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Yes, core tools are extremely important in IATF 16949:2016 application. Especially in the new product launch process, production and quality processes, APQP, PPAP, FMEA, SPC, MSA must be applied for IATF 16949:2016 requirements.
The necessity of these applications is specified in IATF 16949: 2016 standard clauses 8.1,8.3,8.5,8.6,8.7,9.1.1.1 and customer-specific requirements. Especially according to OEM customer-specific requirements, while giving PPAP for a new project, there must be evidence of core tools in the PPAP file. At the same time, the IATF standard is a technical standard and an important purpose is the reduction of scrap, waste, and ensuring continuous improvement. Achieving this goal cannot be achieved without applying Core tools.
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Yes, you can. I always recommend following that practice, particularly, when an internal auditor has less experience, or has little time to prepare an audit to the whole management system. For example, in this free webinar on demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/ - I give an example of preparing a partial audit.
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Design and implementing a quality management system (QMS) implies being knowledgeable about ISO 9001:2015. Now the standard is less and less bureaucratic, it is up to each organization the task to design, develop and implement its QMS.
Setup a project sponsor, a project manager and a project team. Determine the scope of the QMS, your organization may decide to include only certain lines of business. Ensure top management support, get training and as a first step perform a Gap analysis, to determine the amount of work to be done - comparing what your organization already has in place versus ISO 9001:2015 requirements. From that GAP Analysis you can develop your Project Plan, listing what needs to be done, by whom, until when.
Then, an important step is to design a model of how your organization work as a set of interrelated processes. For example:
Decide how to describe and monitor those processes.
From there it is implementation in order to close the gaps found. Then, perform an internal audit and the management review. There you can decide if your organization is ready for a certification audit.
This is a very short description of the journey but below you can find more detailed information:
A - Let me use new company to represent a new company with an established business model, like a restaurant, like a new shoe manufacturing plant, or a new transport company.
B - Let me use start-up company as a designation for a project of company in search of a business model. Startups, in reality, are not yet companies, they are still projects of companies in search of a successful business model and customer fit. So, a startup is like an experiment being done. The startup can be called a company only after finding the right business model, a customer fit, and when it starts scaling. Only then, the procedures and internal standards are ready to be documented.
So, for situation B it is too early to certify. For situation A, I think it is easier to get ISO certification than with an established company (with same resources and motivation). An established company has to unlearn some practices and that it is not always easy.
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I assume that the establishment you are referring to is under extra-EU law and subject to the legislation of its own country. If so, I am afraid it must share personal data in a copyright infringement proceeding. Article 6 paragraph 1 letters c) GDPR allow to disclose personal data to comply with a legal obligation.
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You can consider enrolling in our free EU GDPR Foundations Course
For waste management I find it useful to design a kind of process flow since waste generation, segregation, general collection, disposal, over a plant of the facilities. That way everybody can grasp the whole picture.
Where are wastes generated, of what kind, in what amounts and by whom? – From here you can think about the need and dimension of different bins to collect segregated wastes, who needs training and awareness about what bins to use. Who will collect? Who is responsible for contacts with waste disposal company? What can be or what makes sense to measure?
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I start showing that interaction through a picture like this one.
Then, in each process description I list the main relevant clauses.
The following material will provide you more information about the process approach:
Unfortunately, we still have not develop that procedure, but perhaps this free webinar on demand can help you - - How to perform an internal audit remotely - https://advisera.com/9001academy/webinar/remote-internal-audit-free-webinar-on-demand/ a detailed explanation about how to remotely audit operations using a tablet, a smartphone, CCTV or a drone.
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The risk-based thinking (RBT) should be an ongoing process, it can’t be done once a year and considered as effective. The best way to apply is through the PDCA cycle.
First you should define the scope of RBT. According to clauses 4.4.1 f), 5.1.2 b) and 6.1 of ISO 9001:2015 I recommend determining risks around processes, around products and services and around processes.
About the methodology to treat risks and opportunities there are a lot of available methodologies and there is no single methodology that will fit all organizations. My advice is to do a little research and select the methodology according to criteria that you find appropriate.
Determine the risks and opportunities. Although not mandatory, I recommend using a register to record risks and opportunities.
Next step is, of course, to conduct the risk evaluation. The best way is to include relevant people from your organization and get the most relevant information and data needed for the evaluation. I use and recommend using a simple approach like the one embodied in the following matrix:
For opportunities think advantage instead of severity.
Once you identify unacceptable risk, you need to create the plan for mitigation of those risks. This can be done in same way you performed the preventive actions.
And, at the end, you need to do a follow up to determine whether the actions for risk mitigation were effective and if the risk assessment methodology or scope should be altered. If there is need for further action, you need to initiate corrective actions.
Consider the non-conformities, complaints, devolutions, lost customers as signs, as warnings about the quality to update of the risk assessment or of the risk evaluation. Are they signaling that changes must be made?
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