suggestions, explanations and guidance for the ... · pdf filesuggestions, explanations, and...

1

Suggestions, Explanations and Guidance for the Implementation of the Requirements of the ISO/TS 16949:2009* in the Chemical Industry

October 2009

* Technical specification ISO/TS 16949:2009, third edition 2009-06-15 Quality management systems - Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations This document was prepared by a work group of QM experts of the Verband der Chemischen Industrie e.V. (VCI). Copyright for this text is held by VCI. Dr. Harmut Lardon, BASF SE Dr. Ilka Beuermann, LyondellBasell Industries Norbert Dolezal, Dow Corning GmbH Thomas Kirsch, Albis Plastic GmbH Dr. Karl Moser, Evonik Degussa GmbH Herr Hermann Köhler Verband der Chemischen Industrie e. V. (VCI) Abt. Wissenschaft, Technik und Umwelt Bereich Produktsicherheit Mainzer Landstraße 55 60329 Frankfurt am Main, Deutschland Tel.: +49 069-2556-1400 Fax: +49 069-2556-2400 E-Mail: [email protected]

2

Preface

This brochure may not be used as a basis for certification.

It should provide - from the perspective of experts in the chemical industry, who have

already gained experience in working with the automotive industry requirements –

suggestions, explanations, and guidance for the implementation of the requirements

of ISO/TS 16949:2009 – even if a corresponding certification is not intended.

If a customer does not require a certification based on ISO/TS 16949, e. g. when

supplying raw materials, and if the customer accepts instead a certification according

to ISO 9001:2008 as well as a verification on meeting requirements from ISO/TS

16949, it is recommended to get a clear agreement on the extent of meeting the

automotive requirements.

The ISO/TS 16949 was developed for a QM system for automotive production, and

relevant service part organizations (see ISO/TS 16949:2009, chapter 0.5).

The character and requirements of the procedures and processes in the chemical

industry, however, are in some essential aspects different from those of most of the

automotive suppliers, who provide finished components "just in time" for assembly.

Understandably, the examples, mentioned in this brochure, can not cover the

complexity and diversity of the chemical industry, and therefore do not claim to be

complete.

3

Table of contents

Suggestions, explanations and guidance for the ISO/TS 16949:2009

1 Scope

Page

5

2 Normative references 5

3 Terms and definitions 5

4 Quality management system 7

5 Management responsibility 9

6 Resource management 11

7 Product realization 14

8 Measurement, analysis, and improvement 27

A Explanations for the ISO/TS 16949:2009 annex A 37

B Supplementary literature for the ISO/TS 16949:2009 40

4

1 Scope

1.1 General

The extent and contents of the QM system monitoring (corporate

headquarters, design and development labs, sales units) are to be

agreed upon, in detail, with the respective certification company or

the respective customer. While doing so, the current IATF

certification rules must be taken into account. For example: It is

possible to reduce the effort of external auditing, by using a

corporate audit scheme, or by extending an already existing ISO

9001 certification. Furthermore, not all processes must be audited

during each external audit.

1.2 Application

Customer specific requirements of the respective customers on the

QM system of their suppliers are to be considered in many cases, in

addition to the application of the ISO/TS 16949:2009. Such

customer specific requirements are included in the certification

audits, too.

2 Normative references

No need for further explanation in regard to ISO/TS 16949:2009.

3 Terms and definitions

In the German version of the ISO/TS 16949:2009, published by

VDA-QMC, the terms were re-sorted in alphabetical order, in

contrast to the DIN version, published by the Beuth publishing

company, which maintained the order of the original English version.

It is therefore important to be extra careful when citing term

numbers.

3.1 Terms and definitions for the automotive industry

Some ISO/TS 16949:2009 definitions were explained in the provided

VCI interpretations, additional terms were added as of chapter

section 3.1.13.

3.1.1 Laboratory scope


3.1.2 Special characteristic

No need for further explanations in regard to the ISO/TS

16949:2009; a more detailed definition can be found in PPAP, 4th

edition, March 2006, annex F7.1

5

3.1.3 Remote location

Remote locations in the chemical industry could be, for example:

corporate headquarters, design and development laboratories, sales

units, logistics units and marketing units, which could be performed

by external enterprises as “outsourced processes” as well.

3.1.4 Error proofing

Tools to prevent errors are risk assessments (e.g. FMEA, risk

analyses, statistical planning of experiments – DOE), corrective and

preventive measures.

3.1.5 Laboratory


3.1.6 Design responsible organization


3.1.7 Manufacturing

According to the current interpretation, production materials are

processed materials or semi-finished products, which will become

parts of the automobile with the end customer.

3.1.8 Control plan

No need for further explanation in regard to ISO/TS 16949:2009,

see annex A1.

3.1.9 Site


3.1.10 Predictive maintenance

Condition-based maintenance, including planned revision shut off

and maintenance activities based on machine-aided diagnosis (e.g.

vibration measurement, temperature monitoring, cooling water

analysis).

3.1.11 Preventive maintenance

Time controlled maintenance; it’s based on statistical experience

concerning the life expectancy of equipment parts, or based on

manufacturers’ recommendations.

3.1.12 Premium freight


6

3.1.13 Effectiveness

The extent in which planned activities are realized and planned results

are achieved.

3.1.14 Efficiency

The relationship between the result achieved and the resources used.

3.1.15 Verification

Confirmation, through the provision of objective evidence, that

specified requirements have been fulfilled (according to ISO 9000).

3.1.16 Validation

Confirmation, through the provision of objective evidence, that the

requirements for a specific intended use or a specific intended

application have been fulfilled (according to ISO 9000).

3.1.17 Nonconformity elimination

Correction of an acknowledged nonconformity without affecting the

error cause of the nonconformity.

3.1.18 Corrective action

Elimination of the cause of an acknowledged nonconformity with the

goal to prevent the nonconformity from recurring.

3.1.19 Preventive action

Elimination of possible causes of potential nonconformities.

3.1.20 Continual improvement

Recurring activities in order to increase the ability to fulfill

requirements.

4 Quality management system

4.1 General requirements

The control of outsourced processes should include that process

audits are conducted (comp. ISO 9001:2008, last section in chapter

4.1, in combination with chapter 8.2.2).

4.1.1 General requirements – supplemental

If an organization has outsourced a process, which affects the ability

to deliver products, which meet requirements of customers, laws or

regulations, this process cannot just be ignored or be excluded from

the QM system of the organization. On the contrary, the organization

has to prove that this process is being sufficiently monitored, to

7

ensure that the requirements of ISO 9001:2008 or any other

requirements of the implemented QM system are fulfilled.

This monitoring should, if possible, be performed by means of a

contractual agreement with the provider of the outsourced process,

e.g. by documenting:

a) QM system requirements, including process monitoring,

measurement methods, performance indicators, reports on results

b) specifications and performance check, compliance check of

regulatory and statutory requirements

c) On-site inspections, verifications, audits.

Examples of outsourced processes, of which the requirements

have influence on the product conformity:

Logistics: filling, packaging, disposition, shipment, transport

Service: Maintenance, repairs, IT-support

Production or production steps: re-works, refining stages like the

coloring of plastics, acquisitions

Product inspection in external test laboratories: analyses,

analysis certificates

4.2 Documentation requirements

4.2.1 General

The quality policy of an organization may be included in a statement

of the whole company policy. The policy may be broken down into

different levels of the organization.

The quality objectives should be broken down into different levels of

the organization.

4.2.2 Quality manual

The quality manual may be included in a general or comprehensive

management manual, in which other system requirements are

described, too, e.g. safety management, environmental management,

risk management, etc.

In addition to the six documented procedures, required by ISO

9001:2008, (procedures for the control of documents, control of

records, internal audit management, control of nonconforming

products, corrective actions, preventive actions), at least one further

procedure must be documented for the ISO/TS 16949:2009 (training).

It is important to display the interaction between the processes in an

appropriate way.

8

4.2.3 Control of documents

No need for further explanation in regard to ISO 9001:2008.

4.2.3.1 Engineering specifications

The prescribed interval of 2 working weeks for checking the

specifications, can not always be kept in the chemical industry,

particularly because the interdisciplinary communication channels

may be very different in regard to the sources and the relevant

organization units, e.g. in regard to:

Disclaimers in orders

Internet sources, partly with restrictive access

QM agreements with specifications, liability clauses, etc.

In critical cases, an alternative time schedule must be agreed upon

with the customer.

4.2.4 Control of records

No need for further explanation in regard to ISO 9001:2008 and

ISO/TS 16949:2009.

4.2.4.1 Records retention

Customers’ requirements relating to records, which go beyond statutory

requirements, must be agreed upon in an appropriate way.

5 Management responsibility

5.1 Management commitment

The "top management" is explained in the IATF guidelines for ISO/TS

16949, chapter 5.1.1 and must be clearly defined in each case, to

guarantee that the actual top management will be involved adequately.

5.1.1 Process efficiency

Explanations can be found in the IATF guidelines for the ISO/TS 16949,

chapter 5.1.1

5.2 Customer focus

It is a good practice that top management defines indicators, which

make it possible to measure the customer satisfaction.

5.3 Quality policy


9

5.4 Planning

5.4.1 Quality objectives


5.4.1.1 Quality objectives – upplemental

A business plan is a document of top management, which contains short-

term, mid-term, and long-term strategies, plans, and overriding objectives;

the business plan may be one document or several individual documents.

5.4.2 Quality management system planning

No need for further explanation in regard to ISO 9001:2008

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority


5.5.1.1 Responsibility for quality

Related to the specific shifts all production processes have personnel in

charge (e.g. shift supervisor), who, in case of quality problems, will trigger

the pre-defined shift overlapping information chain.

Due to the process design or for safety reasons, in the chemical industry,

it is usually not possible to stop a production immediately. For example: it

takes several days to shut down high pressure or polymerization

processes. Some discontinuous processes can not be stopped until the

chemical conversion has been completed.

Products that do not meet the specifications, as they were produced

during a malfunction, are locked out. Then they are either reworked,

brought back to production or treated as waste.

5.5.2 Management representative


5.5.2.1 Customer representative

Usually, the customer representative is located in Sales, Technical

Support, Marketing, Design and development, or Product Management.

For more information see IATF guidelines for ISO/TS 16949, chapter

5.5.2.1.

5.5.3 Internal communication

The communication regarding the effectiveness of the quality

10

management, can, for example, be accomplished by adequate

visualization of trends of meaningful indicators with reference to the own

working environment.

5.6 Management review

5.6.1 General

Management reviews are usually performed once a year, if possible

coupled with the business planning. The management review may also be

performed more frequently, if required.

5.6.1.1 Quality management system performance

Advanced explanations can be found in the IATF guidelines for the

ISO/TS 16949, chapter 5.6.1.1.

5.6.2 Review input


5.6.2.1 Review input - supplemental

In addition to the inputs listed in ISO 9001:2008, chapter 5.6.2 under a) -

g), other inputs, as mentioned elsewhere in ISO/TS 16949:2009, are

useful for the review:

Continuous adequacy of the quality policy (5.3)

Performance in comparison to quality objectives (5.4.1)

Quality related losses (costs of poor quality) (5.6.1.1)

Actual and potential failures (FMEA) during the stage of use (5.6.2.1)

Additional freight costs (8.2.1.1)

Design and development indicators (7.3.4.1)

Maintenance objectives (7.5.1.4)

5.6.3 Review output


6 Resource management

Chapter 6 is a logical supplemental of chapter 5; here top management is

asked to decide on the resources needed. There are two main

requirements for an effective management system:

Active participation of top management

Provision of adequate resources

6.1 Provision of resources


11

6.2 Human resources

6.2.1 General

The required personnel criteria "education, training, skills and

experience", as listed in the ISO 9001, do not only refer to activities,

which have a direct influence on the quality of products or services, but

also refer to all activities of personnel that have an influence on the

functionality of the quality management system.

An adequate provision of human resources, works best when based on:

Job and function descriptions

Quality plans

Qualification matrices

Shift and superiors' plannings

Evaluations of the general and individual workloads

6.2.2 Competence, training and awareness


6.2.2.1 Product design skills

In the chemical industry, product design is performed by qualified

personnel like chemists, engineers, lab technicians. Ensuring the

qualification of personnel with product design responsibility, can be

supported by means of, e.g.:

Qualification matrices

Job and function descriptions

6.2.2.2 Training

6.2.2. a, b, c) The procedure of the qualification matrix is widespread in

the industry. In the qualification matrix, the required competences are,

according to the job description, subdivided into several levels,

e.g.:

1. Level: Competent to complete an assignment under supervision

2. Level: Competent to complete an assignment independently

3. Level: Competent to train others

6.2.2 c) Suitable methods for evaluating the effectiveness of the adopted

measures are in parts included in the Kirkpatrick Model, e.g.:

Self-assessment of the training measures by the participants

Measuring the increase of knowledge by taking a test before and after

the training

12

Changes in behavior – usually 6-12 months after training

Management review of the added value based on the training

measures of the past 12-18 months.

Internal and external audits

Appraisal interviews

Interactive kinds of training

6.2.2.3 Training on the job

In the chemical industry, on-the-job training for all personnel (permanent

and contracted) is usually the state of the art. Training records are to be

kept.

6.2.2.4 Employee motivation and empowerment

The motivation of employees can be promoted and, to some extent, be

measured by instruments like e.g. information, appraisal interviews,

regular staff meetings, employee surveys, social benefits, target settings'

and bonus system, premiums, empowerment, recognition, employee

suggestion system of the company.

6.3 Infrastructure


6.3.1 Plant, facility and equipment planning

In the chemical industry, the plant, facility and equipment planning is

usually exactly defined by means of authority approvals. The IATF

guidelines for ISO/TS 16949 contain methods for the evaluation of the

productivity and effectiveness of existing operations.

6.3.2 Contingency plans

In the chemical industry, it is customary to create plans for unexpected

events. This includes for example an early-warning system for chemicals

that are to be classified differently in the future (e.g. carcinogenic,

reprotoxic, etc.), possible supply shortfalls in the availability of raw

materials, as well as strike, power blackout, logistical problems, IT-

availability, fire, facility breakdowns, missing spare parts, pandemics. In

the chemical industry, it is customary to appoint a crisis management

team, which is responsible for leading to decisions in cases of

emergency.

6.4 Work environment

An adequate work environment is usually part of the facility design.

6.4.1 Personnel safety to achieve conformity to product requirements

This issue is especially affected by legal specifications regarding permits

13

and employer's liability insurance associations. Explanations can be found

in the IATF guidelines for the ISO/TS 16949.

6.4.2 Cleanliness of the premises

Examples can be found in the IATF guidelines for the ISO/TS 16949. A

systematic procedure is the Japanese 5S method.

7 Product realization

7.1 Planning of product realization

In the chemical industry, the product realization usually consists of

several phases, like e.g.:

defining the product requirements as well as verification and validation

criteria

product design

production process design

product introduction, including product validation, initial production,

etc.

Some companies already have a standardized procedure, which has

been adapted to the technology of the chemical industry, including project

check lists and project milestones. Companies that, for example, plan and

manufacture chemical engineering equipment, usually have a customized

project plan.

Further details can be found in section 7.3.1 Design and development

planning. Detailed realization suggestions can be found, for example, in

the reference manual Advanced Product Quality Planning and Control

Plan (APQP) or the VDA volume "Entwicklungsabläufe" (design and

development courses).

Quality management plan

The sum of all documents that ensure that the requirements for the

product to be designed and its production process, defined by the

customers as well as by the own organization, may be called "quality

management plan". For example, it could contain a project plan (including

critical path), check lists and breakpoints, as well as summaries and

minutes of management reviews and business plans regarding the

product to be realized (resource management).

Concrete requirements regarding the design of the quality management

plan are not existing in the ISO/TS 16949.

Note 2 is not required in the ISO/TS 16949, because concrete

specifications are listed in chapter 7.3.

14

7.1.1 Planning of product realization – supplemental

Technical customer specifications not only refer to product properties, but

also, for example, specifications regarding the release procedure, test

criteria, test procedures, material exclusion lists, packing specifications,

special labels ("VDA tag ", barcode, customer part number),

communication systems that are to be used, (EDI, CAD, etc.), as well as

entries into the IMDS (International Material Data System).

These documents must be controlled, just as any other document with

instructions.

7.1.2 Acceptance criteria

Acceptance criteria are understood to be detailed specifications, which

are used to monitor the product properties, e.g.: Reference samples

(master samples), transition samples, sampling plans, test frequency,

based on the – perhaps preliminary - process capability.

Attributive data sampling means that a random sample from an entity is

inspected on the existence of one characteristic, e.g. the decision if the

sample characteristic corresponds with the characteristic of the master

sample (e.g. is the sample a white free-flowing powder, without any

impurities). The result of such an inspection can be: present / not present,

or good / bad.

Acceptance criterion "zero defects", means that all inspected samples

must have the attribute "good". In case of batch operation, usually a

100% inspection is performed, inspecting a representative sample from

each batch. In case of continuous production, the location of the sampling

and the inspection frequency must be determined (also see section

8.2.3.1 Monitoring and measurement of production processes).

7.1.3 Confidentiality

How to deal with confidential information should be defined in a contract

in an individual case. Confidential electronic data should be encrypted

when exchanged between contractual partners. The organization should

have a procedure for securing confidential information.

7.1.4 Change control

The changes that are to be controlled in the context of this chapter are

only changes that affect the quality of the product. Other process changes

or document changes are to be taken into account in chapter 4.1 and 4.2.

Changes that affect the quality of the product probably exist when in this

context the content of the control plan has to be changed. Further

explanations can be found in the IATF guidelines for the ISO/TS 16949.

Criteria for the obligation to notify changes can be included in customer-

15

agreed approaches or - as often applied in the chemical industry – in the

specification agreements. Examples can also be found in the PPAP

(Production Part Approval Process) reference manual, especially in

section 3, "Customer notification and submission requirements”.

Within the organization, protected development results (e.g. product

formulations) are classified as confidential. Since the customer purchases

quasi a black box, the changes should be validated jointly with the

customer.

Each change must be documented – in line with chapter 4.2. – with the

implementation date and, if possible, with the batch number. The change

history must include all changes up to product termination, and perhaps

beyond that. The archiving requirements of the customer and the

legislator are decisive. In addition, the VDA volume 1 "Nachweisführung"

(verification management) should be regarded.

NOTE 1: The word “agreement” in note 1 of the English original version

has been translated into German by “Genehmigung” which may possibly

not be completely appropriate. As to the general usage “agreement” could

also be translated by “Einvernehmen mit dem Kunden”. This means it’s

expected that the customer participates in the evaluation of changes, and

that an agreement is reached.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

It is also necessary to define requirements which were not explicitly stated

by the customer, but which are needed – as far as known – for the

intended use. Users of chemical products often do not exactly know the

interactions that make the product “function”. Contrary to the production of

parts, the customer often transforms chemical products in an additional

process step, e.g. from a liquid starting material to a hard film (paint or

adhesive) or, by letting temperature and pressure work on the material,

form a molding with particular properties (see PPAP, 4. edition, chapter

F14).

Therefore it is absolutely useful when the organization – based on their

product knowledge – determines certain handling requirements, of which

the customer has not thought of or could not know of, and adds these to

the specification or the technical data sheet. However, this must not be

mixed up with a recommendation for a certain application.

"Any additional requirements considered necessary by the organization"

16

may be understood to refer to, for example, possible incorrect use, as well

as correct and safe product disposal (see note 2).

NOTE 3: Please note that also the statutory and regulatory requirements

of the country, in which the product is manufactured and marketed, must

be met.

7.2.1.1 Customer-designated special characteristics

If special characteristics were designated with the customers, these

characteristics must be marked in those documents that are used to

control these characteristics. Such documents could, for example, be:

Quality management plan

Product specification

FMEA

Control Plan

Formulation

Test instruction

In customer specific requirements, it can be defined which symbol has to

be used at what point (see IATF guidelines).

7.2.2 Review of requirements related to the product

This includes the review of non-documented customer requirements (e.g.

brought forward verbally or assumed to be self-evident), regarding

whether or not they can be met.

7.2.2.1 Review of requirements related to the product - supplemental

It may be that the customer renounces a formal review of these

requirements. It is possible that this renunciation is included in the

contract conditions in case of internet purchases.

7.2.2.2 Organization manufacturing feasibility

This means a check whether the product can be manufactured in the

required quantity and in the defined quality and be delivered on the

wanted date and price. In doing this possibly arising risks must be

estimated. Further advices can be found in the APQP reference manual

under "Team feasibility commitment and management support”.

For products from the organization's standard program (catalogue

products), it’s only necessary to review the manufacturing feasibility with

regard to the delivery date. Further explanations can be found in the IATF

guidelines for the ISO/TS 16949.

7.2.3 Customer communication

17

The responsibility for the communication with the customers must be

clearly defined. In special cases, it may be useful to agree on a fixed

contact person on both sides, e.g. key account manager, integration

champion, QM representative.

7.2.3.1 Customer communication - supplemental

The CAD data compatibility requirement is usually not relevant for

chemical industry manufacturers. It is more important to set up a network

with the planning departments of some customers, e.g. by means of EDI

as well as entering data into the IMDS (International Material Data

System).

Customers are also beginning to put their technical specifications and

customer specific standards on the internet.

Many customers assume that their requirements (e.g. on their homepage

or on the order confirmations) have been accepted, as long as the

supplier does not contradict in writing, e.g. by means of a business letter

referring to own equivalent standards.

7.3 Design and development


7.3.1 Design and development planning

The design and development planning should be appropriate to the

complexity of the organization and of the product. APQP or VDA 4.3

describe examples of an adequate review, verification and validation of

detailed phase models.

The development phases may absolutely overlap, e.g. first considerations

regarding the production process design may already be started, even

though the formulation of the product has not yet been completed (so-

called simultaneous engineering).

7.3.1.1 Multidisciplinary approach

Multidisciplinary approach generally means that collective knowledge,

needed to fulfill a complex task, is pooled. It has been proven successful

to have multi-functional teams, with a leader who is responsible for the

product realization, from project start until the successful commercial

launch. In individual cases, it may be useful to involve specialists, like

toxicologists and legal staff, as well as customers, or strategically

important suppliers with their knowledge into the team.

7.3.2 Design and development inputs

Here, the conversion of the requirements into objectively verifiable

specifications for the developer is meant, thus that the customer

18

requirements are converted into the language of the organization. For this

purpose, the so-called Design Matrix (see PPAP – appendix F.4) or the

QFD method may be used. While doing so, requirements are

distinguished, regarding:

Shape, color, appearance

Processibility,

Function of the completed product in the product of the customer

Statutory and regulatory requirements and environmental aspects.

In the chemical industry, a detailed and specific determination of the

design and development inputs is not always possible in the early stage

of the product realization, because important product properties often only

will appear when the product will be used in the (planned) customer

product (validation).

7.3.2.1 Product design input

The requirements, regarding the product design inputs, must be

documented. For this, a list of duties, specification, graph, requirements’

profile, etc. may be used. It is recommended to record the results of the

review, too.

7.3.2.2 Manufacturing process design input

The requirements regarding the manufacturing process design input must

be documented. The four listed bullet points are mandatory inputs (for

process capability, also see 8.1, 8.2, ff.). A review must be performed.

7.3.2.3 Special characteristics

The organization is obliged to systematically check, if and to which extent

their products have special characteristics. Further explanations can be

found in the IATF guidelines for the ISO/TS 16949.

Special characteristics, which were determined by the organization itself,

could, for example, affect the processing properties, performance

characteristics or recyclability.

7.3.3 Design and development outputs

Information regarding the purchase, production and providing service,

could, for example, include the following elements:

Product specification

Physical properties

Packaging and durability

Approved raw materials sources

Sampling plans, test equipment and test methods

19

Personnel safety and environmental factors, disposal

Specifics regarding facilities, procedures, and process control

Error prevention measures and reaction plan in case of malfunctions.

It is also important to consider that the design and development outputs

are to be released. Usually, this release is performed by the responsible

design and development leader.

7.3.3.1 Product design outputs - supplemental

In accordance with the ISO/TS 16949 requirements, the terms listed in

this section are - as far as applicable - to be regarded as mandatory. If

individual listings do not apply, like for example reliability tests,

diagnostics guidelines, etc., it must be possible to account for this.

The design and development outputs should be the result of a process,

which includes measures regarding simplification, optimization, innovation

and waste reduction. Further explanations can be found in the IATF

guidelines for the ISO/TS 16949.

7.3.3.2 Manufacturing process design output

The manufacturing process design also includes the development of the

required measurement and test methods, and concludes with the

determination of the preliminary process capability. For chemical

processes, a statement on the preliminary process capability is often only

possible in a restricted extent; it is therefore allowed, with due caution, to

rely on experiences with similar processes.

The outputs listed in this section are also – if applicable - to be regarded

as mandatory. If individual listings do not apply, this must be accounted

for.

The manufacturing process design should be the result of a process,

which includes measures regarding optimization, waste reduction, lean

production and innovation. There are several helpful tools for this, like e.g.

ANDON (electronic control system of the production line), KANBAN,

SMED (Single Minute Exchange Die), Lean Manufacturing and 5S-

method. Further explanations can be found in the IATF guidelines for the

ISO/TS 16949.

7.3.4 Design and development review

Design and development reviews should be performed according to the

phase model of the design and development process. Minutes with

actions and timing are sufficient as verification.

7.3.4.1 Monitoring

Like any other process, the design and development process must also

be reviewed by means of measurement parameters / indicators in regard

20

to its effectiveness and efficiency (see section 5.6.2 "review input"). Part

of these indicators are, amongst others, risk assessment data, e.g. of the

FMEAs (also see 7.3.3.1 and 7.3.3.2), and other possible success factors.

7.3.5 Design and development verification

The goal of design and development verification is to ensure that the

design and development outputs comply with the inputs according to

section 7.3.2. This usually concerns the physical and chemical properties

of the product (e.g. density, purity, melting point, color, etc.)

Usually, lab analyses, tests, development output comparisons with similar

product formulations or record reviews are used for verifications.

The results of the verifications must ensure the conformity of the product

with the specification and must be based on controlled processes.

7.3.6 Design and development validation

Validation is one step further than verification. It can be performed as

processing tests (pilot production), simulation of specific conditions in the

lab or test field, as well as often by the customer, e.g. as field tests. This

experimental phase should be, if possible, completed before regular

ordering starts.

NOTE 2: Since the production process also with new products usually

does not change in the chemical industry, experiences from the

production of other, similar products are used. If products are

manufactured according to a new or a significantly changed process, this

process is validated regarding its ability to meet the product requirements

of the customer.

7.3.6.1 Design and development validation – supplemental

It may be necessary to adjust the own development plan to the schedule

of the customer by mutual agreement.

7.3.6.2 Prototype program

In the chemical industry, instead of prototype programs, it is custom to

perform sample production. The required facilities and tools can be

provided by the customer (e.g. robots, injection molding machine or mold,

etc.).

7.3.6.3 Product approval process

By means of the production process approval and product approval

procedure, verification shall be provided, which shows that products can

be manufactured in the required quality and quantity.

Production process approval and product approval – also first sample

approval – of chemical engineering products are understood to be in the

21

automotive industry: testing a batch, which is manufactured under

production conditions, in connection with individual verification

documents, which shall prove that the agreed specification or required

product properties are met.

The production process approval and product approval should follow the

verification of the production process (see 7.3.5 design and development

verification).

The production process approval and product approval are usually based

on the PPF – procedure (VDA, volume 2, 4th edition, 2004) or the PPAP

procedure (4th edition, 2006, mainly required in the USA). The PPF

procedure includes a process audit by the customer, according to a

regular standard or a checklist from the customer. The advantage of this

is that it is meaningful and field-proven, however, does not regard specific

features of the process engineering in the chemical industry.

The PPAP procedure takes into account the concerns of the chemical

industry. The amount of verification documents has been reduced,

because only relevant fields have to be filled out on the "bulk materials

checklist" appendix F (many fields with "NR= Not Required").

To avoid misinterpretations, some organizations in the chemical industry,

point out that the presented first sample is a product, which is subject to

fluctuations caused by raw materials and manufacturing conditions, and

which may not be considered as purchase according to sample (used to

be legally handled according to §494 BGB).

If products are already approved or listed by the OEM, a production

process approval and product approval by the customer is no longer

required. In case of catalogue products a customer's requirement for a

production process approval and product approval should be questioned

critically.

A procedure for production process approval and product approval, which

is already established within the own organization, may also be used in

regard to suppliers, if the customer does not object.

7.3.7 Control of design and development changes

Changes could be:

Change of raw materials

Product formulation

Test procedure

Specifications

Design / development changes may be required due to, for example:

Revalidation of the toxicity of a part of the formulation

Change in the statutory terms and regulations

22

Change in the applicable standards.

In general you can orientate yourself on the statement, that a change

must be reported if essential design and development documents have to

be changed.

7.4 Purchasing

7.4.1 Purchasing process

Suppliers may be selected and evaluated based on criteria like:

Certificate according to ISO 9001/ISO 14001

Satisfactory delivery performance

Creditworthiness

Price

Positive sampling result

Customer approval, if required

Availability, flexibility, delivery capability.

The delivery availability is often secured by framework agreements.

7.4.1.1 Statutory and regulatory conformity

It should be kept in mind that, when fulfilling the respective statutory and

regulatory requirements, the requirements of the country of destination

have to be met as well. In case of doubt, legal advice should be sought.

7.4.1.2 Supplier quality management system development

According to the requirement of the ISO/TS 16949 all suppliers must be

certified on the basis of ISO 9001: 2008. Unless something else was

arranged with the customer.

Otherwise, in case of a missing ISO 9001: 2008 certification of a supplier,

other measures must be taken, like e.g. supplier audits, quality assurance

agreements, or looking for alternative suppliers.

Further guidelines can be found in the IATF Sanctioned Interpretations:

SI 5 06 ISO/TS 16949:2002 7.4.1.2

http://www.iatfglobaloversight.org/docs/English%20NEW%20%20IATF

%20TS%20SIs%20Non%20Table%20Version.pdf

7.4.1.3 Customer-approved sources

This rarely applies to the chemical industry.

7.4.2 Purchasing information

In the statement of a) “requirements for approval of product, …” the

23

English word “approval” is understood as “release”.

7.4.3 Verification of purchased product


7.4.3.1 Incoming product conformity to requirements


7.4.3.2 Supplier monitoring

If the customer experiences disruptions, which are caused by

nonconforming products from suppliers, which then lead to special

customer requirements (e.g. special notifications), the disruptions’ data

have to be collected and will be integrated into the supplier evaluation. On

time delivery performance and premium freight cases are further criteria

for the supplier evaluation. The costs are not the prime issue here, but

rather the kind and causes related to the incidents with premium freights.

A promotion of "supplier monitoring of the performance of their

manufacturing processes" could be performed by the organization, for

example, by providing feedback to the supplier, concerning their supplier

monitoring results. If necessary, the organization could point out

improvement potentials and motivate the supplier to take improvement

measures.

7.5 Production and service provision

7.5.1 Control of production and service provision


7.5.1.1 Control plan

For a definition see 3.1.8 in the ISO/TS 16949:2009. A respective form

can be found in the APQP reference manual, 2nd edition.

7.5.1.2 Work instructions

The level of detail of work instructions should fit the education level of the

employees. It is not necessary to describe standard activities, which a

skilled worker has learned during his education (e.g. titrations by a lab

worker, welding by a metal worker). Apart from that, we refer to the

detailed remarks in the IATF guidelines.

7.5.1.3 Verification of job set-ups

Job set-ups apply in the chemical industry (if applicable at all) to major

maintenance, product change, reconstruction, initial release of new

facilities, new equipment. Order changes have no meaning in chemical

24

processes, as far as job set-ups are concerned.

In case of maintenance, reconstruction or new equipment, the facility is

released after having been inspected; after a product change, the

cleanliness is attested e.g. in the cleaning protocol. The cleaning method

may depend on the type of product change.

Statistical methods usually cannot be used for job set-ups in the chemical

industry.

7.5.1.4 Preventive and predictive maintenance

see definitions in 3.1.10 and 3.1.11.

7.5.1.5 Management of production tooling

Usually does not apply to the chemical industry.

7.5.1.6 Production scheduling

In the chemical industry, production scheduling is based on orders as well

as on storage management. Due to the processes, a campaign-type of

operation can be often found in the chemical industry.

7.5.1.7 Feedback of information from service

In the chemical industry, members of the commercial or application

engineering external service gather information or customers’ problems,

e.g. in visit reports, which are then forwarded to the responsible authority.

Usually, an IT based process is used for this. This supports the fulfillment

of the statutory product monitoring obligation.

7.5.1.8 Service agreement with customer

Usually not applicable in the chemical industry.

7.5.2 Validation of processes for production and service provision

In the chemical industry, the validation of a production process is often

obtained by the verification and/or validation of the product. Compare also

7.3.6.3

7.5.2.1 Validation of processes for production and service provision –

supplemental


7.5.3 Identification and traceability

In the chemical industry, a physical traceability is often only possible up to

the hand over point (pipework system, tank or silo). Special problems

arise in case of several reactors connected in series, as well as large

tanks, where the assignment of the raw material (batch or date) can only

25

be assured roughly, due to mixing effects during passage. Often, the link

to the respective data can only be made by means of the position

number, date and time.

7.5.3.1 Identification and traceability – supplemental


7.5.4 Customer property

No need for further explanation in regard to ISO 9001:2008 and ISO/TS

16949:2009.

7.5.4.1 Customer-owned production tooling

Usually does not apply to the chemical industry.

7.5.5 Preservation of product


7.5.5.1 Storage and inventory


7.6 Control of monitoring and measuring equipment

To prove that the monitoring and measurement requirements have been

met, it makes sense to consult the results of the statistical inspections

according to 7.6.1.

Provided that there is no traceable standard for test methods, the

following adapted procedure can be used in the chemical industry:

Calibration measurements according to the calibration schedule using

a product that serves as standard of the operation.

Creating a control chart for evaluation of the operation’s course.

Determination of the mean value and the standard deviation and

comparison with the respective specification tolerance (determination

of the Cg value).

7.6.1 Measurement system analysis

The methods that must be used for the measurement system analysis

can, for example, be found in the MSA reference manual, 3rd edition, or

in the guidelines for "Capability verification of measurement systems" (Q-

DAS). They have to be adjusted to the requirements of the test

procedures in the chemical industry.

Provided that tests are performed according to the defined test

procedures as listed in standards (e.g. ASTM, AMS, ISO), the accuracy,

linearity, stability and R&R variation of the measurement system do not

26

have to be verified again by the organization (comp. PPAP 4th edition,

appendix F, number 9).

R&R studies (Gauge Repeatability and Reproducibility Calculations of the

measurement equipment / measurement system) may be helpful for

further tests when determining the influence of tester, test method, test

equipment and test location. Similar test equipment can be grouped.

7.6.2 Calibration/verification records

It makes sense to document all calibration parameters which were

determined, also those within the tolerance limits.

7.6.3 Laboratory requirements

7.6.3.1 Internal laboratories


7.6.3.2 External laboratories

The verification of the qualification of external commercial laboratories is

performed in a meaningful way by means of an accreditation according to

DIN EN ISO/IEC 17025. The verification of the qualification by means of a

customer audit or by a customer approved audit, which is possible

according to ISO/TS 16949, must be agreed upon individually with each

customer. This approach is often not accepted by the customer and is,

with the huge number of customers, hardly to accomplish. Customers are

usually not interested in qualifying the commercial laboratories by audits

or in approving these audits.

8 Measurement, analysis and improvement

8.1 General

The planning and implementation for demonstrating the product

conformity, requires that the inspections are defined based on

documented specifications according to inspection plans. The product

conformity is demonstrated, for example, by means of analysis certificates

or inspection documents, e.g. according to DIN EN 10204 (test report,

inspection certificate).

8.1.1 Identification of statistical tools

In the chemical industry, statistical tools are used for quality control and

for continual improvement. The SPC manual and the MSA manual of the

American OEMs, or the VDA volumes 4 or 5 can be used as reference

manuals.

27

The need for the use of statistical methods must be fundamentally

determined. This includes all processes, defined in the quality planning. If

required, statistical methods have to be used to plan and evaluate

experiments, in design and development, for quality inspections on

supplies, for process control and optimization, and for the final inspection.

In most cases the mean value and the standard deviation of the

measurement parameters are determined.

8.1.2 Knowledge of basic statistical concepts

The applicable statistical basic concepts must - if applicable in the

respective functions - be known, defined and documented. In marketing

these are, for example, tabular comparisons of sales, proceeds, costs and

deviation analyses of costs.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

No need for further explanation in regard to ISO 9001:2008 and ISO/TS

16949:2009.

8.2.1.1 Customer satisfaction – supplemental

Several methods must be applied:

a) The review of the "delivered part quality performance", required in the

ISO/TS 16949:2009, usually contains a statistical collection and

evaluation of the quality of the products delivered. The percentage ratio of

1A quality deliveries or, if applicable, ratios of minor qualities, can be

appropriate indicators for this.

The "ppm nonconformities" indication, which is often used and required in

the automotive industry, is not suitable, as these indicators usually cannot

be determined for process engineering products. The number of

manufacturing batches per year is usually in the range of dozens or some

hundreds, however not thousands or even millions. With one data point

per batch, the population for calculating ppm nonconformities is too low.

Especially in case of contaminations (e.g. rust particles), which often

occur very inhomogeneously, the relation to ppm is not obvious, since it

may apply to rejected quantity, number of particles or number of

deliveries.

b) An evaluation of the "customer disruptions, including field returns"

according to ISO/TS 16949:2009 may also be relevant for the chemical

industry. Customer problems regarding chemical industry products,

usually lead to customer complaints, or claims, which should be seen as

an opportunity and an important feedback from the market and which

28

should be controlled actively. Based on the documented claims, it should

be analyzed according to the claim reason, cause, products and

customers. It should be aimed for the use of an electronic system, which

would also make it easier to analyze complaints’ main areas and to verify

successful corrective actions.

c) The review of the "delivery schedule performance", required according

to ISO/TS 16949:2009, should contain analyses of the delivery reliability

statistics at short intervals, e.g. monthly. Delivery reliability means that the

agreed dates and quantities must be kept. Within the company, it should

be defined in detail, what "agreed date" means (e.g. date desired by the

customer, date confirmed by the own organization, shipment date, date of

arrival with the customer).

If a premium shipment is necessary to enable an in-time-delivery –

usually leading to additional costs – this must be registered and

evaluated. When the cause of the problem has been found, appropriate

corrective measures should follow shortly after.

d) “Customer notifications (formal rebukes by the customers) related to

quality or delivery problems" may include product claims or special status

notifications. The first may for example imply a special release of a time

or quantity limited delivery, the stop of design and development activities

or the exclusion from future business. Special status notifications could

lead to a revocation of the certificate. Further details can be found in the

certification rules of the automotive industry for ISO/TS 16949:2009, 3rd

edition, chapter 8.

e) In addition to the methods, which are directly required in the ISO/TS

16949:2009, an analysis may be carried out on those supplier reviews,

which customers periodically mail or post in the internet. This includes in

most cases the evaluation, if deadlines and product quality have been

met. The result usually leads to a classification as being an A, B, or C

supplier, or to similar ratings.

If the specifications are not met, the supplier (the organization) is required

to take corresponding improvement measures and to provide proof of the

realization of these measures. If the rating of the customer falls beneath a

defined limit, immediate actions must be taken. The realization and

effectiveness of the measures are to be followed up and reviewed.

Customer satisfaction analyses can also be based on periodical customer

surveys, e.g. by field staff members or by external institutes. The survey

results, as well as derived improvement measures should be recorded

systematically and should be made available within the company for

analyses (Customer Relationship Management).

29

A lack of customer feedback should not automatically be regarded as an

indication of customer satisfaction.

8.2.2 Internal audit


8.2.2.1 Quality management system audit

System audits, according to VDA QMC or IATF, must definitely be

conducted in a process-orientated manner. In doing this, approved

customer specific requirements must be audited as well.

8.2.2.2 Manufacturing process audit

No need for further explanations in regard to the ISO/TS 16949:2009.

Helpful instructions for performing process audits can be found in VDA

volume 6.3.

8.2.2.3 Product audit

During a product audit, it will be checked whether the product

requirements for a defined production process step are met. This may

also include checking those features that are not inspected during a

regular approval inspection, or a combination with a layout inspection and

functional testing (see also 8.2.4.1).

In most cases a product audit (dock audit) is performed on a ready-for-

shipment product.

Key aspects of an audit could be:

The labelling of the packed product

packing method

shipping documents

delivery documents

product inspection results

product approval status

data traceability

special customer requirements

further product sample inspections

8.2.2.4 Internal audit plans

In the annual audit plan the system audits, the audits of all important

processes and the product audits have to be planned. While doing so, the

system requirements, as well as possible customer specific requirements

must be taken into account. This should be updated continuously.

30

8.2.2.5 Internal auditor qualification

The qualification, according to the ISO/TS 16949:2009 requirements,

includes that all internal auditors must have passed an auditor training in

line with ISO 19011 for auditing according to ISO/TS 16949:2009. This

ensures that they have and also can prove the required knowledge

regarding the preparation, execution and post-processing of internal

ISO/TS 16949 audits.

The ISO 19011 expects both an adequate auditor training and audit

experience. Therefore all ISO/TS 16949 auditors of a company should

have records, which contain information on when and with whom the

auditor training has been attended (with or without exam?), the validation

date of the auditor certificate, when the auditor attended a refresher

training and to which extent the auditor performed internal ISO/TS16949

audits during the past years.

The auditor qualification specifications may be expanded by customer

specific requirements (e.g. from FORD).

8.2.3 Monitoring and measurement of processes

All management system relevant processes and important indicators for

monitoring of the processes are to be identified.

8.2.3.1 Monitoring and measurement of manufacturing processes

The reference manuals of the automotive industry expect machine and

process capability index inspections, in association with SPC methods

(Statistical Process Control). Identifying process capabilities is often a

long-winded process, because usually only one data point is available per

batch or per time (comp. section 8.1.1 and PPAP, 4th edition, section

F.10), and does therefore not always apply to chemical processes.

Since sampling and testing of in-process samples are also time-

consuming processes (hours until days), quality control charts for

important process features can only be used in time-delay. They are

therefore not suited for process control. According to the technology of

chemical procedures, adapted appropriate statistical methods are used.

The verification of the process performance of new manufacturing

processes is usually performed by means of production tests in various

operational states (pressure, temperature, volume flow, product variants).

The results of these tests slip into the determinations in the manufacturing

control plan.

In the chemical industry, there is a distinction between continuous and

discontinuous production:

31

Discontinuous production in the chemical industry

When a product is manufactured in a discontinuous procedure, the

process parameters (e.g. pressure, temperature) and the product

properties are subject to a continuous change. It is not meaningful to use

SPC here. Instead, information about the course of the process can in this

case be taken from a graphical presentation of the parameters with

indications of the control limits.

The examination of product characteristics is often used to evaluate the

process capability.

Continuous production in the chemical industry

Basically, when manufacturing a product in a continuous procedure, the

process parameters are controlled in such a way, that the process

parameters are continuously kept constant, within specified limits, as

close to the mean value as possible (continuous process control, CPC).

Usually, an automated diagram and a statistical analysis are available,

which replace the manual control charts that were used previously.

To control and monitor the processes, electrical measuring and controlling

instrumentation as well as controlling techniques are used. Those

electrical measuring and controlling devices whose measurement

parameters are linked to the predetermined and to be maintained target

value of a quality characteristic for a product in a chemical process, and

which are therefore listed in the control plan, are regarded as quality

relevant.

A statistical normal distribution of the process and product characteristic

parameters is not existing if the production process is controlled actively,

e.g. in closed control loops. A constant intervention prevents a random

distribution. SPC methods for process controlling can not be used here.

The calculation of cp values or cpk values is methodically wrong and does

not provide correct information. In such cases, a 100% inspection is

required (see 8.2.4). A diagram with specification limits and/or warning

limits based on experiences is useful here.

The processes are conducted and monitored according to the production

control plan. In case of deviations the available reaction plans must be

followed. (compare PPAP, 4th edition).

8.2.4 Monitoring and measurement of product

A sample of the finished product is taken and inspected either after

having reached a specified reaction step, but usually from the final

reaction product. This is then representative for the batch. This approach

32

is called a 100%-inspection (comp. PPAP, 4th edition, section 2.2.11.6,

note 2).

Products of the same quality, but from different batches of a campaign,

can be merged in one lot. If, for example, the products from the

discontinuous production are collected in closed silos or tanks, a sample

may be drawn from the silo or tank after the production period (marked by

the different batches), to measure and evaluate the characteristic

parameters of such a lot.

In case of processes which respond relatively slowly to external

influences, a test frequency is justifiable, e.g. per ton, per palette, per 20

sacks, which is lower than appropriate for processes that change quickly.

If the test frequency was agreed upon with the customer, it may be

decreased upon approval by the customer.

8.2.4.1 Layout inspection and functional testing

Inspection plans must be created when products are to be monitored

during an extended period of time. This could concern, for example,

inspections that are elaborate and are therefore not performed on each

batch or lot (e.g. specifications in the technical data sheet). Examples are

ignition testing or monitoring, which has to be performed by independent

third parties.

If and as far as agreed upon with the customer, inspections regarding the

regular requalification of the products (e.g. according to PPAP or PPF)

may thus be performed.

8.2.4.2 Appearance items


8.3 Control of nonconforming product

The following control measures are possible:

Application as intended

If it has been detected that the existing nonconforming state has no

negative influence on the quality when processed by the customer,

"application as intended" can be issued.

Downgrading or reclassifying

It is possible to downgrade or reclassify products with different quality

requirement levels if the quality level is marked. If a nonconforming

product has already been delivered, the customer must be informed

immediately.

Extraordinary release

33

If the customer agrees on a delivery of off-spec-grade product, an

extraordinary release, meaning a written consent, must be obtained from

the customer.

Post-processing or reworking

Post-processing or reworking is performed, if it is technically possible and

commercially reasonable to change the product concerning the deviant

product characteristics in a way to meet the requirements. The post-

processed product must be re-inspected and re-classified.

Disposal

Non-applicable product is labeled as waste and disposed of in an

appropriate way.

Rejection

If a raw material does not comply with the raw material specifications, the

material is sent back to the supplier.

8.3.1 Control of nonconforming product – supplemental


8.3.2 Control of reworked product


8.3.3 Customer information


8.3.4 Customer waiver

Provided that customer-approved production control plans are available,

the customer must be informed about non-compliant process courses or

about reworking of the product prior to release for delivery.

Analogously, a decision must be taken regarding the whereabouts of

products that no longer meet the specifications or are under the suspicion

of being non-conforming, are non-labeled or are taken back from the

customer after claims (retour shipments), because of external influences

during storage or shipment after the product release.

8.4 Analysis of data


8.4.1 Analysis and use of data

The data is analyzed and used within the company by means of regular

reports, trend analyses and comparisons to the competition (comp. IATF

guidelines for ISO/TS 16949:2002) The individual functions or process

34

owners (e.g. Controlling, Marketing, QM) are responsible for the collection

and analysis of the data, and they have to report, in the Management

Review, to the management team.

Often a Balanced Scorecard Report is used in this context.

In line with the data analysis, it must be reported on the observation of the

product on the market, too (e.g. product observation obligation; for

products that circulate in the USA, the TREAD Act may be relevant).

8.5 Improvement

8.5.1 Continual improvement


8.5.1.1 Continual improvement of the organization

No need for further explanation in regard to ISO/TS 16949:2009. Further

examples can be found in the IATF guidelines.

8.5.1.2 Manufacturing process improvement

The general approach is based on the principle of the Plan-Do-Check-Act

quality cycle. In regard to a continual improvement of the manufacturing

process it is especially important to reduce variation and waste. In this

context the Six-Sigma-Method is an appropriate approach.

The initiation and planning of improvement measures can be performed

by interdisciplinary teams during meetings, supported by common

problem solving methods. Examples of such teams are design and

development teams, product teams, process improvement teams, or Six

Sigma teams. The implementation of the improvement measures and

their effectiveness should be reviewed in periodic follow-up meetings.

8.5.2 Corrective action

Corrective actions usually run through the following stages: analysis,

measure, execution, and review.

8.5.2.1 Problem solving

Examples of problem solving methods can be found in the IATF

guidelines for the ISO/TS 16949, chapter 8.5.2.4.

The 8D method is often used as a structured approach for solving

problems (see file on the VDA-QMC homepage). Customers often require

explicitly that this method is used - sometimes also in a refined manner.

35

The assumed cause should be validated, to ensure that the measure is

effectively working on the right place.

8.5.2.2 Error prevention

Error prevention should be preferred to error detection.

Examples of error prevention methods would be the Ishikawa cause and

effect diagram, Poka-Yoke, the FMEA and the fault tree analysis (also

see IATF guidelines for ISO/TS 16949).

8.5.2.3 Corrective action impact


8.5.2.4 Rejected product test/analysis

To reach an objective result regarding the claimed non-conformity, a

product test/analysis may be performed on the material, which has been

sent back by the customer, or on own reference samples. By doing so, it

should be determined, if there is really a non-conformity and - if this is

correct - the cause of the mistake should be determined and solved, to

prevent recurrence.

The processing time of such a procedure may be used as measurement

parameter for customer satisfaction (see 8.2.1), but the quality of the

investigation should have the first priority.

8.5.3 Preventive action

The FMEA (Failure Mode and Effects Analysis) is a good method for the

preventive detection of potential mistakes and their causes, as well as the

evaluation of the need of actions to possibly avoid the appearance of

mistakes (also see the FMEA reference manual, 4th edition and VDA

volume 4). This method is in many cases required by customers

In addition, a self assessment could be performed, e.g. based on the

EFQM Excellence Model, a Toyota Self Assessment, or, for Ford

suppliers, by a Q1 Manufacturing Assessment.

36

A Interpretations of the ISO/TS 16949:2009 annex A

Control Plan

A.1 Phases of the control plan

The control plan must contain, if applicable, three phases for prototype, pre-

launch, and production. The column on the right explains the ISO/TS 16949

terms in regard to the conditions of the chemical industry.

ISO/TS 16949:2009 requirements Explanation, interpretation

a) Prototype

a description of the dimensional

measurements, material and

performance tests that will occur

during building of the prototype. The

organization shall have a prototype

control plan, if required by the

customer.

Laboratory tests, technical center

tests (if available)

Lab- preparation procedure

Technical center – production

procedure

Test plan for a lab product

Test plan for a technical center

product

b) Pre- launch

a description of the dimensional

measurements, material and

performance tests that occur after

prototype and before full production.

Pre-launch is defined as a production

phase in the process of product

realization, which may be required

after prototype build.

Plant tests

Production procedure for plant test,

incl. Q-relevant measurements / lab

tests

Test plan for test product

(often expanded or fully or partly

identical to the production procedure

or inspection plan of the finished

product.)

Geometrical dimensional checks are

usually not applicable in the chemical

industry.

c) Production

Documentation of product/process

characteristics, process controls, tests

and measurement systems that occur

during mass production.

Each part shall have a control plan

but, in many cases, family control

plans may cover a number of similar

parts produced using a common

process. Control plans are an output

of the quality plan.

(Routine) Production

Production procedure incl. Q-relevant

measurements and lab tests

Test plan for finished product

Quality inspection manual

37

A.2 Elements of the control plan

The organization shall develop a control plan. The requirements for this plan

are, in regard to the chemical industry, explained in the right column.

a) General data


Control plan number Number of the: production procedure,

test plan, quality assurance/inspection

manual and/or the operating manual,

etc.

Issue date and revision date, if any Issue date or revision date of the

documents with instructions listed

above

Customer information (see customer

requirements)

Requirements for the development of

a new product, specification

agreement, quality assurance contract

or list of duties.

Organization's name / site designation No need for further explanations

Part number(s) Product number

Part name / description Product name / description

Engineering change level Version number of the product

description

Phase covered (prototype, pre-launch,

production)

Lab tests or technical center tests,

production tests or (routine)

production

Key contact No need for further explanations

Part/process step number Number of the process step

Process name / operation description Name / short description of the

production process

b) Product control


Product-related special characteristics Special product characteristics

according to specification or quality

agreement with the customer

Other characteristics for control

(number, product or process)

Other Q-relevant product

characteristics or measurement

parameters / lab tests according to

production procedure

Specification / tolerance Product specification

38

c) Process control


Process parameters No need for further explanations

Process-related special

characteristics

Quality relevant production process

measurements

Machines, jigs, fixtures Production facility, equipment,

machines

Tools for manufacturing Tools, etc. are not applicable

d) Methods


Evaluation measurement technique No need for further explanations

Error-proofing Outputs of the Measurement System

Analysis (e.g. gRR values)

Sample size and frequency Size and frequency of the

measurements or tests

Control method Method for monitoring measurement

and test data (e.g. type of used

control chart)

e) Reaction plan


Reaction plan

(include or reference)

Cross-references to test-, work- or

operating instructions

Corrective action Cross-references to test-, work- or

operating instructions

39

B Supplementary literature for the ISO/TS 16949:2009

1 IATF guidelines for ISO/TS 16949:2002, 1st edition 2002

2 Certification Rules of the automotive industry for ISO/TS 16949:2002,

3rd edition, October 2008

3 AIAG Publication Catalogue,

(www.aiag.org)

4 ISO/TS 16949:2002 Implementation Guide, AIAG, 2003

5 The ISO/TS 16949 Answer Book, Radley M. Smith et al, Paton Press LLC

Chico, California 2004, ISBN 1-932828-00-1

6 Various VDA volumes

(www.vda-qmc.de)

7 PPAP-manual, 4th edition, June 2006

8 FMEA-reference manual, 4th edition, June 2008

9 MSA-reference manual, 3rd edition, March 2002

10 SPC-reference manual, 2nd edition, July 2005

11 APQP-reference manual, 2nd edition, July 2008

12 Balanced Scorecard, Burkhard Rüth, WEKA-publishing, 2004,

ISBN 3-8276-2919-5

13 The Six Sigma Way, Peter S. Pande et al, Mc Graw-Hill, 2000,

ISBN 0-07-135806-4

14 The Six Sigma Handbook, Thomas Pyzdek, Mc Graw-Hill, 2003,

ISBN 0-07-141015-5

15 Seven-Step Problem-Solving Process for Truck And Heavy Equipment,

AIAG, 2000

suggestions, explanations and guidance for the ... · pdf filesuggestions, explanations, and...

Documents