Support IATF Clause 7
IATF Clause 7 Support
This clause specifies requirements for the resources and supporting processes needed for an effective QMS.
It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, competence, awareness, communication, and documented information.
We are going to discuss following topic under this clause of IATF16949:-
7.1 Resources
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- People
- Infrastructure (Plant, Facility and Equipment Planning)
- Environment for operation of process
- Monitoring and measurement resources (MSA)
- Measurement traceability (Calibration and laboratory requirement)
- Organizational Knowledge
7.2 Competence (OJT, Internal/External auditor competency)
7.3 Awareness (Employee Motivation and Empowerment)
7.4 Communication
7.5 Documented Information
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- Control of documents (Record retention, Engineering specification)
Resources (section 7.1 of IATF)
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. It ensures there are the right resources, people and infrastructure to meet the organizational goals. It requires an organization to determine and provide the necessary resources to establish, implement, maintain and continually improve the QMS. Simply expressed, this is a very powerful requirement covering all QMS resource needs and now covers both internal and external resources.
1. People:– Labor or Skilled Manpower
2. Infrastructure:- plant, office, building, associated utilities, Transportation services/Logistics, Equipment, Information technology and communication.
3. Plant, Facility and Equipment planning:- This includes an increased focus on risk identification and risk mitigation, evaluating manufacturing feasibility, re-evaluation of changes in processes, and inclusion of on-site supplier activities. In design of plant layout organization need to optimize material flow, material handling and value added use of floor space including control of nonconformity products. Organization
also needs to maintain process effectiveness; 4M change approval, control plan maintenance and verification of Job set-ups.
Capacity planning evaluation during manufacturing feasibility assessments must consider customer-contracted production rates and volumes, not only current order levels. Capacity should be re-evaluated for any process changes.
4. Environment for operation of process:- The organization shall determine, provide and maintain the environment necessary for the operation of
its processes and to achieve conformity of products and services. A third party can be used to demonstrate the organization’s conformity to personal safety, human and physical factors. 5S, Information boards, corporate policy, Temperature and noise control, hazard control are some requirement come under Environment.
5. Monitoring and Measuring Resources:- The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
- There are enhanced requirements that cover calibration and verification records. This includes software installed on employee-owned or customer-owned equipment. There is also an additional requirement that covers internal and external laboratories that are used for inspection, test, or calibration services
- Statistical study shall be conducted to analyze the variation in the result of each type of inspection, measurement, and test equipment system. This study is MSA-Measurement system analysis. The acceptance criteria of this study shall conform to reference manual or as per customer requirement.
6. Measurement Traceability:- Its is requirement considered by organization to provide confidence in validity of measurement result. For this the measuring equipment shall be calibrated and validated as per international standard. Organization should have documented process for managing calibration and validation records. Calibration number should be documented. Calibration sticker should be available.
7. Laboratory requirement:– For internal laboratory requirement the organization shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services.
For External laboratory requirement the laboratory should be accredited to ISO/IEC 17025 or National Equivalent (NABL in India).
8. Organizational Knowledge:- The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. Organizational knowledge deals with requirements for competence, awareness, and communication of the QMS. Organization knowledge- generally gained by experience.
Organizational knowledge can be based on: Internal Source & External Sources
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Internal Sources |
External Sources |
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Intellectual property |
Knowledge from |
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Knowledge gain from |
Knowledge from |
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Lesson Learn from |
Knowledge gain from |
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Lesson learn from successful project |
Knowledge from |
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Knowledge from |
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Competence (Section 7.2 of IATF)
Organizations need to establish a documented process for identifying training needs including awareness, and record a list of the approved auditors. Documented information to be maintained for evidence of competence. This clause differentiates between quality management system auditors, manufacturing process auditors and product auditors. Also this clause clarifies the competence requirements for each type of auditor.
The organization shall determine Competence of person doing work under its control that affects the performance and effectiveness of the quality management system. For this Organization shall ensure that these persons are competent on the basis of appropriate education, training, or experience. To make a person competent, organization can provide On JOB Training.
Personnel must not only be aware of the quality policy, documented information and changes, but they must also understand how they contribute to product or service conformity and safety and the implications of not conforming.
Requirements for on-the-job training (OJT)
On Job training (OJT) and its importance in meeting customer requirements, including other interested parties and requires that relevant people shall be informed about the consequences of nonconformities. This training must also include contract or agency personnel.
Requirements for internal auditor’s competence
The organization shall have a documented process to verify that internal auditor are competent, taking into account any customer specific requirement (CSR).
- Should have automotive process approach for auditing, including risk based thinking (PFMEA, CP).
- Should understand customer specific requirement
- Should be aware about ISO9001 and IATF16949 requirements related to scope of audit
- Understand how to plan, conduct, report and close audit finding.
Second-party auditor competencies are also specified.
Awareness (Section 7.3 of IATF)
The organization shall ensure that persons doing work under the organization’s control are aware of
- The quality policy
- Relevant quality objectives
- Their contribution to the effectiveness of the quality management system, including the benefits of improved performance
- The implications of not conforming to the quality management system requirements.
Awareness should be done to motivate employees, to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization.
Communication (Section 7.4 of IATF)
The organization shall determine the internal and external communications relevant to the quality management system, including:
- On what it will communicate
- When to communicate
- With whom to communicate
- How to communicate
- Who communicates
Documented Information (Section 7.5 of IATF)
For requirements for “documented information” organizations need to determine the level of documented information necessary to control the QMS. This will differ between organizations due to size and complexity. In line with the increased importance of information security and data protection in organizations, there is also greater emphasis on controlling access to documented, current information such as use of passwords. Organizations should also have systems in place to provide a back-up should IT systems crash.
The quality manual can be one main document or a series of multiple documents (hard copy or electronic).This section also requires that the organization’s processes and interactions are documented as part of their QMS. The quality manual needs to document where in the organization’s QMS customer-specific requirements are addressed.
Control of documents (Record retention & Engineering specification)
This clause requires a record retention process that is defined and documented, and that includes the organization’s record retention requirements. Specifically calls out production part approvals, tooling records, product and process design records, purchase orders, and contracts/amendments.
Engineering specifications, Process of manufacturing is documented and agreed with the customer. It also clarifies product design changes and product realization process changes, and the alignment to related sections. If there are no other overriding customer agreements, reviews of engineering standards & specifications changes should be completed within 10 working days of receipt of notification.
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