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  • Annex 12-4

    Great explaination. Thank you

  • Environmental sustainability in the transport sector

    One of the cornerstones of an Environmental Management system is to determine its environmental aspects. Then, it is important to identify the activities with a better environmental return, those relevant for the environment but also with a payback that can motivate top management to invest in environmental sustainability.

    You can find more information in the following links:

  • Clause 4 vs Clause 9

    1. How can we be sure we have identified all the internal and external issues?

    Answer:

    ISO 9001:2015 does not use the word “identify” but the word “determine” and that makes a difference. “Determine” means that it is the organization that decides what is an issue. The purpose is not to make the longest list of issues but the most relevant list of issues. The purpose is not to keep a list of issues but to look for risks and opportunities.

    For example, this week, working with a client they considered:

    • negative internal issue - Low negotiation capacity
    • negative external issues - (Economic crisis x Increased competition in the sector x Falling public / private investment)

    I ask them to see if they could match any risk from mixing those issues. They said what was clear:

    – More competition, tighter margins

    - Is that relevant for any interest party?

    - Yes, it is for the shareholders - they answered.

    - What can the company do about it?

    And they pick a positive internal issue – Experience of working abroad

    Decision – invest much more in commercial contacts in order to win projects abroad

    Arriving at sound decisions to grab opportunities or minimize risks is what is important.

    2.How can we be sure we are monitoring and measuring them effectively?

    Answer:

    This is not about monitoring and measuring (clause 9.1) this is still about clause 4 and perhaps clause 9.3. “monitor and review information” this is more about keeping a radar checking for relevant issues and being able to make decisions about them. Organizations are effective when they avoid or minimize risks and when they are able to grab opportunities. That can be done during management review, for example. An evaluation on the ability to:

    • determine relevant issues
    • evaluate them
    • decide upon them (minimize or avoid risks, take advantage of opportunities)

    You can find more information in the following links:

  • Determining product safety characteristics

    Product safety characteristics affect product design and/or production process design.

    The issue of product safety is related to special characteristics and product safety characteristics are very important for the design and production of products. These important requirements are determined during the product and production design process. For example, material hardness and tensile stress are very important safety characteristics for the durability of brake parts. These characteristics come from product design specifications, product drawing, and design FMEA.

    In addition, the hardness of the material is also affected by the heat treatment conditions in production, production parameters such as temperature and time. Thus, production parameters such as temperature and time of heat treatment are the subject of product safety and they are also special characteristics related to safety for brake parts. Another example is the tightening torque amount for seat manufacturing and seat assembly process. Screw tightening torque is also safety characteristics and can be affected by the wrong set up of production or not calibration of torque meter, both of the causes may come from the production process.

    Critical characteristics of the product and production process; it is defined by legal regulations, security, and significant important critical characteristics.  All these characteristics have different symbols according to customer-specific requirements as (R/S, CC, SC)

    All these characteristics, come from legal regulations, product drawings, product specifications, and production parameters that affect the health of production operators and the durability of the product. 

    According to the IATF 16949 standard, Product Safety is relating to the design and manufacturing of products to ensure they do not represent harm or hazard to customers. As you know customers are regulations, end-users (driver and passenger), OEM plants, the other manufacturing plants, and production operators.  The customer should not be at risk of affecting the safety of the product. These special characteristics related to product safety is determined by regulation, product drawing, and which have to be monitored and controlled at the production point affecting the safety of the product.

    All these requirements must be transferred via product drawing, material specification, DFMEA, PFMEA, Control Plan, etc to the entire supply chain, and the entire supply chain must comply with the product and production-specific characteristics for product safety.

    For more information, please read the following article:

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