supplier. You must take corrective action where there a
significant premium freight problem.
If you have the misfortune to be put on hold, special alert or notification status by any
of your OEM customers, the process for getting out of it can be very time-consuming and
costly. Therefore, besides controlling your own product and delivery performance (see
clause 8.2.1.1), make sure that you are on top of your supplier’s product quality and
delivery using effective evaluation and monitoring controls as well as an effective problem
resolution process when problems do arise.
You must encourage your suppliers to monitor their own manufacturing performance.
Motivate them to use lean manufacturing tools such as – ANDON procedures; direct run first
time quality results; lead time reduction; level scheduling; number of error-proofing
opportunities implemented; planned maintenance; standardized work; workplace
organization and visual controls deployed.
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7.5.1 Control of Production and Service Provision
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Note: Get customer approval if required, after review or update of the control plan.
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The key output of the APQP (your quality plan) process are control plans and work
instructions. Each part must have a control plan, but in many cases, family control plans
may cover a number of similar parts produced using a common process
For each product or part family, control plans must cover all production process steps
from - receipt of materials, production, packaging, storage, delivery and even post-delivery
activities such as installation or training.
Consider using FMEA’s and control plans in other areas of your organization, such as
equipment and facility maintenance; laboratory; tooling operations, etc.
Control plans and work instructions originate as an output from Design and process
FMEA’s (see clause 7.3.2.3 and 7.3.3.2). They define complete controls for the manufacture
of product. Use them for pre-launch and production of end product, sub-assemblies,
components and/or materials. They must include the customer’s and your special
characteristics, any other customer required information and a reaction plan when
processes fail. Review specific requirements at OEM customer or IATF websites.
Work instructions may be viewed as a subset of your quality plan and may relate to a
specific task or activity of your overall product realization process (e.g. setting up a
machine; performing an inspection; packaging a product). If you determine that work
instructions are needed at specific points in your process, then they must be readily
available and relevant i.e. current or right version (see clause 4.2.3d). Note that work
instructions may exist in may forms – narrative; graphical; audio; video; physical display;
etc. Review specific requirements for work instructions at OEM customer or IATF websites.
In combination, these documents address what has to be made; how much has to be
made; when it has to be made; by whom; in what sequence; how it has to be made; what
production equipment to use; what measurement and monitoring tools to use ; when to
inspect; how much to inspect; what to do if problems arise, etc.
These documents are dynamic and must be updated for the changes specified in
7.5.1.1. Your control plans must reference the work instructions specified for the process
steps.
Don’t forget to use the multi-disciplinary approach in developing your Control Plans.
Clauses related to clause 7.5.1.1 include - 7.1.4; 7.3.6.3; 7.3.1.1; 7.3.3.2; 7.3.2.3;
7.3.6.2; 8.2.3.1; 4.2.3.1; 8.5.2.
To improve your QMS, it will be very useful to draw a flow chart to link the flow and
interaction of the activities and sub-processes covered by these clauses, e.g. many
organizations overlook reviewing and updating their FMEA’s and control plans for corrective
action taken to address a manufacturing process problem.
Collectively, these documents include or reference the following information:
Current engineering level/date; customer or your special characteristics; inspection and
test instructions with acceptance criteria (see clause 7.1.2 and 8.2.3.1); material
identification and disposition instructions; operation name and number keyed to the process
flow diagram; part name, number and family; reaction plans; relevant engineering and
manufacturing standards; required tools, gages and other equipment; revision dates and
approvals; SPC and other process monitoring requirements; tool-change intervals and set-
up instructions; visual aids, etc.
Production personnel must have timely access to all information relevant to their
activities. There may be serious risk to production flow, if such information is unavailable or
untimely.
Clause 7.5 does not require a ‘documented’ procedure. However, you must identify and
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use your control plan; a documented
procedure or other combination of specific practices, procedures, work instructions; and
other documents and methods. Look at the risks related to your product, processes and
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resources in determining the extent of documented controls you need to have (also see
clause 4.2.1 notes).
Performance indicators (to measure the effectiveness of production processes in
meeting requirements and achieving quality objectives) should focus on reducing variation
in and improving production processes and related use of resources.
Indicators for production processes be product or process related. Product related
indicators may include reduction - in defect rates, PPM’s (defective parts per million), scrap
rates, waste and rework; improvement in on time delivery, inventory turns (see clause
7.1a).
Production process related indicators may include – reduction in set-up time; run rates;
process cycle time; production scheduling and operator errors and omissions; etc.
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Perform a FMEA on the various types of process equipment you use, to identify key
process equipment to include in your program for planned total preventive maintenance
system. Consider doing this by equipment groups, if all equipment within a group operates
in the same way. Identify maintenance as a process within your QMS as per clause 4.1,
including any outsourced maintenance activities.
Your planned preventive maintenance program should include – schedule and timing;
availability and training of personnel; types and scope of maintenance; records; tracking to
maintenance objectives; use, storage and control of spare parts; control of any
maintenance outsourcing; etc. There are many software programs available to help do this.
Predictive maintenance methods should include a review of manufacturer’s
recommendations; storage; tool wear; optimization of uptime; correlation of SPC data to
predictive maintenance activities; important characteristics of perishable tooling; fluid
analysis; monitoring of circuits; and vibration analysis. Check sub-clause 3.1.7 and 3.1.8
under Terms and Definitions - clause 3 of this standard. Review specific requirements for
maintenance at OEM customer or IATF websites.
Include, as appropriate, maintenance of equipment in your control plans.
Note: Tooling management also applies to availability of tools for vehicle service parts
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Reference appropriate tooling and equipment in your control plans and/or work
instructions.
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competent personnel. Don’t forget to include this process within your QMS as per clause 4.1
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7.5.2 Validation of Processes for Production and Service Provision
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7.5.3 Identification & Traceability
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Note: You cannot use location of product as an indicator of inspection and test status,
unless inherently obvious such as material in an automated production transfer process.
Alternatives are permitted if status is clearly identified, documented and achieves the
designated purpose.
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tracking specific production runs/lots; automated production transfer processes, etc.
Performance indicators (to measure the effectiveness of processes that control
identification and traceability) may include - reduction in identification errors and omissions;
product quality status errors and omissions; and traceability errors and omissions.
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7.5.4 Customer Property
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Note : Includes customer owned returnable packaging and can include intellectual
property
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7.5.5 Preservation of Product
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7.6 Control of Monitoring and Measuring Devices
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Note: A number or other identifier traceable to the device calibration record meets the
intent of 7.6c.
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Any out-of-specification readings as received for calibration or verification
An evaluation of the impact of the out-of-specification condition
Statement of conformity to the specification after calibration or verification
Notification to the customer if suspect product or material been shipped
Note – your internal laboratory may be accredited to ISO/IEC 17025, but it is not
mandatory.
Note 1: Evidence of customer acceptance may include an audit by the customer or an audit
by a customer-approved 2nd party that the laboratory meets the intent of ISO/IEC 17025
Note 2: The equipment manufacturer of a specific MMD, can perform its calibration, if a
qualified laboratory is not available. In such cases, you shall ensure that clause 7.6.3.1
requirements are met.
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measurement. This would depend on the industry you are in and the criticality of end use
for the product (e.g. the precision requirements for an engine block or for ball bearings may
be much greater than say for cutting leather to cover a car seat).
Personnel using MMD’s must have competence and training in the use of MMD’s in
terms of their function, range and precision of measurement, reliability, use and
maintenance.
MMD’s may include measurement and testing tools; equipment; hardware and
software. They may be owned by your organization; your employees or the customer.
MMD’s may be used to verify product as well as to measure process conformity (e.g. a
temperature controller on an oven). Besides MMD’s used for product conformity, you may
need to calibrate and control certain MMD’s used in related and peripheral processes such as
production equipment; tooling; maintenance; etc.
To ensure valid measurement and monitoring results, MMD’s must be controlled.
A process is required, to control the selection; purchase; identification; status; calibration;
use; verification or adjustment; use; handling; maintenance and storage; training;
nonconforming MMD’s; calibration records; etc. Appropriate records need to be kept of the
use of these controls.
All MMD’s used for product verification must be capable of being calibrated, verified or
both. Calibration is setting or correcting an MMD, usually by adjusting it to match or
conform to a dependably known and traceable standard (e.g. adjusting a micrometer or
caliper to conform to master blocks traceable to national standards).
Verification is confirming that the MMD is meeting or performing to acceptable national
measurement standards and does not involve any correction or adjustment (e.g. verifying a
ruler or tape measure against a calibrated ruler that has been calibrated to a national
standard). A ruler or tape measure is generally not capable of being calibrated and when it
gets out of calibration its use must be discontinued.
There are MMD’s that are capable of being both calibrated and verified (e.g. a CMM-
coordinate measuring machine) and may require both to be done in specific situations based
on frequency of use and criticality of measurement. This requirement also applies to the use
of computer software whose calibration status must be established prior to initial use and
reconfirmed (verified) at defined intervals.
You must define the frequency and method of calibration for each type and level (shop
floor; laboratory or standard) of MMD. Your calibration records must identify what standard
you used for calibration and show traceability of the standards you use at your facility to
national or international standards.
In rare circumstances, national or international standards may not exist for calibrating
a specific MMD. In such situations consider using industry, manufacturer or even your own
organizational standard to validate the accuracy and reliability of your MMD. Consult with
your customer if the contractual circumstances require it.
Your control plan must define the measurement and monitoring required and the type
of MMD needed for it, including the frequency of measurement and acceptance criteria. Use
customer reference manuals, such as the Measurement Systems Analysis (MSA) manual, to
conduct statistical studies on MMD’s referenced in your control plans. Ensure that personnel
performing such statistical studies are trained and competent to do so.
A multitude of software tools are available to manage and control MMD’s including all
the record keeping details required by clause 7.6.2. There are many acceptable methods to
identify MMD’s and their calibration status. The methods you select must consider the
manufacturers recommendations; frequency of use; environment the MMD is used in; etc.
Where an MMD is found to be out of calibration, you must take appropriate correction
action to contain and re-verify the product affected, to the extent practical. This is in
addition to containing, repair and recalibration of the defective MMD.
Customer or internal engineering changes may result in a change in product
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measurement, requirements and/or the MMD to be used. These changes would normally be
reflected in your control plan. Ensure that your calibration process shows clear linkage to
your process for change control (clause 7.1.4) and control plan (clause 7.5.1.1).
The quality of measurement data is subject to variability related to the measuring
device, the measuring process, the operator using the measuring device, the product being
measured, the environment the measurements are made in, etc. The study and control of
the statistical characteristics (bias, repeatability, reproducibility, stability and linearity) that
measure these variables is called Measurement System Analysis (MSA).
The TS 16949 standard requires that the MMD or category (verniers, calipers, etc.) of
MMD referenced in product Control Plans be subject to statistical analysis. The analysis
methods and acceptance criteria for the statistical characteristics referred to above must
conform to automotive OEM - MSA reference manuals. Other methods and acceptance
criteria may be used if approved by the customer. Also review specific MSA requirements at
OEM customer or IATF websites.
In many organizations, the internal laboratory may conduct more technical and
comprehensive inspection, testing and calibration using more complex and sensitive
equipment, methods and standards. You must have document the internal laboratory scope;
You must also specify technical requirements for – adequacy of procedures; personnel
training and competency; testing methods; traceability to relevant process standards;
control of test specimens; records needed, etc.
Your internal laboratory scope must specify the tests, evaluations and calibrations it is
qualified to perform; provide a list of the equipment used to perform these activities; and a
list of the methods, standards, etc., used.
The procedures used in the laboratory could be established practices; MMD
manufacturer’s reference or user manuals; industry standards, methods and practices;
customer specified methods; and regulatory methods and practices. These procedures
typically address testing methods and standards; identification and traceability; etc. The
need to have a documented laboratory procedure or manual would depend on the scope and
complexity of product testing and inspection.
OEM customers may have specific competency and training requirements for laboratory
personnel. Refer to OEM websites; IAOB reference material or contact your OEM customer
for the latest requirements.
If you use an external laboratory, you must have evidence that it is ISO/IEC 17025 (or
national equivalent) accredited or acceptable to the customer. Ensure that the external
laboratory’s ISO/IEC 17025 accreditation is not out of date and its scope includes the
activities you have contracted it to perform. Also review specific external laboratory
requirements at OEM customer or IATF websites.
Clause 4.1f requires you to continually improve your processes. Consider using
appropriate performance indicators such as the monthly trends in - the number of out of
calibration MMD’s; or the number of MMD’s past their calibration due date; number of
MMD’s being used and not controlled; etc. Use these indicators to tighten and improve the
effectiveness of your MMD process. If you have significant laboratory activities, it might be
useful to establish similar performance indicators to measure the effectiveness of laboratory
controls.
Clause 7.6 does not require a ‘documented’ procedure. However, you must identify and
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented
procedure or other combination of specific practices, procedures, documents and methods.
Look at the risks related to your product, processes and resources in determining the extent
of documented controls you need to have (also see clause 4.2.1 notes).
Performance indicators (to measure the effectiveness of processes that control MMD’s)
may include reduction - in MMD’s found past due for calibration and being used; reduction
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in damaged, uncontrolled and uncalibrated MMD’s being used; reduction in untrained
personnel found using MMD’s; reduction in lost MMD’s; reduction in MMD’s found out of
calibration; no uncertified external laboratories being used; etc.
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8.1 Measurement, Analysis & Improvement
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process capability studies; control charts; Pareto analysis; variation analysis (special cause,
common cause).
Statistical methods for field analysis include – dependability assessment; Pareto
analysis; traceability analysis; Shainin techniques.
Statistical methods for monitoring and measuring devices – refer to various techniques
in your customer reference manuals – e.g. Measurement Systems Analysis (MSA) reference
manual.
Over-adjustment in clause 8.1.2 refers to making process adjustments that are not
statistically appropriate i.e. tampering.
Define and implement appropriate training and competency requirements for all
personnel using statistical methods, tools and analysis.
Where the any of the monitoring, measurement and analysis processes are done off-
site (e.g. in large organizations, customer satisfaction feedback may be done at head-
office), your QMS must include the off-site processes within your QMS and ensure that such
processes comply with ISO 9001 requirements. Evidence of the off-site facility’s compliance
may include - a copy of their ISO 9001 certification; results of their internal audits to ISO
9001; auditing the outsourced facility; etc. The expectation is to flow down to the off-site
facility, the relevant ISO 9001requirements
Clause 8.1 does not require a ‘documented’ procedure. However, you must identify and
document all processes addressing this clause as part of your QMS (see clause 4.1). For
these processes, you must also identify what specific documents, controls and resources are
needed (see clause 4.2.1d. and 7.1b.). You could use a product quality plan; documented
procedure or other combination of specific practices, procedures, documents and methods.
Look at the risks related to your product, processes and resources in determining the extent
of documented controls you need to have (also see clause 4.2.1 notes).
Performance indicators are not needed for this clause as it provides direction for the
application of monitoring and measurement methods and tools indicators for all QMS
processes. However the output of monitoring and measurement methods used within each
QMS process provides useful performance indicators for determining the degree of
conformity of product and QMS to requirements and whether the QMS has been effectively
implemented and maintained.
Revert back to compliance with the original or superceding specification, when the
customer authorization expires
Properly identify each container of material shipped on an authorization. This also
applies to purchased product
Approve any requests from your suppliers before submission to your customers
8.5 Improvement
8.5.1 Continual Improvement
You shall continually improve the effectiveness of your QMS through the use of:
- Quality policy and quality objectives
- Audit results
- Analysis of data
- Corrective and preventive actions
- Management review
8.5.1.1 Continual Improvement of the Organization
l You shall define a process for continual improvement (see examples in annex B of ISO
9004:2000)
8.5.2.2 Error-proofing
You shall use error-proofing methods in your corrective action process