ISO/TS,ISO/TS 16949, Technical Specification (ISO/TS 16949)

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Consultancy and Training for ISO 9001, ISO/TS 16949, ISO14000, SA 8000, OHSAS, HACCP, CE Mark etc.

Consultancy for Improvement Projects, Productivity, Waste Management, Energy Saving, Workplace Cooperation, Cleaner Production, Quality Circle, VAVE etc

Open and In-House Trainings on APQP, PAP, FMEA, MSA, SPC, Problem Solving, Time Management,

short term courses for Engineers providing class room, laboratory and industrial education

ISO/TS 16949

The ISO/TS16949 is an ISO technical specification aiming to the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 and the first edition was published in March 2002 as ISO/TS 16949:2002.[1]

It was prepared by the International Automotive Task Force (IATF) and the “Technical Committee” of ISO. It harmonizes the country-specific regulations of Quality-Management-Systems.[2]

About 30 percent of the more than 100 existing automobile manufacturers affiliate the requirements of the norm but especially the large Asian manufacturers have differentiated, own requirements for the quality management systems of their corporate group and their suppliers.

TS16949 applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. It is based on ISO 9001.

The requirements are intended to be applied throughout the supply chain. For the first time vehicle assembly plants will be encouraged to seek ISO/TS16949 certification.

Contents

  [hide]

[edit]Historical background

Many suppliers were asked by the car manufacturers (OEMs) to build and certify their quality management system according to the rules and regulations of their own country organizations, such as:

  • VDA (Germany)
  • AIAG (North America)
  • AVSQ (Italy)
  • FIEV (France)
  • SMMT (UK)

But due to this regulation a supplier needed to provide two different certificates for Daimler and Chrysler (VDA 6.1 for Germany and QS 9000 America), even though the supplier delivered only to a single company. These dubieties accelerated the need for harmonization.

[edit]Content of the specification

Aim of the standard is to improve the system and process quality to increase customer satisfaction, to identify problems and risks in production process and supply chain, to eliminate its causes and to examine taken corrections and preventive measures for their effectiveness.[3] The focus lies not on the discovery, but on the avoidance of errors. The eight main chapters of the standards are:

  • Section 1-3: Introduction and Preface
  • Chapter 4: Quality Management System (general requirements, control of documents and records)
  • Chapter 5: Responsibility of the management
  • Chapter 6: Management of resources
  • Chapter 7: Product realization
  • Section 8: Measurement, Analysis and Improvement

The process-oriented approach to business processes that is addressed in the ISO 9001:2008 stands at the forefront of the standard. It looks at the business processes in a process environment in which there are interactions and interfaces that need to be recognized, mapped and controlled by the quality management system. Additionally the gateways to the exterior (to sub-suppliers, customers and to remote locations) are defined. The Standard distinguishes between customer-oriented processes, supporting processes and management processes. This process-oriented approach is meant to improve the understanding of the whole process. Not an isolated process, but the entity of all interacting business processes affect the quality performance of a firm.

A key requirement of ISO / TS 16949:2009 is the fulfillment of customer-specific requirements, set up by the automobile manufacturer in addition to the quality management system of their suppliers. This may have decisively contributed to the worldwide recognition of the TS by many manufacturers.

[edit]Certification

The ISO/TS 16949 can be applied throughout the supply chain in the automotive industry. A certification takes place on the basis of the certification rules issued by the IATF International Automotive Task Force. The certificate is valid for the length of three years and must be confirmed annually by an IATF certified auditor (3rd Party Auditor) of an accredited certification body such as Bureau VeritasDQSSGS S.A.TÜV, or UTAC. Thereafter follows the re-certification for another three years with afresh annual confirmation. A certificate according to ISO/TS 16949 is intended to build up or enforce the confidence of a (potential) customer into the system and process quality of a (potential) supplier. Today, a supplier without a valid certificate has very little chance to serve a Tier 1 supplier and certainly no chance to serve a car manufacturer (OEM) with standard parts.[4]

[edit]Effects

All OEMs (Original Equipment Manufacturer) have declared this technical specification as standard. Whether this will improve the quality of automobiles remains unclear. If the specification meets the promises of its proponents, then we should expect declining number of recalls, with statistical significance, over the next years.

[edit]External links

  • ISO/TS 16949:2009 Quality management systems—Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

Certification bodies :

[edit]References

  1. ^ Kartha, C.P. (2004). “A comparison of ISO 9000:2000 quality system standards, QS9000, ISO/TS 16949 and Baldrige criteria”. The TQM Magazine Volume 16 (Emerald Group Publishing LimitedNumber 5: 336.
  2. ^ Cassel, Michael (2007). ISO/TS 16949 QM in der Automobilindustrie umsetzen. Germany: Carl Hanser Verlag. p. 1.
  3. ^ Kartha, C.P. (2004). “A comparison of ISO 9000:2000 quality system standards, QS9000, ISO/TS 16949 and Baldrige criteria”. The TQM Magazine Volume 16 (Emerald Group Publishing LimitedNumber 5: 336.
  4. ^ Daimler (2002). Global supplier magazine4th quarterDaimler. p. 17.

 

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

Has Organization established, documented, implemented and maintained a QMS and continually improved its effectiveness in accordance with ISO 9001:2000? (Questions in section 4.1 are verified throughout the audit)

The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),

Where has Organization identified the processes needed for the QMS and their application throughout the organization? (See 4.2.2)

The organization shall b) determine the sequence and interaction of these processes,

Where has Organization determined the sequence and interaction of QMS processes?  (See 4.2.2)

The organization shall c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

What are the criteria and methods Organization uses to ensure that the operation and control of QMS processes are effective?

The organization shall d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

Has Organization provided resources and information needed to support the operation and monitoring of QMS processes? (See section 6)

The organization shall e) monitor, measure and analyse these processes, and

How does Organization monitor, measure and analyze QMS processes? (See section 8)

 

The organization shall f) implement actions necessary to achieve planned results and continual improvement of these processes.

How has Organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS?

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2000?

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes.

When Organization outsources any process that affects product conformity with requirements, how is control ensured over such processes? (See 7.4)

Control of such outsourced processes shall be identified within the quality management system.

Where is the control of outsourced processes that affect product conformity with requirements identified within the QMS? (See 7.4)

 

NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

4.1.1 General requirements — Supplemental

Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements.

Does Organization have adequate control over outsourced processes to ensure conformity to all customer requirements?

(See 7.4)

NOTE See also 7.4.1 and 7.4.1.3.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives,

b) a quality manual,

c) documented procedures required by this International Standard,

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard (see 4.2.4).

Does Organization have documented statements of a quality policy and quality objectives? (See 5.3, 5.4.1)

Does Organization have a quality manual? (See 4.2.2)

Does Organization have the documented procedures required by ISO 9001:2000? (See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3)

Are adequate documents in place to ensure the effective planning, operation and control of Organization’s processes?

Does documentation include the records required by ISO 9001:2000?

 

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

How are the documents required by the QMS controlled?

(Documents should be reviewed throughout the audit)

A documented procedure shall be established to define the controls needed

a)      to approve documents for adequacy prior to issue,

b)      to review and update as necessary and re-approve documents?

c)      to ensure that changes and the current revision status of documents are identified?

d)      to ensure that relevant versions of applicable documents are available at points of use?

e)      to ensure that documents remain legible and readily identifiable?

f)      to ensure that documents of external origin are identified and their distribution controlled?

g)      to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

Can you show me a documented procedure that defines the controls needed for each of the following?

a)      approve documents for adequacy prior to issue?

b)      review and update as necessary and re-approve documents?

c)      ensure that changes and the current revision status of documents are identified?

d)      ensure that relevant versions of applicable documents are available at points of use?

e)      ensure that documents remain legible and readily identifiable?

f)      ensure that documents of external origin are identified and their distribution controlled?

prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.3.1 Engineering specifications

The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/ specifications and changes based on customer-required schedule.

What process do you have to assure the timely review, distribution and implementation of customer specifications and changes?

Does it meet customer-required schedule(s)?

Timely review should be as soon as possible, and shall not exceed two working weeks.

Does the review occur in two weeks or less?

The organization shall maintain a record of the date on which each change is implemented in production.  Implementation shall include updated documents.

What records do you have showing implementation dates of changes?  Is there evidence showing that documents are updated?

NOTE A change in these standards/ specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

What records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit)

Records shall remain legible, readily identifiable and retrievable.

Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit)

A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Does Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?

NOTE 1 “Disposition” above includes disposal.

NOTE 2 “Records” also include customer-specified records.

4.2.4.1 Records retention

The control of records shall satisfy regulatory and customer requirements.

Have the record requirements been reviewed to ensure conformance with regulatory and customer requirements?

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

d) conducting management reviews, and

e) ensuring the availability of resources.

How does top management communicate the importance of meeting customer and legal requirements to the organization?

Has a company quality policy been established? (See 5.3)

What are the quality objectives established by top management? (See 5.4.1)

Does top management conduct management reviews?  (See 5.6)

How does top management ensure the availability of resources to support and continually improve the QMS?

5.1.1 Process efficiency

Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency.

How does top management review product realization and support processes to ensure effectiveness and efficiency?  (5.6?)

5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 & 8.2.1).

How does top management ensure that customer requirements are determined and met?

 

5.3 Quality policy

Top management shall ensure that the quality policy

a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

c) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

How does top management ensure that the quality policy is appropriate to the purpose of the organization?

Does the quality policy include a commitment to comply with requirements and continually improve QMS effectiveness?

Are the contents of the quality policy relevant to Organization, and measurable?

Is the quality policy communicated and understood within the organization?

Is there an established process to review the quality policy for continuing suitability?

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization.

Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organization?

The quality objectives shall be measurable and consistent with the quality policy.

Are the quality objectives consistent with the quality policy?  What are the measurements?

5.4.1.1 Quality objectives – Supplemental

Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy.

Are quality objectives and metrics included in the business plan?

NOTE Quality objectives should address customer expectations and be achievable within a defined time period.

5.4.2 Quality management system planning

Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

How do you ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO 9001:2000 section 4.1, as well as the quality objectives?

Top management shall ensure that b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?

 

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.

How are responsibilities and authorities defined and communicated within the organization? (Verify throughout audit)

 

5.5.1.1 Responsibility for quality

Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements.

How are managers responsible for corrective action informed of nonconforming products or processes?

Are they informed in a timely manner?

 

Personnel responsible for product quality shall have the authority to stop production to correct quality problems.

Do personnel responsible for product quality have the authority to stop production to correct quality problems?

 

Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality.

What personnel on each shift have responsibility for ensuring product quality?

 

 

 

5.5.2 Management representative

Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development.

Who has top management designated to ensure that customer requirements are addressed?

Does their responsibility and authority include selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development?

 

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

How is information regarding the effectiveness of the QMS communicated within the organization?

 

 

 

 

5.6 Management review

5.6.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.

What is the frequency that top management reviews the organization’s QMS?

This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

What kinds of information are reviewed in management reviews?  (must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives)

Records from management reviews shall be maintained (see 4.2.4).

Can you show me records from recent management reviews?

5.6.1.1 Quality management system performance

These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process.

Do management reviews include all requirements of the quality management system and performance trends? (Verify records)

5.6.2 Review input

The input to management review shall include information on

a) results of audits,

b) customer feedback,

c) process performance and product conformity,

d) status of preventive and corrective actions,

e) follow-up actions from previous management reviews,

f) changes that could affect the quality management system, and

g) recommendations for improvement.

Can you show me that each of the following were included in review(s)?

a) results of audits,

b) customer feedback,

c) process performance and product conformity,

d) status of preventive and corrective actions,

e) follow-up actions from previous management reviews,

f) changes that could affect the quality management system, and

g) recommendations for improvement

5.6.2.1 Review input – Supplemental

Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment.

Do records show input to management review includes analysis of actual and potential field-failures and their impact? (See also 7.3.4.1)

5.6.3 Review output

The output from the management review shall include any decisions and actions related to

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

What decisions or actions have resulted from management reviews for each of the following?

a) improvement of the effectiveness of the quality management system and its processes,

b) improvement of product related to customer requirements, and

c) resource needs.

 

6 Resource management

6.1 Provision of resources

The organization shall determine and provide the resources needed

a) to implement and maintain the quality management system and continually improve its effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.

What resources has Organization provided to implement and maintain the QMS and continually improve its effectiveness?

What resources has Organization provided to ensure that customer requirements are met?

(See 6.2, 6.3, 6.4)

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

(While auditing, select some personnel performing work affecting product quality)  What are the education, training, skills and experience required by this job/task?

How does this person meet those qualifications?

6.2.2 Competence, awareness and training

The organization shall

a) determine the necessary competence for personnel performing work affecting product quality,

b) provide training or take other actions to satisfy these needs,

c) evaluate the effectiveness of the actions taken,

d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and

e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

How do you determine the necessary education, training, skills and experience for people performing work affecting product quality?

What training or other actions do you provide to satisfy the needs of personnel? (records)

When you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records)

 

(Sample throughout organization)

How do your activities contribute to the achievement of quality objectives?

Where do you maintain records of education, training, skills and experience?

 

 

6.2.2.1 Product design skills

The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques.

Applicable tools and techniques shall be identified by the organization.

What tools and techniques has the organization identified as necessary for product design personnel?

What records do you have showing that product design personnel are competent to design and are skilled in the identified tools and techniques?

6.2.2.2 Training

The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality.

Can you show me documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality?

Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements.

What records do you have that personnel performing specific assigned tasks are qualified – especially to meet customer requirements. (See 6.2.2e)

NOTE 1 This applies to all employees having an effect on quality at all levels of the organization.

NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data.

6.2.2.3 Training on the job

The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel.

What kinds of on-the-job training do you provide for people in new or changed jobs?

Does this include contract and agency personnel?

 

Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements.

How do you inform personnel about the consequences to the customer of nonconformity to quality requirements?  (Sample throughout organization)

 

6.2.2.4 Employee motivation and empowerment

The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation.

What process has been established to motivate employees to

-   achieve quality objectives,

-   to make continual improvements, and

-               to create an environment to promote innovation?

The process shall include the promotion of quality and technological awareness throughout the whole organization.

Does the process include the promotion of quality and technological awareness throughout the whole organization?

 

The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d)].

What process has been established to measure the extent to which personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?

(See 6.2.2d)

6.3 Infrastructure

The 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 (both hardware and software), and

c) supporting services (such as transport or communication).

Are the buildings, workspace, and utilities provided appropriate to achieve conformity to product requirements?  How are they maintained?

What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained?

What supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained?

6.3.1 Plant, facility and equipment planning

The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans.

What groups are involved in developing plant, facility and equipment plans?

(Must be multidisciplinary)

Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow.

Can you show that plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow?

Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.

What methods are used to evaluate and monitor the effectiveness of existing operations?

NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.

6.3.2 Contingency plans

The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.

Can you show me contingency plans for each of the following?

- Utility interruptions

- Labor shortages

- Key equipment failure(s)

- Field returns

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

What kind of work environment is required to achieve conformity to product requirements?  How is this environment managed and maintained?

6.4.1 Personnel safety to achieve product quality

Product safety and means to minimize potential risks to employees shall be addressed by the organization, especially in the design and development process and in manufacturing process activities.

How are product safety and potential risks to employees addressed by Organization?

6.4.2 Cleanliness of premises

The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs.

Does the organization maintain the state of order, cleanliness and repair needed for products and manufacturing processes?  (Verify throughout audit)

7 Product realization

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization.

Where are the processes needed for product realization identified?

Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

Is the planning of product realization consistent with the requirements of the other processes of the QMS?  (Verify there are no inconsistencies or conflicts between quality system procedures)

In planning product realization, the organization shall determine the following, as appropriate:

a)    quality objectives and requirements for the product;

b)    the need to establish processes, documents, and provide resources specific to the product;

c)    required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

d)    records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

Where in the product realization process do you determine the quality objectives and requirements for products?

When planning for product realization, how do you establish processes, documents, and provide resources specific to the product

How do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance?

What records exist showing that both the realization processes and the product meet requirements?

The output of this planning shall be in a form suitable for the organization’s method of operations.

What are the outputs of product realization planning?  Are they in a form suitable for Organization?

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.

NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization.  Advanced product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach.

7.1.1 Planning of product realization – Supplemental

Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan.

Does the quality plan include customer requirements and reference to technical specifications?

7.1.2 Acceptance Criteria

Acceptance criteria shall be defined by the organization and, where required, approved by the customer.

Where are acceptance criteria defined?  When required, does the customer approve them?

For attribute data sampling, the acceptance level shall be zero defects (see 8.2.3.1).

When attribute data sampling, is the acceptance level zero defects?

7.1.3 Confidentiality

The organization shall ensure the confidentiality of customer-contracted products and projects under development, and related product information.

How does the organization ensure the confidentiality of customer-contracted products, projects under development, and related product information?

7.1.4 Change control

The organization shall have a process to control and react to changes that impact product realization.

What process is there to control and react to changes that impact product realization?

NOTE 1 Any product realization change affecting customer requirements requires notification to, and agreement from, the customer.

NOTE 2 The above requirement applies to product and manufacturing process changes.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

The organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,

b) requirements not stated by the customer but necessary for specified or intended use, where known,

c) statutory and regulatory requirements related to the product, and

d) any additional requirements determined by the organization.

How does Organization determine each of the following requirements?

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,

b) requirements not stated by the customer but necessary for specified or intended use, where known,

c) statutory and regulatory requirements related to the product, and

d) any additional requirements determined by the organization.

 

NOTE 1 Post-delivery activities include any after-sales product service provided as part of the customer contract or purchase order.

NOTE 2 This requirement includes recycling, environmental impact and characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes (see 7.3.2.3).

NOTE 3 Compliance to item c) includes all applicable government, safety and environmental regulations, applied to acquisition, storage, handling, recycling, elimination or disposal of materials.

7.2.1.1 Customer-designated special characteristics

The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics.

How do you meet customer requirements for designation, documentation and control of special characteristics?

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product.  This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

a) product requirements are defined,

b) contract or order requirements

c) the organization has the ability to meet the defined requirements.

What kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product?

How do you ensure that product requirements are defined and reviewed before committing to supply product?

How do you ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product?

 
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Can you show me records of the product requirement review results and actions resulting from them?

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

When customers don’t have documented requirements, how do you confirm their requirements before accepting orders?

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes?

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

7.2.2.1 Review of requirements related to the product — Supplemental

Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization.

If you have waived the requirement  for a formal review above, have you obtained customer authorization?

7.2.2.2 Organization manufacturing feasibility

The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis.

What documents do you have that show investigation and confirmation of manufacturing feasibility in the contract review process for proposed products, including risk analysis?

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to

a) product information,

b) enquiries, contracts or order

c) customer feedback, including customer complaints.

What method(s) are used to communicate with customers regarding

-   product information?

-   enquiries, contracts, or order handling, including amendments?

-               feedback, including customer complaints?

7.2.3.1 Customer communication – Supplemental

The organization shall have the ability to communicate necessary information, including data, in a customer-specified language and format (e.g. computer-aided design data, electronic data exchange).

Do your customers require information to be communicated in specific languages and/or formats?

If so, how do you meet those requirements?

7.3 Design and development

NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.

7.3.1 Design and development planning

The organization shall plan and control the design and development of product.

Can you explain to me the process used by Organization to plan and control the design and development of product?

During the design and development planning, the organization shall determine a) the design and development stages,

b) the review, verification and validation that are appropriate to each design and development stage, and

c) the responsibilities and authorities for design and development.

What are the stages in the design and development process?

How do you determine the review, verification and validation activities appropriate to each design and development stage?

How /where are design and development responsibilities and authorities defined?

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

How does Organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development?

Planning output shall be updated, as appropriate, as the design and development progresses.

As product design and development progresses, how are the planning outputs updated?

7.3.1.1 Multidisciplinary approach

The organization shall use a multidisciplinary approach to prepare for product realization, including

-     development/finalization and monitoring of special characteristics

-     development and review of FMEAs, including actions to reduce potential risks, and

-     development and review of control plans.

Do you use a multidisciplinary approach to prepare for product realization?  Does it include:

-   development/finalization and monitoring of special characteristics

-   development and review of FMEAs, including actions to reduce potential risks,

-               development and review of control plans.

NOTE A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality, production and other appropriate personnel.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include

a)    functional and performance requirements,

b)    applicable statutory and regulatory requirements,

c)    where applicable, information derived from previous similar designs, and

d)    other requirements essential for design and development.

What are the design inputs relating to each of the following product requirements?

a)    functional and performance requirements,

b)    applicable statutory and regulatory requirements,

c)    where applicable, information derived from previous similar designs, and

d)    other requirements essential for design and development.

Where are they recorded?

These inputs shall be reviewed for adequacy.

How & when are the design and development inputs reviewed for adequacy?

Requirements shall be complete, unambiguous and not in conflict with each other.

How does Organization ensure that requirements are complete, unambiguous and don’t conflict with each other?

NOTE Special characteristics (see 7.2.1.1) are included in this requirement.

7.3.2.1 Product design input

The organization shall identify, document and review the product design inputs requirements, including the following:

-     customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification, traceability and packaging;

-     use of information: the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature;

-     targets for product quality, life, reliability, durability, maintainability, timing and cost.

Where are product design input requirements documented?

(including the following:

-   contract reviews of requirements such as special characteristics, identification, traceability and packaging;

-   a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature;

-   targets for product quality, life, reliability, durability, maintainability, timing and cost.)

Can you show me they are reviewed?

 

 

7.3.2.2 Manufacturing process design input

The organization shall identify, document and review the manufacturing process design input requirements, including

-     product design output data

-     targets for productivity, process capability and cost,

-     customers requirements, if any, and

-     experience from previous developments.

Where are manufacturing process design input requirements documented? (including the following:

-   product design output data

-   targets for productivity, process capability and cost,

-   customers requirements, if any, and

-   experience from previous developments.)

Can you show me they are reviewed?

 

 

NOTE The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered.

7.3.2.3 Special characteristics

The organization shall identify special characteristics [see 7.3.3 d)] and

-     include all special characteristics in the control plan,

-     comply with customer-specified definitions and symbols, and

-     identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the organization’s equivalent symbol or notation to include those process steps that affect special characteristics.

Can you show me that all special characteristics are identified and included in drawings, FMEAs, control plans, and operator instructions?

Are the customer-specified (or equivalent) symbols used?

Do they meet customer-specified definitions?

Do they include process steps that affect special characteristics?

 

 

 

 

 

NOTE Special characteristics can include product characteristics and process parameters.

7.3.3 Design and development outputs

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

How can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release?

Design and development outputs shall

a) meet the input requirements for design and development,

b) provide appropriate information for purchasing, production and for service provision,

c) contain or reference product acceptance criteria, and

d) specify the characteristics of the product that are essential for its safe and proper use.

Can you show me examples of design and development outputs and how they meet the input requirements?

What outputs include information for purchasing, production and service?

Where are product acceptance criteria specified?

Where are product characteristics needed for safe and proper use specified?

7.3.3.1 Product design outputs – Supplemental

The product design output shall be expressed in terms that can be verified and validated against product design input requirements.

The product design output shall include

-  design FMEA, reliability results

-  product special characteristics, specifications,

-  product error-proofing, as appropriate,

-  product definition including drawings or mathematically based data,

-  product design reviews results, and

-  diagnostic guidelines where applicable

Can you show that the product design outputs include

-  design FMEA, reliability results

-  product special characteristics, specifications,

-  product error-proofing, as appropriate,

-  product definition including drawings or mathematically based data,

-  product design reviews results, and

-  diagnostic guidelines where applicable

Are the outputs expressed in terms that can be verified and validated against product design input requirements?

7.3.3.2 Manufacturing process design output

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.

The manufacturing process design output shall include

-     specifications and drawings.

-     manufacturing process flow chart/ layout,

-     manufacturing process FMEAs,

-     control plan (see 7.5.1.1),

-     work instructions,

-     process approval acceptance criteria,

-     data for quality, reliability, maintainability and measurability

-     results of error-proofing activities, as appropriate, and

-     methods of rapid detection and feedback of product/manufacturing process nonconformities.

Can you show that the manufacturing process design outputs include

-     specifications and drawings,

-     manufacturing process flow chart/ layout,

-     manufacturing process FMEAs,

-     control plans,

-     work instructions,

-     process approval acceptance criteria,

-     data for quality, reliability, maintainability and measurability

-     results of error-proofing activities, as appropriate, and

-     methods of rapid detection and feedback of product/manufacturing process nonconformities.

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)

a)    to evaluate the ability of the results of design and development to meet requirements, and

b)    to identify any problems and propose necessary actions.

At what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b)

 

Can you show me some problems that have been identified and actions proposed at these reviews?

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed

What functions are represented at these reviews?

At each stage, are all functions concerned with that stage represented?

Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

Can you show me records of the results of the reviews and any necessary actions taken?

NOTE These reviews are normally coordinated with the design phases and include manufacturing process design and development.

7.3.4.1 Monitoring

Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review.

Can you show me reports of analysis of measurements at specified design and development stages?

Are summary results included in management reviews? (See 5.6.2)

NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.

What verification activities are performed to ensure that the design and development outputs have met the input requirements?  (See 7.3.3q1)

Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

Can you show me records of the results of the verification activities and resulting actions?

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.

What design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use?

Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

Do records show that validation is done before product shipment?

If not, is the justification recorded?

Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

Can you show me records of the validation activity results and any follow-up actions?

NOTE 1 The validation process normally includes an analysis of field reports for similar products.

NOTE 2 The requirements of 7.3.5 and 7.3.6 above apply to both product and manufacturing processes.

7.3.6.1 Design and development validation – Supplemental

Design and development validation shall be performed in accordance with customer requirements including programme timing.

Is design and development validation performed in accordance with customer requirements, including program timing?

 

7.3.6.2 Prototype programme

When required by the customer, the organization shall have a prototype programme and control plan.

Do your customer(s) require a prototype program and control plan?

If so, can you describe the program?

Can you show me the control plan(s)?

The organization shall use, whenever possible, the same suppliers, tooling and manufacturing processes as will be used in production.

Does Organization’s prototype program use the same suppliers, tooling and manufacturing processes as will be used in production?  If not, what is the justification?

All performance testing activities shall be monitored for timely completion and conformance to requirements.

What records show that performance-testing activities are monitored for timely completion and conformance to requirements?

The organization shall ensure that purchased product conforms to specified purchase requirements.

How do you ensure that purchased product conforms to specified purchase requirements?

The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.

Criteria for selection, evaluation and re-evaluation shall be established.

 
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

Can you show me records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met)

NOTE 1 Purchased products above includes all products and services that affect customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services.

NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier’s quality system and its effectiveness.

7.4.1.1 Regulatory conformity

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements.

Do orders/contracts include requirements for approval of product, procedures, processes and equipment?

Do require any qualification of supplier personnel?  If so, can you show where the requirement is documented?

Do you have any QMS requirements of your suppliers?  If so, can you show me where they are required?

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

How does Organization ensure the adequacy of purchasing requirements before communicating them to the supplier?

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

What inspection or other activities are used to ensure that purchased product meets your purchasing requirements?

Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Do you ever perform product verification at the supplier’s site?

If so, where are the verification arrangements and method of product release identified?

7.4.3.1 Incoming product quality

The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:

-     receipt of, and evaluation of, statistical data by the organization;

-     receiving inspection and/or testing such as sampling based on performance;

-     second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality;

-     part evaluation by a designated laboratory;

-     another method agreed with the customer.

What processes are in place to assure the quality of purchased product?

 

(Must include one or more of following:

-     evaluation of supplier statistical data

-     receiving inspection and/or testing

-     second- or third-party audits of suppliers, along with records of acceptable quality

-     laboratory part evaluation

another method agreed with the customer)

7.4.3.2 Supplier monitoring

Supplier performance shall be monitored through the following indicators:

-   delivered product quality;

-   customer disruptions including field returns;

-   delivery schedule performance (including incidents of premium freight);

-   special status customer notifications related to quality or delivery issues.

How do you monitor supplier performance?

(Must include the following indicators:)

-     delivered product quality

-     customer disruptions including field returns

-     delivery schedule performance (including incidents of premium freight)

special status customer notifications related to quality or delivery issues

The organization shall promote supplier monitoring of the performance of their manufacturing processes.

How do you promote supplier monitoring of the performance of their manufacturing processes?

7.5 Production and service provision

7.5.1 Control of production and service provision  
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

a)    the availability of information that describes the characteristics of the product,

b)    the availability of work instructions, as necessary,

c)    the use of suitable equipment,

d)    the availability and use of monitoring and measuring devices,

e)    the implementation of monitoring and measurement, and

f)    the implementation of release, delivery and post-delivery activities.

When carrying out production (or service) are all of the following controlled conditions in place?

a)    Is information that describes the characteristics of the product available?

b)    Are appropriate work instructions available (if needed)? (See 7.5.1.2)

c)    Is suitable equipment used for carrying out production (or service)?

d)    Are appropriate gages, etc. used in production (or service)?  (See 7.6)

e)    Are appropriate kinds of monitoring and measurement done? (See 8.2.4)

Are proper release, delivery and post-delivery activities in place?

7.5.1.1 Control plan

The organization shall

-     develop control plans (see annex A) at the system, subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and

-     have a control plan for pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs.

Can you show me control plans for system, subsystem, and component/ material levels for product supplied?

Can you show me control plans for both pre-launch and production?

Can you show how the control plans take into consideration design FMEA and process FMEA information?

(See annex A)

 

 

 

The control plan shall

-     list the controls used for the manufacturing process control,

-     include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined both by the customer and the organization,

-     include the customer-required information, if any, and

-     initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable.

(Review control plans to ensure they:

-     list controls used for manufacturing process control

-     include methods for monitoring of control of special characteristics

-     include customer-required information, if any)

Can you show that specified reaction plans have been carried out when a process becomes unstable or not statistically capable?

 

 

Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources or FMEA (see 7.1.4).

What conditions initiate the review and update of control plans?

NOTE Customer approval may be required after review or update of the control plan.

7.5.1.2 Work instructions

The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality.

These instructions shall be accessible for use at the work station.

Do all employees responsible for processes that impact product quality have documented work instructions?

(Verify throughout audit)

Are they accessible for use at the workstation?

These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.

How are the work instructions developed?

 

 

 

7.5.1.3 Verification of job set-ups

Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change.

Can you show me records of job setups that are being performed?

Do they occur at the initial run of a job, material changeover, or job change?

 

Work instructions shall be available for set-up personnel.

What work instructions do you have for job setup personnel?

 

 

The organization shall use statistical methods of verification where applicable.

What statistical methods are used to verify job setups?

 

 

NOTE Last-off-part comparisons are recommended.

7.5.1.4 Preventive and predictive maintenance

The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system.

How do you identify key process equipment?

Can you walk me through your total preventive maintenance system?

 

 

As a minimum, this system shall include the following:

-     planned maintenance activities;

-     packaging and preservation of equipment, tooling and gauging;

-     availability of replacement parts for key manufacturing equipment;

-     documenting, evaluating and improving maintenance objectives.

(Verify that the TPM system includes the following:

-     planned maintenance activities

-     packaging and preservation of equipment, tooling and gauging

-     availability of replacement parts for key manufacturing equipment

-     documenting, evaluating and improving maintenance objectives)

-

The organization shall utilize predictive maintenance methods to continually improve the effectiveness and the efficiency of production equipment.

What predictive maintenance methods do you use?

Can you demonstrate that predictive maintenance has resulted in continual improvement of the effectiveness and efficiency of production equipment?

 

7.5.1.5 Management of production tooling

The organization shall provide resources for tool and gauge design, fabrication and verification activities.

What resources have Organization provided for tool and gage design, fabrication and verification activities?

 

7.5.1.7 Feedback of information from service

A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained.

What is your process to communicate information on service concerns to manufacturing, engineering, and design?

 

 

 

NOTE The intent of the addition of “service concerns” to this subclause is to ensure that the organization is aware of nonconformities that occur external to its organization.

7.5.1.8 Service agreement with customer

When there is a service agreement with the customer, the organization shall verify the effectiveness of

-     any organization service centres,

-     any special-purpose tools or measurement equipment, and

-     the training of service personnel.

Do you have any service agreement(s) with customers?  If so, how do you verify the effectiveness of

-     any organization service centers,

-     any special-purpose tools or measurement equipment, and

-     the training of service personnel?

 

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Do you have any production or service processes where the resulting output cannot be verified later? (This applies to all processes in TS 16949)

If so, how to you validate them?

Validation shall demonstrate the ability of these processes to achieve planned results.

Can you show me records that demonstrate that the validation done has met the requirements?

The organization shall establish arrangements for these processes including, as applicable

a)   defined criteria for review and approval of the processes,

b)   approval of equipment and qualification of personnel,

c)   use of specific methods and procedures

d)   requirements for records (see 4.2.4), and

e)   revalidation.

How are these special processes reviewed and approved?

Can you show me records of personnel and equipment qualification?

Where are specific methods and procedures defined?

Can you show me records for these processes?

When changes are made to processes, how do you revalidate them?

7.5.2.1 Validation of processes for production and service provision – Supplemental

The requirements of 7.5.2 shall apply to all processes for production and service provision.

Are all production processes validated per 7.5.2 above?

 

 

7.5.3 Identification and traceability

7.5.3 Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization.

How do you identify product throughout your processes?  (Verify in production, storage, segregation areas, etc.)

The organization shall identify the product status with respect to monitoring and measurement requirements.

How is product inspection status identified?  (Verify in production, storage, segregation areas, etc.)

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

Can you show me unique identification records for products requiring traceability?

 

NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.

NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious such as material in an automated production transfer process.  Alternatives are permitted, if the status is clearly identified, documented, and achieves the designated purpose.

7.5.3.1 Identification and traceability – Supplemental

The words “Where appropriate” in 7.5.3 above, shall not apply.

Is all product suitably identified?

 

 

7.5.4 Customer property

The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization.

Do you use any customer-owned property?  (Product, packaging, drawings, tooling, gages…)

(If so, ask questions below)

The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product.

How do you ensure that customer-owned property is identified, verified, protected, and safeguarded?

If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

If any customer property is lost, damaged etc., how is it reported to the customer?  Can you show me records regarding this?

NOTE Customer property can include intellectual property.

NOTE Customer-owned returnable packaging is included in this clause.

7.5.4.1 Customer-owned production tooling

Customer-owned tools, manufacturing, test, inspection tooling and equipment shall be permanently marked so that the ownership of each item is visible, and can be determined.

How are customer-owned tools and equipment identified?

 

 

 

 

 

7.5.5 Preservation of product

The organization shall preserve the conformity of product during internal processing and delivery to the intended destination.

How do you preserve the conformity of product during internal processing and delivery?

(Verify product throughout audit)

This preservation shall include identification, handling, packaging, storage and protection.

How do identification, handling, packaging, storage and protection address the preservation of product?

 

Preservation shall also apply to the constituent parts of a product.

Does this also apply to component parts?

 

 

 

7.5.5.1 Storage and inventory

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate planned intervals.

How do you assess the condition of product in stock to detect deterioration?

 

 

The organization shall use an inventory management system to optimize inventory turns over time and assure stock rotation, such as “first-in-first-out” (FIFO).

Can you walk me through your inventory management system?

How does the system optimize inventory turns over time and assure stock rotation?

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

When equipment is found to be out of calibration, how do you assess and record the validity of the previous measuring results?

The organization shall take appropriate action on the equipment and any product affected.

What actions do you take on the equipment and any product affected?

Records of the results of calibration and verification shall be maintained (see 4.2.4).

Can I see your records of the results of calibration and verification?

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

Do you use computer software for monitoring and measurement?   If so, is its ability to perform that function confirmed prior to initial use and reconfirmed as necessary?

NOTE See ISO 10012-1 and ISO 10012-2 for guidance.

NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c) above.

7.6.1 Measurement system analysis

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

Can you show me R&R studies for each type of measuring and test equipment system referenced in the control plan?

(Or other statistical studies analyzing the variation in measurement & test results)

Do the methods and acceptance criteria conform to those in customer reference manuals on MSA or does the customer approve them?

 

7.6.2 Calibration/verification records

Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include

-     equipment identification, including the measurement standard against which the equipment is calibrated,

-     revisions following engineering changes,

-     any out-of-specification readings as received for calibration/verification,

-     an assessment of the impact of out-of-specification condition,

-     statements of conformity to specification after calibration/verification, and

-     notification to the customer if suspect product or material has been shipped.

An organization’s internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services.  This laboratory scope shall be included in the quality management system documentation.

     
  The laboratory shall specify and implement, as a minimum, technical requirements for

-     adequacy of laboratory procedures,

-     competency of the laboratory personnel,

-     testing of the product,

-     capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.), and

-     review of the related records.

Where are laboratory technical requirements specified for

-     adequacy of laboratory procedures,

-     competency of the laboratory personnel,

-     testing of the product,

-     capability to perform these services correctly, traceable to the relevant process standard, and

-     review of the related records?

Have these requirements been implemented?

NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory.

7.6.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either

-     there shall be evidence that the external laboratory is acceptable to the customer, or

-     the laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

Can you show me laboratory scope(s) for external/commercial/independent laboratory facilities that include the capability to perform the required inspection, test or calibration?

Can I see evidence that each laboratory is either accredited, or is acceptable to the customer(s)?

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent.

  NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in 7.6.3.1 have been met.

8 Measurement, analysis and improvement

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity of the product,

How do you plan and implement measurement, analysis and improvement processes needed to demonstrate products conform to requirements?

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed b) to ensure conformity of the quality management system, and

How do you plan and implement measurement, analysis and improvement processes needed to ensure conformity of the QMS?

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed c) to continually improve the effectiveness of the quality management system.

How do you plan and implement measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS?

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

How do you determine what methods to use, including statistical techniques?  How do you determine the extent of their use?

8.1.1 Identification of statistical tools

Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan.

Have appropriate statistical tools for each process been determined and included in the control plan? (see 7.5.1.1)

8.1.2 Knowledge of basic statistical concepts

Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization.

How does Organization ensure that basic statistical concepts are understood and utilized throughout the organization? (verify throughout audit)

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

  As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements.  The methods for obtaining and using this information shall be determined.

How do you obtain information about customer perception as to whether Organization has met customer requirements?

How is this information used?

NOTE Consideration should be given to both internal and external customers.

8.2.1.1 Customer satisfaction — Supplemental

  Customer satisfaction with the organization shall be monitored through continual evaluation of performance of the realization processes.  Performance indicators shall be based on objective data and include, but not be limited to:

-    delivered part quality performance,

-    customer disruptions including field returns,

-    delivery schedule performance (including incidents of premium freight), and

-    customer notifications related to quality or delivery issues.

What realization process performance indicators are used to monitor customer satisfaction?

Do they include at least:

-     delivered part quality performance,

-     customer disruptions including field returns,

-     delivery schedule performance (including incidents of premium freight), and

customer notifications related to quality or delivery issues?

The organization shall monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process.

How do you monitor manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?

8.2.2 Internal audit

  The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b) is effectively implemented and maintained.

Are internal audits being conducted at planned intervals?  Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance)

Do they determine whether the QMS is effectively implemented and maintained? (Review records)

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.

Can you show me an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits?

  The audit criteria, scope, frequency and methods shall be defined.

Where are the audit criteria, scope, frequency and methods defined?

 

 

Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.  Auditors shall not audit their own work.

Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors don’t audit their own work?

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

Can you show me your internal audit procedure?

Can you show me the records of internal QMS audits?

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

Who ensures that actions are taken to eliminate detected nonconformities and their causes?  Are they being taken care of in a timely manner?  (verify with records)

Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

What activities are done to verify the actions taken, and how are the verification results reported?

NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.

8.2.2.1 Quality management system audit

The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements.

Do you have audit records showing that the entire QMS is being audited?

8.2.2.2 Manufacturing process audit

The organization shall audit each manufacturing process to determine its effectiveness.

Do you have records showing that each manufacturing process is being audited to determine its effectiveness?

8.2.2.3 Product audit

The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency.

Are there records showing that products are being audited at appropriate stages of production and delivery?

Do the audits verify conformity to all specified requirements?

8.2.2.4 Internal audit plans

  Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan.

Can you show me an annual audit plan?

Does it show that audits cover all QMS processes, activities and shifts?

When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased.

Is there evidence that audit frequency is increased due to nonconformances or customer complaints?

NOTE Specific checklists should be used for each audit.

Are specific checklists used for each audit?

8.2.2.5 Internal auditor qualification

The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification (see 6.2.2.2).

How do you determine competence of internal auditors to audit the requirements of TS 16949? (See 6.2.2.2 – also customer specific requirements).

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.

What methods are used to monitor and measure the QMS processes?

These methods shall demonstrate the ability of the processes to achieve planned results.

Can you show that they have achieved the desired results?

When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

When the desired results are not achieved, what actions are taken to ensure that the product meets requirements?

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control.

The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions.

These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria.

  The plans shall be reviewed with and approved by the customer when so required.

The organization shall maintain records of effective dates of process changes.

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

 
   
  8.2.4.1 Layout inspection and functional testing
  A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans.  Results shall be available for customer review.

Can you show me layout inspection and functional verification results?

Do they address applicable customer specifications and correlate with the control plan requirements?

Are results available for customer review?

 

 

NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records.

8.2.4.2 Appearance items

For organizations manufacturing parts designated by the customer as “appearance items”, the organization shall provide

-     appropriate resources including lighting for evaluation,

-     masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate,

-     maintenance and control of appearance masters and evaluation equipment, and

-     verification that personnel making appearance evaluations are competent and qualified to do so.

Do you provide parts designated by customer(s) as appearance items?

If so can you show that you have:

-     appropriate resources including lighting for evaluation,

-     masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate,

-     maintenance and control of appearance masters and evaluation equipment, and

verification that personnel making appearance evaluations are competent and qualified to do so

8.3 Control of nonconforming product

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

How do you ensure that nonconforming products are identified and controlled to prevent unintended use or delivery?

(Verify product throughout audit)

The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

Can you show me your documented procedure defining the controls for dealing with nonconforming product?

Does it include related responsibilities and authorities?

  The organization shall deal with nonconforming product by one or more of the following ways:

a) by taking action to eliminate the detected nonconformity;

b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;

c) by taking action to preclude its original intended use or application.

When you have nonconforming product, what methods do you use to deal with it?

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

Can you show me records of nonconforming product and any actions taken?

Are there any records of concessions obtained?

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When nonconforming product is corrected, can you demonstrate that it is re-verified to ensure it conforms to requirements?

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

When nonconforming product is detected after shipment, what actions are taken, such as containment?

(Verify corrective action records)

8.3.1 Control of nonconforming product — Supplemental

Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3).

How are unidentified or suspect products treated?

8.3.2 Control of reworked product

Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel.

Can you show me instructions for rework?

Do they include re-inspection requirements?

Are they accessible and utilized?

8.3.3 Customer information

  Customers shall be informed promptly in the event that nonconforming product has been shipped.

Do you have evidence that customers are promptly notified if nonconforming product is shipped?

8.3.4 Customer waiver

  The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.

Can you show me records of customer approvals prior to processing, whenever deviations from approved product or manufacturing processes occur?

The organization shall maintain a record of the expiration date or quantity authorized.

Do the records indicate expiration date and/or quantity authorized?

The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires.

How do you ensure that original requirements are met when the authorization expires?

Material shipped on an authorization shall be properly identified on each shipping container.

How do you identify material shipped on an authorization?

This applies equally to purchased product. The organization shall agree with any requests from suppliers before submission to the customer.

Do you have records that this process is applied to purchased products also?

Do you review and agree with supplier deviation requests before submitting them to the customer for approval?

8.4 Analysis of data

The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.  This shall include data generated as a result of monitoring and measurement and from other relevant sources.

What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made?

  The analysis of data shall provide information relating to

a) customer satisfaction (see 8.2.1),

b) conformity to product requirements (see 7.2.1),

c) characteristics and trends of processes and products including opportunities for preventive action, and

d) suppliers.

What information does this analysis provide relating to:

-     customer satisfaction? (See 5.6)

-     conformity to product requirements?  (See 5.6)

-     characteristics and trends of processes and products? (See 5.6)

suppliers? (See 7.4.1)

8.4.1 Analysis and use of data

Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following:

-     development of priorities for prompt solutions to customer-related problems;

-     determination of key customer-related trends and correlation for status review, decision-making and longer term planning;

-     an information system for the timely reporting of product information arising from usage.

How do you compare trends in quality and operational performance with progress toward objectives?

Does the comparison lead to action to supporting the following?

-  development of priorities for prompt solutions to customer-related problems;

-  determination of key customer-related trends and correlation for status review, decision-making and longer term planning;

an information system for the timely reporting of product information arising from usage.

NOTE Data should be compared with those of competitors and/or appropriate benchmarks.

8.5 Improvement

8.5.1 Continual improvement

The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

Can you demonstrate that Organization’s QMS effectiveness continually improves?

What tools do you use?

(See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)

8.5.1.1 Continual improvement of the organization

The organization shall define a process for continual improvement (see examples in annex B of ISO 9004:2000).

Where has Organization defined a process for continual improvement?

8.5.1.2 Manufacturing process improvement

  Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters.

Can you show that CI efforts focus on control and reduction of variation in product and process characteristics (after capability, stability, and conformity)?

NOTE 1 Controlled characteristics are documented in the control plan.

NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.

8.5.2 Corrective action

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

Do corrective actions records identify and address root cause(s)?

(Do root causes match actions?)

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

Are actions taken appropriate to the severity of the problem?

The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

Can you show that corrective actions are applied to other similar processes and products?

 

 

8.5.2.4 Rejected product test/analysis

  The organization shall analyse parts rejected by the customer’s manufacturing plants, engineering facilities and dealerships.  The organization shall minimize the cycle time of this process.  Records of these analyses shall be kept and made available upon request.  The organization shall perform analysis and initiate corrective action to prevent recurrence.

Can you show me records of analysis of parts rejected by customer manufacturing plants, engineering facilities and dealerships?

How long does the analysis take?

Are records made available (to customers) upon request?

Is the time consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation?

 

NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation.

8.5.3 Preventive action

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.

How do you determine potential nonconformities to take action one?

Do preventive action records identify and address root cause(s)?

 

Preventive actions shall be appropriate to the effects of the potential problems.

Are actions taken appropriate to the severity of the problem?

 

  A documented procedure shall be established to define requirements for

a) determining potential nonconformities and their causes,

b) evaluating the need for action to prevent occurrence of nonconformities,

c) determining and implementing action needed,

d) records of results of action taken (see 4.2.4), and

e) reviewing preventive action taken.

Can you show me a documented procedure defining requirements for each of the following?

a)   determining potential nonconformities and their causes,

b)   evaluating the need for action to prevent occurrence of nonconformities,

c)   determining and implementing action needed,

d)   records of results of action taken (see 4.2.4), and

e)             reviewing preventive action taken.

Annex A – Control plan

A.1 Phases of the control plan

Control plans are an output of the quality plan.

Are control plans outputs of the quality plan?

A.2 Elements of the control plan

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About Master Group

Master Group is the leading company in the field of quality management system. We are providing complete solution in step-by-step process development through trainings and consultancy. Our expertise are-  QMS Consultancy and Trainings (ISO 9001)  EMS Consultancy and Trainings (ISO 14001)  Lab Certification (ISO 17025)  Social Accountability (SA 8000)  Technical Specification (ISO/TS 16949)  Health and safety (OHSAS)  Food Safety (HACCP)  NABH Accreditation  CE Mark  Process Improvement  Value Analysis, Value Engineering (VAVE)

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